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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 1
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture
Reference Code: GDME1169IDB
Publication Date: November 2012
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 2
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 24
1.2 List of Figures 30
2 Introduction 33
2.1 What is This Report About? 33
3 In Vitro Diagnostics In United States 34
3.1 In Vitro Diagnostics, Market Segmentation 34
3.2 In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 35
3.3 In Vitro Diagnostics Market, United States, Revenue Mix ($m), 2011 37
3.4 In Vitro Diagnostics Market, United States, Category Contribution (%), 2011 38
3.5 In Vitro Diagnostics, United States, Company Share (2010-2011) 45
4 Clinical Chemistry In United States 47
4.1 Clinical Chemistry, Market Segmentation 47
4.2 Clinical Chemistry Market, United States, Revenue Mix ($m), 2011 48
4.3 Clinical Chemistry Market, United States, Segment Contribution (%), 2011 49
4.4 Clinical Chemistry Overall Revenue, (2004-2018) 50
4.4.1 Clinical Chemisty Analyzers, Revenue (2004-2018) 54
4.4.2 Urine Analysis, Revenue (2004-2018) 58
4.5 Clinical Chemistry Distribution Share (2010-2011) 62
4.6 Clinical Chemistry, United States, Company Share (2010-2011) 63
5 Genetic Testing In United States 64
5.1 Genetic Testing, Market Segmentation 64
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 3
5.2 Genetic Testing Market, United States, Revenue Mix ($m), 2011 65
5.3 Genetic Testing Market, United States, Segment Contribution (%), 2011 66
5.4 Genetic Testing Overall Revenue, (2004-2018) 67
5.5 Genetic Testing Distribution Share (2010-2011) 71
5.6 Genetic Testing, United States, Company Share (2010-2011) 72
6 Haematology In United States 74
6.1 Haematology Market, Market Segmentation 74
6.2 Haematology Market, United States, Revenue Mix ($m), 2011 75
6.3 Haematology Market, United States, Segment Contribution (%), 2011 76
6.4 Haematology Overall Revenue, (2004-2018) 77
6.4.1 Haematology Reagents, Revenue, (2004-2018) 81
6.4.2 Immunohaematology, Revenue (2004-2018) 85
6.4.3 Haemostasis, Revenue (2004-2018) 89
6.4.4 Haematology Rapid Tests, Revenue (2004-2018) 93
6.4.5 Haematology Cell Counters, Revenue (2004-2018) 97
6.5 Haematology Distribution Share (2010-2011) 101
6.6 Haematology, United States, Company Share (2010-2011) 102
7 Histology And Cytology In United States 104
7.1 Histology and Cytology Market, Market Segmentation 104
7.2 Histology And Cytology Market, United States, Revenue Mix ($m), 2011 105
7.3 Histology And Cytology Market, United States, Segment Contribution (%), 2011 106
7.4 Histology And Cytology Overall Revenue, (2004-2018) 107
7.5 Histology And Cytology Distribution Share (2010-2011) 111
7.6 Histology And Cytology, United States, Company Share (2010-2011) 112
8 Immuno Chemistry In United States 114
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 4
8.1 Infectious Immunology, Market Segmentation 114
8.2 Immuno Chemistry Market, United States, Revenue Mix ($m), 2011 115
8.3 Immuno Chemistry Market, United States, Segment Contribution (%), 2011 116
8.4 Immuno Chemistry Overall Revenue, (2004-2018) 117
8.4.1 Disease Specific Immunochemistry, Revenue (2004-2018) 121
8.4.2 Drugs of Abuse / Toxicology, Revenue (2004-2018) 125
8.4.3 Endocrinology Tests, Revenue (2004-2018) 129
8.4.4 Immunochemistry Rapid Tests, Revenue (2004-2018) 133
8.4.5 Therapeutic Drug Monitoring, Revenue (2004-2018) 137
8.4.6 Immunochemistry Analyzers, Revenue (2004-2018) 141
8.5 Immuno Chemistry Distribution Share (2010-2011) 145
8.6 Immuno Chemistry, United States, Company Share (2010-2011) 146
9 Infectious Immunology In United States 148
9.1 Infectious Immunology Market, United States, Revenue Mix ($m), 2011 148
9.2 Infectious Immunology Market, United States, Segment Contribution (%), 2011 149
9.3 Infectious Immunology Overall Revenue, (2004-2018) 150
9.3.1 Infectious Immunology Rapid Tests, Revenue (2004-2018) 154
9.4 Infectious Immunology Distribution Share (2010-2011) 158
9.5 Infectious Immunology, United States, Company Share (2010-2011) 159
10 Microbiology Culture In United States 161
10.1 Microbiology Culture, Market Segmentation 161
10.2 Microbiology Culture Market, United States, Revenue Mix ($m), 2011 162
10.3 Microbiology Culture Market, United States, Segment Contribution (%), 2011 163
10.4 Microbiology Culture Overall Revenue, (2004-2018) 164
10.4.1 Microbiology Analyzers, Revenue (2004-2018) 168
10.5 Microbiology Culture Distribution Share (2010-2011) 172
10.6 Microbiology Culture, United States, Company Share (2010-2011) 173
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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11 Overview of Key Companies in United States In Vitro Diagnostics Market 175
11.1 Siemens Healthcare 175
11.1.1 Company Overview 175
11.1.2 Share in the United States In Vitro Diagnostics Market 175
11.2 Abbott Laboratories 176
11.2.1 Company Overview 176
11.2.2 Share in the United States In Vitro Diagnostics Market 176
11.3 F. Hoffmann-La Roche Ltd. 177
11.3.1 Company Overview 177
11.3.2 Share in the United States In Vitro Diagnostics Market 177
11.4 Beckman Coulter, Inc. 178
11.4.1 Company Overview 178
11.4.2 Share the United States In Vitro Diagnostics Market 178
11.5 Ortho-Clinical Diagnostics Inc. 179
11.5.1 Company Overview 179
11.5.2 Share the United States In Vitro Diagnostics Market 179
11.6 Alere Inc. 180
11.6.1 Company Overview 180
11.6.2 Share in the United States In Vitro Diagnostics Market 180
11.7 Danaher Corporation 181
11.7.1 Company Overview 181
11.8 bioMerieux S.A. 181
11.8.1 Company Overview 181
11.9 Becton, Dickinson and Company 182
11.9.1 Company Overview 182
11.10 Bio-Rad Laboratories, Inc. 182
11.10.1 Company Overview 182
11.11 Sysmex Corporation 183
11.11.1 Company Overview 183
11.12 Qiagen N.V. 183
11.12.1 Company Overview 183
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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 6
11.13 Gen-Probe Incorporated 184
11.13.1 Company Overview 184
11.14 DiaSorin S.p.A 184
11.14.1 Company Overview 184
11.15 Immucor, Inc. 185
11.15.1 Company Overview 185
11.16 Cepheid 185
11.16.1 Company Overview 185
11.17 Thermo Fisher Scientific Inc. 186
11.17.1 Company Overview 186
11.18 Hologic, Inc. 186
11.18.1 Company Overview 186
11.19 PerkinElmer, Inc. 187
11.19.1 Company Overview 187
11.20 Grifols, S.A. 187
11.20.1 Company Overview 187
11.21 Olympus Corporation 188
11.21.1 Company Overview 188
11.22 Horiba, Ltd. 188
11.22.1 Company Overview 188
11.23 Life Technologies Corporation 189
11.23.1 Company Overview 189
11.24 Diagnostica Stago, Inc. 189
11.24.1 Company Overview 189
11.25 ELITech Group 190
11.25.1 Company Overview 190
11.26 OraSure Technologies, Inc. 190
11.26.1 Company Overview 190
12 In Vitro Diagnostics Market Pipeline Products 191
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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12.1 Clinical Chemisty Market Pipeline Products 191
12.2 Immuno Chemistry Market Pipeline Products 198
12.3 Haematology Market Pipeline Products 209
12.4 Infectious Immunology Market Pipeline Products 211
12.5 Microbiology Culture Market Pipeline Products 218
12.6 Histology And Cytology Market Pipeline Products 219
12.7 Genetic Testing Market Pipeline Products 220
13 Financial Deals Landscape 225
13.1 Acquisition 225
13.1.1 ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For
$6.5 Million 225
13.1.2 Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature
Detector Company For $18.8 Million 227
13.1.3 Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider 228
13.1.4 AccelPath Acquires DigiPath Solutions For $2.4 Million 229
13.1.5 Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For
$324 Million 230
13.1.6 Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17
Million 232
13.1.7 Leica Biosystems Completes Acquisition Of Aperio Technologies 233
13.1.8 Metabolon Acquires Lipomics Technologies, Diagnostics Company 235
13.1.9 Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million 237
13.1.10 Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company 238
13.1.11 Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics
Company, For $925 Million 239
13.1.12 Life Technologies Acquires Navigenics 241
13.1.13 Genova Diagnostics Acquires Metametrix, Clinical Laboratory 243
13.1.14 Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million 244
13.1.15 Systagenix Acquires O2 Insights 246
13.1.16 LabCorp Completes Acquisition Of Medtox Scientific For $241 Million 247
13.1.17 Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And
Histology Services 249
13.1.18 Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments 250
13.1.19 Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions 251
13.1.20 Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion 252
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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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13.1.21 Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27
Million 254
13.1.22 IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE
Healthcare Bio-Sciences 255
13.2 Partnerships 256
13.2.1 DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple
Sclerosis 256
13.2.2 GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai
School of Medicine 257
13.2.3 Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery 259
13.2.4 CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests 260
13.2.5 Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer
Markers 261
13.2.6 Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry
System 262
13.2.7 Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For
Archimedes Particle Metrology System 263
13.2.8 Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical
Sample Concentrator Kit 264
13.2.9 Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ 265
13.2.10 Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis
Biomarkers 266
13.2.11 BioDot Enters Into Co-Marketing Agreement With JOT Automation 267
13.2.12 Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology 268
13.2.13 LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus
Technologies Partner To Form Broncus Medical 269
13.2.14 Van Andel Institute Enters Into Co-Development Agreement With Emory University 270
13.2.15 Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo
Viability Assessment Test 271
13.2.16 PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing 272
13.2.17 Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit
273
13.2.18 Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik 274
13.2.19 Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays 275
13.2.20 Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology 276
13.2.21 BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays
277
13.2.22 RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA
Technologies For Digital PCR 278
13.2.23 Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For
LymPro Blood Test 279
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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
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13.2.24 Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University
School For Molecular Diagnostic Tests 280
13.2.25 Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview
mets2 Assays 281
13.2.26 Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test
282
13.2.27 Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx 283
13.2.28 Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic
Discovery 284
13.2.29 Vela Diagnostics Enters Into Licensing Agreement With Life Technologies 285
13.2.30 Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n
Biomarker 286
13.2.31 CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital
Microscopy Hematology Solutions 287
13.2.32 Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For
Diagnostic Solutions 288
13.2.33 Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx
Test 290
13.2.34 Genia Technologies Enters Into Co-Development Agreement With Columbia University And
Harvard University 292
13.2.35 NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For
Myeloma Biomarkers 294
13.2.36 Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology 295
13.2.37 Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System
296
13.2.38 Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection
Platform 297
13.2.39 CML HealthCare Enters Into Agreement With MaRS Innovation 298
13.2.40 Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion
Diagnostics Development 299
13.2.41 Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery 300
13.2.42 Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics 301
13.2.43 Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For
Mesothelioma Test 302
13.2.44 Illumina Enters Into Technology Integration Agreement With Partners HealthCare System 303
13.2.45 Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array
Products 304
13.2.46 ImaginAb Enters Into Co-Development Agreement With MacroGenics 305
13.2.47 BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology 306
13.2.48 GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM
Database 307
13.2.49 GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina 308
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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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13.2.50 Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital 309
13.2.51 Affymetrix Enters Into Co-Development Agreement With Pathgen Dx 310
13.2.52 Axela Enters Into Co-Marketing Agreement With OvaGene Oncology 311
13.2.53 University of Michigan Enters Into Joint Venture Agreement With International Genomics
Consortium 312
13.2.54 Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers 313
13.2.55 Curetis Enters Into Licensing Agreement With Cempra For Unyvero 314
13.2.56 Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology 315
13.2.57 Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb 316
13.2.58 Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test
317
13.2.59 Waters Enters Into Co-Development Agreement With Nonlinear Dynamics 318
13.2.60 Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA
Technology 319
13.2.61 Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of
Wisconsin For 99mTc-HYNIC-Duramycin 320
13.2.62 Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For
miRview mets2 Assays 321
13.2.63 Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker
Kits 322
13.2.64 Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies 323
13.2.65 OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for
Prevention of Organ Failure 324
13.2.66 Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex 325
13.2.67 IRIS International Enters Into Distribution Agreement With Alifax 326
13.2.68 EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center 327
13.2.69 SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor
328
13.2.70 Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma 329
13.2.71 RS Medical Enters Into Distribution Agreement With Harvest Technologies 330
13.2.72 Immuno-Biological Labs Enters Into Licensing Agreement With IBL International 331
13.2.73 Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical
Diagnostic Tool 332
13.2.74 HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer
Marker Patent Portfolio 333
13.2.75 Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical
Research 334
13.2.76 WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies 335
13.2.77 BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell
Analysis Technology 336
13.2.78 MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test 337
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United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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13.2.79 Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School
of Medicine 338
13.2.80 Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of
America 339
13.2.81 Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer
Diagnostic Test 340
13.2.82 PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech 341
13.2.83 PrimeraDx Enters Into Co-Development Agreement With Eli Lilly 342
13.2.84 Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For
DNA-FISH Assays 343
13.2.85 Stratos Enters Into Co- Development Agreement With nanoMR 344
13.2.86 Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta
345
13.2.87 Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute 346
14 Recent Developments 347
14.1 Strategy And Business Planning 347
14.1.1 Nov 13, 2012: BG Medicine Provides Business Update 347
14.1.2 Nov 13, 2012: Great Basin Opens New, Expanded Manufacturing Facility In Salt Lake City 348
14.1.3 Nov 07, 2012: Namsa Expands Laboratory In Lyon, France 349
14.1.4 Nov 05, 2012: Flambeau Medical Markets Group Expands New Facility 349
14.1.5 Oct 16, 2012: Alliance HealthCare Services Announces Oncology Therapy Facilities Expansion
349
14.1.6 Oct 11, 2012: Quest Diagnostics To Cut 400-600 Management Jobs; Creates Two New Business
Structures 350
14.1.7 Oct 08, 2012: DSM Pharma And Almac Sign Collaboration Agreement In Biocatalysis 351
14.1.8 Oct 02, 2012: AIBioTech Expands Bioorganic Chemistry Platform 352
14.1.9 Sep 28, 2012: Sigma-Aldrich Invests In Scotland 352
14.1.10 Sep 19, 2012: Fidelis Diagnostics Opens New Office In Denver, Colorado 352
14.1.11 Sep 18, 2012: Hycor Opens European Center Of Operations In Germany To Support European
Distributors And Customers 353
14.1.12 Sep 17, 2012: Pathway Genomics And MD Revolution Partner To Incorporate Genomic And
Mobile Health Technologies Into Chronic Disease Management And Prevention 353
14.1.13 Sep 17, 2012: Boehringer Ingelheim To ShutDown One API Plant In Petersburg, Virginia 354
14.1.14 Sep 10, 2012: Icon Expands US And UK Bioanalytical Laboratories 354
14.1.15 Sep 07, 2012: Charles River Opens New Biomedical Diagnostic Facility In Wilmington,
Massachusetts 355
14.1.16 Aug 29, 2012: Bio-Rad Opens Digital Biology Center To Develop Products For R&D Markets
Based On Its Droplet Digital Technology 355
14.1.17 Aug 14, 2012: Morphotek Opens New Manufacturing Plant In Exton, US 355
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14.1.18 Aug 13, 2012: Elan Announces Plan To Spin-Off Discovery Science And Neotope Biosciences
To Shareholders 356
14.1.19 Aug 01, 2012: Baxter Breaks Ground On $1 Billion Manufacturing Plant In Georgia, US 357
14.1.20 Jul 24, 2012: Life Technologies And SATuRN Collaborate To Increase Access To HIV Testing
In Africa 358
14.1.21 Jul 20, 2012: Seegene To Make Partnership Push With New Multiplex Real-Time PCR Tech358
14.1.22 Jun 26, 2012: Roche To Shut New Jersey Site, Eliminate 1,000 Jobs 359
14.1.23 Jun 21, 2012: Gentris Partners With Shanghai Institutes of Preventative Medicine 360
14.1.24 Jun 07, 2012: PerkinElmer To Create New Personalized Health Innovation Center of
Excellence In Massachusetts, US 361
14.1.25 Jun 05, 2012: Roche Diagnostics Enters Strategic Alliance With med fusion That Recognizes
As Roche MCOE 362
14.1.26 May 31, 2012: N-of-One Signs Agreement With Foundation Medicine To Provide First Patient-
Specific Genomic Diagnostic Solution For Precision Oncology 362
14.1.27 May 23, 2012: Cold Spring Harbor Laboratory Joins Illumina Genome Network 363
14.1.28 May 22, 2012: New York Genome Center Announces Formal Commencement Of Collaborative
Relationship With Illumina 363
14.1.29 May 14, 2012: KineMed And CHDI Foundation Collaborate To Develop New Biomarkers Of
Disease Progression And To Evaluate Potential Therapeutics For Huntington’s Disease 364
14.1.30 May 07, 2012: Werfen Decides To End Beckman Coulter Hemostasis Alliance 365
14.1.31 Apr 24, 2012: Reaction Biology Opens New Protein Production Facility In US 365
14.1.32 Apr 23, 2012: Life Technologies To Build Additional $20m Cell Culture Facility In Scotland 365
14.1.33 Apr 02, 2012: CaridianBCT And Terumo Transfusion Become Terumo BCT 366
14.1.34 Mar 19, 2012: OPKO Health Expands Collaboration With Arctic Partners 366
14.1.35 Mar 12, 2012: Nelson Labs Acquires Building To Accommodate Growth 367
14.1.36 Mar 12, 2012: SAW Instruments Expands Presence In US 367
14.1.37 Mar 06, 2012: Lab21 And ITOR Launch Clinical Genomics Center In US 368
14.1.38 Mar 06, 2012: Almac Adds New Commercial Packaging Facility In Audubon, Pennsylvania 368
14.1.39 Mar 02, 2012: Rubicon Genomics Selects Velesco To Manufacture TransPLEX RNA
Amplification Kits For Clinical Diagnostic Use 369
14.1.40 Mar 01, 2012: Abbott To Build Nutrition Manufacturing Facility In Ohio 369
14.2 Research And Development 370
14.2.1 Nov 07, 2012: MJFF And NINDS Collaborate On Parkinson's Disease Biomarker Discovery
Project 370
14.2.2 Sep 19, 2012: Ten Pharmaceutical Companies Unite To Accelerate Development Of New
Medicines 371
14.2.3 Aug 15, 2012: Biogen Idec And Regulus Therapeutics Form Collaboration To Explore microRNA
Biomarkers For Disease Monitoring And Response To Therapy 372
14.2.4 Aug 15, 2012: Epic Sciences Announces Six Pharma Circulating Tumor Cell Collaborations 372
14.2.5 Apr 23, 2012: Ezose And Hirosaki University To Collaborate In Glycomics Research To Find New
Cancer Biomarkers 373
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Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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14.2.6 Apr 02, 2012: Metabolon Enters Biomarker Research Collaboration With Metabolon 373
14.2.7 Mar 20, 2012: Transgenomic And MD Anderson Collaborate On Circulating Tumor Cell Study
Using ICE COLD-PCR 374
14.2.8 Mar 14, 2012: GE Healthcare And Intel To Establish Companies’ First Joint Technology
Evaluation Laboratory In Israel 374
14.2.9 Mar 08, 2012: Covidien Opens Four Global R&D Centers To Broaden Innovation Focus And
Capabilities 375
14.2.10 Jan 12, 2012: Alere Maintains Exclusive Option To License Miraculins 375
14.2.11 Jan 09, 2012: Bayer HealthCare To Share Lab Space With Start-Up Companies 376
14.3 Legal and Regulatory 376
14.3.1 Nov 09, 2012: Novartis’s Colorado Facility Obtains Clearance From FDA Inspectors 376
14.3.2 Nov 07, 2012: Fluidigm Files Lawsuit Against NanoString For False And Misleading Advertising
Under Lanham Act 377
14.3.3 Nov 02, 2012: Enzo Awarded $49m In Trial Against Applera 377
14.3.4 Oct 22, 2012: Alere Receives FDA Warning Letter Over Weak Response To Manufacturing
Errors 377
14.3.5 Oct 18, 2012: Complete Genomics Announces Court's Favorable Ruling In Patent Litigation
Against Illumina 378
14.3.6 Oct 15, 2012: Genetic Technologies Files Patent Infringement Suits Against Multiple Alleged
Infringers In US 378
14.3.7 Oct 15, 2012: AspenBio Pharma Proposes Corporate Name Change To Venaxis 379
14.3.8 Oct 15, 2012: Fluxion Registers South San Francisco Facility As Medical Device Establishment
With FDA 379
14.3.9 Oct 11, 2012: CorMedix Announces Successful Completion Of ISO 13485 Certification Audit 379
14.3.10 Oct 04, 2012: Hologic Announces Favorable Ruling In Litigation With Becton, Dickinson 380
14.3.11 Sep 26, 2012: Abaxis Announces Settlement Of Patent Litigation With Cepheid 380
14.3.12 Sep 18, 2012: AspenBio Announces Dismissal Of Class Action And Chipman Lawsuits By US
District Court 381
14.3.13 Sep 13, 2012: Promega Announces Federal Judge Overturns Jury Verdict In Patent Rights
Case 381
14.3.14 Sep 05, 2012: RayBiotech Establishes Formal Compliance In Both Good Manufacturing And
Good Laboratory Practices 382
14.3.15 Aug 30, 2012: Genetic Technologies Files Patent Infringement Suit Against Reproductive
Genetics Institute In US 382
14.3.16 Aug 29, 2012: Illumina Announces Favorable Outcome Of Patent Litigation Against Helicos
BioSciences 383
14.3.17 Aug 23, 2012: United Drug Files Motion To Dismiss Legal Action By Catalent Pharma 383
14.3.18 Aug 20, 2012: Agendia Receives ISO Certification For Facilities In Amsterdam And Irvine 383
14.3.19 Aug 16, 2012: US Court of Appeals Upholds Myriad's Gene Patents 384
14.3.20 Aug 10, 2012: EKF Announces Settlement Agreement With HemoCue 384
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14.3.21 Aug 03, 2012: Meso Scale Diagnostics Announces ISO 9001:2008 And ISO 13485:2003
Certifications 385
14.3.22 Aug 01, 2012: MDxHealth CLIA Laboratory In California Receives CAP Accreditation 385
14.3.23 Jul 30, 2012: HTG Molecular Diagnostics Achieves ISO 13485:2003 Certification 385
14.3.24 Jul 24, 2012: PerkinElmer Receives State of Connecticut Clinical Laboratory Licensure And
CLIA Certificate Of Registration For Global DNA Sequencing Services 386
14.3.25 Jul 11, 2012: FDA Issues Class I Recall On Alere Triage Diagnostic Tests 386
14.3.26 Jul 09, 2012: Siemens Receives FDA Warning Letter For Violations Of CGMP Requirements
387
14.3.27 Jul 06, 2012: Sequenom Addresses Preliminary Injunction Decision, Reaffirms Defense Of
Patent 387
14.3.28 Jun 28, 2012: Nodality Receives CLIA Certification For Clinical Laboratory 388
14.3.29 Jun 27, 2012: Excelsior Medical Retracts False Statements, Settles Case With Ivera Medical
388
14.3.30 Jun 18, 2012: Illumina Files Second Patent Infringement Suit Against Complete Genomics 389
14.3.31 Jun 12, 2012: Progenika Receives CAP Certification For Its CLIA Labs 389
14.3.32 May 18, 2012: Champions Oncology Receives CLIA Certification 389
14.3.33 May 14, 2012: Helicos Settles Its Patent Litigation Against Pacific Biosciences 390
14.3.34 May 14, 2012: Helicos Settles Patent Litigation Against Pacific Biosciences 390
14.3.35 May 10, 2012: Metabolon’s Shanghai Jiao Tong University Lab Receives Validation 390
14.3.36 Apr 30, 2012: Vermillion Resolves Non-Contingent Claims With Bio-Rad 391
14.3.37 Apr 24, 2012: FDA Notifies Class I Recall Of Roche’s Elecsys Troponin I and Elecsys Troponin
I STAT Immunoassays 391
14.3.38 Apr 23, 2012: Essential Medical Dismisses Patent Case Against Masimo And Cercacor 391
14.3.39 Mar 26, 2012: Supreme Court of the United States Remands Gene Patenting Case 391
14.3.40 Mar 15, 2012: Seahorse Bioscience’s Labware Division Achieves ISO 9001:2008 Certification
393
14.3.41 Mar 13, 2012: Roche Receives Request For Additional Information From FTC 393
14.3.42 Mar 05, 2012: Atossa Genetics' National Reference Laboratory For Breast Health Receives
CLIA Certification 393
14.3.43 Mar 01, 2012: Illumina Announces Outcome Of First Phase Of Its Patent Litigation Against
LadaTech 394
14.3.44 Mar 01, 2012: Berg Diagnostics Receives CLIA Certification And Launches New Vitamin D
Assay 394
14.3.45 Mar 01, 2012: LadaTech Announces Illumina Found To Infringe Patent 395
14.3.46 Feb 22, 2012: Sequenom Files Motion For Preliminary Injunction Against Aria Diagnostics 395
14.3.47 Feb 21, 2012: Genetic Technologies Successfully Concludes Second Patent Infringement Suit
In US 396
14.3.48 Feb 16, 2012: Illumina Announces Favorable Patent Claim Construction Ruling In Litigation
Against Complete Genomics 396
14.3.49 Feb 03, 2012: London High Court Affirms 3M Legal Victory; Awards Company Litigation Fees
And Costs 396
SAMPLETable of Contents
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Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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14.3.50 Feb 01, 2012: Foundation Medicine Receives CLIA Certification For Its Genomic Sequencing
Laboratory 397
14.4 Government and Public Interest 398
14.4.1 Nov 02, 2012: CMS Issues Final Rule On Medicare’s Payments For Physician Fees For 2013 398
14.4.2 Nov 01, 2012: Researchers Use Blood Testing To Predict Level Of Enzymes That Facilitate
Disease Progression 398
14.4.3 Oct 16, 2012: New Noninvasive Test For Colorectal Cancer Shows Promise: AACR 399
14.4.4 Oct 15, 2012: VeriStrat Predicts Response But Not Survival Benefit From Erlotinib: Study 400
14.4.5 Aug 17, 2012: LabCorp Commends CDC For Revised HCV Testing Guidelines 401
14.4.6 Aug 16, 2012: CDC Now Recommends All Baby Boomers Receive One-Time Hepatitis C Test 401
14.4.7 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic
Wound Care 402
14.4.8 Jun 25, 2012: Loyola University Chicago Stritch School of Medicine Study Of Two Vitamin D
Tests Find Inaccurate 402
14.4.9 Jun 20, 2012: UW Research Shows New Prognosis Tool For Deadly Brain Cancer 403
14.4.10 Jun 19, 2012: Genetic Marker In Vitamin D Receptor Gene Associated With Increased
Pancreatic Cancer Survival 404
14.4.11 Jun 15, 2012: US Senator John Kerry Introduces Senate Resolution Urging Federal Support To
Improve Early Detection Of Prostate Cancer 405
14.4.12 Jun 05, 2012: Noninvasive Genetic Test For Down Syndrome And Edwards Syndrome Highly
Accurate: Study 405
14.4.13 Jun 05, 2012: Battelle Introduces Industry-First Drug Discovery CoLaborative 406
14.4.14 Jun 02, 2012: Researchers Discover DNA Marker That May Indicate Differences In Breast
Cancer 407
14.4.15 May 31, 2012: Researchers Identify Promising Biomarkers And New Therapeutic Targets For
Kidney Cancer: UC Davis 408
14.4.16 May 31, 2012: Nanotechnology Advancement Could Significantly Improve Medical Tests:
Princeton University 409
14.4.17 May 29, 2012: Researchers Discover Biomarker For Advanced Bile Duct Fibrosis And Bile Duct
Cancer: The George Washington University 410
14.4.18 May 24, 2012: New Prostate Cancer Screening Guidelines Face Tough Sell, Study Suggests
411
14.4.19 May 22, 2012: New Biomarkers Reveal Evidence Of Radiation Exposure: Medical College of
Wisconsin 412
14.4.20 May 22, 2012: Biomedical Engineers At UC Davis Develops Microfluidic Chip To Test For
Latent Tuberculosis 413
14.4.21 May 19, 2012: CDC Announces First Ever National Hepatitis Testing Day And Proposes That
All Baby Boomers Be Tested Once For Hepatitis C 414
14.4.22 May 17, 2012: Researchers From University of Florida Uses Traditional Microscope-Based
Diagnosis Method As Starting Point Against Tuberculosis 415
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14.4.23 May 17, 2012: NIH-Led Study Finds Genetic Test Results Do Not Trigger Increased Use Of
Health Services 416
14.4.24 May 15, 2012: New Biomarker Test Predicts Arthritis At Much Earlier Stage: University of
Missouri-Columbia 417
14.4.25 May 15, 2012: Early Biomarker For Pancreatic Cancer Identified: University of California, San
Diego 418
14.4.26 May 15, 2012: FDA Expands Use For FilmArray Respiratory Panel 419
14.4.27 May 14, 2012: Genetic Test Identifies Eye Cancer Tumors Likely To Spread: Washington
University School of Medicine 419
14.4.28 Apr 25, 2012: New Diagnostic Tool Determines Aggressiveness Of Prostate Cancer: UCF 421
14.4.29 Apr 24, 2012: New Microdevice Enables Culture Of Rare Circulating Tumor Cells From Blood
422
14.4.30 Apr 18, 2012: Researchers Develop New Optical Imaging System For Rapid And Accurate
Diagnosis Of Malaria 423
14.4.31 Apr 17, 2012: Saliva Test Could Dramatically Increase Detection Of Oral Cancer: MSU 424
14.4.32 Apr 17, 2012: Northwestern Medicine Scientist Develops First Blood Test To Diagnose Major
Depression In Teens 425
14.4.33 Apr 16, 2012: Biosensia To Showcase Latest Diagnostic Developments At AACC Oak Ridge
Conference 426
14.4.34 Apr 09, 2012: Researchers Identify Genes That May Help In Ovarian Cancer Diagnosis And
Prognosis 426
14.4.35 Apr 06, 2012: Invasive Heart Test Being Dramatically Overused, Stanford Study Shows 427
14.4.36 Apr 05, 2012: Cleveland HeartLab’s Cardiovascular Disease Risk Testing To Be Featured At
TEDMED 2012 429
14.4.37 Apr 04, 2012: Caris Life Presents Novel Findings Regarding Biological Role Of Circulating
Microvesicles 429
14.4.38 Mar 31, 2012: Biomarker Identified In Relation To Drug Response In Refractory Urothelial
Cancer 430
14.4.39 Mar 29, 2012: Complete Genomics Accepts DNA Obtained From Saliva For Whole Human
Genome Sequencing 430
14.4.40 Mar 27, 2012: Siemens Showcases Broad Portfolio Of Infectious Disease Testing Capabilities
At ECCMID 2012 431
14.4.41 Mar 20, 2012: Study Shows Colorectal Cancer Screening Rates High In Patients With Multiple
Health Problems 432
14.4.42 Mar 16, 2012: FDA Proposes Lower Risk Classification For Certain Tuberculosis Tests 433
14.4.43 Mar 16, 2012: Inflammatory Biomarkers Improve Clinical Prediction Of Mortality In COPD 433
14.4.44 Mar 15, 2012: New Professional Guidelines Recognize Benefit Of Genotyping HPV 16 And 18
For Cervical Cancer Prevention By Assessing Individual Patient Risk: Roche 434
14.4.45 Mar 15, 2012: QIAGEN Welcomes US Guideline Changes To Recommend HPV Testing As
Part Of Cervical Cancer Screening 435
14.4.46 Mar 14, 2012: Study Suggests Link Between Helicobacter pylori Bacteria And Adult Type 2
Diabetes 436
SAMPLETable of Contents
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14.4.47 Mar 14, 2012: Predictive Biosciences To Present At GTCbio Oncology Biomarkers Conference
437
14.4.48 Mar 05, 2012: Pall Life Sciences Showcases Innovative Syringe Filter At Pittcon Conference
437
14.4.49 Feb 29, 2012: Cleveland Clinic Children's Hospital Launches Study To Genetically Test For
Autism 438
14.4.50 Feb 27, 2012: New Research Study Could Lead To More Timely Diagnosis And Aid Clinical
Management During Flu Season 439
14.4.51 Feb 04, 2012: Henry Ford Hospital Researchers Identity Potential Biomarker For Osteoarthritis
440
14.4.52 Feb 02, 2012: Scripps Research Scientists Demonstrate Effective New 'Biopsy In A Blood Test'
To Detect Cancer 441
14.4.53 Feb 02, 2012: Study Shows An Investigational Urine Test Can Predict High-Risk Prostate
Cancer In Men Who Choose ‘Watchful Waiting’ 442
14.4.54 Feb 02, 2012: New Research Confirms Need For Lung Cancer Testing: UCCC 443
14.4.55 Feb 01, 2012: Blood Test Accurately Distinguishes Depressed Patients From Healthy Controls:
MGH 444
14.5 Product News 445
14.5.1 Nov 13, 2012: Nanosphere Receives FDA Clearance To Market Test For Detection Of CYP2C19
Mutations Affecting Drug Metabolism 445
14.5.2 Nov 12, 2012: CardioDx To Present Corus CAD At Lazard Capital Markets And Piper Jaffray
Investor Conferences 446
14.5.3 Nov 09, 2012: Natera’s Non-Invasive Prenatal Testing Technology Shows Unparalleled
Specificity, Sensitivity In Clinical Data Presented At American Society of Human Genetics 446
14.5.4 Nov 08, 2012: Cytomedix Receives FDA 510(K) Clearance For Angel cPRP System For
Processing Blood And Bone Marrow Aspirate 447
14.5.5 Nov 08, 2012: CardioDx Announces New Data Supporting Clinical Utility And Validity Of Corus
CAD At American Heart Association Scientific Sessions 2012 448
14.5.6 Nov 08, 2012: Diazyme Receives FDA 510(k) Clearance For Cystatin C POC Test Kit On Smart
Point of Care System 449
14.5.7 Nov 07, 2012: Life Technologies Announces Next-Gen Digital PCR Instrument Designed For
Widespread Adoption 449
14.5.8 Nov 07, 2012: Caris Life Sciences Selects Illumina’s MiSeq System To Enable Next-Generation
Sequencing As Part Of Its Molecular Profiling Service 450
14.5.9 Nov 06, 2012: IntegenX Announces Commercial Introduction Of mRNA Library Preparation Kit
For Next Generation Sequencing 451
14.5.10 Nov 06, 2012: Affymetrix Introduces Axiom miRNA Target Site Genotyping Arrays 451
14.5.11 Nov 06, 2012: Verinata Health's verifi Prenatal Test Expanded To Include Most Common Sex
Chromosome Abnormalities 452
14.5.12 Nov 05, 2012: Atherotech’s VAP Lipid Panel Helps Predict Heart Attack Risk And Improved
Outcomes In African Americans 453
SAMPLETable of Contents
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14.5.13 Nov 05, 2012: Ariosa Diagnostics To Present Clinical Data On Harmony Prenatal Test At
ASHG Annual Meeting 453
14.5.14 Nov 01, 2012: Affymetrix Introduces Axiom Biobank Arrays For Genotyping Studies 454
14.5.15 Oct 29, 2012: CardioDx Announces Clinical And Scientific Presentations At American Heart
Association Scientific Sessions 2012 455
14.5.16 Oct 25, 2012: Verinata Health Files Patent Infringement Action Against Ariosa And LabCorp 456
14.5.17 Oct 24, 2012: Atherotech’s VAP Lipid Panel Is Highlighted In Scientific Presentations At 2012
American Heart Association Scientific Sessions 457
14.5.18 Oct 24, 2012: Verinata Health Announces Presentations Of Its Verifi Prenatal Test At National
Society Of Genetic Counselors Conference 457
14.5.19 Oct 23, 2012: Cytonics Receives Notice Of Allowance For Patent Related To FACT Diagnostic
For Back And Joint Pain 458
14.5.20 Oct 22, 2012: Prometheus Presents Five Abstracts Of Prometheus Anser IFX Assay At ACG
2012 Scientific Meeting 459
14.5.21 Oct 18, 2012: HTG Molecular To Unveil Edge System At AMP Conference 460
14.5.22 Oct 12, 2012: SQI Diagnostics To Launch SQiDlite Multiplexing System At AAPS 460
14.5.23 Oct 11, 2012: Akonni Biosystems To Present Results Of Its Work To Develop TruTip
Automated Solution For Extracting Cell-Free DNA From Maternal Plasma At ASHG Conference 461
14.5.24 Oct 11, 2012: BD Veritor System For Rapid Detection Of RSV Receives FDA 510(k) Clearance
For Nasopharyngeal Wash, Aspirate And Swab In Transport Media Specimens 461
14.5.25 Oct 10, 2012: Myriad's HRD Score Detects Loss Of DNA Repair Function In Ovarian Cancer
462
14.5.26 Oct 09, 2012: Focus Diagnostics And 3M Launch FDA-Cleared Simplexa Test On 3M Cycler
For Molecular Influenza And Respiratory Virus Testing By Moderate Complexity Healthcare Facilities 462
14.5.27 Oct 09, 2012: OraSure Announces Availability Of OraQuick In-Home HIV Test To Consumers
Across US 463
14.5.28 Oct 03, 2012: Roche Announces Availability Of Cobas TaqMan HIV-1 Test v2.0 In US 464
14.5.29 Oct 03, 2012: BD Diagnostics Receives 510(k) FDA Clearance For Nasopharyngeal Wash,
Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of RSV 464
14.5.30 Oct 01, 2012: Inform Genomics Announces Positive Top-Line Results In First Phase Of
Development For Onpart Personalized Medicine Product 465
14.5.31 Oct 01, 2012: IntegenX Announces Commercial Availability Of RapidHIT 200 System In US 466
14.5.32 Oct 01, 2012: Micronics Announces Commercial Launch Of ABORhCard 467
14.5.33 Sep 27, 2012: Life Technologies Receives FDA Clearance For OpTmizer CTS T-Cell
Expansion Tissue Culture Medium 467
14.5.34 Sep 26, 2012: PrimeraDx Receives National Cancer Institute Grant To Develop B-Cell
Lymphoma Panel On ICEPlex System 468
14.5.35 Sep 25, 2012: Gynecor Adds New Cervical Cancer LAB Technology To Help Physicians
Identify Patients At Risk For Cervical Cancer, Improve Treatment Decisions 469
14.5.36 Sep 25, 2012: Genetic Technologies Announces BREVAGen Attains Clearance For Sale Into
Florida 469
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14.5.37 Sep 25, 2012: NanoString Launches Single Cell Gene Expression Solution For nCounter
Analysis System 470
14.5.38 Sep 24, 2012: Study At Columbia University Using Daxor's Blood Volume Analyzer
Demonstrates Hidden Polycythemia In Heart Failure Patients 471
14.5.39 Sep 24, 2012: BD Diagnostics Receives FDA 510(k) Clearance For Nasopharyngeal Wash,
Aspirate And Swab In Transport Media Specimens On BD Veritor System For Rapid Detection Of Flu A +
B 471
14.5.40 Sep 24, 2012: Ariosa Diagnostics Announces Publication Of Clinical Study On Non-invasive
Prenatal Testing For Fetal Trisomy 13 With Harmony Prenatal Test 472
14.5.41 Sep 18, 2012: Fyodor Biotechnologies Receives Phase II SBIR Grant To Develop Broad Urine-
Based Diagnostic Test For Malaria 472
14.5.42 Sep 17, 2012: LipoScience Announces Publication Of Results From Clinical Study In American
Journal of Cardiology 473
14.5.43 Sep 17, 2012: Roche Announces Commercial Availability Of Cobas AmpliPrep/Cobas TaqMan
CMV Test In US 474
14.5.44 Sep 12, 2012: GenMark Diagnostics Receives FDA Clearance For eSensor RVP Test 474
14.5.45 Sep 11, 2012: Cytomedix To Highlight AutoloGel System In Multiple Poster Presentations At
SAWC Fall 2012 475
14.5.46 Sep 06, 2012: PTS Signs Agreement To Provide Point-of-Care Lipid Testing To Life Line
Screening 476
14.5.47 Sep 06, 2012: Polymer Technology Signs Agreement With Life Line Screening To Supply
CardioChek PA Test System 476
14.5.48 Sep 05, 2012: BioReliance To Launch Reconstructed Skin Micronucleus Assay 477
14.5.49 Sep 05, 2012: Cytomedix To Present AutoloGel System In Two Presentations At 4th Congress
Of WUWHS 2012 In Japan 477
14.5.50 Sep 05, 2012: Ariosa Diagnostics Reports Publication Of Clinical Utility Of Harmony Prenatal
Test In General Screening Population 478
14.5.51 Sep 05, 2012: LipoScience Receives FDA Clearance For Vantera Clinical Analyzer 479
14.5.52 Sep 04, 2012: Transgenomic And NYU Collaborate On Lung Cancer Study Using Ice Cold-
PCR For Blood-Based Mutation Detection 480
14.5.53 Aug 29, 2012: Siemens Unveils New Assay For Specific And Stable Free Protein S Antigen
Testing 481
14.5.54 Aug 16, 2012: AWDT Launches ACE Axcel Clinical Chemistry System 481
14.5.55 Aug 14, 2012: Beckman Coulter Announces Publication Of Positive Study Results In Journal of
The American College of Cardiology Distinguish PAPP-A From Other New Cardiovascular Biomarkers 482
14.5.56 Aug 14, 2012: CardioDx To Present Corus CAD At Wedbush PacGrow Life Sciences
Management Access Conference 483
14.5.57 Aug 14, 2012: California Schools VEBA Implements Pathway Fit Nutrigenetic Test For Weight-
Loss 483
14.5.58 Aug 10, 2012: Miraculins To Receive $0.13m Grant For PreVu From Province of Manitoba 484
14.5.59 Aug 09, 2012: Veridex Reports Updated Coding And Payment On Horizon For Circulating
Tumor Cell Testing 485
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14.5.60 Aug 08, 2012: CardioDx Announces Medicare Coverage For Corus CAD Gene Expression
Test For Diagnosis Of Obstructive Coronary Artery Disease 485
14.5.61 Aug 07, 2012: LabCorp Completes And Publishes Clinical Study For Development And
Validation Of PCR Assay For Bacterial Vaginosis 486
14.5.62 Aug 07, 2012: AspenBio Pharma Submits Pre-IDE Information Package To FDA For
AppyScore Appendicitis Test System 487
14.5.63 Aug 07, 2012: Aeterna Zentaris Granted US Patent For AEZS-130 As Diagnostic Test For
Adult Growth Hormone Deficiency 487
14.5.64 Aug 06, 2012: SWOG Selects Sequenta’s LymphoSIGHT Platform For Use In 180-Patient
Mantle Cell Lymphoma Clinical Trial 488
14.5.65 Aug 06, 2012: University of Michigan Informs Interleukin Genetics Of Study Results Using PST
Genetic Test In Determining Frequency Of Dental Cleanings 488
14.5.66 Aug 06, 2012: Cytomedix Announces Medicare Coverage For Autologous PRP Gel In Chronic
Wound Care 489
14.5.67 Aug 03, 2012: Daxor Announces Sale Of BVA-100 Blood Volume Analyzer To Hospital Located
In Arizona 490
14.5.68 Aug 02, 2012: Idaho Technology Provides FilmArray Clinical Diagnostic Pipeline Update 490
14.5.69 Aug 01, 2012: AspenBio Pharma Enhances Product Development And Manufacturing
Capabilities In Preparation For Clinical Trial And Commercialization Of AppyScore 491
14.5.70 Jul 31, 2012: CardioDx’s Corus CAD Gene Expression Test Performs Equally Well In Both
Women And Men for Assessment Of Obstructive Coronary Artery Disease: New Study 492
14.5.71 Jul 31, 2012: New York Genome Center Purchases Four Ion Proton Sequencers For Its New
Innovation Center 493
14.5.72 Jul 31, 2012: Prometheus Launches PROMETHEUS Anser IFX To Help Guide Inflammatory
Bowel Disease Management 494
14.5.73 Jul 30, 2012: MolecularMD Submits PMA Application To FDA For BCR-ABL T315I Mutation
Test 494
14.5.74 Jul 30, 2012: 23andMe Submits First Round Of FDA 510(k) Documentation To FDA 495
14.5.75 Jul 26, 2012: RainDance Technologies Launches First Access Program For RainDrop Digital
PCR System 496
14.5.76 Jul 25, 2012: Cepheid Announces Release Of Updated Xpert BCR-ABL Monitor Test 497
14.5.77 Jul 24, 2012: Genalyte Launches Maverick ENA 4 Assay Kit 497
14.5.78 Jul 24, 2012: Ariosa Diagnostics Completes Clinical Study Of Harmony Prenatal Test On
General Pregnant Patient Population 498
14.5.79 Jul 19, 2012: CBLPath Launches NRAS Gene Mutation Analysis Assay 499
14.5.80 Jul 19, 2012: T2 Biosystems Announces Data Presentation On T2Hemostasis At American
Association for Clinical Chemistry Annual Meeting 499
14.5.81 Jul 18, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At New York
Presbyterian/Weill Cornell Medical Center 500
14.5.82 Jul 17, 2012: Beckman Coulter’s New AU5800 System Featured At 2012 AACC/ASCLS Annual
Meeting And Clinical Lab Expo 500
SAMPLETable of Contents
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14.5.83 Jul 17, 2012: Idaho Technology Initiates Clinical Study For FilmArray Blood Culture
Identification Panel 501
14.5.84 Jul 17, 2012: BD Receives FDA 510(k) Clearance For BD BACTEC Plus Aerobic/F Blood
Culture Plastic Bottles 501
14.5.85 Jul 16, 2012: Roche Introduces Mobile Blood Gas Analyzer For Hospital Point Of Care 502
14.5.86 Jul 16, 2012: Metabolon To Showcase Quantose Test At AACC Clinical Lab Expo 502
14.5.87 Jul 12, 2012: Daxor Announces Placement Of BVA-100 Blood Volume Analyzer At North
Alabama Radiopharmacy 503
14.5.88 Jul 11, 2012: Idaho Technology To Present At 2012 AACC Annual Meeting 503
14.5.89 Jul 11, 2012: Courtagen Releases nucSEEKPDx 504
14.5.90 Jul 09, 2012: Genomic Health Releases Results Of Oncotype DX Breast Cancer Test 504
14.5.91 Jul 09, 2012: SurModics IVD To Launch BioFX TMBX At AACC In Los Angeles 505
14.5.92 Jul 06, 2012: QIAGEN Receives FDA Approval Of Therascreen KRAS RGQ PCR Kit For
Colorectal Cancer 505
14.5.93 Jul 06, 2012: Court Denies Preliminary Injunction Motion Against Ariosa Diagnostics 506
14.5.94 Jul 03, 2012: OraSure Receives FDA Clearance For Its OraQuick In-Home HIV Test 507
14.5.95 Jul 02, 2012: Roche Receives FDA Approval For COBAS TaqMan HIV-1 Test 507
14.5.96 Jul 02, 2012: Verinata Health Expands verifi Prenatal Test To Include Turner Syndrome Option
508
14.5.97 Jul 02, 2012: Seegene To Introduce Real-Time Multiple Mutation Detection Technology For
Drug Resistant Mutations In M. tuberculosis At AACC 2012 508
14.5.98 Jun 28, 2012: Abaxis Enters Into Definitive Agreement To Deliver 300 Piccolo Xpress
Instruments For Four-Year Drug Clinical Trial 509
14.5.99 Jun 28, 2012: IBM Recommends Strategy To Help Improve Cervical Cancer Screening And
Treatment In Kenya 510
14.5.100 Jun 27, 2012: OraSure Supports Rapid HIV Testing Initiatives In Recognition Of 18th Annual
National HIV Testing Day 511
14.5.101 Jun 26, 2012: BIT Companies And DRG Diagnostics To Unveil DRG:HYBRID XL Analyzer 511
14.5.102 Jun 23, 2012: BD Biosciences Launches BD FACSJazz Cell Sorting System 512
14.5.103 Jun 23, 2012: Quantimetrix Launches Complete D 25-OH Vitamin D Control 513
14.5.104 Jun 22, 2012: Accelr8 Presents Study Results For BAC-Xtrax At ASM 2012 513
14.5.105 Jun 22, 2012: Accelr8 Presents Study Results For BACcel Rapid Diagnostic System At ASM
2012 And Receives Acceptance To Present New Blood Study 513
14.5.106 Jun 21, 2012: Siemens Launches Enzygnost Anti-HCV 4.0 Assay 513
14.5.107 Jun 21, 2012: Daxor Announces Placement Of Three BVA-100 Blood Volume Analyzers 514
14.5.108 Jun 20, 2012: BioRealm Secures SBIR Contract To Develop Smokescreen For Tobacco
Addiction 514
14.5.109 Jun 11, 2012: Metabolon’s Quantose IR Test Featured In Five Poster Presentations At 2012
American Diabetes Association Meeting 515
14.5.110 Jun 08, 2012: Cytomedix To Present Multiple Poster Presentations On AutoloGel System At
44th Annual Conference Of WOCN 515
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14.5.111 Jun 07, 2012: QuantRx Biomedical Provides Corporate Update: Focused On Diagnostics And
Feminine Hygiene Segments 516
14.5.112 Jun 07, 2012: Chembio Files PMA Final Module With FDA For DPP HIV 1/2 Assay 517
14.5.113 Jun 05, 2012: Transgenomic Launches ICE COLD-PCR Kit At 2012 ASCO Annual Meeting 518
14.5.114 Jun 05, 2012: Prospective Study Shows Favorable Overall Survival In Cancer Of Unknown
Primary Patients With Therapy Directed By bioTheranostics' CancerTYPE ID 519
14.5.115 Jun 04, 2012: Quantimetrix Introduces Dropper A1c Diabetes Control 519
14.5.116 Jun 04, 2012: Ariosa Diagnostics Completes First Large Cohort Validation Study On Non-
invasive Prenatal Testing For Fetal Trisomy Detection Using Harmony Prenatal Test 520
14.5.117 Jun 01, 2012: NLA Abstracts Examine Clinical Utility Of Atherotech’s VAP Lipid Panel In Type
2 Diabetes Treatment, Heart Disease Risk Assessment 520
14.5.118 Jun 01, 2012: ScotlandsDNA Selects DNA Genotek’s Oragene•DNA Kit For Ancestry Testing
521
14.5.119 Jun 01, 2012: bioTheranostics’ CancerTYPE ID Shows High Accuracy In A Multi-Site Validation
Study And Improved Performance Compared With Standard Of Care In Metastatic Tumor Diagnosis 522
14.5.120 Jun 01, 2012: LipoScience Announces Study Results Of LDL Particle Levels Using NMR
LipoProfile Test 523
14.5.121 May 31, 2012: Pathwork Diagnostics To Present Three Studies At ASCO Annual Meeting 524
14.5.122 May 31, 2012: Illumina Introduces Nextera XT DNA Sample Preparation Kit 525
14.5.123 May 31, 2012: Verinata Health Announces Introduction Of verifi Prenatal Test 526
14.5.124 May 31, 2012: CardioDx To Present Corus CAD At Jefferies 2012 Global Healthcare
Conference 527
14.5.125 May 30, 2012: Response Genetics Announces Presentation Of Lung Cancer Study Results At
2012 ASCO Annual Meeting 527
14.5.126 May 30, 2012: Biocept To Present Clinical Findings On Circulating Tumor Cells At ASCO
Annual Meeting 528
14.5.127 May 29, 2012: Sequenom Reports Recently Released Publication On Sequenom Massarray
Research Use System 529
14.5.128 May 29, 2012: Corgenix Announces Issuance Of Additional US Patent For AspirinWorks (11-
dehydro Thromboxane B2) Test 530
14.5.129 May 29, 2012: Siemens Receives FDA Warning Letter Regarding AD VIA Centaur iPTH
Immunoassay 530
14.5.130 May 24, 2012: Cepheid Receives FDA Clearance For GeneXpert Infinity-80 System For Initial
Use With Xpert Flu Assay 530
14.5.131 May 24, 2012: True Diagnostics Receives CE Mark For TrueDX Platform And TSH Test 531
14.5.132 May 23, 2012: Lucigen Corporation Receives $2.8m SBIR Grant From NIH For Lucigen
Influenza A, B & RSV test 531
14.5.133 May 21, 2012: HistoRx Announces Application Of AQUA Technology To Assessment Of
Messenger RNA In Tissue 532
14.5.134 May 21, 2012: Transgenomic Announces CE IVD Mark For WAVE MCE System 533
14.5.135 May 18, 2012: OraSure Technologies Issues Statement On CDC Proposed Draft Guidelines
For Testing Of Baby Boomers For Hepatitis C 533
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14.5.136 May 18, 2012: Siemens Receives FDA Clearance For RAPIDPoint 500 System - Lactate Assay
534
14.5.137 May 18, 2012: Siemens Receives CE Mark Approval For RAPIDPoint 500 System - Pleural
Fluid pH Testing 534
14.5.138 May 18, 2012: Sequenom Announces Publication Of Clinical Study Results Using CMM's
MaterniT21 PLUS LDT 535
14.5.139 May 16, 2012: NanoString Initiates Second Clinical Validation Study For PAM50-Based Breast
Cancer Assay 536
14.5.140 May 15, 2012: OraSure’s OraQuick In-Home HIV Test Receives Unanimous Positive
Recommendation From FDA Advisory Committee 536
14.5.141 May 15, 2012: Idaho Technology Receives FDA 510(k) Clearance For Expanded FilmArray
Respiratory Panel 537
14.5.142 May 14, 2012: EMD Millipore's Muse Cell Analyzer Wins Red Dot Design Award 2012 538
14.5.143 May 09, 2012: Sequenom Signs Agreement With Coventry Health Care National Network For
CMM MaterniT21 PLUS LDT 538
14.5.144 May 07, 2012: CardioDx To Present Results From Two Studies Evaluating Clinical Utility Of
Corus CAD Gene Expression Test For Obstructive Coronary Artery Disease 539
14.5.145 May 07, 2012: Ariosa Diagnostics Announces Nationwide Launch Of Harmony Prenatal Test
Through LabCorp 539
14.5.146 May 02, 2012: Trovagene Announces Plans To Develop New Test For High Risk HPV Carrier
Screening From Urine 540
14.5.147 May 01, 2012: Singulex Adds Erenna Interleuken -17A/F To Suite Of TH17 Pathway
Immunoassay Kits 541
15 Appendix 542
15.1 Definitions of Markets Covered in the Report 543
15.1.1 In Vitro Diagnostics 543
15.2 Research Methodology 554
15.3 Secondary Research 554
15.4 Primary Research 555
15.5 Models 555
15.6 Forecasts 556
15.7 Expert Panels 556
15.8 GlobalData Consulting 556
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15.9 Disclaimer 556
1.1 List of Tables
Table 1: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 ..................................... 36
Table 2: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011 ....................................................... 38
Table 3: In Vitro Diagnostics Market, United States, Cross-Category Analysis, 2004-2018 ............................................... 40
Table 4: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ...................... 42
Table 5: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ................... 44
Table 6: In Vitro Diagnostics, United States, Company Share by Revenue ($m), USD Constant, 2010-2011................ 46
Table 7: Clinical Chemistry Market, United States, Segment Contribution (%), 2011 .......................................................... 49
Table 8: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ............... 51
Table 9: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............. 53
Table 10: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 55
Table 11: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018........................................................................................................................................................................................ 57
Table 12: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........... 59
Table 13: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ......... 61
Table 14: Clinical Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 62
Table 15: Clinical Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 63
Table 16: Genetic Testing Market, United States, Segment Contribution (%), 2011 ............................................................ 66
Table 17: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ................. 68
Table 18: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............... 70
Table 19: Genetic Testing, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ................. 71
Table 20: Genetic Testing, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 .................... 73
Table 21: Haematology Market, United States, Segment Contribution (%), 2011 ................................................................ 76
Table 22: Haematology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ...................... 78
Table 23: Haematology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ................... 80
Table 24: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 82
Table 25: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 84
Table 26: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-201186
Table 27: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........................................................................................................................................................................................................... 88
Table 28: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............. 90
Table 29: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........... 92
Table 30: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 94
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Table 31: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 96
Table 32: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 98
Table 33: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 100
Table 34: Haematology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ................... 101
Table 35: Haematology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ...................... 103
Table 36: Histology And Cytology Market, United States, Segment Contribution (%), 2011 ............................................ 106
Table 37: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011.. 108
Table 38: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 110
Table 39: Histology And Cytology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 . 111
Table 40: Histology And Cytology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 .... 113
Table 41: Immuno Chemistry Market, United States, Segment Contribution (%), 2011 .................................................... 116
Table 42: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ......... 118
Table 43: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ....... 120
Table 44: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 122
Table 45: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 124
Table 46: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................................ 126
Table 47: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 128
Table 48: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ......................................................................................................................................................................................................... 130
Table 49: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ......................................................................................................................................................................................................... 132
Table 50: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 134
Table 51: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 136
Table 52: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 138
Table 53: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 140
Table 54: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................................ 142
Table 55: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 144
Table 56: Immuno Chemistry, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ......... 145
Table 57: Immuno Chemistry, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ............ 147
Table 58: Infectious Immunology Market, United States, Segment Contribution (%), 2011 ............................................. 149
Table 59: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ... 151
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Table 60: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 . 153
Table 61: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 155
Table 62: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 157
Table 63: Infectious Immunology, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ... 158
Table 64: Infectious Immunology, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ...... 160
Table 65: Microbiology Culture Market, United States, Segment Contribution (%), 2011 ................................................. 163
Table 66: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011....... 165
Table 67: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .... 167
Table 68: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ......................................................................................................................................................................................................... 169
Table 69: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................................ 171
Table 70: Microbiology Culture, United States, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ...... 172
Table 71: Microbiology Culture, United States, Company Share by Revenue ($m), USD Constant, 2010-2011 ......... 174
Table 72: Clinical Chemisty Market Pipeline Products .............................................................................................................. 191
Table 73: Immuno Chemistry Market Pipeline Products ........................................................................................................... 198
Table 74: Haematology Market Pipeline Products ..................................................................................................................... 209
Table 75: Infectious Immunology Market Pipeline Products ..................................................................................................... 211
Table 76: Microbiology Culture Market Pipeline Products ........................................................................................................ 218
Table 77: Histology And Cytology Market Pipeline Products ................................................................................................... 219
Table 78: Genetic Testing Market Pipeline Products ................................................................................................................. 220
Table 79: ERBA Diagnostics Acquires Drew Scientific, Maker Of Analytical Instruments And Reagents, For $6.5 Million ............................................................................................................................................................................................. 225
Table 80: Measurement Specialties Acquires Cambridge Technologies And Resistance Temperature Detector Company For $18.8 Million ........................................................................................................................................................ 227
Table 81: Atossa Genetics Acquires Acueity Healthcare, Diagnostic Device Provider ...................................................... 228
Table 82: AccelPath Acquires DigiPath Solutions For $2.4 Million ........................................................................................ 229
Table 83: Danaher Completes Acquisition Of 91.6% Stake In Iris International, Diagnostic Test Maker, For $324 Million ............................................................................................................................................................................................. 230
Table 84: Charles River Labs Acquires Accugenix, Provider Of Microbe Identification Services, For $17 Million ....... 232
Table 85: Leica Biosystems Completes Acquisition Of Aperio Technologies ...................................................................... 233
Table 86: Metabolon Acquires Lipomics Technologies, Diagnostics Company .................................................................. 235
Table 87: Waters Acquires Blue Reference, Maker Of Application Scientific Databases, For $14 Million .................... 237
Table 88: Life Technologies Acquires Pinpoint Genomics, Molecular Diagnostics Company .......................................... 238
Table 89: Thermo Fisher Scientific Completes Acquisition Of One Lambda, Transplant Diagnostics Company, For $925 Million ................................................................................................................................................................................... 239
Table 90: Life Technologies Acquires Navigenics ..................................................................................................................... 241
Table 91: Genova Diagnostics Acquires Metametrix, Clinical Laboratory ............................................................................ 243
Table 92: Luminex To Acquire GenturaDx, Molecular Diagnostics Company, For $50 Million ........................................ 244
Table 93: Systagenix Acquires O2 Insights ................................................................................................................................ 246
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Table 94: LabCorp Completes Acquisition Of Medtox Scientific For $241 Million .............................................................. 247
Table 95: Flagship Biosciences Acquires Ihctech, Provider Of Research Immunohistochemistry And Histology Services ......................................................................................................................................................................................... 249
Table 96: Halo Healthcare Acquires NeoMatrix, Maker Of Diagnostic Equipments ........................................................... 250
Table 97: Qiagen Acquires AmniSure International, Manufacturer Of Non Invasive Test Solutions ............................... 251
Table 98: Hologic Completes Acquisition Of Gen-Probe For $3.7 Billion ............................................................................. 252
Table 99: Haemonetics To Acquire Hemerus Medical, Provider Of Leukoreduction Technologies, For $27 Million .... 254
Table 100: IntegenX Acquires SV, Provider Of DNA Identification Consumable Products, From GE Healthcare Bio-Sciences ........................................................................................................................................................................................ 255
Table 101: DioGenix Enters Into Agreement With Fast Forward To Develop New Blood Test For Multiple Sclerosis 256
Table 102: GNS Healthcare Enters Into Agreement With Dana-Farber Cancer Institute and Mount Sinai School of Medicine ......................................................................................................................................................................................... 257
Table 103: Crown Bioscience Enters Into Co-Development Agreement With Horizon Discovery ................................... 259
Table 104: CombiMatrix Enters Into Co-Marketing Agreement With Pathology For Prenatal Tests ............................... 260
Table 105: Clinical Genomics Enters Into Licensing Agreement With Quest Diagnostics For Colon Cancer Markers 261
Table 106: Abaxis Enters Into Distribution Agreement With Abbott Point of Care For Piccolo Blood Chemistry System ......................................................................................................................................................................................................... 262
Table 107: Malvern Instruments Enters Into Co-Marketing Agreement With Affinity Biosensors For Archimedes Particle Metrology System .......................................................................................................................................................... 263
Table 108: Exosome Diagnostics Enters Into Co-Development Agreement With Promega For Urine Clinical Sample Concentrator Kit ............................................................................................................................................................................ 264
Table 109: Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ ....................................... 265
Table 110: Ezose Enters Into Co-Development Agreement With Fast Forward For Multiple Sclerosis Biomarkers .... 266
Table 111: BioDot Enters Into Co-Marketing Agreement With JOT Automation ................................................................. 267
Table 112: Sequella Enters Into Licensing Agreement With LabCorp For B-Smart Technology ..................................... 268
Table 113: LifeTech Scientific, DiNova Venture Partners, Themes Investment Partners And Broncus Technologies Partner To Form Broncus Medical ............................................................................................................................................ 269
Table 114: Van Andel Institute Enters Into Co-Development Agreement With Emory University .................................... 270
Table 115: Merck Serono Enters Into Co-Development Agreement With Auxogyn For Early Embryo Viability Assessment Test .......................................................................................................................................................................... 271
Table 116: PGXL Labs Enters Into Joint Venture Agreement With Essential Molecular Testing ..................................... 272
Table 117: Broad Institute Enters Into Distribution Agreement With Appistry For Genome Analysis Toolkit ................. 273
Table 118: Thermo Fisher Enters Into Co-Development Agreement With Immundiagnostik ........................................... 274
Table 119: Sage Labs Enters Into Agreement With Ekam Imaging To Develop Imaging Assays ................................... 275
Table 120: Bruker Enters Into An Agreement With Nextval For High-throughput Screening Technology ...................... 276
Table 121: BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays ............... 277
Table 122: RainDance Technologies Enters Into Co-Development Agreement With Integrated DNA Technologies For Digital PCR .................................................................................................................................................................................... 278
Table 123: Amarantus BioSciences Enters Into Option For Licensing Agreement With Memory Dx For LymPro Blood Test ................................................................................................................................................................................................. 279
Table 124: Iverson Genetic Diagnostics Enters Into Licensing Agreement With Johns Hopkins University School For Molecular Diagnostic Tests ........................................................................................................................................................ 280
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Table 125: Rosetta Genomics Amends Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ............................................................................................................................................................................................ 281
Table 126: Mitomics Enters Into Co-Marketing Agreement With LabCorp For Prostate Core Mitomic Test .................. 282
Table 127: Trillium Diagnostics Enters Into Licensing Agreement With Leukocare For Sepsis Dx ................................. 283
Table 128: Foundation Medicine Enters Into Agreement With Eisai For Genomic Profiling And Diagnostic Discovery ......................................................................................................................................................................................................... 284
Table 129: Vela Diagnostics Enters Into Licensing Agreement With Life Technologies .................................................... 285
Table 130: Augurex Life Sciences Enters Into Licensing Agreement With Quest Diagnostics For 14-3-3n Biomarker ......................................................................................................................................................................................................... 286
Table 131: CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy Hematology Solutions ................................................................................................................................................................. 287
Table 132: Ingenuity Systems Enters Into Co-Development Agreement With Life Technologies For Diagnostic Solutions ........................................................................................................................................................................................ 288
Table 133: Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx Test ..... 290
Table 134: Genia Technologies Enters Into Co-Development Agreement With Columbia University And Harvard University ....................................................................................................................................................................................... 292
Table 135: NextBio Enters Into Agreement With Winship Cancer Institute of Emory University For Myeloma Biomarkers .................................................................................................................................................................................... 294
Table 136: Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology ......................... 295
Table 137: Atossa Enters Into Co-Marketing Agreement With Diagnostics Test Group For MASCT System ............... 296
Table 138: Genalyte Partners Scienion To Provide Sciflexarrayer Dispensers For Maverick Detection Platform ........ 297
Table 139: CML HealthCare Enters Into Agreement With MaRS Innovation ....................................................................... 298
Table 140: Life Technologies Enters Into Agreement With Bristol-Myers Squibb For Companion Diagnostics Development ................................................................................................................................................................................. 299
Table 141: Agilent Technologies Enters Into Co-Marketing Agreement With Molecular Discovery ................................ 300
Table 142: Agilent Technologies Enters Into Co-Marketing Agreement With MRM Proteomics ...................................... 301
Table 143: Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For Mesothelioma Test ....................................................................................................................................................................... 302
Table 144: Illumina Enters Into Technology Integration Agreement With Partners HealthCare System ........................ 303
Table 145: Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array Products .... 304
Table 146: ImaginAb Enters Into Co-Development Agreement With MacroGenics ........................................................... 305
Table 147: BellBrook Labs Enters Into Co-Development Agreement With Reaction Biology ........................................... 306
Table 148: GVK Biosciences Enters Into Licensing Agreement With National Cancer Institute For GOBIOM Database ......................................................................................................................................................................................................... 307
Table 149: GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina ................... 308
Table 150: Perkinelmer Enters Into Co-Development Agreement With Massachusetts General Hospital .................... 309
Table 151: Affymetrix Enters Into Co-Development Agreement With Pathgen Dx ............................................................. 310
Table 152: Axela Enters Into Co-Marketing Agreement With OvaGene Oncology ............................................................. 311
Table 153: University of Michigan Enters Into Joint Venture Agreement With International Genomics Consortium .... 312
Table 154: Regulus Therapeutics Enters Into An Agreement With Biogen Idec For Biomarkers .................................... 313
Table 155: Curetis Enters Into Licensing Agreement With Cempra For Unyvero ............................................................... 314
Table 156: Foundation Medicine Enters Into Co-Development Agreement With Clovis Oncology .................................. 315
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Table 157: Saladax Biomedical Expands Co-Development Agreement With Bristol-Myers Squibb ............................... 316
Table 158: Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test .............. 317
Table 159: Waters Enters Into Co-Development Agreement With Nonlinear Dynamics ................................................... 318
Table 160: Affymetrix Expands Licensing Agreement With Siemens Healthcare For Branched DNA Technology ...... 319
Table 161: Molecular Targeting Technologies Enters Into Licensing Agreement With Medical College of Wisconsin For 99mTc-HYNIC-Duramycin ................................................................................................................................................... 320
Table 162: Rosetta Genomics Enters Into Co-Marketing Agreement With Precision Therapeutics For miRview mets2 Assays ............................................................................................................................................................................................ 321
Table 163: Bio-Rad Labs Enters Into Distribution Agreement With Myriad RBM For Multiplex Biomarker Kits ............ 322
Table 164: Gen-Probe Enters Into Co-Marketing Agreement With Life Technologies ....................................................... 323
Table 165: OriGene Technologies Enters Into Co-Development Agreement With Centre of Excellence for Prevention of Organ Failure ............................................................................................................................................................................ 324
Table 166: Siemens Healthcare Diagnostics Enters Into Distribution Agreement With Sysmex..................................... 325
Table 167: IRIS International Enters Into Distribution Agreement With Alifax ..................................................................... 326
Table 168: EKF Diagnostics Enters Into Licensing Agreement With Joslin Diabetes Center ........................................... 327
Table 169: SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor ................ 328
Table 170: Clovis Oncology Enters Into Co-Development Agreement With Array BioPharma ........................................ 329
Table 171: RS Medical Enters Into Distribution Agreement With Harvest Technologies ................................................... 330
Table 172: Immuno-Biological Labs Enters Into Licensing Agreement With IBL International ......................................... 331
Table 173: Sandia National Labs Plans To Enter Into Licensing Agreement For SpinDx, Medical Diagnostic Tool .... 332
Table 174: HTG Molecular Diagnostics Enters Into Licensing Agreement With Merck For Breast Cancer Marker Patent Portfolio ............................................................................................................................................................................. 333
Table 175: Genisphere Enters Into Co-Development Agreement With Lankenau Institute for Medical Research ....... 334
Table 176: WaferGen Biosystems Enters Into Agreement With Integrated DNA Technologies ...................................... 335
Table 177: BioView Enters Into Co-Development Agreement With ScreenCell For Circulating Tumor Cell Analysis Technology .................................................................................................................................................................................... 336
Table 178: MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test ................................. 337
Table 179: Fluxion Biosciences Enters Into Co-Development Agreement With Stanford University School of Medicine ......................................................................................................................................................................................................... 338
Table 180: Merrimack Pharma Enters Into Co-Development Agreement With Cancer Treatment Centers of America ......................................................................................................................................................................................................... 339
Table 181: Phenomenome Discoveries Enters Into Licensing Agreement With Polymedco For Cancer Diagnostic Test ......................................................................................................................................................................................................... 340
Table 182: PlexPress Enters Into Technology Integration Agreement With Phalanx Biotech .......................................... 341
Table 183: PrimeraDx Enters Into Co-Development Agreement With Eli Lilly ..................................................................... 342
Table 184: Kreatech Diagnostics Enters Into Co-Development Agreement With Oridis Biomarkers For DNA-FISH Assays ............................................................................................................................................................................................ 343
Table 185: Stratos Enters Into Co- Development Agreement With nanoMR ....................................................................... 344
Table 186: Guided Therapeutics Extends Licensing And Co-Development Agreement With Konica Minolta ............... 345
Table 187: Berg Pharma Enters Into Co-Development Agreement With Parkinson's Institute ........................................ 346
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1.2 List of Figures
Figure 1: In Vitro Diagnostics, Market Segmentation.................................................................................................................. 34
Figure 2: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018 .................................... 35
Figure 3: In Vitro Diagnostics Market, United States, Revenue Mix ($m), 2011 .................................................................... 37
Figure 4: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011 ...................................................... 38
Figure 5: In Vitro Diagnostics Market, United States, Cross-Category Analysis, 2004-2018 .............................................. 39
Figure 6: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .................... 41
Figure 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 .................. 43
Figure 8: In Vitro Diagnostics, United States, Company Share (%), 2011 ............................................................................. 45
Figure 9: Clinical Chemistry, Market Segmentation .................................................................................................................... 47
Figure 10: Clinical Chemistry Market, United States, Revenue Mix ($m), 2011 .................................................................... 48
Figure 11: Clinical Chemistry Market, United States, Segment Contribution (%), 2011 ...................................................... 49
Figure 12: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ............ 50
Figure 13: Clinical Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ......... 52
Figure 14: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011........................................................................................................................................................................................ 54
Figure 15: Clinical Chemisty Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018........................................................................................................................................................................................ 56
Figure 16: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .......... 58
Figure 17: Urine Analysis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ....... 60
Figure 18: Clinical Chemistry, United States, Company Share (%), 2011 .............................................................................. 63
Figure 19: Genetic Testing, Market Segmentation ...................................................................................................................... 64
Figure 20: Genetic Testing Market, United States, Revenue Mix ($m), 2011 ........................................................................ 65
Figure 21: Genetic Testing Market, United States, Segment Contribution (%), 2011 .......................................................... 66
Figure 22: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ................ 67
Figure 23: Genetic Testing, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............. 69
Figure 24: Genetic Testing, United States, Company Share (%), 2011 .................................................................................. 72
Figure 25: Haematology Market, Market Segmentation ............................................................................................................. 74
Figure 26: Haematology Market, United States, Revenue Mix ($m), 2011 ............................................................................ 75
Figure 27: Haematology Market, United States, Segment Contribution (%), 2011 ............................................................... 76
Figure 28: Haematology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .................... 77
Figure 29: Haematology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .................. 79
Figure 30: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 81
Figure 31: Haematology Reagents, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 83
Figure 32: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........................................................................................................................................................................................................... 85
Figure 33: Immunohaematology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........................................................................................................................................................................................................... 87
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 31
Figure 34: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............ 89
Figure 35: Haemostasis, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .......... 91
Figure 36: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 93
Figure 37: Haematology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .................................................................................................................................................................................................. 95
Figure 38: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................................................. 97
Figure 39: Haematology Cell Counters, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018........................................................................................................................................................................................ 99
Figure 40: Haematology, United States, Company Share (%), 2011 .................................................................................... 102
Figure 41: Histology and Cytology Market, Market Segmentation ......................................................................................... 104
Figure 42: Histology And Cytology Market, United States, Revenue Mix ($m), 2011 ........................................................ 105
Figure 43: Histology And Cytology Market, United States, Segment Contribution (%), 2011 ........................................... 106
Figure 44: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 107
Figure 45: Histology And Cytology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ......................................................................................................................................................................................................... 109
Figure 46: Histology And Cytology, United States, Company Share (%), 2011 .................................................................. 112
Figure 47: Infectious Immunology, Market Segmentation ........................................................................................................ 114
Figure 48: Immuno Chemistry Market, United States, Revenue Mix ($m), 2011 ................................................................ 115
Figure 49: Immuno Chemistry Market, United States, Segment Contribution (%), 2011 ................................................... 116
Figure 50: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ........ 117
Figure 51: Immuno Chemistry, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ...... 119
Figure 52: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 121
Figure 53: Disease Specific Immunochemistry, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 123
Figure 54: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 125
Figure 55: Drugs of Abuse / Toxicology, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 127
Figure 56: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ......................................................................................................................................................................................................... 129
Figure 57: Endocrinology Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ......................................................................................................................................................................................................... 131
Figure 58: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 133
Figure 59: Immunochemistry Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 135
Figure 60: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 137
Figure 61: Therapeutic Drug Monitoring, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 139
Figure 62: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011...................................................................................................................................................................................... 141
SAMPLETable of Contents
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 32
Figure 63: Immunochemistry Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018...................................................................................................................................................................................... 143
Figure 64: Immuno Chemistry, United States, Company Share (%), 2011 .......................................................................... 146
Figure 65: Infectious Immunology Market, United States, Revenue Mix ($m), 2011 .......................................................... 148
Figure 66: Infectious Immunology Market, United States, Segment Contribution (%), 2011 ............................................ 149
Figure 67: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011.. 150
Figure 68: Infectious Immunology, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 152
Figure 69: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...................................................................................................................................................................... 154
Figure 70: Infectious Immunology Rapid Tests, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................... 156
Figure 71: Infectious Immunology, United States, Company Share (%), 2011 .................................................................... 159
Figure 72: Microbiology Culture, Market Segmentation ........................................................................................................... 161
Figure 73: Microbiology Culture Market, United States, Revenue Mix ($m), 2011 ............................................................. 162
Figure 74: Microbiology Culture Market, United States, Segment Contribution (%), 2011 ................................................ 163
Figure 75: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ..... 164
Figure 76: Microbiology Culture, United States, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ... 166
Figure 77: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................................ 168
Figure 78: Microbiology Analyzers, United States, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................................ 170
Figure 79: Microbiology Culture, United States, Company Share (%), 2011 ....................................................................... 173
Figure 80: Siemens Healthcare, Company Share (%),United States In Vitro Diagnostics Market, 2011 ....................... 175
Figure 81: Abbott Laboratories, Company Share (%),United States In Vitro Diagnostics Market, 2011 ........................ 176
Figure 82: F. Hoffmann-La Roche Ltd., Company Share (%),United States In Vitro Diagnostics Market, 2011 ........... 177
Figure 83: Beckman Coulter, Inc., Company Share (%),the United States In Vitro Diagnostics Market, 2011 ............. 178
Figure 84: Ortho-Clinical Diagnostics Inc., Company Share (%),the United States In Vitro Diagnostics Market, 2011 ......................................................................................................................................................................................................... 179
Figure 85: Alere Inc., Company Share (%),United States In Vitro Diagnostics Market, 2011 ........................................... 180
SAMPLEIntroduction
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 33
2 Introduction
GlobalData’s medical equipment market reports are the ideal guide for anyone wishing to
understand the market better in terms of revenue, distribution shares and company shares.
2.1 What is This Report About?
United States in vitro diagnostics market report provides the following information:
1. Comprehensive data related to the market revenue, distribution share and company share
2. Global corporate-level profiles of key companies operating in the in vitro diagnostics
market in the United States, which includes a brief overview of the company. The selection
of the companies is based on their operational presence in the United States. It includes
key multinationals as well as key local players.
3. A list of key products under development by different companies. The selection of this list
is based on the territory in which these products are being clinically investigated.
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 34
In Vitro Diagnostics
Monoclonal Antibodies
Genetic Testing
Clinical Chemistry
Histology And Cytology
Microbiology Culture
HaematologyImmuno
ChemistryInfectious
Immunology
Clinical Chemisty Analyzers
Urine Analysis
Electrolyte Chemistry Reagents
Metabolite Chemistry Reagents
Enzyme Chemistry Reagents
Clinical Chemistry
Rapid Tests & POC
Haematology Reagents
Haemostasis
Haematology Analyzers
Immunohaematology
Haematology Rapid Tests
Haematology Cell Counters
Immunochemistry Analyzers
Endocrinology Tests
Organ Function Assays
Immunochemistry Rapid Tests
Anemia / Vitamin Tests
Specific Proteins
Disease Specific Immunochemistry
Microbiology Analyzers
Blood Culture
Mycobacteria Culture
Parasitology Culture
Mycology Culture
Immunological Culture
Identification
Bacterial Identification & Susceptibility
Testing
Tissue Typing
Reagents
Other Genetic Tests
Acquired Gene or
Chromosome Alterations
Inborn Gene or
Chromosome Alterations
Therapeutic Drug Monitoring
Drugs of Abuse / Toxicology
Flow Cytometers
Retroviruses
Hepatitis Viruses
Bacteriology
Other Virology
Infectious Immunology Rapid Tests
In Vitro Diagnostics
Monoclonal Antibodies
Genetic Testing
Clinical Chemistry
Histology And Cytology
Microbiology Culture
HaematologyImmuno
ChemistryInfectious
Immunology
Clinical Chemisty Analyzers
Urine Analysis
Electrolyte Chemistry Reagents
Metabolite Chemistry Reagents
Enzyme Chemistry Reagents
Clinical Chemistry
Rapid Tests & POC
Haematology Reagents
Haemostasis
Haematology Analyzers
Immunohaematology
Haematology Rapid Tests
Haematology Cell Counters
Immunochemistry Analyzers
Endocrinology Tests
Organ Function Assays
Immunochemistry Rapid Tests
Anemia / Vitamin Tests
Specific Proteins
Disease Specific Immunochemistry
Microbiology Analyzers
Blood Culture
Mycobacteria Culture
Parasitology Culture
Mycology Culture
Immunological Culture
Identification
Bacterial Identification & Susceptibility
Testing
Tissue Typing
Reagents
Other Genetic Tests
Acquired Gene or
Chromosome Alterations
Inborn Gene or
Chromosome Alterations
Therapeutic Drug Monitoring
Drugs of Abuse / Toxicology
Flow Cytometers
Retroviruses
Hepatitis Viruses
Bacteriology
Other Virology
Infectious Immunology Rapid Tests
Retroviruses
Hepatitis Viruses
Bacteriology
Other Virology
Infectious Immunology Rapid Tests
3 In Vitro Diagnostics In United States
3.1 In Vitro Diagnostics, Market Segmentation
Figure 1: In Vitro Diagnostics, Market Segmentation
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
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3.2 In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018
Figure 2: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
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Table 1: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, 2004-2018
Category 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18
Immuno Chemistry
Clinical Chemistry
Haematology
Infectious Immunology
Microbiology Culture
Histology And Cytology
Genetic Testing
Total
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
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3.4 In Vitro Diagnostics Market, United States, Category Contribution (%), 2011
Figure 4: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011
Source: GlobalData
Table 2: In Vitro Diagnostics Market, United States, Category Contribution (%), 2011
Category Revenue ($m) Contributon Revenue (%) Contributon
Immuno Chemistry
Clinical Chemistry
Haematology
Infectious Immunology
Microbiology Culture
Histology And Cytology
Genetic Testing
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Figure 6: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-
2011
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Table 4: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Historic, 2004-
2011
Category 2004 2005 2006 2007 2008 2009 2010 2011 CAGR
Immuno Chemistry
% Growth
Clinical Chemistry
% Growth
Haematology
% Growth
Infectious Immunology
% Growth
Microbiology Culture
% Growth
Histology And Cytology
% Growth
Genetic Testing
% Growth
Total
% Growth
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Figure 7: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-
2018
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 44
Table 5: In Vitro Diagnostics, United States, Overall Revenue ($m), USD Constant, Forecast, 2011-
2018
Category 2011 2012 2013 2014 2015 2016 2017 2018 CAGR
Immuno Chemistry
% Growth
Clinical Chemistry
% Growth
Haematology
% Growth
Infectious Immunology
% Growth
Microbiology Culture
% Growth
Genetic Testing
% Growth
Histology And Cytology
% Growth
Total
% Growth
Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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3.5 In Vitro Diagnostics, United States, Company Share (2010-2011)
Figure 8: In Vitro Diagnostics, United States, Company Share (%), 2011
Note: Company Share estimates are based on company reports, secondary research and primary research Source: GlobalData
SAMPLEIn Vitro Diagnostics in United States
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Table 6: In Vitro Diagnostics, United States, Company Share by Revenue ($m), USD Constant,
2010-2011
Company Name 2010 2011
Siemens Healthcare
Abbott Laboratories
F. Hoffmann-La Roche Ltd.
Beckman Coulter, Inc.
Ortho-Clinical Diagnostics Inc.
Alere Inc.
bioMerieux S.A.
Becton, Dickinson and Company
Bio-Rad Laboratories, Inc.
Sysmex Corporation
Qiagen N.V.
Gen-Probe Incorporated
Others
Total
Source: GlobalData
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 542
15 Appendix
The data and analysis within this report is driven by Medical eTrack
Medical eTrack gives you the key information to drive sales, investment and deal making activity in
your business. It includes the following information:
15,000+ Market size data tables across 740 medical equipment segments and 39 countries with
historic data from 2004 forecast to 2018
6,000+ Primary expert interviews conducted per annum for ensuring data and report quality
1,100+ Conferences on medical equipment covered
1,000+ Industry leading reports per annum covering growing sectors, market trends, investment
opportunities and competitive landscape
600+ Analysis reports covering market and pipeline product analysis reports by indication, medical
equipment trends and issue reports and investment and M&A trend reports worth over $3 Million
43,000+ Medical equipment companies profiled
1,500+ Private, emerging and technology start-up company profiles
1,500+ Medical equipment manufacturers in China and India
1,500+ Medical equipment companies in Japan
700+ Companies with revenue splits and market shares by category
1,500+ Quarterly and annual medical equipment company financials
700+ Medical equipment company SWOT’s
9,000+ Pipeline product profiles
8,000+ Marketed product profiles
14,000+ Clinical trials
15,000+ Trial investigators
13,000+ New product patents
3,300+ Companies with products in development
17,000+ Deals in the medical equipment industry
1,100+ Surgical and diagnostic procedures by therapy area
40+ Key healthcare indicators by country
o For more information or to receive a free demo of the service visit
http://www.medicaletrack.com/contactus.aspx?RD=Demo=
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 543
15.1 Definitions of Markets Covered in the Report
15.1.1 In Vitro Diagnostics
In Vitro Diagnostics (IVD) include reagents, instruments and systems intended for use in the
diagnosis of disease or other conditions, including the determination of the state of health, in order
to treat or prevent disease. Such reagents, instruments and systems are intended for use in the
collection, preparation and examination of specimens taken from the human body. The categories
tracked under this market are clinical chemistry, immunochemistry, haematology, histology &
cytology, infectious immunology, microbiology culture and genetic testing. In this market only
values have been tracked.
15.1.1.1 Clinical Chemistry
Clinical chemistry includes reagents, test kits and devices that determine the concentration or
activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecules in easily-collected
bodily fluids such as blood, serum, plasma or urine. Immuno chemical reagents are not included
under this category and are tracked separately under Immuno chemistry. This category comprises
of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for
all enzymes, metabolites and electrolyte analysis and instruments used for clinical chemistry
diagnosis are also covered in this category.
Clinical Chemistry Rapid Tests & POC
Clinical chemistry rapid tests provide the test results immediately. These tests are used in low
resource settings with the help of test strips, tablets and solutions. Clinical chemistry PoC
diagnostics are used to determine the concentration or activity of blood gas, electrolytes,
metabolites, enzymes, carbohydrates, proteins, lipids and small molecules. These tests are
performed for the analysis of body fluids such as blood, serum, sputum, urine, feces and others.
Blood glucose testing is not tracked in this segment.
Clinical Chemisty Analyzers
Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry,
metabolite chemistry and electrolyte chemistry. Clinical chemistry analyzers can be fully
automated or semi automated.
Automated Clinical Chemistry Analyzers
A fully automated clinical chemistry analyzer is connected to a software program that allows the
user to feed in most test parameters. The tasks associated with performing the test like dispensing
the reagents and incubation are automated and require minimum manual work.
Semi-Automated Clinical Chemistry Analyzers
A semi-automated clinical chemistry analyzer requires an operator to perform the reagent
dispensing, incubation and other tasks manually.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Electrolyte Chemistry Reagents
Reagents used to quantify or detect electrolytes to detect bodily functions and disease states.
Examples of electrolytes tracked include sodium, potassium, chloride, bicarbonate, magnesium,
calcium etc from the extra cellular fluids of the body.
Enzyme Chemistry Reagents
Reagents and test kits used for quantification and detection of enzymes that act as a marker for
identification and determination of disease states and bodily functions. Examples of enzymes
tracked include acid phosphatase, alkaline phosphatase, creatine kinase lactate dehydrogenase
etc.
Metabolite Chemistry Reagents
Reagents used for the quantification of metabolites for the assessment of bodily functions and
disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin,
bilirubin etc.
Urine Analysis
Urine analysis is the analysis of urine to aid in the diagnosis of disease or to detect the presence of
a specific substance.
Urine Analyzer Reagents
Urine analyzer reagents are the reagents used in urine analyzers.
Urine Analyzers
Urine analyzers are analytical laboratory equipment used in qualitative and semi-quantitative tests
performed on a urine sample.
15.1.1.2 Genetic Testing
Genetic testing reagents are used for the identification of specific syndrome present in an
individual and can improve the accuracy of the diagnostic tests leading to a better treatment.
Reagents used to perform acquired gene or chromosome alterations, inborn gene or chromosome
alterations and other genetic tests have been tracked under this category.
Acquired Gene or Chromosome Alterations
Reagents which are used in genetic tests to detect cancer causing genes/related alterations like
p53, k-ras, BRCA 1+2 etc.
Inborn Gene or Chromosome Alterations
Genetic tests to detect monogenetic disorders (like Cystic Fibrosis, Haemochromatosis,
Prothrombin Mutation etc), polygenetic disorders (like Asthma , Atherosclerosis, Diabetes,
Hypertension, Osteoporosis, etc), chromosomal disorders (like Down's Syndrome, Edwards
Syndrome etc), polymorphisms (like HLA-Typing etc).
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Other Genetic Tests
Other genetic tests include pharmaco-genomics which include test related to cytochrome P450
(CYP 450). These tests can be by either individual tests or multiple tests which are conducted on
micro-arrays.
15.1.1.3 Haematology
Haematology includes reagents, rapid tests and instruments used for determination and diagnosis
of both physiological and pathological aspects of blood and its components. The category also
includes immune related reagents used for analysis of blood and its components.
Haematology Analyzers
Analytical laboratory equipments which are used to perform tests related to blood and its
components. These analyzers are also used to identify and determine morphology of blood and
blood-forming cells such as white blood cells, lymphocytes, monocytes, neutrophils, eosinophils
and basophils.
Haematology Cell Counters
These are blood counters used for complete blood count determination in routine examinations.
Differential Counters
These are instruments which are used in the measurement of the percentage of each type of white
blood cell of an individual. It also detects if there are any abnormal or immature cells in an
individual.
Hemoglobinometers
These are Instruments which are used for colorimetric representation of the percentage of
haemoglobin in a blood sample.
Haematology Rapid Tests
These are spot tests that generate results immediately and can be done in low resource setting.
These tests are performed to detect the Haemoglobin, Erythrocytes and Haematocrit etc
Erythrocytes (Ery)
Rapid test kits used for detecting the concentration of Erythrocytes in human blood are covered
under Erythrocytes (Ery) rapid test kits.
Haematocrit (HCT)
Rapid test kits used for detecting the concentration of Haematocrit (HCT) in human blood are
covered under Haematocrit (HCT) rapid test kits.
Haemoglobin (Hb)
Rapid test kits used for detecting the concentration of haemoglobin in human blood are covered
under Haemoglobin (Hb) rapid test kits.
Haemostasis Rapid Tests (Home Monitoring)
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
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These are spot tests to detect haemostasis. These include prothrombin time rapid test, D-Dimer
rapid test, activated clotting time (ACT) rapid test etc
Haematology Reagents
These are reagents that are provided for substantially lysing the red blood cells in a whole blood
sample prior to haematology analysis.
Haematology Analyzer Reagents
Haematology analyzer reagents are exclusively used in blood lysing techniques. These reagents
generally contain tris-HCl, EDTA, EGTA, SDS, deoxycholate, tritonX, etc.
Slide Stainers
Slide stainers are reagents used in the staining of slides and smears. Reagents like crystal violet,
safranin, etc have been tracked.
Haemostasis
These include test kits and reagents that are used to conduct blood coagulation related tests.
Coagulation analyzers and reagents used to conduct various coagulation tests have been tracked
under this segment.
Coagulation Analyzers
These are automated or semi automated laboratory equipments used in clotting assay,
chromogenic assay, haemostasis profile etc.
Coagulation Factors
Reagents used in the detection of the coagulation factors are covered here. These coagulation
factors such as Factor VII, VIII, IX, XII etc, are involved in the blood coagulation process.
General Coagulation Tests
Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or
PTT), bleeding time, plasma thrombin time etc. These tests are useful to diagnose disease
condition such as Haemophilia, Uremia, Thrombocytopenia and Vitamin K deficiency.
Platelet Factors
These reagents are used to conduct tests in the determination of cytokines belonging to the
chemokine family.
Special Coagulation Tests
These are reagents which are used to conduct special coagulation tests which provide quantitative
determination of anticoagulant activities of heparin and thrombin formation.
Immunohaematology
Immuno haematology studies antigen-antibody reactions and analogous phenomena as they
relate to the pathogenesis and clinical manifestations of blood disorders.
ABO Typing
SAMPLEAppendix
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These are the reagents used for detecting blood types into four categories: Type A, Type B, Type
AB and Type O.
Antibody Detection
Antibody detection is done for the differential diagnosis of many different pathological conditions.
These determinations of specific antibodies to bacterial and viral pathogens as well as to parasites
enable the correct therapeutic measures to be taken.
Rhesus Typing
These are the tests which are used to detect Rh factor (antigen) on the surface of the red blood
cells.
15.1.1.4 Histology And Cytology
These are reagent test kits and instruments used in tissue and cell typing techniques. Flow
cytometers, monoclonal antibodies and tissue typing reagents have been tracked under this
category.
Flow Cytometers
Flow cytometers are an electronic detection apparatus used in a technique for counting and
examining microscopic particles, such as cells and chromosomes, by suspending them in a stream
of fluid.
Monoclonal Antibodies
Monoclonal antibodies for cell surface antigen are antibodies from a single clone of hybridoma
cells. These are used for specific target cells which identify the tissue by the cell surface antigen.
Tissue Typing Reagents
These are the reagents which are used to determine the compatibility of tissues between a
prospective donor and a recipient prior to transplantation.
15.1.1.5 Immuno Chemistry
The immunochemistry category includes reagents, instruments and test kits used for the analysis
of antigen-antibody interactions in any of the bodily fluids. The category includes both test kits and
reagents for quantification and detection of specific proteins, hormones, drug moieties and non-
infectious diseases. Reagents and kits used in the diagnosis of infectious disease are not included
in this category.
Anemia / Vitamin Tests
Reagents used for estimation of anaemia and vitamin deficiency. These includes the reagents
used for quantitative measurement of iron, ferritin, folate and vitamin B 1, 2, 6, 12, Vitamin-D
Disease Specific Immunochemistry
Disease specific immunochemistry is an assay of specific markers of a particular disease. These
tests include assays of mostly antibodies released in response to a specific disease and also other
disease-causing proteins.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 548
Allergy Blood Tests
Allergy Blood test is allergen-specific IgE antibody test used to measure the amount of
immunoglobulin (Ig) E antibodies to a specific allergen in the blood. A blood test tells a physician
what type of antibodies your blood contains in order to provide information on what is causing your
allergies. The test kits or reagents used to perform allergy blood test are covered under this sub
segment.
Auto-Immune Diseases
This includes the reagents and kits used to perform tests for the diagnosis of immune system
disorders and other disease states to detect auto-antibodies, which are antibodies produced
against the body’s own tissues. The tests are used for the diagnosis of certain autoimmune
disease such as Addison’s disease, autoimmune pancreatitis, Celiac disease, Crohns Disease,
Diabetes mellitus type 1, etc. The kits in this sub-segment include anti-nuclear antibody (ANA) kits,
etc.
Cardiac Markers
Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and
other acute coronary syndromes. The tests include assays for proteins and chemicals like Creatine
Kinase-MB (CK-MB), myoglobin, homocysteine, C-Reactive Protein (CRP), troponin T (cTnT) and
troponin I (cTnI), associated with heart diseases.
Rheumatoid - Inflammatory Diseases Markers
These are the reagents used to detect Rheumatoid – Inflammatory diseases markers. These
markers are antigen/antibodies that detect specific antigen/antibodies produced by bone, cartilage
or any other inflammatory disease activity.
Tumor markers
The reagents used in the tests that detect specific antibodies/antigen produced by the tumor itself
or by the body in response to the tumor. Some commonly detected tumor markers include CA19-9,
CA15-3, CA-125, AFP, etc. The tests can assay markers from samples of blood, urine or body
tissue.
Drugs of Abuse / Toxicology
Test kits used to determine the type and approximate amount of legal and illegal drugs a person
has taken are covered under Drugs of abuse/ Toxicology. Screening is most often done using a
blood or urine sample. This segment includes drugs of abuse and toxicology.
Drugs of Abuse
Test kits for measurement of drugs of abuse from blood, serum or urine. These are the systems
used for testing of depressants, narcotics, stimulants and hallucinogens.
Toxicology
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 549
These are test kits for measurement of toxic substances or drugs from the blood or urine sample.
These are systems used for testing of drugs like Acetaminophene (Paracetamol), 5-
Aminolevulinate Dehydratase, Desipramine, Hippuric Acid, Phenols, Ethanol (Alcohol), etc.
Endocrinology Tests
Reagents used for quantification and detection of endocrine hormones secreted in the human
body. These include the thyroid function hormones, pregnancy hormones, individual and specified
hormones.
Fertility or Pregnancy Hormones
Pregnancy test system intended for the early detection of pregnancy by the measurement of
Human Chorionic Gonadotropin (HCG), a placental hormone, in plasma or urine.
Individual and Specified Hormones
Reagents used for a quantitative measurement of specific hormones for any purpose other than
pregnancy and thyroidal hormones are included here. They include reagents for testing of
hormones like Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, Aldosterone etc.
Thyroid Function Hormones
Reagents used for the quantification and detection of hormones secreted by the thyroid gland.
Reagents used to test TSH, T3 and T4 are included in this segment.
Immunochemistry Analyzers
Immunochemistry analyzers are analytical laboratory equipments used to perform tests for specific
proteins and therapeutic drugs. These analyzers are typically offered in modular increments, which
can operate independently or simultaneously as a unit. Analyzers covered under this category
include Chemiluminescence Analyzers, Radioimmunoassay Analyzers, Immunofluorescence
Analyzers and ELISA Instruments. Analyzers used to perform chemical analysis (enzyme,
electrolyte, metabolic or urine analysis are excluded and are covered under clinical chemistry.
Chemiluminescence Analyzers
Chemiluminescence analyzers are analytical laboratory equipments used to detect glow-based
chemiluminescent reactions. These are used for the quantitative determination of bio-molecules
such as hormones, antibodies to infectious diseases and other proteins in human serum and
Plasma.
ELISA Instruments
ELISA Instruments are used in enzyme-linked immuno sorbent assays for the diagnostic analyses
of antigens or antibodies in a solution using colorimetric signals. These instruments include micro
plate readers, ELISA washers, ELISA reader, etc.
Immunofluorescence Analyzers
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Immunofluorescence analyzers are analytical laboratory equipments used for the visualization of
sub cellular distribution antibodies or antigens of interest. Using these analyzers the bio-molecules
of interest are labelled with specific antibodies chemically conjugated with fluorescent dye.
Radioimmunoassay Analyzers
Radioimmunoassay analyzers are analytical laboratory equipments used to measure
concentrations of antigens (for example, hormone levels in the blood) using radioactive
substances without the need to use a bioassay.
Immunochemistry Rapid Tests
Spot test kits intended generally for rapid diagnosis with immediate results, through immuno
assays. Some of the tests carried out using immunochemistry rapid test include rabies virus test,
allergenic food proteins and enteric infection
Drugs of Abuse / Toxicology Rapid Tests
Rapid immunodiagnostic tests intended for immediate detection and measurement of illegal and
legal drugs a person has taken. These tests detects and measures Amphetamines,
Amphetamine/Methamphetamine Specific (+Ecstasy), Barbiturates, Benzodiazepines,
Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressants, etc in
blood, serum and urine samples.
Fertility / Pregnancy Rapid Tests
Rapid immunodiagnostic tests intended for immediate detection of fertility / pregnancy by
measurement of Follicle-stimulating hormone (FSH), Human placental lactogen (HPL), Human
luteinizing hormone (LH) and Human chorionic gonadotropin (HCG) hormone in plasma, serum
and urine samples.
Other Immunochemistry Rapid Tests
Immunodiagnostic tests intended for the immediate detection of Individual and Specified
Hormones/Proteins, Albumin, uAlbumin, Glycosylated/Glycated Haemoglobin, Prostate-specific
antigen (PSA), Bladder tumor antigen (BTA stat), C - Reactive protein, Rheumatoid / Inflammatory
Disease protein, Creatine Kinase, Myoglobin, Troponin, BNP / proBNP, Heart-Type Fatty Acid-
Binding Protein, etc. in plasma, serum and urine samples.
Organ Function Assays
These include test systems usually carried out through blood or urine test, for evaluating the
wellness of a specific organ through an assay of the organ metabolites. These include liver
function tests, kidney function tests etc.
Specific Proteins
These are reagents and test kits which are used to quantify and detect protein molecules from
bodily fluids. Immunoglobulins (without IgE), HAMA, Immunoelectrophoresis & ImmunoFixation
Kits, Complement Components, Transport Proteins, Lipoproteins, AGP, AAT, Micro and Macro G
etc. have been tracked under this segment.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 551
Therapeutic Drug Monitoring
Therapeutic drug monitoring include reagents and test kits intended to measure different types of
therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for
measurement of both proteins based and chemical based therapeutic drugs are covered. This
include tests for antibiotics, anti analgesics, anti-inflammatory, antipyretic and menstrual drugs.
Antibiotic TDM / Antivirus TDM
Therapeutic drug monitoring reagents used for the measurement of antibiotics or antivirus are
covered under antibiotic/antivirus TDM. Reagents used for detection of antibiotics like Gentamicin,
Sisomycin, Streptomycin, Netilmycin etc are covered here.
Cardiovascular TDM
Therapeutic drug monitoring reagents used for the measurement of drugs specific for
cardiovascular diseases at timed intervals in order to maintain a relatively constant concentration
of the medication in the bloodstream are covered under Cardiovascular TDM. Reagents used for
detection of cardiovascular drugs like Digoxin, Procainamide, Propranolol, Quinidine, etc are
covered here.
Central Nervous Systems TDM
Therapeutic drug monitoring reagents used for the measurement of drugs specific for central
nervous system are covered under central nervous systems TDM. Reagents used for detection of
central nervous systems drugs like Carbamazepine, Ethosuximide, Free Primodine, Valproic Acid
etc are covered here.
Immunosuppressant TDM
Therapeutic drug monitoring reagents used for the detection of immunosuppressant concentration
in human body are covered under immunosuppressant TDM. This includes reagents used for
detection of Immunosuppressant like Cyclosporin, Mycophenolate, Tacrolimus, etc.
15.1.1.6 Infectious Immunology
This category includes reagents and test kits used for the detection or quantification of infectious
agents like bacteria and viruses by using antigen-antibody (Ag – Ab) and nucleic acid tests.
Bacteriology
Reagents and test kits to detect the pathogenicity of bacteria such as chlamydia, gonococci,
syphilis, helicobacter pylori, salmonella and so on.
Hepatitis Viruses
These are diagnostic test kits which are used to detect the hepatitis virus such as HAV, HBV,
HCV, HbsAg and HXV.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 552
Infectious Immunology Rapid Tests
Spot test kits intended generally for rapid diagnosis with immediate results, through immuno
assays. Tests carried out using Infectious Immunology rapid test include Hepatitis Virus,
Retrovirus and Other Virology Rapid Tests.
Hepatitis Viruses Rapid Tests
Immunodiagnostic tests intended for immediate detection of HBsAg, HCV Antibody and other
Hepatitis Viruses.
Other Infectious Immunology Rapid Tests
Immunodiagnostic tests intended for immediate detection of Chlamydia Ag, H. pylori, Strep. A,
Strep. B, Syphilis, Clost. diff. including Toxin A and B, Meningitis causitive agents, Legionella,
Strep. Pneumoniae, CMV, RSV, Mononucleosis (EBV), Influenza A and/or B, VZV, Dengue,
Plasmodium (Malaria), etc.
Retroviruses Rapid Tests
Immunodiagnostic rapid tests intended for immediate detection of HIV 1, HIV 1 / 2, HIV Ag/Ab
Combi and other Retroviruses.
Other Virology
These are diagnostic test kits which are used to confirm the antigen/antibody of rubella,
cytomegalovirus, the herpes simplex virus and the Epstein Barr Virus.
Retroviruses
These are diagnostic test kits which are used to detect the antigen/antibody of HIV1, HIV 2 and
HTLV I, HTLVII.
15.1.1.7 Microbiology Culture
This category includes reagents used for the preparation of growth medium for microbial
organisms. This category also includes dehydrated and prepared culture media for micro organism
growth.
Bacterial Identification & Susceptibility Testing
This includes the reagents and test kits (manual and automated) used to identify and test the
sensitivity of bacteria towards an antimicrobial substance.
Blood Culture
Culture media used for the preparation of medium capable of supporting the growth of bacteria
and other micro organisms. It is a culture of blood, used to identify the infection of blood stream
like bacteremia, septicaemia, etc. They are generally in solid/liquid forms or only solid and liquid
forms with constituents specific to the bacteria.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
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Immunological Culture Identification
Reagents used to test the streptococci grouping, meningitis, staphylococci and serotyping.
Microbiology Analyzers
These are analytical laboratory equipments used to perform routine and special microbiology tests.
These include fully automated or semi automated microbiology analyzers.
Automated Microbiology Analyzers
A fully automated analyzer is connected to a software program that allows the user to feed in most
test parameters. The tasks associated with performing the test like dispensing the reagents,
incubation etc are automated and require minimum manual work.
Semi-Automated Microbiology Analyzers
A semi-automated analyzer requires an operator to perform the reagent dispensing, incubation
and other tasks manually.
Mycobacteria Culture
It includes the culture media used for the preparation of medium capable of supporting the growth
of mycobacterium.
Mycology Culture
It includes culture media and reagents for the preparation of culture medium that is capable of
supporting the growth of fungi. These cultures are used to detect infection like dermatophyte
infections, etc
Parasitology Culture
Culture media used for the preparation of medium capable of supporting the growth of blood
parasites like plasmodium, pneumocystis etc.
Note: 1). Value, distribution and company shares figures reflect annual gross sales of in vitro
diagnostics in local currency converted to $ at constant rate. The annual growth (year on year
growth) and compounded annual growth rate (CAGR) in tables is rounded off to one decimal
place.
2). Company share data represents market share (in revenues and as percentage to total market)
of companies in market categories and geographies tracked. The data is rounded off to the
nearest decimal places.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 554
15.2 Research Methodology
GlobalData’s dedicated research and analysis teams consists of qualified professionals with
experience in marketing, market research, consulting background in the medical devices industry
and advanced statistical expertise.
GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and
the Strategic and Competitive Intelligence Professionals (www.scip.org).
All GlobalData databases are continuously updated and revised. The following research
methodology is followed for all databases and reports.
15.3 Secondary Research
The research process begins with exhaustive secondary research on internal and external sources
being carried out to source qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations
and SEC filings;
Industry trade journals, scientific journals and other technical literature;
Internal and external proprietary databases;
Relevant patent and regulatory databases;
National government documents, statistical databases and market reports;
Procedure registries; and
News articles, press releases and web-casts specific to the companies operating in the
market.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 555
15.4 Primary Research
GlobalData conducts thousands of interviews a year with industry participants and commentators
in order to validate its data and analysis. A typical research interview fulfills the following functions:
It provides first-hand information on market size, market trends, growth trends, competitive
landscape and future outlook;
Helps in validating and strengthening the secondary research findings; and
Further develops the analysis team’s expertise and market understanding.
Primary research involves e-mail interactions and telephonic interviews for each market, category,
segment and sub-segment across geographies.
The participants who typically take part in such a process include, but are not limited to:
Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers
and national sales managers;
Hospital stores, laboratories, pharmacies, distributors and paramedics;
Outside experts: investment bankers, valuation experts, research analysts specializing in
specific medical equipment markets; and
Key opinion leaders: physicians and surgeons specializing in different therapeutic areas
corresponding to different kinds of medical equipment.
15.5 Models
Where no hard data is available, GlobalData uses modeling and estimates in order to produce
comprehensive data sets. The following rigorous methodology is adopted:
Available hard data is cross-referenced with the following data types to produce estimates:
Demographic data on population segments;
Macro-economic indicators such as GDP, inflation rate;
Healthcare indicators such as health expenditure, physician base, healthcare infrastructure
and facilities; and
Selected epidemiological and procedure statistics.
Data is then cross-checked by the expert panel. All data and assumptions related to modeling
are stored and are made available to clients on request.
SAMPLEAppendix
United States In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology and
Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture GDME1169IDB / Published November 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 556
15.6 Forecasts
GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast
models:
Historic growth rates;
Macro-indicators such as population trends and healthcare spending;
Forecast epidemiological data; and
Qualitative trend information and assumptions.
The data is then cross-checked by the expert panel.
15.7 Expert Panels
GlobalData uses a panel of experts to cross-verify its databases and forecasts.
GlobalData’s expert panel comprises marketing managers, product specialists, international sales
managers from medical device companies; academics from research universities, KOLs from
hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment
and supplies etc.
Historic data and forecasts are relayed to GlobalData’s expert panel for feedback and adjusted in
accordance with their feedback.
15.8 GlobalData Consulting
We hope that the data and analysis in this brief will help you make informed and imaginative
business decisions. If you have further requirements, GlobalData’s consulting team may be able to
help you. GlobalData offers tailor-made analytical and advisory services to drive your key strategic
decisions.
15.9 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system or transmitted in any
form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior
permission of the publisher, GlobalData.