PCR in Screening and Diagnostics

PCR in Screening and Diagnostics

Polymerase Chain Reaction in Screening and Diagnostics

Market Developments, Growth Areas and Opportunities

June 2013

Copyright © Biopharm Reports 1

Biopharm Reports

Biopharm Reports, Tamarisk House, High Street, Colne, Cambridgeshire PE28 3ND United Kingdom, http://www.biopharmreports.com



The Author John Bates is a market consultant in the life science industry. After a degree in biochemistry and chemistry (1978) and a Ph.D in cancer research in 1981, John joined Upjohn Ltd (now Pfizer), where he managed a team of scientists in the department of biopharmaceutical sciences and drug metabolism. In 1985 he took a similar role with Glaxo Group Research (now GSK), in the department of Biochemical Pharmacology. In 1989 he co-founded Melbourn Scientific Ltd, a CRO operating in the pharmaceutical field, later moving to Acumen Bioscience (drug discovery instrumentation) as Technical Director. John has over twenty years laboratory experience and has worked as a market consultant since 2003, covering many areas of laboratory technology in the fields of chemical and bioanalysis, drug discovery and diagnostics.

Copyright© 2013 BioPharm Reports This Report is published by BioPharm Reports. All Rights Reserved. The reproduction or redistribution of this Report is prohibited, without the prior permission of Biopharm Reports. The information in this report and the opinions, views and conclusions contained herein, are those of the author and publisher. While the information contained in this report is believed to be accurate at the time of publication, Biopharm Reports accepts no liability for the information contained herein, or for its completeness in any respect. Biopharm Reports accepts no liability for any decisions or actions that are taken, based on the content, views or conclusions contained in this report.



Executive Summary Overview PCR Clin 2013 is an independent global study and investigated current and evolving markets in the PCR screening and diagnostics field. Focussed on individuals who use PCR for screening or diagnostic purposes, this study examined current and future (next three years) end‐user practices, including preferences, techniques, applications, current and future purchases from suppliers, and other market areas. Areas covered by this study included current and future PCR techniques, current and future PCR applications, disease biomarkers, current and future PCR company suppliers, preferred instruments and their strengths and weaknesses, software, required and future innovation, samples, sample preparation, financials, costs and budgets, budget breakdown, consumables and therapeutic and other areas. This study was carried out to assist PCR developers and vendors to better understand and support current and evolving needs in this field, and to help scientists compare their own practices with others, and gain insights into emerging technologies and applications.

Study Participants Individuals (n=173) who participated in PCR Clin 2013 work in 49 countries. The top nine participating countries were USA, Germany, Italy, Brazil, Spain, Switzerland, UK, China and Denmark. Regionally, Europe and North America were the greatest participants in PCR Clin 2013 and together represented more than two thirds of participants. Participants in PCR Clin 2013 indicated three general areas of activity in the use of PCR in screening and diagnostics, namely the conduct of routine tests, the development and validation of PCR tests and the use of PCR in qualitative studies. Together, these three areas represented over 70% of the activities. Notably, almost half of these activities are associated with the development and validation of these tests. In this study, almost 90% of participants in PCR Clin 2013 are employed by four organisation types, namely universities, research institutes, Government organisations and hospitals or clinics. PCR Clin 2013 participants reported that they worked in 8 fields, of which universities, research institutes, clinics and hospitals were the largest groups.

All individuals who participated in PCR Clin 2013 use PCR directly in screening and diagnostics in their own laboratory or are closely associated with the use of this technique (e.g. as a laboratory supervisor or manager). More than 90% of the participants hold senior positions as scientists or managers, relating to PCR methods used in screening and diagnostics. This global PCR study involved the participation of a substantial number of PCR end‐users and its findings relating to the use of this technique in screening and diagnostics provide both depth and breadth of technical and market‐related findings relevant to developers and vendors in this field.



Based on the (conservative) assumption that participants’ experience in the use of PCR range from 3 to 5 years, it is calculated that the findings of this study are based on 500 to 800 combined years of knowledge and experience of this technique. The professional positions of participants underline the depth of experience brought to this market study and these include medical doctor, professor, assistant professor, post‐doctoral researcher, Ph.D student, research fellow, managing director, senior scientist, departmental head and other similar positions. Edited



Index Page 1. Introduction 20

1. Introduction 1.1 Study Areas 1.2 Study Questions

2. Study Participants 25 2.1 This Chapter 2.2 Countries Figure 2.1 Countries and numbers of individuals who participated in PCR Clin 2013 Table 2.1 Countries and percentage of individuals who participated in PCR Clin 2013 2.3 Regions Figure 2.2 Global regions of individuals who participated in PCR Clin 2013 2.4 PCR Activities of Participants Figure 2.3 PCR activities of individuals who participated in PCR Clin 2013 2.5 Organisation Figure 2.4 Organisation types of individuals who participated in PCR Clin 2013 2.6 Fields Figure 2.5 Fields of individuals who participated in PCR Clin 2013. 2.7 Participants Table 2.2 Positions of individuals who participated in PCR Clin 2013 2.8 Discussion

3. PCR Techniques 36 3.1 This Chapter 3.2 Current PCR Techniques Figure 3.1 Top currently used PCR techniques (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013



Table 3.1 Top currently used PCR techniques (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013 3.3 Future PCR Techniques Figure 3.2 PCR techniques that PCR Clin 2013 participants indicate they will be using over the next three years (2013 – 2016) in screening and diagnostics Table 3.2 PCR techniques that PCR Clin 2013 participants indicate they will be using over the next three years (2013 – 2016) in screening and diagnostics 3.4 Other Future PCR Techniques 3.5 Discussion Table 3.3 Comparison of Current and Future PCR techniques reported by participants in PCR Clin 2013 3.6 Opportunities

4. PCR Applications 45 4.1 This Chapter 4.2 Current Applications Figure 4.1 Top currently used PCR applications (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013 Table 4.1 Currently used PCR applications (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013 4.3 Other Current PCR Applications 4.4 Future PCR Applications Figure 4.2 PCR applications that PCR Clin 2013 participants indicate they will be using in screening and diagnostics, over the next three years (2013 – 2016) Table 4.2 PCR applications that PCR Clin 2013 participants indicate they will be using in screening and diagnostics, over the next three years (2013 – 2016) 4.5 Other Future PCR Applications 4.6 Discussion Table 4.3 Comparison of Current and Future PCR applications reported by participants in PCR Clin 2013



4.7 Opportunities

5. Companies 53 5.1 This Chapter 5.2 Current Company Suppliers Figure 3.1 Top PCR company suppliers (% of overall suppliers), reported by individuals who participated in PCR Clin 2013 Table 5.1 Top PCR company suppliers (% of overall suppliers), reported by individuals who participated in PCR Clin 2013. 5.3 Other Company Suppliers 5.4 Future Company Suppliers Figure 5.2 Top PCR company suppliers that participants indicate they will be purchasing from over the next three years (2013 – 2016) Table 5.2 PCR company suppliers that participants indicate they will be purchasing from over the next three years (2013 – 2016) 5.5 Other Company Suppliers 5.6 Discussion Table 5.3 Comparison of current and anticipated future PCR company purchases, reported by participants in PCR Clin 2013 Table 5.3 Comparison of current and anticipated future PCR company purchases, reported by participants in PCR Clin 2013 5.7 Opportunities

6. Preferred Companies and Products (Strengths and Weaknesses) 63 6.1 This Chapter 6.2 PCR Preferred Companies Figure 6.1 Top preferred PCR supplier companies (% ), reported by individuals who participated in PCR Clin 2013 Table 6.1 Top preferred PCR supplier companies (%), reported by individuals who participated in PCR Clin 2013 6.3 Preferred PCR Systems



Table 6.2 Preferred PCR systems (%), indicated by individuals who participated in PCR Clin 2013 6.4 Strengths of Preferred Systems 6.5 Weaknesses of Preferred Systems Figure 6.2 Strengths of preferred instruments (%), indicated by individuals who participated in PCR Clin 2013 Figure 6.3 Weaknesses of preferred instruments (%), indicated by individuals who participated in PCR Clin 2013 Table 6.4 Strengths of preferred instruments (%), indicated by individuals who participated in PCR Clin 2013 Table 6.5 Weaknesses of preferred instruments (%), indicated by individuals who participated in PCR Clin 2013 Table 6.6 Participants comments on the strengths of their preferred PCR systems (together with their classification) Table 6.7 Comments on the weaknesses of their preferred PCR systems (together with their classification), indicated by participants in PCR Clin 2013 6.6 Discussion 6.7 Opportunities

7. Expenditure and Budgets 81 7.1 This Chapter 7.2 Current Budgets Figure 7.1 Annual budgets for the conduct of PCR relating to screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 Table 7.1 Annual budgets for the conduct of PCR relating to screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 7.3 Cost per Sample Figure 7.2 Costs per sample for the conduct of PCR relating to screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 Table 7.2 Costs per sample for the conduct of PCR relating to screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 7.4 Budget Breakdown



Figure 7.3 Current budget breakdown associated with PCR relating to screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 Table 7.3 Current budget breakdown associated with PCR relating to screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 Figure 7.4 Future changes in the budget for PCR in screening and diagnostics, over the next three years, indicated by participants in PCR Clin 2013 Table 7.4 Future changes in the budget for PCR in screening and diagnostics, over the next three years, indicated by participants in PCR Clin 2013 7.5 Future Overall Budget Table 7.5 General budget changes for the conduct of PCR over the next three years, indicated by participants in PCR Clin 2013 Table 7.6 Overall mean percentage changes in budgets for PCR over the next three years, indicated by participants in PCR Clin 2013 7.6 Discussion 7.7 Opportunities

8. Purpose of PCR Use 89 8.1 This Chapter 8.2 Purpose Figure 8.1 Reasons or purposes for using PCR in screening and diagnostic, industry, reported by individuals who participated in PCR Clin 2013 Table 8.1 Top reasons or purposes for using PCR in screening and diagnostic, industry, reported by individuals who participated in PCR Clin 2013 8.3 Discussion 8.4 Opportunities

9. Samples 92 9.1 This Chapter 9.2 Study Samples Figure 9.1 Study samples investigated using PCR in screening and diagnostic applications, reported by individuals who participated in PCR Clin 2013 Table 9.1 Study samples investigated using PCR in screening and diagnostic applications, reported by individuals who participated in PCR Clin 2013



9.3 Other samples 9.4 Discussion 9.5 Opportunities

10. Sample Preparation 96 10.1 This Chapter 10.2 Sample Preparation Methods Table 10.1 Sample preparation methods reported by participants in PCR Clin 2013 (NB: where participants used the same words to describe their sample preparation methods, these were merged into one and the number (n) of citations is indicated. However, some participants cited methods which are evidently the same, but expressed in different ways. In these cases they have been included as stated by the individual. Consideration should therefore be given to the fact that many participants have indicated the same methods, but in slightly different ways]. 10.3 Discussion 10.4 Opportunity

11. Therapeutic Areas 104 11.1 This Chapter 11.2 Therapeutic Area Figure 11.1 Top therapeutic areas associated with the use of PCR in screening and diagnostics, reported by individuals who participated in PCR Clin 2013 Table 11.1 Therapeutic areas associated with the use of PCR in screening and diagnostics, reported by individuals who participated in PCR Clin 2013 11.3 Other areas 11.4 Discussion 11.5 Opportunities

12. Disease Biomarkers 109 12.1 This Chapter 12.2 Biomarker Types Figure 12.1 Biomarker types investigated using PCR for screening and diagnostics, reported by individuals who participated in PCR Clin 2013 Table 12.1 Biomarker types investigated using PCR for screening and diagnostics, reported by individuals who participated in PCR Clin 2013 Figure 12.2 Biomarker clinical utilities in screening and diagnostics, indicated by individuals who participated in PCR Clin 2013



Table 12.2 Biomarker clinical utilities in screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 Table 12.3 Specific biomarkers identified in screening and diagnostics, indicated by individuals who participated in PCR Clin 2013 12.3 Discussion and Opportunities 12.4 Opportunities

13. Software 117 13.1 This Chapter 13.2 Software Figure 12.2 Top types of software used in the conduct of PCR, reported by individuals who participated in PCR 2012 Figure 13.1 Types of software used in the conduct of PCR, reported by individuals who participated in PCR Clin 2013 13.3 Discussion 13.4 Opportunity

14. Innovation 122 14.1 This Chapter 14.2 Need for Future Innovation Figure 14.1 Areas of greatest future innovation need in the PCR field, PCR, reported by individuals who participated in PCR Clin 2013 Table 14.1 Areas of greatest future innovation need in the PCR field, PCR, reported by individuals who participated in PCR Clin 2013 Table 14.2 recent innovations that have proved important in their own field of PCR, reported by individuals who participated in PCR Clin 2013 14.3 Discussion

15. Consumables 127 15.1 This Chapter 15.2 Consumables



Table 15.1 PCR consumables reported by participants in PCR Clin 2013 (NB: where participants used the same words to describe their consumables, these were merged into one and the number (n) of citations is indicated. However, some participants cited consumables which are evidently the same, but expressed in different ways. In these cases they have been included as stated by the individual. Consideration should therefore be given to the fact that many participants have indicated the same consumable, but in slightly different ways]. 15.3 Discussion 15.4 Opportunities

16. Discussion 140 16.1 Overview 16.2 Study Participants 16.3 PCR Techniques 16.4 PCR Applications 16.5 PCR Supplier Companies 16.6 Companies, Products, Strengths and Weaknesses 16.7 Expenditure and Budgets 16. 8 Purpose of PCR Use 16.9 Study Samples 16.10 Sample Preparation 16.11 Therapeutic Areas 16.12 Disease Biomarkers 16.13 Software 16.14 Innovation 16.15 Consumables




1. Introduction




1. Introduction Between January and March 2013, Biopharm Reports carried out a market study of the use of PCR in screening and diagnostics (hereafter referred to as PCR Clin 2013). The findings of this study from 173 PCR end‐users are presented in this report.

1.1 Study Areas PCR Clin 2013 is an independent global study and investigated current and evolving markets in the PCR screening and diagnostics field. Focussed on individuals who use PCR for screening or diagnostic purposes, this study examined current and future (next three years) end‐user practices, including preferences, techniques, applications, current and future purchases from suppliers, and other market areas. This study was carried out to assist PCR developers and vendors to better understand and support current and evolving needs in this field, and to help scientists compare their own practices with others, and gain insights into emerging technologies and applications. This PCR study was designed for scientists or managers who use PCR in their everyday activities, but excluded PCR commercial developers and vendors (for the avoidance of bias).

1.2 Study Questions Current PCR techniques: Current use of more than 40 PCR techniques in screening or diagnostics by end‐users, each ranked according to their competitive position. PCR techniques considered include Allele Specific PCR, Arbitrarily Primed PCR (APPCR), Assembly PCR (Polymerase Cycling Assembly, PCA), Asymmetric PCR (A PCR), Bead Emulsion Amplification PCR (BEA), Classical PCR, Colony PCR, Degenerate Oligonucleotide PCR (DOPPCR), Digital PCR (dPCR), Helicase Dependent Amplification (HDA), Hot start PCR, Hyper PCR, Immunocapture PCR, In Silico PCR, Inter Sequence Specific PCR (ISSR), Inverse PCR, Ligation Mediated PCR, Long PCR, Loop Mediated Isothermal Amplification (LAMP), Methylation Specific PCR (MSP), Miniprimer PCR, Multiplex Ligation Dependent Probe Amplification (MLPA), Multiplex PCR, Nested PCR, Overlap Extension PCR ( Splicing by overlap extension, SOE), PANAC (Single Reaction Real Time PCR), PCR array, PCR Denaturing Gradient Gel Electrophoresis (PCR DGGE), PCR Restriction Fragment Length Polymorphism (PCRRFLP), Quantitative PCR (qPCR), Random Amplified Polymorphic DNA (RAPD), Rapid Amplification of cDNA ENDS PCR (RACE PCR), Reverse Transcription PCR (RTPCR), Single Molecule PCR, Single Specific Primer Polymerase, Chain Reaction (SSPPCR), Solid Phase PCR, Stem loop RT PCR, Stepdown PCR, Taqman, Temporal Temperature Gradient Gel Electrophoresis (PCRTTGE), Thermal Asymmetric Interlaced PCR (TAILPCR), Touchdown PCR, Universal Fast Walking or other. Future PCR techniques: Future anticipated use of more than 40 PCR techniques in screening or diagnostics by end‐users over the next three years, each ranked according to their competitive position. PCR techniques considered include Allele Specific PCR, Arbitrarily Primed PCR (APPCR), Assembly PCR (Polymerase Cycling Assembly, PCA), Asymmetric PCR (A PCR), Bead Emulsion Amplification PCR (BEA), Classical PCR, Colony PCR, Degenerate Oligonucleotide PCR



(DOPPCR), Digital PCR (dPCR), Helicase Dependent Amplification (HDA), Hot start PCR, Hyper PCR, Immunocapture PCR, In Silico PCR, Inter Sequence Specific PCR (ISSR), Inverse PCR, Ligation Mediated PCR, Long PCR, Loop Mediated Isothermal Amplification (LAMP), Methylation Specific PCR (MSP), Miniprimer PCR, Multiplex Ligation Dependent Probe Amplification (MLPA), Multiplex PCR, Nested PCR, Overlap Extension PCR ( Splicing by overlap extension, SOE), PANAC (Single Reaction Real Time PCR), PCR array, PCR Denaturing Gradient Gel Electrophoresis (PCR DGGE), PCR Restriction Fragment Length Polymorphism (PCRRFLP), Quantitative PCR (qPCR), Random Amplified Polymorphic DNA (RAPD), Rapid Amplification of cDNA ENDS PCR (RACE PCR), Reverse Transcription PCR (RTPCR), Single Molecule PCR, Single Specific Primer Polymerase, Chain Reaction (SSPPCR), Solid Phase PCR, Stem loop RT PCR, Stepdown PCR, Taqman, Temporal Temperature Gradient Gel Electrophoresis (PCRTTGE), Thermal Asymmetric Interlaced PCR (TAILPCR), Touchdown PCR, Universal Fast Walking or

other. Current PCR applications: Current use of 15 PCR applications in screening or diagnostics by end‐users, each ranked according to their competitive position. Application considered were allele size detection for human ID STR typing, bacterial tipification (REPPCR), cell‐free DNA mutations, cloning, commensal bacteria detection / quantification, community profiling, detection of antimicrobial resistance genes, detection of specific microbial 16S rRNA genes, diagnostics, drug treatment dosage prediction, drug treatment type prediction, fungal species detection, gene expression (mRNA), gene mutations and alterations, generating genetic probes, genetic mapping, genetic material amplification, sequencing, haplotypes, immunocapture PCR mediated virion detection, microbial populations, MicroRNA quantification, pathogen detection/identification, quantitative analysis of gene abundance, site‐directed mutagenesis, tissue typing or other.

Future PCR applications: Application considered were allele size detection for human ID STR typing, bacterial tipification (REPPCR), cell‐free DNA mutations, cloning, commensal bacteria detection / quantification, community profiling, detection of antimicrobial resistance genes, detection of specific microbial 16S rRNA genes, diagnostics, drug treatment dosage prediction, drug treatment type prediction, fungal species detection, gene expression (mRNA), gene mutations and alterations, generating genetic probes, genetic mapping, genetic material amplification, sequencing, haplotypes, immunocapture PCR mediated virion detection, microbial populations, MicroRNA quantification, pathogen detection/identification, quantitative analysis of gene abundance, site‐directed mutagenesis, tissue typing or other.

Biomarker identity: The identities of the main biomarkers investigated using PCR. Biomarker types: The main biomarker types investigated using PCR, including gene variations (mutations/polymorphisms), DNA methylation, gene copy number, gene expression, SNPs, mRNA, MicroRNA, alternative spliced variants or other.

Biomarker utility: The main clinical utilities of biomarkers investigated using PCR, including disease prognosis, disease susceptibility or risk, disease stage or severity, drug type therapy decision‐making, drug type therapy dose, drug discovery, early detection of disease, clinical trial endpoint, guiding treatment, response to therapy, safety or toxicity factors or other areas.



Current company suppliers: End‐users’ preferred current company suppliers for their PCR, including Abbott, Agilent, Applied Biosystems, Becton Dickinson, Bioline, Biometra, Biorad, Biotium, Biozyme, Cepheid, Eppendorf, ESCO, Euroclone, Eurogentec, Fermentas, Finnzymes, Fluidigm, GE Healthcare, Genework, Hain Life sciences, Idaho, Integrated Data Technologies, Invitrogen, Kapa Biosystems, Life Technologies, Luminex, Machery Nagel, MJ Research, New England BioLabs, Perkin Elmer, Promega, Qiagen, Quanta Bioscience, Roche, SensoQuest, Siemens, Sigma Genosys, Stratagene, Takara, Thermofisher or others. Future company suppliers: End‐user’s anticipated preferred company suppliers for their PCR over the next three years, including Abbott, Agilent, Applied Biosystems, Becton Dickinson, Bioline, Biometra, Biorad, Biotium, Biozyme, Cepheid, Eppendorf, ESCO, Euroclone, Eurogentec, Fermentas, Finnzymes, Fluidigm, GE Healthcare, Genework, Hain Life sciences, Idaho, Integrated Data Technologies, Invitrogen, Kapa Biosystems, Life Technologies, Luminex, Machery Nagel, MJ Research, New England BioLabs, Perkin Elmer, Promega, Qiagen, Quanta Bioscience, Roche, SensoQuest, Siemens, Sigma Genosys, Stratagene, Takara, Thermofisher or others. Preferred instrument: End‐users preferred PCR instrument (from their preferred supplier) in the PCR field. Strengths: The strengths of end‐user’s preferred instrument in the PCR field. (How is it meeting their needs in this area?) Weaknesses: The weaknesses of end‐users preferred instrument in the PCR field (how is it failing to meet their needs in this area). Bioinformatics software: End‐users preferred bioinformatics software in the PCR field. Required innovations: End‐users’ views (rated on a scale of 1‐10) on the PCR areas where innovations is most required. Innovation areas considered were sample preparation, ancillary techniques, PCR (qualitative) selectivity, PCR (quantitative) sensitivity, PCR reproducibility, PCR qualitative/quantitative capability, PCR robustness (ruggedness), detection methods, automation, speed or sample throughput, specialist data control systems, specialist bioinformatics systems or other. Samples: End‐user’s main samples analysed using PCR, including animal tissues, cell isolates, cells cerebrospinal fluid, genetic material, human tissues, In‐vitro biological solutions, microbiological materials, plasma, saliva, serum, urine, whole blood or other. Sample Preparation: End‐user’s preferred sample preparation technique. Recent Innovation: End‐user’s views on the most important PCR innovations in their field over the last three years. Financial Budget: End‐user’s annual financial budgets relating to their use of PCR in screening and diagnostics. Cost per sample: End‐users average costs per sample, using PCR in screening and diagnostics.



Current budget breakdown: End user’s current budget breakdown for the use of PCR in screening and diagnostics, relating to reagents and consumables, system control (data handling) software, data analysis (offline) software, PCR instruments, sample preparation and related instrumentation, ancillary systems/instrumentation, general overheads, instrument servicing/repair, staff salaries and other areas. Future budget breakdown: End user’s anticipated future budget breakdown for the use of PCR in screening and diagnostics, relating to reagents and consumables, system control (data handling) software, data analysis (offline) software, PCR instruments, sample preparation and related instrumentation, ancillary systems/instrumentation, general overheads, instrument servicing and repair, staff salaries and other areas. Overall budget: End‐user’s estimates of by how much they anticipate their overall annual financial budget for the use of PCR in screening and diagnostics will change, either increase or decrease, over the next three years. Consumables: End‐users top three consumables in terms of overall costs, that are directly associated with their PCR work in screening and diagnostics. PCR activities: End‐user’s PCR activities in screening and diagnostics, relating to the running of routine PCR tests for clinical decision‐making, the development or validation of PCR tests and the qualitative discovery of disease biomarkers using PCR. Organisation types: Organisation types in this study included universities, research Institutes, small companies, medium sized companies, large international company, clinics, hospitals, government organisations, veterinary organisation and others. Fields: Fields types of participants in this study included biotechnology, clinical, hospital, government, healthcare, pharmaceuticals, research institute, university or other. Therapeutic areas: End‐users’ DNA sequencing activities in terms of their general therapeutic area, including arthritis, autoimmune diseases, done metabolism, cancer, cardiovascular, central nervous system, endocrine, gastrointestinal, genitourinary system, haematology, infections, inflammation, metabolic disorders, musculoskeletal disorders, nutrition, obstetrics and gynaecology, ophthalmology, pain, respiratory, skin or other. Purpose: End‐users’ underlying reasons for using PCR in screening or diagnostics across 12 areas, namely clinical research, routine diagnostics, routine screening, clinical trials, treatment decisions, treatment monitoring, diagnostics research, disease research, drug R&D, drug targets, pathology, toxicology or other.




2. Study Participants



2.1 This Chapter This chapter presents background information relating to PCR end‐users, who participated in PCR Clin 2013.

2.2 Countries Individuals (n=173) who participated in PCR Clin 2013 work in 49 countries. The top nine participating countries were USA, Germany, Italy, Brazil, Spain, Switzerland, UK, China and Denmark (See Figure 2.1).

Figure 2.1 Countries and numbers of

individuals who participated in PCR Clin 2013

Brazil: 4.6% Spain: 4.6 (5%)

Switzerland: 4.6%

USA: 11.0%

Germany: 8.1%

Italy: 7.5%

UK: 4.0%

China: 3.5%

Denmark: 3.5%

Other: 48.6%

Table 2.1 Countries and percentage of individuals who participated in PCR Clin 2013

Country %

USA 11.0

Germany 8.1

Italy 7.5

Brazil 4.6

Spain 4.6

Copyright © Biopharm Reports

19



… Continued Table 2.1 Countries and percentage of individuals who participated in PCR Clin 2013

Country %

Switzerland 4.6

UK 4.0

China 3.5

Denmark 3.5

Sweden 3.5

Australia 2.9

France 2.3

Greece 2.3

India 2.3

Argentina 1.7

Czech Republic 1.7

Finland 1.7

Morocco 1.7

Pakistan 1.7

Poland 1.7

Portugal 1.7

Slovenia 1.7

Belgium 1.2

Canada 1.2

Egypt 1.2

Hungary 1.2

Japan 1.2

Mexico 1.2

Netherlands 1.2

Romania 1.2

Serbia 1.2

Venezuela 1.2

Austria 0.6

Benin 0.6



… Continued Table 2.1 Countries and percentage of individuals who participated in PCR Clin 2013

Country %

Cameroon 0.6

Chile 0.6

Côte d'Ivoire 0.6

France - Reunion Island

0.6

Hong Kong 0.6

Iran 0.6

Iraq 0.6

Israel 0.6

Kazakhstan 0.6

Malaysia 0.6

Nigeria 0.6

Russia 0.6

South Africa 0.6

Trinidad and Tobago 0.6

Tunisia 0.6

2.3 Regions Regionally, Europe and North America were the greatest participants in PCR Clin 2013 and together represented more than two thirds of participants (see Figure 2.2).


Figure 2.2 Global regions of individuals who participated in PCR Clin 2013

Other: 23%

Europe: 56%

North America: 12%

South America: 9%

2.4 PCR Activities of Participants Participants in PCR Clin 2013 indicated three general areas of activity in the use of PCR in screening and diagnostics, namely the conduct of routine tests, the development and validation of PCR tests and the use of PCR in qualitative studies. Together, these three areas represented over 70% of the activities in this area. Notably, almost half of these activities are associated with the development and validation of these tests (see Figure 2.3).



Figure 2.3 PCR activities of individuals who participated in PCR Clin 2013

PCR tests: 26% Development or Validation: 31%

Qualitative discovery: 20%


2.5 Organisation In this study, almost 90% of participants in PCR Clin 2013 are employed by four organisation types, namely universities, research institutes, Government organisations and hospitals or clinics (see Figure 2.4).

Figure 2.4 Organisation types of individuals who participated in PCR Clin 2013

Other: 23%

University: 51%

Research Institute: 17%

Other: 5% Large Companies: 1%

Government: 10%Hospital / Clinics: 11%

Small Companies: 3% Veterinary Organisation: 2%


2.6 Fields PCR Clin 2013 end‐users reported that they worked in 8 fields, of which universities, research institutes, clinics and hospitals were the largest groups. (see Figure 2.5)

Figure 2.5 Fields of individuals

who participated in PCR Clin 2013.

University: 29%

Research Institute: 29%

Pharmaceuticals: 2%

Government: 5%


2.7 Participants

All individuals (n = 173) who participated in PCR Clin 2013 use PCR directly in screening and diagnostics in their own laboratory or are closely associated with the use of this technique (e.g. as a laboratory supervisor or manager). More than 90% of the participants hold senior positions as scientists or managers, relating to PCR methods used in screening and diagnostics (see Table 2.2).

Clinical: 12%

Hospital: 11%

Healthcare: 7% Biotechnology: 5%



2.8 Discussion

This global PCR study involved the participation of a substantial number of PCR end‐users and its findings relating to the use of this technique in screening and diagnostics provide both depth and breadth of technical and market‐related findings relevant to developers and vendors in this field. Based on the (conservative) assumption that participants’ experience in the use of PCR range from 3 to 5 years, it is calculated that the findings of this study are based on 500 to 800 combined years of knowledge and experience of this technique. The professional positions of participants underline the depth of experience brought to this market study and these positions include medical doctor, professor, assistant professor, post‐doctoral researcher, Ph.D student, research fellow, managing director, senior scientist, departmental head and other similar positions.




3. PCR Techniques



3.1 This Chapter This chapter presents findings on the current use of specific PCR techniques in screening and diagnostics, reported by individuals who participated in PCR Clin 2013. Findings are also presented on the anticipated use of specific PCR techniques in screening and diagnostics over the next three years (2013 – 2016).

3.2 Current PCR Techniques Participants in PCR Clin 2013 reported on the current use (or non‐use) of more than 50 PCR techniques for screening and diagnostics, of which the top five are indicated below. Collectively, these five techniques represent three quarters of currently used PCR techniques for screening and diagnostic applications. See Figure 3.1 and Table 3.1

Edited (27.2%)

Edited (18.5%)

Edited (12.7%)

Edited (9.2%)

Edited (7.5%)

Figure 3.1 Top currently used PCR techniques (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013

30

0

10

20




Table 3.1 Currently used PCR techniques (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013

PCR Technique %

27.2

18.5

12.7

9.2

7.5

Hot start PCR 6.9

2.9

2.3

2.3

1.2

0.6

0.6

0.6

0.6

0.6

0.6

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0



… Continued Table 3.1 Currently used PCR techniques (%) in screening and diagnostics, reported by individuals who participated in PCR Clin 2013

PCR Technique %

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Other 5.8

3.3 Future PCR Techniques During the conduct of PCR Clin 2013, participants also reported on their anticipated use of specific PCR techniques for screening and diagnostics over the next three years. The findings to this question are presented in Figure 3.2 and Table 3.2 Of the PCR techniques, the top five indicated by participants are shown below. Collectively, these five techniques represent 63% of those cited.

Edited (24.3%)

Edited (18.5%)

Edited (8.1%)

Edited (6.9%)

Edited (5.2%)


Figure 3.2 PCR techniques that PCR Clin 2013 participants indicate they will be using over the next three years (2013 – 2016) in screening and diagnostics

30

20

10

0

Table 3.2 PCR techniques that PCR Clin 2013 participants indicate they will be using over the next three years (2013 – 2016) in screening and diagnostics

PCR Technique %

24.3

18.5

8.1

6.9

5.2

PCR array 4.6

4.0

2.3

1.7

1.7

1.7

1.2

1.2

1.2

1.2

1.2

1.2




… Continued Table 3.2 PCR techniques that PCR Clin 2013 participants indicate they will be using over the next three years (2013 – 2016) in screening and diagnostics

PCR Technique %

0.6

0.6

0.6

0.6

0.6

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Other 11.0

PCR in Screening and Diagnostics

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