Clinical Imaging: Market and Outsourcing Dynamics - Industry Standard Research...
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Clinical Imaging: Market and
Outsourcing Dynamics
©2014 Industry Standard Research www.ISRreports.com
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Report OverviewClinical imaging has become an integral part of the extensive and expensive research and development process of the pharmaceutical and biotechnology industries. Clinical imaging modalities such as magnetic resonance images (MRI), computed topography scans (CT), and x-rays are fundamental in testing the safety and efficacy of drugs in development phases I through IV.
This report offers two unique perspectives to the clinical imaging service provider market based on the surveys ISR has administered – one from the perspective of companies who currently outsource their imaging services and another from the actual imaging service providers.
7,906Clinical Imaging Trials Analyzed
134Pages
26Companies Included 1. Executive summary
2. Demographics & responsibilities of companies outsourcing imaging services
3. Perspectives on outsourcing from companies that outsource imaging services
4. Experiences & practices of companies outsourcing imaging services
5. Current use of imaging within clinical trials
6. Service provider capabilities
Methodologies
How you can use this report:
Report Structure:
Sponsor Companies:
• Compare potential service providers • Identify which imaging companies are most
recognizable in the imaging service sector• Learn how competitors use imaging service
providers
Imaging Companies:
• Understand the needs and demands that currently exist within the market
• Benchmark current offerings compared to industry averages
• Learn how to differentiate from competitors
ISR gathered content for this report via an exhaustive primary and secondary research effort.
Primary Research:
• 30-45 minute web based quantitative and qualitative survey with 60 respondents from companies who outsource imaging clinical trials
• Company profile questionnaires distributed to CROs profiled in this report
Secondary Research:
• An analysis of clinicaltrials.gov data to provide a high-level overview of current clinical imaging trial activity
• Company and Association information gathered from company websites and publications
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Full-service CROs• Bioclinica• Biomedical Systems• Certus International• Charles River• Covance• ICON• Medpace• PAREXEL Informatics• QPS Holdings, LLC• Caliper Discovery Alliances and Services
Dedicated imaging CROs• Canfield Scientific, Inc• Cardiovascular Imaging Technologies• Clinical Image Management Systems• Flagship BioSciences• ACR Image Metrix• Illuminostics• Imaging Endpoints• Inference Systems• Intrinsic Imaging• Molecular NeuroImaging• Numira Biosciences• Prism Clinical• Radcore Labs• Radiant Sage• VirtualScopic• WorldCare
MRI
PET
Angiograph
ECHO
Tomograph
Ultrasound
SPECT
X-ray
Companies Included:
Imaging Modalities Included:
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Table of ContentsCopyright and usage guidelines
Introduction
Report benefits
Report sections
Methodology and sources
Executive Summary
Imaging provider characteristics
Differentiating imaging-dedicated and full-service CROs
Trends amongst companies that outsource imaging services
Overview of imaging service provider capabilities
Overview of company profile results
ClinicalTrials.gov summary data
Demographics & responsibilities of respondents outsourcing imaging services
Respondent demographics
Type of organization
Job titles of respondents
Corporate headquarters location
Office location
Functional areas of responsibility
Primary functional responsibility
Respondent roles in selecting outsourcing vendors
Perspectives on outsourcing imaging services
Use of imaging modalities
Imaging modalities used in past 12 months
Growth/decline in use of imaging modalities
How imaging is utilized
Imaging needs met by clinical vs. molecular imaging
Anticipated imaging needs met by clinical vs. molecular imaging
Centralized vs. decentralized approach to image reading
Preference for centralized vs. decentralized approach to image reading
Perceived value of imaging service providers
Projected growth/decline in imaging studies – 18 month projection
Experiences & practices of companies outsourcing imaging services
Familiarity with imaging service providers
Level of involvement with imaging trials
Familiarity with imaging service providers
Familiarity with specific imaging service providers
Preferred attributes of imaging service providers
Top 5 attributes of imaging service providers – selected by those outsourcing the service
Top 3 attributes of imaging service providers – selected by those outsourcing the service
Top attribute of imaging service providers – selected by those outsourcing the service
Imaging outsourcing market
Likelihood to outsource specific imaging services
Percent of imaging services that are outsourced
Percent of imaging services to be outsourced – 18 month projection
Current use of imaging within clinical trials
All technologies
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase - industry only
Clinical imaging trails by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
MRI
Number of clinical imaging trials by phase
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Table of ContentsNumber of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase – industry only
MRI clinical imaging trails by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
PET
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase – industry only
PET clinical imaging trials by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
Angiograph
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase - industry only
Angiograph clinical imaging trails by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase– industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
ECHO
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase – industry only
ECHO clinical imaging trials by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
Tomograph
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials
Average number of patients in clinical imaging trials by phase – industry only
Tomograph clinical imaging trails by sponsor company
Clinical imaging trails by sponsor type
Number of interventional imaging trials by phase
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Table of Contents
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
Ultrasound
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase– industry only
Ultrasound clinical imaging trails by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
X-ray
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patient in clinical imaging trials by phase
Average number of patient in clinical imaging trials by phase – industry only
X-ray clinical imaging trails by sponsor company
Clinical imaging trials by sponsor type
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
SPECT
Number of clinical imaging trials by phase
Number of clinical imaging trials by phase – industry only
Average number of patients in clinical imaging trials by phase
Average number of patients in clinical imaging trials by phase – industry only
Clinical imaging trials by sponsor type
SPECT clinical imaging trails by sponsor company
Number of interventional imaging trials by phase
Number of interventional imaging trials by phase – industry only
Average number of patients in interventional imaging trials by phase
Average number of patients in interventional imaging trials by phase – industry only
Service provider capabilities
Capabilities charts
Company Profiles
Company profiles - Dedicated Imaging CROs
Intrinsic Imaging
Radiant Sage
Contact list – Dedicated Imaging CROs
Company profiles - Full-Service CROs
Bioclinica
Biomedical Systems
Medpace
Contact list – Full-Service CROs
About Industry Standard Research
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Introduction
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IntroductionClinical imaging has become an integral part of the extensive and expensive research and development process of the pharmaceutical and biotechnology industries� Clinical imaging modalities such as magnetic resonance images (MRI), computed topography scans (CT), and x-rays are fundamental in testing the safety and efficacy of drugs in development phases I through IV� As is the case with controlled, interventional study designs, the volume of scans that must be done for statistically significant results that successfully eliminate the incidence of type I and type II errors is substantial�
Further, because these scans offer little (if any) quantitative information, reading the data offered by imaging software often requires professionals with backgrounds in radiology� Coupled with equipment and labor costs, the cost of clinical imaging becomes a major factor in the drug development process that requires informed decision-making by both pharmaceutical companies and CROs that outsource or perform their imaging processes�
ISR has identified two types of clinical imaging service providers that are outlined and compared to one another throughout this report� The imaging needs of a company may depend on whether a company requires an imaging service in addition to other clinical research services or would prefer working with a company that focuses exclusively on imaging modalities� ISR will use “multi-service CROs” and “dedicated imaging CROs” to differentiate the two�
• Multi-service CROs: Larger CROs such as ICON have developed imaging departmentswith extensive databases of clinical imaging outputs to augment their full-servicecapabilities�
• Dedicated imaging CROs: Service providers such as ACR Image Metrix focus exclusivelyon imaging services and operate as a vendor to not only pharmaceutical companies, butother CROs in need of imaging services�
Recent industry activity
• July 2013: VirtualScopics, a full-service CRO completed a Phase III breast cancer studywhich included ten thousand image scans and two million data records in five weeks’time with no data errors�
• March 2013: Private equity firm, JLL Partners acquired BioClinica and CoreLab in aneffort to establish an industry model for imaging core lab services� The point being,clinical imaging services are growing within the industry and third party companies aretaking notice�
• March 2012: WorldCare Clinical began offering a 24-hour safety assessment service forclinical images via their WorldPro automated image management platform�
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Perspectives on outsourcing imaging services
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Perceived value of imaging service providers“I view imaging service providers I work with as…” (Base=60)
Projected growth/decline in imaging studies – 18 month projection“Over the next 18 months, how do you expect the volume of imaging studies to change? Your best estimate is fine.” (Base=60)
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Perceived value of imaging service providers
“I view imaging service providers I work with as…” (Base=60)
Projected growth/decline in imaging studies – 18 month projection
“Over the next 18 months, how do you expect the volume of imaging studies to change? Your best estimate is fine.” (Base=60)
10%
48%
42%
0% 10% 20% 30% 40% 50% 60%
Low value-add vendors
Incremental value-add suppliers
High value-add partners
2%
2%
3%
3%
33%
30%
23%
3%
0% 5% 10% 15% 20% 25% 30% 35%
Don’t know
Greatly decrease (>-20%)
Moderately decrease (-10-20%)
Slightly decrease (-5-10%)
Remain roughly constant (+/- 5%)
Slightly increase (5-10%)
Moderately increase (10-20%)
Greatly increase (>20%)
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Perceived value of imaging service providers
“I view imaging service providers I work with as…” (Base=60)
Projected growth/decline in imaging studies – 18 month projection
“Over the next 18 months, how do you expect the volume of imaging studies to change? Your best estimate is fine.” (Base=60)
10%
48%
42%
0% 10% 20% 30% 40% 50% 60%
Low value-add vendors
Incremental value-add suppliers
High value-add partners
2%
2%
3%
3%
33%
30%
23%
3%
0% 5% 10% 15% 20% 25% 30% 35%
Don’t know
Greatly decrease (>-20%)
Moderately decrease (-10-20%)
Slightly decrease (-5-10%)
Remain roughly constant (+/- 5%)
Slightly increase (5-10%)
Moderately increase (10-20%)
Greatly increase (>20%)
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Perspectives on outsourcing imaging services
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Use of imaging modalitiesImaging modalities used in past 12 months“Which of the following imaging services have you used in the past 12 months? (Select all that apply)” (Base=60)
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Perspectives on outsourcing imaging services
Use of imaging modalit ies
Imaging modalit ies used in past 12 months
“Which of the following imaging services have you used in the past 12 months? (Select all that apply)” (Base=60)
0%
2%
3%
3%
5%
5%
8%
12%
12%
13%
15%
17%
17%
18%
18%
33%
42%
47%
48%
62%
72%
0% 10% 20% 30% 40% 50% 60% 70% 80%
Video gait analysis
Orthopantomography (OPT or OPG)
Actigraphy
Photoacoustic imaging
SPECT
Thermal
Autoradiography
Breast thermography
Radiography: Fluoroscopy and Projectional radiographs
Doppler
Diffusion tensor imaging (or Diffusion MRI)
Angiography
Dual energy x-ray absorptiometry (DEXA)
Functional magnetic resonance imaging (fMRI)
Photography
X-ray
Nuclear Medicine: Positron emission tomography (PET)
Ultrasound
Echocardiography (ECHO)
Computed tomography (CT)
Magnetic resonance imaging (MRI)
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Current use of imaging within clinical trials
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Average number of patients in clinical imaging trials by phaseResults are based on the number of trials (N=7,906) reported by clinicaltrials�gov to contain one of the imaging modalities (or variations of that imaging modality) in the trial’s description� The chart reports the average number of patients participating in clinical trials by phase (as well as the total number of that phase’s trials taking place)� How to read chart: “In 2010, for the 193 phase I imaging trials that took place, there was an average of 40 patients participating in each trial�”
2010 2011 2012 2013 Total
Phase 0 1967 (N=19)
29 (N=16)
54 (N=41)
86 (N=19)
451 (N=95)
Phase I 40 (N=193)
43 (N=188)
47 (N=171)
38 (N=68)
42 (N=620)
Phase II 75 (N=444)
87 (N=355)
89 (N=395)
80 (N=219)
83 (N=1413)
Phase III 755 (N=192)
507 (N=201)
1050 (N=181)
296 (N=84)
703 (N=658)
Phase IV 339 (N=217)
458 (N=217)
327 (N=234)
219 (N=76)
358 (N=744)
No Phase 3315 (N=1088)
*516 (N=1141)
4422 (N=1361)
3643 (N=786)
*603(N=4376)
Total 1811 (N=2153)
*391(N=2118)
2656 (N=2383)
2324 (N=1252)
*449(N=7906)
*ISR believes the enrollment figure for the trials taking place in 2011 and subsequently under the total column with “no Phase” listed were heavily influenced by an outlier which was removed�
All Technologies
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2010 2011 2012 2013 Total
Phase 0 1967 (N=19)
Phase I 40 (N=193)
Phase II 75 (N=444)
Phase III 755 (N=192)
Phase IV 339 (N=217)
No Phase 3315 (N=1088)
Total 1811 (N=2153)
Data available in full report
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