Roots Analysis has done a detailed study on Medical Device CRO Market (2nd Edition), 2020-2030, covering various important aspects of the industry and identifying key future growth opportunities.
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Key Market Insights
- Since 2015, over 7,500 medical device focused clinical trials, involving the participation of close to 2.9 million patients across different hospitals / medical centers, have been registered worldwide
- Over 300 CROs presently claim to possess the necessary capabilities to offer a wide range of preclinical and clinical research-related services to medical device-focused business entities
- The market landscape is highly fragmented, featuring the presence of both established players and new entrants; majority of such firms are located in the developed geographies
- Owing to the high competition in this field, stakeholders are steadily expanding their capabilities in order to augment their respective service portfolios and also comply to evolving industry benchmarks
- Over the years, the domain has witnessed an increase in merger and acquisition activity, with many CROs expanding their presence across multiple geographies and growing their respective service portfolios
- Several companies in this domain have established strong brand positions across different regions; in future, such companies are anticipated to contribute the most to the overall revenue generation potential
- Driven by the growing demand for effective treatment modalities across various therapeutic areas, the market is poised to witness sustained growth across various device classes and geographies
- In the long term, we expect the market to reach over USD 15 billion; the current and future opportunity is likely to be distributed across companies of different sizes offering various types of clinical and preclinical services
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Table of Contents
- PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines
- EXECUTIVE SUMMARY
- INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Medical Devices
3.2.1. Historical Evolution of Medical Devices
3.2.2. Classification of Medical Devices
3.3. Overview of Contract Research Organizations (CROs)
3.3.1. Evolution of CROs
3.4. Role of CROs in the Medical Device Industry
3.5. Types of Medical Device CROs
3.6. Types of Services Offered by CROs
3.7. Advantages of Outsourcing Operations to CROs
3.8. Risks and Challenges Associated with Outsourcing
3.9. Key Considerations for Selecting a Suitable CRO Partner
- MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Medical Device CROs: Clinical Service Providers
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters
4.2.5. Analysis by Area of Specialization
4.2.6. Analysis by Device Class
4.2.7. Analysis by Type of Clinical Operation Services Offered
4.2.8. Analysis by Type of Regulatory Affairs-related Services Offered
4.2.9. Analysis by Type of Additional Services Offered
4.2.10. Analysis by Medical Device Regulatory Compliance Authorities
4.3. Medical Device CROs: Preclinical Service Providers
4.3.1. Analysis by Year of Establishment
4.3.2. Analysis by Company Size
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Company Size and Location of Headquarters
4.3.5. Analysis by Type of Preclinical Services Offered
4.4. Medical Device CROs: Standalone Service Providers
4.4.1. Analysis by Year of Establishment
4.4.2. Analysis by Company Size
4.4.3. Analysis by Location of Headquarters
4.4.4. Analysis by Company Size and Location of Headquarters
- REGULATORY AND REIMBURSEMENT LANDSCAPE FOR MEDICAL DEVICES
5.1. Chapter Overview
5.2. General Regulatory and Reimbursement Guidelines for Medical Devices
5.3. Regulatory and Reimbursement Landscape in North America
5.3.1. The US Scenario
5.3.1.1. Regulatory Authority
5.3.1.2. Review / Approval Process
5.3.1.3. Reimbursement Landscape
5.3.1.3.1. Payer Mix
5.3.1.3.2. Reimbursement Process
5.3.2. The Canadian Scenario
5.3.2.1. Regulatory Authority
5.3.2.2. Review / Approval Process
5.3.2.3. Reimbursement Landscape
5.3.2.3.1. Payer Mix
5.3.2.3.2. Reimbursement Process
5.3.3. The Mexican Scenario
5.3.3.1. Regulatory Authority
5.3.3.2. Review / Approval Process
5.3.3.3. Reimbursement Landscape
5.3.3.3.1. Payer Mix
5.4. Regulatory and Reimbursement Landscape in Europe
5.4.1. Overall Scenario
5.4.1.1. Overall Regulatory Authority
5.4.1.2. Overall Review / Approval Process
5.4.2. The UK Scenario
5.4.2.1. Regulatory Authority
5.4.2.2. Review / Approval Process
5.4.2.3. Reimbursement Landscape
5.4.2.3.1. Payer Mix
5.4.2.3.2. Reimbursement Process
5.4.3. The French Scenario
5.4.3.1. Regulatory Authority
5.4.3.2. Review / Approval Process
5.4.3.3. Reimbursement Landscape
5.4.3.3.1. Payer Mix
5.4.3.3.2. Reimbursement Process
5.4.4. The German Scenario
5.4.4.1. Regulatory Authority
5.4.4.2. Review / Approval Process
5.4.4.3. Reimbursement Landscape
5.4.4.3.1. Payer Mix
5.4.4.3.2. Reimbursement Process
5.4.5. The Italian Scenario
5.4.5.1. Regulatory Authority
5.4.5.2. Review / Approval Process
5.4.5.3. Reimbursement Landscape
5.4.5.3.1. Payer Mix
5.4.5.3.2. Reimbursement Process
5.4.6. The Spanish Scenario
5.4.6.1. Regulatory Authority
5.4.6.2. Review / Approval Process
5.4.6.3. Reimbursement Landscape
5.4.6.3.1. Payer Mix
5.4.6.3.2. Reimbursement Process
5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World
5.5.1. The Australian Scenario
5.5.1.1. Regulatory Authority
5.5.1.2. Review / Approval Process
5.5.1.3. Reimbursement Landscape
5.5.1.3.1. Payer Mix
5.5.1.3.2. Reimbursement Process
5.5.2. The Brazilian Scenario
5.5.2.1. Regulatory Authority
5.5.2.2. Review / Approval Process
5.5.2.3. Reimbursement Landscape
5.5.2.3.1. Payer Mix
5.5.2.3.2. Reimbursement Process
5.5.3. The Chinese Scenario
5.5.3.1. Regulatory Authority
5.5.3.2. Review / Approval Process
5.5.3.3. Reimbursement Landscape
5.5.3.3.1. Payer Mix
5.5.3.3.2. Reimbursement Process
5.5.4. The Indian Scenario
5.5.4.1. Regulatory Authority
5.5.4.2. Review / Approval Process
5.5.4.3. Reimbursement Landscape
5.5.4.3.1. Payer Mix
5.5.5. The Israeli Scenario
5.5.5.1. Regulatory Authority
5.5.5.2. Review / Approval Process
5.5.5.3. Reimbursement Landscape
5.5.5.3.1. Payer Mix
5.5.6. The Japanese Scenario
5.5.6.1. Regulatory Authority
5.5.6.2. Review / Approval Process
5.5.6.3. Reimbursement Landscape
5.5.6.3.1. Payer Mix
5.5.6.3.2. Reimbursement Process
5.5.7. The New Zealand Scenario
5.5.7.1. Regulatory Authority
5.5.7.2. Review / Approval Process
5.5.7.3. Reimbursement Landscape
5.5.7.3.1. Payer Mix
5.5.7.3.2. Reimbursement Process
5.5.8. The Singapore Scenario
5.5.8.1. Regulatory Authority
5.5.8.2. Review / Approval Process
5.5.8.3. Reimbursement Landscape
5.5.8.3.1. Payer Mix
5.5.8.3.2. Reimbursement Process
5.5.9. The South Korean Scenario
5.5.9.1. Regulatory Authority
5.5.9.2. Review / Approval Process
5.5.9.3. Reimbursement Landscape
5.5.9.3.1. Payer Mix
5.5.9.3.2. Reimbursement Process
5.5.10. The South African Scenario
5.5.10.1. Regulatory Authority
5.5.10.2. Review / Approval Process
5.5.10.3. Reimbursement Landscape
5.5.11. The Taiwan Scenario
5.5.11.1. Regulatory Authority
5.5.11.2. Review / Approval Process
5.5.11.3. Reimbursement Landscape
5.5.11.3.1. Payer Mix
5.5.11.3.2. Reimbursement Process
5.5.12. The Thailand Scenario
5.5.12.1. Regulatory Authority
5.5.12.2. Review / Approval Process
5.5.12.3. Reimbursement Landscape
5.6. Comparison of Regional Regulatory Control
5.7. Concluding Remarks
- COMPANY PROFILES
6.1. Chapter Overview
6.2. Avania (Formerly known as Factory CRO)
6.2.1. Company Overview
6.2.2. Service Portfolio
6.2.3. Future Outlook
6.3. Charles River Laboratories
6.3.1. Company Overview
6.3.2. Service Portfolio
6.3.3. Future Outlook
6.4. Clinlogix
6.4.1. Company Overview
6.4.2. Service Portfolio
6.4.3. Future Outlook
6.5. CROMSOURCE
6.5.1. Company Overview
6.5.2. Service Portfolio
6.5.3. Future Outloo
6.6. CSSi LifeSciences
6.6.1. Company Overview
6.6.2. Service Portfolio
6.6.3. Future Outlook
6.7. Eurofins Medical device Testing
6.7.1. Company Overview
6.7.2. Service Portfolio
6.7.3. Future Outlook
6.8. genae
6.8.1. Company Overview
6.8.2. Service Portfolio
6.8.3. Future Outlook
6.9. IMARC Research
6.9.1. Company Overview
6.9.2. Service Portfolio
6.9.3. Future Outlook
6.10. IQVIA
6.10.1. Company Overview
6.10.2. Service Portfolio
6.10.3. Future Outlook
6.11. Medpace
6.11.1. Company Overview
6.11.2. Service Portfolio
6.11.3. Future Outlook
6.12. NAMSA
6.12.1. Company Overview
6.12.2. Service Portfolio
6.12.3. Future Outlook
6.13. Qserve Group
6.13.1. Company Overview
6.13.2. Service Portfolio
6.13.3. Future Outlook
6.14. Regulatory and Clinical Research Institute (Now a part of Covance)
6.14.1. Company Overview
6.14.2. Service Portfolio
6.14.3. Future Outlook
6.15. WuXi AppTec
6.15.1. Company Overview
6.15.2. Service Portfolio
6.15.3. Future Outlook
- MEDICAL DEVICE DEVELOPER AND CRO RELATIONSHIPS: KEY VALUE DRIVERS AND PERFORMANCE INDICATORS
7.1. Chapter Overview
7.2. Definition and Importance of Key Performance Indicators (KPIs)
7.3. Key Considerations for Selection of KPIs
7.4. Types of KPIs
7.4.1. Financial Indicators
7.4.1.1. Most Important KPIs
7.4.1.1.1. Financial Stability
7.4.1.1.2. Cost of Services Offered
7.4.1.1.3. Comparative Analysis of Financial Indicators
7.4.1.2. Industry Perspective
7.4.1.2.1. Sponsors’ (Big Pharma) Perspective
7.4.1.2.2. Contract Service Providers’ Perspectiv
7.4.2. Process and Capability Indicators
7.4.2.1. Most Important KPIs
7.4.2.1.1. Proximity to Sponsor
7.4.2.1.2. Capability to Innovate / Mitigate Risk
7.4.2.1.3. Strength of Service Portfolio
7.4.2.1.4. Comparative Analysis of Process / Capability Indicators
7.4.2.2. Industry Perspective
7.4.2.2.1. Sponsors’ (Big Pharma) Perspective
7.4.2.2.2. Contract Service Providers’ Perspective
7.4.3. Market Reputation Indicators
7.4.3.1. Most Important KPIs
7.4.3.1.1. Flexibility / Adaptability
7.4.3.1.2. Time Management
7.4.3.1.3. Quality / Reliability
7.4.3.1.4. Regulatory Compliance / Track Record
7.4.3.1.5. Comparative Analysis of Market Reputation Indicators
7.4.3.2. Industry Perspective
7.4.3.2.1. Sponsors’ (Big Pharma) Perspective
7.4.3.2.2. Contract Service Providers’ Perspective
7.5. Comparison of Key Performance Indicators
7.6. Concluding Remarks
- COMPETITIVE BENCHMARKING
8.1. Chapter Overview
8.2. Assumptions and Methodology
8.3. Competitive Benchmarking by Region
8.3.1. North America, Peer Group I
8.3.2. North America, Peer Group II
8.3.3. North America, Peer Group III
8.3.4. Europe, Peer Group IV
8.3.5. Europe, Peer Group V
8.3.6. Europe, Peer Group VI
8.3.7. Asia-Pacific, Peer Group VII
8.3.8. Asia-Pacific, Peer Group VIII
8.3.9. RoW, Peer Group IX
8.4. Concluding Remarks
- BRAND POSITIONING OF KEY INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Brand Positioning Matrix: Labcorp
9.4. Brand Positioning Matrix: IQVIA
9.5. Brand Positioning Matrix: Syneos Health
9.6. Brand Positioning Matrix: PPD
9.7. Brand Positioning Matrix: ICON
9.8. Brand Positioning Matrix: Charles River Laboratories
9.9. Brand Positioning Matrix: WuXi AppTec
9.10. Brand Positioning Matrix: Medpace
9.11. Brand Positioning Matrix: PAREXEL International
9.12. Brand Positioning Matrix: NAMSA
- CLINICAL TRIAL ANALYSIS
10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Medical Devices: Clinical Trial Analysis
10.3.1. Analysis by Trial Registration Year
10.3.2. Analysis by Trial Status
10.3.3. Analysis by Trial Phase
10.3.4. Analysis by Therapeutic Area
10.3.5. Analysis by Geography
10.3.6. Geographical Analysis by Trial Status
10.4. Analysis by Type of Sponsor
10.5. Medical Devices: Analysis of Enrolled Patient Population
10.5.1. Analysis by Trial Registration Year
10.5.2. Analysis by Trial Status
10.5.3. Analysis by Trial Phase
10.5.4. Analysis by Therapeutic Area
10.5.5. Analysis by Location of Trial Site
10.5.6. Analysis by Trial Status and Location of Trial Site
Contact Details
Gaurav Chaudhary
+1 (415) 800 3415
gaurav.chaudhary@rootsanalysis.com
