The global medical device CRO market is estimated to grow from USD 13.3 billion in the current year to USD 19.3 billion by 2035, at a CAGR of 3.4% during the forecast period, till 2035.

Medical Device CRO Market: Growth and Trends

The increase in geriatric population and disease incidences, primarily chronic diseases, has led to a surge in the demand for novel medical devices across multiple therapeutic areas. Since 2020, the USFDA has approved ~105 medical devices. Further, it is interesting to note that over 35 medical devices receive FDA approval annually. However, one of the primary challenges faced by this industry is the time-consuming and complex product development lifecycle of a new medical device. Specifically, the clinical stage is exceedingly resource intensive, pertaining to higher costs and greater risks. In addition, the stringent regulatory guidelines to ensure the safety of medical devices make it more difficult for industrial leaders.

In order to address the abovementioned bottleneck, medical device developers are actively outsourcing their research operations to specialized medical device CRO. These organizations offer expertise in conducting clinical trials, navigating regulatory requirements, and ensuring compliance with safety standards. By partnering closely with manufacturers, CROs support translating novel ideas into market-ready products while rigorously monitoring throughout the product development lifecycle.

In addition to this, the landscape of medical devices is rapidly changing, driven by the integration of advanced technologies and tools, including risk monitoring tools, advanced data analytics, real world evidence solutions and cloud computing. Owing to the ongoing research and development, and increasing opportunities linked to the medical devices market, it is anticipated that the medical devices CRO market will witness healthy growth in the coming decade.

Medical Device CRO Market: Key Segments

Currently, Clinical Operations Segment Occupies the Largest Share of the Medical Device CRO Market

Based on the scale of operation, the market is segmented into clinical and preclinical services. At present, the clinical services segment holds the maximum share of the medical device CRO market. It is worth highlighting that the increasing number of medical device-focused clinical trials is likely to drive the market in the near future.

Class II Devices Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period

Based on the device class, the market is segmented into Class I, Class II, Class III. Currently, class II devices hold maximum share within the medical devices CRO market. This trend is unlikely to change in the short-mid-term.

Currently, Clinical Trial Management Segment Occupies the Largest Share of the Medical Device CRO Market

Based on the type of clinical services, the market is segmented into clinical trial management, data management, regulatory affairs management, and consulting. At present, clinical trial management holds the maximum share of the medical devices CRO market. This trend is likely to remain the same in the forthcoming years.

Biocompatibility Testing Services Segment is the Fastest Growing Segment of the Medical Device CRO Market During the Forecast Period

Based on the type of preclinical services, the market is segmented into biocompatibility testing, sterility, microbiology testing, material characterization, and analytical services. It is worth highlighting that, at present, sterility and microbial testing holds a larger share of the medical device CRO market. This trend is likely to remain the same in the coming decade.

Currently, CNS Disorders Segment Occupies the Largest Share of the Medical Device CRO Market

Based on the therapeutic area, the market is segmented into cardiovascular disorders, CNS disorders, metabolic disorders, oncological disorders, ophthalmological disorders, orthopedic disorders, pain disorders, psychological disorders, respiratory disorders and other disorders. It is worth highlighting that majority of the current medical device CRO market is captured by CNS disorders.

North America Accounts for the Largest Share of the Market

Based on the key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and the Rest of the world. Majority share is expected to be captured by CROs based in North America. It is worth highlighting that, over the years, the market of the rest of the world is expected to grow at a higher CAGR.

Medical Device CRO Market: Key Insights

The report delves into the current state of the medical device CRO market and identifies potential growth opportunities within the industry. Some key findings from the report include:

• More than 590 CROs currently claim to have the required capabilities to offer a wide range of research and analytical services for medical devices, across different scale of operations.
• The market is well fragmented, featuring a mix of players based across different geographical regions that provide services for a range of medical device classes.
• In pursuit of building a competitive edge, medical devices CROs are actively upgrading / expanding their capabilities to enhance their respective portfolios of offerings.
• Over the years, industry players have undertaken a variety of initiatives to further advance the development / enable the improvement of their proprietary services for medical devices.
• The rising interest in this domain is reflected in the number of mergers and acquisitions that have been reported in the last few years; 53% of such initiatives were focused on geographical consolidation.
• Over 14,000 trials, enrolling close to 4.6 million patients suffering from a myriad of disease indications, have been registered across the globe to evaluate the efficacy and accuracy of medical devices.
• Our proprietary total cost of ownership model suggests an informed estimate of direct and indirect expenses while setting up a contract research facility in different regions over a span of 20 years.
• Driven by the ongoing efforts of industry stakeholders, the medical devices contract research service providers the market is expected to witness steady growth in the coming decade.

Sample Players in the Medical Device CRO Market Profiled in the Report:

• Avania
• Charles River Laboratories
• CROMSOURCE
• CSSi LifeSciences
• Eurofins Medical Testing
• IQVIA
• Medpace
• NAMSA
• Qserve Group
• WuXi AppTec

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Key Topics Covered:

1. PREFACE

1.1. Scope of the Report

1.2. Market Segmentation

1.3. Research Methodology

1.4. Key Questions Answered

1.5. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview

3.2. Overview of Medical Devices

3.3. Overview of Contract Research Organizations (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 While Selecting a Suitable CRO Partner

4. MARKET LANDSCAPE

4.1. Chapter Overview

4.2. Medical Device CROs: Clinical Service Providers

4.3. Medical Device CROs: Preclinical Service Providers

4.4. Medical Device CROs: Standalone Service Providers

5. 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

5.4. Regulatory and Reimbursement Landscape in Europe

5.5. Regulatory and Reimbursement Landscape in Asia-Pacific and Rest of the World

5.6. Comparison of Regional Regulatory Control

5.7. Concluding Remarks

6. COMPANY PROFILES

6.1. Chapter Overview

6.2. Avania (Formerly known as Factory CRO)

6.3. Charles River Laboratories

6.4. CROMSOURCE

6.5. CSSi LifeSciences

6.6. Eurofins Medical Device Testing

6.7. IQVIA

6.8. Medpace

6.9. NAMSA

6.10. Qserve Group

6.11. WuXi AppTec

7. 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

7.5. Comparison of Key Performance Indicators

7.6. Concluding Remarks

8. COMPETITIVE BENCHMARKING

8.1. Chapter Overview

8.2. Assumptions and Methodology

8.3. Competitive Benchmarking by Region

8.4. Concluding Remarks

9. 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: NAMSA

10. CLINICAL TRIAL ANALYSIS

10.1. Chapter Overview

10.2. Scope and Methodology

10.3. Medical Devices: Clinical Trial Analysis

10.4. Medical Devices: Analysis by Enrolled Patient Population

11. MERGERS AND ACQUISITIONS

11.1. Chapter Overview

11.2. Merger and Acquisition Models

11.3. Medical Device CROs: Mergers and Acquisitions

12. TOTAL COST OF OWNERSHIP FOR MEDICAL DEVICES CONTRACT RESEARCH ORGANIZATION

12.1. Chapter Overview

12.2. Key Parameters

12.3. Assumptions and Methodology

12.4. Sample Dataset for the estimation of Total Cost of Ownership

13. SURVEY INSIGHTS

13.1. Chapter Overview

13.2. Designation of Respondents

13.3. Types of Services Offered

13.4. Target Therapeutic Area

13.5. Average Number of Annual Projects

13.6. Market Opportunity

14. MARKET SIZING AND OPPORTUNITY ANALYSIS

14.1. Chapter Overview

14.2. Assumptions and Forecast Methodology

14.3. Overall Medical Device CROs Market, till 2035

14.4. Medical Device CROs Market in North America, till 2035

14.5. Medical Device CROs Market in Europe, till 2035

14.6. Medical Device CROs Market in Asia-Pacific, till 2035

14.7. Medical Device CROs Market in Rest of the World, till 2035

15. SWOT ANALYSIS

15.1. Chapter Overview

15.2. Strengths

15.3. Weaknesses

15.4. Opportunities

15.5. Threats

15.6. Concluding Remarks

16. FUTURE TRENDS AND OPPORTUNITIES

16.1. Chapter Overview

16.2. Anticipated Growth in Number of Connected Devices

16.3. Adoption of Data Analytics and Real-Time Monitoring Solutions

16.4. Need for Cloud-based Computing and Storage Solutions

16.5. Growing Demand for Real World Evidence to Obtain Regulatory Approval

16.6. Concluding Remarks

17. CONCLUDING REMARKS

18. INTERVIEW TRANSCRIPTS

18.1. Chapter Overview

18.2. HungaroTrial

18.2.1. Company Snapshot

18.2.2. Interview Transcript: Lajos Sarosi, Chief Executive Officer and Co-founder

18.3. ClinChoice

18.3.1. Company Snapshot

18.3.2. Lee King, Senior Vice President of Business Development and Marketing

18.4. NAMSA

18.4.1. Company Snapshot

18.4.2. Christopher Rupp, Vice President of Global Marketing and Commercial Operations

18.5. CTC North

18.5.1. Company Snapshot

18.5.2. Claus Hemiker, Head of Business Development

18.6. CW Research & Management

18.6.1. Company Snapshot

18.6.2. Christian Wolflehner, General Manager

18.7. CROMSOURCE

18.7.1. Company Snapshot

18.7.2. Troy McCall, Chief Operating Officer

18.8. Metrics Research

18.8.1. Company Snapshot

18.8.2. Nazish Urooj, Senior manager, Medical & Clinical Operations

18.9. Vyomus Consulting

18.9.1. Company Snapshot

18.9.2. C. Omprakash, Technical Director and Partner

18.10. A+ Science

18.10.1. Company Snapshot

18.10.2. Tania Persson, Director of Business Development

18.11. AtoZ-CRO

18.11.1 Company Snapshot

18.11.2. Alexa Foltin-Mertgen, Business Development Manager

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