Dublin, Dec. 18, 2025 (GLOBE NEWSWIRE) -- The "Medical Device CRO Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Target Therapeutic Area, Scale of Operation, Device Class, Type of Clinical Service Offered, Type of Preclinical Service Offered and Key Geographies" has been added to ResearchAndMarkets.com's offering.
The global medical device CRO market is projected to grow from USD 13.3 billion in the current year to USD 19.3 billion by 2035, driven by a significant CAGR during the forecast period. This growth is largely fueled by the increasing elderly population and the prevalence of chronic illnesses, sparking a demand for innovative medical devices. Since 2020, the USFDA has approved approximately 105 medical devices, with over 35 gaining approval each year. However, the industry faces hurdles, including a complex and resource-demanding product development phase, enhanced by regulatory mandates ensuring medical devices' safety, which complicate operations for industry leaders.
To navigate these challenges, medical device developers increasingly outsource research activities to specialized CROs, which excel in handling clinical studies, regulatory demands, and safety compliance. These organizations facilitate the transition of innovative concepts to market, efficiently managing the product development lifecycle. The rapid integration of advanced technologies and tools, like risk monitoring systems and cloud computing, is reshaping the medical device landscape, forecasting significant growth for the CRO market in the coming decade.
Key insights from the report reveal that over 590 CROs claim competency in offering diverse research and analytical services for medical devices. The market is notably fragmented, with various players across different regions providing services for a range of device classes. CROs are continuously enhancing their capabilities to better their service offerings, evident in strategic mergers and acquisitions, where 53% target geographical consolidation. Over 14,000 trials involving approximately 4.6 million patients with various conditions are registered worldwide to assess medical devices' efficacy and accuracy. The market's steady growth is expected, propelled by stakeholders' ongoing efforts.
The market segmentation reveals that clinical operations currently command the largest share. Notably, the clinical services sector remains dominant due to rising clinical trials on medical devices. Meanwhile, Class II devices are poised as the fastest-growing segment. In preclinical services, biocompatibility testing emerges as the fastest-growing type, though sterility and microbial testing hold a significant market share. CNS disorders dominate the therapeutic area segment, reflecting a substantial part of the device CRO market. Geographically, North America leads the charge with the largest market share, though other regions are expected to grow at higher CAGRs over the years.
Prominent players within this space include Avania, Charles River Laboratories, CROMSOURCE, CSSi LifeSciences, Eurofins Medical Testing, IQVIA, Medpace, NAMSA, Qserve Group, and WuXi AppTec. The research report, bolstered by conversations with various industry stakeholders, investigates several factors, including market sizing, competitive benchmarking, regulatory landscapes, and clinical trials analysis.
The study addresses critical questions like the number of active companies, leading market players, influencers on market evolution, and market size forecasts. It offers a comprehensive market overview, including SWOT analysis, to guide stakeholders in making informed decisions. Additional benefits include complimentary PPT insights, Excel data packs, and content customization, coupled with report walkthrough sessions for detailed understanding, ensuring stakeholders are well-equipped to navigate and excel in the medical device CRO market.
Key Topics Covered
Section I: Report Overview
1. Preface
2. Research Methodology
3. Market Dynamics
4. Macro-Economic Indicators
Section II: Qualitative Insights
5. Executive Summary
6. Introduction
7. Regulatory and Reimbursement Landscape for Medical Devices
Section III: Competitive Landscape
8. Medical Device Preclinical CROs: Market Landscape
9. Medical Device Clinical CROs: Market Landscape
10. Brand Positioning Analysis: Preclinical Medical Device CROs
11. Competitive Benchmarking: Clinical CROs
Section IV: Company Profiles
12. Company Profiles
Section V: Market Trends
13. Mergers and Acquisitions
14. Clinical Trial Analysis
15. Future Trends and Opportunities
Section VI: Market Forecast and Opportunity Analysis
16. SWOT Analysis
17. Global Medical Device CRO Market
18. Medical Device CRO Market, by Class of Medical Device
19. Medical Device CRO Market, by Type of Medical Device
20. Medical Device CRO Market, by Scale of Operation
21. Medical Device CRO Market, by Type of Preclinical Service Offered
22. Medical Device CRO Market, by Type of Clinical Service Offered
23. Medical Device CRO Market, by Company Size
24. Medical Device CRO Market, by Type of Original Equipment Manufacturer
25. Medical Device CRO Market, by Target Indication
26. Medical Device CRO Market, by Geographical Regions
27. Medical Device CRO Market, by Leading Players
Section VII: Case Study
28. Medical Device Developer and CRO Relationships: Key Value Drivers and Performance Indicators
29. Total Cost of Ownership for Medical Devices CROs
30. Case Study: List of Additional Medical Device CROs
Section VIII: Other Exclusive Insights
31. Conclusion
32. Executive Insights
Section IX: Appendices
33. Appendix I: Tabulated Data
34. Appendix II: List of Additional Medical Device Clinical CROs
35. Appendix III: List of Companies and Organizations
A selection of companies mentioned in this report includes, but is not limited to:
- 1MED
- 4Clinics
- 4Pharma
- A+ Science
- Abiogenesis Clinpharm
- Abond CRO
- Absorption Systems
- Absorption Systems
- ABX-CRO
- Acceliant
- Accell Clinical Research
- AccelLAB
- Accelovance
- Accredited Consultants
- AccuLab Life Sciences
- Accuprec Research Labs
- Accutest Research Laboratories
- Acorn Regulatory
- Acrapack
- acromion
- aCROss Medical
- ACT FARMA CRO
- Activa Cro
- ADAX International
- Advanced Drug Development Services
- Advanced Medical Research
- Advena
- Affinity Bio Partners
- Afortiori Development
- Afra Pharma Consultant
- Aginko Research
- AICROS
- CETERA
- AIX Scientifics
- AJW Technology Consultants
- AKRN
- Al Tamimi & Company
- Alera Labs
- Alira Health
- Allied Clinical Management
- Altair Clinical
- Altasciences
- Altiora
- AlvaMed
- Amarex
- American Preclinical Services (Acquired by NAMSA)
- and many, many more!
For more information about this report visit https://www.researchandmarkets.com/r/v4eihr
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