The global preclinical medical device testing services market is estimated to be USD 3.91 billion in 2024 and is expected to reach USD 10.34 billion by 2035, with a CAGR of 9.24% during the forecast period 2025-2035. Regulations and compliance requirements are becoming more and more stringent. The market will develop due to the emergence of advanced testing technologies, the growing trend of outsourcing in R&D, and the increased focus on patient safety and product quality.
In response to increasing patient safety concerns and a heightened emphasis on product quality, manufacturers in the medical device industry are prioritizing high-quality, accurate preclinical testing. There is a growing demand for testing services that minimize risks and enhance device reliability, as these measures are essential to prevent device recalls and improve patient outcomes. A notable development in this arena occurred in November 2023 when Crown Bioscience, in collaboration with JSR Life Sciences, announced the launch of OrganoidXplore. This innovative service offering provides robust, reproducible, and clinically relevant outputs, significantly accelerating preclinical oncology drug discovery. By reshaping the landscape of cancer treatment development, OrganoidXplore exemplifies the commitment to advancing product quality and enhancing patient safety in the medical device sector.
By service, the biocompatibility tests segment accounted for the highest revenue-grossing segment in the global preclinical medical device testing services market in 2024 owing to the stringent regulatory requirements and the critical need to ensure device safety and compatibility with human tissues. For instance, Veranex announced in December 2023 that it had acquired the preclinical facility T3 Labs. Veranex will be able to finish the entire MedTech development process - from concept to commercialization - after acquiring T3 Labs. Additionally, the chemistry test segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for precise chemical analysis to detect impurities and potential contaminants, which is essential for device safety.
By testing type, the physical testing accounted for the highest revenue-grossing segment in the global preclinical medical device testing services market in 2024 owing to the increasing focus on mechanical durability, tensile strength, and performance reliability of medical devices under various conditions. For instance, STEMart began offering medical device testing services to researchers worldwide in May 2023. The business can help customers by making sure that medical devices are inspected accurately in compliance with ISO 10992 & ISO 18562 standards, American Society of Testing Materials standards, FDA recommendations, and other requirements. Additionally, the chemical/biological testing segment is predicted to grow at the fastest CAGR during the forecast period owing to its growing role in ensuring devices meet biocompatibility standards, minimizing toxicological risks, and fulfilling regulatory requirements.
By end-user, the academic institutions segment accounted for the highest revenue-grossing segment in the global preclinical medical device testing services market in 2024 owing to the extensive research activities, availability of testing facilities, and partnerships with medical device companies for early-stage testing. For instance, TÜV SÜD opened a new facility in Minnesota in June 2023. It has ISO 17025 accreditation for medical device chemical and biological testing. It is a component of the business's dedication to offering top-notch medical equipment services. Additionally, the contract research organizations segment is predicted to grow at the fastest CAGR during the forecast period owing to its ability to provide cost-effective, specialized, and efficient testing services, which helps medical device companies reduce time to market.
North American region is anticipated to have the highest revenue share during the forecast period owing to the well-established healthcare infrastructure, high R&D investment in medical technology, and the presence of leading medical device companies and regulatory agencies such as the FDA, which mandates stringent testing standards. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the expanding medical device market, rising healthcare expenditure, increasing outsourcing of testing services, and supportive government initiatives to enhance healthcare quality and regulatory compliance. For instance, Glucotrack, Inc. reported in October 2023 that it has started preclinical animal research for an implanted continuous glucose monitor (CGM).
This comprehensive research report focuses on the global and regional market size and forecasts from 2024 to 2035.
In response to increasing patient safety concerns and a heightened emphasis on product quality, manufacturers in the medical device industry are prioritizing high-quality, accurate preclinical testing. There is a growing demand for testing services that minimize risks and enhance device reliability, as these measures are essential to prevent device recalls and improve patient outcomes. A notable development in this arena occurred in November 2023 when Crown Bioscience, in collaboration with JSR Life Sciences, announced the launch of OrganoidXplore. This innovative service offering provides robust, reproducible, and clinically relevant outputs, significantly accelerating preclinical oncology drug discovery. By reshaping the landscape of cancer treatment development, OrganoidXplore exemplifies the commitment to advancing product quality and enhancing patient safety in the medical device sector.
By service, the biocompatibility tests segment accounted for the highest revenue-grossing segment in the global preclinical medical device testing services market in 2024 owing to the stringent regulatory requirements and the critical need to ensure device safety and compatibility with human tissues. For instance, Veranex announced in December 2023 that it had acquired the preclinical facility T3 Labs. Veranex will be able to finish the entire MedTech development process - from concept to commercialization - after acquiring T3 Labs. Additionally, the chemistry test segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for precise chemical analysis to detect impurities and potential contaminants, which is essential for device safety.
By testing type, the physical testing accounted for the highest revenue-grossing segment in the global preclinical medical device testing services market in 2024 owing to the increasing focus on mechanical durability, tensile strength, and performance reliability of medical devices under various conditions. For instance, STEMart began offering medical device testing services to researchers worldwide in May 2023. The business can help customers by making sure that medical devices are inspected accurately in compliance with ISO 10992 & ISO 18562 standards, American Society of Testing Materials standards, FDA recommendations, and other requirements. Additionally, the chemical/biological testing segment is predicted to grow at the fastest CAGR during the forecast period owing to its growing role in ensuring devices meet biocompatibility standards, minimizing toxicological risks, and fulfilling regulatory requirements.
By end-user, the academic institutions segment accounted for the highest revenue-grossing segment in the global preclinical medical device testing services market in 2024 owing to the extensive research activities, availability of testing facilities, and partnerships with medical device companies for early-stage testing. For instance, TÜV SÜD opened a new facility in Minnesota in June 2023. It has ISO 17025 accreditation for medical device chemical and biological testing. It is a component of the business's dedication to offering top-notch medical equipment services. Additionally, the contract research organizations segment is predicted to grow at the fastest CAGR during the forecast period owing to its ability to provide cost-effective, specialized, and efficient testing services, which helps medical device companies reduce time to market.
North American region is anticipated to have the highest revenue share during the forecast period owing to the well-established healthcare infrastructure, high R&D investment in medical technology, and the presence of leading medical device companies and regulatory agencies such as the FDA, which mandates stringent testing standards. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the expanding medical device market, rising healthcare expenditure, increasing outsourcing of testing services, and supportive government initiatives to enhance healthcare quality and regulatory compliance. For instance, Glucotrack, Inc. reported in October 2023 that it has started preclinical animal research for an implanted continuous glucose monitor (CGM).
This comprehensive research report focuses on the global and regional market size and forecasts from 2024 to 2035.
Report Scope:
- Base Year: 2024
- Forecast Period: 2025-2035
- Study Coverage
- Market Forecast by Service, Testing Type, and End-User
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
- 20% Free Customization Available to Meet Your Exact Requirement.
Segmentation: Preclinical Medical Device Testing Services Market Report 2024 - 2035
Preclinical Medical Device Testing Services Market Analysis & Forecast by Service 2024 - 2035 (Revenue USD Bn)
- Biocompatibility Tests
- Chemistry Test
- Microbiology & Sterility Testing
- Bioburden Determination
- Pyrogen & Endotoxin Testing
- Sterility Test and Validation
- Antimicrobial Activity Testing
- Others
- Package Validation
Preclinical Medical Device Testing Services Market Analysis & Forecast by Testing Type 2024 - 2035 (Revenue USD Bn)
- Physical Testing
- Chemical/Biological Testing
- Cybersecurity Testing
- Microbiology and Sterility Testing
Preclinical Medical Device Testing Services Market Analysis & Forecast by End-User 2024 - 2035 (Revenue USD Bn)
- Academic Institutions
- Contract Research Organizations
- Others
Preclinical Medical Device Testing Services Market Analysis & Forecast by Region 2024 - 2035 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Preclinical Medical Device Testing Services Market: Services Estimates & Trend Analysis
8. Preclinical Medical Device Testing Services Market: Testing Type Estimates & Trend Analysis
9. Preclinical Medical Device Testing Services Market: End-User Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Preclinical Medical Device Testing Services Market
12. Europe Global Preclinical Medical Device Testing Services Market
13. Asia Pacific Global Preclinical Medical Device Testing Services Market
14. Latin America Global Preclinical Medical Device Testing Services Market
15. MEA Global Preclinical Medical Device Testing Services Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Charles River Laboratories International, Inc.
- Eurofins Scientific
- SGS S.A.
- WuXi AppTec
- Pace Analytical Services, LLC
- North American Science Associates, Inc. (NAMSA)
- Intertek Group plc
- Medistri SA
- Toxikon Corporation
- Biomatech (subsidiary of Evonik)
- American Preclinical Services, LLC (APS)
- Labcorp Drug Development
- Element Materials Technology
- Accuprec Research Labs Pvt. Ltd.
- Nelson Laboratories, LLC
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | December 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 3.91 Billion |
| Forecasted Market Value ( USD | $ 10.34 Billion |
| Compound Annual Growth Rate | 9.2% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
