The North America and Europe preclinical medical device testing services market size is expected to reach USD 3.14 billion by 2030, expanding at a CAGR of 9.3% from 2025 to 2030, according to a new report by Grand View Research, Inc. The increase in the number of small medical devices lacking in-house testing capabilities and complexity in product design are the major factors driving the growth of the market.
There has been an increase in the number of players operating in the market over the last decade. Due to this large number, it has witnessed fierce competition. To sustain the market, a mix of defensive and offensive marketing strategies is used. For instance, extensive R&D, competitive pricing, new product launches, collaborative development, regional expansion, and mergers and acquisitions.
The COVID-19 pandemic has created a huge demand for these services. The rise was not significant in the first half, but it became more significant in the second as the industry adapted to operating during the pandemic. There has been an increase in the production and testing of personal protective equipment, and several projects that were put on hold because of COVID have resumed personal protective equipment. The epidemic has increased demand for a wide range of medical gadgets, diverting attention from those needed for surgery. COVID-19 vaccinations, ventilators, and pulse oximeters are the main goods seeing an increase in demand.
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In 2024, the biocompatibility tests segment dominated the market, accounting for a revenue share of 44.7%. Manufacturing safe and effective goods is a top priority for medical device manufacturers, and quality assurance is crucial in accomplishing this aim.
The chemistry test segment is expected to rise with the fastest CAGR of 9.6% in the forecast period. Chemistry tests support the medical device industry across the value chain.
North America preclinical medical device testing services market dominated in 2024 with a larger share of 55.0%.
Grand View Research has segmented the North America and Europe preclinical medical device testing services market on the basis of service and region:
North America And Europe Preclinical Medical Device Testing Services Service Outlook (Revenue, USD Million, 2018 - 2030)
Biocompatibility Tests
Chemistry Test
Microbiology & Sterility Testing
Bioburden Determination
Pyrogen & Endotoxin Testing
Sterility Test and Validation
Ethylene Oxide (EO) gas sterilization
Gamma-irradiation
E-beam sterilization
X-ray sterilization
Antimicrobial Activity Testing
Others
Package Validation
North America And Europe Preclinical Medical Device Testing Services Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Sweden
Denmark
Norway
List of Key Players of North America And Europe Preclinical Medical Device Testing Services Market
SGS SA
Toxikon, Inc.
Eurofins Scientific
Pace Analytical Services LLC
Intertek Group Plc
WUXI APPTEC
TÜV SÜD AG
Sterigenics International LLC
Nelson Labs
North American Science Associates, Inc.
American Preclinical Services
Charles River Laboratories International, Inc.
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