U.S. Medical Device Analytical Testing Outsourcing Market Size & Outlook
The medical device analytical testing outsourcing market in the United States is expected to reach a projected revenue of US$ 3,697.9 million by 2030. A compound annual growth rate of 8.3% is expected of the United States medical device analytical testing outsourcing market from 2025 to 2030.
U.S. medical device analytical testing outsourcing market highlights
The U.S. medical device analytical testing outsourcing market generated a revenue of USD 2,295.9 million in 2024 and is expected to reach USD 3,697.9 million by 2030.
The U.S. market is expected to grow at a CAGR of 8.3% from 2025 to 2030.
In terms of segment, other tests was the largest revenue generating services in 2024.
Other tests is the most lucrative services segment registering the fastest growth during the forecast period.
Medical device analytical testing outsourcing market data book summary
Market revenue in 2024
USD 2,295.9 million
Market revenue in 2030
USD 3,697.9 million
Growth rate
8.3% (CAGR from 2025 to 2030)
Largest segment
Other tests
Fastest growing segment
Other tests
Historical data
2018 - 2023
Base year
2024
Forecast period
2025 - 2030
Quantitative units
Revenue in USD million
Market segmentation
Extractable and leachable, Material characterization, Physical testing, Bioburden testing, Sterility testing, Other tests
Key market players worldwide
SGS AG, Labcorp Holdings Inc, Eurofins Scientific SE, Intertek Group PLC, Wuxi AppTec Co Ltd, Inotiv Inc, Charles River Laboratories International Inc, Pace Analytical Services, NAMSA, Medical Device Testing Services
Other key industry trends
In terms of revenue, U.S. accounted for 35.1% of the global medical device analytical testing outsourcing market in 2024.
Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
In North America, U.S. medical device analytical testing outsourcing market is projected to lead the regional market in terms of revenue in 2030.
Canada is the fastest growing regional market in North America and is projected to reach USD 340.7 million by 2030.
The U.S. held the largest market share of 89.9% in 2021 and is expected to grow at a significant rate over the forecast period. This can be attributed to presence of various multinational players such as Charles River Laboratories, WuXi AppTec, and SGS SA.
Increased need for scrutiny pertaining to the quality of devices and reorganizing of classes is a key factor expected to impose additional testing requirements on manufacturers. These requirements can be met by partnering with laboratories that perform tests at an affordable price rather than installing in-house analytical tools.
Medical device manufacturing is a growing industry in the U.S. medical devices space and includes several types of instruments such as active and passive implantable devices. The U.S. also holds a competitive advantage in many industries that the medical device industry relies upon such as software development, biotechnology, instrumentation, telecommunications, and microelectronics.
U.S. Medical Device Analytical Testing Outsourcing Market Outlook
The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to Medical Device Analytical Testing Outsourcing Market Outlook will help companies and investors design strategic landscapes.
Other Tests was the largest segment with a revenue share of 20.15% in 2024.
Horizon Databook has segmented the U.S. medical device analytical testing outsourcing market based on extractable and leachable, material characterization, physical testing, bioburden testing, sterility testing, other tests covering the revenue growth of each sub-segment from 2018 to 2030.
The U.S. held the largest market share of 89.9% in 2021 and is expected to grow at a significant rate over the forecast period. This can be attributed to presence of various multinational players such as Charles River Laboratories, WuXi AppTec, and SGS SA.
Increased need for scrutiny pertaining to the quality of devices and reorganizing of classes is a key factor expected to impose additional testing requirements on manufacturers. These requirements can be met by partnering with laboratories that perform tests at an affordable price rather than installing in-house analytical tools.
Medical device manufacturing is a growing industry in the U.S. medical devices space and includes several types of instruments such as active and passive implantable devices. The U.S. also holds a competitive advantage in many industries that the medical device industry relies upon such as software development, biotechnology, instrumentation, telecommunications, and microelectronics.
U.S. Medical Device Analytical Testing Outsourcing Market Services Outlook (Revenue, USD Million , 2018-2030)
Extractable and leachable
Material characterization
Physical testing
Bioburden testing
Sterility testing
Other tests
U.S. Medical Device Analytical Testing Outsourcing Market Therapeutic Areas Outlook (Revenue, USD Million , 2018-2030)
Cardiology
Diagnostic Imaging
Orthopedic
IVD
Ophthalmic
General & Plastic Surgery
Drug Delivery
Endoscopy
Dental
Diabetes Care
Others
U.S. Medical Device Analytical Testing Outsourcing Market End Use Outlook (Revenue, USD Million , 2018-2030)
Others
Hospital
U.S. Medical Device Analytical Testing Outsourcing Market Device Type Outlook (Revenue, USD Million , 2018-2030)
Others
Reprocessed Devices
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Horizon Databook provides a detailed overview of country-level data and insights on the U.S. Medical Device Analytical Testing Outsourcing Market Outlook, including forecasts for subscribers. This country databook contains high-level insights into U.S. Medical Device Analytical Testing Outsourcing Market Outlook from 2018 to 2030, including revenue numbers, major trends, and company profiles.
U.S. Medical Device Analytical Testing Outsourcing Market, 2018-2030 (US$M)