U.S. Medical Device Outsourcing Market Size & Outlook
- HC Outsourcing
- Clinical & Non-Clinical Outsourcing Services
- Medical Device Outsourcing Market Outlook
- Clinical & Non-Clinical Outsourcing Services
Global Market
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U.S. medical device outsourcing market highlights
- The U.S. medical device outsourcing market generated a revenue of USD 34,406.4 million in 2025 and is expected to reach USD 95,762.9 million by 2033.
- The U.S. market is expected to grow at a CAGR of 13.9% from 2026 to 2033.
- In terms of segment, cardiology was the largest revenue generating application in 2025.
- General & Plastic Surgery is the most lucrative application segment registering the fastest growth during the forecast period.
Medical device outsourcing market data book summary
| Market revenue in 2025 | USD 34,406.4 million |
| Market revenue in 2033 | USD 95,762.9 million |
| Growth rate | 13.9% (CAGR from 2026 to 2033) |
| Largest segment | Cardiology |
| Fastest growing segment | General & Plastic Surgery |
| Historical data | 2021 - 2024 |
| Base year | 2025 |
| Forecast period | 2026 - 2033 |
| Quantitative units | Revenue in USD million |
| Market segmentation | Cardiology, Diagnostic imaging, Orthopedic, IVD, Ophthalmic, General & Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care, Other Application |
| Key market players worldwide | SGS AG, Labcorp Holdings Inc, Eurofins Scientific SE, Pace Analytical Services, Intertek Group PLC, Wuxi AppTec Co Ltd, Sotera Health Co Ordinary Shares, Charles River Laboratories International Inc, Medical Device Testing Services, FREYR Battery Inc, PAREXEL, Accell, Genpact Ltd, Criterium Inc., Promedica International, Medpace Holdings Inc, Icon PLC, IQVIA Holdings Inc, Integer Holdings Corp, Tecomet, Jabil Inc, Flex Ltd, Celestica Inc Ordinary Shares (Subordinate Voting), Sanmina Corp, Plexus Corp, Molex, Steris PLC, West Pharmaceutical Services Inc, NAMSA, TUV SUD, RJR Consulting, Mandala International, Global Regulatory Partners, Emergo Group, BioTeknica Engineering & Regulatory Services |
Other key industry trends
- In terms of revenue, U.S. accounted for 21.8% of the global medical device outsourcing market in 2025.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2033.
- In North America, U.S. medical device outsourcing market is projected to lead the regional market in terms of revenue in 2033.
- Canada is the fastest growing regional market in North America and is projected to reach USD 16,717.7 million by 2033.
The U.S. held the largest market share of 86.54% in North America in 2023. Large medical device companies are outsourcing parts of their regulatory functions, such as report writing & publishing, clinical trial application services, product design, and product maintenance, to regulatory service providers, thereby contributing to the growth of the medical device outsourcing market in the U.S.
These companies are also increasingly inclined toward medical device outsourcing due to the requirement of high maintenance and efficient systems for the management of raw materials, which results in minimizing the overall setup costs.
Moreover, medical device outsourcing helps the company focus on core capabilities, the sharing of associated risks, and improved service delivery, which are pertinent to gaining competitive advantages.
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Publish Date: Jan 15, 2026
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Medical Device Outsourcing Market Scope
Medical Device Outsourcing Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| Steris PLC | View profile | 17,100 | 5960 Heisley Road, Mentor, OH, United States, 44060 | www.steris-ir.com |
| Sotera Health Co Ordinary Shares | View profile | 3,000 | 9100 South Hills Boulevard, Suite 300, Broadview Heights, OH, United States, 44147 | investors.soterahealth.com |
| Eurofins Scientific SE | View profile | 61,798 | 23 Val Fleuri, Luxembourg, Luxembourg, L-1526 | www.eurofins.com |
| Charles River Laboratories International Inc | View profile | 21,400 | 251 Ballardvale Street, Wilmington, MA, United States, 01887 | www.criver.com |
| West Pharmaceutical Services Inc | View profile | 10,600 | 530 Herman O. West Drive, Exton, PA, United States, 19341-1147 | www.westpharma.com |
| Labcorp Holdings Inc | View profile | 67,000 | 358 South Main Street, Burlington, NC, United States, 27215 | www.labcorp.com |
| Flex Ltd | View profile | 148,115 | 2 Changi South Lane, Singapore, Singapore, 486123 | www.flex.com |
| Jabil Inc | View profile | 236,000 | 10800 Roosevelt Boulevard North, Saint Petersburg, FL, United States, 33716 | www.jabil.com |
| Plexus Corp | View profile | 25,000 | One Plexus Way, P.O. Box 156, Neenah, WI, United States, 54957 | www.plexus.com |
| Celestica Inc Ordinary Shares (Subordinate Voting) | View profile | 26,554 | 5140 Yonge Street, Suite 1900, Toronto, ON, Canada, M2N 6L7 | www.celestica.com |
U.S. Medical Device 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 Outsourcing Market Outlook will help companies and investors design strategic landscapes.
Cardiology was the largest segment with a revenue share of 25.9% in 2025.
Horizon Databook has segmented the U.S. medical device outsourcing market based on cardiology, diagnostic imaging, orthopedic, ivd, ophthalmic, general & plastic surgery, drug delivery, dental, endoscopy, diabetes care, other application covering the revenue growth of each sub-segment from 2021 to 2033.
The U.S. held the largest market share of 86.54% in North America in 2023. Large medical device companies are outsourcing parts of their regulatory functions, such as report writing & publishing, clinical trial application services, product design, and product maintenance, to regulatory service providers, thereby contributing to the growth of the medical device outsourcing market in the U.S.
These companies are also increasingly inclined toward medical device outsourcing due to the requirement of high maintenance and efficient systems for the management of raw materials, which results in minimizing the overall setup costs.
Moreover, medical device outsourcing helps the company focus on core capabilities, the sharing of associated risks, and improved service delivery, which are pertinent to gaining competitive advantages.
- U.S. Medical Device Outsourcing Market Application Outlook (Revenue, USD Million , 2021-2033)
- Cardiology
- Diagnostic imaging
- Orthopedic
- IVD
- Ophthalmic
- General & Plastic Surgery
- Drug Delivery
- Dental
- Endoscopy
- Diabetes Care
- Other Application
- U.S. Medical Device Outsourcing Market Services Outlook (Revenue, USD Million , 2021-2033)
- Quality Assurance Services
- Regulatory Consulting Services
- Product Design & Development Services
- Product Testing & Sterilization Services
- Product Implementation Services
- Product Upgrade Services
- Product Maintenance Services
- Contract Manufacturing Services
- U.S. Medical Device Outsourcing Market Class Type Outlook (Revenue, USD Million , 2021-2033)
- Class I
- Class II
- Class III
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Horizon Databook provides a detailed overview of country-level data and insights on the U.S. Medical Device Outsourcing Market Outlook, including forecasts for subscribers. This country databook contains high-level insights into U.S. Medical Device Outsourcing Market Outlook from 2021 to 2033, including revenue numbers, major trends, and company profiles.
U.S. Medical Device Outsourcing Market, 2021-2033 (US$M)
US Application - Medical Device Outsourcing Market Statistics, 2025 - 2033 (US$M)
