North America Medical Device Outsourcing Market Size & Outlook
The medical device outsourcing market in North America is expected to reach a projected revenue of US$ 117,608.0 million by 2033. A compound annual growth rate of 14% is expected of North America medical device outsourcing market from 2026 to 2033.
North America medical device outsourcing market highlights
The North America medical device outsourcing market generated a revenue of USD 41,999.7 million in 2025.
The market is expected to grow at a CAGR of 14% 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.
Country-wise, Canada is expected to register the highest CAGR from 2026 to 2033.
North America data book summary
Market revenue in 2025
USD 41,999.7 million
Market revenue in 2033
USD 117,608.0 million
Growth rate
14% (CAGR from 2026 to 2033)
Largest segment
Cardiology
Fastest growing segment
General & Plastic Surgery
Historical data covered
2021 - 2024
Base year for estimation
2025
Forecast period covered
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, North America region accounted for 26.6% of the global medical device outsourcing market in 2025.
Globally, Asia Pacific is projected to lead the regional market in terms of revenue in 2033.
North America is the fastest growing regional market and is projected to reach USD 117,608.0 million by 2033.
North America was one of the major contributors to the growth of the medical device outsourcing market in 2023. This region is home to numerous medical device companies, which are outsourcing parts of their regulatory and consulting functions to regulatory service providers, thereby contributing to the growth of the medical device outsourcing market.
The high cost of R&D is a major challenge, which has encouraged various medical device companies in North America to outsource functions to third-party vendors with high levels of expertise in the domain.
The rapid increase in the manufacturing of medical devices to meet the high demand for efficient healthcare in the region is expected to be one of the major factors contributing to the market growth in North America.
North America 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 25.92% in 2025.
Horizon Databook has segmented the North America 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.
North America was one of the major contributors to the growth of the medical device outsourcing market in 2023. This region is home to numerous medical device companies, which are outsourcing parts of their regulatory and consulting functions to regulatory service providers, thereby contributing to the growth of the medical device outsourcing market.
The high cost of R&D is a major challenge, which has encouraged various medical device companies in North America to outsource functions to third-party vendors with high levels of expertise in the domain.
The rapid increase in the manufacturing of medical devices to meet the high demand for efficient healthcare in the region is expected to be one of the major factors contributing to the market growth in North America.
North America 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
North America 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
North America 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 continent-level data and insights on the North America Medical Device Outsourcing Market Outlook, including forecasts for subscribers. This continent databook contains high-level insights into North America Medical Device Outsourcing Market Outlook from 2021 to 2033, including revenue numbers, major trends, and company profiles.
North America Medical Device Outsourcing Market, 2021-2033 (US$M)