Medical Device Outsourcing Market to hit $386.08 Billion by 2033 - Grand View Research, Inc.

SAN FRANCISCO, Nov. 11, 2025 /PRNewswire/ -- The global medical device outsourcing market size is projected to reach USD 386.08 billion by 2033, growing at a CAGR of 13.29% from 2025 to 2033. The market is driven by increasing demand for medical devices, combined with the rising price competition and the requirement to reduce costs. The medical device business is under continual pressure to regulate costs without compromising on the R&D process, time to market, or associated safety & quality, even as segment growth is driven by novel technologies, process developments, and a rapidly aging population, which together result in increasingly stringent and complex regulations due to heightened market competition.

Simultaneously, regulatory approval procedures are becoming more stringent and time-consuming, necessitating that market players receive product approvals on the first attempt to gain higher market share while managing continuous changes in regulatory requirements across different business activities and multiple geographies worldwide, since noncompliance may result in penalties, delays, and subsequent revenue loss. To mitigate these challenges and capitalize on opportunities like geographic expansion (aimed at speedy global approvals), Medical device Original Equipment Manufacturers (OEMs) can benefit from outsourcing some operations to achieve increased agility, low operational costs, reduced time to market, and a high return on investment, transforming their companies from cost centers into strategic investments; this environment is consequently expected to create strong demand for medical affairs and regulatory affairs outsourcing services.

The market is classified by service into contract manufacturing, quality assurance, regulatory affairs, product design & development, product testing & sterilization, product implementation, product upgrade, and product maintenance services, with contract manufacturing services accounting for the largest revenue share at 55.1% in 2024. This dominance is fueled by market players striving to reduce costs due to shrinking profit margins, which involves implementing shift work to curtail fixed costs, and by the fact that contract manufacturing enables small and medium-sized companies, which often lack skilled labor and technical resources, to complete projects, with the Asia Pacific considered the hub for this activity. Conversely, the quality assurance segment is anticipated to grow at the fastest CAGR during the forecast period, driven by the increasing emphasis on regulatory compliance, the rising complexity of product development, and the growing need to maintain high standards of product safety and efficacy, further propelled by the surge in outsourcing of quality assurance activities by pharmaceutical, biotechnology, and medical device companies to specialized service providers.

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The market, segmented by application into cardiology, diagnostic imaging, orthopedic, IVD, ophthalmic, general & plastic surgery, drug delivery, dental, endoscopy, diabetes care, and others, saw the cardiology segment hold the largest share in 2024, a result of the rising prevalence of cardiovascular devices and increasing incidences of conditions such as angina pectoris, myocardial infarction, hypertensive heart disease, rheumatic heart diseases, atrial fibrillation, and congenital heart disease. Conversely, the general & plastic surgery segment is anticipated to grow at the fastest CAGR during the forecast period, driven by the increasing demand for cosmetic surgeries, which is expected to boost the outsourcing of both general and cosmetic surgical devices, particularly specialized items like fixation devices, extremity splints, and epilators that require specialized molding and machining processes typically handled by outsourced component manufacturers.

Medical Device Outsourcing Market Report Highlights:

Read full market research report on Medical Device Outsourcing Market with TOC - Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance Services, Contract Manufacturing, Regulatory Affairs Services), By Application (Cardiology, Diagnostic Imaging, IVD, Orthopedic), By Class Type, By Region, And Segment Forecasts, 2025 - 2033

Medical Device Outsourcing Market Segmentation

Grand View Research has segmented the global medical device outsourcing market report based on service, application, class type, and region:

Medical Device Outsourcing Market - Service Outlook (Revenue, USD Million, 2021 - 2033)

Medical Device Outsourcing Market - Application Outlook (Revenue, USD Million, 2021 - 2033)

Medical Device Outsourcing Market - Class Type Outlook (Revenue, USD Million, 2021 - 2033)

Medical Device Outsourcing Market - Regional Outlook (Revenue, USD Million, 2021 - 2033)

List of Key Players in the Medical Device Outsourcing Market

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