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

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Nov 11, 2025, 11:30 ET

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:

The contract manufacturing services segment accounted for the largest revenue share of 55.1% in 2024, driven by medical device market players striving to reduce costs due to shrinking profit margins, which has led to companies implementing shift work to curtail fixed costs.
The general & plastic surgery segment is anticipated to grow at the fastest CAGR during the forecast period.
The Class II segment held the largest revenue share in the global market in 2024, accounting for almost 43% of medical devices due to their high cost.
The Asia Pacific medical device outsourcing industry captured the largest market share of 40.98% in 2024, driven by a large manufacturing base, lower labor costs, and the growing adoption of advanced medical technologies.

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)

Quality Assurance Services
Regulatory Affairs Services

Clinical trials applications and product registrations
Regulatory writing and publishing
Legal representation
Other

Product Design and Development Services

Designing & Engineering
Machining
Molding
Packaging

Product Testing & Sterilization Services
Product Implementation Services
Product Upgrade Services
Product Maintenance Services
Contract Manufacturing Services

Accessories Manufacturing
Assembly Manufacturing
Component Manufacturing
Device Manufacturing

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

Cardiology

Class I
Class II
Class III

Diagnostic imaging

Class I
Class II
Class III

Orthopedic

Class I
Class II
Class III

Class I
Class II
Class III

Ophthalmic

Class I
Class II
Class III

General and plastic surgery

Class I
Class II
Class III

Drug delivery

Class I
Class II
Class III

Dental

Class I
Class II
Class III

Endoscopy

Class I
Class II
Class III

Diabetes care

Class I
Class II
Class III

Others

Class I
Class II
Class III

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

Class I
Class II
Class III

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

North America

U.S.
Canada
Mexico

Europe

UK
Germany
France
Italy
Spain
Denmark
Norway
Sweden

Asia Pacific

Japan
China
India
Australia
South Korea
Thailand

Latin America

Brazil
Argentina

Middle East and Africa (MEA)

South Africa
Saudi Arabia
UAE
Kuwait
Oman
Qatar

List of Key Players in the Medical Device Outsourcing Market

SGS SA
Laboratory Corporation of America Holdings
Eurofins Scientific
Pace Analytical Services, Inc.
Intertek Group plc
WuXi AppTec
Charles River Laboratories
Freyr
PAREXEL International Corporation
Criterium, Inc.
Medpace
ICON plc.
IQVIA Inc.
Integer Holdings Corporation

Check out more related studies published by Grand View Research:

Medical Billing Outsourcing Market - The global medical billing outsourcing market size is expected to reach USD 44.30 billion by 2033, registering a CAGR of 13.06% from 2025 to 2033, according to a new report by Grand View Research, Inc. The market is driven primarily by factors such as the increasing importance of regulatory compliance and risk management, the growing need to streamline the medical billing process, and efforts to reduce internal processing costs.
Medical Affairs Outsourcing Market - The global medical affairs outsourcing market size is expected to reach USD 4.6 billion registering a CAGR of 13.6% from 2023 to 2030 according to a new report by Grand View Research, Inc. Transformation in the medical education and the rising number of orphan therapies for treatment of rare diseases are some of the key factors propelling the market growth. The pharmaceutical companies are looking for assistance to systematically position the therapeutic outcomes of these therapies in the market.
Medical Imaging Outsourcing Market - The global medical imaging outsourcing market size is estimated to reach USD 25.23 billion by 2030, registering to grow at a CAGR of 12.6% from 2025 to 2030 according to a new report by Grand View Research, Inc. Growing demand for early diagnosis of chronic diseases as well as improvement of the quality of care with rapid and precise reporting capabilities are propelling the market growth.
Medical Device Analytical Testing Outsourcing Market - The global medical device analytical testing outsourcing market size is estimated to reach USD 10.53 billion by 2030, expanding at a CAGR of 8.3% from 2025 to 2030, according to a new report by Grand View Research, Inc. Several medical device companies outsource analytical testing operations to decrease business risks, accelerate product market entrance, and lower expenses. As a result of this considerable rise in spending levels, medical device original equipment manufacturers (OEMs) quickly shift to outsourcing as a cost-cutting technique.

About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

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