, /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

• IVD

• 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.

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