Medical Device Outsourcing Market To Reach $386.08 Billion By 2033

Medical Device Outsourcing Market Growth & Trends

The global medical device outsourcing market size is expected to reach USD 386.08 billion by 2033, registering a CAGR of 13.29% from 2025 to 2033, according to a new report by Grand View Research, Inc. Rising demand for advanced medical products and a growing trend of offshoring is fueling the medical device outsourcing market growth.

Regulatory bodies are emphasizing the quality of the healthcare devices provided to the public which is becoming burdensome to handle. To meet the regulatory scenario, various services like regulatory consulting are being utilized by the industry players. For example, the European Medical Device Regulation undertakes special spontaneous inspection of outsourced products to test the quality as well as conformity with standards.

Contract manufacturers, especially in developed countries like the U.S., EU nations, and Japan, comply with the international standard for the quality management system, which makes them a preferred option as compared with contract manufacturers in India and China. However, regulatory changes anticipated in developing countries ensure compliance by contract manufacturers. Demand for regulatory compliance is expected to boost the growth of consulting services such as remediation, compliance, and QMS, thereby contributing to the growth of the global medical device outsourcing market.

Owing to COVID-19, there was a decline in the number of diagnoses for other diseases like cancer and tuberculosis among others. The recovery from COVID-19 is expected to increase demand for the medical devices used for diagnosing these diseases. Public organizations across the globe are taking initiatives to increase the production of medical equipment to prevent a future shortage. For instance, in January 2021, U.S. president Joseph Biden in response to the pandemic preparedness emphasized improving gaps in the supply chain by augmenting domestic manufacturing of test kits, PPE, and durable medical equipment.

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Medical Device Outsourcing Market Report Highlights

• Based on service, the contract manufacturing services segment accounted for the largest revenue share of 55.1% in 2024. The quality assurance segment is anticipated to grow at the fastest CAGR during the forecast period.

• Based on application, the cardiology segment held the largest share in 2024. The general & plastic surgery segment is anticipated to grow at the fastest CAGR during the forecast period.

• Based on class type, class II type medical devices accounted for the largest market share in 2024. The Class I segment is anticipated to grow at a considerable CAGR over the forecast period.

• The Asia Pacific medical device outsourcing industry captured the largest market share of 40.98% in 2024. The medical device outsourcing industry in China held the largest share in 2024.

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 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 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 Class Type Outlook (Revenue, USD Million, 2021 - 2033)

• Class I

• Class II

• Class III

Medical Device Outsourcing 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 of 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