The global medical device outsourcing market size is expected to reach USD 292.9 billion by 2030, at a CAGR of 12.8% from 2024 to 2030, 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.

Gather more insights about the market drivers, restrains and growth of the Global Medical Device Outsourcing Market

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.

Medical Device Outsourcing Market Report Highlights

• The contract manufacturing market dominated the market with a share of 54.4% in 2023 owing to the growing trend of outsourcing by OEM to third-party manufacturers, especially in emerging countries
• The cardiology segment dominated the application segment with a market share of 21% in 2023. Rising demand for cardiovascular devices as a result of the increasing prevalence of associated conditions is attributed to the growth of outsourcing of these devices
• The Class II segment dominated the class type market and accounted for 81.34% in 2023. The key factors contributing to the growth of the segment are the majority of the devices almost 43.0% fall under this category and the cost of medical devices is also high
• Asia Pacific region dominated the global market in 2022 with a share of 41.3% owing to lower cost and availability of skilled human resources.

Browse through Grand View Research's Medical Devices Industry Research Reports.

• High Pressure Balloon Catheter Market: The global high pressure balloon catheter market size was estimated at USD 3.03 billion in 2024 and is anticipated to grow at a CAGR of 8.90% from 2025 to 2030.
• Wearable Artificial Kidney Market: The global wearable artificial kidney market size was valued at USD 575.5 million in 2024 and is anticipated to grow at a CAGR of 6.9% from 2025 to 2030.

Medical Device Outsourcing Market Segmentation

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

Medical Device Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)

• Quality Assurance
• Regulatory Affairs Services
  • Clinical Trials Applications & Product Registrations
  • Regulatory Writing & Publishing
  • Legal Representation
  • Others
• Product Design & Development Services
  • Designing & Engineering
  • Machining
  • Molding
  • Packaging
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing
  • Accessories Manufacturing
  • Assembly Manufacturing
  • Component Manufacturing
  • Device Manufacturing

Medical Device Outsourcing Application Outlook (Revenue, USD Million, 2018 - 2030)

• Cardiology
• Diagnostic Imaging
• Orthopedic
• IVD
• Ophthalmic
• General & Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care
• Others

Medical Device Outsourcing Class Outlook (Revenue, USD Million, 2018 - 2030)

• Class I
• Class II
• Class III

Medical Device Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
  • Switzerland
  • Sweden
  • Belgium
  • Russia
• Asia Pacific
  • Japan
  • China
  • India
  • Indonesia
  • Malaysia
  • Singapore
  • South Korea
  • Thailand
  • Taiwan
  • Australia
  • Philippines
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Chile
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Egypt

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