Medical Device Outsourcing Market Current Scenario with Future Aspect Analysis

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Services (Quality Assurance, Contract Manufacturing), By Therapeutic Area (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General And Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care), By Class (Class I, Class II, And Class III)- Market Outlook And Industry Analysis 2035"

The global Medical Device Outsourcing Market Size is valued at USD 160.96 billion in 2025 and is predicted to reach USD 494.35 billion by the year 2035 at a 12.0% CAGR during the forecast period for 2026 to 2035.

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Leading medical contract manufacturers focus on the design and production of medical devices while offering critical services such as UV bonding, injection molding, and other advanced manufacturing processes to original equipment manufacturers (OEMs) and medical device companies. The medical device manufacturing outsourcing market is primarily driven by the increasing global geriatric population, rising life expectancy, and the growing demand for innovation and technological advancement within the healthcare sector.

The market is projected to maintain steady growth over the forecast period, supported by rising demand for medical devices, increasing cost pressures, and the need to enhance operational efficiency. Furthermore, the growing complexity of product design and engineering, coupled with the entry of new market participants, is expected to shape the future development and competitive landscape of the industry.

List of Prominent Players in the Medical Device Outsourcing Market:
• SGS SA
• Laboratory Corporation of America Holdings
• Euro fins Scientific
• Pace Analytical Services, Inc.
• Intertek Group plc
• WuXiAppTec
• North American Science Associates, LLC
• TÜV SÜD
• Sterigenics U.S.
• LLC (GTCR, LLC)
• Charles River Laboratories
• Medical Device Testing Services
• RJR Consulting, Inc.
• Mandala International.
• Freyr
• Global Regulatory Partners
• PAREXEL International Corporation (EQT Private Equity and Goldman Sachs Asset Management)
• Emergo (UL LLC)
• Bioteknica
• Accell Clinical Research, LLC
• Genpact.; Criterium, Inc.
• Promedica International
• Med pace
• ICON plc.
• IQVIA Inc.
• Integer Holdings Corporation
• Tecomet Inc. (Charlesbank Capital Partners, LLC)
• Jabil Inc.
• FLEX LTD.
• Celestica Inc.
• Sanmina Corporation.
• Plexus Corp.
• Phillips Medisize (Molex, LLC)
• Cantel Medical Corp. (STERIS plc)
• West Pharmaceutical Services, Inc.

Market Dynamics:
Drivers-
The medical device analytical testing outsourcing market is being driven by increasing demand for testing and validation services, including physical assessments, sterility testing, and other analytical evaluations. Rising utilization of these services for medical devices such as cardiovascular, orthopedic, and dental implants further supports market growth, as manufacturers seek to ensure product safety, efficacy, and regulatory compliance.

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Challenges:
The market faces challenges from stringent regulatory requirements established by organizations such as the International Organization for Standardization (ISO), as well as disruptions in supply chain operations, particularly during global crises such as the COVID-19 pandemic. Despite these obstacles, opportunities are growing due to the expanding aging population and the increasing adoption of interventional medical devices (IMDs), which are driving demand for outsourced analytical testing services.

Regional Trends:
The Asia-Pacific region is expected to secure a significant share of the medical device outsourcing market and demonstrate robust growth at a high compound annual growth rate (CAGR) over the forecast period. This growth is fueled by the rising prevalence of chronic diseases and the resulting demand for medical devices.

The presence of major industry players and cost-efficient manufacturing capabilities further supports regional expansion. North America continues to be a leading market for outsourced medical device manufacturing, driven by heightened demand for medical products and increased investment in healthcare infrastructure across the region.

Recent Developments:
• In December 2021, Oscor Inc. was purchased by Integer Holdings, a US-based advanced medical device outsourcing business, for $220 million. By broadening the product selection in steerable sheaths and cardiac and neurostimulation leads and by introducing low-cost manufacturing capability to support expansion, this purchase of Oscor improves Integer's capabilities to service clients. Oscor is a US-based business that provides outsourcing services for medical devices.

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Segmentation of Medical Device Outsourcing Market-
By Service-
• Quality Assurance
• Regulatory Affairs Services
o Clinical trials applications and product registrations
o Regulatory writing and publishing
o Legal representation
o Other
• Product Design and Development Services
o Designing & Engineering
o Machining
o Molding
o Packaging
• Product Testing & Sterilization Services
• Product Implementation Services
• Product Upgrade Services
• Product Maintenance Services
• Contract Manufacturing
o Accessories Manufacturing
o Assembly Manufacturing
o Component Manufacturing
o Device Manufacturing
By Class Type-
• Class I
• Class II
• Class III
By Application
• Cardiology
• Diagnostic imaging
• Orthopedic
• IVD
• Ophthalmic
• General and plastic surgery
• Drug delivery
• Dental
• Endoscopy
• Diabetes care
• Others
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of the Middle East and Africa

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