Medical Device Outsourcing Market Growth Driven by Rising Demand for Quality Assurance and Contract Manufacturing Services

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"

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.

Get Free Access to Demo Report, Excel Pivot and ToC: https://www.insightaceanalytic.com/request-sample/1698

Leading medical contract manufacturers are integral to the healthcare sector, offering not only the design and production of medical devices but also a range of essential services, including UV bonding, injection molding, and other specialized manufacturing processes for major original equipment manufacturers (OEMs) and medical device companies.

The global medical device manufacturing outsourcing market is projected to experience significant growth, driven primarily by the expanding geriatric population, increasing global life expectancy, and rising demand for advanced medical technologies. Additional growth factors include the escalating need for medical devices, heightened price competition, and the growing imperative for manufacturers to optimize operational efficiency and reduce costs.

Moreover, the increasing complexity of product engineering and the entry of new participants into the market are expected to influence industry dynamics. The aging population remains a key driver of market expansion, given the higher prevalence of age-related health conditions. For instance, according to the U.S. Census Bureau, over 54 million Americans were aged 65 or older in 2019, while Eurostat reported that 20.3% of the European Union population fell within the same age bracket, with Italy having the highest proportion of elderly residents. These demographic trends underscore the rising demand for outsourced medical device manufacturing services, which is expected to continue shaping market growth in the coming years.

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.

Expert Knowledge, Just a Click Away: https://calendly.com/insightaceanalytic/30min?month=2025-02

Market Dynamics
Drivers:
The expansion of the medical device analytical testing outsourcing market is primarily driven by the growing demand for comprehensive device testing and validation services. Increasing reliance on analytical evaluations-such as physical testing, sterility assessments, and other critical performance analyses-is accelerating market growth. This trend is further reinforced by the rising need for testing services across a diverse range of medical device segments, including cardiovascular, orthopedic, and dental implants.

Challenges:
Market growth is constrained by several factors, including stringent regulatory standards established by organizations such as the International Organization for Standardization (ISO), as well as supply chain disruptions resulting from global crises, including pandemics. The increasing complexity of compliance requirements in outsourcing arrangements, coupled with the proliferation of specialized service offerings, adds further operational challenges for market participants. Nonetheless, the aging global population and the rising adoption of interventional medical devices (IMDs) present significant opportunities for continued market development.

Regional Trends:
The Asia-Pacific region is anticipated to secure a substantial share of the global medical device outsourcing market, supported by robust revenue growth and an accelerating compound annual growth rate (CAGR) over the forecast period. Key growth drivers include the rising prevalence of chronic diseases, increasing demand for medical devices, competitive pricing strategies, and the presence of prominent industry players.

In contrast, North America is experiencing rapid expansion in medical device outsourcing, driven by escalating demand for medical supplies and substantial investment in healthcare infrastructure. These factors position the region as a critical hub for outsourced medical device manufacturing and analytical testing services.

Unlock Your GTM Strategy: https://www.insightaceanalytic.com/customisation/1698

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.

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

Read Overview Report- https://www.insightaceanalytic.com/report/medical-device-outsourcing-market/1698

About Us:
InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

Contact us:
InsightAce Analytic Pvt. Ltd.
Visit: https://www.insightaceanalytic.com/
Tel : +1 607 400-7072
Asia: +91 79 72967118
info@insightaceanalytic.com

This release was published on openPR.