U.S. Medical Device Outsourcing Market To Reach $63.40 Billion By 2030

U.S. Medical Device Outsourcing Market Growth & Trends

The U.S. medical device outsourcing market size is expected to reach USD 63.40 billion in 2030 and is expected to grow at a CAGR of 13.0% over the forecast period, according to a new report by Grand View Research, Inc. This market is growing as a result of increased offshore trends, a rise in demand for high-tech medical devices, and stringent regulation for medical devices in the U.S.

The medical device industry has always been highly competitive, and categories such as coronary stents, orthopedic devices, and wound care are moving toward maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, smaller companies are gaining market share by offering low prices and introducing innovative business models. Due to the convergence of mounting challenges and changing market dynamics, medical device manufacturers are likely to opt for outsourcing business models to reduce costs, manage business risks, and improve service delivery. This factor is expected to propel market growth over the forecast period.

The government authorities have escalated funds for the research and development of essential devices, thus driving the market. The majority of clinical research globally devices are conducted in the U.S. alone according to Clinical Trials .gov. In case of the medical device also significant studies are conducted in the U.S.

For instance, as of February 2023, over 25033, research for medical devices was registered in the Clinical Trials .gov. Medical device companies are conducting research in the country owing to the availability of skilled labor and advanced infrastructure, as well as the presence of a significant number of CROs offering quality services. All these factors are expected to support the market in the post-Pandemic period.

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U.S. Medical Device Outsourcing Market Report Highlights

• The U.S. medical device outsourcing industry is developing due to stricter FDA regulations, which require manufacturers to seek specialized compliance support

• The market is rapidly transforming due to evolving regulatory requirements, cost pressures, and the need for faster time to market

• The U.S. medical device outsourcing industry is driven by cost containment pressures, stringent regulatory compliance, and increasing complexity in device development.

• The contract manufacturing segment accounted for the largest share of 46.74% in 2024. The segment growth is owing to increasing cost pressures, stringent FDA regulatory requirements, and the growing complexity of medical devices

• Based on application, the cardiology segment dominated the market in 2024. The growing demand for cardiovascular devices due to the high prevalence rate of cardiovascular diseases (CVDs) is attributed to the growth of outsourcing these devices

U.S. Medical Device Outsourcing Market Segmentation

Grand View Research has segmented the U.S. medical device outsourcing market on the basis of service, application, and class:

U.S. Medical Device Outsourcing Service Outlook (Revenue, USD Million; 2018 - 2030)

• Quality Assurance Services

• Regulatory Affairs Services

  • Clinical Trial Applications & Product Registration

  • Regulatory Writing & Publishing

  • Legal Representation

  • Others

• Product Design and Development Services

  • Designing & Engineering

  • Machining

  • Molding

  • Packaging

• Data Management and Biostatistics

• Product Testing & Sterilization Services

• Product Implementation Services

• Product Upgrade Services

• Product Maintenance Services

• Contract Manufacturing

  • Accessories Manufacturing

  • Assembly Manufacturing

  • Component Manufacturing

  • Device Manufacturing

• Others

U.S. Medical Device Outsourcing Application Outlook (Revenue, USD Million; 2018 - 2030)

• Cardiology

• Diagnostic Imaging

• Orthopedic

• IVD

• Ophthalmic

• General & Plastic Surgery

• Drug Delivery

  • Prefilled Syringe

  • Autoinjectors

  • Infusion Pump

  • Others

• Dental

• Endoscopy

• Diabetes Care

• Others

U.S. Medical Device Outsourcing Class Outlook (Revenue, USD Million; 2018 - 2030)

• Class I

• Class II

• Class III

U.S. Medical Device Outsourcing Application by Class Outlook (Revenue, USD Million; 2018 - 2030)

• 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 & 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

List of Key Players in the U.S. Medical Device Outsourcing  Market

• SGS SA

• Laboratory Corporation Of America Holdings

• Eurofins Scientific

• Pace Analytical Services, Inc.

• TÜV SÜD

• Charles River Laboratories

• Freyr

• Global Regulatory Partners

• Parexel International Corporation

• Genpact

• Criterium, Inc.

• Promedica International

• Medpace

• ICON Plc.

• IQVIA Inc.

• Integer Holdings Corporation

• Jabil Inc.

• Flex Ltd.

• Plexus Corp.

• West Pharmaceutical Services, Inc.