U.S. Medical Device Outsourcing Market Worth $46.2 Billion by 2028

September 2021 | Report Format: Electronic (PDF)

U.S. Medical Device Outsourcing Market Growth & Trends

The U.S. medical device outsourcing market size is expected to reach USD 46.2 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 10.3% from 2021 to 2028. The growing geriatric population, rising surgical procedures, and increasing demand for cost curbing tools are some key growth drivers for the U.S. market.

The medical device industry has become competitive and categories such as coronary stents, orthopedic devices, and wound care are moving towards maturity. As high-impact scientific innovation in the above categories is difficult to identify, 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, many medical device manufacturers have opted for outsourcing business models to reduce cost, manage business risks, and improve service delivery. All the aforementioned facts are hence expected to propel the market growth over the forecast period.

The development of medical devices and supplies required in assisting COVID patients and medical professionals is increasing. The government authorities have escalated funds for the research & development of essential devices, thus increasing the demand in the U.S. market. Major companies have solely relied on contract manufacturers to ramp up the production of COVID-19-related medical components, such as test kits, ventilators, and respirators. The major reasons for outsourcing amid the COVID crisis include a streamlined supply chain, costing efficiencies, and logistical alignment.

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U.S. Medical Device Outsourcing Market Report Highlights

  • Based on service, the contract manufacturing segment dominated the market with a share of 55.5% in 2020 owing to the growing trend of outsourcing by OEM to third-party manufacturers, especially in emerging countries

  • Regulatory consulting services are projected to exhibit a significant growth rate over the forecast period. Complex regulatory requirements related to writing and submission of clinical study reports promote outsourcing of noncore regulatory functions, such as regulatory writing and publishing

  • By application, class II medical devices held the largest share of 67.2% in 2020 and are expected to dominate the U.S. market throughout the forecast period

  • Mergers and acquisitions and capacity expansion are a few of the common strategies adopted by market players to gain a competitive edge in the market

  • In February 2020, Teleflex acquired HPC Medical Products (HPC), a company involved in medical tubing and wire components. The acquisition will help Teleflex to strengthen its catheter contract manufacturing capabilities

U.S. Medical Device Outsourcing Market Segmentation

Grand View Research has segmented the U.S. medical device outsourcing market based on service and application:

U.S. Medical Device Outsourcing Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Quality Assurance

  • Regulatory Consulting 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

    • Accessories manufacturing

    • Assembly manufacturing

    • Component manufacturing

    • Device manufacturing

U.S. Medical Device Outsourcing Application Outlook (Revenue, USD Million, 2016 - 2028)

  • Class I

  • Class II

  • Class III

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

  • Integer Holdings Corporation

  • Avail Medical Products Inc.

  • Active Implants

  • Omnica Corporation

  • Teleflex Inc.

  • Kinematic Climax, Inc.

  • Cantel Medical Corporation

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