GVR Report cover U.S. Medical Device Outsourcing Market Size, Share & Trends Report

U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Service (Contract Manufacturing, Quality Assurance), By Application (Class I, Class II, Class III), And Segment Forecasts, 2021 - 2028

  • Published Date: Sep, 2021
  • Base Year for Estimate: 2020
  • Report ID: 978-1-68038-600-4
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 79

Report Overview

The U.S. medical device outsourcing market size was valued at USD 21.8 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 10.3% from 2021 to 2028. Key drivers of the market include rising demand for medical devices and a subsequent rise in the demand for cost containment. Furthermore, associated benefits such as reduction in production cost and focus on core competencies by the organizations are expected to propel the market growth over the forecast period. Increasing COVID-19 cases across the U.S. have delayed medical procedures; thereby, creating a challenging environment for the manufacturers. Many companies had temporarily ceased their research & development activities due to complete lockdowns, which they are expected to slowly reverse back to normal.

U.S. medical device outsourcing market size, by service, 2018 - 2028 (USD Billion)

The growing complexities in product engineering, coupled with an increase in small-sized manufacturers, are expected to present this market with future growth opportunities. The rapidly increasing geriatric population, which is prone to chronic medical conditions, is also anticipated to drive the market by widening the target patient base.

Diagnostic tests and kits have played an essential role in fighting against the spread of COVID-19. However, these kits along with the numerous medical products were imported from low-cost manufacturing countries. Strict restrictions along global boundaries interrupted the global supply chains and resulted in delays of shipments from other countries. The dependence on medical devices in other countries has hampered production and availability, thus affecting the supply chain.

The medical device industry is currently facing challenging headwinds. Sharp cutbacks in public spending in the U.S. are a major issue faced by medical device manufacturers. Increasing price, profitability pressure, growing competition, coupled with a high degree of industry maturity, have has a great impact on this market. Amendments in the ISO standards are expected to boost the demand for quality assurance and regulatory affairs service providers in the U.S. and the European region as Small and Medium-sized Enterprises (SME) would require third-party assistance to comply with new ISO standards.

However, the coronavirus pandemic has caused a severe disruption in the supply chain, which has led to shortages and a severe slowing of production. It has stressed the need for scalable manufacturing operations among original equipment manufacturers, particularly those undertaking production associated to test kits and diagnostic systems. Full-service CMOs continue to garner increased OEM engagement owing to supply chain issues. The shortage in medical supply resulted in the reduction of the market entry barriers as the U.S. FDA authorized over 250 Emergency Use Authorizations (EUAs) since February 2020. The EUAs cover in vitro diagnostics and other testing kits, PPE kits and ventilators, and ECMO devices, among others.

Service Insights

The contract manufacturing segment led the market and accounted for 55.5% share of the U.S. revenue in 2020. Based on service, the market is categorized into quality assurance, regulatory affairs services, product implementation, product upgrade, product maintenance, product design and development services, product testing and sterilization services, and contract manufacturing services.

The product design and development services segment held a significant share in 2020. This segment is further segmented into designing and engineering, machining, molding, and packaging. Product design and development partners help in reducing time-to-market for a new device, thus speeding up the Return on Investment (ROI). Product design and development outsourcing has proved to be a crucial strategic tool facilitating the firms to gain or retain leadership or help in international expansion.

Application Insights

Class II medical devices accounted for the largest share of 67.2% in 2020 and are likely to remain dominant throughout the forecast period. These equipment possess a lower risk potential of injury or life threat to the patients. They include infusion pumps, powered wheelchairs, surgical drapes, and other minimal risk equipment. Relatively simpler technologies compared to class III and moderate risk make this equipment class the most outsourced one.

U.S. medical device outsourcing market share, by application, 2020 (%)

The cardiovascular devices majorly fall under class II as per the FDA classification, which is moderate to high risk. The class II cardiovascular devices such as catheters, catheter balloons, pacemakers, electrocardiograms, and other monitoring devices require a greater level of accuracy and precision manufacturing. Hence, the market contribution by such devices is expected to continue during the forecast period. A similar trend may be observed for orthopedic class II devices as well.

Key Companies & Market Share Insights

Market players are constantly involved in providing a wide range of medical device outsourcing services and equipment, which can be an effective cost curbing tool for the recipient organization. Participants are also involved in mergers and acquisitions in order to increase penetration. For example, in February 2020, Integer announces the acquisition of an Israel-based R&D contract manufacturing company called Inomec. The acquisition will help Integer expand its global footprint in medical devices outsourcing.

In September 2019, Active Implants received breakthrough device designation for their artificial knee meniscus product from the FDA. This, in turn, accelerated the review and approval process, helping them launch the product in the U.S. market. The availability of high-quality service vendors and providers is expected to maintain the growth in outsourcing. Some prominent players in the U.S. medical device outsourcing market include:

  • Accellent Inc.

  • MDMI Technologies Inc.

  • Integer Holdings Corporation

  • Avail Medical Products Inc.

  • Active Implants

  • Omnica Corporation

  • Teleflex Inc.

  • Kinematic Climax, Inc.

  • Cantel Medical Corporation

U.S. Medical Device Outsourcing Market Report Scope

Report Attribute


Market Size value in 2021

USD 23.3 billion

Revenue forecast in 2028

USD 46.2 billion

Growth Rate

CAGR of 10.3% from 2021 to 2028

Base year for estimation


Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD million/billion and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Service, application

Country scope


Key companies profiled

Integer Holdings Corporation; Avail Medical Products Inc.; Active Implants; Omnica Corporation; Teleflex Inc.; Kinematic Climax, Inc.; Cantel Medical Corporation

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country & segment scope.

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options


Segments Covered in the Report

This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research, Inc. has segmented the U.S. medical device outsourcing market report on the basis of service and application:

  • Service Outlook (Revenue, USD Million, 2016 - 2028)

    • Quality Assurance

    • Regulatory Consulting Services

      • Clinical Trials Applications and Product Registrations

      • Regulatory Writing and Publishing

      • Legal Representation

      • Others

    • 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

  • Application Outlook (Revenue, USD Million, 2016 - 2028)

    • Class I

    • Class II

    • Class III

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