U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report By Service (Product Upgrade Services, Product Design & Development Services, Quality Assurance, Contract Manufacturing), And Segment Forecasts, 2022 - 2030

Report Overview

The U.S. medical device outsourcing market size was valued at USD 23.3 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 11.2% over the forecast period. The COVID-19 pandemic in 2020 had delayed medical procedures; thereby, creating a challenging environment for the manufacturers. Many companies had temporarily ceased their research & development activities due to complete lockdowns. This had led to a severe disruption in the supply chain, which caused the shortages & a slowing down of production. The recovery of the market has started as the earlier shortage in medical supply is overcome when market entry barriers are reduced. The increased production of test kits and diagnostic systems has also helped in the recovery.

Since February 2020, the FDA has authorized over 250 Emergency Use Authorizations (EUAs). The EUAs cover in vitro diagnostics and other testing kits, PPE kits and ventilators, and ECMO devices, among others. Diagnostic tests and kits have played an essential role in fighting against the spread of COVID-19. However, these kits along with numerous medical products were imported from low-cost manufacturing countries, such as China, India, and Germany. Growing complexities in product engineering, coupled with an increase in the number of 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 market growth by widening the target patient base.

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. 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 prices, profitability pressure, growing competition coupled with a high degree of industry maturity 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 Europe region as Small & Medium-sized Enterprises (SMEs) would require third-party assistance to comply with new ISO standards.

Service Insights

The contract manufacturing services segment dominated the market in 2021 and accounted for the largest share of more than 56.00% of the overall market revenue. On the basis of services, the market is categorized into quality assurance, regulatory affairs services, product design & development services, product testing & sterilization services, product implementation, product upgrade, product maintenance, and contract manufacturing services. Regulatory affairs, product design & development as well as contract manufacturing services have been further analyzed in this study.

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. The outsourcing of product design and development services held the second-largest share of the market in 2021. This segment is further divided into designing & engineering, machining, molding, and packaging.

Key Companies & Market Share Insights

The companies are constantly involved in providing a wide range of services and equipment, which can be an effective cost curbing tool for the recipient organization. Participants are also involved in mergers and acquisitions to increase their market share.  For instance, Teleflex Medical OEM acquired HPC Medical Products (HPC) to provide enhanced custom-engineered medical devices and also to expand and diversify its medical device portfolio. With this acquisition, the company will provide MedTech technology used in a variety of medical device applications.

In September 2019, Active Implants received breakthrough device designation from the FDA for their artificial knee meniscus product, designed for patients that undergo meniscus surgery and still have persistent pain. It is not fixed to soft bone and tissues due to its unique materials, structure, and design. After FDA’s breakthrough device program, accelerated the review and approval process, helping them launch the product in the U.S. market. The availability of high-quality service providers is expected to maintain the growth in outsourcing. Some of the players operating in the U.S. medical device outsourcing market are:

• Integer Holdings Corporation

• Avail Medsystems, Inc.

• Active Implants.

• Omnica Corporation

• Teleflex Incorporated

• Cantel Medical Corp. (STERIS plc)

• SGS SA

• Laboratory Corporation of America Holdings

• Eurofins Scientific

• Pace Analytical Services, Inc.

• Intertek Group plc

• WuXi AppTec

• IQVIA Inc.

• Charles River Laboratories

• ICON plc.

• PAREXEL International Corporation

• Medpace

• Premier Research

• North American Science Associates, LLC

• Sterigenics U.S., LLC (GTCR, LLC)

U.S. Medical Device Outsourcing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at a country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. 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, application, and region:

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

  • Quality Assurance

  • Regulatory Affairs 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 Market Application Outlook (USD Million, 2018 - 2030)

  • Cardiology

  • Diagnostic imaging

  • Orthopedic

  • IVD

  • Ophthalmic

  • General and plastic surgery

  • Drug delivery

  • Dental

  • Endoscopy

  • Diabetes care

  • Others

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

  • Class I

  • Class II

  • Class III