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.
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.
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)
Report Attribute |
Details |
Market Size value in 2022 |
USD 25.16 billion |
Revenue forecast in 2030 |
USD 59.01 billion |
Growth rate |
CAGR of 11.2% from 2022 to 2030 |
Base year for estimation |
2021 |
Historical data |
2018 - 2020 |
Forecast period |
2022 - 2030 |
Quantitative units |
Revenue in USD million/billion and CAGR from 2022 to 2030 |
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
Segments covered |
Services, application, class |
Country scope |
U.S. |
Key companies profiled |
Integer Holdings Corporation; Avail Medsystems, Inc. ; Active Implants.; Omnica Corp.; 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) |
Customization scope |
Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
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
b. The U.S. medical device outsourcing market size was estimated at USD 23.3 billion in 2021 and is expected to reach USD 25.2 billion in 2022.
b. The U.S. medical device outsourcing market is expected to grow at a compound annual growth rate of 11.2% from 2022 to 2030 to reach USD 59.01 billion by 2030.
b. Contract manufacturing dominated the U.S. medical device outsourcing market with a share of 55.11% in 2021. Medical device market players are striving to reduce costs as profit margins are shrinking. To curtail fixed costs, companies are implementing shift work.
b. Some key players operating in the U.S. medical device outsourcing market include Accellent Inc., Active Implants Corporation LLC, MDMI Technologies Inc., Kinetics Climax, Inc, Omnica Corporation, Teleflex Medical OEM, and Avail Medical Products, Inc.
b. Key factors that are driving the market growth include rising price competition and requirement to reduce costs, increasing complexity, product design, &engineering, and rise in surgical procedures and increasing demand for surgical equipment.
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With Covid-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for Covid19 as a key market contributor.
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