According to latest report, the U.S. medical device outsourcing market size is calculated at USD 35.30 billion in 2025 and is expected to reach around USD 94.80 billion by 2034, growing at a CAGR of 11.6% for the forecasted period.
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U.S. Medical Device Outsourcing Market Report Highlights
• By application, the cardiology segment accounted for the largest share of 31.8% the market in 2024.
• By application, the general and plastic surgery segment is expected to grow at the fastest rate in the market during the forecast period of 2025 to 2034.
• Class II type medical devices accounted for the largest revenue share of 74.6% in 2024 and the segment is expected to register the fastest CAGR of over 11.0% over the forecast period.
• By service, the quality assurance segment held a dominant presence in the U.S. medical device outsourcing market in 2024.
• By service, the regulatory affairs services segment is predicted to witness significant growth in the market over the forecast period.
The increasing demand for technically advanced medical devices in the U.S., outsourcing non-core activities to works upon core practices and compete in the region, and increasing demand for cost effective research and manufacturing medical devices are driving factors for the U.S. medical device outsourcing market.
The medical device outsourcing is the term represents the practice which involves contraction of particular tasks like manufacturing, research and development and regulatory affairs to another parties, called as third parties instead of handling them in their own production house as it may hinder growth of core workings and diver energy and resources to complex manufacturing for products. There is a vast range of medical outsourcing pattern is available which consists of product design, testing, prototyping, post market surveillance which streamlines the processes and increases innovative products and their sales.
By recognizing the pattern made by medica device market in the unites states, it is expected to foster significantly owing to the increasing demand for advanced medical technologies, growing regulatory complexities and demand for production solution which require low cost to handle. Additionally, increasing technological advancement like 3D printing, robotics and IoT are transforming the medical device outsourcing market. Outsourcing allows manufacturers with scalability and flexibility for schedule in production so that they can make required changes in medical devices as per demand from consumers.
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U.S. Medical Device Outsourcing Market Report Scope
|
Report Attribute |
Details |
|
Market Size value in 2025 |
USD 35.30 billion |
|
Revenue forecast in 2034 |
USD 94.80 billion |
|
Growth Rate |
CAGR 11.6% from 2025 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD Million and CAGR from 2024 to 2034 |
|
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) |
Major Trends in the Market
Government backed R&D
The major trend that, U.S. medical device outsourcing market holds is increasing initiatives by authorities and government to support extensive research and development to innovate in the sector of medical devices. According to the clinical trials.gov, majority of clinical research has been conducted in the U.S. alone across the globe highlighting its potential in the medical device market.
- For instance, up to Feb 2023, nearly 25033 clinical devices were registered in the clinical trials. Medical device enterprises tend to conduct research in the United States due to the presence of highly skilled workforce and efficient way of working, augmenting the markets growth further.
Growing demand for cost-effective solutions
Another trending factor for the market is increasing demand for cost-effective solutions which enables device manufacturers to outsource several devices and their functioning along with research and development, moreover, the rapid technological advancement like automation and digitalization has helps manufacturers to increase their efficiency and innovation for development of new products.
- According to the data published by the U.S. bureau of labor statistics, the medical device outsourcing market has employed nearly 400,000 people in the United States to the year 2023.
Integration of artificial intelligence
Since artificial intelligence has significantly impacted every sector, the medical device outsourcing market is no exception. Integration of data analytics and artificial intelligence help medical device manufacturers to leverage these technologies by analyzing huge datasets and to optimize manufacturing processes include improving quality control of the products. Further predictive maintenance can help to increase the efficiency and safety of the product by detecting potential breakage before it occurs.
Opportunities in the market
Increased CVDs as major reason of mortal rate
The significant opportunity that U.S. medical device outsourcing market holds is increasing rate of mortality due to frequent cases of cardiovascular diseases which is still one of the concerning healthcare conditions which most people suffering from. Advanced medical devices manufactured for cardiovascular emergencies encompass stents, pacemakers and diagnostic imaging tools. Outsourcing of such devices plays a critical role in fostering the markets growth as they are essential healthcare tools needed to manufacture precisely, creating array of opportunities to develop the market within region. Also, by technological advancement diagnostic tools witnessing surge in demand as a preventive healthcare measure by many healthcare professionals and consumers.
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Market Segmentation
By service
By service, contract manufacturing segment accounted for the largest market share, hence dominating the U.S. medical device outsourcing market. Service segment is further divided into various subsegment includes, regulatory consulting services, product design and development services, quality assurance services, product testing and sterilization services, product upgrade, product implementation, product maintenance and contract manufacturing services. Major players in the U.S. medical device market are looking for cost reduction as profit margin is reducing with time. Many manufacturers in the U.S. are offering quality services are expected to foster segments growth.
By service, the quality assurance segment is anticipated to grow at the fastest CAGR rate during the foreseeable period. Various standards like accountability and health insurance portability need to be met by the medical device manufacturing process. ISO 13458 audits are conducted by medical device outsourcing service providers and are the major reason for the market’s expansion.
By application
By application, the cardiology segment accounted for the largest market share, thus dominating the market. The market is further segmented into different subsegments like cardiology, IVD, orthopedic, diagnostic imaging, dental, general and plastic surgery etc. According to the data revealed by U.S. CDC, every 34second, one person dies due to cardiac arrest in the U.S. reason behind this is increasing prevalence of conditions like hypertensive heart disease, atrial fibrillation, rheumatic heart disease within U.S. hence, demand for cardiovascular devices has seen a rapid surge in recent years, promoting the growth of cardiology segment.
By application, general and plastic surgery device outsourcing registered the fastest growing rate during the upcoming period. The expansion of this segment can be related to the presence of leading outsourcing companies in the unites states with robust infrastructure and equipped with advanced facilities. These firms adhere to the regulations set by authorities for the safety of patients attracting more consumers, fueling its growth in the market. Also, increasing awareness about physical appearance and overall high living standard, cosmetic operations witnessing surge in demand in the united states.in turn, a positively influencing need for special equipment for such delicate surgeries.
By class
By class, class II medical device segment accounted for the largest market share, thus dominating the U.S. medical device outsourcing market. The growth of this segment can be attributed to the substantial cost of these devices. These devices are sensitive as they are kept continuously in contact with patients. Owing to their complexity, such devices are outsourced for their development and required manufacturing, increasing the segments expansion in the market.
By class, Class I medical device expected to witness fastest growth rate during forecast period. The growth of this segment has many aspects including its low risk while use on patients, which is key driver of the segments thrive. Class I device includes latex gloves, bedpans, stethoscopes, bandages, irrigating dental syringes and more. These devices are used by medical professionals more frequently in daily checking.
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U.S. Medical Device Outsourcing Market Top Key Companies:
- 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)
What is Going Around the Globe?
Ø On 29th January 2025, three leading companies of medical device industry, Tyber medical LLC, Intech and Resolve surgical technologies have made collaboration aiming to provide innovative, high-quality and reliable solution for OEM customers, surgeons and patients.
Ø In Jan 2022, Celestica Inc introduces its AbelConn Electronics factory from Minnesota which officially acquired the ISO certification to manufacture medical devices.
U.S. Medical Device Outsourcing Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2034. For this study, Statifacts has segmented the global U.S. Medical Device Outsourcing Market
By Service
• Product Upgrade Services
• Regulatory Affairs Services
o Legal representation
o Clinical trials applications
o Regulatory writing and publishing
• Quality Assurance
• Product Maintenance Services
• Product Testing & Sterilization Services
• Product Design and Development Services
o Molding
o Designing & engineering
o Machining
o Packaging
• Product Implementation Services
• Contract Manufacturing
o Accessories manufacturing
o Component manufacturing
o Device manufacturing
o Assembly manufacturing
By Application
• Drug delivery
• Dental
• Diabetes care
• Cardiology
• Endoscopy
• IVD
• Ophthalmic
• Diagnostic imaging
• Orthopedic
• General and plastic surgery
• Others
By Class
• Class I
• Class I
• Class III
By Regional
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East Africa
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