Dublin, May 21, 2025 (GLOBE NEWSWIRE) — The “U.S. Medical Device Outsourcing Market Size, Share & Trends Analysis Report by Service (Quality Assurance, Contract Manufacturing), Application (Cardiology, Diagnostic Imaging, IVD), Class (Class I, Class II, Class III), Country, with Growth Forecasts, 2025-2030” report has been added to ResearchAndMarkets.com’s offering.
The U.S. Medical Device Outsourcing Market was valued at USD 30.96 Billion in 2024, and is projected to reach USD 63.40 Billion by 2030, rising at a CAGR of 13.00%. This market is growing as a result of increased offshore trends, a rise in demand for high-tech medical devices, and stringent regulation for medical devices in the U.S.
The medical device industry has always been highly competitive, and categories such as coronary stents, orthopedic devices, and wound care are moving toward maturity. As high-impact scientific innovation in the above categories is difficult to achieve and is a time-consuming process, 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, medical device manufacturers are likely to opt for outsourcing business models to reduce costs, manage business risks, and improve service delivery. This factor is expected to propel market growth over the forecast period.
The government authorities have escalated funds for the research and development of essential devices, thus driving the market. The majority of clinical research globally devices are conducted in the U.S. alone according to Clinical Trials .gov. In case of the medical device also significant studies are conducted in the U.S.
For instance, as of February 2023, over 25033, research for medical devices was registered in the Clinical Trials .gov. Medical device companies are conducting research in the country owing to the availability of skilled labor and advanced infrastructure, as well as the presence of a significant number of CROs offering quality services. All these factors are expected to support the market in the post-Pandemic period.
U.S. Medical Device Outsourcing Market Report Highlights
- The U.S. medical device outsourcing industry is developing due to stricter FDA regulations, which require manufacturers to seek specialized compliance support
- The market is rapidly transforming due to evolving regulatory requirements, cost pressures, and the need for faster time to market
- The U.S. medical device outsourcing industry is driven by cost containment pressures, stringent regulatory compliance, and increasing complexity in device development.
- The contract manufacturing segment accounted for the largest share of 46.74% in 2024. The segment growth is owing to increasing cost pressures, stringent FDA regulatory requirements, and the growing complexity of medical devices
- Based on application, the cardiology segment dominated the market in 2024. The growing demand for cardiovascular devices due to the high prevalence rate of cardiovascular diseases (CVDs) is attributed to the growth of outsourcing these devices
Why Should You Buy This Report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
Key Attributes:
Report Attribute | Details |
No. of Pages | 190 |
Forecast Period | 2024 – 2030 |
Estimated Market Value (USD) in 2024 | $30.96 Billion |
Forecasted Market Value (USD) by 2030 | $63.4 Billion |
Compound Annual Growth Rate | 13.0% |
Regions Covered | United States |
Market Dynamics
Market Driver Analysis
- Changing Regulatory Landscape
- Increase in The Offshoring of Medical Device Manufacturing
- Rising Demand for Advanced Products
- Implementation of International Standards by Contract Manufacturers
- Rising Price Competition and The Need to Reduce Costs
- Increasing Complexity in Product Design and Engineering
Market Restraint Analysis
- Compliance Issues While Outsourcing
- Regulatory and Legal Compliance
- Contractual Obligations
Industry Challenges
Market Analysis Tools
- Porter’s Five Forces Analysis
- PESTEL by SWOT Analysis
- COVID-19 Impact Analysis
Technological Advancements
Regulatory Framework
Pricing Model Analysis
Companies Featured
- SGS SA
- Laboratory Corporation of America Holdings
- Eurofins Scientific
- Pace Analytical Services, Inc.
- TUV SUD
- Charles River Laboratories
- Freyr
- Global Regulatory Partners
- Parexel International Corporation
- Genpact
- Criterium, Inc.
- Promedica International
- Medpace
- ICON Plc.
- IQVIA Inc.
- Integer Holdings Corporation
- Jabil Inc.
- Flex Ltd.
- Plexus Corp.
- West Pharmaceutical Services, Inc.
For more information about this report visit https://www.researchandmarkets.com/r/30uj24
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- U.S. Medical Device Outsourcing Market