U.S. Medical Device Regulatory Affairs Market Size & Outlook
U.S. medical device regulatory affairs market, 2018-2030 (US$M)
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U.S. medical device regulatory affairs market highlights
- The U.S. medical device regulatory affairs market generated a revenue of USD 1,701.0 million in 2023 and is expected to reach USD 3,326.4 million by 2030.
- The U.S. market is expected to grow at a CAGR of 10.1% from 2024 to 2030.
- In terms of segment, regulatory writing & publishing was the largest revenue generating services in 2023.
- Legal Representation is the most lucrative services segment registering the fastest growth during the forecast period.
Medical device regulatory affairs market data book summary
| Market revenue in 2023 | USD 1,701.0 million |
| Market revenue in 2030 | USD 3,326.4 million |
| Growth rate | 10.1% (CAGR from 2023 to 2030) |
| Largest segment | Regulatory writing & publishing |
| Fastest growing segment | Legal Representation |
| Historical data | 2018 - 2022 |
| Base year | 2023 |
| Forecast period | 2024 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Other Services |
| Key market players worldwide | Labcorp Holdings Inc, Icon PLC, IQVIA Holdings Inc, Intertek Group PLC, SGS AG, Promedica International, Integer Holdings Corp, Medpace Holdings Inc, Emergo Group, Freyr Solutions |
Other key industry trends
- In terms of revenue, U.S. accounted for 25.8% of the global medical device regulatory affairs market in 2023.
- Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
- In North America, U.S. medical device regulatory affairs market is projected to lead the regional market in terms of revenue in 2030.
- U.S. is the fastest growing regional market in North America and is projected to reach USD 3,326.4 million by 2030.
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Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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U.S. medical device regulatory affairs market outlook
The databook is designed to serve as a comprehensive guide to navigating this sector. The databook focuses on market statistics denoted in the form of revenue and y-o-y growth and CAGR across the globe and regions. A detailed competitive and opportunity analyses related to medical device regulatory affairs market will help companies and investors design strategic landscapes.
Regulatory writing & publishing was the largest segment with a revenue share of 36.51% in 2023. Horizon Databook has segmented the U.S. medical device regulatory affairs market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, other services covering the revenue growth of each sub-segment from 2018 to 2030.
The large number of medical device companies operating in the U.S. proceed toward regulatory affairs and consulting for their product registration, clinical trial application, and legal representation, thereby contributing to the growth of the medical device regulatory affairs market in the U.S.
The increased efforts by the government and regulatory agencies to avoid medical device failure and injurious effects are expected to propel the regional market growth. In addition, the highly modernized healthcare system of the region demands more innovative medical devices in the healthcare system.
This is expected to boost the market demand for various medical devices, propelling the requirement for regulatory affairs for medical devices. Moreover, the presence of the FDA in the U.S. compels medical device manufacturers to comply with its guidelines. However, the changing biocompatibility guidance is expected to hamper the regional market growth.
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Target buyers of U.S. medical device regulatory affairs market databook
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Our clientele includes a mix of medical device regulatory affairs market companies, investment firms, advisory firms & academic institutions.
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30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
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Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
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The rest of the revenue is generated working with academic and research not-for-profit institutes. We do our bit of pro-bono by working with these institutions at subsidized rates.
Horizon Databook provides a detailed overview of country-level data and insights on the U.S. medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into U.S. medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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U.S. medical device regulatory affairs market size, by services, 2018-2030 (US$M)
U.S. Medical Device Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)
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