U.S. Medical Device Regulatory Affairs Market Size & Outlook
U.S. medical device regulatory affairs market, 2018-2030 (US$M)
Related Markets
U.S. medical device regulatory affairs market highlights
- The U.S. medical device regulatory affairs market generated a revenue of USD 1,908.2 million in 2024 and is expected to reach USD 3,346.0 million by 2030.
- The U.S. market is expected to grow at a CAGR of 9.8% from 2025 to 2030.
- In terms of segment, outsource was the largest revenue generating service provider in 2024.
- Outsource is the most lucrative service provider segment registering the fastest growth during the forecast period.
Medical device regulatory affairs market data book summary
| Market revenue in 2024 | USD 1,908.2 million |
| Market revenue in 2030 | USD 3,346.0 million |
| Growth rate | 9.8% (CAGR from 2025 to 2030) |
| Largest segment | Outsource |
| Fastest growing segment | Outsource |
| Historical data | 2018 - 2023 |
| Base year | 2024 |
| Forecast period | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsource |
Other key industry trends
- In terms of revenue, U.S. accounted for 28.3% of the global medical device regulatory affairs market in 2024.
- 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 3,346.0 million by 2030.
No credit card required*
Horizon in a snapshot
- 30K+ Global Market Reports
- 120K+ Country Reports
- 1.2M+ Market Statistics
- 200K+ Company Profiles
- Industry insights and more
Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|
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.
Outsource was the largest segment with a revenue share of 65.75% in 2024. Horizon Databook has segmented the U.S. medical device regulatory affairs market based on in-house, outsource 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.
Reasons to subscribe to U.S. medical device regulatory affairs market databook:
-
Access to comprehensive data: Horizon Databook provides over 1 million market statistics and 20,000+ reports, offering extensive coverage across various industries and regions.
-
Informed decision making: Subscribers gain insights into market trends, customer preferences, and competitor strategies, empowering informed business decisions.
-
Cost-Effective solution: It's recognized as the world's most cost-effective market research database, offering high ROI through its vast repository of data and reports.
-
Customizable reports: Tailored reports and analytics allow companies to drill down into specific markets, demographics, or product segments, adapting to unique business needs.
-
Strategic advantage: By staying updated with the latest market intelligence, companies can stay ahead of competitors, anticipate industry shifts, and capitalize on emerging opportunities.
Target buyers of U.S. medical device regulatory affairs market databook
-
Our clientele includes a mix of medical device regulatory affairs market companies, investment firms, advisory firms & academic institutions.
-
30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
-
Approximately 65% of our revenue is generated working with competitive intelligence & market intelligence teams of market participants (manufacturers, service providers, etc.).
-
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.
Partial client list
U.S. medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)
U.S. Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
Related industry reports
Related regional statistics
Sign up - it's easy, and free!
Sign up and get instant basic access to databook, upgrade
when ready, or enjoy our
free plan indefinitely.
Included in Horizon account
- 30K+ Global Market Reports
- 120K+ Country Reports
- 1.2M+ Market Statistics
- 200K+ Company Profiles
- Industry insights and more
