U.S. Regulatory Affairs Market Size & Outlook, 2023-2030
U.S. regulatory affairs market, 2018-2030 (US$M)
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U.S. regulatory affairs market highlights
- The U.S. regulatory affairs market generated a revenue of USD 4,233.6 million in 2023 and is expected to reach USD 7,446.3 million by 2030.
- The U.S. market is expected to grow at a CAGR of 8.4% from 2024 to 2030.
- In terms of segment, outsourcing was the largest revenue generating type in 2023.
- Outsourcing is the most lucrative type segment registering the fastest growth during the forecast period.
Regulatory affairs market data book summary
| Market revenue in 2023 | USD 4,233.6 million |
| Market revenue in 2030 | USD 7,446.3 million |
| Growth rate | 8.4% (CAGR from 2023 to 2030) |
| Largest segment | Outsourcing |
| Fastest growing segment | Outsourcing |
| Historical data | 2018 - 2022 |
| Base year | 2023 |
| Forecast period | 2024 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsourcing |
| Key market players worldwide | Genpact Ltd, Criterium Inc., Icon PLC, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Labcorp Holdings Inc, FREYR Battery Inc, Pharmexon, Cambridge Design Partnership, Voisin Consulting Life Sciences, Accell, PAREXEL, Promedica International, PharmaLex, NDA Regulatory Service GmbH, QVigilance, BlueReg Group |
Other key industry trends
- In terms of revenue, U.S. accounted for 28.2% of the global 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. 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 7,446.3 million by 2030.
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Regulatory Affairs Market Scope
Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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U.S. 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 regulatory affairs market will help companies and investors design strategic landscapes.
Outsourcing was the largest segment with a revenue share of 58.13% in 2023. Horizon Databook has segmented the U.S. regulatory affairs market based on in-house, outsourcing covering the revenue growth of each sub-segment from 2018 to 2030.
The U.S. accounts for a major share of clinical trial applications across the globe with 33.0% of total clinical trial applications being filed within the country in the year 2014-2016. Along with branded and patented products, there is also a strong demand for cost-effective generic and biosimilar products in this region.
In addition, there is also a significant increase in the import of generic and biosimilar products from emerging countries, which is increasing the demand for regulatory service providers in the region.
Big biopharmaceutical and medical device companies are outsourcing part of their regulatory functions such as report writing & publishing and clinical trial application services to regulatory service providers, thereby contributing to the growth of Regulatory affairs market in the U.S.
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Horizon Databook provides a detailed overview of country-level data and insights on the U.S. regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into U.S. regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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U.S. regulatory affairs market size, by type, 2018-2030 (US$M)
U.S. Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)
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