U.S. Pharmaceutical Regulatory Affairs Market Size & Outlook
U.S. pharmaceutical regulatory affairs market, 2018-2030 (US$M)
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U.S. pharmaceutical regulatory affairs market highlights
- The U.S. pharmaceutical regulatory affairs market generated a revenue of USD 1,428.2 million in 2023 and is expected to reach USD 2,414.9 million by 2030.
- The U.S. market is expected to grow at a CAGR of 7.8% 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.
Pharmaceutical regulatory affairs market data book summary
| Market revenue in 2023 | USD 1,428.2 million |
| Market revenue in 2030 | USD 2,414.9 million |
| Growth rate | 7.8% (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, IQVIA Holdings Inc, Icon PLC, Wuxi AppTec Co Ltd, Charles River Laboratories International Inc, Cencora Inc, Pharmexon, Genpact Ltd, Freyr Solutions, PAREXEL |
Other key industry trends
- In terms of revenue, U.S. accounted for 28.0% of the global pharmaceutical 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. pharmaceutical 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 2,414.9 million by 2030.
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Pharmaceutical Regulatory Affairs Market Scope
Pharmaceutical Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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U.S. pharmaceutical 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 pharmaceutical 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. pharmaceutical 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 U.S. accounts for a major share of clinical trial registrations globally, with 31.0% of the total clinical trial registered within the country as of November 2022. Along with branded and patented products, there is a strong demand for cost-effective generic and biosimilar products in the U.S.
In addition, there has been a significant increase in the import of generic and biosimilar products from emerging countries, thereby increasing the demand for regulatory service providers in the region.
Leading 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 overall market growth in the U.S.
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Target buyers of U.S. pharmaceutical regulatory affairs market databook
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Our clientele includes a mix of pharmaceutical 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. pharmaceutical regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into U.S. pharmaceutical regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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U.S. pharmaceutical regulatory affairs market size, by services, 2018-2030 (US$M)
U.S. Pharmaceutical Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)
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