U.S. Regulatory Affairs Outsourcing Market Size & Outlook
U.S. regulatory affairs outsourcing market, 2018-2030 (US$M)
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U.S. regulatory affairs outsourcing market highlights
- The U.S. regulatory affairs outsourcing market generated a revenue of USD 1,844.3 million in 2023 and is expected to reach USD 3,144.7 million by 2030.
- The U.S. market is expected to grow at a CAGR of 7.9% from 2024 to 2030.
- In terms of segment, product registration & clinical trial applications was the largest revenue generating service in 2023.
- Legal representation is the most lucrative service segment registering the fastest growth during the forecast period.
Regulatory affairs outsourcing market data book summary
| Market revenue in 2023 | USD 1,844.3 million |
| Market revenue in 2030 | USD 3,144.7 million |
| Growth rate | 7.9% (CAGR from 2023 to 2030) |
| Largest segment | Product registration & clinical trial applications |
| 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, Regulatory Submissions, Regulatory Operations, Other services |
| Key market players worldwide | Genpact Ltd, Criterium Inc., Promedica International, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Icon PLC, Labcorp Drug Development, FREYR Battery Inc, Cencora Inc, Pharmexon, QVigilance, BlueReg Group, ZEINCRO Group |
Other key industry trends
- In terms of revenue, U.S. accounted for 27.8% of the global regulatory affairs outsourcing 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 outsourcing 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 3,144.7 million by 2030.
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Regulatory Affairs Outsourcing Market Scope
Regulatory Affairs Outsourcing Market Companies
| Name | Profile | # Employees | HQ | Website |
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U.S. regulatory affairs outsourcing 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 outsourcing market will help companies and investors design strategic landscapes.
Product registration & clinical trial applications was the largest segment with a revenue share of 25.93% in 2023. Horizon Databook has segmented the U.S. regulatory affairs outsourcing market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, 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 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 the Regulatory affairs outsourcing market in the U.S.
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Target buyers of U.S. regulatory affairs outsourcing market databook
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Our clientele includes a mix of regulatory affairs outsourcing 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. regulatory affairs outsourcing market , including forecasts for subscribers. This country databook contains high-level insights into U.S. regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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U.S. regulatory affairs outsourcing market size, by service, 2018-2030 (US$M)
U.S. Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)
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