North America Regulatory Affairs Outsourcing Market Size & Outlook
North America regulatory affairs outsourcing market, 2018-2030 (US$M)
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North America regulatory affairs outsourcing market highlights
- The North America regulatory affairs outsourcing market generated a revenue of USD 2,028.8 million in 2023.
- The market is expected to grow at a CAGR of 7.8% 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.
- Country-wise, U.S. is expected to register the highest CAGR from 2024 to 2030.
North America data book summary
| Market revenue in 2023 | USD 2,028.8 million |
| Market revenue in 2030 | USD 3,423.2 million |
| Growth rate | 7.8% (CAGR from 2023 to 2030) |
| Largest segment | Product registration & clinical trial applications |
| Fastest growing segment | Legal representation |
| Historical data covered | 2018 - 2022 |
| Base year for estimation | 2023 |
| Forecast period covered | 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, North America region accounted for 30.6% of the global regulatory affairs outsourcing market in 2023.
- Globally, Asia Pacific is projected to lead the regional market in terms of revenue in 2030.
- Asia Pacific is the fastest growing regional market and is projected to reach USD 5,028.6 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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North America 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 North America 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.
North America is known to have one of the most stringent regulatory systems across the world. Contrary to the belief that there has been a decline in FDA approvals for new drugs, in 2015, 45 drugs were approved.
There has been a tremendous increase in approval of biologics, which account for 39.0% of total new drug approvals and this indicates the growing pipeline of biotechnology products. Stringent regulatory processes and growing R&D expenditure in North America are anticipated to increase the demand for outsourcing regulatory affairs services by large biopharmaceuticals.
North America is home to numerous biopharmaceutical and medical device companies, which are outsourcing part of their regulatory functions to regulatory service providers, thereby contributing to the growth of the Regulatory affairs outsourcing market.
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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 continent-level data and insights on the North America regulatory affairs outsourcing market , including forecasts for subscribers. This continent databook contains high-level insights into North America regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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North America regulatory affairs outsourcing market size, by country, 2018-2030 (US$M)
North America Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)
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