North America Biopharmaceutical Regulatory Affairs Market Size & Outlook
North America biopharmaceutical regulatory affairs market, 2018-2030 (US$M)
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North America biopharmaceutical regulatory affairs market highlights
- The North America biopharmaceutical regulatory affairs market generated a revenue of USD 1,173.1 million in 2023.
- The market is expected to grow at a CAGR of 7.9% from 2024 to 2030.
- In terms of segment, regulatory writing & publishing was the largest revenue generating services in 2023.
- Other Services is the most lucrative services 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 1,173.1 million |
| Market revenue in 2030 | USD 2,002.6 million |
| Growth rate | 7.9% (CAGR from 2023 to 2030) |
| Largest segment | Regulatory writing & publishing |
| Fastest growing segment | Other Services |
| 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, Other Services |
| Key market players worldwide | Genpact Ltd, Icon PLC, Promedica International, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Labcorp Drug Development, Cencora Inc, Pharmexon, QVigilance, Voisin Consulting Life Sciences, Accell, Criterium Inc., Freyr Solutions, PharmaLex, NDA Regulatory Service GmbH, BlueReg Group, Cambridge Regulatory Services |
Other key industry trends
- In terms of revenue, North America region accounted for 30.9% of the global biopharmaceutical regulatory affairs 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 2,521.7 million by 2030.
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Biopharmaceutical Regulatory Affairs Market Scope
Biopharmaceutical Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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North America biopharmaceutical 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 biopharmaceutical regulatory affairs market will help companies and investors design strategic landscapes.
Regulatory writing & publishing was the largest segment with a revenue share of 31.57% in 2023. Horizon Databook has segmented the North America biopharmaceutical 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.
North America is known to have one of the most stringent regulatory systems globally. In 2021, there was a significant increase in the approval of biologics, accounting for 39.0% of the total new drug approvals. This trend indicates the growing pipeline of biotechnology products.
The stringent regulatory processes and growing Research & Development (R&D) expenditure in North America are anticipated to increase the demand for outsourcing regulatory affairs services among leading biopharmaceuticals.
Numerous biopharmaceutical and medical device companies in North America have opted to outsource certain regulatory functions to regulatory service providers, thus contributing to the growth of the pharmaceutical regulatory affairs market.
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Our clientele includes a mix of biopharmaceutical regulatory affairs market companies, investment firms, advisory firms & academic institutions.
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Horizon Databook provides a detailed overview of continent-level data and insights on the North America biopharmaceutical regulatory affairs market , including forecasts for subscribers. This continent databook contains high-level insights into North America biopharmaceutical regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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North America biopharmaceutical regulatory affairs market size, by country, 2018-2030 (US$M)
North America Biopharmaceutical Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)
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