Global Biopharmaceutical Regulatory Affairs Market Size & Outlook
Global biopharmaceutical regulatory affairs market, 2018-2030 (US$M)
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Global biopharmaceutical regulatory affairs market highlights
- The global biopharmaceutical regulatory affairs market generated a revenue of USD 3,792.4 million in 2023 and is expected to reach USD 6,433.1 million by 2030.
- The market is expected to grow at a CAGR (2024 - 2030) of 7.8% by 2030.
- In terms of segment, regulatory writing & publishing accounted for a revenue of USD 1,195.7 million in 2023.
- Legal Representation is the most lucrative services segment registering the fastest growth during the forecast period.
- In terms of region, Asia Pacific was the largest revenue generating market in 2023.
- Country-wise, South Korea is expected to register the highest CAGR from 2024 to 2030.
Global data book summary
| Market revenue in 2023 | USD 3,792.4 million |
| Market revenue in 2030 | USD 6,433.1 million |
| Growth rate | 7.8% (CAGR from 2023 to 2030) |
| Largest segment | Regulatory writing & publishing |
| 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, Other Services |
Other key industry trends
- In terms of revenue, the North America accounted for 30.9% of the global biopharmaceutical regulatory affairs market in 2023.
- By country, the U.S. is projected to lead the global market in terms of revenue in 2030.
- By country, South Korea is the fastest growing regional market and is projected to reach USD 107.1 million by 2030.
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Biopharmaceutical Regulatory Affairs Market Scope
Biopharmaceutical Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|
Global 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 31.53% in 2023. Horizon Databook has segmented the Global 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.
- Global Biopharmaceutical Regulatory Affairs Services Outlook (Revenue, USD Million, 2018-2030)
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Writing
- Publishing
- Product Registration & Clinical Trial Applications
- Other Services
- Global Biopharmaceutical Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018-2030)
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
- Global Biopharmaceutical Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018-2030)
- Preclinical
- Clinical studies
- PMA
- Global Biopharmaceutical Regulatory Affairs Service Provicer Outlook (Revenue, USD Million, 2018-2030)
- In-house
- Outsourcing
- Global Biopharmaceutical Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018-2030)
- Small
- Medium
- Large
- Global Biopharmaceutical Regulatory Affairs Biologics Outlook (Revenue, USD Million, 2018-2030)
- Biotech
- ATMP
- Biosimilars
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Target buyers of Global biopharmaceutical regulatory affairs market databook
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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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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 global-level data and insights on the Global biopharmaceutical regulatory affairs market , including forecasts for subscribers. This global databook contains high-level insights into Global biopharmaceutical regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Global biopharmaceutical regulatory affairs market size, by regions, 2018-2030 (US$M)
Top 10 countries: Biopharmaceutical regulatory affairs market size, 2023 (US$M)
Global biopharmaceutical regulatory affairs market share, by services, 2023 & 2030 (%, US$M)
Biopharmaceutical regulatory affairs market: Opportunity assessment by country
Global biopharmaceutical regulatory affairs market, by region, 2023 (US$M)
| Services | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | CAGR |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| North America | 821.0 | 879.0 | 942.7 | 1,013.0 | 1,089.7 | 1,173.1 | 1,262.8 | 1,360.3 | 1,467.1 | 1,583.8 | 1,711.2 | 1,850.3 | 2,002.6 | 7.9% |
| Europe | 638.4 | 676.5 | 718.3 | 764.0 | 813.5 | 866.9 | 923.8 | 985.1 | 1,051.7 | 1,123.8 | 1,200.3 | 1,282.9 | 1,372.2 | 6.8% |
| Asia Pacific | 974.9 | 1,049.1 | 1,131.0 | 1,221.3 | 1,320.2 | 1,428.1 | 1,544.5 | 1,671.6 | 1,811.0 | 1,963.8 | 2,132.8 | 2,318.2 | 2,521.7 | 8.5% |
| Latin America | 129.0 | 137.7 | 147.3 | 157.8 | 169.2 | 181.6 | 194.9 | 209.4 | 225.1 | 242.3 | 261.0 | 281.3 | 303.6 | 7.6% |
| MEA | 103.0 | 109.6 | 116.8 | 124.8 | 133.4 | 142.7 | 152.7 | 163.5 | 175.2 | 187.9 | 201.7 | 216.8 | 233.1 | 7.3% |
| Overall | 2,666.2 | 2,851.9 | 3,056.1 | 3,280.9 | 3,525.9 | 3,792.4 | 4,078.6 | 4,389.8 | 4,730.1 | 5,101.6 | 5,506.9 | 5,949.5 | 6,433.1 | 7.8% |
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