Global Regulatory Affairs Outsourcing Market Size & Outlook
Global regulatory affairs outsourcing market, 2018-2030 (US$M)
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Global regulatory affairs outsourcing market highlights
- The global regulatory affairs outsourcing market generated a revenue of USD 6,626.5 million in 2023 and is expected to reach USD 11,313.7 million by 2030.
- The market is expected to grow at a CAGR (2024 - 2030) of 7.9% by 2030.
- In terms of segment, product registration & clinical trial applications accounted for a revenue of USD 1,719.6 million in 2023.
- Legal representation is the most lucrative service 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, Israel is expected to register the highest CAGR from 2024 to 2030.
Global data book summary
| Market revenue in 2023 | USD 6,626.5 million |
| Market revenue in 2030 | USD 11,313.7 million |
| Growth rate | 7.9% (CAGR from 2023 to 2030) |
| Largest segment | Product registration & clinical trial applications |
| Fastest growing segment | Legal representation |
| Historical data 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 |
Other key industry trends
- In terms of revenue, the North America accounted for 30.6% of the global regulatory affairs outsourcing market in 2023.
- By country, the U.S. is projected to lead the global market in terms of revenue in 2030.
- By country, Israel is the fastest growing regional market and is projected to reach USD 17.8 million by 2030.
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Regulatory Affairs Outsourcing Market Scope
Regulatory Affairs Outsourcing Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|
Global 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 25.95% in 2023. Horizon Databook has segmented the Global 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.
- Global Regulatory Affairs Outsourcing Service Outlook (Revenue, USD Million, 2018-2030)
- Regulatory consulting
- Strategy & Development Planning
- QA Consulting
- Agent Services
- Others
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Project Management Services
- Others
- Regulatory Submissions
- Regulatory Operations
- Other services
- Regulatory consulting
- Global Regulatory Affairs Outsourcing Category Outlook (Revenue, USD Million, 2018-2030)
- Drugs
- Innovators
- Generics
- Biologics
- Biotech
- ATMP
- Biosimilars
- Medical Devices
- Diagnostics
- Therapeutics
- Drugs
- Global Regulatory Affairs Outsourcing End Use Outlook (Revenue, USD Million, 2018-2030)
- Biotechnology Companies
- Pharmaceutical Companies
- Medical Device Companies
- Global Regulatory Affairs Outsourcing Company Size Outlook (Revenue, USD Million, 2018-2030)
- Small
- Small Sized Biotech/biopharmaceutical Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Small Sized Pharmaceutical Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Small Sized Medical Device Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Small Sized Biotech/biopharmaceutical Companies
- Medium
- Medium Sized Biotech/biopharmaceutical Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Medium Sized Pharmaceutical Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Medium Sized Medical Device Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Medium Sized Biotech/biopharmaceutical Companies
- Large
- Large Sized Biotech/biopharmaceutical Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Large Sized Pharmaceutical Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Large Sized Medical Device Companies
- Regulatory consulting
- Legal representation
- Regulatory writing & publishing
- Product registration & clinical trial applications
- Regulatory Submissions
- Regulatory Operations
- Other services
- Large Sized Biotech/biopharmaceutical Companies
- Small
- Global Regulatory Affairs Outsourcing Indication Outlook (Revenue, USD Million, 2018-2030)
- Oncology
- Neurology
- Cardiology
- Immunology
- Others
- Global Regulatory Affairs Outsourcing Stage Outlook (Revenue, USD Million, 2018-2030)
- Preclinical
- Clinical studies
- PMA
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Target buyers of Global 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 global-level data and insights on the Global regulatory affairs outsourcing market , including forecasts for subscribers. This global databook contains high-level insights into Global regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Global regulatory affairs outsourcing market size, by regions, 2018-2030 (US$M)
Top 10 countries: Regulatory affairs outsourcing market size, 2023 (US$M)
Global regulatory affairs outsourcing market share, by service, 2023 & 2030 (%, US$M)
Regulatory affairs outsourcing market: Opportunity assessment by country
Global regulatory affairs outsourcing market, by region, 2023 (US$M)
| Service | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 | 2027 | 2028 | 2029 | 2030 | CAGR |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| North America | 1,793.1 | 2,002.6 | 1,868.4 | 2,010.4 | 1,960.2 | 2,028.8 | 2,114.0 | 2,262.0 | 2,449.7 | 2,657.9 | 2,886.5 | 3,140.5 | 3,423.2 | 7.8% |
| Europe | 1,396.9 | 1,544.0 | 1,425.8 | 1,518.2 | 1,430.2 | 1,460.2 | 1,525.9 | 1,614.4 | 1,714.6 | 1,826.0 | 1,948.3 | 2,083.9 | 2,234.4 | 6.3% |
| Asia Pacific | 2,152.7 | 2,428.0 | 2,287.7 | 2,485.9 | 2,473.5 | 2,641.7 | 2,876.8 | 3,138.6 | 3,433.6 | 3,764.4 | 4,136.5 | 4,555.6 | 5,028.6 | 9.6% |
| Latin America | 265.1 | 286.1 | 257.9 | 268.0 | 264.0 | 262.4 | 271.1 | 280.6 | 290.7 | 301.6 | 313.5 | 326.2 | 340.0 | 3.8% |
| MEA | 224.3 | 246.9 | 226.3 | 238.3 | 234.8 | 233.4 | 240.4 | 247.6 | 255.1 | 262.8 | 270.8 | 279.1 | 287.6 | 3.0% |
| Overall | 5,832.2 | 6,507.6 | 6,066.0 | 6,521.0 | 6,362.6 | 6,626.5 | 7,028.2 | 7,543.2 | 8,143.6 | 8,812.8 | 9,555.5 | 10,385.3 | 11,313.7 | 7.9% |
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