Global Regulatory Affairs Outsourcing Market Size & Outlook
The regulatory affairs outsourcing industry worldwide is expected to reach a projected revenue of US$ 11,313.7 million by 2030. A compound annual growth rate of 7.9% is expected of the worldwide regulatory affairs outsourcing industry from 2024 to 2030.
Revenue, 2023 (US$M)
$6,626.5
Forecast, 2030 (US$M)
$11,313.7
CAGR, 2024 - 2030
7.9%
Report Coverage
Worldwide
Global regulatory affairs outsourcing market, 2018-2030 (US$M)
Related Markets
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 segmentation & scope
Strategy & Development Planning
QA Consulting
Agent Services
Others
Legal representation
Regulatory writing & publishing
Project Management Services
Others
Regulatory Submissions
Regulatory Operations
Other services
Innovators
Generics
Biotech
ATMP
Biosimilars
Diagnostics
Therapeutics
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Indication
Oncology
Neurology
Cardiology
Immunology
Others
Stage
Preclinical
Clinical studies
PMA
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.
Partial client list
Global regulatory affairs outsourcing market statistics, by regions, 2018-2030 (US$M)
Top 10 countries: Regulatory affairs outsourcing market size, 2023 (USD Million)
Top 10 countries: Regulatory affairs outsourcing market size, 2023 (USD Million)
Global regulatory affairs outsourcing market, by region, 2023 (US$M)
Related regional statistics
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