Global Biologics Regulatory Affairs Outsourcing Market Size & Outlook
Global biologics regulatory affairs outsourcing market, 2018-2030 (US$M)
Related Markets
Global biologics regulatory affairs outsourcing market highlights
- The global biologics regulatory affairs outsourcing market generated a revenue of USD 2,077.8 million in 2023 and is expected to reach USD 3,690.8 million by 2030.
- The market is expected to grow at a CAGR (2024 - 2030) of 8.6% by 2030.
- In terms of segment, regulatory writing & publishing accounted for a revenue of USD 538.1 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, Kuwait is expected to register the highest CAGR from 2024 to 2030.
Global data book summary
| Market revenue in 2023 | USD 2,077.8 million |
| Market revenue in 2030 | USD 3,690.8 million |
| Growth rate | 8.6% (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 | Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, Regulatory Submissions, Regulatory Operations, Other Services, Regulatory Consulting |
Other key industry trends
- In terms of revenue, the North America accounted for 30.5% of the global biologics 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, Kuwait is the fastest growing regional market and is projected to reach USD 8.1 million by 2030.
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Biologics Regulatory Affairs Outsourcing Market Scope
Biologics Regulatory Affairs Outsourcing Market Companies
| Name | Profile | # Employees | HQ | Website |
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Global biologics 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 biologics regulatory affairs outsourcing market will help companies and investors design strategic landscapes.
Regulatory writing & publishing was the largest segment with a revenue share of 25.9% in 2023. Horizon Databook has segmented the Global biologics regulatory affairs outsourcing market based on legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, other services, regulatory consulting covering the revenue growth of each sub-segment from 2018 to 2030.
- Global Biologics Regulatory Affairs Outsourcing Services Outlook (Revenue, USD Million, 2018-2030)
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Regulatory Consulting
- Strategy & Development Planning
- QA Consulting
- Agent Services
- Others
- Global Biologics Regulatory Affairs Outsourcing Phase Outlook (Revenue, USD Million, 2018-2030)
- Preclinical
- Clinical
- Phase I
- Phase II
- Phase III
- Phase IV
- Global Biologics Regulatory Affairs Outsourcing Phase By Service Outlook (Revenue, USD Million, 2018-2030)
- Preclinical
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Clinical
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Preclinical
- Global Biologics Regulatory Affairs Outsourcing Modality Outlook (Revenue, USD Million, 2018-2030)
- Monoclonal Antibodies (mAbs)
- Recombinant Proteins
- Vaccines
- Cell & Gene Therapies
- Biosimilars
- Others
- Global Biologics Regulatory Affairs Outsourcing Phase by Modality Outlook (Revenue, USD Million, 2018-2030)
- Preclinical
- Monoclonal Antibodies (mAbs)
- Recombinant Proteins
- Vaccines
- Cell & Gene Therapies
- Biosimilars
- Others
- Clinical
- Monoclonal Antibodies (mAbs)
- Recombinant Proteins
- Vaccines
- Cell & Gene Therapies
- Biosimilars
- Others
- Preclinical
- Global Biologics Regulatory Affairs Outsourcing Modality by Services Outlook (Revenue, USD Million, 2018-2030)
- Monoclonal Antibodies (mAbs)
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Recombinant Proteins
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Vaccines
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Cell & Gene Therapies
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Biosimilars
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Others
- Regulatory Consulting
- Legal Representation
- Regulatory Writing & Publishing
- Product Registration & Clinical Trial Applications
- Regulatory Submissions
- Regulatory Operations
- Other Services
- Monoclonal Antibodies (mAbs)
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Target buyers of Global biologics regulatory affairs outsourcing market databook
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Our clientele includes a mix of biologics 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 biologics regulatory affairs outsourcing market , including forecasts for subscribers. This global databook contains high-level insights into Global biologics regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
Partial client list
Global biologics regulatory affairs outsourcing market size, by regions, 2018-2030 (US$M)
Top 10 countries: Biologics regulatory affairs outsourcing market size, 2023 (US$M)
Global biologics regulatory affairs outsourcing market share, by services, 2023 & 2030 (%, US$M)
Biologics regulatory affairs outsourcing market: Opportunity assessment by country
Global biologics regulatory affairs outsourcing market, by region, 2023 (US$M)
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