Europe Regulatory Affairs Outsourcing Market Size & Outlook

The regulatory affairs outsourcing market in Europe is expected to reach a projected revenue of US$ 2,234.4 million by 2030. A compound annual growth rate of 6.3% is expected of Europe regulatory affairs outsourcing market from 2024 to 2030.
Revenue, 2023 (US$M)
$1,460.2
Forecast, 2030 (US$M)
$2,234.4
CAGR, 2024 - 2030
6.3%
Report Coverage
Europe

Europe regulatory affairs outsourcing market, 2018-2030 (US$M)

Europe

Related Markets

Europe regulatory affairs outsourcing market highlights

  • The Europe regulatory affairs outsourcing market generated a revenue of USD 1,460.2 million in 2023.
  • The market is expected to grow at a CAGR of 6.3% from 2024 to 2030.
  • In terms of segment, product registration & clinical trial applications was the largest revenue generating service in 2023.
  • Legal representation is the most lucrative service segment registering the fastest growth during the forecast period.
  • Country-wise, UK is expected to register the highest CAGR from 2024 to 2030.


Europe data book summary

Market revenue in 2023USD 1,460.2 million
Market revenue in 2030USD 2,234.4 million
Growth rate6.3% (CAGR from 2023 to 2030)
Largest segmentProduct registration & clinical trial applications
Fastest growing segmentLegal representation
Historical data covered2018 - 2022
Base year for estimation2023
Forecast period covered2024 - 2030
Quantitative unitsRevenue in USD million
Market segmentationRegulatory consulting, Legal representation, Regulatory writing & publishing, Product registration & clinical trial applications, Regulatory Submissions, Regulatory Operations, Other services
Key market players worldwideGenpact Ltd, Criterium Inc., Promedica International, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Icon PLC, Labcorp Drug Development, FREYR Battery Inc, Cencora Inc, Pharmexon, QVigilance, BlueReg Group, ZEINCRO Group


Other key industry trends

  • In terms of revenue, Europe region accounted for 22.0% of the global regulatory affairs outsourcing 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 5,028.6 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
Biotechnology Companies
Pharmaceutical Companies
Medical Device Companies
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

Europe 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 25.96% in 2023. Horizon Databook has segmented the Europe 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.


Europe is a decentralized pharmaceutical market. Entry in the European market requires players to possess extensive knowledge about different regulatory procedures in various member states of the European Union. 

Small- and mid-size biopharmaceutical companies that do not have a regulatory affairs department usually hire a regulatory consultant or a legal representative to assist them through various stages of regulatory approval processes required for commercializing their product in Europe. 

The European Medicine Agency (EMA), Europe’s regulatory agency covers 25.0% market of worldwide pharmaceutical sales and this is one of the leading drivers for outsourcing trend related to regulatory affairs in the life sciences sector as higher number of drugs for regulatory approval would mean greater demand for regulatory services by life sciences companies in the region. 

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  • Our clientele includes a mix of regulatory affairs outsourcing market companies, investment firms, advisory firms & academic institutions.
  • 30% of our revenue is generated working with investment firms and helping them identify viable opportunity areas.
  • 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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Horizon Databook provides a detailed overview of continent-level data and insights on the Europe regulatory affairs outsourcing market , including forecasts for subscribers. This continent databook contains high-level insights into Europe regulatory affairs outsourcing market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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Europe regulatory affairs outsourcing market size, by country, 2018-2030 (US$M)

Europe Regulatory Affairs Outsourcing Market Outlook Share, 2023 & 2030 (US$M)

Europe regulatory affairs outsourcing market size, by country, 2018-2030 (US$M)

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