Europe Regulatory Affairs Market Size & Outlook, 2025-2030
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Europe regulatory affairs market highlights
- The Europe regulatory affairs market generated a revenue of USD 3,747.2 million in 2024.
- The market is expected to grow at a CAGR of 7.7% from 2025 to 2030.
- In terms of segment, outsourcing was the largest revenue generating type in 2024.
- Outsourcing is the most lucrative type segment registering the fastest growth during the forecast period.
- Country-wise, UK is expected to register the highest CAGR from 2025 to 2030.
Europe data book summary
| Market revenue in 2024 | USD 3,747.2 million |
| Market revenue in 2030 | USD 5,839.8 million |
| Growth rate | 7.7% (CAGR from 2025 to 2030) |
| Largest segment | Outsourcing |
| Fastest growing segment | Outsourcing |
| Historical data covered | 2018 - 2023 |
| Base year for estimation | 2024 |
| Forecast period covered | 2025 - 2030 |
| Quantitative units | Revenue in USD million |
| Market segmentation | In-house, Outsourcing |
| Key market players worldwide | Genpact Ltd, Criterium Inc., Icon PLC, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Labcorp Holdings Inc, FREYR Battery Inc, Pharmexon, Cambridge Design Partnership, Voisin Consulting Life Sciences, Accell, PAREXEL, Promedica International, PharmaLex, NDA Regulatory Service GmbH, QVigilance, BlueReg Group |
Other key industry trends
- In terms of revenue, Europe region accounted for 22.8% of the global regulatory affairs market in 2024.
- 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 10,696.0 million by 2030.
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Regulatory Affairs Market Scope
Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
|---|---|---|---|---|
| BlueReg Group | View profile | 101-250 | Paris, Ile-de-France, France, Europe | https://blue-reg.com |
| QVigilance | View profile | 11-50 | Hitchin, Hertford, United Kingdom, Europe | https://www.qvigilance.com |
| NDA Regulatory Service GmbH | View profile | 101-250 | München, Bayern, Germany, Europe | http://www.ndareg.com/ |
| PharmaLex | View profile | 1001-5000 | Friedrichsdorf, Hessen, Germany, Europe | http://www.pharmalex.com/ |
| Promedica International | View profile | 11-50 | Costa Mesa, California, United States, North America | https://promedica-intl.com |
| PAREXEL | View profile | 10001+ | Waltham, Massachusetts, United States, North America | http://www.parexel.com |
| Accell | View profile | 11-50 | Warrenton, Virginia, United States, North America | https://accellclinical.com/ |
| Voisin Consulting Life Sciences | View profile | 251-500 | San Francisco, California, United States, North America | http://voisinconsulting.com/ |
| Pharmexon | View profile | 11-50 | Prague, Hlavni mesto Praha, Czech Republic, Europe | https://pharmexon.com |
| FREYR Battery Inc | View profile | 212 | Boulevard Royal, 22-24, Level 2449, Luxembourg, Luxembourg, L-2449 | https://www.freyrbattery.com |
| Medpace Holdings Inc | View profile | 5800 | 5375 Medpace Way, Cincinnati, OH, United States, 45227 | https://www.medpace.com |
| Wuxi AppTec Co Ltd | View profile | 41116 | 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, China, People's Republic of, 200131 | https://www.wuxiapptec.com |
| Icon PLC | View profile | 41150 | South County Business Park, Leopardstown, Dublin, Ireland, D18 X5R3 | https://www.iconplc.com |
| Criterium Inc. | View profile | 101-250 | Saratoga Springs, New York, United States, North America | http://criteriuminc.com |
| Genpact Ltd | View profile | 131000 | 22 Victoria Street, Canon's Court, Hamilton, Bermuda, HM 12 | https://www.genpact.com |
| Cambridge Design Partnership | View profile | 251-500 | Bourn, Cambridgeshire, United Kingdom, Europe | https://www.cambridge-design.com/ |
| Labcorp Holdings Inc | View profile | 67000 | 358 South Main Street, Burlington, NC, United States, 27215 | https://www.labcorp.com |
| Charles River Laboratories International Inc | View profile | 21400 | 251 Ballardvale Street, Wilmington, MA, United States, 01887 | https://www.criver.com |
Europe 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 regulatory affairs market will help companies and investors design strategic landscapes.
Outsourcing was the largest segment with a revenue share of 64.54% in 2024. Horizon Databook has segmented the Europe regulatory affairs market based on in-house, outsourcing 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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Horizon Databook provides a detailed overview of continent-level data and insights on the Europe regulatory affairs market , including forecasts for subscribers. This continent databook contains high-level insights into Europe regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Europe regulatory affairs market size, by country, 2018-2030 (US$M)
Europe Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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