Europe Medical Device Regulatory Affairs Market Size & Outlook
Europe medical device regulatory affairs market, 2018-2030 (US$M)
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Europe medical device regulatory affairs market highlights
- The Europe medical device regulatory affairs market generated a revenue of USD 1,539.1 million in 2024.
- The market is expected to grow at a CAGR of 8.5% from 2025 to 2030.
- In terms of segment, outsource was the largest revenue generating service provider in 2024.
- Outsource is the most lucrative service provider 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 1,539.1 million |
| Market revenue in 2030 | USD 2,506.3 million |
| Growth rate | 8.5% (CAGR from 2025 to 2030) |
| Largest segment | Outsource |
| Fastest growing segment | Outsource |
| 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, Outsource |
Other key industry trends
- In terms of revenue, Europe region accounted for 22.8% of the global medical device 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 4,590.5 million by 2030.
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Medical Device Regulatory Affairs Market Scope
Medical Device Regulatory Affairs Market Companies
| Name | Profile | # Employees | HQ | Website |
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Europe medical device 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 medical device regulatory affairs market will help companies and investors design strategic landscapes.
Outsource was the largest segment with a revenue share of 65.49% in 2024. Horizon Databook has segmented the Europe medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
Europe is one of the most advanced regions globally, with advanced technologies and infrastructure, resulting in better healthcare facilities and patient care. Players seeking entry into the European market require extensive knowledge of different regulatory procedures and services in various EU member states.
Small and midsized medical device regulatory companies are emerging in the region to satisfy the high demand for regulatory affairs created due to the increased production of medical devices. However, frequent medical device regulation changes may restrain the regional market growth. Moreover, medical device certification companies have to satisfy the additional requirements raised by medical device companies and conduct frequent audits.
Managing the increased cost is another factor that may impede regional market growth. The new regulatory framework in Europe is expected to improve postmarketing monitoring and product quality testing service segments of the regulatory agencies.
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Target buyers of Europe medical device regulatory affairs market databook
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Our clientele includes a mix of medical device regulatory affairs 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 continent-level data and insights on the Europe medical device regulatory affairs market , including forecasts for subscribers. This continent databook contains high-level insights into Europe medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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Europe medical device regulatory affairs market size, by country, 2018-2030 (US$M)
Europe Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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