Europe Medical Device Regulatory Affairs Market Size & Outlook

The medical device regulatory affairs market in Europe is expected to reach a projected revenue of US$ 2,829.7 million by 2030. A compound annual growth rate of 9.7% is expected of Europe medical device regulatory affairs market from 2024 to 2030.
Revenue, 2023 (US$M)
$1,475.4
Forecast, 2030 (US$M)
$2,829.7
CAGR, 2024 - 2030
9.7%
Report Coverage
Europe

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

Europe

Related Markets

Europe medical device regulatory affairs market highlights

  • The Europe medical device regulatory affairs market generated a revenue of USD 1,475.4 million in 2023.
  • The market is expected to grow at a CAGR of 9.7% from 2024 to 2030.
  • In terms of segment, regulatory writing & publishing was the largest revenue generating services in 2023.
  • Legal Representation is the most lucrative services 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 1,475.4 million
Market revenue in 2030USD 2,829.7 million
Growth rate9.7% (CAGR from 2023 to 2030)
Largest segmentRegulatory writing & publishing
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, Other Services
Key market players worldwideLabcorp Holdings Inc, Icon PLC, IQVIA Holdings Inc, Intertek Group PLC, SGS AG, Promedica International, Integer Holdings Corp, Medpace Holdings Inc, Emergo Group, Freyr Solutions


Other key industry trends

  • In terms of revenue, Europe region accounted for 22.4% of the global medical device regulatory affairs 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 5,191.6 million by 2030.

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Medical Device Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

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.


Regulatory writing & publishing was the largest segment with a revenue share of 36.51% in 2023. Horizon Databook has segmented the Europe medical device regulatory affairs market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, other services 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.

Managing the increased cost is another factor that may impede regional market growth. The new regulatory framework in Europe is expected to improve post-marketing 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

  • Our clientele includes a mix of medical device regulatory affairs 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.).
  • 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, 2023 & 2030 (US$M)

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

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