Global Medical Device Regulatory Affairs Market Size & Outlook

The medical device regulatory affairs industry worldwide is expected to reach a projected revenue of US$ 12,785.2 million by 2030. A compound annual growth rate of 9.9% is expected of the worldwide medical device regulatory affairs industry from 2024 to 2030.
Revenue, 2023 (US$M)
$6,585.3
Forecast, 2030 (US$M)
$12,785.2
CAGR, 2024 - 2030
9.9%
Report Coverage
Worldwide

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

Related Markets

Global medical device regulatory affairs market highlights

  • The global medical device regulatory affairs market generated a revenue of USD 6,585.3 million in 2023 and is expected to reach USD 12,785.2 million by 2030.
  • The market is expected to grow at a CAGR (2024 - 2030) of 9.9% by 2030.
  • In terms of segment, regulatory writing & publishing accounted for a revenue of USD 3,147.6 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 2023USD 6,585.3 million
Market revenue in 2030USD 12,785.2 million
Growth rate9.9% (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

Other key industry trends

  • In terms of revenue, the North America accounted for 28.4% of the global medical device regulatory affairs 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 16.8 million by 2030.

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Medical Device Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

Global 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 47.8% in 2023. Horizon Databook has segmented the Global 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.


  • Global Medical Device Regulatory Affairs Services Outlook (Revenue, USD Million, 2018-2030)
    • Regulatory Consulting
    • Legal Representation
    • Regulatory Writing & Publishing
      • Writing
      • Publishing
    • Product Registration & Clinical Trial Applications
    • Other Services
  • Global Medical Device Regulatory Affairs Indication Outlook (Revenue, USD Million, 2018-2030)
    • Oncology
    • Neurology
    • Cardiology
    • Immunology
    • Others
  • Global Medical Device Regulatory Affairs Product Stage Outlook (Revenue, USD Million, 2018-2030)
    • Preclinical
    • Clinical studies
    • PMA
  • Global Medical Device Regulatory Affairs Service Provicer Outlook (Revenue, USD Million, 2018-2030)
    • In-house
    • Outsourcing
  • Global Medical Device Regulatory Affairs Company Size Outlook (Revenue, USD Million, 2018-2030)
    • Small
    • Medium
    • Large
  • Global Medical Device Regulatory Affairs Device Type Outlook (Revenue, USD Million, 2018-2030)
    • Diagnostics
    • Therapeutics

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  • Access to comprehensive data: Horizon Databook provides over 1 million market statistics and 20,000+ reports, offering extensive coverage across various industries and regions.
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Target buyers of Global 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 global-level data and insights on the Global medical device regulatory affairs market , including forecasts for subscribers. This global databook contains high-level insights into Global medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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

Top 10 countries: Medical device regulatory affairs market size, 2023 (US$M)

Global medical device regulatory affairs market share, by services, 2023 & 2030 (%, US$M)

Medical device regulatory affairs market: Opportunity assessment by country

Global medical device regulatory affairs market, by region, 2023 (US$M)

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

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