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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  • Strategic advantage: By staying updated with the latest market intelligence, companies can stay ahead of competitors, anticipate industry shifts, and capitalize on emerging opportunities.

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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