North America Medical Device Regulatory Affairs Market Size & Outlook

The medical device regulatory affairs market in North America is expected to reach a projected revenue of US$ 3,621.0 million by 2030. A compound annual growth rate of 9.9% is expected of North America medical device regulatory affairs market from 2024 to 2030.
Revenue, 2023 (US$M)
$1,871.2
Forecast, 2030 (US$M)
$3,621.0
CAGR, 2024 - 2030
9.9%
Report Coverage
North America

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

North

Related Markets

North America medical device regulatory affairs market highlights

  • The North America medical device regulatory affairs market generated a revenue of USD 1,871.2 million in 2023.
  • The market is expected to grow at a CAGR of 9.9% 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, U.S. is expected to register the highest CAGR from 2024 to 2030.


North America data book summary

Market revenue in 2023USD 1,871.2 million
Market revenue in 2030USD 3,621.0 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
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, North America region accounted for 28.4% 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.

No credit card required*

Horizon in a snapshot

  • 30K+ Global Market Reports
  • 120K+ Country Reports
  • 1.2M+ Market Statistics
  • 200K+ Company Profiles
  • Industry insights and more

Medical Device Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

North America 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 North America 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.


North America is expected to be a key region for the medical device regulatory affairs market over the forecast period. This region is home to numerous medical device companies outsourcing regulatory consulting and clinical trial applications to regulatory service providers, thereby contributing to the growth of the medical device regulatory affairs market.

The frequent updating by the FDA on medical device compatibility is a major factor that may hinder regional market growth. In addition, the growing digitalization and COVID-19 have pressurized the medical device regulatory agencies to evolve.

The rapid increase in the manufacturing of medical devices is expected to meet the high demand for efficient healthcare in the region and is expected to be one of the major factors contributing to market growth in North America.

Reasons to subscribe to North America medical device regulatory affairs market databook:

  • Access to comprehensive data: Horizon Databook provides over 1 million market statistics and 20,000+ reports, offering extensive coverage across various industries and regions.
  • Informed decision making: Subscribers gain insights into market trends, customer preferences, and competitor strategies, empowering informed business decisions.
  • Cost-Effective solution: It's recognized as the world's most cost-effective market research database, offering high ROI through its vast repository of data and reports.
  • Customizable reports: Tailored reports and analytics allow companies to drill down into specific markets, demographics, or product segments, adapting to unique business needs.
  • 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 North America 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 North America medical device regulatory affairs market , including forecasts for subscribers. This continent databook contains high-level insights into North America medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

Partial client list

  • logo

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

North America Medical Device Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)

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

Sign up - it's easy, and free!

Sign up and get instant basic access to databook, upgrade
when ready, or enjoy our free plan indefinitely.

Explore all plans

Included in Horizon account

  • 30K+ Global Market Reports
  • 120K+ Country Reports
  • 1.2M+ Market Statistics
  • 200K+ Company Profiles
  • Industry insights and more