North America Medical Device Regulatory Affairs Market Size & Outlook
North America medical device regulatory affairs market, 2018-2030 (US$M)
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North America medical device regulatory affairs market highlights
- The North America medical device regulatory affairs market generated a revenue of USD 2,167.1 million in 2024.
- The market is expected to grow at a CAGR of 9.6% 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, U.S. is expected to register the highest CAGR from 2025 to 2030.
North America data book summary
| Market revenue in 2024 | USD 2,167.1 million |
| Market revenue in 2030 | USD 3,762.6 million |
| Growth rate | 9.6% (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, North America region accounted for 32.1% 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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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.
Outsource was the largest segment with a revenue share of 65.59% in 2024. Horizon Databook has segmented the North America medical device regulatory affairs market based on in-house, outsource 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.
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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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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.
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North America medical device regulatory affairs market size, by country, 2018-2030 (US$M)
North America Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)
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