Market revenue in 2024 | USD 1,908.2 million |
Market revenue in 2030 | USD 3,346.0 million |
Growth rate | 9.8% (CAGR from 2025 to 2030) |
Largest segment | Outsource |
Fastest growing segment | Outsource |
Historical data | 2018 - 2023 |
Base year | 2024 |
Forecast period | 2025 - 2030 |
Quantitative units | Revenue in USD million |
Market segmentation | In-house, Outsource |
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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 65.75% in 2024. Horizon Databook has segmented the U.S. medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.
The large number of medical device companies operating in the U.S. proceed toward regulatory affairs and consulting for their product registration, clinical trial application, and legal representation, thereby contributing to the growth of the medical device regulatory affairs market in the U.S. The increased efforts by the government and regulatory agencies to avoid medical device failure and injurious effects are expected to propel the regional market growth.
In addition, the highly modernized healthcare system of the region demands more innovative medical devices in the healthcare system. This is expected to boost the market demand for various medical devices, propelling the requirement for regulatory affairs for medical devices. Moreover, the presence of the FDA in the U.S. compels medical device manufacturers to comply with its guidelines. However, the changing biocompatibility guidance is expected to hamper the regional market growth.
Horizon Databook provides a detailed overview of country-level data and insights on the U.S. medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into U.S. medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.
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