Sweden Medical Device Regulatory Affairs Market Size & Outlook

The medical device regulatory affairs market in Sweden is expected to reach a projected revenue of US$ 85.7 million by 2030. A compound annual growth rate of 8.9% is expected of Sweden medical device regulatory affairs market from 2025 to 2030.
Revenue, 2024 (US$M)
$51.3
Forecast, 2030 (US$M)
$85.7
CAGR, 2025 - 2030
8.9%
Report Coverage
Sweden

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

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

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Sweden medical device regulatory affairs market highlights

  • The Sweden medical device regulatory affairs market generated a revenue of USD 51.3 million in 2024 and is expected to reach USD 85.7 million by 2030.
  • The Sweden market is expected to grow at a CAGR of 8.9% 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.


Medical device regulatory affairs market data book summary

Market revenue in 2024USD 51.3 million
Market revenue in 2030USD 85.7 million
Growth rate8.9% (CAGR from 2025 to 2030)
Largest segmentOutsource
Fastest growing segmentOutsource
Historical data2018 - 2023
Base year2024
Forecast period2025 - 2030
Quantitative unitsRevenue in USD million
Market segmentationIn-house, Outsource


Other key industry trends

  • In terms of revenue, Sweden accounted for 0.8% of the global medical device regulatory affairs market in 2024.
  • Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
  • In Europe, UK medical device regulatory affairs market is projected to lead the regional market in terms of revenue in 2030.
  • UK is the fastest growing regional market in Europe and is projected to reach USD 478.4 million by 2030.

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Medical Device Regulatory Affairs Market Scope

Medical device regulatory affairs market segmentation & scope
In-house
Outsource
Regulatory Consulting
Legal Representation
Regulatory Writing & Publishing
Product Registration & Clinical Trial Applications
Other Services
Diagnostics
Therapeutics

Medical Device Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

Sweden 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 65.3% in 2024. Horizon Databook has segmented the Sweden medical device regulatory affairs market based on in-house, outsource covering the revenue growth of each sub-segment from 2018 to 2030.


Sweden has a large number of medical device manufacturers operating in the country. The considerable presence of medical device manufacturers fuels the demand for medical devices regulatory affairs market. Some of the market players are Roche, Ava Women, Symbios Orthopédie SA, Optiswiss AG New Valve Technology, and Mediconsult AG.

The efforts of the Swedish government to provide modern healthcare infrastructure and treatments are another major factor boosting the development of medical device regulatory affairs market in the country. In addition, increasing research and development activities in the country are propelling demand for regulatory affairs services in the country.

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Target buyers of Sweden 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 country-level data and insights on the Sweden medical device regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into Sweden medical device regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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Sweden medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)

Sweden Medical Device Regulatory Affairs Market Outlook Share, 2024 & 2030 (US$M)

Sweden medical device regulatory affairs market size, by service provider, 2018-2030 (US$M)

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