Japan Pharmaceutical Regulatory Affairs Market Size & Outlook

The pharmaceutical regulatory affairs market in Japan is expected to reach a projected revenue of US$ 1,041.2 million by 2030. A compound annual growth rate of 8.4% is expected of Japan pharmaceutical regulatory affairs market from 2024 to 2030.
Revenue, 2023 (US$M)
$594.2
Forecast, 2030 (US$M)
$1,041.2
CAGR, 2024 - 2030
8.4%
Report Coverage
Japan

Japan pharmaceutical regulatory affairs market, 2018-2030 (US$M)

Japan

Related Markets

Japan pharmaceutical regulatory affairs market highlights

  • The Japan pharmaceutical regulatory affairs market generated a revenue of USD 594.2 million in 2023 and is expected to reach USD 1,041.2 million by 2030.
  • The Japan market is expected to grow at a CAGR of 8.3% 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.


Pharmaceutical regulatory affairs market data book summary

Market revenue in 2023USD 594.2 million
Market revenue in 2030USD 1,041.2 million
Growth rate8.3% (CAGR from 2023 to 2030)
Largest segmentRegulatory writing & publishing
Fastest growing segmentLegal Representation
Historical data2018 - 2022
Base year2023
Forecast period2024 - 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, IQVIA Holdings Inc, Icon PLC, Wuxi AppTec Co Ltd, Charles River Laboratories International Inc, Cencora Inc, Pharmexon, Genpact Ltd, Freyr Solutions, PAREXEL


Other key industry trends

  • In terms of revenue, Japan accounted for 11.7% of the global pharmaceutical regulatory affairs market in 2023.
  • Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
  • In Asia Pacific, Japan pharmaceutical regulatory affairs market is projected to lead the regional market in terms of revenue in 2030.
  • India is the fastest growing regional market in Asia Pacific and is projected to reach USD 698.2 million by 2030.

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Pharmaceutical Regulatory Affairs Market Companies

Name Profile # Employees HQ Website

Japan pharmaceutical 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 pharmaceutical regulatory affairs market will help companies and investors design strategic landscapes.


Regulatory writing & publishing was the largest segment with a revenue share of 36.54% in 2023. Horizon Databook has segmented the Japan pharmaceutical 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.


Japan is the second largest pharmaceutical market, followed by the U.S. The well-established pharmaceutical industry in Japan is the major factor driving the pharmaceutical regulatory affairs market.

The country is expected to dominate the pharmaceutical regulatory affairs market during the forecast period in Asia Pacific due to the rising demand for new and cost-effective medicines, which may attract investments from biopharmaceutical companies.

Rising demand for generics due to government support and improvement in regulatory approval processes are expected to increase the number of market entrants, propelling the demand for regulatory services. Increasing costs of R&D and pricing pressure may restrain the growth of the regulatory outsourcing market in this country.

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  • Our clientele includes a mix of pharmaceutical 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 Japan pharmaceutical regulatory affairs market , including forecasts for subscribers. This country databook contains high-level insights into Japan pharmaceutical regulatory affairs market from 2018 to 2030, including revenue numbers, major trends, and company profiles.

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Japan pharmaceutical regulatory affairs market size, by services, 2018-2030 (US$M)

Japan Pharmaceutical Regulatory Affairs Market Outlook Share, 2023 & 2030 (US$M)

Japan pharmaceutical regulatory affairs market size, by services, 2018-2030 (US$M)

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