Japan Regulatory Affairs Outsourcing Market Size & Outlook

The regulatory affairs outsourcing market in Japan is expected to reach a projected revenue of US$ 1,503.2 million by 2030. A compound annual growth rate of 9.5% is expected of Japan regulatory affairs outsourcing market from 2024 to 2030.
Revenue, 2023 (US$M)
$798.7
Forecast, 2030 (US$M)
$1,503.2
CAGR, 2024 - 2030
9.5%
Report Coverage
Japan

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

Japan

Related Markets

Japan regulatory affairs outsourcing market highlights

  • The Japan regulatory affairs outsourcing market generated a revenue of USD 798.7 million in 2023 and is expected to reach USD 1,503.2 million by 2030.
  • The Japan market is expected to grow at a CAGR of 9.5% from 2024 to 2030.
  • In terms of segment, product registration & clinical trial applications was the largest revenue generating service in 2023.
  • Legal representation is the most lucrative service segment registering the fastest growth during the forecast period.


Regulatory affairs outsourcing market data book summary

Market revenue in 2023USD 798.7 million
Market revenue in 2030USD 1,503.2 million
Growth rate9.5% (CAGR from 2023 to 2030)
Largest segmentProduct registration & clinical trial applications
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, Regulatory Submissions, Regulatory Operations, Other services
Key market players worldwideGenpact Ltd, Criterium Inc., Promedica International, Wuxi AppTec Co Ltd, Medpace Holdings Inc, Charles River Laboratories International Inc, Icon PLC, Labcorp Drug Development, FREYR Battery Inc, Cencora Inc, Pharmexon, QVigilance, BlueReg Group, ZEINCRO Group


Other key industry trends

  • In terms of revenue, Japan accounted for 12.1% of the global regulatory affairs outsourcing market in 2023.
  • Country-wise, U.S. is expected to lead the global market in terms of revenue in 2030.
  • In Asia Pacific, Japan regulatory affairs outsourcing 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 1,056.9 million by 2030.

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Regulatory Affairs Outsourcing Market Scope

Regulatory affairs outsourcing market segmentation & scope
Strategy & Development Planning
QA Consulting
Agent Services
Others
Legal representation
Regulatory writing & publishing
Project Management Services
Others
Regulatory Submissions
Regulatory Operations
Other services
Innovators
Generics
Biotech
ATMP
Biosimilars
Diagnostics
Therapeutics
Biotechnology Companies
Pharmaceutical Companies
Medical Device Companies
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Regulatory consulting
Legal representation
Regulatory writing & publishing
Product registration & clinical trial applications
Regulatory Submissions
Regulatory Operations
Other services
Indication
Oncology
Neurology
Cardiology
Immunology
Others
Stage
Preclinical
Clinical studies
PMA

Regulatory Affairs Outsourcing Market Companies

Name Profile # Employees HQ Website

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


Product registration & clinical trial applications was the largest segment with a revenue share of 25.93% in 2023. Horizon Databook has segmented the Japan regulatory affairs outsourcing market based on regulatory consulting, legal representation, regulatory writing & publishing, product registration & clinical trial applications, regulatory submissions, regulatory operations, other services covering the revenue growth of each sub-segment from 2018 to 2030.


Japan is the second largest pharmaceutical market after the U.S., thus driving the Regulatory affairs outsourcing market within the region. 

The region is expected to dominate the Regulatory affairs outsourcing market during the forecast period in the Asia Pacific region, owing to rising demand for new and cost-effective medicines, which may attract investments from biopharmaceutical companies in this region. 

Rising demand for generics due to government support and improvement in regulatory approval processes are expected to result in increase in market entrants, thereby propelling the demand for regulatory services in this region.

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Target buyers of Japan regulatory affairs outsourcing market databook

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

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Japan regulatory affairs outsourcing market size, by service, 2018-2030 (US$M)

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

Japan regulatory affairs outsourcing market size, by service, 2018-2030 (US$M)

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