Regulatory Affairs Outsourcing Market Worth $12.4 Billion By 2025

August 2017 | Report Format: Electronic (PDF)

The global regulatory affairs outsourcing market is expected to reach USD 12.4 billion by 2025, according to a new report by Grand View Research, Inc. Outsourcing of regulatory affairs functions to CROs or other individual service providers offers life science companies the benefit to achieve cost efficiency and reduce the overall approval process time by eliminating delays associated with regulatory submission requirements. These benefits are primarily driving the outsourcing trend and hence impacting the market over the forecast period.

The augmenting disease prevalence in Asia Pacific and MEA regions and increasing number of clinical trials being conducted is stimulating life science companies to expand into these regions thereby increasing the demand of these services. Changing regulatory landscape especially in developing regions and stringent directive requirements in developed regions such as North America and Europe are driving the adoption of outsourcing trend in regulatory affairs function. Growth in emerging areas such as biosimilars and orphan drug is expected to stimulate the demand for regulatory expertise thereby contributing to the growth of regulatory affairs outsourcing market.

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Further Key Findings From The Study Suggest:

  • Based on product, legal representation is expected to witness lucrative growth during the forecast period owing to healthcare reforms especially in emerging regions such as India and China. Also, rising demand of legal representation in regions such as Europe for gaining market authorization for companies who do not have an established base in the region. For instance, small or mid-size biopharmaceutical companies having domestic only, requires legal representative if they want to expand their presence in European countries such as UK and Germany. Regulatory writing and publishing is expected to be the leading segment during the forecast period.

  • Few of the industry players for the regulatory affairs outsourcing market are Clinical Research, Clinilabs Inc., Criterium Inc., PRA International, Promedica International, Wuxi AppTec, Medpace Inc.The other major players include Pharmaceutical Product Development(PPD), PAREXEL International Corporation, Charles River Laboratories International Inc., and Covance Inc.

  • There has been a trend of strategic partnership between services providers for increasing service portfolio or expanding regional presence. For instance, PPD formed a joint venture with Shin Nippon Biomedical Laboratories Ltd. (SNBL), leading provider of development services to biopharmaceuticals, to provide clinical development services in Japan including function based services such as regulatory and pharmacovigilance.

Grand View Research has segmented the regulatory affairs outsourcing market on the basis of service, and region:

Regulatory Affairs Outsourcing Product Outlook (Revenue, USD Million; 2014 - 2025)

  • Regulatory consulting

  • Legal Representation

  • Regulatory writing and publishing

  • Product registration and clinical trial applications

  • Others

Regulatory Affairs Outsourcing Regional Outlook (Revenue, USD Million; 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

  • Asia Pacific

    • China

    • Japan

    • India

  • Latin America

    • Mexico

    • Brazil

  • MEA

    • South Africa

    • Saudi Arabia

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