Regulatory Affairs Outsourcing Market Size Worth $13.9 Billion By 2026

March 2019 | Report Format: Electronic (PDF)

The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2026, according to a new report by Grand View Research, Inc. it is projected to register a CAGR of 11.9% during the forecast period. Outsourcing regulatory affairs activities to the Contract Research Organizations (CROs) offers cost efficiency, reduced regulatory submission time, and quality control in the overall manufacturing process. These factors are anticipated to propel the growth over the forecast period.

Large companies address capacity problems and lack of expertise in their internal departments through outsourcing to smaller mid-size companies. It also eliminates additional work load and consolidates regulatory departments to avoid duplication of work. Regulatory affairs include activities such as drug master files, technical writing, and review of Chemistry, Manufacturing, and Controls (CMC), eCTD conversion, query management, Investigational New Drug (IND) maintenance, serious adverse events reporting, labeling, and drug shipment approvals for clinical trials.

Regulatory affairs outsourcing witnessed few important industry events. For instance, in August 2018, U.K. based Syneos Health acquired Kinapse, a provider of pharmaco-vigilance consulting and post market regulatory services. With this acquisition, the company aims to double its consulting footprint in Europe and associated commercial services. Moreover, in October 2018, PAREXEL International Corporation introduced the new China Advisory Services to help pharmaceutical companies in seeking market opportunities within China, to have an early mover advantage. The services include agency engagements, market access, and commercial strategies. This happened on the backdrop of recent reforms implemented by the National Medicinal Products Administration (NMPA), such as expedited approvals, faster Multi-regional Clinical Trials (MCT) applications, and clinical trial approvals in two months.

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Further key findings from the report suggest:

  • The regulatory writing and publishing emerged as the largest segment with a market share of over 35.0% in 2018. Legal representation segment is expected to register the highest CAGR of 12.8%, over the forecast period, owing to regulatory reforms in the emerging nations

  • North America regulatory affairs outsourcing market held the market share of over 20.0%, in 2018 owing to rising requirements in the region. Moreover, presence of big pharmaceutical and biotech companies seeking workload management is also favoring regional growth

  • Asia Pacific isexpected to witness substantial growth in near future, owing to unmet needs of the huge population base, low labor cost, and improving healthcare infrastructure

  • Some of the companies operating in the market include Accell Clinical Research; PRA International; PAREXEL International Corporation; Quintiles Transnational Holdings; Charles River Laboratories International Inc.; Clinilabs Inc.; Criterium Inc.; Wuxi AppTec; and Medpace Inc.

Grand View Research has segmented the global regulatory affairs outsourcing market based on service and region:

Regulatory Affairs Outsourcing Service Outlook (Revenue, USD Million, 2015 - 2026)

  • Regulatory Consulting

  • Legal Representation

  • Regulatory Writing and Publishing

  • Product Registration and Clinical Trial Application

  • Other Regulatory Service

Regulatory Affairs Outsourcing Regional Outlook (Revenue, USD Million, 2015 - 2026)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

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