Regulatory Affairs Outsourcing Market Is Estimated To Secure A Market Value Of US$ 15.11 Billion By 2032

Rockville, United States, 2023-Jul-20 — /EPR Network/ —

The global regulatory affairs outsourcing market is estimated to secure a market value of US$ 15.11 Bn by 2032. The worth of the market is anticipated to be US$ 7 Bn in 2022, and the projected growth rate is 8% during the forecast period from 2022 to 2032.

According to Fact. MR- a market research and competitive intelligence provider- demand for regulatory affairs outsourcing expanded at a value CAGR of 6.5% from 2015 to 2021, reaching a value of US$ 6 Bn. Regulatory affairs outsourcing services are widely used to develop generic and orphan drugs, which acts as a catalyst to market growth.

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Key Market Segments Covered in the Global Regulatory Affairs Outsourcing Market

  • By Services
    • Regulatory Consulting Outsourcing
    • Legal Representation Outsourcing
    • Regulatory Writing & Publishing Outsourcing
    • Other Regulatory Affairs Outsourcing Services
  • By Company Size
    • Small Sized Companies
    • Medium Sized Companies
    •  Large Sized Companies
  • By Category
    • Drugs
      • Generics
      • Innovators
    • Biologics
      • Biotech
      • ATMPs
      • Biosimilars
    • Medical Devices
      • Therapeutic
      • Diagnostic
  • By Indication
    • Oncology
    • Neurology
    • Radiology
    • Immunology
    • Other Indications
  • By Stage
    • Pre-Clinical
    • Clinical
    • Post Market Authorization
  • By End Use
    • Medical Device Companies
    • Pharmaceutical Companies
    • Biotechnology Companies
  • Regions 
    • North America
    • MEA
    • Latin America
    • Europe
    • Asia-Pacific

Key Takeaways from the Market Study

  • The global regulatory affairs outsourcing market to value US$ 7 Bn in 2022
  • From 2015-2021, regulatory affairs outsourcing demand flourished at a 6.5% CAGR
  • APAC to garner a market share of 37% in 2022 with respect to regulatory affairs outsourcing
  • Clinical studies segment procured the largest market share of 46% in 2021.
  • Based on end-user segment, the pharmaceutical companies segment to secure the largest market share of 38% in 2022.

Key Players of the Global Cloud Computing Market

  • Accell Clinical Research LLC
  • GenPact Ltd.
  • Criterium Inc.
  • PRA Health Sciences
  • Promedica International
  • WuxI AppTec Inc.
  • Medspace
  • Charles River Laboratories International Inc.
  • ICON Plc.
  • Labcorp

Competitive Landscape

The players of the global regulatory affairs outsourcing market focus on expanding their global influence. Some of the adopted strategies are partnerships, collaborations, and acquisitions. Recent key developments among key players are:

  • ProPharma Group, an Odyssey Investment Partners portfolio company, announced the acquisition of iSafety Systems in August 2021. Pharmacovigilance outsourcing company iSafety is based in India.
  • ICON plc bought PRA Health Sciences, a CRO, in July 2021. The acquisition was made with the intention of expanding ICON plc’s offering of services. ICON will remain the company’s official name. The organization seeks to become the most advanced clinical research organization and healthcare intelligence by bringing together 38,000 workers from 47 different nations.

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