Regulatory Affairs Outsourcing Market In-Depth Research On Basis Of Services, End Use, Region And Forecast To 2027

17/apr/2020 12:52:35 Grand View Research Contatta l'autore

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Regulatory Affairs Outsourcing Market

San Francisco, 17 April 2020: The Report Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service (Legal Representation, Regulatory Consulting), By End Use (Medical Device Companies, Pharmaceutical Companies), By Region, And Segment Forecasts, 2020 - 2027

The global regulatory affairs outsourcing market size is expected to reach USD 15.6 billion by 2027, expanding at a CAGR of 11.9%, according to a new report by Grand View Research, Inc. The entry of life sciences companies in global markets and the evolution of new areas such as orphan drugs, biosimilars, and personalized medicine are propelling market growth.

A significant increase in the fixed costs of in-house resources for healthcare regulatory affairs and operation activities like training, technology, specialized knowledge, and facilities are driving life science firms to outsource these functions. Also, the rising number of clinical trials is expected to boost the demand for the services such as clinical trial applications and product registration in these regions.

Product specific clinical advice and strategy along with healthcare regulatory compliance at the early stages of product development can be critical for the product approval. Failure to address the compliance in the early development stage often leads to delay in the approval process owing to inappropriately designed studies, manufacturing oversights, omitted studies, and other failures to meet the regulatory requirements.

Addressing local governing challenges and constant changes in the regulations of the major markets such as U.S., Europe, and Asia is creating demand for the services. Compliance with the current regulations has become an immense chore, leave alone trying to stay current with developments around the world. Amendments to current regulations are likely to complicate the governing pathway for the industry. This, in turn, is anticipated to drive the market for healthcare regulatory affairs outsourcing over the forecast period.

Access Research Report of Regulatory Affairs Outsourcing Market

Further key findings from the report suggest:

  • The regulatory writing and publishing segment dominated the regulatory affairs outsourcing market in 2019 with a share of around 35.6% as they are offered from early stages of development to post-marketing authorization phase and is vital for success of a product
  • The legal representation segment is anticipated to register the fastest growth of 12.8% over the forecast period
  • Asia Pacific held the maximum share of the global market for regulatory affairs outsourcing, accounting for 43.0% of the market share in 2019. This can be attributed to the relatively lower cost for outsourcing, skilled workforce with technical expertise, and expansion of life sciences companies in countries such as India and China
  • Some of the players operating in the market are Accell Clinical Research, LLC.; GenPact Ltd.; Criterium, Inc.; PRA Health Sciences; Promedica International; WuXi AppTec, Inc.; Medpace; Pharmaceutical Product Development, LLC (PPD); Charles River Laboratories International, Inc.; ICON plc; Covance, Parexel International Corporation; Inc.; and Freyr.

Browse more reports of this category by Grand View Research at:

Grand View Research has segmented the global regulatory affairs outsourcing market based on services, end use, and region:

Regulatory Affairs Outsourcing Services Outlook (Revenue, USD Million, 2016 - 2027)

  • Regulatory consulting
  • Legal representation
  • Regulatory writing and publishing
  • Product registration and clinical trial application
  • Other services

Regulatory Affairs Outsourcing End-Use Outlook (Revenue, USD Million, 2016 - 2027)

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

Regulatory Affairs Outsourcing Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

Access Press Release of Regulatory Affairs Outsourcing Market @

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.

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