Who Are The Key Companies/Players In The Regulatory Affairs Outsourcing Market?

 Regulatory Affairs Outsourcing Industry Overview

The global regulatory affairs outsourcing market size was estimated at USD 6.5 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 8.9% from 2022 to 2030. The outsourcing of regulatory affairs has become an increasingly important practice in the healthcare industry. An increase in geographical expansion activities by companies that aim for speedy approvals in local markets is expected to contribute to the adoption of outsourcing models for regulatory services. The outsourcing market for regulatory affairs is expanding rapidly due to the increase in R&D activities, augmenting the volume of clinical trial applications and product registration.

Companies are under constant pressure to procure timely clinical approvals from regulators in different regions. Such actions are further promoting the demand for regulatory affairs services thus contributing to the market growth. Regulatory affairs functions are challenging. The increasing demand to obtain approval for new products while maintaining compliance and doing more with fewer drives the market. The pressure to reduce costs by life sciences companies is also very high. The use of generics and demand for drugs & medical devices at lesser prices are expected to rise to reduce healthcare costs.

Gather more insights about the market drivers, restrains and growth of the Global Regulatory Affairs Outsourcing market

An increase in out-of-pocket expenses, uneven economic growth, and measures taken by various governments to contain the cost of drugs are expected to contribute to the economic and competitive pressure, which, in turn, is expected to drive the demand for regulatory affairs outsourcing among the life science companies. Product-specific clinical advice & strategy along with regulatory compliance at the early stages of the product development can be critical to product approval. Failure to address regulatory 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.

Such factors are likely to improve the demand for regulatory affairs outsourcing in the life sciences industry. The outbreak of the COVID-19 pandemic has created a negative impact on the market. The initial lockdown had led to the closure of clinical trial sites and related activities. Moreover, regulatory bodies paused their activities for a while focusing on tracking the supply chain activities. Nearly all the components critical to drug development to reduce the spread of the virus at the beginning of the pandemic had affected the market negatively.

However, the pandemic had created an urgent need for treatment of COVID-19 infection, owing to which, regulatory authorities, such as the U.S. FDA, and the European Union (EU), had given emergency use authorization for various COVID-19 testing devices and treatments. Such actions by the regulatory agencies are expected to improve the demand for regulatory affairs outsourcing in the market post-pandemic. The market witnessed a rebound in revenue in 2021 as several companies focused on the development of novel therapeutics for the treatment of COVID-19 infection. Moreover, the growth in R&D activities for new vaccines, therapeutics, and medical devices has further driven the market growth post-2020.

Browse through Grand View Research's Medical Devices Industry Research Reports.

  • Clinical Trials Market - The global clinical trials market size was valued at USD 47.0 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.8% from 2022 to 2030. However, the market growth was hindered in 2020 due to the COVID-19 pandemic. In 2020, Parexel and Synairgen plc formed a strategic collaboration for conducting a Phase III study of an Interferon-beta (IFN-beta) treatment for COVID-19 patients.
  • Life Sciences BPO Market - The global life sciences BPO market was valued at USD 195 billion in 2015. The high growth is attributed to certain key factors, which include the rising costs of drug development, pre-clinical research, clinical trials, and post-marketing surveillance.

Regulatory Affairs Outsourcing Market Segmentation

Grand View Research has segmented the global regulatory affairs outsourcing market based on Service, Company Size, Category, Indication, Stage, End-use, and region:

  • Services Outlook (Revenue, USD Million, 2018 - 2030)
    • Regulatory Consulting
    • Legal Representation
    • Regulatory Writing & Publishing
    • Product Registration & Clinical Trial Applications
    • Other Services
  • Company Size Outlook (Revenue, USD Million, 2018 - 2030)
    • Small
    • Medium
    • Large
  • Category Outlook (Revenue, USD Million, 2018 - 2030)
    • Drugs
      • Generics
      • Innovators
    • Biologics
      • Biotech
      • ATMPs
      • Biosimilars
    • Medical devices
      • Therapeutic
      • Diagnostic
    • Indication Outlook (Revenue, USD Million, 2018 - 2030)
      • Oncology
      • Neurology
      • Cardiology
      • Immunology
      • Others
    • Stage Outlook (Revenue, USD Million, 2018 - 2030)
      • Preclinical
      • Clinical
      • PMA (Post Market Authorization)
    • End-use Outlook (Revenue, USD Million, 2018 - 2030)
      • Medical Device Companies
      • Pharmaceutical Companies
      • Biotechnology Companies
    • Regional Outlook (Revenue, USD Million, 2018 - 2030)
    • North America
    • Europe
    • Asia Pacific
    • Latin America
    • Middle East & Africa (MEA)

Market Share Insights

  • August 2021: ProPharma Group acquired iSafety Systems., an Indian pharmacovigilance service provider, for strengthening its market position in pharmacovigilance.
  • July 2021: ICON plc acquired a CRO involved in providing drug development and regulatory consulting services, namely PRA Health Sciences. This acquisition was aimed at enhancing the services portfolio of ICON plc.

Key Companies profiled:

Some prominent players in the global regulatory affairs outsourcing market include

  • Accell Clinical Research, LLC
  • GenPact Ltd.
  • Criterium, Inc.
  • PRA Health Sciences
  • Promedica International
  • Regenold GmbH
  • BioMapas
  • Zeincro Group
  • Parexel International Corp.
  • Charles River Laboratories International, Inc.
  • ICON plc
  • Covance
  • Freyr

Order a free sample PDF of the regulatory affairs outsourcing Market Intelligence Study, published by Grand View Research.

 

About Grand View Research

Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead.

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