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Regulatory Affairs Outsourcing Market Size Worth $12.86 Billion By 2025 | CAGR: 12.3%

Published Date : 21 / 04 / 18  | Report Format: PDF

The global regulatory affairs outsourcing market is expected to grow at growth rate of 12.3% to reach USD 12.86 billion by 2025.

Outsourcing is an integral part of any pharmaceutical and biotechnology companies’ value chain during the phase of research and development. Increase in competition among life sciences companies is encouraging market players to outsource clinical trial activities to accelerate their approval process and gain a competitive edge in the market. Also, a significant rise in drug development studies conducted in emerging economies has fueled the demand for outsourcing activities in regulatory services, providing a healthy platform for this industry development.

Furthermore, associated benefits with outsourcing activities further stimulate the market growth. For example, regulatory outsourcing consultants are familiar with clinical regulations, preparing submissions, dossier requirements, quality systems and labeling which can improve company’s regulatory strategy and often save time and money. However, the risk associated with data security coupled with lack of standardization is a major challenge as organizations are outsourcing their regulatory functions to offshore regions like the Asia Pacific and Latin America.

Key Takeaways

  • In 2017, regulatory writing and publishing segment captured the highest share, USD 1.6 billion during the same year.
  • Legal representation segment witnessed positive growth from 2017 to 2025, amounting 702.5 million in 2017.
  • Asia Pacific region is considered to be the fastest growing, at a 15.2% CAGR versus North America’s 10.8% from 2017 to 2025.
  • North America captured 20.98% share of the overall market. Regulatory approval procedures are becoming more stringent and time-consuming in these regions thus, slow down the industry growth to some extent.
  • Strategic collaboration with pharmaceutical companies to provide pharmaceutical research services helped the key player to capture significant revenue share. For instance, in July 2016, ICON plc collaborated with Mereo Biopharma Group plc, a specialty biopharmaceutical company, to become an exclusive provider of drug development services to Mereo BioPharma. Through this engagement, the company is aimed to expand its product offerings.


  • In-depth analysis of the key market dynamics
  • Granular analysis of the current market scenario and expected factors to affect the market
  • Detailed analysis of the geographic region, regional and county wise analysis
  • Highlight on the strategies that are being adopted by the key players in this market to stay competitive
  • Extensive analysis of the key players dominating the market

The scope of this report covers the market by its major segments, which include as follows:

Market Segmentation


  • Regulatory Writing & Publishing
  • Regulatory Consulting
  • Clinical Trial & Product Registration
  • Legal Representation
  • Others


  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • Rest of Europe
  • Asia Pacific
    • India
    • China
    • Rest of APAC
  • Rest of the World
    • Middle East and Africa
    • Latin America


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