Global Regulatory Affairs Outsourcing Market to Surpass US$ 9.1 Billion by 2027 – Coherent Market Insights

11:32 EST 7 Nov 2019 | Businesswire
Coherent Market Insights

According to Coherent Market Insights, the global regulatory affairs outsourcing Market was valued at US$ 3,683.7 million in 2019, and is projected to exhibit a CAGR of 12.0% over the forecast period (2019 – 2027).

Key Trends and Analysis of the Regulatory Affairs Outsourcing Market:

Key trends in the market are increasing research and development expenditure in the healthcare sector, rising number of clinical trials, high complexity in research and development, and stringent government regulations.

Increasing research and development expenditure in the healthcare sector is the major factor that is expected to bolster the market growth. For instance, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), 2016, pharmaceutical and biotechnology companies invested an estimated US$ 58.8 billion in research and development in 2015, which was majority of all biopharmaceutical R&D spending in the U.S.

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The pharmaceutical and biotechnology companies are actively adopting outsourcing services in order to expand their presence and product offerings in the global market. For instance, in May 2017, Rich Pharma, Inc., a developer of oncology therapies, selected IND 2 Results, LLC as a CRO to provide protocol development, medical writing, and regulatory consulting services for its clinical trials on treatment of Hodgkin’s Lymphoma and Acute Myelocytic Leukemia.

Furthermore, key players operating in the market are focused on adopting acquisition and collaboration strategies in order to expand their offerings in potential markets. For instance, in April 2019, Charles River Laboratories International, Inc. acquired Citoxlab, a non-clinical Contract Research Organization (CRO) offering regulated safety assessment services, medical device testing, and other services. The acquisition has expanded Charles’ offerings and strengthened its market position as a CRO.

However, price fluctuation and hidden cost of regulatory affairs outsourcing services are some of the major factors hindering the market growth. Use of technological platforms, which includes software for clinical data management, database, document management, and other technology enhances the overall process and provides quality data, however, it increases the cost of outsourcing services, which can hamper demand for regulatory affairs outsourcing services.

Key Market Takeaways:

  • The Regulatory Affairs Outsourcing Market is expected to exhibit a CAGR of 12.0% during the forecast period (2019 – 2027), owing to increasing focus of product manufacturers on expanding their supply in emerging economies, increasing adoption of inorganic growth strategies by market players, high complexity in research and development, and stringent government regulations. For instance, in October 2017, PAREXEL International Corporation and Microsoft Corporation announced an alliance for drug development. Under the alliance, Microsoft’s cloud infrastructure and PAREXEL’s clinical and regulatory technology domain knowledge were integrated to bolster clinical research, and market access of pharmaceutical and biotechnological companies.
  • Rising adoption of service launch and facility expansion strategy by the market players is the major factor driving market growth. In March 2018, Parexel International Corporation launched PAREXEL's Medical Writing Solutions for offering communication services throughout the process of drug development and commercialization
  • Key players operating in the global regulatory affairs outsourcing market include WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.

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Market Segmentation:

  • Global Regulatory Affairs Outsourcing Market, By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
  • Global Regulatory Affairs Outsourcing Market, By Application:
    • Pharma and Biotech Products
    • Medical Devices
  • Global Regulatory Affairs Outsourcing Market, By Geography/Region:
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Mexico
      • Argentina
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • France
      • Italy
      • Spain
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • Central Africa
      • North Africa
  • Company Profiles


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