Regulatory Affairs Outsourcing Market Size, Demand, Competitive Analysis, Regional Growth and Forecast by 2021-2026

According to IMARC Group’s latest report, titled “Regulatory Affairs Outsourcing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026”, the global regulatory affairs outsourcing market grew at a CAGR of around 10% during 2015-2020. Regulatory affairs outsourcing is the process of hiring third-party services by the government bodies and private enterprises to ensure public health and safety. The services include managing regulatory requirements for innovator drugs, generic drugs, biologics, biosimilars, etc. The outsourcing organizations control the safety and efficacy of the medicines and ensure that they are safe for consumption. These services are required for clinical trial and patent application, product registration, legal representation, and regulatory writing and publishing. Pharmaceutical companies also opt for these services to seek speedy government approvals.

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The expanding pharmaceutical and biotechnological industries across the globe are primarily driving the growth of the market. Furthermore, the growing emphasis of numerous pharmaceutical organizations to enhance their operations and supplies, particularly across the developing nations, is also augmenting the market growth. Moreover, outsourcing of regulatory affairs also help in reducing the costs associated with managing in-house resources, such as facilities, technology, training, specialized knowledge and geographic regulations. Additionally, these services are increasingly being used to develop biosimilar and generic drugs, which is further catalyzing the market growth. Besides this, numerous life science-based organizations are rapidly outsourcing non-core functions and regulatory services to increase their overall operational efficiencies, which is expected to further propel the market in the coming years. Looking forward, IMARC Group expects the global regulatory affairs outsourcing market to exhibit strong growth during the next five years.

As the novel coronavirus (COVID-19) crisis takes over the world, we are continuously tracking the changes in the markets, as well as the industry behaviors of the consumers globally and our estimates about the latest market trends and forecasts are being done after considering the impact of this pandemic.

Competitive Landscape with Key Players:

  • Charles River Laboratories International Inc.
  • Covance Inc (Laboratory Corporation of America Holdings)
  • Freyr
  • ICON Plc
  • Medpace Holdings Inc.
  • Parexel International Corporation
  • Pharmaceutical Product Development LLC
  • Promedica International- A California Corporation
  • Wuxi AppTec Co. Ltd.

Market Segmentation:Breakup by Services:

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

Breakup by Company Size:

  • Small
  • Medium
  • Large 

Breakup by Category:

  • Generic Drugs
  • Innovator Drugs
  • Biologic Drugs
  • Biosimilars
  • Medical Devices
    • Therapeutic
    • Diagnostic
  • Others

Breakup by Indication:

  • Oncology
  • Neurology
  • Cardiology
  • Immunology
  • Others

Breakup by Stage:

  • Preclinical
  • Clinical
  • PMA (Post Market Authorization)

Breakup by End User:

  • Medical Device Companies
  • Pharmaceutical Companies
  • Biotechnology Companies

Breakup by Region:

  • North America (United States, Canada)
  • Europe (Germany, France, United Kingdom, Italy, Spain, Others)
  • Asia Pacific (China, Japan, India, Australia, Indonesia, Korea, Others)
  • Latin America (Brazil, Mexico, Others)
  • Middle East and Africa (United Arab Emirates, Saudi Arabia, Qatar, Iraq, Others)

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Key highlights of the report:                                                    

  • Market Performance (2015-2020)
  • Market Outlook (2021-2026)
  • Market Trends
  • Market Drivers and Success Factors
  • The Impact of COVID-19 on the Global Market
  • Value Chain Analysis
  • Structure of the Global Market
  • Comprehensive mapping of the competitive landscape

If you need specific information that is not currently within the scope of the report, we will provide it to you as a part of the customization.

About Us

IMARC Group is a leading market research company that offers management strategy and market research worldwide. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

IMARC’s information products include major market, scientific, economic and technological developments for business leaders in pharmaceutical, industrial, and high technology organizations. Market forecasts and industry analysis for biotechnology, advanced materials, pharmaceuticals, food and beverage, travel and tourism, nanotechnology and novel processing methods are at the top of the company’s expertise.

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