Published: Apr, 2018

The global regulatory affairs outsourcing market is fragmented and a very small number of players have been able to acquire dominance in the market. There exists a large number of small and medium-sized companies in the market which is granting high bargaining power to clients and buyers. The competition between market players is extremely high. The players are competing with each other by differentiating their products and providing products in cheaper prices. The acceptance of electronic submissions on account of technological advancements by healthcare authorities and compliance agencies will drive the growth prospects of the global regulatory affairs outsourcing market, states Transparency Market Research (TMR).

According to Transparency Market Research, the global regulatory affairs outsourcing market will be worth US$5,746.2 million by 2023, with the demand expanding at a notable CAGR of 10.1% during the forecast period of 2017 to 2023. On the basis of type of regulatory affairs services, it is expected that clinical trial applications and product registration segment will be gaining immense traction on account of patent expires, and need for developing new products due to the growing prevalence of chronic, bacterial, and viral diseases. As a number of products in clinical trials is increasing, the demand for product registration services and clinical trial application services is increasing.

global regulatory affairs outsourcing market

Emerging Nations Holding Immense Growth Opportunities

On the basis of geography it is expected that the emerging nations in Latin America and Asia Pacific will turn out to be extremely promising markets for regulatory affairs outsourcing. product development, rise in the commercialization units, increasing number of researches and availability of cheap resources and raw materials will drive the growth of this market in emerging economies. Also, the vast pool of patient population in Asia Pacific will create a favorable environment for growth. Many new entrants are using emerging nations for launching themselves in order to later on venture into the bigger markets of North America and Europe.

Realization that Outsourcing is Cost Effective and Resource Effective Favoring Demand

According to the lead author of the support, the rising pace with which innovations are taking place in the medical sector, growing investments in research and development activities, and increasing competition between the players are helping the regulatory affairs outsourcing market to grow. Companies within the market are finding ways of reducing cost in order to attract more customers. The market is also growing due to the rising awareness and realization that outsourcing is cost-effective and resource effective way for the managing of data generated during approvals, clinical trials, and patent approvals.

Presence of Strict Regulatory Framework Governing Aspects of Marketing and Development of Drugs to Boost Growth of Market

Also, in many countries there is a presence of strict regulatory framework which governs each aspect of development and marketing of clinical drugs and medical devices, which makes it necessary that the regulatory documents be as per the define guidelines. This is driving the preference for professional service providers who all free services such as efficient handling of data relating to regulatory affairs.

The information presented in this review is based on a Transparency Market Research report, titled, “Regulatory Affairs Outsourcing Market (Services - Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, and Consulting and Legal Representation) - Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2017 - 2023.”

Key Segments of the Global Regulatory Affairs Outsourcing Market 

By Services

  • Regulatory Submissions
  • Clinical Trial Applications and Product Registrations
  • Regulatory Writing and Publishing
  • Regulatory Consulting and Legal Representation
  • Other Regulatory Affairs

By Geography

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • Rest of Europe
  • Asia Pacific (APAC)
    • India
    • China
    • Japan
    • Rest of APAC
  • Latin America (LATAM)
    • Brazil
    • Mexico
    • Rest of LATAM
  • Middle East and Africa (MEA)
    • South Africa
    • Rest of MEA 

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