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Rising Outsourcing by Pharma and Biotech Companies to Boost Demand for Regulatory Affairs Outsourcing Services, Says TMR

Posted on Sep 15, 2016

The global regulatory affairs outsourcing market is highly fragmented in nature and hence very few key players are dominating the market. The top three companies accounted for 30.2% of the global market in 2013. These top three companies are Quintiles Transnational Holdings, Inc., Covance, Inc., and Pharmaceutical Product Development, LLC. At present, many medical and pharmaceutical companies are focusing on minimizing their drug development costs by availing regulatory affairs outsourcing services from key companies. Transparency market Research (TMR) in its new report states that companies operating in this global market are focusing on research and development activities to introduce new regulatory affairs outsourcing services. 

As per the report, the global regulatory affairs outsourcing market is predicted to reach US$4,490.4 mn by 2020. By service, in 2013, the global regulatory affairs outsourcing market was dominated by the regulatory writing and publishing segment, followed by the clinical trial application and product registrations segment. The regulatory writing and publishing segment is expected to reach US$1,957.4 mn by 2020 and is likely to maintain its dominance throughout the forecast period. 

The regulatory affairs outsourcing market is gaining significant push in the global outsourcing market. Medical device manufacturing and pharmaceutical manufacturing companies are in collaboration with many outsourcing organizations to get their devices approved and launched in the global market. 

Rising Number of Pharma Companies in Asia Pacific to Boost Demand for Regulatory Affairs Outsourcing Services 

Regionally, in 2013, North America dominated the global market for regulatory affairs outsourcing. However, Asia Pacific is expected to take over the leadership by 2020. Asia Pacific is predicted to hold 36.3% of the global regulatory affairs outsourcing market by 2020. The growth of the market for regulatory affairs outsourcing in this region is driven by the availability of skilled labor at affordable costs, the rising government support, the rising number of pharmaceutical and biotechnology companies, and large population base. 

Growing Outsourcing Trend to Impact Business of Regulatory Affairs Outsourcing Services 

Healthcare companies prefer to outsource regulatory affairs services to save cost and time. A rising outsourcing trend among pharma companies is observed, especially in the regulatory affairs outsourcing area. The high cost of research and development activities and the increasing number of patent expiration have also boosted the outsourcing of regulatory affairs services. As drug development and approval procedures require a huge amount of documentation, many pharmaceutical companies are seeking support from international regulatory affairs service providers. The presence of strict regulatory framework has pushed healthcare companies to restructure their operations by consistently outsourcing regulatory support services to the contract research organizations. 

Rapid Pricing Fluctuations to Hamper Demand for Regulatory Affairs Services 

With pricing fluctuations and hidden costs, the global regulatory affairs outsourcing market is expected to be hampered in the years to come. The advent of cloud-based platforms and social media has remade many industries. Although organizations are increasingly adopting cloud-based technologies, it has resulted in rising risks of data security. Although the regulatory affairs outsourcing services are growing, the reliability of services is considered as a major threat by many pharma organizations. All these factors are predicted to hamper the global regulatory affairs outsourcing market. 

Demand for Regulatory Affairs Outsourcing Services to Rise from Emerging Economies   

Emerging nations are predicted to become lucrative destinations for regulatory affairs outsourcing services. Rising investments in research and development activities and the availability of expertise and technology will benefit emerging nations such as India and China. Companies operating in the life science market are shifting their focus towards outsourcing services, which is again expected to benefit the global market for regulatory affairs outsourcing.  

This information is based on the findings of a report published by Transparency Market Research titled “Regulatory Affairs Outsourcing Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2014 - 2020.” 

The global regulatory affairs outsourcing market is segmented into the following categories:

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 

Global Regulatory Affairs Outsourcing Market, 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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