Stringent Regulatory Requirements across Regional and International Markets to Lead to Increased Adoption of Regulatory Affairs Outsourcing

Regulatory maintenance of products that are already on the market or are in clinical trials is a highly exhaustive, complex, and time- and resource-consuming task, taking up a large share of a life sciences company’s regulatory resources every year. These activities, providing hardly any competitive advantage to the company, end-up restricting the company from employing its best regulatory resources onto innovations and core competencies. 

As the global healthcare industry becomes increasingly competitive in terms of budget cuts, globalizations, and restructuring, life sciences companies are faced with unprecedented threats to their survival. The large and expanding product portfolios of life science companies, covering numerous verticals, make regulatory compliance for companies even tough. Companies have started to realize the need to focus on core competencies in order to sustain in the tough scenario. This factor has improved the scope of growth for the regulatory affairs outsourcing market.

In one of its recent market research reports, Transparency Market Research estimates that the global market for regulatory affairs outsourcing will expand at a promising CAGR of 11.5% over the period between 2015 and 2023. At this pace, the market could rise to an opportunity of US$5.7 bn by 2023 from US$1.9 bn in 2014.


In this blog post, TMR analysts analyze some of the key trends in the market, predicting how they will impact the overall development of the market in the next few years. 

What are the key factors that will drive the market in the next few years?

Life sciences companies are most likely to resort to outsourcing regulatory affairs owing to factors such as cost competitiveness, effective results in diverse markets with a vast set of regulatory compliances governing several aspects related to drugs and medical devices. Presently, nearly 70% of the globe’s leading biotech and pharmaceutical companies have started to outsource their regulatory affairs. While this represents a significant portion of the market, it still has scope of expansion as a number of new and regional companies are looking to expand their business in the international market. 

Opportunities abound chiefly in emerging economies such as India and China, which have thriving pharmaceutical and biotech companies and are the preferred locations for business expansion for international companies owing to low manufacturing costs. Asia Pacific also offers vast growth opportunities for the global regulatory affair outsourcing market owing to the presence of a large number of service providers.

Which kinds of regulatory affairs are most commonly outsourced by life science companies?

A variety of regulatory affair services are commonly outsourced by life sciences companies, including regulatory submissions, regulatory writing and publishing, and clinical trial applications and product registrations. Of these, the regulatory writing and publishing segment is the most commonly outsourced regulatory affair by life sciences companies. The segment accounted for over 40% of the revenue generated by the global regulatory affairs outsourcing market in 2014. The segment is expected to continue raking in vast demand in the near future as well, chiefly owing to the complex, diverse, and the rapidly evolving regulatory landscape of international, national, regional, and domestic markets. 

In the near future, however, the segment of clinical trial applications and product registrations is expected to take over as the most promising area of regulatory affairs outsourcing. The segment will expand at the most promising pace and will present vast growth opportunities for regulatory affairs service providers. Factors such as rapid rate of introduction of new drugs, patent expiries, and the increased prevalence of several bacterial, viral, and chronic diseases, which has prompted biotech companies to focus more on novel products, will contribute to the rise in demand for clinical trial applications and product registrations services. 

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