Currently, the global Healthcare Regulatory Affairs Outsourcing Market is dominated by numerous prominent players. The key players operating in this market offer comprehensive knowledge in managing healthcare regulatory affairs. These companies mainly intend to help firms overcome challenges and accelerate clinical processes.
On a regional basis, the global healthcare regulatory affairs outsourcing market in the Americas is segmented into two major regions, i.e., North America and Latin America. The North American region is likely to hold the major share in the region is due to the increasing prevalence of chronic diseases. The rising prevalence of cancer and other chronic diseases demands the discovery of newer and effective drugs which is anticipated to fuel the market growth in this region.
For instance, according to the Centers for Disease Control and Prevention, in 2014, 9,421 new cases of tuberculosis were registered in the US. Moreover, according to the National Cancer Institute, in 2016, around 1,685,210 new cases of cancer had been diagnosed in the US.
Additionally, the rising incidence of several chronic diseases such as cancer and other infectious diseases have encouraged biopharmaceutical companies to develop many new products. This rising development of products in clinical trials, the demand for clinical trial application and product registration services is increasing, thus driving the growth of this market.
The Global healthcare regulatory affairs outsourcing industry value of USD 3,120.4 million in 2017 and is projected to grow at a CAGR of 9.4% over the forecast period. The healthcare regulatory affairs outsourcing offers medical writing and publishing which plays an important role to develop high-quality documents for the clinical research process. The rising, increasing number of patent expirations and growing research and development activities are some factors that are likely to propel the market growth during the assessment period.
For instance, the International Federation of Pharmaceutical Manufacturers & Associations stated that around 1,919 and 1,308 drugs are in development for cancer and neurology, respectively. Additionally, IFPMA stated that in 2014, there were 401 drugs in the pipeline for diabetes and 208 drugs in development for HIV/AIDS. Furthermore, IFPMA specified that their members have 119 ongoing R&D projects related to neglected tropical diseases.
On the other hand, the risk associated with data security and lack of standardization may hamper the market growth during the assessment period.
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