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The global nonalcoholic steatohepatitis (NASH) therapeutics market is expected to witness significant growth due to current unmet medical need of NASH, scarcity of the permanent treatment of the disease, increasing prevalence of obesity, and high demand for safe and effective medication. The regulatory bodies are supporting the NASH market by providing designations and funding for speeding up the drug development process. In March 2015, obeticholic acid, an investigational Phase III clinical trial drug candidate of Intercept Pharmaceuticals Inc., received breakthrough therapy designation from the U.S. Food and Drug Administration for the treatment of patients with NASH.
The pipeline of NASH therapeutics is rich with more than 50 drugs. The pharmaceutical companies are actively involved in the research and development of drug for NASH. In June 2016, The Zydus Cadila initiated Phase III clinical trials of Saroglitazar to study its effect in adult NASH patients.
NASH is a type of liver disease, which is characterized by liver inflammation and fat accumulation, in the absence of significant alcohol consumption. It is the more severe form of nonalcoholic fatty liver disease. In NASH, fat accumulation, hepatic inflammation and hepatic triglyceride accumulation may ultimately lead to liver cirrhosis. North America is an emerging epidemic of obesity due to NASH. According to the NIH, NASH affects 2% to 5% of Americans and it is one of the major causes of cirrhosis.
A large number of pharmaceutical companies are investing huge capital for the development of NASH therapeutics. However, certain factors such as unknown etiology, complex pathophysiology, and high treatment cost of NASH are expected to hamper the growth of the global market during the forecast period.
Geographically, North America is expected to be the largest market for NASH therapeutics owing to the large number of research and development activities, high healthcare expenditure and high incidence of obesity. The U.S. contributed largest revenue to the North American market and it is expected to remain the largest market globally, during the forecast period.
Some of the key players operating in the global NASH therapeutics market are Genfit SA, Gilead Sciences, Inc., Novo Nordisk A/S, Intercept Pharmaceuticals, Inc., Enzo Biochem, Inc., Raptor Pharmaceutical Corp., Conatus Pharmaceuticals Inc., Zydus Cadila Healthcare Limited., Novartis AG, and Shire plc.