AMR analysis suggests that commercialization of NASH therapeutics and diagnostics in the market would not only lower healthcare expenses of patients but would also increase its (NASH therapeutics) share in the overall fatty liver disease therapeutics market. Commercialization of GFT505 and OCA would give the NASH therapeutics market a boost as these drugs are meant to specifically treat fatty liver diseases.
Additionally, the popularity of diagnostic biomarker technologies in the diagnosis of liver diseases would also accelerate market growth. However, presence of stringent regulatory guidelines and insufficient information regarding the pathophysiology of NASH tissue is considered to restrain in the commercialization of potential drugs.
Nonalcoholic Steatohepatitis (NASH) Market is expected to garner $1.6 billion by 2020, registering a CAGR of 25.6% during the period 2014-2020. The high prevalence of Type II diabetes and obesity, which lead to NASH and other nonalcoholic fatty liver diseases (NAFLD), would boost market growth.North America’sheightened focus of NASH research has resulted in its accounting for nearly half of the global market. It is also the region with the maximum occurrences of NASH and other nonalcoholic fatty liver diseases. Europe ranks second in terms of the prevalence of NASH.
Increase in cycles of clinical trials and their success rate has increased the probability of industries receiving commercial approval for NASH therapeutics by the end of 2017. The market growth is restricted by factors such as NASHs complex and enigmatic physiological structure and inefficient diagnostics technology; these factors could also prolong the commercialization process for NASH therapeutics. Nevertheless, certain key players competing in the market are conducting extensive research on NASH therapeutics and are receiving positive results from clinical trials.
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The results of a recent clinical trial conducted by Genfit satisfied concerns of the EMA (European Medicines Agency), regarding the efficacy and safety of GFT5o5 as therapeutics for NASH. The EMA finally recommended that the development of GFT5o5 as a therapeutic drug progress to Phase III of the clinical trial. Additionally, Dainippon Sumitomo Pharma (DSP), a partner of Intercept Pharmaceuticals, initiated a phase 2 clinical trial to test the safety and efficacy of one daily dose of OCA in 200 adult NASH patients. The trial is expected to be completed in the first half of 2016.
Most giant biopharmaceutical manufacturing companies are currently attempting to develop novel therapeutics for the treatment of NASH. These companies are adopting clinical trials and approval as key strategies in order to gain competitive edge. Most of these companies operate from the United States and are collaborating with private research and academic institutes to conduct clinical trials. Key companies profiled in the report are: Genfit, Gilead Science, Novo Nordisk, Intercepts Pharmaceuticals, Enzo Biochem, Inc. and Raptor Pharmaceutical Corp.