A new report by Allied Market Research entitled, "Nonalcoholic Steatohepatitis Market (Pipeline analysis, drug class and Geography) Global Size, Industry Analysis, Trends, Opportunities, Growth and Forecast, 2013 - 2020", indicates that the global nonalcoholic steatohepatitis (NASH) market would reach $1.6 billion by 2020 registering CAGR of 25.6% from 2014 to 2020. The high prevalence of Type II diabetes and obesity, which lead to NASH and other non-alcoholic fatty liver diseases (NAFLD), would boost market growth. North America's heightened focus on NASH research has resulted in it accounting for nearly half of the global market. It is also the region with the maximum occurrences of NASH and other non-alcoholic fatty liver diseases.Europe ranks second in terms of the prevalence of NASH.
The number of patients living with the diabetes worldwide is expected to soar from 371 million in 2012 to 552 million by 2030. This suggests that by 2030, there will be 3 new cases of diabetes every 10 seconds. "The rampant growth of diabetes and obesity has prompted pharmaceutical manufacturers to seek out novel pharmaceutical solutions to tap promising potential in NASH," states AMR analyst Roshan Deshmukh. "Instrumental initiatives and increasing clinical trials for the development of novel NASH therapeutics will steer its faster commercialization," adds the analyst. Concerted efforts in research and development from companies such as Genfit, Gilead Science, Novo Nordisk, Raptor Pharmaceutical Corp. and Intercepts Pharmaceuticals would help them gain core competencies in this market. Dainippon Sumitomo Pharma (DSP), a partner of Intercept Pharmaceuticals, initiated a phase 2 clinical trial to test the safety and efficacy of daily dose of Obeticholic Acid (OCA) in 200 adult NASH patients. The trial is expected to be completed in the first half of 2016. Thus, prevalence of diabetes and research and developments in the field of fatty liver disease therapeutics would supplement market growth in the next six years.
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 restraint in commercialization of potential drugs.
In Europe, NASH is most prevalent in Germany, Italy, Spain, France and the United Kingdom. Intercept Pharmaceuticals, in collaboration with DSP, is developing obeticholic acid for commercialization in the United States and European countries. This drug is expected to receive commercial approval by the end 2017. Developing economies, particularly in the Asia-Pacific region, are the fastest growing markets for NASH therapeutics and are expected to have a double digit growth rate during the analysis period. The chief reason behind this growth is the high prevalence of nonalcoholic fatty liver diseases in densely populated countries such as China, Japan and Korea with prevalence rate of 12% to 24% per year. In western industrialized countries, the prevalence rate is estimated to be approximately 20% to 40%.
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.
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