Albany, NY -- (SBWIRE) -- 12/14/2015 -- Nonalcoholic Steatohepatitis (NASH) is one of the forms of nonalcoholic fatty liver disease (NAFLD), characterized by hepatocyte injury (ballooning) marked by presence of hepatic steatosis, inflammation, and fibrosis. Clinical studies have identified a strong correlation of NASH with certain risk factors diabetes and obesity. Moreover, recent breakthroughs have taken place in mapping the genetic factors behind NASH, to identify the predisposition of an individual or population at large for developing NASH. Further, the prevalence of NASH coincides with other liver-associated morbidity such as hepatic steatosis which was found among 27% of the diagnosed NASH population. Similarly, nonspecific hepatitis, granulomatous liver disease, and nodular regenerative hyperplasia were other conditions which are commonly found in NASH affected patients.

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Geographically, the prevalence of NASH was found to be nearly 30% in the U.S. while on the other hand the trend is rising in the East and West Asian countries, where the prevalence was found to be 17 and 9%, respectively. Thus, at present established markets such as the U.S. offer attractive opportunities for growth this may eventually trickle down to the Asian market.
The overall growth in the NASH drug treatment market can be linked with its association of obesity and insulin resistance in countries with high obesity & diabetes prevalence. However, at present, the information on natural history of this disease is sparse. There are very few U.S. FDA approved drugs, namely obeticholic acid (OCA)which received in 2015 and aramchol in 2014, which received the Breakthrough Therapy Designation (BTD) and Fast Track Designation respectively for NASH treatment. OCA is a bile acid analog and the first NASH agonist of the bile acid receptor farnesoid X receptor (FXR) in Liver and aramchol is a synthetic fatty and bile acid conjugate also known as FABACs. Therefore, there is a huge demand for developing new drugs and other therapeutic treatment for this disease.

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Currently, there are very few pharmaceutical companies in this market, and thus, new market players could seek entry by tapping this market opportunity. Key drivers for continued growth in the established markets are attributed to the rapid rise in demand for NASH drug, as it is one of the major causes for cirrhosis in the U.S. after liver diseases such as hepatitis, and alcoholic induced liver disorders. Further, NASH is one of the leading causes for hepatocellular cancer, where NASH condition acts like a silent killer without any symptoms of cirrhosis. It is also found to be one of the major contributors of chronic liver diseases (CLD) in North America, which often leads to liver transplantation surgeries in the event of organ failure. Therefore, there is a need to develop new diagnostic and therapeutic strategies in the NASH market.
The disease is relatively under-reported compared to other liver disorders, since; liver biopsy is the confirmatory test for diagnosing NASH. Therefore, diagnostic service market of NASH carries the potential to spearhead the market growth. Since, the progression of NASH occurs over a span of time in the form of a gradual and subtle process, NASH could either halt or reverse back to normal without any treatment on its own due to the regenerative characteristic features of liver. These factors could act as a barrier in the diagnostic market.
Some of the major leading players in this market include AstraZenecaplc, Echosense SA, Exalenz Bioscience Inc., Galmed Pharmaceuticals Ltd., Intercept Pharmaceuticals, Inc., One Way Liver Genomics, S.L, Perspectum Diagnostics, and Vital Therapies, Inc.

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