According to a recent market study published by Transparency Market Research (TMR), Nonalcoholic Steatohepatitis (NASH) is a type 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 such as insulin resistance, oxidative stress and release of toxic inflammatory proteins (cytokines). 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. The disease requires liver transplantation surgeries in the event of the organ failing. However, at present, the information on natural history of this disease is sparse.
The American Liver Foundation has raised issues concerning the propensity of NASH progression. Since, NASH patients whose condition has progressed to cirrhosis are at a higher risk of developing hepatocellular cancer (HCC). Thus, NASH progression into advanced liver disease has become a primary concern, as NASH is being identified as one of the potential causes for hepatocellular cancer (HCC), according to the facts and findings published by American Liver Foundation.
In terms of diagnostic technology for NASH, NASH can be first identified by elevations in liver functioning tests based on the blood sample, without the presence of signs and symptoms of other liver disorders among those who are usually nonalcoholic or rarely consume alcohol. However, liver biopsy is a widely accepted confirmatory diagnostic test for distinguishing NASH from other liver morbidities. Therefore, there is a need to develop new diagnostic and therapeutic strategies in the NASH market. For instance, OWLiver test is an in vitro patented diagnostic test technology for determination of the stage of non-alcoholic fatty liver disease and differentiates simple steatosis and non-alcoholic steatohepatitis (NASH). It is a metabolomic based non-invasive assays for fatty liver screening and for NASH diagnosis, which is developed and patented by One Way Liver Genomics, S.L. (OWL). Hence, there is a potential untapped market for diagnosis of NASH through non-invasive diagnostic technology, which would aid identification of NASH in early stages and for screening at risk population who are at greater risk of developing NASH.
Therefore, the market for Nonalcoholic Steatohepatitis (NASH) is currently at a nascent stage as there are no U.S. FDA approved drugs for NASH to date. However, there are a number of pipeline drugs in Phase III and II such as Elafibranor, Aramchol etc., which are potential drug candidates for entering the NASH market. There is a huge potential for biotech and pharmaceutical companies for channeling their research and development activities for interventions in diagnosis and treatment of NASH. The key drivers, which will fuel this market, are attributed to the increasing incidence of NAFLD cases, which may eventually transform to NASH, obesity, changing lifestyle patterns, which have a close association with NASH. The overall growth in the market can be linked with the association of NASH with other morbid conditions such as obesity and insulin resistance. Therefore, there is a huge unmet demand for NASH drugs and other therapeutic treatment for this disease, which offers lucrative opportunities for the market players.
Players in the market for NASH include AstraZeneca plc, Echosense SA, Exalenz Bioscience Inc., Galmed Pharmaceuticals Ltd., Galectin Therapeutics Inc., GENFIT Corp, Intercept Pharmaceuticals, Inc., One Way Liver Genomics, S.L, Matinas Biopharma Holdings, Inc. Perspectum Diagnostics, and Vital Therapies, Inc.
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