Non-alcoholic fatty liver disease (NAFLD), is the most common group of conditions in which there is an excess fat accumulation in the liver in people who intake little or no alcohol. It has been affecting many people mostly in developed countries and is known as fatty liver. However, in the most severe cases, people may develop Non-Alcoholic Steatohepatitis (NASH) where the accumulation of fat leads to liver inflammation and serious cirrhosis. It is characterized by severe damage to liver tissues and prominent scarring which can ultimately give rise to a situation where the liver transplant is indispensable.
According to the DelveInsight’s estimates, total NAFLD prevalent cases in the 7MM were found to be 179,728,244 in 2017. Of all the NAFLD prevalent cases in the 7MM, approximately 19% of the population fulfilled the criteria for NASH. Moreover, the highest prevalence of NASH was seen in the United States, accounting for almost 50% of the total prevalent cases, followed by Japan. If we talk about European countries, Germany had the highest NASH prevalence and Spain was the least affected.
NASH is one of the main reasons why many Americans are undergoing liver transplantation at present. NASH has also surpassed alcoholic liver inflammation as a reason for the transplantation of the liver. If we go by this scenario, it is quite clear that the patient pool for NASH is going to increase in the coming years. And the irony is that at present, there is no approved treatment or drug available in the market. This has resulted in off-label therapies dominating the NASH therapeutics market. In the early stages, lifestyle management like weight loss and diet planning is adopted. The medications are administered during the later stages when the above lifestyle modification fails. Off-label therapies like Vitamin E is the most prescribed one to patients who are struggling with NASH but are diabetes free. On the contrary, Pioglitazone is administered to patients who are already suffering from type II diabetes along with NASH. Similarly, to NASH patients who are also at the risk of cardiovascular disease, are prescribed with Statins.
If we talk about the NASH market share of off label therapies, it will keep on experiencing a steady growth until a standard approved therapy enters the NASH treatment market. Absence of any approved drugs for NASH treatment has urged many key players like Genfit, Intercept Pharmaceuticals, Gilead Sciences, Allergan, Galmed Pharmaceuticals, Bristol-Myers Squibb, Cirius Therapeuticsa and many more to shift their focus towards developing a novel drug therapy to target NASH directly.
The failure of Gilead’s NASH prospect Selonsertib that too in Phase III trials wiped off the hopes of many.
Obeticholic Acid (OCA) under clinical trials being run by Intercept Pharmaceuticals is being the most looked upon drug for NASH treatment and is expected to grab the most NASH therapeutic share. It is the only drug which has received Breakthrough Therapy designation.
As already mentioned above, the treatment of NASH is limited to lifestyle changes and off-label therapies to treat the associated morbidities. However, the launch of and clinical investigation of many drugs of new drugs solely directed to treat NASH for sure can augment NASH therapeutic share.