NASH is defined as the most common form of Nonalcoholic fatty liver disease (NAFLD). The disease is characterized by a spectrum of symptoms including simple steatosis, increased levels of fibrosis, and cirrhosis of the liver. NASH can also result in advanced fibrosis, NASH cirrhosis, and NASH Decompensated Cirrhosis.

Though the primary cause of NASH is not yet identified, however, we do know that it is closely related to conditions like obesity, type II diabetes, and hyperlipidemia. With the increasing prevalence of these diseases, NASH prevalence is also on the rise. Currently, there is no licensed drug available for the treatment of NASH, also the awareness about the disease is increasing this presents a significant opportunity for drug makers. However, this opportunity comes with associated challenges as well. NASH shows very few or no symptoms and is often diagnosed as a result of liver biopsy undertaken to investigate the possibility of a related disease.

Due to highly potential market, companies are extensively working on the given indication and have a robust pipeline of drugs for the treatment of NASH. Currently, there are more than 25 drugs in Phase II and Phase III stages of clinical development worldwide. There are four drugs in the Phase III stage, namely Elafibranor (Genfit Pharma), Obeticholic Acid (Intercept Pharmaceuticals), Selonsertib (Gilead Sciences) and Cenicriviroc (Allergan). Drugs that are in the Phase II stage include NGM282 (NGM Biopharmceuticals), Emricasan (Conatus Pharmaceuticals Inc.), IVA 337 (Inventia Pharma), BMS 986036 (Bristol-Myers Squibb). These drugs have shown effectiveness against following fibrosis stages-

  • Genfit’s Elafibranor has indicated a greater impact efficacy in reducing the intracellular lipid accumulation and alleviating inflammation and fibrosis when compared to Intercept’s Obeticholic acid (OCA). Indeed, Elafibranor looks like a promising drug for the treatment of NASH. On the other hand, OCA has shown to have a greater efficacy in restoring glucose homeostasis and has a breakthrough designation for the treatment of NASH.
  • Tobira’s Cenicriviroc, acquired by Allergan, failed to meet the primary endpoint but has depicted efficacy in mitigating fibrosis, and successfully met the secondary endpoint in its Phase IIb CENTAUR study. On the other hand, Selonsertib met both its primary and secondary endpoints in combination with Simtuzumab. Its effectiveness in monotherapy is yet to be proven.
  • Bristol-Myers Squibb’s BMS 986036 has demonstrated statistically significant improvements in the exploratory endpoints and safety profile for NASH.

Amongst all the drugs in the pipeline, Obeticholic acid seems to be leading the race in the market and has progressed the farthest in clinical trials, and successfully acquired an FDA approval.

DelveInsight believes that as many as 8 drugs are likely to be launched for the treatment of NASH from 2023-2027. The market share of 7MM has shown an increased trend with highest being in the United States, followed by EU5 and Japan in 2016. This trend is believed to be followed in near future also due to rise in the ongoing epidemics of obesity and type II diabetes worldwide.

According to DelveInsight, it is estimated that the market size of Nonalcoholic Steatohepatitis (NASH) in 7MM will increase and reach up to 49.25 Billion in 2027, with the CAGR of 23.0% for the period 2015-2027. NASH is becoming a highly unmet medical need and a leading cause of liver transplantation, increasing the requirement of advanced therapies