Non-alcoholic steatohepatitis (NASH) is an advanced form of the non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition in which too much fat builds up in the liver. If left untreated, NAFLD can lead to serious liver problems. NASH is inflammation of the liver caused by excess fat cells in it (fatty liver disease). It is caused when that extra fat turns into inflammation (swelling in the liver) and fibrosis (scarring) of the liver. If severe enough, NASH can lead to cirrhosis or liver cancer, potentially requiring a liver transplant, which presents a difficult situation. Thus, there is an increase demand for safe and effective therapeutics and diagnostics worldwide.
Market Statistics:
The global Non-Alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market is estimated to account for US$ 17,552.7 Mn in terms of value by the end of 2023.
Drivers:
Increase in demand for safe and effective NASH therapeutics and diagnostics across the globe is expected to boost the growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market over the forecast period. For instance, in May 2022, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer Inc.’s investigational combination therapy for the treatment of NASH with liver fibrosis; ervogastat (PF-06865571, diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) & clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). Fast Track designation from the FDA reinforces Pfizer’s belief in ervogastat/clesacostat as a potential treatment for NASH, a serious, progressive liver disease with no currently approved therapies.
Opportunities:
Increase in burden/prevalence of NASH across the globe is expected to offer significant growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. For instance, according to the Global Liver Institute (or International NASH Day), NASH is a hidden epidemic. It is the progressive form of NAFLD, and affects more than 115 million people around the world, and an estimated 357 million people will be affected by 2030. Moreover, NAFLD and NASH are major risk factors for concurrent conditions: more than 70% of patients are obese, up to 75% have type 2 diabetes, and anywhere from 20 to 80% have hyperlipidemia. If left untreated, NASH may lead to cirrhosis, liver cancer, and liver transplant.
Restraints:
Lack of effective diagnostics for NAFLD and lack of advancements in therapeutic field are major factors expected to hamper growth of the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market. It has been observed that an increasing number of people worldwide are being diagnosed with NASH and NAFLD each year, and the only primary method of treatment is weight loss. Moreover, it has been observed that after almost 35 years its formal description and 15 years of intense study from researchers around the world, there is still no approved drug for the treatment of NASH. Moreover, there are no FDA-cleared/approved diagnostic tests, specifically designed for the identification of NASH.
Global Non-alcoholic Steatohepatitis (NASH) Therapeutics and Diagnostics Market- Impact of Coronavirus (Covid-19) Pandemic:
NAFLD represents the high risk for severe COVID-19 irrespective to gender, and independent of metabolic syndrome specifically in male gender. Moreover, obesity, hypertension, and metabolic syndrome were also significantly associated with severe COVID-19. NAFLD can play major role in the outcome of COVID-19 illness due to frequent association with comorbidities. This in turn is expected to increase the risk of NASH as well as increase the demand for safe/effective NASH therapeutics and diagnostics, driving the market growth.
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Key Takeaways:
The global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market was valued at US$ 14,624.2 Mn in 2022 and is forecast to reach a value of US$ 63,354.6 Mn by 2030 at a CAGR of 20.13% between 2023 and 2030.
Among product Diagnostics segment held dominant position in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market in 2022, accounting for 67.0% share in terms of value, increasing approval and launch of new products is expected to propel growth of the segment during the forecast period.
Market Trends:
Increasing awareness about NASH is one of the key trends expected to boost growth of the global biosurgery market. With the increase in awareness among people, demand for novel therapeutics and diagnostics is also increasing with a rapid pace. International NASH Day is an initiative started by the Global Liver Institute to raise awareness of the growing worldwide epidemic of NAFLD and its more advanced form, NASH. There are an increasing number of awareness programs for the disease to help patients, healthcare professionals, and researchers better diagnose/treat NASH. This trend is expected to continue over the forecast period, driving the market growth.
Competitive Landscape:
Major players operating in the global non-alcoholic steatohepatitis (NASH) therapeutics and diagnostics market include Novartis AG, Allergan Plc., Viking Therapeutics, Merck & Co., Zydus Cadila, Novo Nordisk A/S, GENFIT SA, Gilead Sciences Inc., Galmed Pharmaceuticals, Madrigal Pharmaceuticals, and Intercept Pharmaceuticals Inc., among others.
Recent Developments:
In March 2019, Madrigal Pharmaceuticals, Inc. announced that it has initiated its Phase 3 trial in non-alcoholic steatohepatitis (NASH) with its once daily, oral thyroid hormone receptor beta selective agonist, MGL-3196 (resmetirom). This double-blind, placebo-controlled study will be conducted at more than 150 sites in the United States and the rest of the world.
In March 2019, Genfit started trading on NASDAQ, and issued new shares in its existing Euronext Paris listing. The company raised a total of EUR 120 million (about US$ 135 million).
In February 2019, Intercept Pharmaceuticals, Inc. announced positive results from its pivotal Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with liver fibrosis owing to non-alcoholic steatohepatitis (NASH).
In October 2018, Novartis entered into a clinical development agreement with Pfizer, which will include a study combining tropifexor and one/more Pfizer compounds for the treatment of NASH.
