Research Reports

Market Overview

• Global Non-alcoholic Steatohepatitis Treatment Market Expected to Reach a high CAGR of 54% By 2026: DataM Intelligence
• Nonalcoholic steatohepatitis (NASH) is a progressive form of nonalcoholic fatty liver disease (NAFLD) in which there is an abnormal accumulation of fat in the liver. This can lead to inflammation and liver cell damage, which can cause liver fibrosis or scarring and may further progress to cirrhosis or liver cancer. NASH is known to be chronic yet silent disease with few or no symptoms and is often unrecognized and underdiagnosed. Risk factors of NASH include diabetes, obesity, insulin resistance, abnormal levels of cholesterol, and metabolic syndrome.

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Market Dynamics

• The global market for the NASH (non-alcoholic steatohepatitis) treatment market is primarily driven by the rising prevalence of NASH and the strong presence of pipeline drugs. For instance, Pfizer is currently researching multiple ways to treat NASH at its different stages of progression. The company entered into a non-exclusive clinical development agreement with Novartis to investigate one or more combination therapies for the treatment of NASH. Owing to lack of symptoms, NASH is often unrecognized and underdiagnosed, but it is believed to affect over 6% of the adult population worldwide, and with no currently available treatments, NASH is most likely to be the leading cause for liver transplant by 2020. Other factors such as the growing prevalence of diabetes, obesity, and rising demand for therapeutics are expected to influence the market growth further. As there are no therapeutic options approved to treat patients with NASH currently, there is a high unmet need for the drugs, and as a result, any new drug launched is expected to see rapid acceptance buy patients with NASH. According to the International Diabetes Federation, Diabetes Atlas Eighth edition 2017, about 425 million adults are diabetic worldwide, and by 2045, the diabetic population is estimated to rise to 629 million. According to WHO, in 2016, over 1.9 billion adults (18+ population) were overweight, of which over 650 million adults were obese. Overall, around 13% of the world’s adult population (11% of men and 15% of women) were obese in 2016.
• However, the lack of demand in developing countries and insufficient diagnostic technologies for NASH may hinder market progress. 

Market Segment Analysis

• By Drug, the global NASH (Non-alcoholic Steatohepatitis) Treatment market is segmented into Vitamin E, Pioglitazone, Ocaliva, Elafibranor, and Selonsertib & Cenicriviroc and others. Vitamin E and Pioglitazone segments currently hold the most significant market shares due to their efficacy. Some studies suggest that pioglitazone, a treatment for type 2 diabetes, improves NASH in patients that don’t have diabetes. Another study by the National Institute of Diabetes and Digestive and Kidney Diseases’ NASH Clinical Research Network identified that treatment with vitamin E or pioglitazone improved NASH in about half of the people treated. However, there is no clinical validation for the long term effects of this treatment. On the other hand, elafibranor and selonsertib & cenicriviroc shares are anticipated to show significant growth due to many drugs currently in the pipeline.

Geographical Analysis

• North America occupied a dominant market share of the global NASH treatment market in 2018. Market dominance is mainly attributed to factors such as the rising prevalence of obesity & diabetes, increasing incidence of NASH, and robust pipeline drugs among local players. For instance, in June 2019, Crown Bioscience announced four new preclinical translational NASH models are in development. According to NIH, approximately 12% of US adults suffer from NASH, which is approximately 30 million people, and the prevalence is projected to increase by over 60% between 2015 and 2030. According to the National Diabetes Statistics Report, in 2017, 30.3 million people in the US have diabetes, which is nearly one in 10 Americans. According to the CDC, in 2016, the obesity prevalence rate was 39.8%, and the condition affected approximately 93.3 million adults in the US. Moreover, the advanced regional healthcare infrastructure, rise in healthcare expenditure, the presence of established market players and high investment in R&D activities by them are likely to boost the North America NASH Treatment market growth.

Competitive Analysis

• To increase the user base and improve their NASH (Non-alcoholic Steatohepatitis) Treatment market presence, companies are increasingly investing in R&D to have a strong drug pipeline. Moreover, several key companies have adopted merger and acquisition policies, clinical agreements, and collaborations to improve market presence also expand its geographical footprint in the global NASH treatment market.
• Major Players in the global NASH Treatment market include Allergan plc, Pfizer Inc., and Novartis AG.
• In June 2019, Crown Bioscience announced four new preclinical translational NASH models in development.
• In June 2019, GENFIT, initiated a Phase II clinical trial to evaluate the effect of a 6-week, once-daily treatment of elafibranor (120mg) vs. placebo on hepatic lipid composition in patients with Nonalcoholic Fatty Liver (NAFL).
• In April 2019, Novartis announced the acquisition of IFM Tre, a subsidiary of IFM Therapeutics LLC. The acquisition is anticipated to provide Novartis full rights to IFM Tre's portfolio of NLRP3 inhibitors which includes – IFM-2427, a clinical-stage systemic antagonist for an array of chronic inflammatory disorders, such as gout, atherosclerosis, and NASH.
• In October 2018, Pfizer Inc. and Novartis signed a non-exclusive clinical development agreement for clinical investigation of one or more combination therapies for the treatment of NASH. The companies together will conduct both non-clinical and Phase 1 clinical studies of Pfizer’s investigational drug therapies, including acetyl CoA-carboxylase inhibitor (PF-05221304, currently in Phase II), a diacylglycerol O-Acyltransferase 2 (DGAT2) inhibitor (PF-06865571, Phase 1) and a ketohexokinase (KHK) inhibitor (PF-06835919, Phase 2), along with Novartis’s tropifexor, a non-bile acid, farnesoid X receptor (FXR) agonist.
• In April 2017, Allergan entered into a clinical trial agreement with Novartis to conduct a Phase IIb study, using Allergan's cenicriviroc (CVC) and Novartis' lead FXR agonist for the treatment of NASH. The Phase IIb study will evaluate safety, efficacy, and tolerability of this multi-therapy treatment approach for NASH. 

Key Takeaways:

• The global market for the NASH (Non-alcoholic Steatohepatitis) Treatment Market is primarily driven by the rising prevalence of NASH and the strong presence of pipeline drugs. Other factors such as the growing prevalence of diabetes, obesity, and rising demand for therapeutics are expected to influence the market growth further.
• Vitamin E and Pioglitazone segments currently hold the most significant market shares due to their efficacy.
• North America accounts for the largest share in the global NASH Treatment market, owing to factors such as the rising prevalence of obesity and diabetes, increasing incidence of NASH, and recent drug approvals.
• Adopting merger and acquisitions policies, clinical collaborations, and regional expansion to help key market players to stand out as strong competitors in the NASH treatment market.

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