Non-Alcoholic Steatohepatitis Therapeutics and Diagnostics Market is segmented By Therapeutics (Ocaliva, Elafibranor, Cenicriviroc, Selonsertib, Others), By Diagnostics (Imaging Techniques, Diagnostic Tests, Biopsy), By Sales Channel (Hospital Pharmacy, Online Channel, Retail Channel), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031
Report Overview
Non-alcoholic steatohepatitis therapeutics and diagnostics market was valued USD million in 2023 and is estimated to reach USD million by 2031, growing at a CAGR of 22.31% during the forecast period (2024-2031).
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 a chronic yet silent disease with few or no symptoms and is often unrecognized and underdiagnosed. NASH risk factors include diabetes, obesity, insulin resistance, abnormal levels of cholesterol, and metabolic syndrome. Therefore, no medicines have been approved to treat NASH. However, researchers are studying medicines that may improve these conditions.
Market Summary
Metrics | Details |
| Market CAGR | 22.31% |
| Segments Covered | By Diagnostics, By Diagnostics Segment, By Therapeutics, By Sales Channel, and By Region |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
| Fastest Growing Region | Asia Pacific |
| Largest Market Share | North America |
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Market Growth Drivers
The rising prevalence of NASH and the strong presence of pipeline drugs are expected to drive market growth.
Semaglutide, developed by Novo Nordisk, is a long-acting GLP-1 analog designed as a once-daily therapy for nonalcoholic fatty liver disease (NASH). Novo Nordisk is currently developing it for NASH at the phase III stage. Moreover, resmetirom (MGL-3196) from Madrigal Pharmaceuticals is a first-in-class, orally-administered, small-molecule, liver-directed thyroid hormone receptor (THR) selective agonist. Resmetirom has an appealing, distinct profile as a prospective treatment for nonalcoholic steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD), and associated dyslipidemias, according to preclinical, toxicological, Phase 1 and Phase 2 clinical evidence. In addition, Pfizer is 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 to treat NASH. Owing to a lack of symptoms, NASH is often unrecognized and underdiagnosed. Still, 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 of liver transplant by 2020. Other factors, such as the growing prevalence of diabetes, obesity, and rising demand for therapeutics, are expected to influence market growth further. As no therapeutic options are 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 by patients with NASH.
Restraint:
However, the lack of demand in developing countries and insufficient diagnostic technologies for NASH may hinder market progress.
Industry Analysis
The non-alcoholic steatohepatitis treatment market provides in-depth analysis of the market based on various industry factors such as unmet needs, pricing analysis, supply chain analysis, regulatory analysis, epidemiology etc.
Market Segmentation Analysis
Vitamin E and Pioglitazone segment is expected to hold the largest market share in the non-alcoholic steatohepatitis treatment market.
The vitamin E and pioglitazone segment accounted for the largest market share in 2021. The most widely administered medicines for non-alcoholic steatohepatitis are off-label medications such as Vitamin E. However, due to medical concerns, Vitamin E is not suggested for diabetic individuals. In contrast, Pioglitazone is prescribed to NASH patients with type 2 diabetes. Statins are another off-label medicine that is provided to NASH patients who are at risk of cardiovascular disease. Furthermore, the NASH market is extensively engaged in robust R&D activities; numerous possible paths for NASH treatments are in R&D, including lipogenesis inhibitors, drugs targeting the farnesoid X receptor axis, ASK1 inhibitors, and many more. Therefore, it has increased the adoption of vitamin E and pioglitazone drugs.
Market Geographical Share
North American region is expected to hold the largest market share in the global non-alcoholic steatohepatitis treatment market.
North America accounted for the largest market share in 2021. The rising prevalence of obesity & diabetes, increasing incidence of NASH, and robust pipeline drugs among local players are the factors to drive in the forecast period. For instance, according to the Centers for Disease Control and Prevention, All U.S. states and territories have an obesity rate of at least 20%. Overall, adult obesity rates are higher for women. The percentage of obese children is rising, with 39 million overweight and obese children under age five in 2020. Moreover, the U.S. spends almost $150 billion annually on obesity-related medical costs, and one in four young adults is too heavy to serve in the U.S. military.
Moreover, Pfizer Inc., a pharmaceutical and biotechnology company, announced in May 2022 that it had received FDA Fast Track designation to expedite the development of the non-alcoholic steatohepatitis (NASH) medications ervogastat and clesacostat. Pfizer's investigational combination medication for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis, ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat, is called Fast Track (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). Pfizer's nonclinical research and a Phase 2a clinical study of ervogastat/clesacostat demonstrated that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile, which influenced the FDA's conclusion. Pfizer is researching ervogastat/clesacostat in Phase 2 clinical trial that will be completed in 2024 to assess the impact of medication on the resolution of NASH or improvement in liver fibrosis. Thus, from the above statements, the North American region accounted for the largest market share in the forecast period.
Market Competitive Landscape
Major key players in the non-alcoholic steatohepatitis treatment market are Allergan plc., Pfizer Inc, Gilead Sciences, Inc., Genfit SA, Novartis AG, Intercepts Pharmaceuticals, Cadila Healthcare Ltd, Novo Nordisk, Raptor Pharmaceutical Corp. and Galmed Pharmaceuticals Ltd.
Novo Nordisk:
Overview:
Novo Nordisk A/S is a Danish multinational pharmaceutical company and a full European Federation of Pharmaceutical Industries and Associations member. The company manufactures and markets pharmaceutical products and services, specifically diabetes care medications and devices. Novo Nordisk is also involved with hemostasis management, growth hormone therapy and hormone replacement therapy. The company makes several drugs under various brand names, including Levemir, Tresiba, NovoLog, Novolin R, NovoSeven, NovoEight and Victoza. Moreover, the company markets its products in around 170 countries.
Pipeline Products:
The companies conducted a phase 2b double-blind, placebo-controlled study to investigate the safety and efficacy of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, and a fixed-dose combination of Gilead’s investigational FXR agonist cilofexor and investigational ACC inhibitor firsocostat, alone and in combination in people with compensated cirrhosis (F4) due to NASH.
The global non-alcoholic steatohepatitis treatment market report would provide an access to an approx. 45+market data table, 40+figures and 180pages
