Non-Alcoholic Steatohepatitis (NASH) Market Valued at USD 2,114M in 2023, Expected Strong Growth Through 2034

Across the 7MM countries, the Non-Alcoholic Steatohepatitis (NASH) market size was valued at approximately USD 2,114 million in 2023 and is expected to expand at a notable CAGR over the forecast period (2020–2034). DelveInsight’s comprehensive market research provides critical insights into such market trends, enabling stakeholders to understand growth drivers, emerging opportunities, and potential challenges within the Non-Alcoholic Steatohepatitis landscape.

In 2023, the United States led the NASH market among the 7MM, with a valuation of approximately USD 1,519 million, and is expected to grow further by 2034. Within Europe, Germany had the largest NASH market at around USD 89 million, while Spain reported the smallest, at USD 50 million. Japan’s NASH market was valued at roughly USD 260 million in 2023, with projections indicating continued growth through 2034.

In 2023, the estimated prevalence of NASH across the 7MM was approximately 42 million cases, with around 15 million diagnosed a number expected to increase by 2034. NASH severity is classified into stages F0 through F4. In the United States, the F1 stage represented the largest share of diagnosed cases in 2023, accounting for roughly 38% of the total. According to DelveInsight, the US had the highest number of diagnosed NASH cases among the 7MM in 2023, totaling about 9.4 million.

In comparison, the EU4 and UK collectively reported around 3.6 million NASH cases, while Japan accounted for approximately 2.5 million. Across the 7MM, diagnosed NASH cases were higher in males than females, with males representing 56% of the total. In 2023, Japan contributed roughly 16% of the total diagnosed NASH cases within the 7MM, and this figure is expected to increase over the forecast period (2020–2034).

DelveInsight’s report “Non-Alcoholic Steatohepatitis Market Insights, Epidemiology, and Market Forecast-2034” provides a comprehensive analysis of the Non-Alcoholic Steatohepatitis landscape. The report delivers detailed insights into the disease, including historical and projected epidemiology, helping stakeholders understand the prevalence, incidence, and patient demographics across key regions.

Additionally, it examines Non-Alcoholic Steatohepatitis market dynamics, offering a thorough assessment of current and emerging market trends, treatment patterns, and therapeutic developments. The analysis spans major markets, including the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan, equipping decision-makers with actionable intelligence for strategic planning, investment, and research initiatives.

To Know in detail about the Non-Alcoholic Steatohepatitis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Non-Alcoholic Steatohepatitis Market Forecast

Some of the key facts of the Non-Alcoholic Steatohepatitis Market Report:

• Key Non-Alcoholic Steatohepatitis Companies: Inventiva Pharma, Zydus Therapeutics, Novo Nordisk A/S, Viking Therapeutics, Madrigal Pharmaceuticals, Inc, Hepagene, Enyo Pharma, Galectin Therapeutics Inc., 89bio, Inc., Akero Therapeutics, Inc, NeuroBo Pharmaceuticals Inc, Novo Nordisk A/S, J2H Biotech, Haisco Pharmaceutical, Altimmune, Inc., AstraZeneca, Boehringer Ingelheim, Can-Fite BioPharma, Madrigal Pharmaceuticals, GlaxoSmithKline, 89bio, Inc., Akero Therapeutics, Inc, Regeneron Pharmaceuticals, Hepagene (Shanghai) Co., Ltd., Inventiva Pharma, Hanmi Pharmaceutical, Madrigal Pharmaceuticals, Inc., Sinew Pharma Inc., Boston Pharmaceuticals, and others
• Key Non-Alcoholic Steatohepatitis Therapies: Lanifibranor, Saroglitazar Magnesium, Semaglutide, VK2809, MGL-3196, HPG1860, Vonafexor (EYP001), Belapectin, Pegozafermin, Efruxifermin (EFX), DA-1241, NNC0194, J2H-1702, HSK31679, Pemvidutide, AZD9550, Survodutide, Namodenoson, Resmetirom, GSK4532990, BIO89-100, EFX, ALN-HSD, HPG1860, IVA337, HM15211, MGL-3196, SNP-610, BOS-580, and others
• The Non-Alcoholic Steatohepatitis epidemiology based on gender analyzed that males have a slightly higher likelihood of being affected by NASH compared to females in the 7MM.
• The Non-Alcoholic Steatohepatitis market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Non-Alcoholic Steatohepatitis pipeline products will significantly revolutionize the Non-Alcoholic Steatohepatitis market dynamics.

Non-Alcoholic Steatohepatitis Overview

Non-Alcoholic Steatohepatitis (NASH) is a serious form of non-alcoholic fatty liver disease (NAFLD) characterized by fat accumulation, inflammation, and liver cell damage. Unlike simple fatty liver, NASH can progress to fibrosis, cirrhosis, and even liver cancer. It is often associated with obesity, type 2 diabetes, high cholesterol, and metabolic syndrome. Many people may have no symptoms initially, but common signs include fatigue, abdominal discomfort, and elevated liver enzymes. Management focuses on lifestyle changes, controlling underlying conditions, and emerging pharmacological treatments.

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Key Trends in Non-Alcoholic Steatohepatitis Therapeutics Market:

• Growing demand driven by metabolic disease burden: Rising prevalence of obesity, type 2 diabetes, insulin resistance and metabolic syndrome worldwide is fueling more NASH diagnoses and increasing demand for effective treatments.
• Shift from lifestyle‑only to pharmacological and targeted therapies: As awareness grows that lifestyle changes alone often aren’t sufficient, pharmaceutical development is accelerating with novel therapies aimed at reducing liver fat, inflammation, and fibrosis.
• Rise of combination therapies and multi‑pathway approaches: Because NASH involves metabolic, inflammatory, and fibrotic processes, drug developers increasingly favor combination regimens or drugs that act on multiple biological pathways simultaneously for better efficacy.
• Advances in diagnostics & non‑invasive detection: New non-invasive diagnostic methods (imaging, biomarkers, elastography) are gaining traction, allowing earlier detection and monitoring without relying solely on invasive liver biopsies.
• R&D momentum and regulatory momentum opening doors: A robust pipeline of drug candidates (anti‑fibrotic agents, metabolic modulators, etc.) combined with increasing investments and favorable regulatory/regulatory‑supportive environment is making NASH a rising focus area for pharma/biotech. 

Non-Alcoholic Steatohepatitis Epidemiology

The Non-Alcoholic Steatohepatitis epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Non-Alcoholic Steatohepatitis Epidemiology Segmentation:

The Non-Alcoholic Steatohepatitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of Non-Alcoholic Steatohepatitis
• Prevalent Cases of Non-Alcoholic Steatohepatitis by severity
• Gender-specific Prevalence of Non-Alcoholic Steatohepatitis
• Diagnosed Cases of Episodic and Chronic Non-Alcoholic Steatohepatitis

Download the report to understand which factors are driving Non-Alcoholic Steatohepatitis epidemiology trends @ Non-Alcoholic Steatohepatitis Epidemiology Forecast

Recent Development In The Non-Alcoholic Steatohepatitis Treatment Landscape:

• In December 2025, PathAI has achieved a landmark regulatory milestone as the FDA qualified its AIM-MASH AI Assist tool, making it the first AI-powered pathology biomarker to receive such recognition under the FDA’s Drug Development Tool (DDT) program. This follows a similar qualification by the European Medicines Agency (EMA) earlier in the year, positioning AIM-MASH as the first tool of its kind to hold regulatory approval in both the U.S. and EU.
• In December 2025, Galmed announced the grant of new use patents for the combination of Aramchol and Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for the treatment of MASH. The newly issued patent in South Korea complements previously granted patents in the United States, Europe, Canada, and other regions, with the U.S. patent set to expire in July 2042. Aramchol, a first-in-class, Phase 3-ready drug candidate, has demonstrated significant fibrosis improvement in advanced clinical trials.
• In Sept 2025, Echosens announced that the FDA’s Center for Drug Evaluation and Research (CDER) has accepted its Letter of Intent to qualify Liver Stiffness Measurement using FibroScan® as a surrogate endpoint in clinical trials for metabolic dysfunction-associated steatohepatitis (MASH).
• In August 2025, Madrigal Pharmaceuticals announced that the European Commission has granted conditional marketing authorization for Rezdiffra (resmetirom) to treat adults with noncirrhotic MASH and moderate to advanced liver fibrosis. With this approval, Rezdiffra becomes the first and only therapy for MASH authorized in the EU. 
• In May 2025, Novo Nordisk has announced that it will share new data from its metabolic and cardiovascular health portfolio at the 32nd European Congress on Obesity (ECO), taking place from May 11–14, 2025. The presentations will feature real-world evidence studies on semaglutide, further analyses from the SELECT cardiovascular outcomes trial, and results from part 1 of the Phase 3 ESSENCE trial for metabolic dysfunction-associated steatohepatitis (MASH).
• In May 2025, An interim analysis from the Phase III ESSENCE trial (NCT04822181), published in The New England Journal of Medicine, showed that weekly semaglutide led to notable improvements in both steatohepatitis and fibrosis among patients with metabolic dysfunction–associated steatohepatitis (MASH). The treatment also improved metabolic indicators and noninvasive liver health markers. Researchers emphasized semaglutide's ability to target both liver damage and the metabolic dysfunction driving disease progression, highlighting its promise as a holistic treatment option for MASH.
• In March 2025, Long-term use of Rezdiffra (resmetirom) has demonstrated a reduction in liver fibrosis in most patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH), where the liver continues to function despite permanent scarring. These results come from two-year data of the Phase 3 MAESTRO-NAFLD-1 trial (NCT04197479), recently announced by the drug’s developer, Madrigal Pharmaceuticals.

Non-Alcoholic Steatohepatitis Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Non-Alcoholic Steatohepatitis market or expected to get launched during the study period. The analysis covers Non-Alcoholic Steatohepatitis market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Non-Alcoholic Steatohepatitis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Non-Alcoholic Steatohepatitis Therapies and Key Companies

• REZDIFFRA (resmetirom): Madrigal Pharmaceuticals
• Pegozafermin: 89bio, Inc
• Efruxifermin (EFX): Akero Therapeutics, Inc.
• Belapectin: Galectin Therapeutics
• Lanifibranor: Inventiva Pharma
• Saroglitazar Magnesium: Zydus Therapeutics
• Semaglutide: Novo Nordisk A/S
• VK2809: Viking Therapeutics
• MGL-3196: Madrigal Pharmaceuticals, Inc
• HPG1860: Hepagene
• Vonafexor (EYP001): Enyo Pharma
• DA-1241: NeuroBo Pharmaceuticals Inc
• NNC0194: Novo Nordisk A/S
• J2H-1702: J2H Biotech
• HSK31679: Haisco Pharmaceutical
• Pemvidutide: Altimmune, Inc.
• AZD9550: AstraZeneca
• Survodutide: Boehringer Ingelheim
• Namodenoson: Can-Fite BioPharma
• Resmetirom: Madrigal Pharmaceuticals
• GSK4532990: GlaxoSmithKline
• BIO89-100: 89bio, Inc.
• EFX: Akero Therapeutics, Inc
• ALN-HSD: Regeneron Pharmaceuticals
• HPG1860: Hepagene (Shanghai) Co., Ltd.
• IVA337: Inventiva Pharma
• HM15211: Hanmi Pharmaceutical
• VK2809: Viking Therapeutics, Inc.
• MGL-3196: Madrigal Pharmaceuticals, Inc.
• SNP-610: Sinew Pharma Inc.
• BOS-580: Boston Pharmaceuticals

Discover more about therapies set to grab major Non-Alcoholic Steatohepatitis market share @ Non-Alcoholic Steatohepatitis Treatment Landscape

Non-Alcoholic Steatohepatitis Market Drivers

• Rising Prevalence of NASH and NAFLD: Increasing cases of obesity, diabetes, and metabolic syndrome are driving NASH incidence globally.
• Growing Awareness and Screening: Enhanced disease awareness and improved diagnostic methods are boosting early detection and treatment demand.
• Advancements in Therapeutics: Development of novel drugs targeting fibrosis, inflammation, and metabolic pathways is expanding treatment options.
• Supportive Regulatory Environment: Orphan drug designations and expedited review pathways facilitate faster market entry for new therapies.
  R&D Investments: Increased focus by biopharmaceutical companies on innovative NASH treatments fuels market growth.

Non-Alcoholic Steatohepatitis Market Barriers

• Lack of Approved Therapies: Limited availability of effective FDA-approved drugs restricts treatment options.
• High Treatment Costs: Expensive therapies and long-term management may limit patient access, especially in emerging markets.
• Complex Disease Pathophysiology: Heterogeneous progression and multifactorial causes make drug development challenging.
• Patient Non-Compliance: Lifestyle modifications, essential for management, are difficult for patients to maintain consistently.
• Market Fragmentation: Differences in healthcare infrastructure and treatment adoption across regions hinder uniform growth.

Scope of the Non-Alcoholic Steatohepatitis Market Report

• Study Period: 2020–2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Non-Alcoholic Steatohepatitis Companies: Inventiva Pharma, Zydus Therapeutics, Novo Nordisk A/S, Viking Therapeutics, Madrigal Pharmaceuticals, Inc, Hepagene, Enyo Pharma, Galectin Therapeutics Inc., 89bio, Inc., Akero Therapeutics, Inc, NeuroBo Pharmaceuticals Inc, Novo Nordisk A/S, J2H Biotech, Haisco Pharmaceutical, Altimmune, Inc., AstraZeneca, Boehringer Ingelheim, Can-Fite BioPharma, Madrigal Pharmaceuticals, GlaxoSmithKline, 89bio, Inc., Akero Therapeutics, Inc, Regeneron Pharmaceuticals, Hepagene (Shanghai) Co., Ltd., Inventiva Pharma, Hanmi Pharmaceutical, Madrigal Pharmaceuticals, Inc., Sinew Pharma Inc., Boston Pharmaceuticals, and others
• Key Non-Alcoholic Steatohepatitis Therapies: Lanifibranor, Saroglitazar Magnesium, Semaglutide, VK2809, MGL-3196, HPG1860, Vonafexor (EYP001), Belapectin, Pegozafermin, Efruxifermin (EFX), DA-1241, NNC0194, J2H-1702, HSK31679, Pemvidutide, AZD9550, Survodutide, Namodenoson, Resmetirom, GSK4532990, BIO89-100, EFX, ALN-HSD, HPG1860, IVA337, HM15211, MGL-3196, SNP-610, BOS-580, and others
• Non-Alcoholic Steatohepatitis Therapeutic Assessment: Non-Alcoholic Steatohepatitis current marketed and Non-Alcoholic Steatohepatitis emerging therapies
• Non-Alcoholic Steatohepatitis Market Dynamics: Non-Alcoholic Steatohepatitis market drivers and Non-Alcoholic Steatohepatitis market barriers
• Non-Alcoholic Steatohepatitis Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• Non-Alcoholic Steatohepatitis Unmet Needs, KOL’s views, Analyst’s views, Non-Alcoholic Steatohepatitis Market Access and Reimbursement 

To know more about Non-Alcoholic Steatohepatitis companies working in the treatment market, visit @ Non-Alcoholic Steatohepatitis Clinical Trials and Therapeutic Assessment

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