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(Albany, New York) – October 15, 2026: DelveInsight’s report “MASH Market Insights, Epidemiology, and Market Forecast-2036” provides a comprehensive analysis of the MASH 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 MASH 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 MASH market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; MASH Market Forecast

Some of the key facts of the MASH Market Report:

• The MASH market size across the 7MM was valued at approximately USD 3 billion in 2025 and is projected to grow at a significant CAGR through 2036, reaching a substantially higher market value by the end of the forecast period.

• In 2025, the US MASH market accounted for more than USD 2 billion of the total market across the 7MM. According to DelveInsight’s analysis, the market is expected to expand during the forecast period (2026–2036), driven by the introduction of emerging therapies and advancements in treatment options.

• In October 2026, Madrigal Pharmaceuticals reported published findings demonstrating that resmetirom maintained consistent efficacy across common genetic risk variants associated with metabolic dysfunction-associated steatohepatitis (MASH). These results support further assessment of treatment effectiveness across different patient subgroups.

• In September 2026, Tangram Therapeutics announced that its investigational small interfering RNA (siRNA) therapy, TGM-312, has advanced to Part B of the Phase I/II RESTORE-MASH clinical trial. The candidate targets SLC25A5 and is being evaluated for its potential to reduce liver fat accumulation and inflammation associated with MASH.

• In August 2026, Altimmune announced the launch of the Phase III PERFORMA trial to assess pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH). Pemvidutide, a dual GLP-1 and glucagon receptor agonist, is being investigated for its potential to improve liver health while promoting weight loss.

• In May 2026, Altimmune presented 48-week results from the Phase IIb IMPACT trial at EASL 2026, demonstrating improvements in lipid profiles and several cardiometabolic risk factors in patients with metabolic dysfunction-associated steatohepatitis (MASH). These findings further support the continued clinical development of the investigational therapy.

• In July 2026, The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved semaglutide (Wegovy) for treating metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis (stages F2–F3).

• In July 2026, Madrigal Pharmaceuticals announced that the United States Patent and Trademark Office (USPTO) issued three new US patents for resmetirom, strengthening the IP portfolio for REZDIFFRA. Two patents covering F2/F3 MASH are expected to be listed in the FDA Orange Book, including a patent covering weight-threshold step-down dosing in patients receiving moderate CYP2C8 inhibitors, with protection extending to 2045. A third patent covers the use of resmetirom for well-compensated cirrhosis (F4c), providing protection through 2042.

• In July 2026, Suzhou Ribo Life Science and its subsidiary Ribocure Pharmaceuticals, alongside Madrigal Pharmaceuticals, announced achieving their first candidate drug nomination milestone under their siRNA research partnership. The collaboration focuses on developing advanced RNA therapeutics for liver diseases, specifically targeting metabolic dysfunction-associated steatohepatitis (MASH). Reached just a few months into the agreement, this milestone will trigger the immediate start of IND-enabling studies to support planned clinical trials. The partnership blends Ribo’s oligonucleotide drug delivery platforms with Madrigal’s clinical expertise in MASH to deliver novel, targeted treatment options for patients worldwide.

• In June 2026, semaglutide received approval in Japan for noncirrhotic MASH with moderate-to-advanced fibrosis (F2–F3), becoming the first treatment specifically approved for MASH in Japan. In March 2026, semaglutide received a conditional marketing authorisation in the EU under the brand name KAYSHILD, for adults with non-cirrhotic MASH and moderate-to-advanced liver fibrosis (F2–F3).

• In January 2026, Sagimet Biosciences announced that it would present a poster at the 10th Annual MASH-TAG Conference highlighting anti-fibrotic effects observed in F3 and qFibrosis stage 4 MASH patients from the Phase IIb FASCINATE-2 trial evaluating denifanstat.

• According to DelveInsight’s analysts, the EU4 and the UK MASH Treatment Market Size was found to be ~USD 500 million in 2025, which is further expected to increase in the forecast period (2026–2036).

• The MASH Therapeutics Market Size in Japan was ~USD 100 million in 2025, accounting for nearly 3% of the MASH Market of the 7MM, and it is anticipated to change by 2036.

• MASH affects an estimated 1.5–6.5% of US adults, representing approximately 9–15 million individuals, with prevalence projected to increase by 63% by 2030.

• Despite its higher incidence in males, MASH is the leading cause of liver transplantation among women in the United States and the second leading cause among men.

• In 2025, EU4 and the UK accounted for ~3 million diagnosed prevalent cases of MASH, with Germany reporting the highest burden, followed by Italy, while Spain had the lowest.

• Approximately 9–30% of Japanese adults have ultrasonography-diagnosed MASLD, with at least 10–20% diagnosed with MASH.

• In Japan, MASH prevalence was substantially higher among obese MASLD patients (17.3%) than lean MASLD patients (3.8%), based on biopsy-confirmed cases.

• Key MASH 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 MASH 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 MASH market across the 7MM is projected to grow at a robust CAGR during 2026–2036, driven by the anticipated launch of innovative therapies such as efruxifermin (EFX), VK2809, efimosfermin alfa (BOS-580), icosabutate, denifanstat, and pegozafermin, among others. Furthermore, the increasing prevalence of MASH, attributed to rising obesity rates, sedentary lifestyles, unhealthy dietary habits, an aging population, and improved disease awareness and diagnosis, is expected to further accelerate market growth.

• The MASH market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage MASH pipeline products will significantly revolutionize the MASH market dynamics.

MASH Overview

Metabolic Dysfunction-Associated Steatohepatitis (MASH) is a progressive liver disease characterized by fat accumulation, inflammation, and liver cell damage. It is commonly associated with obesity, type 2 diabetes, insulin resistance, and metabolic disorders. If left untreated, MASH can progress to liver fibrosis, cirrhosis, and liver failure. Increasing disease prevalence and the development of emerging therapies are driving research and treatment advancements in the MASH market.

Get a Free sample for the MASH Market Forecast, Size & Share Analysis Report:

https://www.delveinsight.com/report-store/metabolic-dysfunction-associated-steatohepatitis-mash-market

MASH Epidemiology

The MASH epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. 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.

MASH Epidemiology Segmentation:

The MASH market report proffers epidemiological analysis for the study period 2022–2036 in the 7MM segmented into:

• Total MASH Prevalence Cases of MASLD/NAFLD

• Total Prevalent Cases of MASH/MASH

• Total Diagnosed Prevalent Cases of MASH/MASH

• Severity-specific Diagnosed Prevalent Cases of MASH/MASH

Download the report to understand which factors are driving MASH epidemiology trends @ MASH Epidemiology Forecast

MASH Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the MASH market or expected to get launched during the study period. The analysis covers MASH 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 MASH 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.

MASH 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 MASH market share @ MASH Treatment Landscape

MASH Market Drivers

• Rising Disease Prevalence: Increasing rates of obesity, type 2 diabetes, insulin resistance, and metabolic syndrome are contributing to the growing prevalence of MASH.

• Advancements in Drug Development: Emerging therapies such as efruxifermin, pegozafermin, and denifanstat are expected to expand treatment options and drive market growth.

• Improved Disease Awareness and Diagnosis: Greater awareness among healthcare professionals and advancements in diagnostic techniques are supporting early detection and treatment.

• Growing Demand for Effective Treatments: The risk of disease progression to liver fibrosis, cirrhosis, and liver failure is increasing the demand for effective therapeutic interventions.

• Increasing Research and Investment: Rising pharmaceutical investment and clinical research activities are accelerating the development of innovative MASH treatments.

MASH Market Barriers

• High Treatment Development Costs: Extensive clinical trials and regulatory requirements increase the cost and complexity of developing new MASH therapies.

• Diagnostic Challenges: The asymptomatic nature of early-stage MASH and the limitations of non-invasive diagnostic methods may delay diagnosis and treatment.

• Limited Treatment Options: Despite recent therapeutic advances, treatment options remain limited for certain patient populations and stages of disease.

• Safety and Efficacy Concerns: Potential adverse effects, long-term safety uncertainties, and the need to demonstrate sustained clinical benefits may hinder therapy adoption.

• High Treatment Costs and Access Barriers: Expensive therapies, reimbursement limitations, and disparities in healthcare access may restrict patient uptake across markets.

Scope of the MASH Market Report

• Study Period: 2022–2036

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key MASH 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 MASH 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

• MASH Therapeutic Assessment: MASH current marketed and MASH emerging therapies

• MASH Market Dynamics: MASH market drivers and MASH market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• MASH Unmet Needs, KOL’s views, Analyst’s views, MASH Market Access and Reimbursement

To know more about MASH companies working in the treatment market, visit @ MASH Clinical Trials and Therapeutic Assessment

Table of Contents

1. MASH Market Report Introduction

2. Executive Summary for MASH

3. SWOT analysis of MASH

4. MASH Patient Share (%) Overview at a Glance

5. MASH Market Overview at a Glance

6. MASH Disease Background and Overview

7. MASH Epidemiology and Patient Population

8. Country-Specific Patient Population of MASH

9. MASH Current Treatment and Medical Practices

10. MASH Unmet Needs

11. MASH Emerging Therapies

12. MASH Market Outlook

13. Country-Wise MASH Market Analysis (2022 –2036)

14. MASH Market Access and Reimbursement of Therapies

15. MASH Market Drivers

16. MASH Market Barriers

17. MASH Appendix

18. MASH Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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