Opportunities include scalable noninvasive diagnosis, therapies for compensated cirrhosis, and differentiated liver-directed, metabolic, antifibrotic, and combination regimens. Rising awareness and undertreatment support expansion across the US, Europe, and Japan.

Dublin, Sept. 10, 2026 (GLOBE NEWSWIRE) -- The "Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Market Insights, Epidemiology, and Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Insights, Epidemiology and Forecast to 2036

The metabolic dysfunction-associated steatohepatitis (MASH) market is entering a period of significant expansion across the seven major markets (7MM): the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan. Growth is being driven by the rising prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD), higher rates of obesity and type 2 diabetes, improving diagnosis, and growing demand for pharmacological therapies targeting hepatic steatosis, inflammation, and fibrosis.

The report, Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Market Insights, Epidemiology and Market Forecast - 2036, provides an in-depth assessment of historical and forecast epidemiology, current treatment practices, emerging therapies, market access, reimbursement, drug uptake, and competitive dynamics from 2022 to 2036. It also evaluates therapy-level market share, peak patient share, regional growth opportunities, and the commercial potential of MASH treatments across the 7MM.

Key MASH Market Insights

MASH affects approximately 5% of adults globally, while an estimated 10% to 30% of people with MASLD may progress to MASH.
Prevalence is estimated at slightly below 3% across the United Kingdom, France, and Germany, although diagnosis rates remain under 18%.
The United States accounted for the largest share of the 7MM MASH market in 2025, supported by its substantial at-risk population, established hepatology infrastructure, regulatory activity, and early adoption of approved treatments.
Moderate-to-advanced F2-F3 fibrosis is the principal addressable segment for currently approved therapies.
Compensated F4 cirrhosis remains a major unmet medical need and a key development opportunity for next-generation therapies.
Interest in sequential and combination treatment strategies is increasing as clinicians assess the complementary effects of incretin-based therapies and liver-directed agents.

MASH Epidemiology and Patient Burden

MASH affects an estimated 1.5% to 6.5% of adults in the United States, representing approximately 9 million to 15 million people. Prevalence is projected to rise substantially as obesity, insulin resistance, type 2 diabetes, and metabolic syndrome become more common. Although MASH incidence is higher among men, the disease is the leading cause of liver transplantation among women in the United States and the second leading cause among men.

In 2025, the EU4 and the United Kingdom accounted for approximately 3 million diagnosed prevalent cases. Germany reported the highest burden, followed by Italy, while Spain recorded the lowest among these markets. In Japan, an estimated 9% to 30% of adults have ultrasonography-diagnosed MASLD, with at least 10% to 20% diagnosed with MASH. Biopsy-confirmed prevalence is considerably higher among obese MASLD patients than among lean MASLD patients.

Underdiagnosis remains a central market barrier because MASH frequently progresses without clear symptoms. Broader adoption of validated non-invasive testing, improved fibrosis staging, and risk-based case finding could expand the diagnosed and treatment-eligible population during the forecast period.

Current MASH Treatment Landscape

MASH management continues to incorporate weight loss, calorie-controlled nutrition, physical activity, and treatment of metabolic comorbidities. Bariatric surgery may be considered for eligible patients, while multidisciplinary management can involve hepatologists, endocrinologists, cardiologists, and dietitians.

The treatment paradigm changed in March 2024 when the US Food and Drug Administration approved resmetirom (REZDIFFRA) for adults with noncirrhotic MASH and moderate-to-advanced F2-F3 fibrosis, in conjunction with diet and exercise. Resmetirom is a once-daily oral, liver-directed thyroid hormone receptor beta agonist developed by Madrigal Pharmaceuticals. The therapy is also under investigation in Phase III development for patients with MASH-related compensated cirrhosis.

Semaglutide, marketed as WEGOVY and KAYSHILD, has further expanded the treatment landscape. The once-weekly GLP-1 receptor agonist improves weight and metabolic parameters while reducing hepatic steatosis and liver inflammation. Semaglutide was approved in the United States in August 2025 for adults with noncirrhotic MASH and F2-F3 fibrosis. It subsequently received conditional marketing authorization in the European Union in March 2026, approval in Japan in June 2026, and authorization from the UK Medicines and Healthcare products Regulatory Agency in July 2026 for eligible patients with moderate-to-advanced fibrosis.

MASH Pipeline and Competitive Analysis

The MASH drug pipeline includes FGF21 analogues, thyroid hormone receptor beta agonists, PPAR modulators, incretin-based therapies, and other metabolic and antifibrotic candidates. Several programs are advancing through Phase III trials, including studies in compensated F4 MASH, where treatment options remain limited.

Efruxifermin is a long-acting FGF21 analogue being developed for pre-cirrhotic MASH with F2-F3 fibrosis and compensated F4 disease. The Phase III SYNCHRONY program includes studies in biopsy-confirmed noncirrhotic MASH, compensated cirrhosis, and broader real-world MASLD and MASH populations. Novo Nordisk announced its approximately USD 4.7 billion acquisition of Akero Therapeutics in October 2025, adding efruxifermin to its MASH portfolio.

Efimosfermin alfa is a once-monthly, long-acting FGF21 analogue in Phase III development for F2-F3 MASH and compensated F4 cirrhosis. GSK acquired the asset from Boston Pharmaceuticals in July 2025. The ZENITH studies are evaluating patients with F2-F3 disease, while the NEBULA trials focus on compensated F4 MASH. In April 2026, efimosfermin received FDA Breakthrough Therapy Designation and European Medicines Agency PRIME designation following Phase II findings demonstrating improvement in liver fibrosis.

Leading companies shaping the MASH competitive landscape include Madrigal Pharmaceuticals, Novo Nordisk, Eli Lilly, Akero Therapeutics, Amgen, Viking Therapeutics, Sagimet Biosciences, and GSK.

Drug Class and Uptake Outlook

FGF21 analogues and metabolic-fibrosis modulators: Key candidates include efruxifermin and efimosfermin alfa, which are being evaluated for effects on hepatic lipid metabolism, insulin sensitivity, inflammation, and fibrosis.
THR-beta agonists: This class includes approved resmetirom and investigational candidates such as Viking Therapeutics' VK2809.
Incretin-based therapies: Semaglutide and tirzepatide target metabolic dysfunction and weight reduction, with potential downstream benefits for hepatic steatosis and MASH activity.
Other liver-directed therapies: Emerging programs target lipotoxicity, inflammation, fibrosis, and additional pathways involved in disease progression.

Resmetirom and semaglutide are expected to maintain strong uptake because of their regulatory approvals, clinical evidence, and early commercial positioning. Among emerging therapies, efruxifermin and efimosfermin alfa may achieve significant adoption if ongoing Phase III trials confirm meaningful fibrosis improvement and acceptable safety. Tirzepatide and other metabolic therapies are expected to gain adoption as evidence, physician awareness, reimbursement, and regulatory coverage expand.

MASH Market Drivers and Unmet Needs

The principal MASH market drivers include a growing treatment-eligible population, improving awareness, advances in non-invasive diagnosis, and the transition from lifestyle-based care to targeted pharmacotherapy. Market segmentation is expected to become increasingly important by fibrosis stage, metabolic comorbidity, mechanism of action, route of administration, dosing frequency, and suitability for combination treatment.

Important unmet needs include limited treatment options across early and advanced fibrosis stages, persistent underdiagnosis, insufficient use of scalable non-invasive tests, and the need for therapies that address the multifactorial drivers of MASH. Additional evidence is also required to define optimal treatment sequencing, combination strategies, long-term clinical outcomes, and management of compensated cirrhosis.

Market Access, Pricing, and Reimbursement

The report evaluates country-level access and reimbursement conditions, cost-effectiveness, patient affordability programs, out-of-pocket expenses, and coverage through public and private prescription drug programs. It also assesses MASH therapy pricing, relevant analogues for emerging treatments, and the influence of pricing on access, adherence, and long-term uptake.

Regional dynamics are expected to remain differentiated. The United States leads in commercial potential, clinical development, and regulatory activity, while Europe and Japan are progressing toward broader adoption of MASH-specific therapies. Reimbursement requirements, diagnostic pathways, fibrosis confirmation, and treatment eligibility criteria will materially influence regional uptake.

Report Scope and Strategic Value

The MASH market report combines epidemiology-based bottom-up forecasting with competitive intelligence, clinical development analysis, SWOT assessment, conjoint analysis, and insights from key opinion leaders. Primary research included engagement with specialists across the 7MM, including experts affiliated with the University of Mississippi Medical Center, the University of Bologna, and Teikyo University School of Medicine.

The analysis ranks emerging therapies using clinical efficacy, safety, tolerability, route and frequency of administration, market-entry timing, probability of success, and addressable patient population. It also examines patient journeys, treatment preferences, prescription patterns, therapy switching, access barriers, and physician adoption.

Eleven-year MASH market forecast through 2036
Diagnosed patient population and epidemiology forecasts
Current and emerging MASH therapy profiles
Drug uptake and peak patient share analysis
Market size, competitive share, and growth projections
Pricing, reimbursement, and analogue assessment
Clinical development and regulatory milestone analysis
MASH treatment-addressable market evaluation
SWOT, conjoint, and market attractiveness analyses

MASH Market Outlook to 2036

The MASH market is expected to sustain strong growth through 2036 as diagnosis improves and disease-modifying therapies become available across additional fibrosis stages. Resmetirom and semaglutide have established the initial commercial foundation, while Phase III candidates could intensify competition and broaden treatment options for patients with F2-F3 fibrosis and compensated F4 disease.

Companies that demonstrate durable fibrosis improvement, favorable safety, convenient administration, access to accurately identified patients, and compelling pharmacoeconomic value will be best positioned in the evolving MASH therapeutics market. The report supports pharmaceutical companies, biotechnology developers, investors, healthcare organizations, and market-access teams seeking to evaluate MASH market opportunities, prioritize pipelines, and develop evidence-based commercialization strategies across the 7MM.

Key Topics Covered:

1. Key Insights

2. Report Introduction

3. Executive Summary of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

4. Key Events
4.1. Upcoming Key Catalysts
4.2. Key Transactions And Collaborations
4.3. News Flow

5. Epidemiology and Market Forecast Methodology

6. Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Overview at a Glance
6.1. Emerging Landscape Analysis (By Phase, Molecule Type, and RoA)
6.2. Market Share (%) Distribution of MASH by Therapies in the 7MM, in 2025
6.3. Market Share (%) Distribution of MASH by Therapies in the 7MM, in 2036

7. Disease Background and Overview of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
7.1. Introduction
7.2. Causes and Risk Factors
7.3. Signs and Symptoms
7.4. Pathophysiology
7.5. Biomarkers
7.6. Diagnosis
7.7. Diagnostic Algorithm
7.7.1. Differential Diagnosis
7.7.2. Diagnosis Guidelines

8. Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
8.1. Treatment Algorithm
8.2. Treatment Guidelines

9. Epidemiology and Patient Population of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. MASLD Prevalent Cases in the 7MM
9.4. MASH Prevalent Cases in the 7MM
9.5. The United States
9.5.1. MASLD Prevalent Cases in the United States
9.5.2. MASH Prevalent Cases in the United States
9.5.3. MASH Diagnosed Prevalent Cases in the United States
9.5.4. MASH Diagnosed Prevalent Cases by Severity in the United States
9.5.5. MASH Diagnosed Prevalent Cases by Gender in the United States
9.5.6. MASH Treated Cases in the United States
9.6. EU4 and the UK
9.6.1. MASLD Prevalent Cases in EU4 and the UK
9.6.2. MASH Prevalent Cases in EU4 and the UK
9.6.3. MASH Diagnosed Prevalent Cases in EU4 and the UK
9.6.4. MASH Diagnosed Prevalent Cases by Severity in EU4 and the UK
9.6.5. MASH Diagnosed Prevalent Cases by Gender in EU4 and the UK
9.6.6. MASH Treated Cases in EU4 and the UK
9.7. Japan
9.7.1. MASLD Prevalent Cases in Japan
9.7.2. MASH Prevalent Cases in Japan
9.7.3. MASH Diagnosed Prevalent Cases in Japan
9.7.4. MASH Diagnosed Prevalent Cases by Severity in Japan
9.7.5. MASH Diagnosed Prevalent Cases by Gender in Japan
9.7.6. MASH Treated Cases in Japan

10. Patient Journey of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

11. Marketed Drugs of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
11.1. Competitive Landscape of Marketed Drugs
11.2. Resmetirom (REZDIFFRA): Madrigal Pharmaceuticals
11.2.1. Drug Description
11.2.2. Regulatory Milestones
11.2.2. Other Developmental Activities
11.2.3. Clinical Development
11.2.3.1. Clinical Trials Information
11.2.4. Safety and Efficacy
11.2.5. Analyst's Views
11.3. Semaglutide (WEGOVY/KAYSHILD): Novo Nordisk
11.3.1. Drug Description
11.3.2. Regulatory Milestones
11.3.2. Other Developmental Activities
11.3.3. Clinical Development
11.3.3.1. Clinical Trials Information
11.3.4. Safety and Efficacy
11.3.5. Analyst's Views

12. Emerging Drugs of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
12.1. Competitive Landscape of Emerging Drugs
12.2. Efruxifermin: Akero Therapeutics (acquired by Novo Nordisk)
12.2.1. Drug Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.3.1. Clinical Trials Information
12.2.4. Safety and Efficacy
12.2.5. Analyst's Views
12.3. Efimosfermin alfa: GSK
12.3.1. Drug Description
12.3.2. Other Developmental Activities
12.3.3. Clinical Development
12.3.3.1. Clinical Trials Information
12.3.4. Safety and Efficacy
12.3.5. Analyst's Views
12.4. VK2809: Viking Therapeutics
12.4.1. Drug Description
12.4.2. Other Developmental Activities
12.4.3. Clinical Development
12.4.3.1. Clinical Trials Information
12.4.4. Safety and Efficacy
12.4.5. Analyst's Views

Note: List to be continued in the report

13. Metabolic Dysfunction-Associated Steatohepatitis (MASH): 7MM Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Conjoint Analysis
13.4. Key Market Forecast Assumptions
13.4.1. Cost Assumptions
13.4.2. Pricing Trends
13.4.3. Analogue Assessment
13.4.4. Launch Year and Therapy Uptakes
13.5. Total Market Size of MASH in the 7MM
13.6. Total Market Size of MASH by Therapies in the 7MM
13.7. The United States
13.7.1. Total Market Size of MASH in the United States
13.7.2. Total Market Size of MASH by Therapies in the United States
13.8. EU4 and the UK
13.8.1. Total Market Size of MASH in EU4 and the UK
13.8.2. Total Market Size of MASH by Therapies in EU4 and the UK

13.9. Japan
13.9.1. Total Market Size of MASH in Japan
13.9.2. Total Market Size of MASH by Therapies in Japan

14. Unmet Needs of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

15. SWOT Analysis of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

16. KOL Views of Metabolic Dysfunction-Associated Steatohepatitis (MASH)
16.1. Experts/KOL Interview Highlights

17. Market Access and Reimbursement
17.1. The United States
17.2. EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. The United Kingdom
17.3. Japan
17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
17.5. Market Access and Reimbursement of MASH Therapies

18. Appendix
18.1. Bibliography
18.2. Report Methodology

19. Analyst's Capabilities

20. Disclaimer

21. About the Publisher

List of Tables
Table 1: Summary of MASH Market and Epidemiology [2022-2036]
Table 2: Key Events
Table 3: Treatment Algorithm of MASH
Table 4: Total Diagnosed Prevalent Cases of MASH in the 7MM [2022-2036]
Table 5: Total Prevalent Cases of MASLD/NAFLD in the US [2022-2036]
Table 6: Total Prevalent Cases of MASH/NASH in the US [2022-2036]
Table 7: Total Diagnosed Prevalent Cases of MASH/NASH in the US [2022-2036]
Table 8: Severity-specific Diagnosed Prevalent Cases of MASH/NASH in the US [2022-2036]
Table 9: Total Prevalent Cases of MASLD/NAFLD in EU4 and the UK [2022-2036]
Table 10: Total Prevalent Cases of MASH/NASH in EU4 and the UK [2022-2036]
Table 11: Total Diagnosed Prevalent Cases of MASH/NASH in EU4 and the UK [2022-2036]
Table 12: Severity-specific Diagnosed Prevalent Cases of MASH/NASH in EU4 and the UK [2022-2036]
Table 13: Total Prevalent Cases of MASLD/NAFLD in Japan [2022-2036]
Table 14: Total Prevalent Cases of MASH/NASH in Japan [2022-2036]
Table 15: Total Diagnosed Prevalent Cases of MASH/NASH in Japan [2022-2036]
Table 16: Severity-specific Diagnosed Prevalent Cases of MASH/NASH in Japan [2022-2036]
Table 17: REZDIFFRA, Clinical Trial Description, 2025
Table 18: Comparison of Emerging Drugs
Table 19: Efruxifermin (EFX), Clinical Trial Description, 2025
Table 20: Denifanstat, Clinical Trial Description, 2025
Table 21: Survodutide, Clinical Trial Description, 2025
Table 22: Pegozafermin, Clinical Trial Description, 2025
Table 23: Lanifibranor, Clinical Trial Description, 2025
Table 24: Aramchol, Clinical Trial Description, 2025
Table 25: Semaglutide, Clinical Trial Description, 2025
Table 26: VK2809, Clinical Trial Description, 2025
Table 27: Rencofilstat, Clinical Trial Description, 2025
Table 28: Ervogastat + clesacostat, Clinical Trial Description, 2025
Table 29: HTD1801, Clinical Trial Description, 2025
Table 30: BOS-580, Clinical Trial Description, 2025
Table 31: HU6, Clinical Trial Description, 2025
Table 32: LPCN 1144, Clinical Trial Description, 2025
Table 33: ALG-055009, Clinical Trial Description, 2025
Table 34: MN-001, Clinical Trial Description, 2025
Table 35: Icosabutate, Clinical Trial Description, 2025
Table 36: Tirzepatide, Clinical Trial Description, 2025
Table 37: Key Market Forecast Assumption of MASH in the US
Table 38: Key Market Forecast Assumption of MASH in EU4 and the UK
Table 39: Key Market Forecast Assumption of MASH in Japan
Table 40: Total Market Size of MASH in the 7MM, in USD million [2022-2036]
Table 41: Market Size of MASH by Therapies in the 7MM, in USD million [2022-2036]
Table 42: Total Market Size of MASH in the US, in USD million [2022-2036]
Table 43: Market Size of MASH by Therapies in the US, in USD million [2022-2036]
Table 44: Total Market Size of MASH in EU4 and the UK, in USD million [2022-2036]
Table 45: Market Size of MASH by Therapies in EU4 and the UK, in USD million [2022-2036]
Table 46: Total Market Size of MASH in Japan, in USD million [2022-2036]

Table 47: Market Size of MASH by Therapies in Japan, in USD million [2022-2036]

List of Figures
Figure 1: Total Diagnosed Prevalent Cases of MASH in the 7MM [2022-2036]
Figure 2: Total Prevalent Cases of MASLD/NAFLD in the US [2022-2036]
Figure 3: Total Prevalent Cases of MASH/NASH in the US [2022-2036]
Figure 4: Total Diagnosed Prevalent Cases of MASH/NASH in the US [2022-2036]
Figure 5: Severity-specific Diagnosed Prevalent Cases of MASH/NASH in the US [2022-2036]
Figure 6: Total Prevalent Cases of MASLD/NAFLD in EU4 and the UK [2022-2036]
Figure 7: Total Prevalent Cases of MASH/NASH in EU4 and the UK [2022-2036]
Figure 8: Total Diagnosed Prevalent Cases of MASH/NASH in EU4 and the UK [2022-2036]
Figure 9: Severity-specific Diagnosed Prevalent Cases of MASH/NASH in EU4 and the UK [2022-2036]
Figure 10: Total Prevalent Cases of MASLD/NAFLD in Japan [2022-2036]
Figure 11: Total Prevalent Cases of MASH/NASH in Japan [2022-2036]
Figure 12: Total Diagnosed Prevalent Cases of MASH/NASH in Japan [2022-2036]
Figure 13: Severity-specific Diagnosed Prevalent Cases of MASH/NASH in Japan [2022-2036]
Figure 14: Patient Journey
Figure 15: Total Market Size of MASH in the 7MM, in USD million [2022-2036]
Figure 16: Market Size of MASH by Therapies in the 7MM, in USD million [2022-2036]
Figure 17: Total Market Size of MASH in the US, in USD million [2022-2036]
Figure 18: Market Size of MASH by Therapies in the US, in USD million [2022-2036]
Figure 19: Total Market Size of MASH in EU4 and the UK, in USD million [2022-2036]
Figure 20: Market Size of MASH by Therapies in EU4 and the UK, in USD million [2022-2036]
Figure 21: Total Market Size of MASH in Japan, in USD million [2022-2036]
Figure 22: Market Size of MASH by Therapies in Japan, in USD million [2022-2036]
Figure 23: Unmet Needs
Figure 24: SWOT Analysis
Figure 25: Health Technology Assessment
Figure 26: Reimbursement Process in the US
Figure 27: Reimbursement Process in Germany
Figure 28: Reimbursement Process in France
Figure 29: Reimbursement Process in Italy
Figure 30: Reimbursement Process in Spain
Figure 31: Reimbursement Process in the UK

Figure 32: Reimbursement Process in Japan

A selection of companies mentioned in this report includes, but is not limited to:

Madrigal Pharmaceuticals
Novo Nordisk
Eli Lilly
Akero Therapeutics
Amgen
Viking Therapeutics
GSK

For more information about this report visit https://www.researchandmarkets.com/r/ohq1vn

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