대사 기능 장애 관련 지방간염(MASH) : 시장 인사이트, 역학 및 시장 예측(2036년)

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Insights and Trends

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) market is witnessing strong growth across the leading markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, driven by the rising prevalence of metabolic dysfunction-associated liver disease (MASLD), increasing disease awareness and diagnosis, and the growing demand for effective pharmacological therapies targeting liver inflammation and fibrosis.
• MASH affects approximately 5% of adults globally, with an estimated 10-30% of individuals with MASLD progressing to MASH.
• MASH prevalence is estimated at just under 3% of the population across the United Kingdom, France, and Germany, while diagnosis rates remain below 18%.
• MASH exhibits a distinct sex-based disparity, with males showing a higher propensity for disease progression than females.
• The treatment of MASH primarily involves lifestyle modification, metabolic risk-factor management, and disease-directed therapies such as resmetirom (REZDIFFRA) and semaglutide (WEGOVY) for eligible patients with noncirrhotic MASH and F2-F3 fibrosis.
• F2-F3 fibrosis has emerged as the key treatable segment for currently approved MASH therapies, while F4/compensated cirrhosis remains a major unmet need, creating substantial opportunity for next-generation therapies.
• The MASH treatment landscape is rapidly expanding, with approved therapies complemented by a broad pipeline of FGF21 analogs, THR-B agonists, PPAR modulators, and incretin-based therapies. Key emerging assets include efruxifermin and efimosfermin alfa, with several candidates advancing into Phase III and expanding development into compensated F4 MASH, where significant unmet need remains.
• The complementary effects of incretin-based therapies on weight and cardiometabolic risk and liver-directed agents on steatosis and fibrosis are driving interest in sequential or combination treatment strategies, although prospective evidence remains limited.

DelveInsight's 'Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of MASH, historical and forecasted epidemiology, as well as the MASH market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The MASH market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates MASH patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in MASH and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market

• Rising MASH prevalence and at-risk population

The increasing prevalence of MASH, driven by the growing burden of obesity, type 2 diabetes, and metabolic syndrome, is expanding the addressable patient population and supporting market growth across major markets.

• Expanding MASH treatment landscape

The MASH market is transitioning from a largely lifestyle-based treatment paradigm toward pharmacological management, following the approval of resmetirom (REZDIFFRA) and the emergence of additional late-stage candidates, including semaglutide, alongside several investigational therapies targeting different stages and mechanisms of disease.

• Growing Opportunities in targeted MASH therapies

The increasing understanding of hepatic inflammation, lipotoxicity, and fibrosis is creating opportunities for therapies targeting the underlying drivers of MASH, with the emergence of liver-directed and metabolic therapies broadening treatment options beyond lifestyle modification.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Understanding and Treatment Algorithm

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Overview and Diagnosis

Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH, is a progressive form of fatty liver disease characterized by excessive fat accumulation (steatosis), liver inflammation, and hepatocellular injury. MASH is often asymptomatic, although some patients may experience fatigue or pain in the upper-right abdomen; symptoms may become more apparent as liver damage progresses. Persistent inflammation can lead to fibrosis and cirrhosis, resulting in irreversible liver damage and substantially increasing the risk of hepatocellular carcinoma (HCC). Advanced MASH may also cause serious complications, including ascites, hepatic encephalopathy, and variceal bleeding, and is a leading cause of liver transplantation.

MASH is frequently detected incidentally during routine blood tests or screening for other conditions, with elevated liver enzymes serving as an early indicator. Although routine screening for MASLD/MASH is not currently recommended, individuals at risk may undergo blood tests, BMI assessment, ultrasound, CT scan, and non-invasive elastography to evaluate liver fat and fibrosis. Diagnosis also requires excluding other causes of hepatic steatosis, particularly alcohol-associated liver disease, through clinical assessment and alcohol-use history.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment

The first-line management of MASH focuses on lifestyle modification and weight loss, including a healthy, calorie-controlled diet and increased physical activity. A 3%-5% reduction in body weight may improve hepatic steatosis, while weight loss of >10% may provide greater benefits for liver fibrosis. Regular moderate-intensity exercise may also improve MASH outcomes, while bariatric surgery may be considered for eligible patients. In March 2024, the FDA approved resmetirom (REZDIFFRA) for adults with noncirrhotic MASH/NASH and moderate-to-advanced fibrosis (F2-F3), in conjunction with diet and exercise, making it the first FDA-approved pharmacologic treatment for MASH. Management may involve a multidisciplinary care team, including hepatologists, dietitians, cardiologists, and endocrinologists, depending on patients' comorbidities and disease severity.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Unmet Needs

The section "unmet needs of MASH" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Limited treatment options across early and advanced MASH stages

2. High disease underdiagnosis due to asymptomatic progression and diagnostic barriers

3. Limited adoption of scalable non-invasive tests for early and accurate diagnosis

4. Need for therapies addressing the multifactorial drivers of MASH, including lipotoxicity, inflammation, and fibrosis, and others.....

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Epidemiology

Key Findings from Metabolic Dysfunction-Associated Steatohepatitis (MASH) Epidemiological Analysis and Forecast

• 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.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drug Chapters & Competitive Analysis

The MASH drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the MASH treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the MASH therapeutics market.

Approved Therapies for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Resmetirom (REZDIFFRA): Madrigal Pharmaceuticals

Resmetirom is a once-daily oral, liver-directed thyroid hormone receptor beta (THR-B) agonist designed to selectively target the liver and reduce hepatic steatosis, inflammation, and fibrosis in patients with MASH. In March 2024, it became the first FDA-approved therapy for noncirrhotic MASH with moderate-to-advanced liver fibrosis (F2-F3), to be used in conjunction with diet and exercise. The drug is also being investigated in a Phase III clinical trial for MASH with compensated cirrhosis (F4c). In Q2 2026, REZDIFFRA generated net sales of USD 364.3 million, representing 71% year-over-year growth, reflecting strong commercial uptake since its launch.

Semaglutide (WEGOVY/KAYSHILD): Novo Nordisk

Semaglutide is a once-weekly SC GLP-1 receptor agonist that promotes weight loss and improves metabolic parameters, with benefits in MASH through reductions in body weight, hepatic steatosis, and liver inflammation. In August 2025, semaglutide became the first GLP-1 treatment approved for MASH in the US, for adults with noncirrhotic MASH and moderate-to-advanced liver fibrosis (F2-F3). In Japan, with its latest approval, semaglutide became the first treatment approved specifically for MASH, further establishing semaglutide as an important therapy in the Japanese MASH treatment landscape.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Pipeline Analysis

Efruxifermin: Akero Therapeutics (acquired by Novo Nordisk)

Efruxifermin is a long-acting FGF21 analogue designed to improve hepatic steatosis, lipid metabolism, insulin sensitivity, and liver fibrosis in patients with MASH. The once-weekly SC therapy is being developed across multiple stages of MASH, including pre-cirrhotic MASH with F2-F3 fibrosis and F4.

The drug is currently being investigated in Phase III through the ongoing SYNCHRONY program, which includes SYNCHRONY Histology in patients with biopsy-confirmed noncirrhotic MASH and F2-F3 fibrosis, SYNCHRONY Outcomes in patients with MASH-related compensated cirrhosis (F4), and SYNCHRONY Real-World in patients with MASLD/MASH across F1-F4 fibrosis. Phase III safety and tolerability results from SYNCHRONY Real-World are expected in Q4 2026.

In October 2025, Novo Nordisk announced its acquisition of Akero Therapeutics for approximately USD 4.7 billion, bringing efruxifermin into its MASH portfolio. The Phase III SYNCHRONY program is ongoing, building on Phase IIb results showing significant fibrosis improvement in both F2-F3 and F4 MASH populations.

Efimosfermin alfa: GSK

Efimosfermin alfa is a once-monthly SC long-acting FGF21 analogue designed to regulate key metabolic pathways, reduce liver fat and inflammation, and improve liver fibrosis in patients with MASH. The drug is acquired by GSK from Boston Pharmaceuticals in July 2025, bringing the asset into its liver disease portfolio. Further, it is currently in Phase III, with the ZENITH program evaluating patients with F2-F3 MASH; ZENITH-1 and ZENITH-2 are actively recruiting. GSK is also evaluating efimosfermin in Phase III NEBULA trials in compensated F4 MASH cirrhosis.

In April 2026, efimosfermin received FDA Breakthrough Therapy Designation and EMA PRIME designation for MASH, following Phase II data showing improvement in liver fibrosis.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Key Players, Market Leaders and Emerging Companies

• Madrigal Pharmaceuticals
• Novo Nordisk
• Eli Lilly
• Akero Therapeutics
• Amgen
• Viking Therapeutics
• Sagimet Biosciences
• GSK, and others

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drug Updates

• In July 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved semaglutide (WEGOVY) for the treatment of MASH in adults with moderate-to-advanced liver fibrosis (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 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).

Drug Class Insights

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Outlook

The MASH market is undergoing a major transformation from lifestyle modification and off-label/metabolic management toward disease-directed pharmacotherapy targeting hepatic steatosis, inflammation, and fibrosis. Historically, treatment relied primarily on weight loss through diet and exercise, management of metabolic comorbidities, and off-label use of agents targeting obesity or T2D, with limited options specifically addressing the underlying liver pathology. The treatment landscape has now shifted with the approval of resmetirom (REZDIFFRA) in March 2024 and semaglutide (WEGOVY/KAYSHILD) in August 2025 for adults with noncirrhotic MASH and moderate-to-advanced fibrosis (F2-F3), establishing the first disease-specific pharmacological options in the US. The emergence of these therapies has created a more competitive treatment environment, while a broad pipeline targeting FGF21 agonism, thyroid hormone receptor-B activation, and incretin-based mechanisms continues to advance, with key assets such as efruxifermin, efimosfermin alfa, and others in Phase III development and several programs expanding into F4.

Overall, increasing disease awareness, rising prevalence of obesity and T2D, improvements in non-invasive liver disease diagnosis and staging, and the emergence of multiple disease-modifying therapies are expected to drive continued MASH market growth, with increasing segmentation by fibrosis stage, treatment mechanism, metabolic comorbidity, and route/frequency of administration, creating opportunities for established pharmaceutical companies and emerging biotechnology innovators.

• In 2025, the US accounted for the largest share of the MASH market among the 7MM, supported by a large at-risk population, high disease awareness, established hepatology infrastructure, and early adoption of newly approved therapies.
• The MASH market is transitioning from predominantly lifestyle and metabolic management toward targeted disease-modifying treatment, with resmetirom and semaglutide establishing the initial commercial market and emerging therapies such as efruxifermin, efimosfermin alfa, and others expected to intensify competition through differentiated mechanisms and potential benefits across fibrosis stages.
• Regional market dynamics show the US leading in clinical development, regulatory activity, and commercial potential, while Europe and Japan are also progressing toward broader adoption of MASH-specific therapies.

The MASH market comprises FGF21 agonists and metabolic/fibrosis-modulating therapies, thyroid hormone receptor-B (THR-B) agonists, incretin-based therapies, and other liver-directed metabolic and anti-fibrotic therapies, with multiple drug classes targeting hepatic steatosis, inflammation, metabolic dysfunction, and fibrosis associated with MASH.

• FGF21 agonists and metabolic/fibrosis-modulating therapies: These therapies are designed to improve hepatic lipid metabolism, insulin sensitivity, steatosis, inflammation, and fibrosis by mimicking or enhancing FGF21 signaling. Representative therapies include efruxifermin by Novo Nordisk and efimosfermin alfa by GSK.
• THR-B agonists: These therapies selectively activate hepatic THR-B to enhance lipid metabolism, reduce hepatic fat accumulation, and potentially improve liver inflammation and fibrosis. Key therapies include resmetirom (REZDIFFRA) by Madrigal Pharmaceuticals and investigational VK2809 by Viking Therapeutics.
• Incretin-based therapies: These therapies target GLP-1 and/or GIP pathways to promote weight loss and improve insulin sensitivity and metabolic dysfunction, with downstream reductions in hepatic steatosis and MASH activity. Key therapies include semaglutide (WEGOVY/KAYSHILD) by Novo Nordisk and tirzepatide by Eli Lilly.

Lifestyle modification, metabolic risk-factor management, and approved liver-directed therapies currently form the foundation of the MASH treatment landscape, while FGF21 agonists, THR-B agonists, incretin-based therapies, and others are driving future innovation aimed at addressing the underlying metabolic, inflammatory, and fibrotic mechanisms of disease.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the MASH market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The uptake of therapies in MASH is expected to vary across approved liver-directed treatments, metabolic therapies, and emerging disease-modifying agents. Existing therapies such as resmetirom (REZDIFFRA) and semaglutide (WEGOVY/KAYSHILD) are expected to account for the highest uptake, supported by established clinical evidence and regulatory approvals. Among emerging therapies, efruxifermin and efimosfermin alfa are anticipated to witness relatively stronger future uptake owing to their potential to improve hepatic steatosis and fibrosis and their ongoing Phase III development, while tirzepatide and other targeted metabolic therapies are expected to gain gradual adoption as clinical evidence, regulatory approvals, and physician awareness continue to expand.

Market Access and Reimbursement of MASH

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Metabolic Dysfunction-Associated Steatohepatitis (MASH) Therapies Price Scenario & Trends

Pricing and analogue assessment of MASH therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

To keep up with MASH market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the MASH emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in MASH, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of Mississippi Medical Center, University of Bologna, and Teikyo University School of Medicine, etc. were contacted. Their opinions help understand and validate current and emerging MASH therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in MASH.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Metabolic Dysfunction-Associated Steatohepatitis (MASH), strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of MASH, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the MASH market, historical and forecasted market size, market share by therapies, detailed assumptions, and the rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM MASH market.

Report Insights

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patient Population Forecast
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Therapeutics Market Size
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Pipeline Analysis
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Size and Trends
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Opportunity (Current and Forecasted)

Report Key Strengths

• Epidemiology-based (Epi-based) Bottom-up Forecasting
• Artificial Intelligence (AI)-enabled Market Research Report
• 11-year Forecast
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Outlook (North America, Europe, Asia-Pacific)
• Patient Burden Trends (By Geography)
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Treatment Addressable Market (TAM)
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Competitive Landscape
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Major Companies Insights
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Price Trends and Analogue Assessment
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Therapies Drug Adoption/Uptake
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Therapies Peak Patient Share Analysis

Report Assessment

• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Current Treatment Practices
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Unmet Needs
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Clinical Development Analysis
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Emerging Drugs Product Profiles
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Market Attractiveness
• Metabolic Dysfunction-Associated Steatohepatitis (MASH) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

• What was the Metabolic Dysfunction-Associated Steatohepatitis (MASH) market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
• What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
• What can be the future treatment paradigm of Metabolic Dysfunction-Associated Steatohepatitis (MASH)?
• What are the disease risks, burdens, and unmet needs of Metabolic Dysfunction-Associated Steatohepatitis (MASH)? What will be the growth opportunities across the 7MM concerning the patient population with Metabolic Dysfunction-Associated Steatohepatitis (MASH)?
• Who is the major future competitor in the market, and how will the competitors affect their market share?
• What are the current options for the treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)? What are the current guidelines for treating Metabolic Dysfunction-Associated Steatohepatitis (MASH) in the US, Europe, and Japan?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Metabolic Dysfunction-Associated Steatohepatitis (MASH) market.
• Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
• This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

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

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. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight