PUBLISHER: DelveInsight | PRODUCT CODE: 2118847
PUBLISHER: DelveInsight | PRODUCT CODE: 2118847
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
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.
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.
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) 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.
Key Findings from Metabolic Dysfunction-Associated Steatohepatitis (MASH) Epidemiological Analysis and Forecast
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
Metabolic Dysfunction-Associated Steatohepatitis (MASH) Drug Updates
Drug Class Insights
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.
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.
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.
Market Insights
13..9. Japan