PUBLISHER: DelveInsight | PRODUCT CODE: 2018986
PUBLISHER: DelveInsight | PRODUCT CODE: 2018986
DelveInsight's "MASH Treatment 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, France, Italy, and Spain) and the United Kingdom, and Japan.
The MASH Treatment Market Report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MASH market size from 2022 to 2036. The report also covers MASH treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
MASH Treatment Market: Understanding and Algorithm
MASH, previously known as NASH, is a severe and progressive form of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD). It is characterized by liver inflammation and damage along with excess fat accumulation. While MASLD results from fat buildup in the liver, MASH occurs when this buildup triggers inflammation and tissue damage, potentially leading to liver scarring and cirrhosis-a life-threatening condition.
Despite its seriousness, MASH often presents without noticeable symptoms. When symptoms do appear, they may include fatigue and mild pain in the upper right abdomen. As the disease advances to cirrhosis, patients may experience easy bleeding and bruising, jaundice, fluid retention, loss of appetite, nausea, leg swelling, confusion, drowsiness, slurred speech, and spider-like blood vessels on the skin. MASH is most commonly associated with obesity, diabetes, high cholesterol, high triglycerides, poor diet, metabolic syndrome, polycystic ovary syndrome, sleep apnea, and hypothyroidism. Typically, MASH remain asymptomatic in the early stages, but as liver damage progresses, symptoms may become more apparent.
MASH Diagnosis
The MASH Diagnosis is confirmed through a combination of clinical evaluation and specialized tests. Liver biopsy remains the gold standard for diagnosing MASH, providing critical information on liver inflammation, steatosis, and fibrosis staging. Non-invasive tools, such as MR-EFF and FibroScan, are gaining traction for assessing fat content and liver stiffness, offering alternatives to biopsy with reduced risk. Blood tests, including liver enzyme levels, help identify potential liver dysfunction, while imaging techniques like MRI and ultrasound are used to detect hepatic steatosis. In cases where biopsy is not feasible, these methods assist in estimating the severity of liver damage.
MASH Treatment
The MASH Treatment revolves around lifestyle modifications aimed at reducing liver fat and preventing disease progression. Weight loss of 5-10% has been shown to improve both biochemical markers and liver histology, with a combination of calorie reduction, exercise, and a balanced diet as key components. In particular, eliminating high fructose corn syrup and increasing omega-3 fatty acids in the diet have demonstrated benefits. The inclusion of one to two cups of caffeinated drip coffee daily may also reduce liver fibrosis.
Antioxidants like vitamin E can offer modest benefits in non-diabetic patients, though caution is advised with high doses due to the potential risk of increased all-cause mortality. For those with diabetes, the recommended dose of vitamin E should not exceed 400 units per day. Thiazolidinediones may improve insulin sensitivity but have side effects such as weight gain and cardiovascular risks, limiting their use. For patients with advanced liver disease and decompensated cirrhosis, liver transplantation remains the last resort, though there is a risk of NAFLD recurrence post-transplant.
As the market is derived using a patient-based model, the MASH epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total MASH Prevalence Cases of MASLD/NAFLD, total prevalent cases of MASH/NASH, total diagnosed prevalent cases of MASH/NASH, and severity-specific diagnosed prevalent cases of MASH/NASH in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.
Recent Developments and MASH Clinical Trials
MASH Drugs Market Chapters
The drug chapter segment of the MASH drugs market report encloses a detailed analysis of MASH-marketed drugs and mid to late-stage (Phase III and Phase II) MASH Pipeline Drugs analysis. It also helps understand the MASH Clinical Trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
MASH Marketed Drugs
REZDIFFRA (resmetirom), a Thyroid Hormone Receptor-beta (THR-B) agonist, is approved for treating adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2-F3), in conjunction with diet and exercise. It received accelerated approval due to improvements in MASH and fibrosis.
In March 2024, the US FDA approved REZDIFFRA for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3).
Madrigal Pharmaceuticals plans a country-by-country launch in Europe, starting in Germany in the second half of 2025, pending EMA approval, making it the first therapy for MASH liver fibrosis in the region. REZDIFFRA's recommended dosage varies based on body weight, with adjustments for CYP2C8 inhibitors. It works as a partial agonist of THR-B, primarily reducing intrahepatic triglycerides.
In February 2025, Madrigal announced new two-year data from the compensated MASH cirrhosis arm of the MAESTRO-NAFLD-1 trial, showing the potential benefit of REZDIFFRA in patients with compensated MASH cirrhosis.
MASH Emerging Drugs
Efruxifermin (EFX), is Akero's lead product candidate for MASH. It is a differentiated Fc-FGF21 fusion protein engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly SC dosing and is active in the pipeline for Pre-cirrhotic MASH (F2-F3) and Compensated Cirrhosis due to MASH (F4).
In November 2025, Akero Therapeutics reported additional Phase IIb SYMMETRY and HARMONY analyses at the AASLD Liver Meeting, further supporting efruxifermin's antifibrotic effect and demonstrating alignment between digital and conventional pathology findings.
In May 2025, at the EASL Congress, the company presented Phase IIb SYMMETRY data showing efruxifermin significantly improved fibrosis without worsening MASH in compensated cirrhosis, indicating disease-modifying potential.
VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid hormone beta receptor that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders.
In November 2024, Viking Therapeutics presented results from the Phase IIb VOYAGE study of VK2809 in biopsy-confirmed NASH/MASH at the 75th Liver Meeting, hosted by the AASLD, including Week 52 secondary endpoint results.
In June 2024, Viking Therapeutics reported positive 52-week histologic data from the Phase IIb VOYAGE study of VK2809, highlighting achievement of secondary endpoints showing histologic improvements via biopsy after 52 weeks. The study had previously met its primary endpoint, with significant liver fat reductions by Week 12 compared to placebo.
VK2809 also successfully achieved primary and secondary endpoints in a Phase IIa study for the treatment of patients with elevated LDL-C and Non-alcoholic Fatty Liver Disease (NAFLD).
BOS-580 also known as Efimosfermin Alfa is a long-acting, once-monthly FGF21 analogue under development for the treatment of MASH, previously known as NASH. It is an investigational Phase III fusion protein with extended half-life, targeting three FGF21 receptors for a balanced pharmacological effect.
In July 2025, GSK reported the completion of its acquisition of efimosfermin alfa from Boston Pharmaceuticals.
In November 2024, Boston Pharmaceuticals reported positive Phase II data on (BOS-580) in F2/F3 MASH at AASLD 2024. The once-monthly treatment showed significant fibrosis improvement (>=1 stage) without worsening of MASH after 24 weeks. Two-thirds of efimosfermin-treated patients achieved significant MASH resolution without worsening fibrosis compared to placebo.
MASH Drugs Market Insights
Efruxifermin (EFX) is an investigational Fc-FGF21 fusion protein developed by Akero Therapeutics for the treatment of MASH. Designed to mimic the biological activity of FGF21, EFX aims to address key drivers of MASH by reducing liver fat and inflammation, reversing fibrosis, and improving insulin sensitivity and lipid metabolism. In a 96-week Phase IIb study, 39% of patients with compensated cirrhosis due to MASH experienced a reversal of cirrhosis without worsening of the disease, compared to 15% in the placebo group. These promising results have led to the initiation of the Phase III SYNCHRONY clinical program, which includes trials evaluating EFX in patients with pre-cirrhotic MASH (F2-F3 fibrosis) and those with compensated cirrhosis (F4) due to MASH.
Pegozafermin is an investigational glycoPEGylated analog of Fibroblast Growth Factor 21 (FGF21) developed by 89bio for the treatment of MASH and fibrosis. Engineered to mimic and extend the activity of native FGF21, pegozafermin aims to address metabolic abnormalities underlying liver diseases. In a Phase IIb trial, pegozafermin demonstrated significant improvements in liver fibrosis among MASH patients, supporting its progression to Phase III studies. Notably, the ENLIGHTEN-Cirrhosis Phase III trial has been initiated to evaluate its efficacy in MASH patients with compensated cirrhosis (F4), marking the first FGF21 analog to reach this advanced stage in such a population.
The MASH treatment landscape is rapidly evolving, particularly with the USFDA's accelerated approval of Madrigal's REZDIFFRA, now considered a key therapy for patients with moderate to advanced liver fibrosis. This selective thyroid hormone receptor-beta agonist has shifted the approach from invasive liver biopsies to non-invasive diagnostic methods, improving patient access to treatment. The landscape is further shaped by a diverse pipeline of therapies targeting various mechanisms, such as FXR agonists, PPAR modulators, and GLP-1 receptor agonists, with clinical trials exploring combination therapies to address the complex nature of the disease. As researchers focus on personalized medicine and better patient stratification, the priority remains refining treatment strategies while navigating challenges in trial recruitment and regulatory requirements. The combination of emerging therapies and existing lifestyle interventions continues to influence clinical practice in managing MASH/NASH.
Emerging pipeline treatments for MASH include efruxifermin (EFX), VK2809, efimosfermin alfa (BOS-580), icosabutate, denifanstat and pegozafermin, among others.
This section focuses on the uptake rate of potential MASH drugs expected to be launched in the market during 2022-2036.
Metabolic Dysfunction-Associated Steatohepatitis Pipeline Development Activities
The MASH pipeline segment report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key MASH Companies involved in developing targeted therapeutics.
Pipeline Development Activities
The MASH pipeline segment report covers information on collaborations, acquisitions and mergers, licensing, and patent details for MASH emerging therapies.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on MASH evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of California, US, Arizona Liver Health, US, Houston Research Institute, US , University of Bonn, Germany, Hospital Saint-Antoine - Ap-Hp Sorbonne University, France, Fondazione Policlinico Universitario Agostino Gemelli, Italy, Instituto de Investigaciones Biomedicas August Pi i Sunyer (IDIBAPS), Spain, Royal Infirmary of Edinburgh, UK , and Aichi Medical University, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or MASH market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
As per the KOLs from the US, MASH affects approximately 5% of the US adult population, driven by the growing burden of obesity, diabetes, and metabolic syndrome. Despite up to 75% of individuals with MASLD having underlying MASH, many remain undiagnosed due to gaps in screening and inconsistent diagnostic pathways. The lack of standardized criteria and reliance on varied data sources contribute to discrepancies in MASH Prevalence estimates, underscoring the urgent need for real-world epidemiological studies. Improved risk stratification and broader adoption of noninvasive diagnostic tools are essential to identifying high-risk patients earlier and mitigating long-term disease burden.
As per the KOLs from France, MASLD is a growing public health challenge in France, particularly among men and those with metabolic risk factors. The link between diabetes and advanced fibrosis highlights the urgency of national screening programs. Strengthening preventive strategies through metabolic health initiatives and physician education is key to reducing long-term disease burden
As per the KOLs from Japan, the increasing prevalence of MASLD and MASH in Japan reflects global trends, yet lean-MASH remains a distinct concern. The interplay between metabolic health and fibrosis progression remains incompletely understood, emphasizing the need for longitudinal studies and improved noninvasive diagnostics to refine risk stratification and treatment pathways
MASH Therapeutics Market: Qualitative Analysis
We perform Qualitative and MASH Therapeutics Market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, 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. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving MASH treatment market landscape.
Conjoint Analysis analyzes multiple 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. To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, 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.
MASH Therapeutics Market Access and Reimbursement
REZDIFFRA
Madrigal offers a Co-pay Savings Card for eligible, commercially insured patients, allowing them to save on REZDIFFRA, with costs as low as USD 10. In 2025, the Inflation Reduction Act (IRA) introduces new affordability options for those on Medicare Part D, aiming to reduce prescription drug costs. These changes focus on making prescription costs more manageable for seniors living in the US.
Starting January 2025, a key change to the Medicare Part D program includes a USD 2,000 annual cap on out-of-pocket prescription drug costs, down from USD 3,250 in 2024. Additionally, the "donut hole" coverage gap will be eliminated. Once the USD 2,000 limit is reached, Medicare will cover any remaining prescription costs for the year.
For individuals who find the USD 2,000 cap financially challenging, the Medicare Prescription Payment Plan (MPPP) can help. The MPPP allows eligible participants to spread their prescription costs across monthly payments. They will receive a monthly statement from their Part D plan showing their costs, which will be evenly distributed over the year. Individuals can join the MPPP at any time, including during open enrollment, by contacting the number on their Part D plan ID card, visiting the plan website, or mailing in a form.
Furthermore, the Extra Help program, also known as the Low-Income Subsidy (LIS), will expand its full benefits to assist people with limited income in obtaining Part D prescription drug coverage. In 2024, participants may qualify for this subsidy if they earn up to USD 22,590 annually (for a single person) or USD 30,660 (for a couple) and meet other requirements. Additionally, their assets must be below USD 17,220 (for a single person) or USD 34,360 (for a couple) to be eligible. The income limits are updated annually based on the Federal Poverty Level.
The MASH Therapeutics Market Report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
MASH Therapeutics Market Report Scope
MASH Treatment Market Insights
MASH Epidemiology Insights
Current MASH Treatment Market Scenario, Marketed Drugs, and Emerging Therapies