Metabolic Dysfunction-Associated Steatohepatitis (MASH) - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights

• In 2023, there were an estimated 42 million prevalent cases of MASH in the 7MM. Out of these, a total of ~15 million cases were diagnosed, and this number is projected to increase by the end of 2034 in the 7MM.
• In 2023, the market size of metabolic dysfunction-associated steatohepatitis (MASH) was highest in the US among the 7MM, accounting for approximately USD 1.51 billion which is further expected to increase by 2034.
• The Severity-specific prevalent cases of metabolic dysfunction-associated steatohepatitis (MASH) are divided into the following groups: F0 Stage, F1 Stage, F2 stage, F3 stage, and F4 stage. In the United States, a higher number of cases were observed in the F1 stage compared to others, comprising around 38% of the total diagnosed cases in 2023.
• In 2023, of the total gender-specific diagnosed prevalent cases of MASH in EU4 and the UK nearly 2.01 million cases occurred in males and 1.65 million cases among females. It is projected that by 2034, the number of cases will increase more significantly in males compared to females.
• In March 2024, Madrigal Pharmaceuticals’ groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-ß agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2-F3 fibrosis.
• The emerging drug Pegozafermin is expected to launch in the US market by 2026, the drug has the potential to reduce the disease burden of metabolic dysfunction-associated steatohepatitis (MASH) in the forecasted years.

This report delivers an in-depth understanding of the Metabolic dysfunction-associated steatohepatitis (MASH), historical and forecasted epidemiology as well as the Metabolic dysfunction-associated steatohepatitis (MASH) market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Metabolic dysfunction-associated steatohepatitis (MASH) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Metabolic dysfunction-associated steatohepatitis (MASH) market size from 2020 to 2034. The report also covers current metabolic dysfunction-associated steatohepatitis (MASH) treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Metabolic dysfunction-associated steatohepatitis (MASH) Overview

Metabolic dysfunction-associated steatotic liver disease (MASLD), is an umbrella term that encompasses the entire spectrum of fatty liver disease, from simple steatosis to more progressive steatosis with associated hepatitis, fibrosis, cirrhosis, and in some cases hepatocellular carcinoma. Metabolic dysfunction-associated steatohepatitis (MASH) is the progressive form of liver injury that carries a risk of progressive fibrosis, cirrhosis, and end-stage liver disease. It is a common chronic liver disease and is defined as liver inflammation and damage caused by a buildup of fat in the liver. Much like adults, children who have certain unhealthy conditions may also develop MASLD and MASH. In June 2023, it was decided by patient and professional groups working with liver diseases to change the name of NASH (Nonalcoholic steatohepatitis) to MASH.

Metabolic dysfunction-associated steatohepatitis (MASH) Diagnosis

Diagnosis and staging of MASH remain linked to histology, however professional guidelines and practice guidance now recommend noninvasive tools (NITs) such as blood-based or imaging techniques to assess the likelihood of fibrosis and predict risk of disease progression.

Probably the most urgent need in the field of MASH is the identification of biomarkers that would help diagnose and monitor disease progression. In primary-care settings where numerous individuals are exposed to metabolic risk factors, biomarkers can help identify those at high risk of MAFLD-related liver disease. In secondary- and tertiary-care settings, biomarkers can identify those with advanced/severe MASH. This will help provide prognostic information and select those needing specific, liver-directed therapy. Biomarkers, or imaging methods, can also reliably monitor disease progression; however, this may necessitate more than simply understanding the fibrosis stage. Recent studies have shown that the transition from MAFLD to MASH can sometimes occur with advanced fibrosis.

This justifies long-term follow-up, even in patients without steatohepatitis at diagnosis, and especially if metabolic risk factors persist or worsen. Hence, there is a strong need to predict the response to pharmacological or nonpharmacological interventions. Ongoing trials are striving to identify companion tests for specific molecules that will eventually eliminate the need for histology to document efficacy. The successful development of biomarkers can lead to a timely prediction of drug response and shorten the timelines for completing clinical trials, reducing useless drug exposure in non-responder patients.

Metabolic dysfunction-associated steatohepatitis (MASH) Treatment

The primary treatments for metabolic dysfunction-associated steatohepatitis (MASH) encompass lifestyle modifications and medical interventions. Effective weight loss of 7-10% of initial body weight can significantly reduce liver inflammation and fibrosis. Adopting a heart-healthy diet, rich in fruits, vegetables, whole grains, and healthy fats, alongside 150 minutes of moderate-to-vigorous exercise weekly, is crucial.

Medications, including the recently FDA-approved resmetirom (REZDIFFRA), should complement diet and exercise. Liver biopsy remains the definitive diagnostic tool to confirm MASH and assess liver damage. Managing associated conditions like obesity, diabetes, and metabolic syndrome is vital for overall treatment efficacy. However, achieving sustained lifestyle changes and ensuring medication adherence pose significant challenges in MASH management.

Metabolic dysfunction-associated steatohepatitis (MASH) Epidemiology

As the market is derived using a patient-based model, the Metabolic dysfunction-associated steatohepatitis (MASH) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Prevalent Cases of Metabolic dysfunction-associated steatohepatitis (MASH), Diagnosed Prevalent Cases of Metabolic dysfunction-associated steatohepatitis (MASH), Gender-specific Diagnosed Prevalent Cases of Metabolic dysfunction-associated steatohepatitis (MASH), and Severity-specific Diagnosed Prevalent Cases of Metabolic dysfunction-associated steatohepatitis (MASH) in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• Based on estimates, the United States had the highest number of diagnosed prevalent cases of MASH in 2023, with a total of ~9.4 million cases. Following the US, EU4 and the UK had ~3.6 million cases, while Japan had ~2.5 million cases.
• The categorization based on gender, showed that diagnosed prevalent cases in males were higher than in females in the 7MM. The male-diagnosed prevalent cases accounted for 56% of the total cases in the 7MM.
• Japan accounted for approximately 16% of the total MASH Diagnosed Prevalent Cases in the 7MM in 2023. These cases are expected to increase in the study period (2020-2034).

Metabolic dysfunction-associated steatohepatitis (MASH) Drug Chapters

The drug chapter segment of the metabolic dysfunction-associated steatohepatitis (MASH) report encloses a detailed analysis of metabolic dysfunction-associated steatohepatitis (MASH) off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Metabolic dysfunction-associated steatohepatitis (MASH) clinical trial 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.

Marketed Drugs

REZDIFFRA (resmetirom): Madrigal Pharmaceuticals

REZDIFFRA is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). The emergence of the inaugural medication for MASH is a true game-changer for healthcare providers, the research community, and, most importantly, patients living with this serious liver condition. Based on the robust efficacy and safety data generated in two large Phase III MAESTRO studies, it is believed that REZDIFFRA will become the foundational therapy for patients with MASH with moderate to advanced liver fibrosis. As well as since now that the FDA has approved REZDIFFRA for MASH, pharmaceutical companies will have a better understanding of the thresholds they must meet to get future approvals.

Physicians hope the REZDIFFRA’s approval “energizes” the field and leads to more treatment advances. Madrigal Pharmaceuticals has already garnered widespread support among physicians. A significant portion of gastroenterologists plan to incorporate the brand into their practice within six months of its launch. They estimate that over a third of their patients with MASH/NASH could benefit from the drug, suggesting rapid adoption and utilization. Physicians are hopeful that insurance providers will cover the cost of REZDIFFRA and are poised to offer it to eligible MASH patients once it becomes available.

Emerging Drugs

Pegozafermin: 89bio, Inc

Pegozafermin or BIO89-100 is a compound that specifically targets and activates a receptor known as fibroblast growth factor 21 (FGF21). FGF21 is a hormone involved in regulating glucose and lipid metabolism, and it has been shown to have potential therapeutic effects in MASH.

• Preclinical studies and early-stage clinical trials of BIO89-100 have shown promising results in improving metabolic parameters and reducing liver fat accumulation in patients with MASH.
• In May 2024, 89bio initiated Phase III ENLIGHTEN-Cirrhosis Trial of Pegozafermin in MASH patients with compensated cirrhosis.
• In October 2024, 89bio, Inc. reported that new analyses from the Phase IIb ENLIVEN trial, which investigates the efficacy of pegozafermin in patients with MASH and fibrosis, will be presented in four poster sessions at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2024 in November 2024 in San Diego, California.

Efruxifermin (EFX): Akero Therapeutics, Inc.

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. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treating MASH.

• In June 2024, the company initiated the SYNCHRONY Outcomes study, a Phase III trial evaluating the efficacy and safety of efruxifermin (EFX) in patients with compensated cirrhosis, F4 due to MASH.

Belapectin: Galectin Therapeutics

Belapectin a complex carbohydrate drug, targets galectin-3, a critical protein in fatty liver disease and fibrosis pathogenesis. Galectin-3 plays a major role in organ scarring diseases, including the liver, lung, kidney, heart, and vascular systems fibrotic disorders. The drug binds to galectin-3 proteins and disrupts its function.

• In April 2024, the company reported the positive outcome of its fifth independent data and safety monitoring board (DSMB) meeting for NAVIGATE, its seamless, adaptive, Phase IIb/III study of belapectin in patients with cirrhotic portal hypertension caused by MASH. The topline results from the interim analysis of the Phase IIb (Stage 1) portion of NAVIGATE is expected in the fourth quarter of 2024.

Metabolic dysfunction-associated steatohepatitis (MASH) Market Outlook

Until mid-March, the therapeutic landscape of NASH lacked FDA, EMA, or PMDA-approved medications, relying primarily on lifestyle adjustments like diet and exercise. Supplemental interventions encompassed off-label usage of vitamin E and antidiabetic agents (e.g., pioglitazone, liraglutide) and liver transplantation in case of severe stages. Given NASH’s multifaceted pathogenesis, effective treatment demands comprehensive targeting of various cellular and molecular pathways.

The incidence of MASLD is significantly associated with T2DM and obesity, especially in patients with a higher body mass index (BMI). In contrast, the incidence of MASLD is decreased in patients with T2DM, who received treatments such as sodium-glucose cotransporter-2 (SGLT2) inhibitors, GLP-1 receptor antagonists, and insulin. Vitamin E, known for its antioxidant effects, is considered a first-line pharmacological treatment in managing MASH, especially when diet and other lifestyle changes are insufficient. Antifibrotic reagents can prevent the progression of liver fibrosis and MASLD to fibrotic MASH. The effects of pioglitazone (anti-diabetes agents) on MASH histology with T2D have been extensively established, but several concerns exist, such as body weight gain, fluid retention, cancer incidence, and bone fracture. In addition, there are some other targets for MASLD and MASH treatments, such as G protein-coupled receptors (GPCRs), estrogen-related receptor alpha (ERRa), bone morphogenetic proteins (BMPs), and KLFs. Bariatric surgery (BS) or weight loss surgery is the most effective way to treat obesity and diabetes by reducing food absorption and modulating gut hormone secretion and metabolic dysfunction.

American Association for the Study of Liver Diseases (AASLD) MASLD practice guidance statement recommends off-label use of vitamin E in noncirrhotic, non-diabetic patients with biopsy-proven MASH and pioglitazone for the management of diabetic patients with biopsy-proven MASH.

In conclusion, the advent of REZDIFFRA marks a significant breakthrough in MASH treatment, offering hope and promise to millions affected by this complex liver condition. As the pioneering FDA-approved therapy for MASH, REZDIFFRA leads innovation, transforming treatment. While other emerging therapies such as lanifibranor, VK2809, Semaglutide, and others show promise in addressing MASH, REZDIFFRA’s unique efficacy and safety profile position it as the cornerstone of MASH management. As we navigate this dynamic era of medical advancement, REZDIFFRA stands as a guiding light, illuminating the path toward a future where effective treatment and improved outcomes are within reach for all those affected by MASH.

• The total market size of metabolic dysfunction-associated steatohepatitis (MASH) in the 7MM was approximately USD 2.11 billion in 2023 and is projected to increase during the forecast period (2024-2034).
• Among European countries, Germany accounted for the maximum market size of USD 89 million in 2023 while Spain occupied the bottom of the ladder in the same year with USD 50 million.
• The market size of metabolic dysfunction-associated steatohepatitis (MASH) in Japan was nearly USD 260 million in 2023, which is further expected to increase by 2034.

Metabolic dysfunction-associated steatohepatitis (MASH) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Lanifibranor/ IVA337 in the US is expected to be launched by 2027 with a peak share of 2.9%. HPG1860 is anticipated to take 7 years to peak with slow-medium uptake.

Metabolic dysfunction-associated steatohepatitis (MASH) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for metabolic dysfunction-associated steatohepatitis (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 the secondary research. Industry Experts were contacted for insights on metabolic dysfunction-associated steatohepatitis (MASH) evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from the University of Florida Gainesville, Florida; University of Colorado Anschutz Medical Campus, Aurora, Colorado; Department of Hepatology and Gastroenterology, Charité University Medicine Berlin, Berlin; Newcastle University, United Kingdom; The Japanese Society of Gastroenterology (JSGE), Tokyo, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or metabolic dysfunction-associated steatohepatitis (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.

Qualitative Analysis

We perform Qualitative and 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 treatment landscape.

Conjoint Analysis analyzes multiple approved and 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.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

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.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of metabolic dysfunction-associated steatohepatitis (MASH), explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Metabolic dysfunction-associated steatohepatitis (MASH) market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the 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 shape and drive the 7MM Metabolic dysfunction-associated steatohepatitis (MASH) market.

Metabolic dysfunction-associated steatohepatitis (MASH) Report Insights

• Patient Population
• Therapeutic Approaches
• Metabolic dysfunction-associated steatohepatitis (MASH) Pipeline Analysis
• Metabolic dysfunction-associated steatohepatitis (MASH) Market Size and Trends
• Existing and Future Market Opportunity

Metabolic dysfunction-associated steatohepatitis (MASH) Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Metabolic dysfunction-associated steatohepatitis (MASH) Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Metabolic dysfunction-associated steatohepatitis (MASH) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the metabolic dysfunction-associated steatohepatitis (MASH) total market size, the market size by therapies, and market share (%) distribution in 2020, and how it would all look in 2034? What are the contributing factors for this growth?
• Will the coverage of drugs depend on their efficacy in metabolic dysfunction-associated steatohepatitis (MASH)?
• What will be the impact on the market with the launch of emerging drugs?
• Which is going to be the largest contributor to the market in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of metabolic dysfunction-associated steatohepatitis (MASH)? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to metabolic dysfunction-associated steatohepatitis (MASH)?
• What is the historical and forecasted Metabolic dysfunction-associated steatohepatitis (MASH) patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Why do patients develop persistent metabolic dysfunction-associated steatohepatitis (MASH) symptoms? Why is the current year diagnosis rate not high?
• Which type of severity is the largest contributor in patients affected with metabolic dysfunction-associated steatohepatitis (MASH)?
• What factors are affecting the increase in the diagnosis of metabolic dysfunction-associated steatohepatitis (MASH)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of metabolic dysfunction-associated steatohepatitis (MASH)? What are the current treatment guidelines for the treatment of Metabolic dysfunction-associated steatohepatitis (MASH) in the US and Europe?
• How many companies are developing therapies for the treatment of metabolic dysfunction-associated steatohepatitis (MASH)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for metabolic dysfunction-associated steatohepatitis (MASH)?
• What will be the impact on the market after the expected patent expiry of the emerging drug?
• What is the cost burden of off-label therapies on patients?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of recommended therapies? Focus on reimbursement policies.
• How the approval of REZDIFFRA (resmetirom) is going to change the market dynamics of MASH?
• What are the 7MM historical and forecasted market of metabolic dysfunction-associated steatohepatitis (MASH)?

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.
• 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.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around 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.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The metabolic dysfunction-associated steatohepatitis (MASH) Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the metabolic dysfunction-associated steatohepatitis (MASH) market?

The Metabolic dysfunction-associated steatohepatitis (MASH) market is quite robust. The major layers are 89bio, Inc., Akero Therapeutics, Galectin Therapeutics, Viking Therapeutics, Novo Nordisk A/S, Inventiva, and others which are currently developing drugs for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the metabolic dysfunction-associated steatohepatitis (MASH) market?

The increase in diagnosed prevalent cases of metabolic dysfunction-associated steatohepatitis (MASH) and the launch of emerging therapies are attributed to be the key drivers for increasing the metabolic dysfunction-associated steatohepatitis (MASH) market.

5. What is the expected impact of emerging therapies or advancements in metabolic dysfunction-associated steatohepatitis (MASH) treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the metabolic dysfunction-associated steatohepatitis (MASH) treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Metabolic dysfunction-associated steatohepatitis (MASH) market.