DelveInsight’s “Nonalcoholic Steatohepatitis Market Insight, Epidemiology And Market Forecast – 2034” report delivers an in-depth understanding of the NASH, historical and forecasted epidemiology as well as the NASH therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
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Key Takeaways from the Nonalcoholic Steatohepatitis Market Report
The NASH Market Size in the 7MM was approximately ~USD 2,114 million in 2023 and is projected to increase during the forecast period (2024–2034).
The US recorded the highest NASH Market Size among the 7MM in 2023, accounting for approximately USD 1,519 million.
In 2023, there were an estimated 42 million NASH prevalence cases in the 7MM, of which ~15 million cases were diagnosed, a number expected to increase by 2034.
In the United States, the F1 stage accounted for around 38% of total diagnosed NASH cases in 2023, the highest among the severity-specific groups.
In EU4 and the UK, nearly 2,018 thousand diagnosed NASH cases occurred in males compared to 1,656 thousand in females in 2023, with male cases projected to rise more significantly by 2034.
In March 2024, Madrigal Pharmaceuticals’ REZDIFFRA (resmetirom) received accelerated FDA approval, becoming the first FDA-sanctioned therapy for adults with non-cirrhotic NASH with F2–F3 fibrosis.
In November 2024, Novo Nordisk reported positive Phase 3 ESSENCE trial results, with once-weekly 2.4 mg semaglutide improving liver fibrosis and resolving steatohepatitis without worsening fibrosis.
Pegozafermin is expected to launch in the US NASH market by 2026, with potential to reduce the disease burden of NASH in the coming years.
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Nonalcoholic Steatohepatitis Market Overview
Nonalcoholic Steatohepatitis is the progressive form of liver injury that carries a risk of progressive fibrosis, cirrhosis, and end-stage liver disease. It is defined as liver inflammation and damage caused by a buildup of fat in the liver, and is among the more serious presentations of NAFLD, affecting both adults and, in some cases, children.
Many people accumulate fat in the liver without symptoms or complications; however, in some individuals this fat causes inflammation and cellular damage, impairing liver function. NASH resembles liver disease associated with long-term heavy drinking, and sustained damage can lead to fibrosis or scarring, which, if severe, may progress to cirrhosis and permanent liver damage. According to the American Liver Foundation, the exact cause of NAFLD is unknown, though risk is elevated in individuals with overweight or obesity, type 2 diabetes or pre-diabetes, and abnormal blood lipid levels.
Factors Driving the Growth of the Nonalcoholic Steatohepatitis MarketNonalcoholic Steatohepatitis Rising Prevalence
In 2023, the 7MM recorded approximately 42 million NASH cases, with around 15 million diagnosed, and the US accounted for the largest market share at USD 1,519 million. Increasing obesity, diabetes, and metabolic syndrome prevalence are driving a rise in diagnosed cases, with projections indicating continued growth through 2034.
Nonalcoholic Steatohepatitis Market Dynamics
NASH severity-specific prevalence shows the F1 stage as the most common in the US, representing 38% of diagnosed cases. Gender-specific analysis in EU4 and the UK highlights a higher male prevalence, with 2,018 thousand male cases versus 1,656 thousand female cases. Growing awareness, improved diagnostic tools, and rising lifestyle-related risk factors are key drivers of market expansion.
Nonalcoholic Steatohepatitis Treatment Landscape
Current treatment approaches include lifestyle modifications, metabolic modulators, and emerging pharmacotherapies targeting fibrosis and steatohepatitis resolution. Semaglutide demonstrated efficacy in the Phase 3 ESSENCE trial, improving liver fibrosis and resolving steatohepatitis without worsening fibrosis. REZDIFFRA (resmetirom) received accelerated FDA approval as the first therapy for adults with non-cirrhotic NASH and F2–F3 fibrosis, marking a milestone in NASH management. Denifanstat has progressed to Phase 3 following successful FDA end-of-Phase 2 interactions.
Nonalcoholic Steatohepatitis Clinical Trials and Emerging Therapies
Pegozafermin (BIO89-100) by 89bio targets FGF21 to improve glucose and lipid metabolism, with the Phase III ENLIGHTEN-Cirrhosis trial initiated in May 2024. Efruxifermin (EFX) by Akero Therapeutics is a differentiated Fc-FGF21 fusion protein evaluated in the Phase III SYNCHRONY Outcomes study for F4 NASH patients. Belapectin by Galectin Therapeutics targets galectin-3 to address fibrosis and is being evaluated in the adaptive Phase IIb/III NAVIGATE trial. These emerging therapies indicate a robust pipeline poised to address unmet clinical needs in NASH.
Nonalcoholic Steatohepatitis Market Segment Analysis
The NASH epidemiology segmentation in the report covers Total Prevalence Cases, Total Diagnosed Prevalence Cases, Gender-specific Diagnosed Prevalence Cases, and Severity-specific Diagnosed Prevalence Cases across the 7MM. In 2023, the United States held the highest number of diagnosed prevalence cases at ~9.4 million, followed by EU4 and the UK combined at ~3.6 million, and Japan at ~2.5 million. Male-diagnosed prevalent cases accounted for 56% of total cases across the 7MM, reflecting a consistent gender skew across regions.
Nonalcoholic Steatohepatitis Market Regional AnalysisThe United States is Expected to Dominate the Overall Nonalcoholic Steatohepatitis Market
The United States held the highest NASH Market Size among the 7MM in 2023 at USD 1,519 million and also recorded the highest number of diagnosed prevalence cases at ~9.4 million, driven by rising obesity, diabetes, and metabolic syndrome prevalence alongside growing clinical and regulatory momentum following REZDIFFRA’s approval.
Among European countries, Germany accounted for the highest NASH Market Size at USD 89 million in 2023, while Spain recorded the lowest at USD 50 million in the same year. EU4 and the UK together recorded ~3.6 million diagnosed prevalence cases in 2023, with 2,018 thousand cases in males compared to 1,656 thousand in females.
Japan recorded a NASH Market Size of nearly USD 260 million in 2023, expected to increase by 2034, and accounted for approximately 16% of total NASH diagnosed prevalent cases in the 7MM.
Nonalcoholic Steatohepatitis Key Companies
Nonalcoholic Steatohepatitis Companies include:
Inventiva Pharma
Zydus Therapeutics
Novo Nordisk A/S
Eli Lilly and Company
Madrigal Pharmaceuticals, Inc
Terns, Inc.
Intercept Pharmaceuticals
Enyo Pharma
89bio, Inc.
Akero Therapeutics, Inc
And Others.
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Latest Highlights from the Nonalcoholic Steatohepatitis Market
In March 2024, Madrigal Pharmaceuticals’ REZDIFFRA (resmetirom) received accelerated FDA approval, becoming the first and only FDA-sanctioned therapy for adults with non-cirrhotic NASH and F2–F3 fibrosis.
In May 2024, 89bio initiated the Phase III ENLIGHTEN-Cirrhosis trial of Pegozafermin in NASH patients with compensated cirrhosis.
In June 2024, Akero Therapeutics initiated the Phase III SYNCHRONY Outcomes study evaluating efruxifermin in patients with compensated cirrhosis, F4 due to NASH.
In October 2024, Sagimet Biosciences completed end-of-Phase 2 interactions with the FDA for denifanstat, paving the way for Phase 3 trials.
In October 2024, 89bio reported new analyses from the Phase IIb ENLIVEN trial to be presented at the AASLD Liver Meeting 2024.
In November 2024, Novo Nordisk announced positive Phase 3 ESSENCE trial results for semaglutide in NASH patients with stage 2 or stage 3 fibrosis.
Galectin Therapeutics reported positive fifth independent DSMB meeting outcomes for its adaptive Phase IIb/III NAVIGATE trial of belapectin in patients with cirrhotic portal hypertension caused by NASH.
Pegozafermin is expected to launch in the US NASH market by 2026.
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Nonalcoholic Steatohepatitis Market Outlook
Until mid-March 2024, the NASH therapeutics market landscape lacked FDA, EMA, or PMDA-approved medications, relying primarily on lifestyle adjustments like diet and exercise, alongside off-label use of vitamin E and antidiabetic agents such as pioglitazone and liraglutide, with liver transplantation reserved for severe stages. Given NASH’s multifaceted pathogenesis, effective treatment demands comprehensive targeting of various cellular and molecular pathways, including SGLT2 inhibitors, GLP-1 receptor antagonists, and insulin, alongside emerging targets such as GPCRs, ERRα, BMPs, and KLFs. Bariatric surgery remains among the most effective interventions for obesity and diabetes-related metabolic dysfunction underlying NASH.
The AASLD MASLD practice guidance recommends off-label vitamin E in noncirrhotic, non-diabetic patients with biopsy-proven NASH, and pioglitazone for diabetic patients with biopsy-proven NASH. The advent of REZDIFFRA marks a significant breakthrough as the pioneering FDA-approved NASH therapy, while emerging therapies such as lanifibranor, VK2809, and semaglutide continue to show promise, positioning the NASH treatment landscape for continued transformation through 2034.
Scope of the Nonalcoholic Steatohepatitis Market Report
Study Period: 2020–2034
Forecast Period: 2023–2034
Nonalcoholic Steatohepatitis Market Size (2023): ~USD 2,114 million in the 7MM
Geographies Covered: The United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan
Major Nonalcoholic Steatohepatitis Companies: Inventiva Pharma, Zydus Therapeutics, Novo Nordisk A/S, Eli Lilly and Company, Madrigal Pharmaceuticals, Inc, Terns, Inc., Intercept Pharmaceuticals, Enyo Pharma, 89bio, Inc., Akero Therapeutics, Inc, and others.
Market Segments Covered: Total Prevalence Cases, Total Diagnosed Prevalence Cases, Gender-specific Diagnosed Prevalence Cases, Severity-specific Diagnosed Prevalence Cases, and Geography.
Competitive Intelligence Analysis: Market trends, drug uptake, pipeline development activities, collaborations, acquisitions, licensing, patent details, regulatory approvals, and reimbursement scenario.
Key Focus Areas: NASH Epidemiology Forecast, Marketed and Emerging Drugs, Drugs Uptake, Pipeline Development Activities, and Reimbursement Scenario.
Table of Contents
Key Insights
Executive Summary of Nonalcoholic Steatohepatitis (NASH)
Competitive Intelligence Analysis for Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic Steatohepatitis (NASH): Market Overview at a Glance
Nonalcoholic Steatohepatitis (NASH): Disease Background and Overview
Nonalcoholic Steatohepatitis Patient Journey
Nonalcoholic Steatohepatitis (NASH) Epidemiology and Patient Population
Nonalcoholic Steatohepatitis Treatment Algorithm, Current Treatment, and Medical Practices
Nonalcoholic Steatohepatitis (NASH) Unmet Needs
Key Endpoints of Nonalcoholic Steatohepatitis (NASH) Treatment
Nonalcoholic Steatohepatitis (NASH) Marketed Products
Nonalcoholic Steatohepatitis (NASH) Emerging Therapies
Nonalcoholic Steatohepatitis (NASH): Seven Major Market Analysis
Attribute Analysis
7MM: Nonalcoholic Steatohepatitis Market Outlook
Access and Reimbursement Overview of Nonalcoholic Steatohepatitis (NASH)
KOL Views
Nonalcoholic Steatohepatitis Market Drivers
Nonalcoholic Steatohepatitis Market Barriers
Appendix
DelveInsight Capabilities
Disclaimer
About DelveInsight
How DelveInsight’s Nonalcoholic Steatohepatitis Market Report Helps CXOs and Business Leaders
Evaluate the current and future market opportunity across key regions, including the United States, EU4, the United Kingdom, and Japan, through detailed epidemiology forecasts and market trend analysis.
Benchmark leading NASH therapies and pipeline candidates through comprehensive competitive intelligence, company profiling, drug uptake analysis, and pipeline development tracking.
Identify potential licensing, acquisition, co-development, and strategic partnership opportunities by monitoring emerging NASH companies, novel FGF21-targeting and antifibrotic mechanisms, and recent industry collaborations.
Assess the impact of upcoming regulatory approvals, clinical trial readouts, and reimbursement developments on market share, pricing strategies, adoption rates, and commercial success.
Support strategic decision-making with insights into KOL perspectives, unmet needs, severity- and gender-specific epidemiology trends, and evolving market dynamics within the Nonalcoholic Steatohepatitis landscape.
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