DelveInsight’s “Nonalcoholic Steatohepatitis Market Insight, Epidemiology And Market Forecast – 2034” report provides a comprehensive analysis of the NASH epidemiological trends, treatment approaches, and market dynamics across the 7MM, which include the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
The NASH market size in the 7MM was valued at approximately USD 2 billion in 2023 and is projected to experience notable growth throughout the forecast period (2024-2034). The US dominated the Nonalcoholic Steatohepatitis market in 2023, accounting for approximately USD 1.5 billion of the total market share in the studied region. Further, Germany accounted for the maximum Nonalcoholic Steatohepatitis market size among European countries, with USD 89 million in 2023.
Download the NASH Market report to understand which factors are driving the MASH therapeutic market @ NASH Market Trends.
NASH (Nonalcoholic Steatohepatitis) was officially renamed to MASH (Metabolic Dysfunction-Associated Steatohepatitis) in 2023 by leading liver disease authorities, including the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL), to better reflect its metabolic origins. This change is part of a broader overhaul of fatty liver disease terminology. The updated nomenclature aims to reduce stigma, improve diagnostic clarity, and align disease names more closely with underlying metabolic risk factors, ultimately supporting better patient care and research efforts worldwide.
The report reveals that approximately 42 million prevalent NASH cases existed in the 7MM in 2023, with roughly 15 million total cases diagnosed, a number projected to increase steadily by the end of 2034. Epidemiological data further indicate that among diagnosed cases in the United States, the F1 stage of liver fibrosis comprised around 38% of patients in 2023, underscoring the significant burden of early-stage disease that may progress to more severe fibrosis without intervention.
Additionally, gender-specific analysis of NASH prevalence reveals a notable disparity, with male patients accounting for approximately 56% of total diagnosed cases across the 7MM in 2023, a trend projected to continue till 2034.
Discover evolving trends in the NASH patient pool forecasts @ NASH Epidemiology Analysis.
The report also analyzes the current and emerging trends in the nonalcoholic steatohepatitis treatment market. The NASH treatment landscape witnessed a transformative milestone with the approval of REZDIFFRA by Madrigal Pharmaceuticals (NASDAQ: MDGL) in March 2024, marking a pivotal advancement as the only FDA-approved therapy for adults with non-cirrhotic NASH accompanied by moderate to advanced liver fibrosis. The robust efficacy and safety profile demonstrated in two large Phase III MAESTRO studies positions REZDIFFRA as the foundational therapy for NASH patients.
Beyond REZDIFFRA, several emerging therapies are also poised to reshape the future of NASH treatment. In November 2024, Novo Nordisk (CPH: NOVO-B) announced promising results from Phase III trials for Semaglutide in treating nonalcoholic steatohepatitis. This glucagon-like peptide-1 receptor agonist is expected to play a significant role in addressing the metabolic dysfunctions associated with NASH.
In April 2025, 89bio (NASDAQ: ETNB) announced significant progress in the clinical development of pegozafermin, an innovative FGF21 analog for treating NASH. Currently undergoing Phase III trials, pegozafermin holds a Breakthrough Therapy designation from the FDA and PRIME status from the EMA, positioning it as a potential game-changer in addressing liver and cardiometabolic diseases. This emerging drug is expected to launch in the US NASH market by 2026, reducing the disease burden significantly.
Other emerging therapies for the NASH treatment include GLP-1/glucagon receptor agonists, such as Tirzepatide from Eli Lilly and Survodutide from Boehringer Ingelheim. Additionally, FGF21 analogues like Efruxifermin from Akero Therapeutics (NASDAQ: AKRO) and thyroid hormone receptor (THR-β) agonists, including VK2809 from Viking Therapeutics and ALG-055009 from Aligos Therapeutics, are currently undergoing clinical trials to evaluate their safety, efficacy, and tolerability in patients with NASH.
In February 2025, Galectin Therapeutics’ belapectin demonstrated a more than 68% reduction in new varices among US patients in the Phase IIb/III NAVIGATE trial. Galectin (NASDAQ: GALT) anticipates releasing 36-month follow-up data in Q2 2025, with plans to engage the FDA and potential partners on regulatory pathways. These findings position belapectin as a potential first-in-class therapy for NASH cirrhosis with portal hypertension, addressing a significant patient population in the US lacking FDA-approved treatments. These developments, alongside other pipeline advancements, signal a dynamic shift in the therapeutic approach to NASH management.
Discover recent advancements in the NASH treatment landscape @ NASH Recent Developments.
The competitive landscape for NASH therapeutics continues to evolve rapidly, with numerous pharmaceutical companies driving innovations in the NASH therapeutic area. Key players shaping the future of NASH treatment include Inventiva Pharma (EPA: IVA), Zydus Therapeutics (NSE: ZYDUSLIFE), Novo Nordisk A/S (CPH: NOVO-B), Eli Lilly and Company (NYSE: LLY), Madrigal Pharmaceuticals (NASDAQ: MDGL), Terns Inc. (NASDAQ: TERN), Intercept Pharmaceuticals (NASDAQ: ICPT), Enyo Pharma, 89bio Inc. (NASDAQ: ETNB), Akero Therapeutics Inc. (NASDAQ: AKRO), and Galectin Therapeutics (NASDAQ: GALT), among others.
The advent of REZDIFFRA and several promising pipeline developments signal a new era in NASH management. As understanding of disease pathogenesis advances and novel therapies target various cellular and molecular NASH pathways involved, patients and healthcare providers can anticipate a future with expanded treatment options, improved outcomes, and potentially reduced disease burden. The NASH market is positioned for substantial growth, driven by innovation, increasing prevalence, and the critical unmet need for effective therapeutic interventions in this progressive liver disease.
Table of Contents
1. Key Insights
2. Executive Summary of Nonalcoholic Steatohepatitis (NASH)
3. Competitive Intelligence Analysis for Nonalcoholic Steatohepatitis (NASH)
4. Nonalcoholic Steatohepatitis (NASH): Market Overview at a Glance
5. Nonalcoholic Steatohepatitis (NASH): Disease Background and Overview
6. NASH Patient Journey
7. NASH Epidemiology and Patient Population
8. Nonalcoholic Steatohepatitis Treatment Algorithm, Current Treatment, and Medical Practices
9. NASH Unmet Needs
10. Key Endpoints of NASH Treatment
11. NASH Marketed Products
12. NASH Emerging Therapies
13. Nonalcoholic Steatohepatitis (NASH): Seven Major Market Analysis
14. Attribute analysis
15. 7MM: Nonalcoholic Steatohepatitis Market Outlook
16. Access and Reimbursement Overview of Nonalcoholic Steatohepatitis (NASH)
17. KOL Views
18. NASH Market Drivers
19. NASH Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
Related Reports:
Non-Alcoholic Steatohepatitis (NASH) Pipeline Insight
Non-Alcoholic Steatohepatitis Pipeline Insight provides comprehensive insights about the NASH pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the NASH companies, including Guangdong Raynovent Biotech, Dr. Falk Pharma GmbH, Enyo Pharma, Viking Therapeutics, Eli Lilly and Company, Sagimet Biosciences, Terns, Sinew Pharma, Madrigal Pharmaceuticals, Hepion Pharmaceuticals, Poxel SA, Pfizer, CytoDyn, Altimmune, Oramed, Ltd, PharmaKing, Can-Fite Biopharma, and Cirius Therapeutics, among others.
About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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