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Metabolic Dysfunction-Associated Steatohepatitis (MASH): Seven-Market Drug Forecast and Market Analysis - Update

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    Report

  • 131 Pages
  • June 2025
  • Region: Global
  • GlobalData
  • ID: 6108235
This report covers the 7 major markets and provides an Excel-based forecast model for the Metabolic Dysfunction-Associated Steatohepatitis (MASH) market through 2032.

The analyst estimated that drug sales for MASH in 2022 were approximately $802.3 million across the 7MM, with the market size anticipated to grow to approximately $20.3 billion by 2032, at a compound annual growth rate (CAGR) of 38.2%.
Major drivers of growth during the forecast period include the anticipated launch of several pipeline agents including those within the GLP-1RA drug class such as Novo Nordisk’s semaglutide, an increase in the prevalence of MASH, and anticipated increase in use of non-invasive tests for diagnosing and managing MASH.
Despite the recent FDA approval of Madrigal Pharmaceuticals’ Rezdiffra as the first-to-market therapy for MASH, several unmet needs remain within this disease space, with the most substantial need centered on availability of more approved therapies for the disease.

Scope

  • Overview of Metabolic Dysfunction-Associated Steatohepatitis (MASH), including epidemiology, symptoms, diagnosis, and disease management.
  • Annualized MASH therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2022 to 2032.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the MASH therapeutics market.
  • Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for MASH treatment. The most promising candidates in late-stage development are profiled.
  • Analysis of the current and future market competition in the global MASH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the 7MM MASH therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 7MM MASH therapeutics market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 MASH: Executive Summary
1.1 Summary of Changes
1.2 The MASH market will grow significantly during the forecast period, reaching sales of $20.2 billion in 2032
1.3 R&D strategies in MASH include unique MOAs, staging of MASH, and exploring combination therapies
1.4 More approved treatment options and use of non-invasive diagnosis options remain the greatest unmet needs in the MASH space
1.5 Opportunity for non-invasive tests to be at the forefront of MASH patient diagnosis and management
1.6 Innovative pipeline products demonstrating high levels of effectiveness and tolerable safety profiles will acquire large market share
1.7 What do physicians think?
2 Introduction
2.1 Catalyst
2.2 Related reports
2.3 Upcoming reports
3 Disease Overview
3.1 Etiology and pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or staging systems
4 Epidemiology
4.1 Disease background
4.2 Risk factors and comorbidities
4.3 Global and historical trends
4.4 Forecast methodology
4.4.1 Sources
4.4.2 Forecast assumptions and methods
4.4.3 Forecast assumptions and methods: diagnosed prevalent cases of MASLD
4.4.4 Forecast assumptions and methods: total prevalent cases of MASLD
4.4.5 Forecast assumptions and methods: diagnosed prevalent cases of MASH
4.4.6 Forecast assumptions and methods: diagnosed prevalent cases of MASH by fibrosis stage
4.4.7 Forecast assumptions and methods: diagnosed prevalent cases of MASH with compensated and decompensated cirrhosis
4.5 Epidemiological forecast for MASH (2022-32)
4.5.1 Diagnosed prevalent cases of MASH
4.5.2 Age-specific diagnosed prevalent cases of MASH
4.5.3 Sex-specific diagnosed prevalent cases of MASH
4.5.4 Diagnosed prevalent cases of MASH by fibrosis stage
4.5.5 Diagnosed prevalent cases of cirrhosis attributable to MASH
4.6 Discussion
4.6.1 Epidemiological forecast insight
4.6.2 Obesity omission
4.6.3 COVID-19 impact
4.6.4 Limitations of the analysis
4.6.5 Strengths of the analysis
5 Disease Management
5.1 Diagnosis overview
5.2 Treatment
5.2.1 Rezdiffra
5.2.2 Vitamin E
5.2.3 Pioglitazone
5.3 Guidelines
5.4 Key opinion leader insights on disease management
5.4.1 Guidelines on diagnosis and non-invasive testing
5.4.2 Guidelines on treatment
6 Competitive Assessment
6.1 Overview
7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Need for more approved therapies
7.3 Cost-efficient non-invasive tests for patient monitoring and potential diagnosis
7.4 Understanding of MASH pathophysiology
7.5 Cost-effective novel therapies and improved access
8 R&D Strategies
8.1 Overview
8.1.1 Combination therapies to target multiple pathways
8.1.2 Differential targeting of early- and late-stage NASH
8.1.3 Use of AI to facilitate drug discovery and to standardize histologic scoring
8.2 Clinical trials design
8.2.1 Patient selection
8.2.2 Clinically meaningful endpoints and study period
8.2.3 Employing biomarkers to measure therapeutic response
9 Pipeline Assessment
9.1 Overview
9.2 Promising drugs in clinical development
10 Pipeline Valuation Analysis
10.1 Overview
10.2 Competitive assessment
11 Current and Future Players
11.1 Overview
11.2 Deal-making trends
12 Market Outlook
12.1 Global markets
12.1.1 Forecast
12.1.2 Drivers and barriers - global issues
12.2 US
12.2.1 Forecast
12.2.2 Key events
12.2.3 Drivers and barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key events
12.3.3 Drivers and barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key events
12.4.3 Drivers and barriers
13 Appendix
13.1 Bibliography
13.2 Abbreviations
13.3 Methodology
13.3.1 Forecasting methodology
13.4 Primary research - KOLs and payers interviewed for this report
13.4.1 KOLs
13.4.2 Payer(s)
13.5 Primary research - prescriber survey
13.6 About the authors
13.6.1 Analyst
13.6.2 Managing Analyst
13.6.3 Therapy Area Director
13.6.4 Epidemiologist
13.6.5 Managing Epidemiologist
13.6.6 Vice President of Disease Intelligence and Epidemiology
13.6.7 Global Head of Pharma Research, Analysis, and Competitive Intelligence
  • About the Analyst
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Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Kowa Co Ltd
  • GSK plc
  • Eli Lilly and Co
  • Ionis Pharmaceuticals Inc
  • Hanmi Pharmaceuticals Co Ltd
  • Alnylam Pharmaceuticals Inc
  • Sagimet Biosciences Inc
  • Altimmune Inc
  • Madrigal Pharmaceuticals Inc
  • Corcept Therapeutics Inc
  • BioVie Inc
  • Gilead Sciences
  • Zydus Lifesciences Ltd
  • Boehringer Ingelheim
  • Galectin Therapeutics Inc
  • Poxel SA
  • Viking Therapeutics Inc
  • Boston Pharmaceuticals Inc
  • NorthSea Therapeutics BV
  • Akero Therapeutics Inc
  • D&D Pharmatech Co Ltd
  • 89bio Inc
  • HighTide Therapeutics Inc
  • Rivus Pharmaceuticals Inc
  • Regeneron GmbH