Metabolic Dysfunction-Associated Steatohepatitis (MASH): Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2032

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This report covers the 7 major markets and provides an Excel-based forecast model for the Metabolic Dysfunction-Associated Steatohepatitis (MASH) market through 2032.

GlobalData 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.

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

Table of Contents

List of Contents

List of Tables

List of Figures

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

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