Chapter 1: Preface

• 1.1 Report Description

• 1.2 Scope of the Study

• 1.3 Research Objectives

• 1.4 Key Assumptions

• 1.5 Currency and Measurements Used in the Report

Chapter 2: Executive Summary

• 2.1 Global THR-β Agonist Market — Snapshot

• 2.2 Key Findings by Segment

• 2.3 Key Findings by Region

• 2.4 Analyst Recommendations

Chapter 3: Market Overview and Introduction

• 3.1 Introduction to THR-β Agonists

  • 3.1.1 Definition, Mechanism of Action, and Concept

  • 3.1.2 Thyroid Hormone Receptor Beta (TRβ) — Biological Background

  • 3.1.3 Differentiation from Non-Selective Thyroid Hormone Therapies

  • 3.1.4 Role of THR-β Agonists in Metabolic and Liver Disease Management

• 3.2 Historical Evolution of THR-β Agonist Development

  • 3.2.1 Early Thyromimetic Drug Candidates (Sobetirome, Eprotirome) and Lessons Learned

  • 3.2.2 Emergence of Liver-Selective and Isoform-Selective TRβ Agonist Design

  • 3.2.3 Transition from Investigational to Commercially Approved Therapy

• 3.3 Regulatory and Standards Landscape

  • 3.3.1 FDA Regulatory Framework for MASH Drug Approvals

  • 3.3.2 EMA and European Regulatory Pathways

  • 3.3.3 PMDA (Japan) and Asia-Pacific Regulatory Considerations

  • 3.3.4 Histologic and Non-Invasive Endpoint Guidelines (EASL, AASLD)

• 3.4 Value Chain Analysis

  • 3.4.1 Drug Discovery and Preclinical Research Organizations

  • 3.4.2 Clinical-Stage Biotechnology Companies

  • 3.4.3 Commercial-Stage Pharmaceutical Manufacturers

  • 3.4.4 Diagnostic and Non-Invasive Testing Providers (FibroScan, MRI-PDFF)

  • 3.4.5 Specialty Pharmacy and Distribution Networks

  • 3.4.6 Payers, HTA Bodies, and Reimbursement Gatekeepers

  • 3.4.7 End Users: Hepatologists, Gastroenterologists, Endocrinologists, and Patients

Chapter 4: Market Dynamics

• 4.1 Market Drivers

  • 4.1.1 High Unmet Medical Need in Metabolic Dysfunction-Associated Steatohepatitis (MASH/MASLD)

  • 4.1.2 First-in-Class FDA Approval of Resmetirom (Rezdiffra) Creating a New Therapeutic Category

  • 4.1.3 Rapid Adoption of Non-Invasive Diagnostics (FibroScan, MRI-PDFF, FIB-4) Expanding Eligible Patient Pool

  • 4.1.4 Rising Global Prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD), Obesity, and Type 2 Diabetes

  • 4.1.5 Growing Preference for Oral Liver-Targeted Therapies Over Injectable Alternatives

  • 4.1.6 Expanding Payer Coverage and Reimbursement Frameworks in High-Income Regions

  • 4.1.7 Increasing Research into Combination Therapy Regimens (THR-β + GLP-1 / PPAR Agonists)

  • 4.1.8 Advances in Trial Design Using Surrogate Biomarker and Imaging Endpoints

  • 4.1.9 Growing Geriatric Population and Rising Burden of Metabolic Disorders Globally

  • 4.1.10 Personalized Medicine Trends Driving Precision Eligibility Strategies

• 4.2 Market Restraints

  • 4.2.1 Majority of Global MASH Patients Remaining Undiagnosed

  • 4.2.2 High Cost of Long-Term Therapy and Affordability Constraints in Emerging Markets

  • 4.2.3 Cardiovascular and Thyroid Off-Target Safety Risks Requiring Ongoing Surveillance

  • 4.2.4 Complex Prior Authorization Requirements and Payer Step-Edit Processes

  • 4.2.5 Competitive Displacement Risk from GLP-1 Agonist and Combination Regimen Therapies

  • 4.2.6 Lessons from Past Thyromimetic Failures Increasing Regulatory Vigilance

  • 4.2.7 Limited Specialist Infrastructure in Low- and Middle-Income Countries

• 4.3 Market Opportunities

  • 4.3.1 Label Expansion into F4 (Cirrhosis) Patient Populations Pending Outcomes Data

  • 4.3.2 Commercialization Potential in Japan, Germany, UK, and Other High-Access Markets

  • 4.3.3 Development of Rezdiffra-Based Combination Therapy Protocols

  • 4.3.4 Rising Adoption in Commercial and Private Healthcare Networks in Asia-Pacific

  • 4.3.5 Integration of THR-β Agonists into Primary Care Screening Programs via NIT Workflows

  • 4.3.6 Licensing, Co-Promotion, and Regional Commercialization Partnership Opportunities

  • 4.3.7 Outcomes-Based Contracting Models with Payers Supporting Long-Term Market Sustainability

• 4.4 Market Challenges

  • 4.4.1 Demonstrating Long-Term Fibrosis Benefit and Cardiovascular Safety in Real-World Settings

  • 4.4.2 Market Education Gaps Among Primary Care Physicians and Endocrinologists

  • 4.4.3 Standardization of Fibrosis Staging Across Global Health Systems

  • 4.4.4 Treatment Persistence and Adherence in Chronic Therapy Settings

• 4.5 Porter's Five Forces Analysis

  • 4.5.1 Bargaining Power of Buyers

  • 4.5.2 Bargaining Power of Suppliers

  • 4.5.3 Threat of New Entrants

  • 4.5.4 Threat of Substitutes

  • 4.5.5 Competitive Rivalry

• 4.6 PEST Analysis

  • 4.6.1 Political Factors

  • 4.6.2 Economic Factors

  • 4.6.3 Social Factors

  • 4.6.4 Technological Factors

Chapter 5: Global Epidemiology and Patient Population Analysis

• 5.1 Global MASLD and MASH Patient Base

  • 5.1.1 Total MASLD Prevalence and Global Distribution

  • 5.1.2 Progression Rates from MASLD to MASH

  • 5.1.3 Diagnosed vs. Undiagnosed Patient Populations

• 5.2 Fibrosis-Stratified Patient Distribution

  • 5.2.1 F0–F1 Patient Population

  • 5.2.2 F2 MASH Patient Population (Moderate Fibrosis)

  • 5.2.3 F3 MASH Patient Population (Pre-Cirrhotic, High Clinical Urgency)

  • 5.2.4 F4 Cirrhosis Patient Population

• 5.3 THR-β Agonist–Eligible Patient Pool

  • 5.3.1 Non-Cirrhotic MASH Patients in Scope (F2–F3)

  • 5.3.2 Exclusion Criteria and Contraindications

  • 5.3.3 Net Addressable Patient Population

• 5.4 Regional Epidemiology

  • 5.4.1 North America

  • 5.4.2 Europe

  • 5.4.3 Asia Pacific

  • 5.4.4 Middle East and Africa

  • 5.4.5 South America

• 5.5 Epidemiology by Key Countries

  • 5.5.1 United States

  • 5.5.2 EU5 (Germany, France, Italy, Spain, United Kingdom)

  • 5.5.3 Japan

  • 5.5.4 China

  • 5.5.5 India

Chapter 6: Current Treatment Landscape and Standard of Care

• 6.1 Lifestyle and Metabolic Management Practices

  • 6.1.1 Weight Loss Interventions and Dietary Modifications

  • 6.1.2 Management of Comorbid Diabetes, Obesity, and Dyslipidemia

• 6.2 Off-Label and Emerging Pharmacologic Treatment Patterns

  • 6.2.1 GLP-1 Receptor Agonists and Their Role in MASH Management

  • 6.2.2 PPAR Agonists and FGF21 Analog Programs

  • 6.2.3 Vitamin E, Pioglitazone, and Other Metabolic Agents

• 6.3 Approved THR-β Agonist Therapy — Rezdiffra (Resmetirom)

  • 6.3.1 Mechanism of Action and Liver-Selective Targeting

  • 6.3.2 Clinical Efficacy: MAESTRO-NASH Pivotal Trial Outcomes

  • 6.3.3 Safety and Tolerability Profile

  • 6.3.4 FDA Approval Status, Label Scope, and Approved Patient Population

  • 6.3.5 Positioning in Clinical Practice by Fibrosis Stage

• 6.4 Remaining Treatment Gaps

  • 6.4.1 Patient Segments Not Yet Addressable

  • 6.4.2 Limitations of Current Standard of Care

Chapter 7: Global THR-β Agonist Market — By Drug Type / Asset Class

• 7.1 Overview and Definition

• 7.2 Approved THR-β Agonists

  • 7.2.1 Market Overview and Revenue Contribution

  • 7.2.2 Market Attractiveness and Growth Analysis

• 7.3 Clinical-Stage THR-β Agonists (Phase II / Phase III)

  • 7.3.1 Market Overview and Pipeline Revenue Potential

  • 7.3.2 Market Attractiveness and Growth Analysis

• 7.4 Combination Therapy (THR-β Agonist–Based Regimens)

  • 7.4.1 Market Overview

  • 7.4.2 THR-β + GLP-1 Agonist Combination Potential

  • 7.4.3 THR-β + PPAR or FGF21 Combination Approaches

  • 7.4.4 Market Attractiveness and Growth Analysis

Chapter 8: Global THR-β Agonist Market — By Fibrosis Stage

• 8.1 Overview and Definition

• 8.2 F2 MASH (Moderate Fibrosis)

  • 8.2.1 Market Overview and Clinical Profile

  • 8.2.2 Market Attractiveness and Growth Analysis

• 8.3 F3 MASH (Pre-Cirrhotic, Severe Fibrosis)

  • 8.3.1 Market Overview and Clinical Profile

  • 8.3.2 Market Attractiveness and Growth Analysis

• 8.4 Potential Expansion to F4 (Cirrhosis) Stage

  • 8.4.1 Current Exclusion and Label Constraints

  • 8.4.2 Potential Future Eligibility Based on Outcomes Data

Chapter 9: Global THR-β Agonist Market — By Diagnosis Pathway

• 9.1 Overview and Definition

• 9.2 Biopsy-Confirmed Patients

  • 9.2.1 Market Overview

  • 9.2.2 Declining Utilization Trends and Clinical Challenges

  • 9.2.3 Market Attractiveness and Growth Analysis

• 9.3 Non-Invasive Test (NIT)–Confirmed Patients

  • 9.3.1 FibroScan (Transient Elastography)

  • 9.3.2 MRI-PDFF and MR Elastography

  • 9.3.3 Blood-Based Panels (FIB-4, ELF Score)

  • 9.3.4 Market Attractiveness and Growth Analysis

• 9.4 NIT Adoption as a Market Expansion Lever

  • 9.4.1 Changes to Payer Eligibility Thresholds

  • 9.4.2 Treated Patient Upside Scenarios with NIT Scale-Up

Chapter 10: Global THR-β Agonist Market — By Treatment Setting

• 10.1 Overview and Definition

• 10.2 Hepatology and Gastroenterology Clinics

  • 10.2.1 Market Overview

  • 10.2.2 Role as Frontline Prescribers

  • 10.2.3 Market Attractiveness and Growth Analysis

• 10.3 Metabolic and Endocrinology Practices

  • 10.3.1 Market Overview

  • 10.3.2 Emergence as Second-Tier Prescribers

  • 10.3.3 Market Attractiveness and Growth Analysis

• 10.4 Tertiary Hospitals and Academic Medical Centers

  • 10.4.1 Market Overview

  • 10.4.2 Role in Complex Case Management and Real-World Evidence Generation

  • 10.4.3 Market Attractiveness and Growth Analysis

• 10.5 Community Health Networks and Integrated Delivery Networks (IDNs)

  • 10.5.1 Market Overview

  • 10.5.2 Adoption Constraints and Scale Potential

  • 10.5.3 Market Attractiveness and Growth Analysis

Chapter 11: Global THR-β Agonist Market — By Application

• 11.1 Overview and Definition

• 11.2 Metabolic Dysfunction-Associated Steatohepatitis (MASH / MASLD)

  • 11.2.1 Market Overview

  • 11.2.2 Liver Fat Reduction and Fibrosis Resolution Outcomes

  • 11.2.3 Market Attractiveness and Growth Analysis

• 11.3 Metabolic Diseases (Lipid Disorders and Dyslipidemia)

  • 11.3.1 Market Overview

  • 11.3.2 THR-β Agonists as Lipid-Lowering Agents

  • 11.3.3 Market Attractiveness and Growth Analysis

• 11.4 Cardiovascular Disease

  • 11.4.1 Market Overview

  • 11.4.2 Role in Reduction of Atherosclerotic and Metabolic Cardiovascular Risk

  • 11.4.3 Market Attractiveness and Growth Analysis

• 11.5 Thyroid-Related Disorders

  • 11.5.1 Market Overview

  • 11.5.2 Historical and Emerging Therapeutic Applications

  • 11.5.3 Market Attractiveness and Growth Analysis

• 11.6 Other Applications

  • 11.6.1 Obesity and Metabolic Syndrome

  • 11.6.2 Pediatric MASH (Off-Label and Research Use)

Chapter 12: Global THR-β Agonist Market — By Region

• 12.1 Overview

• 12.2 North America

  • 12.2.1 Market Overview

  • 12.2.2 United States

  • 12.2.3 Canada

  • 12.2.4 Mexico

• 12.3 Europe

  • 12.3.1 Market Overview

  • 12.3.2 Germany

  • 12.3.3 United Kingdom

  • 12.3.4 France

  • 12.3.5 Italy

  • 12.3.6 Spain

  • 12.3.7 Netherlands

  • 12.3.8 Rest of Europe

• 12.4 Asia Pacific

  • 12.4.1 Market Overview

  • 12.4.2 Japan

  • 12.4.3 China

  • 12.4.4 India

  • 12.4.5 South Korea

  • 12.4.6 Australia

  • 12.4.7 Taiwan, Indonesia, and Southeast Asia

  • 12.4.8 Rest of Asia Pacific

• 12.5 Middle East and Africa

  • 12.5.1 Market Overview

  • 12.5.2 Saudi Arabia

  • 12.5.3 United Arab Emirates

  • 12.5.4 South Africa

  • 12.5.5 Egypt, Nigeria, and Turkey

  • 12.5.6 Rest of Middle East and Africa

• 12.6 South America

  • 12.6.1 Market Overview

  • 12.6.2 Brazil

  • 12.6.3 Argentina

  • 12.6.4 Mexico

  • 12.6.5 Rest of South America

Chapter 13: Competitive Landscape

• 13.1 Market Concentration and Competitive Intensity Mapping

• 13.2 Market Share Analysis of Leading Players

• 13.3 Competitive Benchmarking Framework

  • 13.3.1 Drug Asset Stage and Clinical Development Progress

  • 13.3.2 Liver-Selectivity and Isoform-Selectivity Profile

  • 13.3.3 Fibrosis Endpoint and Imaging Efficacy Data

  • 13.3.4 Geographic Presence and Commercialization Reach

  • 13.3.5 R&D Investment and Innovation Pipeline

  • 13.3.6 Strategic Partnerships, Licensing Deals, and M&A Activity

• 13.4 Direct Competitive Pipeline Overview

  • 13.4.1 Resmetirom (Rezdiffra) — Madrigal Pharmaceuticals (Approved, Global Anchor)

  • 13.4.2 VK2809 — Viking Therapeutics (Phase III, Liver-Targeted Prodrug)

  • 13.4.3 TERN-501 — Terns Pharmaceuticals (Phase II, Combination-Oriented Strategy)

  • 13.4.4 ASC41 — Ascletis Pharma (Phase II, China-Focused)

  • 13.4.5 ALG-055009 — Aligos Therapeutics (Phase I)

  • 13.4.6 ECC4703 — Eccogene (Preclinical/Phase I)

• 13.5 Key Recent Developments

  • 13.5.1 Product Approvals and Commercial Launches

  • 13.5.2 Clinical Trial Milestones and Data Readouts

  • 13.5.3 Acquisitions, Mergers, and Licensing Agreements

  • 13.5.4 Collaborations, Partnerships, and Joint Ventures

  • 13.5.5 Capacity Expansions and Manufacturing Investments

Chapter 14: Company Profiles

The final report includes a complete list of companies

• Madrigal Pharmaceuticals, Inc.

  • Company Overview

  • Financial Performance

  • Product Portfolio

  • Strategic Initiatives

  • SWOT Analysis

• Viking Therapeutics, Inc.

• Terns Pharmaceuticals, Inc.

• Ascletis Pharma Inc.

• Aligos Therapeutics, Inc.

• Eccogene Co., Ltd.

• Eli Lilly and Company

• Novo Nordisk A/S

• AstraZeneca PLC

• Gilead Sciences, Inc.

• Bristol-Myers Squibb Company

• Pfizer Inc.

• Boehringer Ingelheim GmbH

• Intercept Pharmaceuticals, Inc.

• Inventiva Pharma S.A.

Chapter 15: Appendix

• Research Methodology Detail

  • Secondary Research Sources

  • Primary Research Approach

  • Data Triangulation and Validation Process

  • Assumptions and Limitations

• List of Abbreviations

• List of Tables and Figures

• Related Market Reports

Chapter 16: Disclaimer