알코올성 간염 치료 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the alcoholic hepatitis treatment market size is expected to increase from USD 3.27 billion in 2025 to USD 3.45 billion in 2026 and reach USD 4.96 billion by 2031, growing at a CAGR of 7.49% over 2026-2031.

Global Alcoholic Hepatitis Treatment Market Trends and Insights

Rising Alcohol-Associated Liver Disease Burden

The growing burden of alcohol-related liver disease enlarges the patient pool for the alcoholic hepatitis treatment market. The rising prevalence of alcohol use disorder across the globe is boosting the demand and market growth. According to the American Liver Foundation, alcohol-associated liver disease (ALD) accounted for 5.1% of the global burden of disease and injury. This change complicates treatment development because earlier studies often enrolled predominantly male populations. The projected economic impact of alcohol-related liver disease in the United States could double by 2040 without intervention, which supports continued demand for prevention, hospital care, and treatment pathways.

Increasing Clinical Investment in Disease-Modifying Therapies

Clinical investment is widening the development pipeline for the alcoholic hepatitis treatment market. The Phase 3 LCAH3141 study of larsucosterol is recruiting 350 participants with alcohol-associated hepatitis, making it the most advanced registrational program. The FDA has agreed that one successful pivotal study could support a New Drug Application for larsucosterol, which reduces the usual requirement for two positive trials. The candidate has FDA Breakthrough Therapy and Fast Track designations, which can support a more efficient review process. Aldeyra Therapeutics reported statistically significant MELD score improvement with ADX-629 in October 2025, adding another mechanism to the clinical pipeline.

Absence of an Approved Disease-Modifying Therapy

The lack of an approved disease-modifying therapy remains the main constraint on the alcoholic hepatitis treatment market. Clinicians rely on off-label corticosteroids and supportive care because neither the FDA nor the EMA has approved a specific therapy for alcohol-associated hepatitis. This limits structured commercialization and makes reimbursement less predictable, especially in price-sensitive health systems. Health technology assessment bodies in Europe and Asia-Pacific also need strong comparative data before supporting off-label treatment at scale. Intercept Pharmaceuticals ended the Phase 2a FRESH study of INT-787 in March 2026 after finding no clear evidence of potential benefit. The result shows why durable clinical evidence is necessary before the alcoholic hepatitis treatment market can move beyond its current care model.

Other drivers and restraints analyzed in the detailed report include:

1. Guideline-Based Severity Scoring and Treatment Adoption
2. Expansion of Hospital-Based Severe Disease Management
3. Limited Durability and Infection Risk of Corticosteroids

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Pharmacological therapy held 73.23% of the alcoholic hepatitis treatment market share in 2025. The segment remains central because corticosteroid-based protocols are established in hospital practice and alternative therapies are not yet available at scale. Nutritional and supportive care supplies a stable base through enteral nutrition and zinc supplementation.

Stem cell therapy is forecast to grow at a 12.34% CAGR from 2026 to 2031. This treatment type has drawn interest from mesenchymal stem cell programs that have reported safety findings and early efficacy signals in alcohol-related liver disease. A 2025 real-world study reported an adjusted hazard ratio of 0.14 for 5-year mortality after bone marrow-derived mesenchymal stem cell transplantation in matched cohorts with decompensated liver cirrhosis.

Corticosteroids held 38.34% of the alcoholic hepatitis treatment market share in 2025. Prednisolone remains the main drug in established treatment protocols for patients meeting severe-disease criteria. Hemorheologic agents, including pentoxifylline, have seen lower use after evidence questioned their benefit beyond corticosteroids alone. Antioxidants and hepatoprotective agents retain an adjunct role, particularly N-acetylcysteine in the PROCORNAC study.

Monoclonal antibodies are forecast to expand at a 13.42% CAGR through 2031. Programs in this class include agents that target IL-1, TNF, fibrosis pathways, the gut-liver axis, and epigenetic dysregulation. The commercial outlook remains uncertain because canakinumab did not improve clinical or biochemical outcomes in a Phase 2 study.

Acute alcoholic hepatitis accounted for 78.34% of the disease-type segment in 2025. It was also reported as the fastest-growing disease-type sub-segment, with a 8.78% CAGR from 2026 to 2031. Acute episodes are the main point for clinical intervention because patients often require hospital treatment and are eligible for therapeutic trials. Severe cases are typically defined using measures such as MDF scores of 32 or higher or MELD scores of 21 to 30. This defined clinical profile helps investigators enroll patients and assess treatment outcomes consistently. As a result, acute disease remains the primary focus for commercial development in the alcoholic hepatitis treatment market.

Chronic alcoholic hepatitis generates demand through ongoing alcohol use disorder treatment, hepatoprotective medicines, and nutrition programs. It does not carry the same immediate inpatient urgency as acute disease, which limits high-value hospitalization spending. A June 2026 natural-history study reported a high incidence of combined liver and alcohol-use events within 6 months of an alcohol-associated hepatitis presentation.

Complete Report Scope:

• By Treatment Type
  • Pharmacological Therapy
  • Stem Cell Therapy
  • Nutritional & Supportive Care
• By Drug Class
  • Corticosteroids
  • Hemorheologic Agents
  • Monoclonal Antibodies
  • Antioxidants & Hepatoprotective Agents
  • Alcohol Use Disorder Medications
  • Other Drug Classes
• By Disease Type
  • Acute Alcoholic Hepatitis
  • Chronic Alcoholic Hepatitis
• By Disease Severity
  • Mild Alcoholic Hepatitis
  • Moderate Alcoholic Hepatitis
  • Severe Alcoholic Hepatitis
• By Route of Administration
  • Oral
  • Parenteral
• By End User
  • Hospitals
  • Specialty Liver Clinics
  • Transplant Centers
  • Private Treatment Centers
  • Other End Users
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Other Distribution Channels
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 42.34% of the alcoholic hepatitis treatment market size in 2025. The United States supports this position through an estimated 164,000 annual hospital admissions for alcohol-associated hepatitis. The region has a favorable development setting because larsucosterol has an FDA Breakthrough Therapy Designation and is being studied in a U.S.-focused regulatory pathway.

Europe is the second-largest regional block in the supply of material, led by Germany, France, the United Kingdom, and Italy. EASL-aligned clinical practice gives health systems a consistent framework for identifying and managing severe disease. University Hospital Lille began the PROCORNAC Phase 3 study in May 2026, showing the strength of Europe's academic trial infrastructure.

Asia-Pacific is forecast to grow at an 11.36% CAGR through 2031, the fastest regional rate in the alcoholic hepatitis treatment market. China and India are important opportunities because alcohol use disorder prevalence is rising, and hospital hepatology capacity is improving. Central Asia had the highest global incidence and death rates for alcohol-related liver disease.

1. Abbvie
2. Alkermes plc
3. AstraZeneca
4. Bausch Health
5. Cipla
6. DURECT Corporation
7. Roche
8. Genfit S.A.
9. Gilead Sciences
10. Intercept Pharmaceuticals
11. Johnson & Johnson
12. Mallinckrodt Pharmaceuticals
13. Merck
14. Novartis
15. Pfizer
16. Sanofi
17. Teva Pharmaceutical Industries
18. Viatris
19. Viking Therapeutics, Inc.
20. Zydus Lifesciences Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Alcohol-Associated Liver Disease Burden
  • 4.2.2 Expansion of Hospital-Based Severe Disease Management
  • 4.2.3 Increasing Clinical Investment in Disease-Modifying Therapies
  • 4.2.4 Guideline-Based Severity Scoring and Treatment Adoption
  • 4.2.5 Integrated Alcohol Use Disorder and Hepatology Care Pathways
  • 4.2.6 Earlier Referral for Selected Liver Transplantation Candidates
• 4.3 Market Restraints
  • 4.3.1 Absence of an Approved Disease-Modifying Therapy
  • 4.3.2 Limited Durability and Infection Risk of Corticosteroids
  • 4.3.3 Underdiagnosis and Low Uptake of Alcohol Use Disorder Treatment
  • 4.3.4 Trial Endpoint and Patient-Heterogeneity Risk
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Treatment Type
  • 5.1.1 Pharmacological Therapy
  • 5.1.2 Stem Cell Therapy
  • 5.1.3 Nutritional & Supportive Care
• 5.2 By Drug Class
  • 5.2.1 Corticosteroids
  • 5.2.2 Hemorheologic Agents
  • 5.2.3 Monoclonal Antibodies
  • 5.2.4 Antioxidants & Hepatoprotective Agents
  • 5.2.5 Alcohol Use Disorder Medications
  • 5.2.6 Other Drug Classes
• 5.3 By Disease Type
  • 5.3.1 Acute Alcoholic Hepatitis
  • 5.3.2 Chronic Alcoholic Hepatitis
• 5.4 By Disease Severity
  • 5.4.1 Mild Alcoholic Hepatitis
  • 5.4.2 Moderate Alcoholic Hepatitis
  • 5.4.3 Severe Alcoholic Hepatitis
• 5.5 By Route of Administration
  • 5.5.1 Oral
  • 5.5.2 Parenteral
• 5.6 By End User
  • 5.6.1 Hospitals
  • 5.6.2 Specialty Liver Clinics
  • 5.6.3 Transplant Centers
  • 5.6.4 Private Treatment Centers
  • 5.6.5 Other End Users
• 5.7 By Distribution Channel
  • 5.7.1 Hospital Pharmacies
  • 5.7.2 Retail Pharmacies
  • 5.7.3 Online Pharmacies
  • 5.7.4 Other Distribution Channels
• 5.8 By Geography
  • 5.8.1 North America
    • 5.8.1.1 United States
    • 5.8.1.2 Canada
    • 5.8.1.3 Mexico
  • 5.8.2 Europe
    • 5.8.2.1 Germany
    • 5.8.2.2 United Kingdom
    • 5.8.2.3 France
    • 5.8.2.4 Italy
    • 5.8.2.5 Spain
    • 5.8.2.6 Rest of Europe
  • 5.8.3 Asia-Pacific
    • 5.8.3.1 China
    • 5.8.3.2 India
    • 5.8.3.3 Japan
    • 5.8.3.4 Australia
    • 5.8.3.5 South Korea
    • 5.8.3.6 Rest of Asia-Pacific
  • 5.8.4 Middle East and Africa
    • 5.8.4.1 GCC
    • 5.8.4.2 South Africa
    • 5.8.4.3 Rest of Middle East and Africa
  • 5.8.5 South America
    • 5.8.5.1 Brazil
    • 5.8.5.2 Argentina
    • 5.8.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)}
  • 6.3.1 AbbVie Inc.
  • 6.3.2 Alkermes plc
  • 6.3.3 AstraZeneca plc
  • 6.3.4 Bausch Health Companies Inc.
  • 6.3.5 Cipla Limited
  • 6.3.6 DURECT Corporation
  • 6.3.7 F. Hoffmann-La Roche Ltd
  • 6.3.8 Genfit S.A.
  • 6.3.9 Gilead Sciences, Inc.
  • 6.3.10 Intercept Pharmaceuticals, Inc.
  • 6.3.11 Johnson & Johnson
  • 6.3.12 Mallinckrodt Pharmaceuticals
  • 6.3.13 Merck & Co., Inc.
  • 6.3.14 Novartis AG
  • 6.3.15 Pfizer Inc.
  • 6.3.16 Sanofi
  • 6.3.17 Teva Pharmaceutical Industries Ltd.
  • 6.3.18 Viatris Inc.
  • 6.3.19 Viking Therapeutics, Inc.
  • 6.3.20 Zydus Lifesciences Limited

7 Market Opportunities & Future Outlook

• 7.1 White-space & unmet-need assessment