The Alcohol-associated Liver Disease (ALD) Market is projected to witness outstanding expansion during the forecast period, driven by gradual therapeutic innovation, rising disease awareness, and increasing emphasis on targeted, mechanism-based treatment approaches. The anticipated emergence of mid-stage therapies such as Larsucosterol (DUR-928) (Bausch Health), GSK4532990 (GSK), INT-787 [Alfasigma (Intercept Pharmaceuticals)], Pemvidutide (Altimmune), NTR-101 (Nterica), and others is expected to intensify competition across the ALD treatment landscape through 2036.

According to DelveInsight's recently published Alcohol-associated Liver Disease Market Insights report, the report provides a comprehensive assessment of current treatment practices, emerging therapies, individual therapy market shares, epidemiology, and historical and forecasted market sizes from 2022 to 2036 across the 7MM, comprising the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Alcohol-associated Liver Disease Market Key Highlights

  • The ALD market in the 7MM was valued at approximately USD 145 million in 2025.
  • The United States represented approximately 59% of the total 7MM ALD market in 2025.
  • The total number of diagnosed prevalent cases of ALD across the 7MM reached approximately 12.1 million in 2025.
  • Leading companies developing ALD therapies include Bausch Health, GSK, Alfasigma (Intercept Pharmaceuticals), Altimmune, Nterica, and others.
  • Promising therapies in clinical development include Larsucosterol (DUR-928), GSK4532990, INT-787, Pemvidutide, NTR-101, and others.
  • Larsucosterol is estimated to generate the highest ALD therapy revenue in the United States by 2036.
  • The ALD market is projected to grow at a CAGR of 31.1% during 2026–2036.

Discover the future of the Alcohol-associated Liver Disease treatment market @ Alcohol-associated Liver Disease Market Report

Key Factors Driving the Alcohol-associated Liver Disease Market

Rising Global Alcohol Consumption and Changing Drinking Patterns

Increasing alcohol consumption and changing drinking patterns remain important contributors to the growing burden of ALD. Rising alcohol use among women, combined with potential biological differences in susceptibility to liver injury, further underscores the need for targeted and scalable treatment approaches.

Increasing Overlap Between ALD, Obesity, and Metabolic Dysfunction

The growing recognition of the relationship between ALD and metabolic conditions such as obesity and insulin resistance is creating opportunities for metabolic-focused treatments. GLP-1-based therapies and combination approaches could become increasingly relevant as researchers explore the interaction between alcohol-related and metabolic liver injury.

Emergence of Microbiome-based and Precision Medicine Approaches

The ALD pipeline is gradually moving toward mechanism-based therapies targeting inflammation, fibrosis, metabolic dysfunction, and other disease drivers. This shift reflects increasing interest in precision medicine and innovative therapeutic modalities for patients with substantial unmet medical needs.

Diversification of Therapeutic Approaches

The emerging ALD landscape extends beyond traditional corticosteroid-based management and includes diverse approaches such as GLP-1/glucagon dual agonists, FXR agonists, RNA interference therapies, and microbiome-directed therapies. These candidates are designed to address upstream mechanisms involving metabolism, inflammation, fibrosis, and microbial dysbiosis.

Expected Launch of Emerging ALD Therapies

The ALD market is expected to evolve as emerging therapies progress through clinical development and potentially reach the market. Key candidates include Larsucosterol (DUR-928), GSK4532990, INT-787, Pemvidutide, NTR-101, and others.

Alcohol-associated Liver Disease Market Analysis

Management of ALD remains largely supportive and depends on disease severity, with long-term alcohol abstinence serving as a cornerstone of care.

For patients with severe alcohol-associated hepatitis, corticosteroids may be used in selected cases, although their benefits are variable and primarily associated with short-term survival. Nutritional support, management of complications, and multidisciplinary care remain important components of treatment.

For eligible patients with advanced disease and liver failure, liver transplantation remains the most effective strategy for significantly improving survival.

Despite the considerable clinical and socioeconomic burden of ALD, there are currently no FDA-approved therapies that directly modify the underlying disease progression. Existing treatment approaches primarily focus on managing symptoms, preventing complications, and addressing the consequences of progressive liver injury.

The therapeutic landscape is nevertheless evolving, with investigational candidates advancing through early- and mid-stage clinical development. These therapies aim to address key disease mechanisms involving metabolic dysfunction, inflammation, fibrosis, and other pathological processes.

Alcohol-associated Liver Disease Competitive Landscape

The ALD pipeline includes several investigational therapies with differentiated mechanisms of action. Key candidates include:

Bausch Health's Larsucosterol (DUR-928)

Larsucosterol is an endogenous sulfated oxysterol and epigenetic regulator designed to inhibit DNA methyltransferases (DNMT1, DNMT3a, and DNMT3b). Through its effects on inflammatory signaling, lipid metabolism, and cellular stress pathways, the therapy is being developed to reduce liver injury and support liver repair in alcohol-associated hepatitis.

The US FDA has granted larsucosterol Fast Track and Breakthrough Therapy designations. A Phase III study in severe alcoholic hepatitis was initiated in early 2026, with topline results anticipated in 2028. Based on the projected primary completion timeline, regulatory approval could potentially occur in early 2029, followed by a commercial launch later that year.

GSK's GSK4532990

GSK4532990 is an investigational RNA interference (RNAi) therapy targeting HSD17B13, a gene associated with susceptibility to liver disease.

By reducing hepatic HSD17B13 expression, the therapy aims to replicate protective effects associated with loss-of-function variants and potentially reduce liver inflammation and injury. GSK4532990 is currently being evaluated in Phase II clinical development for ALD under an exclusive licensing agreement with Arrowhead Pharmaceuticals.

INT-787

INT-787 is a next-generation oral farnesoid X receptor (FXR) agonist initially developed by Intercept Pharmaceuticals and subsequently incorporated into Alfasigma's liver disease portfolio following its acquisition of Intercept.

The candidate is designed to regulate metabolic, inflammatory, and fibrotic pathways and is currently being evaluated in the Phase IIa FRESH trial for severe alcoholic hepatitis.

Pemvidutide

Pemvidutide, developed by Altimmune, represents an emerging metabolic approach within the ALD pipeline. Its development reflects growing interest in therapies that may address the metabolic dysfunction associated with liver disease.

NTR-101

NTR-101 represents another emerging candidate in the ALD pipeline and contributes to the increasing diversification of treatment approaches being investigated for this high-unmet-need disease area.

The anticipated development and potential launch of these therapies could significantly influence the ALD market landscape over the coming years, particularly if clinical trials demonstrate meaningful improvements in disease outcomes.

Discover more about emerging ALD pipeline therapies @ Alcohol-associated Liver Disease Drugs

Recent Developments in the Alcohol-associated Liver Disease Market

  • March 2026: Altimmune announced that the use of pemvidutide for ALD, including reducing liver fibrosis, is protected under a pending US provisional patent application. The company plans to pursue a non-provisional US application and corresponding international PCT filing.
  • November 2025: GSK presented updates from its liver disease pipeline, including GSK4532990 for ALD, at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2025.
  • September 2025: Bausch Health Companies completed its tender offer to acquire DURECT Corporation, purchasing all outstanding shares for USD 1.75 per share in cash, representing approximately USD 63 million upfront, with additional milestone payments potentially reaching USD 350 million based on future net sales.

What Is Alcohol-associated Liver Disease?

Alcohol-associated liver disease refers to a spectrum of liver disorders associated with excessive and prolonged alcohol consumption. The disease can range from alcohol-associated steatosis and hepatitis to fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma.

Chronic alcohol exposure can disrupt liver metabolism and contribute to fat accumulation, inflammation, oxidative stress, and progressive liver scarring. Early-stage disease may improve with alcohol cessation, while advanced disease can result in irreversible liver damage and serious complications.

ALD remains a significant global health burden, with disease risk influenced by factors including alcohol consumption patterns, genetics, obesity, viral hepatitis, and nutritional status.

Alcohol-associated Liver Disease Epidemiology

According to DelveInsight's estimates, the total number of diagnosed prevalent cases of ALD in the 7MM was approximately 12.1 million in 2025.

In the United States, among stage-specific diagnosed prevalent cases of ALD, alcohol-associated steatosis accounted for approximately 3.2 million cases in 2025, followed by alcohol-associated steatohepatitis and alcohol-associated cirrhosis.

The ALD epidemiology analysis covers:

  • Total diagnosed prevalent cases of ALD
  • Stage-specific diagnosed prevalent cases of ALD
  • Gender-specific diagnosed prevalent cases of ALD
  • Diagnosed prevalent cases of ALD by fibrosis stage
  • Diagnosed prevalent cases of ALD by fatty liver grade
  • Total prevalent cases of alcohol use disorder in ALD
  • Total treated cases of ALD

Alcohol-associated Liver Disease Market Report Metrics

  • Study Period: 2022–2036
  • Geographical Coverage: 7MM, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan
  • ALD Market CAGR: 31.1% during 2026–2036
  • ALD Market Size in 2025: Approximately USD 145 million
  • Projected ALD Market Size by 2036: Approximately USD 2.2 billion
  • Key Companies: Bausch Health, GSK, Alfasigma (Intercept Pharmaceuticals), Evive Biotech, Altimmune, Nterica, and others
  • Key Therapies: Larsucosterol (DUR-928), GSK4532990, INT-787, F-652, Pemvidutide, NTR-101, and others

Scope of the Alcohol-associated Liver Disease Market Report

The report provides comprehensive insights into:

  • Alcohol-associated Liver Disease patient population forecast
  • Alcohol-associated Liver Disease therapeutics market size
  • Alcohol-associated Liver Disease pipeline analysis
  • Alcohol-associated Liver Disease market size and trends
  • Alcohol-associated Liver Disease market opportunities
  • Alcohol-associated Liver Disease unmet needs
  • Key opinion leader (KOL) perspectives
  • Market access and reimbursement
  • Competitive landscape and emerging therapies

Download the report to understand emerging ALD therapies and market trends @ Alcohol-associated Liver Disease Market Analysis

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About DelveInsight

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