Acute on Chronic Liver Failure Market Set to Grow by 2034 as Novel Therapeutic Approaches Enter Clinical Pipeline | DelveInsight

According to DelveInsight's analysis, the acute on chronic liver failure market is anticipated to increase during the forecast period (2025–2034), owing to the launch of emerging therapies such as Genfit's VS-01, G1090N (reformulation of NTZ), SRT-015, CLM-022, VS-02-HE, Yaqrit's YAQ005, Grifols Therapeutics' ALBUTINE (Albumin 5%), and others, and healthcare spending in the 7MM.

LAS VEGAS, Dec. 8, 2025 /PRNewswire/ -- DelveInsight's Acute on Chronic Liver Failure Market Insights report includes a comprehensive understanding of current treatment practices, acute on chronic liver failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan). 

Acute on Chronic Liver Failure Market Summary

• The market size for acute on chronic liver failure in the leading markets is expected to grow significantly by 2034.
• The United States accounted for the highest acute on chronic liver failure treatment market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries, the United Kingdom, and Japan.
• In the US, infection-associated ACLF with more than two organ failures accounts for approximately 24% of cases.
• Leading acute on chronic liver failure companies developing emerging therapies, such as Genfit, Yaqrit, Grifols Therapeutics, and others, are developing new therapy for acute on chronic liver failure that can be available in the acute on chronic liver failure market in the coming years. 
• The promising acute on chronic liver failure therapies in clinical trials include VS-01, G1090N (reformulation of NTZ), SRT-015, CLM-022, VS-02-HE, YAQ005, ALBUTINE (Albumin 5%), and others.

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Key Factors Driving the Growth of the Acute on Chronic Liver Failure Market 

Rising Chronic Liver Disease Prevalence 

The increasing prevalence of chronic liver diseases such as cirrhosis, alcoholic liver disease, hepatitis (B and C), and MAFLD is leading to a larger pool of patients at risk for ACLF. This rise significantly contributes to the growing incidence of ACLF globally, which is a serious complication with high short-term mortality.

Advances in Medical Treatments

Recent progress in medical treatments, spanning innovative diagnostic tools, targeted drug therapies, and novel combination approaches, has led to improved outcomes for patients with ACLF. These advances include the introduction of new drug classes such as antivirals and immunosuppressants, along with ongoing developments in gene and cell-based therapies that aim to address unmet needs beyond traditional supportive care and organ transplantation.

Rising ACLF Clinical Trial Activities

The ACLF drug development landscape remains limited, with only a handful of companies actively advancing therapies. Genfit leads the field with four assets in its R&D pipeline, including programs currently in Phase 2. Its candidates—VS-01, G1090N (a reformulation of NTZ), SRT-015, CLM-022, and VS-02-HE—target distinct mechanisms and utilize complementary biological pathways. Beyond these, other notable ACLF candidates in clinical trials include YAQ005 (Yaqrit) and ALBUTEINE (albumin 5%) from Grifols Therapeutics, among others.

Acute on Chronic Liver Failure Market Analysis

ACLF remains a significant unmet medical need, with no approved therapies and minimal benefits from existing lifestyle-focused interventions. This multifactorial syndrome often develops in patients with underlying liver disorders such as alcohol-associated liver disease, drug-induced liver injury, or viral hepatitis. The absence of targeted pharmacological options underscores a substantial therapeutic void.

This unmet need presents a compelling opportunity for pharmaceutical innovation. Developers of the first approved therapies for ACLF stand to gain early-mover advantages, including regulatory incentives, enhanced physician adoption, and favorable market positioning. Given the condition's progressive nature and high morbidity, there is strong justification for expedited drug development and regulatory acceleration to bring effective, targeted treatments to patients sooner.

An increasing number of biopharmaceutical companies are investing in ACLF research programs, reflecting the growing recognition of the disease as a distinct and pressing clinical challenge. Focused investment in this area not only offers commercial potential but also promises to redefine patient outcomes by improving survival and quality of life. As understanding of ACLF's underlying mechanisms advances, the need for innovative, mechanism-based therapies tailored to its complex pathophysiology becomes ever more evident.

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Acute on Chronic Liver Failure Competitive Landscape

The ACLF pipeline remains narrow, with only a few companies pursuing drug development. Genfit is leading with 4 assets in research and development, including those currently in Phase 2. VS-01, G1090N (reformulation of NTZ), SRT-015, CLM-022, and VS-02-HE are all based on differentiated mechanisms of actions leveraging complementary pathways. Apart from these, the other candidates in ACLF clinical trials include YAQ005 (Yaqrit) and ALBUTEINE (albumin 5%) (Grifols Therapeutics), among others.

Genfit's VS-01 is an innovative liposomal intraperitoneal solution developed to facilitate the removal of various toxic metabolites, most notably ammonia, that accumulate in patients suffering from decompensated liver cirrhosis and hepatic encephalopathy. By promoting metabolic waste clearance, the therapy seeks to mitigate complications linked to liver impairment. The company is advancing its clinical program with the Phase IIa UNVEIL-IT study, which is evaluating the efficacy, safety, and tolerability of VS-01 in adults with ACLF.

Grifols Therapeutics' Albumin 5% is a sterile intravenous preparation derived from pooled human plasma, containing primarily albumin. It acts as a plasma volume expander, aiding in the restoration and maintenance of blood volume and serum albumin levels. By replenishing circulating albumin, it helps sustain oncotic pressure and fluid equilibrium, making it an essential therapy for patients with hypovolemia or hypoalbuminemia.

Currently, the product is being investigated in the Phase III APACHE clinical trial, which is evaluating the effect of plasma exchange with 5% human serum albumin on short-term survival in high-risk ACLF patients, with a focus on its potential to reduce in-hospital mortality.

The anticipated launch of these emerging therapies are poised to transform the acute on chronic liver failure market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the acute on chronic liver failure market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about therapy for acute on chronic liver failure @ Acute on Chronic Liver Failure Clinical Trials 

What is Acute on Chronic Liver Failure?

Acute on chronic liver failure represents a rapid and severe worsening in individuals with chronic liver disease or cirrhosis, marked by acute hepatic decompensation and failure of one or more extrahepatic organs, leading to significant morbidity and mortality. However, its diagnosis remains difficult due to the lack of universally accepted criteria and validated biomarkers. Variations in definitions across EASL and other regional guidelines further hinder early detection and clinical decision-making. Therefore, standardized diagnostic frameworks and reliable predictive tools are urgently needed to improve timely intervention and patient outcomes.

Acute on Chronic Liver Failure Epidemiology Segmentation

The acute on chronic liver failure epidemiology section provides insights into the historical and current acute on chronic liver failure patient pool and forecasted trends for the leading markets. Our secondary analysis reveals that female sex is associated with an increased risk of developing ACLF compared to males. This finding underscores the importance of considering sex-based differences in risk assessment and highlights the need for tailored approaches to manage ACLF.

The acute on chronic liver failure market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets, segmented into:

• Total Prevalent Cases of ACLF
• Total Diagnosed Prevalent Cases of ACLF
• Diagnosed Prevalent Cases of ACLF by Grade
• Gender-specific Diagnosed Prevalent Cases of ACLF
• Total Treated Cases of ACLF

Scope of the Acute on Chronic Liver Failure Market Report

• Therapeutic Assessment: Acute on Chronic Liver Failure current marketed and emerging therapies
• Acute on Chronic Liver Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Acute on Chronic Liver Failure Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Acute on Chronic Liver Failure Market Access and Reimbursement

Download the report to understand which factors are driving acute on chronic liver failure therapeutics market trends @ Acute on Chronic Liver Failure Market Trends

Table of Contents

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SOURCE DelveInsight Business Research, LLP