Hepatic Encephalopathy Market Size in the 7MM is projected to grow at a steady CAGR over the forecast period of 2026-2042

(Albany, US), October 21, 2026 – DelveInsight’s ‘Hepatic Encephalopathy Market Insights, Epidemiology and Market Forecast 2042’ report delivers an in-depth understanding of Hepatic Encephalopathy, historical and forecasted epidemiology, as well as the Hepatic Encephalopathy market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Hepatic Encephalopathy Market Report

• In May 2025, EnteroBiotix Limited announced positive results from its Phase Ib clinical trial evaluating EBX-102, its next-generation oral full-spectrum microbiome product, in patients with liver cirrhosis and Hepatic Encephalopathy. The data were presented during an oral session at the EASL Congress 2025 in Amsterdam, the Netherlands.
• In February 2025, Yaqrit announced that its recently acquired ammonia scavenger, L-ornithine phenylacetate (OPA), is progressing to Phase III for the treatment of acute hepatic encephalopathy, a life-threatening complication of decompensated cirrhosis.
• According to DelveInsight’s analysis, the HE market size was found to be ~USD 950 million in the 7MM in 2025, and it is projected to reach ~USD 1,200 million by 2042, growing at a CAGR of ~1.5% during 2026-2042.
• The United States held the largest share of the HE market among the 7MM, accounting for approximately 64% of the total market in 2025.
• In 2025, Rifaximin in combination with Lactulose led the US HE treatment market and is projected to retain its position as the dominant market leader through 2042.
• The 7MM had nearly 356,500 diagnosed prevalent cases of HE in 2025, and this number is expected to increase during the forecast period.
• Lactulose remains the first-line therapy for HE, with rifaximin added for recurrence or inadequate response. Xifaxan (rifaximin) is the only approved drug, and current management relies largely on off-label therapies with variable efficacy and safety concerns during long-term use.
• Substantial unmet need persists, including the lack of multiple approved disease-specific therapies, the economic burden of disease, shortcomings of current treatment, and patient progression to advanced liver disease.
• The leading Hepatic Encephalopathy Companies include Bausch Health, Vedanta Biosciences, Yaqrit Discovery, and others.
• Promising Hepatic Encephalopathy Therapies include Xifaxan (Rifaximin), Rifaximin SSD, VE303, YAQ007, and others.

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Hepatic Encephalopathy Overview

Hepatic Encephalopathy is a diagnosis of exclusion characterized by a spectrum of neuropsychiatric disturbances resulting from the accumulation of neurotoxins in patients with liver dysfunction or portosystemic shunting. It differs in presentation and pathophysiology between chronic liver disease, acute liver failure, and acute-on-chronic liver failure, with mechanisms extending beyond hyperammonemia to include systemic inflammation, gut dysbiosis, altered neurotransmission, oxidative stress, manganese deposition, and other toxins. HE is broadly classified into covert (minimal HE and West Haven grade 1) and overt (grades 2–4) forms, representing a continuum of severity. Overt HE is defined by disorientation or asterixis, while minimal HE, affecting up to 80% of patients with cirrhosis, requires specialized testing for detection. Diagnosis begins with assessment of airway and vital signs, followed by a detailed history and examination to identify triggers and rule out mimics such as alcohol withdrawal. Ammonia levels are often elevated but are not diagnostic and correlate poorly with severity, although normal levels have high negative predictive value. Psychometric tests such as the Number Connection Test and Critical Flicker Frequency are sensitive for minimal HE, while EEG and CT or MRI help exclude seizures and structural causes.

Hepatic Encephalopathy Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases of Hepatic Encephalopathy
• Gender-specific Cases of Hepatic Encephalopathy
• Age-specific Cases of Hepatic Encephalopathy
• Type-specific Cases of Hepatic Encephalopathy
• Grade-specific Cases of Hepatic Encephalopathy
• Hepatic Encephalopathy Patients with Ascites

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Hepatic Encephalopathy Epidemiology Key Findings

• The total number of diagnosed prevalent cases of HE in the 7MM was nearly 356,500 in 2025 and is projected to increase during the forecast period.
• The United States contributed the largest share of diagnosed prevalent cases of HE, accounting for approximately 60% in 2025.
• HE predominantly affected males, with approximately 144,000 males diagnosed compared to 67,000 females in the US in 2025.
• Among EU4 and the UK, Germany accounted for the maximum number of HE cases (approx. 20,000), followed by the UK (approx. 16,100) and France (approx. 16,000), while Spain had the fewest (approx. 11,000) in 2022.
• In EU4 and the UK, individuals between the ages of 45 and 54 were the most affected by HE, with approximately 24,000 cases reported in 2025.
• Based on severity, HE is classified as covert (CHE) and overt (OHE). The US had a total of approximately 120,000 CHE and 80,000 OHE cases in 2022.
• In the 7MM, the total number of HE patients with ascites was approximately 225,000 in 2025, and this number is expected to increase by 2042.

Approved Therapies for Hepatic Encephalopathy

Xifaxan (rifaximin) is currently the only approved drug for HE. In 2022, Xifaxan captured a market of approximately USD 111 million in the 7MM from monotherapy use of rifaximin in CHE.

Xifaxan (Rifaximin): Bausch Health

Xifaxan (rifaximin) 550 mg tablets, developed and marketed by Salix Pharmaceuticals (a subsidiary of Bausch Health), are indicated to reduce the risk of recurrent overt hepatic encephalopathy in adults aged 18 years and older. First approved in the US in 2010, rifaximin is a non-absorbed, broad-spectrum, gastrointestinal-selective antibiotic derived from rifamycin that targets Gram-positive and Gram-negative, aerobic and anaerobic ammonia-producing bacteria, thereby lowering systemic ammonia levels implicated in HE. It remains within the gastrointestinal tract without significant absorption and acts by binding to the β-subunit of bacterial DNA-dependent RNA polymerase, inhibiting bacterial RNA synthesis. The estimated annual treatment cost of Xifaxan ranges between USD 24,000 and 30,000, compared with USD 1,000 to 2,000 for lactulose.

Hepatic Encephalopathy Pipeline Analysis

VE303: Vedanta Biosciences

VE303 is an orally administered, wholly owned defined bacterial consortium composed of eight live commensal strains, formulated as a standardized oral pharmaceutical product manufactured from pure clonal cell banks. The selected strains act synergistically by competing with C. difficile for growth substrates and producing secondary bile acids and short-chain fatty acids that enhance gut barrier integrity and mitigate intestinal inflammation. VE303 is in Phase II development for the treatment of Hepatic Encephalopathy, with an anticipated US launch in 2028.

YAQ007: Yaqrit Discovery

YAQ007 is an oral ammonia-scavenging agent in Phase II development for Hepatic Encephalopathy. Ammonia scavengers lower systemic ammonia by providing alternative elimination pathways, addressing the neurotoxicity that results when impaired liver function and portosystemic shunting reduce ammonia detoxification.

Discover more about therapies set to grab Major Hepatic Encephalopathy Market Share @ Hepatic Encephalopathy Market Drivers and Barriers

Hepatic Encephalopathy Market Outlook

HE is a multifactorial neuropsychiatric complication of liver insufficiency or portosystemic shunting, and current management centers on reducing intestinal ammonia production and absorption. Non-absorbable disaccharides such as lactulose and lactitol remain the cornerstone of therapy for acute episodes and for primary and secondary prevention. Antibiotics aimed at colonic decontamination, including neomycin, metronidazole, and vancomycin, further decrease ammonia-producing gut bacteria. Second-line and emerging options include polyethylene glycol 3350–electrolyte solution, ammonia scavengers, branched-chain amino acids, fecal microbiota transplantation, and L-ornithine L-aspartate. Emerging therapies from companies such as Vedanta Biosciences (VE303) and Yaqrit Discovery (YAQ007) are expected to change the market landscape during the forecast period, through approaches such as microbiome modulation and ammonia scavenging. Emerging pipeline agents are expected to see gradual adoption as clinical evidence matures and guideline integration evolves. Overall, the launch of new therapies, improved diagnosis, and rising disease awareness are expected to drive steady growth in the 7MM HE market through 2042.

Hepatic Encephalopathy Treatment Landscape

Management of HE involves supportive care, correction of precipitating factors, and ammonia-lowering therapy. Patients require adequate nutrition without protein restriction (35–40 kcal/kg/day; 1.2–1.5 g/kg/day protein), proper hydration, electrolyte correction, and a safe environment while avoiding sedatives. Triggers such as constipation, infections, electrolyte imbalance, hypovolemia, renal dysfunction, and sedative use must be promptly treated. First-line therapy is lactulose, titrated to 2–3 soft stools daily, with rifaximin added for recurrence or inadequate response. Refractory cases due to portosystemic shunts may require shunt occlusion, while liver transplantation is indicated in advanced cirrhosis and can reverse cognitive impairment. Key factors driving the market include a high unmet need for effective approved therapies, an expanding clinical development pipeline, and improved diagnosis and awareness.

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Scope of the Hepatic Encephalopathy Market Report

• Coverage- 7MM
• Study Period- 2022-2042
• Forecast Period- 2026-2042
• Hepatic Encephalopathy Companies- Bausch Health, Vedanta Biosciences, Yaqrit Discovery, and others.
• Hepatic Encephalopathy Therapies- Xifaxan (Rifaximin), Rifaximin SSD, VE303, YAQ007, and others.
• Hepatic Encephalopathy Market Dynamics: Hepatic Encephalopathy market drivers and market barriers
• Hepatic Encephalopathy Competitive Intelligence Analysis: SWOT Analysis, Conjoint Analysis
• Hepatic Encephalopathy Unmet Needs, KOL Views, Reimbursement

Table of Contents

1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. Epidemiology and Market Forecast Methodology
6. Hepatic Encephalopathy Market Overview at a Glance
7. Disease Background and Overview of Hepatic Encephalopathy
8. Epidemiology and Patient Population of Hepatic Encephalopathy
9. Patient Journey of Hepatic Encephalopathy
10. Marketed Therapies
11. Emerging Therapies
12. Hepatic Encephalopathy: 7MM Analysis
13. Unmet Needs of Hepatic Encephalopathy
14. SWOT Analysis of Hepatic Encephalopathy
15. KOL Views of Hepatic Encephalopathy
16. Market Access and Reimbursement of Hepatic Encephalopathy
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight