Hepatic Encephalopathy - Market Insight, Epidemiology and Market Forecast - 2032

This ‘Hepatic Encephalopathy (HE)-Market Insights, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of the Hepatic Encephalopathy, historical and forecasted epidemiology as well as the Hepatic Encephalopathy market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The HE market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted 7MM HE market size from 2019 to 2032. The Report also covers current HE treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Hepatic Encephalopathy (HE) Disease Understanding and Treatment Algorithm

Hepatic Encephalopathy (HE) Overview

Hepatic encephalopathy (HE) is a brain disorder that develops in some individuals with liver disease. HE presents as a spectrum of neuropsychiatric symptoms ranging from subtle fluctuating cognitive impairment to coma and is a significant contributor to morbidity in patients with liver disease. It is observed in acute liver failure, liver bypass procedures - for example, shunt surgery and trans-jugular intrahepatic portosystemic shunt - and cirrhosis, classified as Type A, B, and C HE, respectively.

Moreover, HE can be associated with more severe symptoms, including reduced alertness, shortened attention span, disruptions in sleep patterns, mild confusion, slowing ability to perform mental tasks, and mood or personality changes. More noticeable changes in memory, concentration, or intellectual function than in minimal hepatic encephalopathy (MHE) may also be observed.

The pathophysiology of HE is multifactorial and involves agents such as ammonia (NH3), inflammatory cytokines, manganese deposition in the basal ganglia, and benzodiazepine-like compounds (i.e., gamma-aminobutyric acid [GABA]); recent studies have also recognized roles of microbiota and aromatic amino acids. Although HE pathogenesis is a complex entity with multiple components resulting in functional impairment of neuronal cells - none of which are well understood - NH3 has been considered the primary pathophysiologic mechanism of HE.

HE is classified into two broad categories based on severity, covert hepatic encephalopathy (CHE) and overt hepatic encephalopathy (OHE). When affected individuals have obvious, outward signs and symptoms, the disorder may be referred to as OHE.

Hepatic Encephalopathy (HE) Diagnosis

Defining and diagnosing HE, particularly CHE, remains challenging. In CHE, there are no clinical signs or symptoms; however, patients have neuropsychological deficiencies that can be detected with psychometric or neuropsychological testing.

The HE diagnosis is based on the presence of a spectrum of neuropsychiatric abnormalities in patients with liver dysfunction after excluding unrelated neurologic and/or metabolic causes of encephalopathy.

Hepatic Encephalopathy (HE) Treatment

The treatment of acute or persistent HE has changed very little during the past 40 years. However, with newer agents under investigation, the available treatment options will increase over 5 years. Until then, treatment options are limited to correcting or removing precipitating causes, dietary changes, and pharmacologic approaches that are focused on the use of non-absorbable disaccharides. Additional pharmacological agents available include certain antibiotics, drugs to eliminate ammonia from the plasma, and a few other drugs with special indications.

Management of OHE includes treating patients with acute HE episodes, preventing HE recurrence, and identifying and managing precipitating factors associated with HE development. The two primary forms of medical therapy for HE are non-absorbable disaccharides (i.e., lactitol and lactulose) and non-absorbable antibiotics (i.e., Rifaximin).

The hyperammonemia and inflammation that occurs due to urea breakdown in cirrhotic have led to the development of HE treatments that target gut bacteria. Treatments for OHE are approved by the US FDA while some unapproved treatments are also available for use. It is important to remember that in patients with cirrhosis and portosystemic shunting, skeletal muscle mass and renal clearance are vital to neurotoxin clearance.

Hepatic Encephalopathy (HE) Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of hepatic encephalopathy, gender-specific diagnosed prevalent cases of hepatic encephalopathy, age-specific diagnosed prevalent cases of hepatic encephalopathy, and type-specific diagnosed prevalent cases of hepatic encephalopathy scenario of Hepatic Encephalopathy (HE) in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• Total diagnosed prevalent cases of Cirrhosis (hospitalized) in the 7MM was found to be 862,508 cases in 2021. These cases are expected to increase by 2032 at a CAGR of 0.63% during the study period (2019-2032).
• The diagnosed prevalent cases of Hepatic Encephalopathy in the 7MM are expected to increase at a CAGR of 0.61% for the study period of 2019-2032.
• Among 7MM, the United States has the highest diagnosed prevalent cases of hepatic encephalopathy with 205,664 cases in 2021.
• Assessments as per the analysts show that the majority of cases of Hepatic Encephalopathy are occupied by males as compared to females. There was a total of 149,518 male and 56,146 female cases of Hepatic Encephalopathy in 2021 in the United States.
• The age-specific data revealed that the highest number of Hepatic Encephalopathy people affected with was found in the age group of 45-54 years, while people < 25 years are the least affected.
• HE is divided into two broad categories based on severity, Covert Hepatic Encephalopathy (CHE) and Overt Hepatic Encephalopathy (OHE). There were a total 123,399 CHE and 82,266 OHE cases of Hepatic Encephalopathy in 2021 in the United States.
• In EU-5, the United Kingdom has the highest number of cases of HE with 28,212 cases in 2021, followed by Germany with 26,672 cases and France with 22,382 cases. While Spain has the least number of cases with 9,326 in 2021.
• In 2021, Japan had 29,464 diagnosed prevalent cases of HE. .

Hepatic Encephalopathy (HE) Epidemiology

The epidemiology segment also provides the Hepatic Encephalopathy (HE) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Hepatic Encephalopathy (HE) Drug Chapters

The drug chapter segment of the Hepatic Encephalopathy (HE) report encloses the detailed analysis of HE marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the HE clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

Hepatic Encephalopathy (HE) Marketed Drugs

Xifaxan (Rifaximin/OHE7): Salix Pharmaceuticals/Bausch Health

Xifaxan (Rifaximin) tablets (550 mg) developed and marketed by Salix Pharmaceuticals (a subsidiary of Valeant Pharmaceuticals), was indicated for the reduction in risk of Overt HE recurrence in patients ≥ 18 years of age. It is also being marketed to treat Travelers' Diarrhea and IBS-D (Irritable Bowel Syndrome with Diarrhea). Salix is exploring the potential additional indications, formulations, clinical trials, and co-promotion arrangements for Xifaxan to capitalize on the potential for Xifaxan, including development programs in Crohn's disease and liver disease. Similar molecule Rifaximin (SSD) from Salix Pharmaceuticals is under clinical evaluation for the treatment of OHE.

Hepatic Encephalopathy (HE) Emerging Drugs

AXA1665: Axcella Health, Inc.

AXA1665 - Axcella's product candidate for a reduction in risk of recurrent OHE - is a composition of eight amino acids and derivatives designed to target multiple metabolic pathways intersecting key organ systems, including the liver, muscle, and gut. The company is currently evaluating AXA1665 in the Phase II stage of clinical development as a product candidate to reduce the risk of OHE recurrence in adult patients with liver cirrhosis.

GR3027 (Golexanolone): Umecrine Cognition

Umecrine Cognition, a Karolinska Development (KDEV), is developing novel GR3027 (golexanolone), an orally administrated small molecule to treat patients diagnosed with HE. Golexanolone is a GABAA-receptor modulating steroid antagonist (GAMSA) designed to antagonize positive GABAA-receptor modulation by endogenous neuroactive steroids. Golexanolone belongs to a novel class of neurosteroid-based drugs for oral administration. According to the company pipeline, although the drug is being investigated for HE, the trial is being conducted for CHE in Phase I/IIa trial.

Hepatic Encephalopathy (HE) Market Outlook

The United States contributes to the major share of the HE market as compared to other countries, such as EU5 (Italy, Spain, United Kingdom, France, and Germany) and Japan.

Management of OHE includes treating patients with acute HE episodes, preventing HE recurrence, and identifying and managing precipitating factors associated with HE development. The two primary forms of medical therapy for HE are non-absorbable disaccharides (i.e., lactitol and lactulose) and non-absorbable antibiotics (i.e., Rifaximin). The hyperammonemia and inflammation that occurs due to urea breakdown in cirrhotics have led to the development of HE treatments that target gut bacteria. Treatments for OHE are approved by the US FDA while some unapproved treatments are also available for use. It is important to remember that in patients with cirrhosis and portosystemic shunting, skeletal muscle mass and renal clearance are vital to neurotoxin clearance.

Treatment options for CHE are derived from prior experience in patients with episodic HE. Given the lack of clinical signs, CHE is rarely recognized or treated outside of clinical trials. The treatment of CHE is on an as-needed basis. First-line treatment is a 4- to 8-week trial of lactulose. If the patient improves, treatment can continue. Due to the high cost of Rifaximin, it is usually not used for CHE.

According to the publisher, Hepatic Encephalopathy 7MM is expected to change in the study period 2019-2032.

Key Findings

• The market size of Hepatic Encephalopathy (HE) in seven major markets was USD 1,563 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 4.66% for the study period (2019-2032)
• Expected Launch of potential therapies may increase market size in the coming years, assisted by an increase in the diagnosed prevalent population of Hepatic Encephalopathy.
• Upcoming therapies such as Golexanolone (GR3027) and Rifaximin (SSD) have the potential to create a significant positive shift in the Hepatic Encephalopathy market size.
• The United States accounts for the largest market size of Hepatic Encephalopathy, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.
• Among the EU5 countries, Germany had the highest market size with USD 48 million in 2021, while Spain had the lowest market size of Hepatic Encephalopathy with USD 17 million in 2021.

The United States Market Outlook

This section provides the total Hepatic Encephalopathy (HE) market size and market size by therapies in the United States.

EU-5 Market Outlook

The total Hepatic Encephalopathy (HE) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Hepatic Encephalopathy (HE) market size and market size by therapies in Japan are provided.

Hepatic Encephalopathy (HE) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Hepatic Encephalopathy market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Hepatic Encephalopathy market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Hepatic Encephalopathy (HE) Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages also analyze key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Hepatic Encephalopathy emerging therapies.

Reimbursement Scenario in Hepatic Encephalopathy (HE)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitively and market Intelligence analysis of the Hepatic Encephalopathy (HE) market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Hepatic Encephalopathy, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Hepatic Encephalopathy epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Hepatic Encephalopathy is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Hepatic Encephalopathy market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Hepatic Encephalopathy market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing prevalence will positively drive the Hepatic Encephalopathy market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Hepatic Encephalopathy R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Hepatic Encephalopathy. Launch of emerging therapies will significantly impact the Hepatic Encephalopathy market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Hepatic Encephalopathy (HE) Report Insights

• Patient Population
• Therapeutic Approaches
• Hepatic Encephalopathy Pipeline Analysis
• Hepatic Encephalopathy Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Hepatic Encephalopathy (HE) Report Key Strengths

• 11-Years Forecast
• 7MM Coverage
• Hepatic Encephalopathy Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Hepatic Encephalopathy (HE) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

Market Insights:

• What was the Hepatic Encephalopathy market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Hepatic Encephalopathy total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Hepatic Encephalopathy market size during the forecast period (2022-2032)?
• At what CAGR, the Hepatic Encephalopathy market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Hepatic Encephalopathy market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Hepatic Encephalopathy market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden and unmet needs of Hepatic Encephalopathy?
• What is the historical Hepatic Encephalopathy patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
• What would be the forecasted patient pool of Hepatic Encephalopathy at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Hepatic Encephalopathy?
• Out of the above-mentioned countries, which country would have the highest prevalence population of Hepatic Encephalopathy (HE) during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Hepatic Encephalopathy along with the approved therapy?
• What are the current treatment guidelines for the treatment of Hepatic Encephalopathy in the US and Europe?
• What are the Hepatic Encephalopathy marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Hepatic Encephalopathy?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Hepatic Encephalopathy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hepatic Encephalopathy therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hepatic Encephalopathy and their status?
• What are the key designations that have been granted for the emerging therapies for Hepatic Encephalopathy?
• What are the 7MM historical and forecasted market of Hepatic Encephalopathy?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Hepatic Encephalopathy.
• To understand the future market competition in the Hepatic Encephalopathy market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Hepatic Encephalopathy in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Hepatic Encephalopathy market.
• To understand the future market competition in the Hepatic Encephalopathy market.