Liver Cirrhosis - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The Liver Cirrhosis market size in the 7MM was nearly USD 3,100 million in 2023, which is further anticipated to increase with a siginificant CAGR during the forecast period from (2024-2034).
• Liver cirrhosis is a chronic and progressive liver disease characterized by the replacement of healthy liver tissue with scar tissue estimated to approximately 3,390 thousand diagnosed prevalent population in 2023 in the 7MM.
• Liver cirrhosis is a significant health issue in the United States, and its prevalence has been increasing over the past few decades. According to DelveInsight estimates, among the 7MM, the US has most number of cases of Liver Cirrhosis accounting for 61% of cases alone, followed by Japan, Germany, and Italy in 2023.
• The market size of liver cirrhosis influenced by various factors such as the pharmaceuticals and treatment options available for managing the condition, prevalence of liver cirrhosis, advancements in treatment options, healthcare infrastructure, and reimbursement policies.
• In 2023, the market size of Liver Cirrhosis was highest in the US among the 7MM, accounting for approximately USD 2,180 million which is further expected to increase by 2034.
• The market size of Liver Cirrhosis in Japan was nearly USD 361 million in 2023, accounting for 12% of the total market of the 7MM, which is expected to rise by 2034.
• The total market size of liver cirrhosis is anticipated to upsurge during the forecast period due to the expected entry of emerging therapies that includes Efruxifermin (EFX), Belapectin and others.
• The most extensive clinical study into liver cirrhosis ever conducted worldwide has been announced by Newcastle University, University of Edinburgh and leading research-driven biopharmaceutical company, Boehringer Ingelheim.
• The ADVANCE (Accelerating Discovery: Actionable NASH Cirrhosis Endpoints) study will be the most detailed observational study of its kind enrolling the largest number of patients and providing a detailed analysis of liver health. This will not only enhance the understanding of MASH cirrhosis, but also help to identify translational biomarkers that will accelerate the development of future therapies.
• Prolonged and excessive alcohol consumption can cause significant damage to the liver, leading to inflammation, fibrosis, and eventually cirrhosis. The analysis showed that Alcohol liver Disease (ALD) causes the highest number of liver cirrhosis cases in the 7MM.

DelveInsight's "Liver Cirrhosis Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the Liver Cirrhosis, historical and forecasted epidemiology as well as the Liver Cirrhosis therapeutics market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain) and the United Kingdom, and Japan.

The Liver Cirrhosis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Liver Cirrhosis market size from 2020 to 2034. The Report also covers current Liver Cirrhosis treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Liver Cirrhosis Treatment Market

Liver Cirrhosis Overview

Cirrhosis is the histological development of regenerative nodules surrounded by fibrous bands in response to chronic liver injury, leading to portal hypertension and end-stage liver disease. In this late-stage liver disease, the healthy liver tissue is replaced with scar tissue, and the liver is permanently damaged, and scar tissue keeps the liver from working properly. Cirrhosis has many signs and symptoms, such as fatigue and severe itchy skin, and they may not appear until the liver is badly damaged. Causes include alcoholic liver disease, nonalcoholic fatty liver disease, chronic hepatitis C, and chronic hepatitis B.

Liver Cirrhosis Diagnosis

Organizations like the European Association for the Study of the Liver (EASL), the Japanese Society of Gastroenterology (JSGE), and the American Association for the Study of Liver Diseases (AASLD), and others have published criteria for diagnosing liver cirrhosis.

Most people with early-stage liver cirrhosis do not exhibit any symptoms. Cirrhosis is frequently initially identified during a regular blood test or checkup. Laboratory and imaging tests are typically performed to help confirm a diagnosis. The key diagnosis that confirms cirrhosis is the biopsy, an invasive diagnostic procedure. Even though percutaneous liver biopsy (PLB) has very low mortality and morbidity rates, patients frequently find it uncomfortable and frightening.

When visible symptoms like jaundice start to show up, the disease progresses to the end stage, which is irreversible and cannot be cured, leaving liver transplantation as the last option. Before the onset of an irreversible disease, a diagnosis would allow for interventions (such as alcohol brief interventions, antiviral therapies, and weight loss). Hence, finding time to prioritize patients who are healthy but at-risk patients is difficult in a health system already trying to deliver good quality care to people with established diseases.

One of the major unmet needs in cirrhosis treatment is better methods to detect cirrhosis early before it progresses to a more severe stage. Improved screening and diagnostic tools, such as noninvasive tests and biomarkers, are needed to detect cirrhosis earlier. Also, there is a significant need for biomarkers to diagnose, monitor, and manage cirrhosis. Biomarkers are measurable indicators of a biological process, and they can be used to identify and track disease progression, predict treatment response, and monitor the effectiveness of therapy.

Biomarkers can be used to detect cirrhosis at an early stage before symptoms develop. They can also be used to monitor disease progression and response to treatment. This can help healthcare providers adjust treatment plans and improve patient outcomes. Biomarkers can be used in clinical trials to identify patients more likely to respond to a particular therapy which will eventually help drug developers design more effective treatments for cirrhosis.

Currently, the diagnosis and monitoring of cirrhosis rely mainly on imaging tests and blood tests that measure liver function. While these tests are helpful, they are not always accurate or sensitive enough to detect early-stage cirrhosis or predict disease progression. Therefore, developing more accurate and reliable biomarkers is critical for improving the diagnosis, monitoring, and management of cirrhosis.

Liver Cirrhosis Treatment

The treatment for cirrhosis depends on what has caused it. Cirrhosis cannot usually be cured, but there are ways to manage the symptoms and complications and stop the condition from worsening. Some of the diseases that cause cirrhosis can be cured. Treating the underlying causes of cirrhosis may keep cirrhosis from worsening and help prevent liver failure. Successful treatment may slowly improve some liver scarring.

Treating the underlying cause of liver damage - for example, treating underlying hepatitis (B or C) virus infection, or the removal of blood to lower iron levels in hemochromatosis

Making dietary and lifestyle changes - a nutritious, low-fat, high-protein diet and exercise can help people to avoid malnutrition.

Chronic liver disease patients, especially those with decompensated cirrhosis, often face several potentially life-altering consequences that can significantly affect daily activities and quality of life. They have specific needs for high levels of supportive care due to their disabilities and the complicated treatments that go along with them.

To provide the proper care, it is crucial to identify the underlying cause of hepatic decompensation through a thorough history, examination, and investigations. Cirrhosis can lead to a variety of complications, such as ascites (fluid accumulation in the abdomen), hepatic encephalopathy (brain dysfunction due to liver failure), and variceal bleeding (bleeding from enlarged veins in the esophagus or stomach). Although treatments are available for these complications, they are often ineffective and have significant side effects. Hemodialysis, IV antibiotics, and banding surgeries are all forms of treatment and are expensive. Better therapies are needed to manage these complications and improve the quality of life for patients with cirrhosis.

The most significant treatment for liver cirrhosis is a liver transplant, which is costly and burdens the patients and their families. It has been noticed that patients who require liver transplants are more than donors of the liver, making the treatment of cirrhosis patients a crucial task, and about 30% die waiting. Decompensated cirrhosis is frequent in acute care facilities and has a high fatality rate. A care bundle can help ensure that patients receive the right management of their difficulties systematically. The further development of new and novel treatments should take care of the significant burden on patient life by reducing the cost of therapies.

Liver Cirrhosis Epidemiology

As the market is derived using the patient-based model, the Liver Cirrhosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Liver Cirrhosis, and Etiology-specific Diagnosed Prevalent Cases of Liver Cirrhosis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034.

• The total diagnosed prevalent cases of Liver Cirrhosis in the US comprised approximately 2,070 thousand in 2023 and are projected to increase during the forecast period.
• As per DelveInsight's estimates, the US alone accounts the highest number of total diagnosed prevalent cases, of liver cirrhosis in the 7MM, followed by EU4 and the UK and Japan, contributing to 24% and 14% of all liver cirrhosis cases respectively.
• The etiology-specific distribution of diagnosed prevalent cases of liver cirrhosis showed MASH, HCV, HVB, ALD, and PBC comprised 13%, 45%, 15%, 26%, and 2% cases in Japan, respectively.
• EU4 and the UK accounted for around 830 thousand diagnosed prevalent cases of liver cirrhosis in 2023. Of these cases, Germany accounted for the highest number of cases.

Liver Cirrhosis Drug Chapters

The drug chapter segment of the Liver Cirrhosis report encloses a detailed analysis of Liver Cirrhosis off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Liver Cirrhosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Liver Cirrhosis Emerging Drugs

Efruxifermin (AKR-001): Akero Therapeutics, Inc.

Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for MASH cirrhosis. EFX is designed to offer convenient once-weekly SC dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine if approved. EFX is currently being evaluated in Phase IIb clinical trials in patients with biopsy-confirmed NASH: the SYMMETRY study in cirrhotic patients with compensated F4 fibrosis. EFX shows the potential to be an effective treatment for patients with cirrhosis due to MASH. Currently the drug is in Phase II of clinical development for the treatment of MASH cirrhosis.

Belapectin (GR-MD-02): Galectin Therapeutics Inc.

Belapectin (GR-MD-02), a galectin-3 inhibitor, has been demonstrated in preclinical models to reverse liver fibrosis and cirrhosis and in clinical studies to decrease portal hypertension and prevent its complication: the development of esophageal varices. Belapectin can potentially treat many diseases due to galectin-3's involvement in multiple key biological pathways such as fibrosis, immune cell function and immunity, cell differentiation, cell growth, and apoptosis (cell death). The importance of galectin-3 in the fibrotic process is supported by experimental evidence. Animals with the galectin-3 gene "knocked-out" can no longer develop fibrosis in response to experimental stimuli compared to animals with an intact galectin-3 gene. The company is using galectin-3 inhibitors to treat advanced liver fibrosis and liver cirrhosis in MASH patients. They have completed two Phase I clinical studies, a Phase II clinical study in MASH patients with advanced fibrosis (NASH-FX) and a second Phase IIb clinical trial in MASH patients with compensated cirrhosis and portal hypertension (NASH-CX).

Belapectin (GR-MD-02) is a proprietary galactoarabino-rhamnogalacturonan polysaccharide polymer comprising galacturonic acid, galactose, arabinose, rhamnose and smaller amounts of other sugars. Structural studies have shown that belapectin binds to galectin-1 and galectin-3, with greater binding affinity to galectin-3. Belapectin targets extracellular galectins.

A Phase II clinical trial of belapectin in NASH cirrhosis was the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in portal hypertension or liver biopsy in patients with NASH cirrhosis without varices.

Zibotentan/dapagliflozin: Astrazeneca

AstraZeneca's combination therapy, zibotentan/dapagliflozin, is currently in Phase II clinical development targeting liver cirrhosis. This innovative treatment leverages the synergistic mechanisms of zibotentan, an endothelin A receptor antagonist, and dapagliflozin, a SGLT2 inhibitor marketed as Farxiga in the US and Forxiga globally. The small molecule duo is being evaluated in the ZEAL-UNLOCK study (Phase IIb) to assess its safety profile. Initiated in February 2024, this trial aims for a primary completion by January 2025. The study's impactful results could redefine therapeutic strategies for liver cirrhosis, addressing a significant unmet medical need.

Liver Cirrhosis Market Outlook

With first approved therapy for advanced hepatic cirrhosis in 2024, the market outlook for liver cirrhosis is expected to expand.

The most popular drug classes used to treat Liver Cirrhosis include antivirals, antibiotics, antifibrotics, etc. For individuals with severely decompensated cirrhosis, early antiviral therapy is crucial. Antiviral therapy for Chronic Hepatitis B's primary objective is to reduce hepatic dysfunction and save patients from death. Interferon alpha (IFN) and nucleos (t) ide analogs are antiviral medications that are clinically used.

Currently there are no approved therapies for Liver Cirrhosis. Recently, in March 2024, Madrigal Pharmaceuticals' groundbreaking product, REZDIFFRA (resmetirom), a once-daily, oral THR-B agonist, received accelerated endorsement from the US FDA based on results from the Phase III MAESTRO-NASH trial. This approval marks a significant stride in the medical landscape, as REZDIFFRA becomes the inaugural and sole FDA-sanctioned therapy for adults afflicted with non-cirrhotic MASH, accompanied by moderate to advanced liver scarring (fibrosis) corresponding to stages F2-F3 fibrosis. Resmetirom (MGL-3196) is not approved for the treatment of liver cirrhosis.

The exclusion criteria for the Phase III clinical trial of resmetirom specifically excluded patients with cirrhosis, defined as stage 4 fibrosis. Additionally, the abstract of the MAESTRO-NAFLD-1 trial states that resmetirom was evaluated in adults with nonalcoholic fatty liver disease and presumed MASH, but does not mention cirrhosis.

The launch of emerging therapies, such as Belapectin/ GR-MD-02 (Galectin Therapeutics Inc.), Efruxifermin (Akero Therapeutics, Inc), Zibotentan/dapagliflozin (Astrazeneca), and others are expected to impact the market positively. The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.

• The market size of Liver Cirrhosis in the 7MM was nearly USD 3,100 million in 2023, which is further anticipated to increase during the forecast period.
• The EU4 and the UK accounted for the approximately USD 566 million market size of Liver Cirrhosis approximately in 2023.
• Among the EU countries, Germany had the highest market size with nearly USD 152 million in 2023, while Spain had the lowest market size for Liver Cirrhosis with USD ~77 million in 2023.
• With the expected launch of upcoming therapies, such as Belapectin and Efruxifermin, among others, the total market size of Liver Cirrhosis is expected to show change in the upcoming years.

Liver Cirrhosis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, Belapectin in the US is expected to be launched by 2026 with a peak share of 4.0%. Efruxifermin is anticipated to take 6 years to peak with a medium uptake.

Liver Cirrhosis Pipeline Development Activities

The report provides insights into different Liver Cirrhosis clincial trials within Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Liver Cirrhosis emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Liver Cirrhosis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from the University of Florida Gainesville, Stanford University, Liver Unit, Hospital Clinic of Barcelona, Iwate Medical University, Leipzig University Hospital, University of Florida Gainesville, Florida, Service des Maladies de l'Appareil digestif, Hopital Huriez, CHU, Lille, France, Liver Unit, Hospital Clinic of Barcelona, Barcelona, Spain, Division of Hepatology, Department of Internal Medicine, Iwate Medical University, Morioka, and others.

Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Liver Cirrhosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Liver Cirrhosis Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of Liver Cirrhosis, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Liver Cirrhosis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Liver Cirrhosis market.

Liver Cirrhosis Report Insights

• Liver Cirrhosis Patient Population
• Liver Cirrhosis Therapeutic Approaches
• Liver Cirrhosis Pipeline Analysis
• Liver Cirrhosis Market Size and Trends
• Existing and Future Market Opportunity

Liver Cirrhosis Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Liver Cirrhosis Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Liver Cirrhosis Drugs Uptake
• Key Liver Cirrhosis Market Forecast Assumptions

Liver Cirrhosis Report Assessment

• Current Liver Cirrhosis Treatment Practices
• Liver Cirrhosis Unmet Needs
• Liver Cirrhosis Pipeline Product Profiles
• Liver Cirrhosis Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Liver Cirrhosis Market Drivers
• Liver Cirrhosis Market Barriers

Key Questions Answered In The Liver Cirrhosis Market Report:

Liver Cirrhosis Market Insights

• What was the Liver Cirrhosis market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Liver Cirrhosis total market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Liver Cirrhosis market size during the forecast period (2024-2034)?
• At what CAGR, the Liver Cirrhosis market is expected to grow at the 7MM level during the forecast period (2024-2034)?
• What would be the Liver Cirrhosis market outlook across the 7MM during the forecast period (2024-2034)?
• What would be the Liver Cirrhosis market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Liver Cirrhosis Epidemiology Insights

• What is the disease risk, burden, and unmet needs of Liver Cirrhosis?
• What is the historical Liver Cirrhosis patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient population of Liver Cirrhosis at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Liver Cirrhosis?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Liver Cirrhosis during the forecast period (2024-2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024-2034)?

Current Liver Cirrhosis Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Liver Cirrhosis along with the approved therapy?
• What are the current treatment guidelines for the treatment of Liver Cirrhosis in the US, Europe, And Japan?
• What are the Liver Cirrhosis 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 Liver Cirrhosis?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Liver Cirrhosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Liver Cirrhosis therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Liver Cirrhosis and their status?
• What are the key designations that have been granted for the emerging therapies for Liver Cirrhosis?
• What are the 7MM historical and forecasted market of Liver Cirrhosis?

Reasons to Buy Liver Cirrhosis Market Forecast Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Liver Cirrhosis Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), 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.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What is the forecast period covered in the report?

The Liver Cirrhosis Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Liver Cirrhosis market?

The Liver Cirrhosis market is quite robust. The major layers are Akero Therapeutics, Inc., Galectin Therapeutics Inc., and others which are currently developing drugs for the treatment of Liver Cirrhosis.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Liver Cirrhosis market?

The increase in diagnosed prevalent cases of Liver Cirrhosis and the launch of emerging therapies are attributed to be the key drivers for increasing the Liver Cirrhosis market.

5. What is the expected impact of emerging therapies or advancements in Liver Cirrhosis treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Liver Cirrhosis treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Liver Cirrhosis marke