Liver Cirrhosis - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights:

• Liver cirrhosis is a chronic and progressive liver disease characterized by the replacement of healthy liver tissue with scar tissue estimated to affect nearly 3.5 million people in 2022 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 followed by Japan, Germany, and Italy in 2022.
• 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. As per DelveInsight research, based on historical data, the US consistently captured the highest market among the 7MM, whereas Spain had the lowest market. The market size of liver cirrhosis was estimated to be around USD 2 billion in the US in 2022 and nearly USD 75 million in Spain.
• The current treatment market for liver cirrhosis includes vitamin E, anti-fibrotic, antiviral, immunosuppressant, beta-blockers, and others used off-label.
• 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.
• 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 - 2032" report delivers an in-depth understanding of the Liver Cirrhosis, historical and forecasted epidemiology, and the Liver Cirrhosis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Liver Cirrhosis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM, liver cirrhosis market size from 2019 to 2032. The report also covers current liver cirrhosis treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032.

Disease Understanding and Treatment Algorithm

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

The diagnosis of cirrhosis is usually based on the presence of a risk factor for cirrhosis, such as alcohol use or obesity, and is confirmed by physical examination, blood tests, and imaging. The doctor will ask about the person's medical history and symptoms and perform a thorough physical examination to observe for clinical signs of the disease. The Child-Pugh scoring system (the Child-Pugh-Turcotte score) was designed to predict mortality in cirrhosis patients.

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

Further details related to country-based variations are provided in the report.

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.

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 2019 to 2032. The total diagnosed prevalent cases of Liver Cirrhosis in the 7MM comprised approximately 3.5 million cases in 2022 and are projected to increase during the forecast period.

• The US consistently showed to have highest diagnosed prevalent cases of liver cirrhosis with nearly 2 million cases in 2022 among 7MM. As per DelveInsight's estimates, the country alone accounts for nearly 61% of total diagnosed prevalent cases, of liver cirrhosis in the 7MM, followed by Japan, contributing 15% of all liver cirrhosis cases.
• The etiology-specific distribution of diagnosed prevalent cases of liver cirrhosis showed NASH, HCV, HVB, ALD, and PBC comprised 28%, 27%, 11%, 33%, and 2% cases, respectively.
• EU4 and the UK accounted for around 0.8 million diagnosed prevalent cases of liver cirrhosis in 2022. 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 marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands 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.

Emerging Drugs

Resmetirom (MGL-3196): Madrigal Pharmaceuticals, Inc.

Resmetirom (formerly MGL-3196) is a thyroid hormone receptor B-agonist. Thyroid hormone receptors can be classified as a-receptors and B-receptors, and activating the a-receptor results in all of the symptoms associated with more thyroid gland activity. In December 2022, Madrigal announced topline results from the pivotal Phase III MAESTRO-NASH biopsy study of resmetirom. In addition, this study has the potential to support an additional indication for resmetirom in patients with well-compensated NASH cirrhosis.

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

Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. 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 NASH.

Note: Detailed emerging therapies assessment will be provided in the final report of liver cirrhosis.

Drug Class Insights

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.

Liver Cirrhosis Market Outlook

With no approved therapies for advanced hepatic cirrhosis, treatments are urgently needed to stabilize or reverse fibrotic disease progression. The US FDA has approved several drugs to treat CHB, CHC, and PBC, but none target cirrhosis patients. There is, however, growing optimism that new medications that favor the natural history of the disease are likely to emerge within the next 3-5 years.

The launch of emerging therapies, such as Resmetirom (Madrigal Pharmaceuticals, Inc.) and Efruxifermin (Akero Therapeutics, Inc), are expected to impact the market positively.

• The total market size of Liver Cirrhosis in the 7MM was around USD 3 billion in 2022 which is estimated to increase by 2032 at a significant CAGR.
• Among the 7MM, the US captured the highest market share in 2022, covering a total of 70% market, followed by Japan.
• In 2022, EU4 and the UK captured nearly 18% of the total market in the 7MM.
• Among the forecasted emerging therapies, Efruxifermin (EFX) is expected to capture the highest market in the 7MM by 2032.

Liver Cirrhosis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2019-2032. For example, for MGL-3196 (Resmetirom), in the US we expect the drug uptake to be medium with a probability-adjusted peak share of around 5%, and years to the peak to be 6 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

Liver Cirrhosis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyses 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's 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, 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 to understand and validate current and emerging therapies and 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 cost of newly approved medications is usually high; patients can escape from proper treatment or opt for off-label and cheap medications. It affects access to newly launched medications in the market, and reimbursement is crucial. Often, the decision to reimburse comes down to the drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, care setting, unmet need, the magnitude of incremental benefit claims, and costs.

The days of fee-for-service medicine may soon be over, and the healthcare market is steadily moving toward value-based payment models. In most of the country, insurance carriers are increasingly assembling narrow provider networks to try and rein in costs.

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 Report:

• The report covers a segment of key events, an executive summary, descriptive overview of Liver Cirrhosis, explaining its causes, signs and symptoms, pathogenesis, 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, along with 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

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

Liver Cirrhosis Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Liver Cirrhosis Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Liver Cirrhosis Report Assessment

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

Key Questions:

Market Insights

• What was the Liver Cirrhosis total market size, the market size by therapies, and market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market for Liver Cirrhosis?
• What will be the impact of the Resmetirom launch in the market?
• How will Belapectin compete with the other emerging therapies for Liver Cirrhosis after approval?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of Liver Cirrhosis? What will be the growth opportunities across the 7MM concerning the patient population of Liver Cirrhosis?
• What is the historical and forecasted Liver Cirrhosis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which type of Liver Cirrhosis is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating Liver Cirrhosis? What are the current guidelines for treating Liver Cirrhosis in the US and Europe?
• How many companies are developing therapies for treating Liver Cirrhosis?
• How many emerging therapies are in the mid-stage and late stage of development for treating Liver Cirrhosis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Liver Cirrhosis?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of Liver Cirrhosis?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Liver Cirrhosis Market.
• Insights on patient burden/disease prevalence, 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.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• 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 the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.