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

Key Highlights:

• Decompensated cirrhosis is most prevalent in adults over the age of 50, with a significant increase in patients over the age of 60 due to factors such as chronic alcohol consumption, chronic hepatitis, and metabolic comorbidities.
• Decompensated cirrhosis is an advanced liver disease stage marked by severe fibrosis, significantly impairing liver function and leading to critical complications such as ascites (fluid accumulation in the abdomen), hepatic encephalopathy (neurological disturbances), and oesophageal varices, which can cause dangerous bleeding.
• The complications significantly increase the risk of mortality and often require hospitalisation and evaluation for possible liver transplantation.
• Treatment focuses on symptom management, complication prevention, and addressing the underlying cause, with liver transplantation as the definitive treatment for eligible patients.
• The therapeutic pipeline for decompensated cirrhosis remains limited, with most candidates still in early or mid-stage development and no approved pharmacologic options to alter disease progression.
• The emerging drug pipeline for decompensated cirrhosis includes candidates, such as Albutein (Grifols), and others.
• Mikrobiomik is conducting a Phase III clinical trial in Spain (EUCT number 2023-509151-13-00) to assess the use of Fecal Microbiota Transplantation (FMT) in patients with decompensated cirrhosis.

DelveInsight's "Decompensated cirrhosis- Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of Decompensated cirrhosis epidemiology, market, and clinical development in Decompensated cirrhosis. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Decompensated cirrhosis market trends in the United States, EU4 (Germany, France, Italy, and Spain ) and the United Kingdom, and Japan.

The Decompensated cirrhosis market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Decompensated cirrhosis market size from 2020 to 2034 in 7MM. The report also covers current Decompensated cirrhosis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

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

Decompensated Cirrhosis Understanding and Treatment Algorithm

Decompensated cirrhosis Overview

Decompensated cirrhosis is the advanced stage of chronic liver disease in which the liver can no longer maintain its essential functions due to extensive fibrosis and structural distortion. It develops when previously compensated cirrhosis progresses, leading to the onset of overt clinical complications such as ascites, variceal bleeding, hepatic encephalopathy, and jaundice.

Cirrhosis usually doesn't cause any symptoms in its earlier stages. But as it progresses to decompensated cirrhosis, it can cause: Jaundice, Fatigue, Weight loss, Easy bleeding and bruising, Bloated abdomen due to fluid accumulation (ascites), Swollen legs, Confusion, slurred speech, or drowsiness (hepatic encephalopathy), Nausea and loss of appetite, Spider veins, Redness on the palms of the hands, Shrinking testicles and breast growth in men, Unexplained itchiness.

Decompensated Cirrhosis Treatment

Treatment options for decompensated cirrhosis are limited, and reversal of the condition is generally not possible at this advanced stage of liver disease. Candidates with at least one symptom of decompensated cirrhosis and a MELD score of 15 or higher are typically considered for liver transplantation. Transplants may involve either a partial or whole liver from a donor, with the ability of liver tissue to regenerate allowing for partial grafts from living donors; both the transplanted liver and the donor's liver typically regenerate within a few months. Although liver transplantation offers a potentially life-saving intervention, it is a complex procedure that requires comprehensive evaluation at a transplant center to determine suitability and optimize outcomes.

Decompensated cirrhosis Epidemiology

The Decompensated cirrhosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as Diagnosed Prevalent Cases of Liver Cirrhosis, Type-specific Diagnosed Prevalent Cases of Liver Cirrhosis, Diagnosed Prevalent Cases of Decompensated Cirrhosis, Gender-specific Diagnosed Prevalent Cases of Decompensated Cirrhosis, and Age-specific Diagnosed Prevalent Cases of Decompensated Cirrhosis in the 7MM, covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• In the B, approximately 58.4% of patients had compensated cirrhosis, whereas 41.6% either presented with decompensated cirrhosis at diagnosis or progressed to it over time, reflecting a significant proportion advancing to this severe stage of liver disease.
• Decompensated cirrhosis is observed more frequently in men than in women, reflecting a notable gender disparity in the occurrence of this advanced stage of liver disease, which may be influenced by differences in risk factor exposure, disease progression, and underlying health behaviors.
• In Japan, decompensated cirrhosis cases are predominantly linked to chronic liver diseases, with hepatitis C virus (HCV) infection being the major historical contributor to liver cirrhosis.
• The prevalence of decompensated cirrhosis varies across age groups, with the greatest impact seen in males aged 60-69, who account for about 53.8% of admissions, followed by those aged 50-59, representing approximately 46.2%.

Decompensated cirrhosis Drug Chapters

The drug chapter segment of the Decompensated Cirrhosis Report encloses a detailed analysis of decompensated cirrhosis marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the decompensated cirrhosis pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Emerging Drugs

ALBUTEIN (albumin): Grifols

In decompensated cirrhosis, albumin is being investigated not just as supportive care but as a disease-modifying therapy aimed at addressing systemic inflammation and circulatory dysfunction that drive complications and organ failure. The Phase III PRECIOSA trial assessed long-term, high-dose albumin in patients with decompensated cirrhosis and ascites, demonstrating reductions in serious complications such as hepatorenal syndrome and spontaneous bacterial peritonitis, along with improved short-term outcomes, although the primary endpoint of one-year transplant-free survival was not met. These results highlight albumin's potential to alter disease trajectory in decompensated cirrhosis, positioning it as a candidate for long-term therapy subject to further clinical validation.

ALBUTEIN (Human albumin) is already an approved, marketed plasma-derived therapy used in many settings, such as hypovolemia (shock, trauma, burns), cardiopulmonary bypass, acute liver failure, large-volume paracentesis in cirrhosis, and hypoalbuminemia of various causes.

Decompensated Cirrhosis Market Outlook

The decompensated cirrhosis market relies on albumin for symptomatic management, which, while effective, does not alter disease progression, highlighting a clear unmet need for disease-modifying therapies. The Phase III PRECIOSA trial showed that long-term, high-dose albumin provided early benefits in transplant-free survival and complication reduction, though it did not meet its primary endpoint, sustaining use in targeted European subgroups without redefining the market. In parallel, Mikrobiomik's Phase III trial in Spain (EUCT 2023-509151-13-00) evaluating fecal microbiota transplantation (FMT) represents a potential first-in-class approach to modulate the gut-liver axis, reduce infections, and slow progression. Overall, the market is expected to remain stable, anchored by albumin, while emerging interventions like FMT signal opportunities for genuine disease-modifying impact.

Decompensated cirrhosis drug uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Decompensated cirrhosis Activities

The report provides insights into different therapeutic candidates in the Phase III and Phase II stages. 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 Decompensated cirrhosis therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as the National Institute of Allergy and Infectious Diseases, USA, University of Michigan, US, Washington University School of Medicine, US, University Medical Center Hamburg-Eppendorf, US, and University Graduate School of Medicine, US, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or decompensated cirrhosis market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches Decompensated cirrhosis, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

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.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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 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

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used 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, a descriptive overview of Decompensated 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 the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborate profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the decompensated cirrhosis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our 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 in shaping and driving the 7MM Decompensated cirrhosis market.

Decompensated cirrhosis Report Insights

• Patient Population
• Therapeutic Approach: Decompensated cirrhosis
• Decompensated Cirrhosis Pipeline Analysis
• Decompensated Cirrhosis Market Size and Trends
• Existing and future Market Opportunity

Decompensated cirrhosis Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Decompensated Cirrhosis Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Decompensated Cirrhosis Report Assessment

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

FAQs:

• What is the historical and forecasted Decompensated cirrhosis patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which treatment approach Decompensated cirrhosis will have a significant impact on the Decompensated cirrhosis drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of Decompensated cirrhosis?
• How many companies are developing therapies for the treatment of Decompensated cirrhosis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• 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?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the decompensated 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.
• Understand the existing market opportunities 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 to 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 expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.