비대상성 간경변 시장은 증상 관리에서 알부민에 의존합니다. 이것은 효과적이지만, 질병의 진행을 변화시키는 것이 아니라 질병 변형 요법에 대한 명백한 미충족 요구를 부각시키고 있습니다. Phase III PRECIOSA 시험은 장기 및 고용량 알부민 투여가 이식 불필요한 생존기간의 조기 개선과 합병증 감소에 효과를 보였으나, 주요 평가 항목을 달성할 수 없었고, 대상으로 하는 유럽의 서브그룹에서의 사용의 지속은 인정되었지만, 시장의 재정의에는 이르지 않았습니다. 한편, 스페인에서 실시하는 Microbiomik에 의한 Phase III 시험(EUCT 2023-509151-13-00)에서는 대변 미생물총 이식(FMT)이 장간축의 조절, 감염증의 감소, 진행 지연을 위한 잠재적인 퍼스트 인 클래스의 접근법으로 평가되고 있습니다. 전반적으로 시장은 알부민을 기반으로 안정을 유지할 것으로 예상되는 반면, FMT와 같은 새로운 치료법은 진정한 질병 변형 효과를 가져올 가능성을 보여줍니다.
본 보고서에서는 비대상성 간경변의 주요 7개 시장(미국, 독일, 스페인, 이탈리아, 프랑스, 영국, 일본)에 대한 조사 분석을 실시하고, 각국 시장 규모와 예측, 각 치료법 시장 점유율, 현재의 치료법, 암멧 필요 등의 정보를 제공합니다.
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.
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.
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.
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.
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.