2023년 주요 7개국의 알코올성 간염 유병자 수는 약 110만 명으로 진단되었습니다. 이 중 미국이 23%, EU4와 영국이 63%, 일본이 14%를 차지합니다. 알코올성 간염 시장은 꾸준히 성장하고 있으며, 2024년부터 2034년까지 CAGR은 6%입니다. 이러한 주요 7개국에서의 확대는 유전적 영향과 음주 등 생활습관 요인에 따른 발병률 증가와 더불어, 랄스코스테롤 및 INT-787과 같은 혁신적인 치료제의 도입이 주도하고 있습니다. 알코올성 간염에 대한 효과적인 약물 치료는 현재 FDA가 승인한 치료제가 없어 미충족 수요가 큰 상황입니다. 이러한 격차는 환자들의 임상 결과를 개선하고 사망률을 낮추기 위한 혁신적인 약물 개발이 시급하다는 것을 강조하고 있습니다.
2022년 11월, 인터셉트는 간학회(The Liver Meeting)에서 건강한 성인에서 INT-787의 우수한 안전성 및 내약성 프로파일을 보여주는 인체적용시험(First-in-Human) 데이터를 발표하였습니다.
알코올성 간염의 중요한 시장 장벽은 질병의 중증도를 정확하게 식별하고 계층화할 수 있는 강력한 진단 도구가 없다는 것입니다. 이러한 한계는 조기 개입을 방해하고, 임상시험에 대한 환자 등록을 감소시키며, 표적 치료제의 개발을 방해하고, 궁극적으로 치료 성과와 시장 성장 잠재력에 영향을 미칩니다.
알코올성 간염은 과도한 알코올 섭취로 인한 간 염증을 특징으로 하며, 일반적으로 수십 년 동안 하루에 약 8-10잔의 과음으로 특징지어집니다. 환자는 종종 발열, 식욕부진, 체중감소, 피로감, 전신 쇠약감, 메스꺼움, 구토, 진행성 황달 등의 임상증상을 보입니다. 주요 위험요인은 장기간의 알코올 남용, 남성, 고령, 간질환의 병발 등입니다. 병인에는 알코올이 간세포에 미치는 독성 작용이 관여하여 산화 스트레스, 염증 반응 및 후속 간 손상을 유발합니다. 이러한 복잡한 요인의 상호작용이 알코올성 간염의 병태생리에 기여하고 있으며, 효과적인 예방 및 관리 전략의 필요성을 강조하고 있습니다.
알코올성 간염의 진단은 병력, 신체 소견, 검사 항목의 종합적인 평가가 필요합니다. 임상의는 환자의 음주력을 확인하고, 음주량, 종류, 최근 음주량 증가(많은 경우 생활상의 심각한 스트레스와 관련이 있음)에 주의를 기울여야 합니다. 신체 소견으로는 간종대, 황달, 복수 등이 있습니다. 임상 검사에서 아스파르트산 아미노전이효소(AST)와 알라닌 아미노전이효소(ALT)의 비율이 1.5 이상, 혈청 빌리루빈 수치가 2mg/dL 이상, γ-글루타밀 전이효소(GGT), 평균 적혈구 용적(MCV) 등의 지표도 진단을 뒷받침합니다. 진단을 뒷받침합니다. 현저한 백혈구 증가와 낮은 총 콜레스테롤 수치(100mg/dL 미만)는 예후가 좋지 않을 수 있습니다. 불확실한 경우, 테크네튬 유황 콜로이드 간비장 스캔과 같은 영상 진단법을 사용하여 비침습적으로 AH를 확인할 수 있습니다.
본 보고서는 주요 7개국 알코올성 간염 시장에 대해 조사했으며, 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지의 시장 규모 예측, 미충족 의료 수요 등을 조사하여 전해드립니다.
DelveInsight's "Alcoholic Hepatitis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of alcoholic hepatitis, historical and forecasted epidemiology, as well as the alcoholic hepatitis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The alcoholic hepatitis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM alcoholic hepatitis market size from 2020 to 2034. The report also covers alcoholic hepatitis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Alcoholic Hepatitis overview
Alcoholic hepatitis is characterized by inflammation of the liver resulting from excessive alcohol intake, typically marked by a history of heavy drinking, approximately 8-10 drinks per day over several decades. Patients often present with clinical features such as fever, anorexia, weight loss, fatigue, generalized weakness, nausea, vomiting, and progressive jaundice. Key risk factors include prolonged alcohol abuse, male gender, older age, and the presence of coexisting liver diseases. The etiology involves the toxic effects of alcohol on liver cells, leading to oxidative stress, inflammatory responses, and subsequent liver damage. This complex interplay of factors contributes to the pathophysiology of alcoholic hepatitis, underscoring the need for effective prevention and management strategies.
Alcoholic Hepatitis diagnosis
The diagnosis of alcoholic hepatitis involves a comprehensive evaluation of clinical history, physical examination, and targeted laboratory tests. Clinicians must ascertain the patient's alcohol consumption history, noting the volume, type, and recent increases in intake, often linked to significant life stressors. Physical findings may include hepatomegaly, jaundice, and ascites. Laboratory tests typically reveal an elevated aspartate aminotransferase (AST) to alanine aminotransferase (ALT) ratio greater than 1.5, alongside elevated serum bilirubin levels exceeding 2 mg/dL. Additional markers, such as gamma-glutamyltransferase (GGT) and mean corpuscular volume (MCV), may support the diagnosis. A pronounced leukocytosis and low total cholesterol levels (<100 mg/dL) can indicate a poor prognosis. In uncertain cases, imaging modalities like a technetium sulfur colloid liver-spleen scan may be employed to confirm AH noninvasively, while liver biopsy is rarely indicated unless to clarify discrepancies in alcohol consumption history. Further details related to country-based variations are provided in the report...
Alcoholic Hepatitis treatment
The treatment landscape for alcoholic hepatitis (AH) primarily involves strategies such as complete alcohol abstinence, nutritional support, and pharmacological interventions, including corticosteroids and pentoxifylline, along with liver transplantation for eligible patients. Corticosteroids are regarded as the standard of care for patients with severe AH who do not exhibit signs of concomitant sepsis; however, only approximately 40% of patients qualify for this therapy. The absence of effective pharmaceutical options for the remaining patient population highlights a critical gap in the treatment paradigm. Significant advancements in therapeutic development targeting this unmet need are anticipated to profoundly transform the market landscape during the forecast period, emphasizing the necessity for innovative solutions.
As the market is derived using a patient-based model, the Alcoholic Hepatitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of alcoholic hepatitis, total diagnosed prevalent cases of alcoholic hepatitis, gender-specific diagnosed prevalent cases of alcoholic hepatitis, and severity-specific diagnosed prevalent cases of alcoholic hepatitis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
Emerging Drugs
Larsucosterol: Durect Corporation
Larsucosterol, an endogenous sulfated oxysterol and epigenetic modulator, regulates gene expression by inhibiting DNA methyltransferases (DNMT1, DNMT3a, DNMT3b), addressing epigenetic dysregulation seen in acute conditions like alcoholic hepatitis (AH) and chronic diseases like MASH. In April 2024, DURECT Corporation announced topline results from the Phase IIb AHFIRM trial, demonstrating a compelling efficacy signal with a clinically relevant 90-day mortality reduction of 41% for the 30 mg dose and 35% for the 90 mg dose compared to standard of care. The FDA granted Breakthrough Therapy Designation to larsucosterol for severe AH in May 2024. DURECT plans to present these results at the EASL Congress 2024 and hold an End of Phase 2 (EOP2) meeting with the FDA to discuss the Phase III registration trial design in the first quarter of 2024.
INT-787: Intercept Pharmaceuticals
INT-787, developed by Intercept Pharmaceuticals, is a selective FXR agonist under investigation for severe alcohol-associated hepatitis (sAH). By activating FXR, INT-787 modulates bile acid metabolism and reduces liver inflammation. Alcohol-related liver disease, which is now the leading cause for liver transplant listings in the US, has seen a rise in sAH cases requiring transplantation. In May 2024, Intercept announced that nine abstracts related to primary biliary cholangitis (PBC) and alcohol-related liver disease would be presented at the EASL Congress in Milan (June 5-8). Results showed INT-787 was well tolerated in healthy subjects, with most treatment-emergent adverse events being mild and no treatment-limiting or serious adverse events reported.
Drug Class Insights
The treatment of alcoholic hepatitis involves several drug classes aimed at reducing inflammation and liver damage. Corticosteroids, such as prednisolone, are the standard of care for severe AH, reducing inflammation but with limited eligibility due to infection risks. Antioxidants like N-acetylcysteine are used to combat oxidative stress in the liver. Pentoxifylline, a phosphodiesterase inhibitor, helps reduce inflammation and fibrosis, though its efficacy is debated. TNF-alpha inhibitors, such as infliximab, target inflammation pathways but are not widely recommended due to safety concerns. Emerging therapies include epigenetic modulators like Larsucosterol, and FXR agonists such as INT-787, which aim to address underlying liver dysfunction and inflammation.
The treatment landscape for alcoholic hepatitis primarily involves abstinence, nutritional support, corticosteroids, pentoxifylline, and liver transplantation. Despite corticosteroids being the standard of care for severe AH patients without sepsis, only about 40% of patients are eligible for this therapy, leaving significant unmet needs. Emerging therapies like Larsucosterol and INT-787 are poised to address these gaps. Larsucosterol, an endogenous sulfated oxysterol and epigenetic modulator, inhibits DNA methyltransferases, regulating gene expression and addressing epigenetic dysregulation in AH and MASH. INT-787, a selective FXR agonist, modulates bile acid metabolism and reduces liver inflammation in severe alcohol-associated hepatitis (sAH).
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Larsucosterol is expected to enter the US market in 202X and is projected to have a medium uptake during the forecast period.
Alcoholic Hepatitis Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. 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 emerging therapies for Alcoholic Hepatitis.
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 our secondary research. Industry Experts contacted for insights on Alcoholic Hepatitis 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, Medical Professionals, Professors, Directors, and Others.
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Department of Internal Medicine, Division of Gastroenterology, Virginia Commonwealth University School of Medicine; Department of Internal Medicine, University of Texas Medical Branch, Galveston, United States, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Alcoholic Hepatitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Physician's View
As per the KOLs from the US, Although there is not one specific sign or symptom related to alcoholic hepatitis (AH), a constellation of symptoms and signs can help make the diagnosis of AH with reasonable accuracy. Documentation of chronic and active alcohol abuse is paramount in making a diagnosis of AH. Clinical presentation after abstinence for more than 3 m should raise doubts about the diagnosis of AH and dictate the need for considering other causes of liver disease, decompensation of alcoholic cirrhosis, sepsis, and malignancy as the cause of the patient's clinical profile.
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 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.
To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.
Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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 provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Alcoholic Hepatitis report insights
Alcoholic Hepatitis report key strengths
Alcoholic Hepatitis report assessment
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
The table of contents is not exhaustive; the final content may vary.