非酒精性脂肪性肝炎（NASH）：全球市場展望、流行病學、競爭格局和市場預測報告（32個主要市場），2025-2035年

市場概覽

• 預計義大利 NASH 市場將從 2025 年的 9,500 萬美元成長到 2035 年的 8.5 億美元。
• 以下因素正在推動市場成長：
• 擴大新型疾病修正治療的應用
• 診斷技術的進步和對慢性肝病認知的提高
• 未來的進展取決於能夠有效減少纖維化和阻止疾病進展的治療方法。

非酒精性脂肪性肝炎（NASH）概述

代謝失調相關性脂肪性肝炎（MASH）（曾被稱為非酒精性脂肪性肝炎（NASH））是一種進行性發炎性肝病，其特徵為脂肪肝、小葉發炎、肝細胞氣球樣變性和進行性性纖維化。它由脂質毒性、氧化壓力以及代謝因素（如第2型糖尿病和肥胖）引起，在晚期，肝硬化和肝細胞癌的風險顯著增加。診斷包括組織學標準（肝臟切片檢查）、非侵入性彈性影像和FIB-4評分的綜合評估。雖然持續減重仍然是治療的基本原則，但治療模式已從單純的生活方式介入發生了根本性的轉變。此治療方案已獲得兩大監管機構的批准。其中一種是甲狀腺激素受體BETA促效劑「Rezdiffra（瑞斯美羅）」，用於治療伴有中度至重度纖維化的非肝硬化性MASH；另一種是GLP-1受體促效劑「Wegovy（Semaglutide）」，該藥在突破性的3期臨床試驗結果公佈後，已獲批用於治療肝硬化前期患者。同時，由於監管機構明確拒絕批准，並指出存在安全風險，傳統的候選藥物，例如法尼醇X受體促效劑奧貝膽酸，已完全放棄。目前，後期臨床開發平臺依賴替代途徑，其中以口服泛PPAR促效劑雷尼菲拉諾最為領先，該藥即將完成3期NATiV3檢驗試驗。此外，諸如替澤帕肽等先進的雙/三聯腸促胰素製劑也在研發中。定期進行非侵入性監測對於指導終身管理至關重要。

主要亮點

• 根據預測，德國 NASH 患者人數將從 2025 年的 3,705,760 人增加到 2035 年的 4,772,710 人。
• NASH 是一種進行性肝病，如果不治療，會導致肝纖維化、肝硬化，甚至肝功能衰竭。
• 肥胖症和第2型糖尿病的盛行率不斷上升，持續加重疾病負擔。
• 目前仍有大量未滿足的治療需求，亟需能夠延緩疾病惡化並改善肝功能結果的治療方法。

市場定義：

• 北美洲（美國、加拿大）
• 歐洲（奧地利、比利時、捷克、丹麥、芬蘭、法國、德國、希臘、義大利、荷蘭、挪威、波蘭、葡萄牙、俄羅斯、西班牙、瑞典、瑞士、英國）
• 中東（沙烏地阿拉伯、阿拉伯聯合大公國、科威特、土耳其）
• 亞太地區（澳洲、中國、香港、印度、印尼、日本、馬來西亞、紐西蘭、菲律賓、新加坡、韓國、台灣、泰國、越南）
• 非洲（埃及、奈及利亞、南非、摩洛哥）
• 南美洲/拉丁美洲（阿根廷、巴西、智利、哥倫比亞、墨西哥、秘魯）

格式化和更新訊息

• 詳細報告（PDF）
• 市場預測模型（基於微軟Excel）
• 流行病學數據（MS Excel，互動式工具）
• 高階主管洞察（PPT簡報）
• 其他功能：定期更新、自訂和顧問支援。
• 根據 Thelansis 的政策，我們確保所有最新更新在發布前都反映在報告內容和市場模型中。

主要問題

• 如何最佳化在 32 個市場（北美、歐洲、中東、亞太、非洲和南美/拉丁美洲）的藥物開發和生命週期管理策略？
• 從發病率、盛行率、人群組成以及接受藥物治療的患者人數來看，患者數量分別是多少？
• 未來十年市場收入和病患佔有率的預測是多少？
• 哪些因素對市場趨勢影響最大？
• 受訪專家對目前和新興的治療方法有何看法？
• 哪款在研發線產品最有前景？其上市潛力及未來市場定位如何？
• 主要未被滿足的需求是什麼？ KOL 對目標受眾有何期望？
• 為確保藥物獲得批准並順利進入市場，必須滿足哪些關鍵的監管和支付方要求？

目標國家

• 北美洲（美國、加拿大）
• 歐洲（奧地利、比利時、捷克、丹麥、芬蘭、法國、德國、希臘、義大利、荷蘭、挪威、波蘭、葡萄牙、俄羅斯、西班牙、瑞典、瑞士、英國）
• 中東

大公司

• Novo Nordisk A/S
• Inipharm Australia Pty Ltd.
• Madrigal Pharmaceuticals, Inc.
• Xiamen Amoytop Biotech Co., Ltd.
• Arrowhead Pharmaceuticals
• Sunshine Lake Pharma Co., Ltd.
• Haisco Pharmaceutical Group Co., Ltd.
• Altimmune, Inc.
• Hoffmann-La Roche
• Corcept Therapeutics
• AstraZeneca
• Boehringer Ingelheim
• Merck Sharp &Dohme LLC
• Akero Therapeutics, Inc.
• 89bio, Inc.
• Terns, Inc.
• NGM Biopharmaceuticals, Inc.
• Inventiva Pharma
• Hanmi Pharmaceutical Company Limited
• Sinew Pharma Inc.
• Eli Lilly and Company
• Gilead Sciences
• Zydus Therapeutics Inc.
• HighTide Biopharma Pty Ltd.
• Hudson Biotech
• Regeneron Pharmaceuticals
• Neuraly, Inc.

目錄

第1章：主要調查結果和分析師說明

• 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章：疾病背景

• 疾病定義、分類、病因和病理生理學、藥物標靶等。

第3章：流行病學

• 重點
• 發病率/盛行率
• 已確診並正在接受藥物治療的患者族群。
• 合併症
• 其他相關患者群

第4章 市場規模及預測

• 重點
• 市場促進因素與限制因素
• 按藥物類別分類的趨勢
• 各國具體趨勢

第5章 競爭情勢

• 目前的治療方法
• 重點
• 診斷和治療過程/演算法
• 目前主要療法－概述及關鍵意見領袖見解
• 新興療法
• 重點
• 值得關注的後期新興療法—概述、市場上市預期和關鍵意見領袖見解
• 值得關注的早期管道

第6章：未滿足的需求與目標產品分析

• 尚未滿足的主要需求及其透過新興療法實現的潛力。
• TPP分析與KOL展望

第7章 監理與報銷環境

第8章附錄

Global Non-Alcoholic Steatohepatitis (NASH) Market Outlook

Thelansis's "Global Non-Alcoholic Steatohepatitis (NASH) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report (Top 32 Markets) - 2025 To 2035" covers disease overview, epidemiology, kidney biopsy cases, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential NASH treatment modalities options for the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America).

Non-Alcoholic Steatohepatitis (NASH) Overview

Metabolic dysfunction-associated steatohepatitis (MASH), formerly non-alcoholic steatohepatitis (NASH), is a progressive inflammatory liver disease characterized by hepatic steatosis, lobular inflammation, hepatocyte ballooning, and progressive fibrosis. Driven by lipotoxicity, oxidative stress, and metabolic drivers like type 2 diabetes and obesity, advanced stages pose significant risks of cirrhosis and hepatocellular carcinoma. Diagnosis combines liver biopsy as the histological standard with non-invasive elastography and FIB-4 scoring. While sustained weight reduction remains foundational, the therapeutic paradigm has fundamentally shifted away from purely lifestyle interventions. Care is anchored by two major regulatory approvals: the thyroid hormone receptor beta agonist Rezdiffra (resmetirom) for non-cirrhotic MASH with moderate-to-advanced fibrosis, and the newly approved GLP-1 receptor agonist Wegovy (semaglutide), indicated for pre-cirrhotic phenotypes following landmark Phase 3 trials. Conversely, historical candidates like the farnesoid X receptor agonist obeticholic acid have been completely abandoned following definitive regulatory rejections due to safety risks. The active late-stage pipeline relies on alternative pathways, led by the oral pan-PPAR agonist lanifibranor, which is completing Phase 3 NATiV3 validation, alongside advanced dual/triple incretins like tirzepatide. Regular non-invasive tracking is mandatory to guide lifelong management.

Key Highlights

• In Germany, the prevalent NASH population is projected to increase from 3,705,760 in 2025 to 4,772,710 by 2035.
• NASH is a progressive liver disease that can lead to fibrosis, cirrhosis, and liver failure if left untreated.
• Rising obesity and type 2 diabetes prevalence continue to drive disease burden.
• Significant unmet need remains for therapies that slow disease progression and improve liver outcomes.

Market Overview

• The Italy NASH market is projected to grow from $95M in 2025 to $850M by 2035.
• Market growth is driven by:
• Increasing adoption of emerging disease-modifying therapies
• Improved diagnosis and growing awareness of chronic liver disease
• Future growth will depend on therapies that effectively reduce fibrosis and prevent disease progression.

Market Definition:

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle East (Saudi Arabia, UAE, Kuwait, Turkey)
• Asia Pacific (Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam)
• Africa (Egypt, Nigeria, South Africa, Morocco)
• South / Latin America (Argentina, Brazil, Chile, Colombia, Mexico, Peru)

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across the 32 markets (North America, Europe, Middle East, Asia Pacific, Africa, South / Latin America)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• North America (United States, Canada)
• Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, United Kingdom)
• Middle Ea

Companies Mentioned

• Novo Nordisk A/S
• Inipharm Australia Pty Ltd.
• Madrigal Pharmaceuticals, Inc.
• Xiamen Amoytop Biotech Co., Ltd.
• Arrowhead Pharmaceuticals
• Sunshine Lake Pharma Co., Ltd.
• Haisco Pharmaceutical Group Co., Ltd.
• Altimmune, Inc.
• Hoffmann-La Roche
• Corcept Therapeutics
• AstraZeneca
• Boehringer Ingelheim
• Merck Sharp & Dohme LLC
• Akero Therapeutics, Inc.
• 89bio, Inc.
• Terns, Inc.
• NGM Biopharmaceuticals, Inc.
• Inventiva Pharma
• Hanmi Pharmaceutical Company Limited
• Sinew Pharma Inc.
• Eli Lilly and Company
• Gilead Sciences
• Zydus Therapeutics Inc.
• HighTide Biopharma Pty Ltd.
• Hudson Biotech
• Regeneron Pharmaceuticals
• Neuraly, Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
• Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)