非酒精性脂肪性肝炎 (NASH)：新型療法、未滿足的需求和 TPP 洞察報告，2026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。
• 推動市場成長的因素如下：
• 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）和 TPP 的新興療法見解

Thelansis 的《非酒精性脂肪性肝炎（NASH）：新型療法、未滿足的需求和 TPP 洞察報告，2026》對該適應症的關鍵新興療法和主要藥物發現機會進行了全面分析，包括不斷變化的競爭格局、未滿足的需求、目標產品概況（TPP）、臨床試驗設計以及關鍵意見領袖（KOL）的見解。

非酒精性脂肪性肝炎（NASH）概述

非酒精性脂肪性肝炎（NAHHE），在目前的臨床和監管指南中更準確地稱為「代謝紊亂相關性脂肪性肝炎」，是一種進行性肝病，其特徵是肝臟脂肪堆積，與肥胖、胰島素抵抗及相關代謝紊亂密切相關，並逐漸發展為進行性和纖維化，最終導致肝硬化和肝功能衰竭。這個名稱的改變反映了對該疾病定義的轉變，從最初「非酒精相關」的負面定義，轉向由實際代謝因素定義的定義。這項轉變已廣泛應用於科學文獻、監管申報和藥品附加檔。臨床治療也取得了顯著進展，從最初沒有獲批藥物治療，發展到如今靶向肝臟、活化特定甲狀腺激素受體通路的口服藥物，隨後，已用於治療糖尿病和肥胖的促效劑也被應用於肝臟健康領域。診斷方法也得到了進步，非侵入性血液檢測和影像學檢查擴大用於評估纖維化的進展，而不再僅依賴切片檢查。

主要亮點

• 根據預測，德國非酒精性脂肪性肝炎（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，持續加重疾病的負擔。
• 目前仍有大量未被滿足的治療需求，即能夠延緩疾病進展及改善肝功能預後的治療方法。

透過對醫生和關鍵意見領袖（KOL）的調查所獲得的見解：

• 透過對關鍵意見領袖（KOL）的訪談，獲得了更多見解，進一步完善了調查結果。
• 調查問卷將根據客戶的要求進行客製化。

交付成果格式：

• PowerPoint簡報
• MS Excel

主要問題

• 詳細的競爭格局趨勢
• 管道分析
• 符合新興療法條件的患者
• 主要企業
• 主要作用機制
• 發布日期預測等。
• 臨床試驗趨勢分析
• 目標患者群
• 試驗終點
• 測試設計
• 受試者招募標準等。
• 未滿足的需求和機會
• 目前主要療法的有效性
• 未滿足需求的關鍵領域
• 主要未滿足需求的市場規模估算
• 目標產品概況
• 特徵和級別
• 醫生開立的處方
• 預期患者佔有率
• 關鍵意見領袖對領先新興療法的見解
• 認知程度
• 預期用途/治療方案
• 以滿足重大未滿足需求的程度
• KOL評論

目標國家

• G8
  • 美國
  • EU5
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 日本
  • 中國

提及公司

• 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 主要調查結果及分析師說明

• 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章 競爭情勢

• 目前的治療方法
• 重點
• 診斷和治療過程/演算法
• 主要療法概述及關鍵意見領袖見解
• 新興療法
• 重點
• 診斷和治療過程/演算法
• 領先的新興療法 - 概述和關鍵意見領袖見解

第3章 產品屬性分析

• 重點
• 科學屬性
• 商業性屬性
• 產品定位

第4章 初步調查

• 目前治療狀態
• 主要治療方法與目標患者族群的比較
• 主要特點和優勢
• 未來治療環境
• 當前挑戰
• 未滿足的需求
• 新興療法
• 主要治療方法與目標患者族群的比較
• 主要特點和優勢
• 未來治療前景
• 未滿足的需求和關鍵意見領袖的期望

第5章 未滿足的需求和TPP分析

• 主要未滿足需求及新興療法的未來成就
• TPP分析與KOL預期

第6章 監理與償付環境

第7章 附錄

Non-Alcoholic Steatohepatitis (NASH) Emerging Therapy and TPP Insights

Thelansis's "Non-Alcoholic Steatohepatitis (NASH) Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

Non-Alcoholic Steatohepatitis (NASH) Overview

Non-alcoholic steatohepatitis, now more accurately referred to in current clinical and regulatory guidance as metabolic dysfunction associated steatohepatitis, is a progressive liver disease that develops when fat buildup in the liver, closely tied to obesity, insulin resistance, and related metabolic conditions, advances into inflammation and scarring that can eventually lead to cirrhosis and liver failure. That naming shift reflects a broader move away from defining the disease by what it is not, namely alcohol related, toward defining it by its actual metabolic drivers, a change now widely adopted across scientific literature, regulatory filings, and drug labeling. Clinically, treatment has evolved just as significantly, moving from a landscape with no approved pharmacologic therapy toward one featuring a liver-targeted oral therapy that activates a specific thyroid hormone receptor pathway, followed by a GLP-1 receptor agonist already established in diabetes and obesity care extending its benefits into liver health. Diagnosis has also evolved, increasingly relying on non-invasive blood-based and imaging tools to stage fibrosis rather than defaulting to biopsy.

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.

Insights driven by surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard will cost USD 1,750 per country

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 risk, etc.

2. Competitive Landscape

• Current therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key current therapies - profiles and KOL insights
• Emerging therapies
• Key takeaways
• Dx and Tx journey/algorithm
• Key emerging therapies - profiles and KOL insights

3. Product Attribute Analysis

• Key takeaways
• Scientific attributes
• Commercial attributes
• Product positioning

4. Primary Market Research

• Current treatment landscape
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Current challenges
• Unmet needs
• Emerging therapies
• Key therapies vs. focused patient segment
• Key attributes and benefits
• Futures treatment landscape
• Unmet needs and KOL expectations

5. Unmet Need and TPP Analysis

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

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

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