非酒精性脂肪性肝炎（NASH）：市場機會的分析和預測（至2029年）

2019年，八個主要國家（美國，加拿大，法國，德國，意大利，西班牙，英國，日本）的非酒精性脂肪性肝炎（NASH）藥物銷售額將達到1.440億。預計到2029年將增長到272億美元，複合年增長率為68.8％。美國是最大的市場，佔總市場的94.3％，其次是歐洲國家（4.5％）和日本（1.2％）。市場的主要推動力是領先管道產品的認證和投放前景以及無創檢查方法的廣泛使用。

在本報告中，我們分析了有關非酒精性脂肪性肝炎（NASH）藥物（診斷劑，治療劑等）的最新研發趨勢以及未來市場趨勢的展望，並對該疾病和當前的治療方法，未滿足需求/市場機會的評估，未來10年的流行率/市場規模的預測值，臨床試驗的進展，新治療劑的流水線評估，未來市場/技術趨勢等我們正在調查。

目錄

第1章目錄

第2章非酒精性脂肪性肝炎（NASH）：執行摘要

• 銷量增長率：與持續藥物批准相關
• 組合方法是一項重要策略
• 未滿足需求的水平仍然很重要
• 非侵入性檢查的機會將成為NASH患者診斷和管理的重中之重
• 高效的創新管道產品佔據了很大的市場份額
• 醫生的意見

第3章簡介

第4章疾病概述

• 病因與病理生理
• 疾病分類/分期系統

第5章流行病學

• 疾病背景
• 危險因素和合併症
• 過去的全球趨勢
  • NASH總人數
  • 接受過NASH的既往患者人數
• 預測方法
  • 來源
  • 未使用的來源
  • 預測的前提條件和方法
  • NASH總人數
  • 接受過NASH的既往患者人數
  • NASH患病率：按纖維化分期
• NASH流行病學預測（2019-2029）
  • NASH總人數
  • 接受過NASH的既往患者人數
  • NASH患病率：按年齡
  • NASH患病率：按性別
  • NASH患病率：按纖維化分期
• 討論
  • 流行病學預測結果的考慮
  • 分析極限
  • 分析優勢

第6章當前的治療方法

• 概述
• 診斷
• 治療
  • 維生素E
  • □格列酮
• 準則

第7章未滿足的需求和市場機會的評估

• 概述
• 缺乏批准的治療
• 具有成本效益的非侵入性測試，可用於患者監測和潛在診斷
• 瞭解NASH的病理生理學
• 新的具有成本效益的治療方法和改善的獲取

第8章研究與開發（R＆D）策略

• 概述
  • 針對多種途徑的聯合療法
  • 早期/晚期NASH差異定位
• 試用設計
  • 患者選擇
  • 具有臨床意義的終點和分析時間
  • 提交監管機構時圍繞端點的不確定性
  • 採用生物標誌物來衡量治療反應

第9章管道評估

第10章管道評估分析

第11章附錄

Non-alcoholic steatohepatitis (NASH) is a common, often clinically silent liver disease characterized by the presence of steatosis (fatty liver), in addition to liver inflammation and damage. Unlike alcoholic liver disease, NASH occurs in those who drink little or no alcohol. NASH usually presents with few or no symptoms, and most people affected with the disease feel healthy and are unaware they have a problem. However, symptoms including fatigue, weight loss, and weakness emerge once the disease has progressed to a more advanced stage, like cirrhosis. NASH is suspected if elevated liver enzymes are detected during routine blood panels, but it is only definitively diagnosed when a liver biopsy is performed.

Both NASH and non-alcoholic fatty liver (NAFL) are histologically categorized under the umbrella of non-alcoholic fatty liver disease (NAFLD). NAFL is defined as the presence of a fatty liver with no evidence of hepatocellular injury or fibrosis, whereas NASH is defined as the presence of fatty liver and inflammation with evidence of hepatocyte injury, with or without fibrosis. NASH can progress to more advanced stages of liver disease including cirrhosis, liver failure, and in rare cases, liver cancer.

Key Highlights

• Over the 10-year forecast period, GlobalData estimates the sales for the NASH market to grow from $144.4M in 2019 to $27.2B in 2029 at a Compound Annual Growth Rate (CAGR) of 68.8% across the 7MM. At the end of 2029, the US will contribute around 94.3% of global sales, while the 5EU and Japan will account for around 4.5% and 1.2% of sales, respectively.
• GlobalData expects the main drivers of growth during the forecast period to be the US launch of Intercept's Ocaliva in 2021, Inventiva's lanifibranor in 2025 and Novo Nordisk's Ozempic in 2026. Ozempic is anticipated to have rapid growth and be the highest grossing therapy by 2029 in NASH.
• Throughout the forecast period, cost of therapy and slow reimbursement rates will likely hinder uptake of certain therapies. GlobalData also expects finding an alternative to liver biopsy will remain a challenge for diagnosis and measuring treatment response, although novel non-invasive tests such as Genfit's NIS-4 could become validated in hopes of boosting diagnosis rates throughout the period.

Key Questions Answered

• How will the NASH therapeutic market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) will change from 2019-2029?
• What NASH therapeutics are in clinical development?
• How do the clinical and commercial attributes of NASH therapies in development compare with one another, and which will become market leaders?
• What are the remaining unmet needs in NASH?
• What drivers and barriers will affect NASH therapy sales in the 7MM over the forecast period?

Scope

• Overview of current and future therapeutic approaches in treating NASH in patients with stages F2-F4.
• Topline NASH market revenue from 2019-2029. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
• Key topics covered include current treatment options, unmet needs and opportunities, pipeline valuation analysis of the NASH market in the 7MM.
• Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of pipeline products.
• Analysis of the current and future market competition in the global NASH market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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Table of Contents

1 Table of Contents

• 1.1 List of Tables
• 1.2 List of Figures

2 NASH: Executive Summary

• 2.1 Sales Growth Expected to Correlate with Successive Drug Approvals
• 2.2 Combination Approaches Will Become a Key Strategy
• 2.3 Level of Unmet Need Remains Significant
• 2.4 Opportunity for Non-invasive Tests to Be at the Forefront of NASH Patient Diagnosis and Management
• 2.5 Innovative Pipeline Products Demonstrating High Levels of Effectiveness will Acquire Large Market Share
• 2.6 What Do Physicians Think?

3 Introduction

• 3.1 Catalyst
• 3.2 Related Reports
• 3.3 Upcoming Related Reports

4 Disease Overview

• 4.1 Etiology and Pathophysiology
  • 4.1.1 Etiology
  • 4.1.2 Pathophysiology
• 4.2 Classification or Staging Systems

5 Epidemiology

• 5.1 Disease Background
• 5.2 Risk Factors and Comorbidities
• 5.3 Global and Historical Trends
  • 5.3.1 Total Prevalence of NASH
  • 5.3.2 Diagnosed Prevalence of NASH
• 5.4 Forecast Methodology
  • 5.4.1 Sources
  • 5.4.2 Sources Not Used
  • 5.4.3 Forecast Assumptions and Methods
  • 5.4.4 Total Prevalent Cases of NASH
  • 5.4.5 Diagnosed Prevalent Cases of NASH
  • 5.4.6 Diagnosed Prevalent Cases of NASH by Stage of Fibrosis
• 5.5 Epidemiological Forecast for NASH (2019-2029)
  • 5.5.1 Total Prevalent Cases of NASH
  • 5.5.2 Diagnosed Prevalent Cases of NASH
  • 5.5.3 Age-Specific Diagnosed Prevalent Cases of NASH
  • 5.5.4 Sex-Specific Diagnosed Prevalent Cases of NASH
  • 5.5.5 Diagnosed Prevalent Cases of NASH by Stage of Fibrosis
• 5.6 Discussion
  • 5.6.1 Epidemiological Forecast Insight
  • 5.6.2 Limitations of the Analysis
  • 5.6.3 Strengths of the Analysis

6 Current Treatment Options

• 6.1 Overview
• 6.2 Diagnosis
• 6.3 Treatment
  • 6.3.1 Vitamin E
  • 6.3.2 Pioglitazone
• 6.4 Guidelines

7 Unmet Needs and Opportunity Assessment

• 7.1 Overview
• 7.2 Lack of Approved Therapies
• 7.3 Cost Efficient Non-Invasive Tests for Patient Monitoring and Potential Diagnosis
• 7.4 Understanding of NASH Pathophysiology
• 7.5 Cost-Effective Novel Therapies and Improved Access

8 R&D Strategies

• 8.1 Overview
  • 8.1.1 Combination Therapies to Target Multiple Pathways
  • 8.1.2 Differential Targeting of Early and Late-Stage NASH
• 8.2 Clinical Trials Design
  • 8.2.1 Patient Selection
  • 8.2.2 Clinically Meaningful Endpoints and Study Period
  • 8.2.3 Uncertainty Surrounding Endpoints for Regulatory Submission
  • 8.2.4 Employing Biomarkers to Measure Therapeutic Response

9 Pipeline Assessment

10 Pipeline Valuation Analysis

11 Appendix

List of Tables

List of Tables

• Table 1: NASH: Key Metrics in the 7MM
• Table 2: NASH Clinical Research Network Histological Scoring System
• Table 3: Risk Factors and Comorbidities for NASH
• Table 4: Treatment Guidelines for NAFLD/NASH
• Table 5: Recommendations for Pharmacolog

List of Figures

List of Figures

• Figure 1: Global Sales Forecast by Country for NASH in 2019 and 2029
• Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Vitamin E
• Figure 3: Stages of Liver Disease
• Figure 4: Pathways of Current