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非アルコール性脂肪性肝炎 (NASH) 治療薬のアジア太平洋地域市場:2024年までの見通し

Nonalcoholic Steatohepatitis Therapeutics in Asia-Pacific Markets to 2024 - Launch of NASH-Specific Premium Products and Rising Prevalence to Drive the Market

発行 GlobalData 商品コード 758900
出版日 ページ情報 英文 112 Pages
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非アルコール性脂肪性肝炎 (NASH) 治療薬のアジア太平洋地域市場:2024年までの見通し Nonalcoholic Steatohepatitis Therapeutics in Asia-Pacific Markets to 2024 - Launch of NASH-Specific Premium Products and Rising Prevalence to Drive the Market
出版日: 2018年12月03日 ページ情報: 英文 112 Pages
概要

アジア太平洋地域の非アルコール性脂肪性肝炎 (NASH) 治療薬市場は、2017年〜2024年のCAGR (複合年間成長率) で、17.2%の成長が予測されています。

当レポートでは、アジア太平洋地域の非アルコール性脂肪性肝炎 (NASH) 治療薬市場について調査分析し、市場促進要因、疾患の概要、上市製品、パイプライン、有望薬の評価、市場予測、主要取引など、体系的な情報を提供しています。

第1章 目次

第2章 イントロダクション

  • 疾患の概要
  • 疫学
  • 症状
  • 病因と病態生理
  • 診断
  • 分類
  • 予後
  • 併存疾患
  • 治療選択肢と治療アルゴリズム

第3章 上市製品

  • 概要
  • 上市製品の有効性と安全性の比較

第4章 パイプライン分析

  • 概要
  • パイプライン:開発段階別、分子タイプ別、投与経路別、プログラムタイプ別
  • パイプライン:分子標的別
  • 有望なパイプライン候補薬
  • パイプライン製品の有効性と安全性の比較
  • 製品競争力の枠組み

第5章 治験分析

  • 失敗率
  • 治験の規模
  • 治験の期間
  • 治験メトリクスの概要

第6章 複数シナリオの予測

  • 地域別市場
  • アジア太平洋地域市場
  • インド
  • 中国
  • オーストラリア
  • 韓国
  • 日本

第7章 促進要因と障壁

  • 促進要因
  • 障壁

第8章 取引と戦略的統合

  • ライセンス取引
  • 共同開発取引

第9章 付録

図表

List of Tables

  • Table 1: NAFLD Definitions and Phenotypes 10
  • Table 2: Major Symptoms of NASH 11
  • Table 3: Etiologies of NASH 12
  • Table 4: Histopathological Abnormalities in NASH 17
  • Table 5 NAFLD Activity Score and Staging System 20
  • Table 6: Therapeutic Management in NASH 24
  • Table 7: NASH Therapeutics Market, Global, Licensing Deals Valued $100m and Above, 2007-2018 86
  • Table 8: NASH Therapeutics Market, Global, Co-development Deals with Deal Value 10 and above, 2007-2018 92
  • Table 9: NASH Therapeutics Market, Global, All Pipeline Products, Discovery, 2018 93
  • Table 10: NASH Therapeutics Market, Global, All Pipeline Products, Preclinical, 2018 95
  • Table 11: NASH Therapeutics Market, Global, All Pipeline Products, IND/CTA-filed, 2018 98
  • Table 12: NASH Therapeutics Market, Global, All Pipeline Products, Phase I, 2018 99
  • Table 13: NASH Therapeutics Market, Global, All Pipeline Products, Phase II, 2018 100
  • Table 14: NASH Therapeutics Market, Global, All Pipeline Products, Phase III, 2018 101
  • Table 15: NASH Therapeutics Market, APAC, Market Forecast, 2017-2024 101
  • Table 16: NASH Therapeutics Market, India, Market Forecast, 2017-2024 102
  • Table 17: NASH Therapeutics Market, China, Market Forecast, 2017-2024 102
  • Table 18: NASH Therapeutics Market, Australia, Market Forecast, 2017-2024 103
  • Table 19: NASH Therapeutics Market, South Korea, Market Forecast, 2017-2024 103
  • Table 20: NASH Therapeutics Market, Japan, Market Forecast, 2017-2024 104

List of Figures

  • Figure 1: Pathophysiology of Hepatic Steatosis 13
  • Figure 2: Factors Contributing to Development of NASH from Steatotic Liver 15
  • Figure 3: Diagnostic Flow Chart for NASH 16
  • Figure 4: Stages of NASH Progression 19
  • Figure 5: Treatment Options in NASH (Potential Therapeutic Targets) 21
  • Figure 6: NASH Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products for NASH Treatment, 2018 31
  • Figure 7: NASH Therapeutics Market, Global, Pipeline, 2018 33
  • Figure 8 NASH Therapeutics Market, Global, Pipeline by Molecular Target, 2018 34
  • Figure 9: NASH Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2018 35
  • Figure 10: NASH Therapeutics Market, APAC, Selonsertib Forecast ($m), 2023-2024 37
  • Figure 11: NASH Therapeutics Market, APAC, Elafibrinor Forecast ($m), 2023-2024 39
  • Figure 12: NASH Therapeutics Market, APAC, Saroglitazar Forecast ($m), 2020-2024 40
  • Figure 13: NASH Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products for NASH Treatment, 2018 46
  • Figure 14: NASH Therapeutics Market, Competitor Matrix for NASH Marketed and Pipeline Products, 2018 47
  • Figure 15: NASH Therapeutics Market, Global, Average Clinical Trial Failure Rate (%), 2017 49
  • Figure 16: NASH Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type (%), 2007-2017 50
  • Figure 17: NASH Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target (%), 2007-2017 51
  • Figure 18: NASH Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type, 2007-2017 52
  • Figure 19: NASH Therapeutics Market, Global, Clinical Trial Size per Product by Molecular Target, 2007-2017 53
  • Figure 20: NASH Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Type, 2007-2017 54
  • Figure 21: NASH Therapeutics Market, Global, Clinical Trial Size per Trial by Molecular Target, 2007-2017 55
  • Figure 22: NASH Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, 2007-2017 56
  • Figure 23: NASH Therapeutics Market, Global, Clinical Trial Duration by Molecular Target, 2007-2017 57
  • Figure 24: NASH Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecule Type 58
  • Figure 25: NASH Therapeutics Market, Comparison of Average Trial Metrics by Phase and Molecular Target 58
  • Figure 26: NASH Therapeutics Market, APAC, Treatment Patterns (million), 2017-2024 60
  • Figure 27: NASH Therapeutics Market, APAC, Market Size ($m), 2017-2024 61
  • Figure 28: NASH Therapeutics Market, India, Treatment Usage Patterns (million), 2017-2024 62
  • Figure 29: NASH Therapeutics Market, India, Annual Cost of Therapy ($), 2017-2024 63
  • Figure 30: NASH Therapeutics Market, India, Market Size ($m), 2017-2024 64
  • Figure 31: NASH Therapeutics Market, China, Treatment Usage Patterns (millions), 2017-2024 65
  • Figure 32: NASH Therapeutics Market, China, Annual Cost of Therapy ($), 2017-2024 66
  • Figure 33: NASH Therapeutics Market, China, Market Size ($m), 2017-2024 67
  • Figure 34: NASH Therapeutics Market, Australia, Treatment Usage Patterns (million), 2017-2024 68
  • Figure 35: NASH Therapeutics Market, Australia, Annual Cost of Therapy ($), 2017-2024 70
  • Figure 36: NASH Therapeutics Market, Australia, Market Size ($m), 2017-2024 71
  • Figure 37: NASH Therapeutics Market, South Korea, Treatment Usage Patterns (million), 2017-2024 72
  • Figure 38: NASH Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2017-2024 73
  • Figure 39: NASH Therapeutics Market, South Korea, Market Size ($m), 2017-2024 74
  • Figure 40: NASH Therapeutics Market, Japan, Treatment Usage Patterns (millions), 2017-2024 75
  • Figure 41: NASH Therapeutics Market, Japan, Annual Cost of Therapy ($), 2017-2024 76
  • Figure 42: NASH Therapeutics Market, Japan, Market Size ($m), 2017-2024 77
  • Figure 43: NASH Therapeutics Market, Global, Licensing Deals by Region and Value, 2007-2018 81
  • Figure 44: NASH Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 82
  • Figure 45: NASH Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 83
  • Figure 46: NASH Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2007-2018 84
  • Figure 47: NASH Therapeutics Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2007-2018 85
  • Figure 48: NASH Therapeutics Market, Global, Co-development Deals by Region, 2007-2018 87
  • Figure 49: NASH Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2007-2018 88
  • Figure 50: NASH Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2007-2018 89
  • Figure 51: NASH Therapeutics Market, Global, Co-development Deals by Molecule Type and Stage of Development, 2007-2018 90
  • Figure 52: NASH Therapeutics Market, Global, Co-development Deals by Molecular Target, 2007-2018 91
目次
Product Code: GBIHC487MR

Abstract

Nonalcoholic Steatohepatitis Therapeutics in Asia-Pacific Markets to 2024 - Launch of NASH-Specific Premium Products and Rising Prevalence to Drive the Market

Summary

Non-Alcoholic Steato-Hepatitis (NASH) is the "silent" liver disease. It resembles alcoholic liver disease, but occurs in people who drink little or no alcohol, especially people who are middle-aged and overweight or obese. Non-Alcoholic Steato-Hepatitis (NASH) is an advanced form of Non-Alcoholic Fatty Liver Disease (NAFLD). Non-Alcoholic Fatty Liver Disease (NAFLD) is caused by accumulation of fat in the liver. When this also causes inflammation and damage to hepatic cells, it is known as Non-Alcoholic Steato-Hepatitis (NASH), which can lead to scarring of the liver.

Non-Alcoholic Fatty Liver Disease (NAFLD) has become the most common liver disease worldwide. Global prevalence of Non-Alcoholic Fatty Liver Disease (NAFLD) is estimated at 24%; the highest rates are in South America and the Middle East, followed by the US and Europe. Non-Alcoholic Fatty Liver Disease (NAFLD) is also an emerging problem in the Asia-Pacific region, where it is likely to increase in the future. Currently, the prevalence population of Non-Alcoholic Fatty Liver Disease (NAFLD) in Asia is around 25%, like many Western countries. Non-Alcoholic Steato-Hepatitis (NASH) is present in at least 20% of obese adults or children and in at least 5% of those who are overweight. The prevalence of Non-Alcoholic Steato-Hepatitis (NASH) in biopsy-proven Non-Alcoholic Fatty Liver Disease (NAFLD) patients is 63.5% in Asia.

The Asia-Pacific (APAC) Non-Alcoholic Steato-Hepatitis (NASH) market is forecast to grow at a compound annual growth rate (CAGR) of 17.2% from 2017 to 2024. Over the forecast period the prevalence of Non-Alcoholic Steato-Hepatitis (NASH) is expected to increase significantly across the APAC markets, in parallel with the increasing prevalence of associated risk factors such as obesity, type II diabetes (T2D), dyslipidemia and other metabolic conditions.

The rising prevalence population, together with the significant diagnostic advancements using ultrasound and biomarkers, improving health awareness, and increasing affordability and healthcare access, will increase diagnosis and the treatment-receiving population, driving demand and contributing to market growth.

Scope

  • The NASH Asia-Pacific market will be valued at $102.6m in 2024, growing from $33.7m in 2017 at a CAGR of 17.2%.
  • How will the approval of NASH-specific therapies affect the market?
  • The NASH market has cheap, generic, off-label drugs, making it a particularly difficult market to penetrate. What are the main barriers a new therapy faces when entering the NASH market?
  • How will the annual cost of therapy and market size vary between the five assessed Asia-Pacific markets?
  • How will changes in risk factors such as population age, obesity, type 2 diabetes, NAFLD, metabolic syndrome and lifestyle influence the market?
  • The pipeline for NASH therapies is quite diverse with a range of molecule types and molecular targets.
  • Which molecular targets appear most frequently in the pipeline?
  • How have the late-stage therapies performed in clinical trials?
  • The level of unmet need in the NASH market is significantly high. Will the pipeline drugs fulfill these unmet needs?
  • Various drivers and barriers will influence the market over the forecast period.
  • Licensing deals are the most common form of strategic alliance in NASH, with total deal values ranging from under $10m to over $300m.
  • How do deal frequency and value compare between target families and molecule types?
  • What were the terms and conditions of key licensing deals?

Reasons to buy

  • This report will enable you to:
  • Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis, including a clinical comparison of marketed therapies.
  • Visualize the composition of the NASH market in terms of the dominant therapies for each patient subset, along with their clinical and commercial standing. Unmet needs are highlighted to allow a competitive understanding of gaps in the market.
  • Analyze the NASH pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target.
  • Understand the potential of late-stage therapies with extensive profiles of products that could enter the market over the forecast period, highlighting clinical performance, potential commercial positioning, and how they will compete with other therapies.
  • Predict NASH market growth in the five assessed Asia-Pacific markets, with epidemiological and annual cost of therapy forecasts across India, China, Australia, South Korea and Japan, as well as the individual contributions of promising late-stage molecules to market growth.
  • Identify commercial opportunities in the NASH deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 7
  • 1.2 List of Figures 8

2 Introduction 10

  • 2.1 Disease Introduction 10
  • 2.2 Epidemiology 10
  • 2.3 Symptoms 11
  • 2.4 Etiology and Pathophysiology 12
    • 2.4.1 Etiology 12
    • 2.4.2 Pathophysiology 12
  • 2.5 Diagnosis 16
    • 2.5.1 Non-invasive Tests 17
  • 2.6 Disease Classification 18
  • 2.7 Prognosis 20
  • 2.8 Co-morbidities 20
  • 2.9 Treatment Options and Treatment Algorithm 20
    • 2.9.1 Treatment Options 20
    • 2.9.2 Treatment Algorithm 23
    • 2.9.3 Non-pharmacological Treatments 25

3 Marketed Products 27

  • 3.1 Overview 27
    • 3.1.1 Vitamin E 27
    • 3.1.2 Pentoxifylline 27
    • 3.1.3 Pioglitazone 28
  • 3.2 Comparative Efficacy and Safety of Marketed Products 29

4 Pipeline Analysis 32

  • 4.1 Overview 32
  • 4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 32
  • 4.3 Pipeline by Molecular Target 34
  • 4.4 Promising Pipeline Candidates 35
    • 4.4.1 Selonsertib - Gilead 35
    • 4.4.2 Elafibrinor - Genfit 37
    • 4.4.3 Saroglitazar - Zydus 39
    • 4.4.4 Ocaliva (obeticholic acid) - Intercept Pharmaceuticals 40
    • 4.4.5 Cenicriviroc - Allergan 42
    • 4.4.6 Aramchol - Galmed 44
  • 4.5 Comparative Efficacy and Safety of Pipeline Products 44
  • 4.6 Product Competitiveness Framework 46

5 Clinical Trial Analysis 48

  • 5.1 Failure Rate 48
    • 5.1.1 Overall Failure Rate 48
    • 5.1.2 Failure Rate by Phase and Molecule Type 50
    • 5.1.3 Failure Rate by Phase and Molecular Target 51
  • 5.2 Clinical Trial Size 52
    • 5.2.1 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 52
    • 5.2.2 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 54
  • 5.3 Clinical Trial Duration 55
    • 5.3.1 Clinical Trial Duration by Molecule Type 55
    • 5.3.2 Clinical Trial Duration by Molecular Target 57
  • 5.4 Summary of Clinical Trial Metrics 58

6 Multi-scenario Forecast 59

  • 6.1 Geographical Markets 59
  • 6.2 Asia-Pacific Market 59
  • 6.3 India 61
    • 6.3.1 Treatment Usage Patterns 61
    • 6.3.2 Annual Cost of Therapy 62
    • 6.3.3 Market Size 63
  • 6.4 China 64
    • 6.4.1 Treatment Usage Patterns 64
    • 6.4.2 Annual Cost of Therapy 65
    • 6.4.3 Market Size 67
  • 6.5 Australia 67
    • 6.5.1 Treatment Usage Patterns 67
    • 6.5.2 Annual Cost of Therapy 69
    • 6.5.3 Market Size 71
  • 6.6 South Korea 72
    • 6.6.1 Treatment Usage Patterns 72
    • 6.6.2 Annual Cost of Therapy 73
    • 6.6.3 Market Size 74
  • 6.7 Japan 75
    • 6.7.1 Treatment Usage Patterns 75
    • 6.7.2 Annual Cost of Therapy 75
    • 6.7.3 Market Size 77

7 Drivers and Barriers 78

  • 7.1 Drivers 78
    • 7.1.1 Rising Awareness and Growing Prevalence of the Disease 78
    • 7.1.2 Launch of NASH-Specific Therapies 78
    • 7.1.3 Advancements in Diagnostic Procedures for NASH 78
    • 7.1.4 Increasing Awareness and Diversified Healthcare Reform 79
  • 7.2 Barriers 79
    • 7.2.1 Delayed Diagnosis Due to Complex Pathophysiology 79
    • 7.2.2 Low Diagnosis and Treatment Rate 79
    • 7.2.3 High Cost Therapies May Lead to Reimbursement issues 80

8 Deals and Strategic Consolidations 81

  • 8.1 Licensing Deals 81
    • 8.1.1 Deals by Region and Value 81
    • 8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 82
    • 8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 83
    • 8.1.4 Key Licensing Deals 85
  • 8.2 Co-development Deals 87
    • 8.2.1 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 88
    • 8.2.2 Deal Value by Stage of Development, Molecule Type, and Molecular Target 89
    • 8.2.3 Key Co-development Deals 91

9 Appendix 93

  • 9.1 All Pipeline Drugs by Stage of Development 93
    • 9.1.1 Discovery 93
    • 9.1.2 Preclinical 95
    • 9.1.3 IND/CTA-filed 98
    • 9.1.4 Phase I 99
    • 9.1.5 Phase II 100
    • 9.1.6 Phase III 101
  • 9.2 Summary of Multi-scenario Market Forecasts to 2024 101
    • 9.2.1 Asia-Pacific 101
    • 9.2.2 India 102
    • 9.2.3 China 102
    • 9.2.4 Australia 103
    • 9.2.5 South Korea 103
    • 9.2.6 Japan 104
  • 9.3 Bibliography 104
  • 9.4 Abbreviations 107
  • 9.5 Research Methodology 108
    • 9.5.1 Secondary Research 109
    • 9.5.2 Marketed Product Profiles 109
    • 9.5.3 Late-Stage Pipeline Candidates 110
    • 9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 110
    • 9.5.5 Product Competitiveness Framework 110
    • 9.5.6 Pipeline Analysis 110
    • 9.5.7 Forecasting Model 111
    • 9.5.8 Deals Data Analysis 112
  • 9.6 Contact Us 112
  • 9.7 Disclaimer 112
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