特発性肺線維症(IPF)治療薬の世界市場機会分析

◆英語タイトル:OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis - Opportunity Analysis and Forecast to 2025
◆商品コード:GDHC059POA
◆発行会社(調査会社):GlobalData
◆発行日:2016年6月6日
◆ページ数:186
◆レポート言語:英語
◆レポート形式:PDF
◆納品方法:Eメール
◆調査対象地域:グローバル
◆産業分野:製薬・医療
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当調査レポートでは、特発性肺線維症(IPF)治療薬の世界市場機会について調査・分析し、以下の構成でお届けいたします。
・イントロダクション
・特発性肺線維症(IPF)の概要:病因、病態生理、症状
・疫学:リスク要因、併存症、グローバル動向、予測方法、疫学的予測結果
・特発性肺線維症(IPF)治療薬市場の現状:診断、治療概要、臨床診療、主要な医薬品
・アンメット・ニーズ及び市場機会分析
・研究開発戦略
・パイプライン分析
・パイプラインの価値分析
【レポートの概要】

OpportunityAnalyzer: Idiopathic Pulmonary Fibrosis – Opportunity Analysis and Forecast to 2025

Summary

The IPF therapeutic market is currently dominated by the only two drugs that have gained marketing approval for IPF – Roche’s Esbriet and Boehringer Ingelheim’s Ofev. Esbriet was the first drug to gain approval for IPF in 2011 when it was approved for use in Europe, a full four years before rival Ofev. However, both gained approval into the largest IPF market of the US on the same day in October 2014. The top-selling drug in IPF in value terms is Roche’s Esbriet, which GlobalData estimates generated approximately $572m in 2015 from the seven major markets. There is high R&D activity for the development of new therapies for IPF and eight promising therapies can potentially enter the market from 2015 to 2025. Numerous novel targets are being studied in the IPF pipeline, with major pharmaceutical players Roche, Sanofi, Bristol-Myers Squibb, and Biogen all active in the development process. Other promising pipeline candidates include FibroGen’s CTGF inhibitor, Promedior’s PTX2 protein, Afferent’s P2X3 receptor antagonist, and MediciNova’s 5-LO/LT pathway inhibitor. The continued uptake of Esbriet and Ofev, combined with the introduction of new novel drugs will shape the future competitive landscape and drive growth in the IPF market.

Highlights

Key Questions Answered

- What was the impact of Esbriet and Ofev on the IPF market following their FDA approval in 2014 and what is their future outlook within this market?
- What do physicians think about Esbriet and Ofev, and how they will be used for IPF during the forecast period?
- What is the significance of late-phase pipeline products and how will their launch shape the future treatment landscape in IPF?
- What are the unmet needs within the IPF market?
- What are the remaining opportunities within the IPF market?

Key Findings

- The main drivers of growth for the IPF market include the increasing uptake of Esbriet and Ofev, the launch of new novel treatment options during the second half of the forecast period, and the increasing number of prevalent cases of IPF.
- R&D strategies include the development of novel therapies, partnerships and acquisitions, combination of therapies, and targeting niche patient subpopulations.
- The IPF therapeutic market is characterized by significant unmet needs. The most pressing unmet need is the development of a product capable of either stabilizing or reversing progression of IPF. Current therapies Esbriet and Ofev do not address this need and are only capable of slowing disease progression.
- With high R&D activity in the IPF therapeutic market, physicians are looking forward to pipeline products becoming available, which will enable them to improve patients’ treatment.

Scope

- Overview of IPF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current treatment options.
- Annualized IPF therapeutic market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the IPF therapeutics markets.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of mid-stage pipeline drugs.
- Analysis of the current and future market competition in the global IPF therapeutics markets. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to –
- Develop and design in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global IPF therapeutic markets.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global IPF therapeutic markets in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global IPF therapeutic markets from 2015-2025.
- Organize sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

【レポートの目次】

1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 15
1.2 List of Figures 18
2 Introduction 19
2.1 Catalyst 19
2.2 Related Reports 20
3 Disease Overview 21
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 25
3.2 Classification or Staging System 28
3.3 Prognosis 31
3.4 Quality of Life 31
3.5 Symptoms 32
4 Epidemiology 34
4.1 Disease Background 34
4.2 Risk Factors and Comorbidities 34
4.3 Global Trends 36
4.3.1 Incidence 36
4.3.2 Prevalence 37
4.4 Forecast Methodology 39
4.4.1 Sources Used 39
4.4.2 Forecast Assumptions and Methods 44
4.4.3 Sources Not Used 51
4.5 Epidemiological Forecast for IPF (2015-2025) 52
4.5.1 Diagnosed Incident Cases 52
4.5.2 Diagnosed Prevalent Cases 60
4.5.3 IPF Mortality 67
4.6 Discussion 72
4.6.1 Epidemiological Forecast Insight 72
4.6.2 Limitations of the Analysis 73
4.6.3 Strengths of the Analysis 74
5 Current Treatment Options 75
5.1 Overview 75
5.2 Product Profiles – Major Brands 77
5.2.1 Esbriet (Pirfenidone) 77
5.2.2 Ofev (Nintedanib) 82
5.2.3 Fluimucil (N-acetylcysteine) 87
6 Unmet Needs Assessment and Opportunity Analysis 91
6.1 Overview 91
6.2 Lack of an Efficacious Drug 92
6.2.1 Overview 92
6.2.2 Gap Analysis 93
6.2.3 Opportunity 93
6.3 Patient Access to Costly Treatments 93
6.3.1 Overview 93
6.3.2 Gap Analysis 94
6.3.3 Opportunity 95
6.4 Early and Prompt Diagnosis 95
6.4.1 Overview 95
6.4.2 Gap Analysis 96
6.4.3 Opportunity 97
6.5 Unrecognized Disease 97
6.5.1 Overview 97
6.5.2 Gap Analysis 98
6.5.3 Opportunity 98
6.6 Lack of Treatment Options for Patients with Late Stage Disease 99
6.6.1 Overview 99
6.6.2 Gap Analysis 100
6.6.3 Opportunity 100
6.7 Improvement in Patient Quality Of Life 100
6.7.1 Overview 100
6.7.2 Gap Analysis 101
6.7.3 Opportunity 101
6.8 Improved Side Effects and Dosing Regimen 101
6.8.1 Overview 101
6.8.2 Gap Analysis 102
6.8.3 Opportunity 102
7 R&D Strategies 103
7.1 Overview 103
7.1.1 Drug Development Strategy: Combination Therapy 103
7.1.2 Improving Understanding of Disease Mechanism 104
7.1.3 Licensing and Alliances 105
7.1.4 Niche Patient Subgroups 105
7.2 Clinical Trial Design 106
7.2.1 Selection of Appropriate Clinical Trial Endpoints 106
8 Pipeline Assessment 108
8.1 Overview 108
8.2 Promising Drugs in Clinical Development 110
8.2.1 FG-3019 110
8.2.2 PRM-151 114
8.2.3 Lebrikizumab 118
8.2.4 SAR-156597 120
8.2.5 BG-00011 123
8.2.6 BMS-986020 126
8.2.7 AF-219 128
8.2.8 Tipelukast 131
8.3 Innovative Early-Stage Approaches 133
8.3.1 Combination Therapy 137
8.3.2 Biomarkers 139
8.3.3 Stem Cell Therapy 140
9 Pipeline Valuation Analysis 141
9.1 Clinical Benchmarking of Key Pipeline Drugs 141
9.1.1 Standards of Care – Esbriet and Ofev 141
9.1.2 PRM-151 142
9.1.3 FG-3019 143
9.1.4 Other Pipeline Products 144
9.2 Commercial Benchmarking of Key Pipeline Drugs 146
9.2.1 Standards of Care – Esbriet and Ofev 146
9.2.2 PRM-151 147
9.2.3 FG-3019 148
9.2.4 Other Pipeline Products 148
9.3 Competitive Assessment 150
9.4 Top-Line Ten-Year Forecast 151
9.4.1 US 155
9.4.2 5EU 156
9.4.3 Japan 158
10 Appendix 159
10.1 Bibliography 159
10.2 Abbreviations 169
10.3 Methodology 173
10.4 Forecasting Methodology 173
10.4.1 Diagnosed IPF Patients 173
10.4.2 Percent Drug-Treated Patients 174
10.4.3 Drugs Included in Each Therapeutic Class 174
10.4.4 Launch and Patent Expiry Dates 174
10.4.5 General Pricing Assumptions 175
10.4.6 Individual Drug Assumptions 176
10.4.7 Generic Erosion 178
10.4.8 Pricing of Pipeline Agents 178
10.5 Physicians and Specialists Included in this Study 180
10.6 Primary Research – Prescriber Survey 182
10.7 About the Authors 183
10.7.1 Author 183
10.7.2 Therapy Area Director 183
10.7.3 Epidemiologist 183
10.7.4 Global Director of Therapy Analysis and Epidemiology 184
10.7.5 Global Head of Healthcare 184
10.8 About GlobalData 185
10.9 Disclaimer 185

1.1 List of Tables
Table 1: Idiopathic Interstitial Pneumonias and Associated Histological Patterns 24
Table 2: The GAP Index 29
Table 3: The GAP Index and Staging System 30
Table 4: Risk Factors and Comorbidities of IPF 35
Table 5: 7MM, Sources Used to Forecast the Diagnosed Incident Cases of IPF 40
Table 6: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of IPF 41
Table 7: 7MM, except Japan, Sources Used to Forecast Severity Segmentation of Diagnosed Incident Cases and Diagnosed Prevalent Cases of IPF 42
Table 8: 7MM, Sources Used to Forecast IPF Deaths 43
Table 9: 7MM, Sources Not Used in the Epidemiological Analysis of IPF 52
Table 10: 7MM, Diagnosed Incident Cases of IPF, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025 53
Table 11: 7MM, Age-Specific Diagnosed Incident Cases of IPF, Both Sexes, N (Row %), 2015 55
Table 12: 7MM, Sex-Specific Diagnosed Incident Cases of IPF, Ages ≥18 Years, N (Row %), 2015 57
Table 13: 7MM, Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025 61
Table 14: 7MM, Age-Specific Diagnosed Prevalent Cases of IPF, Both Sexes, N (Row %), 2015 62
Table 15: 7MM, Sex-Specific Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, N (Row %), 2015 64
Table 16: 7MM, IPF Deaths, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025 68
Table 17: 7MM, Age-Specific IPF Deaths, Both Sexes, N (Row %), 2015 69
Table 18: 7MM, Sex-Specific IPF Deaths, Ages ≥18 Years, N (Row %), 2015 71
Table 19: Leading Treatments for IPF, 7MM 2016 76
Table 20: Product Profile - Esbriet 78
Table 21: Safety of Esbriet 81
Table 22: Esbriet SWOT Analysis, 2016 82
Table 23: Product Profile - Ofev 83
Table 24: Safety of Ofev 86
Table 25: Ofev SWOT Analysis, 2016 87
Table 26: Product Profile - Fluimucil 88
Table 27: Fluimucil SWOT Analysis, 2016 90
Table 28: Unmet Need and Opportunities in IPF, 2016 92
Table 29: IPF - Late-Stage Pipeline, May 2016 110
Table 30: Product Profile - FG-3019 112
Table 31: FG-3019 SWOT Analysis, 2016 114
Table 32: Product Profile - PRM-151 116
Table 33: PRM-151 SWOT Analysis, 2016 117
Table 34: Product Profile - Lebrikizumab 119
Table 35: Lebrikizumab SWOT Analysis, 2016 120
Table 36: Product Profile - SAR-156597 121
Table 37: SAR-156597 SWOT Analysis, 2016 122
Table 38: Product Profile - BG-00011 124
Table 39: BG-00011 SWOT Analysis, 2016 125
Table 40: Product Profile - BMS-986020 126
Table 41: BMS-986020 SWOT Analysis, 2016 128
Table 42: Product Profile - AF-219 129
Table 43: AF-219 SWOT Analysis, 2016 130
Table 44: Product Profile -Tipelukast 132
Table 45: Tipelukast SWOT Analysis, 2016 133
Table 46: Early-stage pipeline products in IPF, May 2016 137
Table 47: Clinical Benchmark of Key Pipeline Drugs in IPF 145
Table 48: Commercial Benchmark of Key Pipeline Drugs in IPF 149
Table 49: Top-Line Sales Forecast ($m) for IPF, 2015-2025 153
Table 50: Key Events Impacting Sales for IPF, 2015-2025 155
Table 51: IPF Market - Drivers and Barriers, 2015-2025 155
Table 52: Key Launch Dates 174
Table 53: Key Patent Expiries 175
Table 54: Key Historical and Projected Launch Dates 175
Table 55: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 182

1.2 List of Figures
Figure 1: The Induction and Progression of IPF 22
Figure 2: Classifications of Idiopathic Interstitial Pneumonia 23
Figure 3: 7MM, Diagnosed Incident Cases of IPF, Ages ≥18 Years, Both Sexes, N, 2015-2025 54
Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of IPF, Both Sexes, N, 2015 56
Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of IPF, Ages ≥18 Years, 2015 58
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of IPF, Ages ≥18 Years, N, 2015 59
Figure 7: US and 5EU, Diagnosed Incident Cases of IPF by Severity, Both Sexes, Ages ≥18, 2015 60
Figure 8: 7MM, Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025 61
Figure 9: 7MM, Age-Specific Diagnosed Prevalent Cases of IPF, Both Sexes, N, 2015 63
Figure 10: 7MM, Sex-Specific Diagnosed Prevalent Cases of IPF, Ages ≥18 Years, 2015 65
Figure 11: 7MM, Age-Standardized Diagnosed Prevalence of IPF, Ages ≥18 Years, N, 2015 66
Figure 12: US and 5EU, Diagnosed Prevalent Cases of IPF by Severity, Both Sexes, Ages ≥18 Years, 2015 67
Figure 13: 7MM, IPF Deaths, Ages ≥18 Years, Both Sexes, N, Selected Years 2015-2025 68
Figure 14: 7MM, Age-Specific IPF Deaths, Both Sexes, N, 2015 70
Figure 15: 7MM, Sex-Specific IPF Deaths, Ages ≥18 Years, 2015 72
Figure 16: Competitive Assessment of Late-Stage Pipeline Agents in IPF, 2015-2025 151
Figure 17: Global Sales for IPF by Region, 2015-2025 154

【掲載企業】

Afferent Pharmaceuticals
Biogen
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
FibroGen
Galapagos
Genentech
GlaxoSmithKline
Kadmon Corporation
MediciNova
Moerae Matrix
Promedior
ProMetic Life Sciences
Roche
Samumed
Sanofi
Teva Pharmaceuticals

【レポートのキーワード】

特発性肺線維症(IPF)

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