Idiopathic Pulmonary Fibrosis (IPF)：市場分析及び予測（～2017）...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
3 Disease Overview 17
3.1 Etiology and Pathophysiology 20
3.2 Pathophysiology 21
3.2.1 Overview 21
3.2.2 Genetic Predisposition 22
3.2.3 New theories 22
3.2.4 The vulnerable alveolar epithelium in IPF 23
3.2.5 Emergence of pathologic mesenchymal phenotypes 24
3.2.6 From AECII injury to lung fibrosis 25
3.3 Prognosis and Biomarkers 26
3.4 Symptoms 27
4 Epidemiology 29
4.1 Risk Factors and Comorbidities 30
4.1.1 There is almost no risk of IPF among long-term heavy smokers 30
4.1.2 Common workplace inhalants pose a large risk in many occupations 31
4.1.3 Gastroesophageal reflux is common in IPF patients 32
4.2 Global and Historical Trends 33
4.2.1 US 33
4.2.2 5EU 34
4.3 Forecast Methodology 35
4.3.1 Sources Used 36
4.3.2 Forecast Assumptions and Methods 37
4.3.3 Sources Not Used 41
4.4 Epidemiology Forecast for Idiopathic Pulmonary Fibrosis (2012–2022) 42
4.4.1 Total Incident Cases of Idiopathic Pulmonary Fibrosis 42
4.4.2 Age-Specific Incident Cases of Idiopathic Pulmonary Fibrosis 44
4.4.3 Sex-Specific Incident Cases of Idiopathic Pulmonary Fibrosis 45
4.4.4 Total Prevalent Cases of Idiopathic Pulmonary Fibrosis 46
4.4.5 Age-Specific Prevalent Cases of Idiopathic Pulmonary Fibrosis 48
4.4.6 Sex-Specific Prevalent Cases of Idiopathic Pulmonary Fibrosis 49
4.5 Discussion 51
4.5.1 Conclusions on Epidemiology Trends 51
4.5.2 Limitations of the Analysis 52
4.5.3 Strengths of the Analysis 52
5 Current Treatment Options 53
5.1 Overview 53
5.2 Product Profiles – Major Brands 54
5.2.1 Esbriet (pirfenidone) 54
5.2.2 Fluimucil (N-acetylcysteine) 59
6 Unmet Needs Assessment and Oppportunity Analysis 63
6.1 Overview 63
6.2 Unmet Needs Analysis 64
6.2.1 Absence of an efficacious drug 64
6.2.2 Access to treatment/cost 65
6.2.3 Early and prompt diagnosis 66
6.2.4 Unrecognized disease 67
6.2.5 Lack of biomarkers and suitable clinical trials 68
6.2.6 Better side effects and dosing regimen 68
6.2.7 Understanding the complexity of the disease 69
6.3 Opportunity Analysis 70
6.3.1 A drug that can reach a satisfactory level of efficacy 70
6.3.2 The standardization of HRCT images 70
6.3.3 A drug with improved dosing and side effects 70
6.3.4 Improvement in patient quality of life 70
6.3.5 Increased collaboration with academia 71
7 R&D Strategies 72
7.1 Overview 72
7.1.1 Drug development strategies: the oncology approach 72
7.1.2 Improved understanding of disease mechanism 73
7.1.3 Niche patient subgroups 74
7.1.4 Licensing and Alliances 74
7.2 Clinical Trial Design 75
7.2.1 Selection of Appropriate Clinical Trial Endpoints 75
7.2.2 Approval Disparities Between the FDA and EMA 76
7.2.3 Current Clinical Trial Design 78
7.2.4 Future outlook in IPF clinical trial design 80
8 Pipeline Assessment 82
8.1 Overview 82
8.2 Promising Drugs in Clinical Development 86
8.2.1 Ninetedanib 86
8.2.2 STX-100 91
8.2.3 GS-6624 95
8.3 Innovative Early-Stage Approaches 98
8.3.1 Biomarkers/Personal Medicine 99
8.3.2 Stem Cells 100
8.3.3 MicroRNA 100
8.3.4 Antiviral Therapy 101
9 Pipeline Valuation Analysis 102
9.1 Clinical Benchmark of Key Pipeline Drugs 102
9.2 Commercial Benchmark of Key Pipeline Drugs 104
9.3 Competitive Assessment 105
9.4 Top-Line Five-Year Forecast 107
9.4.1 US 109
9.4.2 5EU 110
10 Appendix 113
10.1 Bibliography 113
10.2 Abbreviations 123
10.3 Methodology 127
10.4 Forecasting Methodology 127
10.4.1 Prevalant IPF Patients 127
10.4.2 Percent Drug-Treated Patients 127
10.4.3 Drugs Included in Each Therapeutic Class 128
10.4.4 Launch and Patent Expiry Dates 128
10.4.5 General Pricing Assumptions 128
10.4.6 Individual Drug Assumptions 129
10.4.7 Pricing of Pipeline Agents 130
10.5 Physicians and Specialists Included in this Study 131
10.6 About the Authors 132
10.6.1 Author 132
10.6.2 Epidemiologists 133
10.6.3 Global Director of Epidemiology and Clinical Trials Analysis 135
10.6.4 Global Head of Healthcare 135
10.7 About GlobalData 136
10.8 Contact Us 136
10.9 Disclaimer 136