Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
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 11
2.4.1 Pathophysiology 12
2.5 Diagnosis 14
2.6 Disease Stages 15
2.7 Prognosis 17
2.8 Treatment Guidelines and Options 18
2.8.1 Treatment Algorithm 18
2.8.2 Pharmacological Treatments 21
2.8.3 Non-Pharmacological Treatments 25
3 Marketed Products 27
3.1 Overview 27
3.2 ICS for the Maintenance Treatment of Asthma 27
3.2.1 Arnuity (fluticasone furoate) – GlaxoSmithKline 27
3.3 ICS–LABA Combination Therapy for the Maintenance Treatment of Asthma 28
3.3.1 Seretide/Adoair (fluticasone propionate and salmeterol xinafoate) – GlaxoSmithKline 28
3.3.2 Symbicort (budesonide and formoterol fumarate) – AstraZeneca, Co-promotion with Astellas Pharma 29
3.3.3 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) – GlaxoSmithKline 30
3.3.4 Flutiform (fluticasone propionate and formoterol fumarate) – SkyePharma 31
3.4 Add-on Therapy to ICS or ICS–LABA Therapies for the Maintenance Treatment of Asthma 31
3.4.1 Xolair (omalizumab) – Novartis and Genentech 31
3.4.2 Montelukast Sodium – Merck & Co 33
3.4.3 Spiriva (tiotropium bromide) – Boehringer Ingelheim 34
3.4.4 Nucala (mepolizumab) – GlaxoSmithKline 35
3.5 Comparative Efficacy and Safety of Marketed Products 36
4 Pipeline Analysis 39
4.1 Overview 39
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 39
4.3 Pipeline by Molecular Target 41
4.4 Promising Pipeline Molecules 45
4.4.1 Reslizumab – Teva Pharmaceutical 45
4.4.2 Dupilumab – Regeneron/Sanofi 47
4.4.3 Tralokinumab – AstraZeneca 49
4.4.4 Benralizumab – AstraZeneca 51
4.4.5 Fevipiprant – Novartis 53
4.5 Comparative Efficacy and Safety of Pipeline Products 54
4.6 Product Competitiveness Framework 56
5 Clinical Trial Analysis 58
5.1 Failure Rate 58
5.1.1 Overall Failure Rate 58
5.1.2 Failure Rate by Phase and Molecule Type 60
5.1.3 Failure Rate by Phase and Molecular Target 61
5.2 Clinical Trial Duration 61
5.2.1 Clinical Trial Duration by Molecule Type 61
5.2.2 Clinical Trial Duration by Molecular Target 62
5.3 Clinical Trial Size 63
5.3.1 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 64
5.3.2 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 65
5.4 Summary of Clinical Trial Metrics 67
6 Multi-Scenario Forecast 69
6.1 Geographical Markets 69
6.2 Asia-Pacific Market 70
6.3 India 72
6.3.1 Treatment Usage Patterns 72
6.3.2 Annual Cost of Therapy 73
6.3.3 Market Size 73
6.4 China 74
6.4.1 Treatment Usage Patterns 74
6.4.2 Annual Cost of Therapy 75
6.4.3 Market Size 76
6.5 Australia 77
6.5.1 Treatment Usage Patterns 77
6.5.2 Annual Cost of Therapy 78
6.5.3 Market Size 79
6.6 South Korea 80
6.6.1 Treatment Usage Patterns 80
6.6.2 Annual Cost of Therapy 81
6.6.3 Market Size 82
6.7 Japan 83
6.7.1 Treatment Usage Patterns 83
6.7.2 Annual Cost of Therapy 84
6.7.3 Market Size 85
7 Drivers and Barriers 87
7.1 Drivers 87
7.1.1 Rising Aging Population and Asthma Risk Factors 87
7.1.2 Promising Product Pipeline and Launch of First-in-Class Molecules 87
7.1.3 New Costly Market Entries 87
7.1.4 Diversified Healthcare Reform to Boost Market Growth 88
7.2 Barriers 88
7.2.1 Sales Erosion by Generics 88
7.2.2 Competition from Traditional Medicines 88
7.2.3 Treatment Regimen Adherence 88
7.2.4 Limited Understanding of Underlying Causes 88
7.2.5 Lack of Awareness and Affordability of High-Cost Biological Products 89
8 Deals and Strategic Consolidations 90
8.1 Licensing Deals 90
8.1.1 Deals by Region and Value 90
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 91
8.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 92
8.1.4 Key Licensing Deals 95
8.2 Co-development Deals 99
8.2.1 Deals by Region and Value 99
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 100
8.2.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 101
8.2.4 Key Co-development Deals 103
9 Appendix 106
9.1 All Pipeline Drugs by Phase of Development 106
9.1.1 Discovery 106
9.1.2 Preclinical 108
9.1.3 Investigational New Drug/ Clinical Trial Authorization-Filed 113
9.1.4 Phase I 114
9.1.5 Phase II 116
9.1.6 Phase III 118
9.1.7 Pre-registration 119
9.2 Summary of Multi-Scenario Market Forecasts to 2023 119
9.2.1 Asia-Pacific 119
9.2.2 China 119
9.2.3 India 120
9.2.4 Australia 120
9.2.5 South Korea 121
9.2.6 Japan 121
9.3 References 122
9.4 Abbreviations 128
9.5 Research Methodology 130
9.5.1 Secondary Research 131
9.5.2 Marketed Product Profiles 131
9.5.3 Late-Stage Pipeline Candidates 131
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 131
9.5.5 Product Competitiveness Framework 132
9.5.6 Pipeline Analysis 132
9.5.7 Forecasting Model 133
9.5.8 Deals Data Analysis 134
9.6 Contact Us 134
9.7 Disclaimer 134