Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 12
2.1 Therapy Area Introduction 12
2.2 Symptoms 13
2.3 Diagnosis 13
2.3.1 Asthma 13
2.3.2 Chronic Obstructive Pulmonary Disease 14
2.3.3 Idiopathic Pulmonary Fibrosis 15
2.3.4 Cystic Fibrosis 16
2.4 Etiology and Pathophysiology 16
2.4.1 Asthma 16
2.4.2 Chronic Obstructive Pulmonary Disease 18
2.4.3 Idiopathic Pulmonary Fibrosis 20
2.4.4 Cystic Fibrosis 22
2.5 Epidemiology 23
2.5.1 Asthma 24
2.5.2 Chronic Obstructive Pulmonary Disease 25
2.5.3 Idiopathic Pulmonary Fibrosis 26
2.5.4 Cystic Fibrosis 27
2.6 Prognosis and Disease Staging 28
2.6.1 Asthma 28
2.6.2 Chronic Obstructive Pulmonary Disease 31
2.6.3 Idiopathic Pulmonary Fibrosis 32
2.6.4 Cystic Fibrosis 34
2.7 Treatment 36
2.7.1 Asthma 36
2.7.2 Chronic Obstructive Pulmonary Disease 37
2.7.3 Idiopathic Pulmonary Fibrosis 38
2.7.4 Cystic Fibrosis 38
3 Key Marketed Products 41
3.1 Overview 41
3.2 Advair – GSK 42
3.3 Symbicort – AstraZeneca/Astellas 44
3.4 Spiriva – Boehringer Ingelheim 47
3.5 Xolair – Roche/Novartis 48
3.6 Ventolin – GSK 50
3.7 Pulmicort – Astra Zeneca 51
3.8 Orkambi – Vertex 52
3.9 Relvar/Breo Ellipta – GSK 53
3.10 Singulair – Merck & Co. 55
3.11 Esbriet – Roche 57
3.12 Kalydeco – Vertex 59
3.13 Conclusion 60
4 Pipeline Landscape Assessment 62
4.1 Overview 62
4.2 Pipeline Development Landscape 63
4.3 Molecular Targets in the Pipeline 66
4.4 Clinical Trials 68
4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 68
4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 72
4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 76
4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 80
4.5 Assessment of Key Pipeline Products 83
4.5.1 Ivacaftor and Tezacaftor – Vertex 83
4.5.2 (Fluticasone Furoate plus Umeclidinium Bromide plus Vilanterol Trifenatate) – GlaxoSmithKline/Innoviva 84
4.5.3 Dupixent – Regeneron Pharmaceuticals/Sanofi 85
4.5.4 Benralizumab – AstraZeneca/Medimmune 86
4.5.5 Tralokinumab – AstraZeneca 88
4.5.6 PT010 (Budesonide plus Formoterol Fumarate plus Glycopyrrolate) – AstraZeneca/Pearl Therapeutics 89
4.5.7 Conclusion 90
4.6 Conclusion 90
5 Multi-scenario Market Forecast to 2023 92
5.1 Overall Market Size 92
5.2 Generic Penetration 95
5.3 Revenue Forecast by Molecular Target 96
5.3.1 G Protein-Coupled Receptors 96
5.3.2 Immune/Inflammatory Mediators 98
5.3.3 Transcription Factors 98
5.3.4 Signal Transduction 99
5.3.5 CFTR Modulator 100
6 Company Analysis and Positioning 102
6.1 Revenue and Market Share Analysis by Company 104
6.1.1 GlaxoSmithKline 108
6.1.2 Vertex 110
6.1.3 AstraZeneca 110
6.1.4 Roche 112
6.1.5 Boehringer Ingelheim 113
6.1.6 Novartis 114
6.1.7 Teva 115
6.1.8 Sumitomo Dainippon 116
6.1.9 Regeneron 117
6.1.10 Merck & Co. 118
6.2 Company Landscape 119
6.3 Marketed and Pipeline Portfolio Analysis 119
7 Strategic Consolidations 122
7.1 Licensing Deals 122
7.1.1 Deal by Region, Year and Value 122
7.1.2 Deals by Stage of Development and Value 124
7.1.3 Deals by Molecule Type and Molecular Target 125
7.1.4 Table for Licensing Deals Valued Above $100m 126
7.2 Co-development Deals 132
7.2.1 Deals by Region, Year and Value 132
7.2.2 Deals by Stage of Development and Value 134
7.2.3 Deals by Molecule Type, Mechanism of Action and Value 135
7.2.4 Table for Co-development Deals Valued Above $100m 136
8 Appendix 139
8.1 Bibliography 139
8.2 All Pipeline Drugs by Phase 147
8.2.1 Discovery 147
8.2.2 Preclinical 148
8.2.3 IND/CTA-Filed/Phase 0 149
8.2.4 Phase I 149
8.2.5 Phase II 150
8.2.6 Phase III 151
8.2.7 Pre-registration 151
8.3 Abbreviations 152
8.4 Methodology 153
8.4.1 Coverage 153
8.4.2 Secondary Research 153
8.4.3 Market Size and Revenue Forecasts 154
8.4.4 Pipeline Analysis 154
8.4.5 Competitive Landscape 154
8.5 Contact Us 155
8.6 Disclaimer 155