1 Table of Contents 1 Table of Contents 4 1.1 List of Tables 6 1.2 List of Figures 7 2 Introduction 10 2.1 Therapy Area Introduction 10 2.2 Epidemiology 10 2.2.1 Asthma 11 2.2.2 Chronic Obstructive Pulmonary Fibrosis 12 2.2.3 Idiopathic Pulmonary Fibrosis 13 2.2.4 Cystic Fibrosis 14 2.3 Pathophysiology 15 2.3.1 Asthma 15 2.3.2 Chronic Obstructive Pulmonary Disease 17 2.3.3 Idiopathic Pulmonary Fibrosis 18 2.3.4 Cystic Fibrosis 20 2.4 Symptoms 21 2.5 Diagnosis 22 2.5.1 Asthma 22 2.5.2 Chronic Obstructive Pulmonary Fibrosis 22 2.5.3 Idiopathic Pulmonary Fibrosis 23 2.5.4 Cystic Fibrosis 24 2.6 Disease Severity and Prognosis 24 2.6.1 Asthma 24 2.6.2 Chronic Obstructive Pulmonary Fibrosis 27 2.6.3 Idiopathic Pulmonary Fibrosis 29 2.6.4 Cystic Fibrosis 30 2.7 Treatment 32 2.7.1 Asthma 32 2.7.2 Chronic Obstructive Pulmonary Fibrosis 33 2.7.3 Idiopathic Pulmonary Fibrosis 33 2.7.4 Cystic Fibrosis 34 3 Key Marketed Products 36 3.1 Overview 36 3.2 Advair - GSK 37 3.3 Spiriva - Boehringer Ingelheim, Pfizer 39 3.4 Symbicort - AstraZeneca/Astellas 41 3.5 Singulair (montelukast) - Merck & Co. 43 3.6 Flixotide/Flovent - GSK 45 3.7 Ventolin - GSK 47 3.8 Kalydeco - Vertex 48 3.9 Pulmozyme - Roche 50 3.10 Esbriet - Roche 51 3.11 TOBI - Novartis 53 3.12 Conclusion 54 4 Pipeline Landscape Assessment 56 4.1 Overview 56 4.2 Pipeline Development Landscape 56 4.3 Molecular Targets in the Pipeline 59 4.4 Clinical Trials 61 4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 61 4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 65 4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 68 4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 71 4.4.5 Conclusion 74 5 Multi-scenario Market Forecast to 2022 75 5.1 Overall Market Size 75 5.2 Generic Penetration 76 5.3 Revenue Forecast by Molecular Target 79 5.3.1 G-Protein Coupled Receptors 79 5.3.2 Immune/Inflammatory Mediators 80 5.3.3 Transcription Factors 81 5.3.4 Signal Transduction 82 5.3.5 CFTR Modulator 83 5.4 Assessment of Key Pipeline Products 84 5.4.1 Dupilumab - Regeneron Pharmaceuticals/Sanofi 84 5.4.2 Benralizumab - AstraZeneca/Medimmune 85 5.4.3 Lebrikizumab - Roche/Genentech 87 5.4.4 PT010 (Budesonide plus Formoterol Fumarate plus Glycopyrronium) - AstraZeneca/Pearl Therapeutics 88 5.4.5 Tralokinumab - AstraZeneca 89 5.4.6 Batefenterol - GSK/Theravance 90 5.4.7 Conclusion 91 6 Company Analysis and Positioning 92 6.1 Revenue and Market Share Analysis by Company 93 6.1.1 GlaxoSmithKline 97 6.1.2 Vertex 98 6.1.3 AstraZeneca 99 6.1.4 Roche 101 6.1.5 Novartis 102 6.1.6 Boehringer Ingelheim 103 6.2 Company Landscape 104 6.3 Marketed and Pipeline Portfolio Analysis 105 7 Strategic Consolidations 109 7.1 Licensing Deals 109 7.1.1 Deal by Region, Year and Value 109 7.1.2 Deals by Stage of Development and Value 111 7.1.3 Deals by Molecule Type and Molecular Target 112 7.1.4 Table for Licensing Deals Valued Above $100m 114 7.2 Co-development Deals 117 7.2.1 Deals by Region, Year and Value 117 7.2.2 Deals by Stage of Development and Value 118 7.2.3 Deals by Molecule Type, Mechanism of Action and Value 119 7.2.4 Table for Co-development Deals Valued Above $100m 121 8 Appendix 123 8.1 Bibliography 123 8.2 All Pipeline Drugs by Phase 130 8.2.1 Discovery 130 8.2.2 Preclinical 139 8.2.3 IND/CTA filed/Phase 0 171 8.2.4 Phase I 172 8.2.5 Phase II 181 8.2.6 Phase III 191 8.2.7 Pre-registration 197 8.3 Abbreviations 199 8.4 Methodology 200 8.4.1 Coverage 200 8.4.2 Secondary Research 200 8.4.3 Market Size and Revenue Forecasts 201 8.4.4 Pipeline Analysis 201 8.4.5 Competitive Landscape 201 8.5 Contact Us 202 8.6 Disclaimer 202

1.1 List of Tables Table 1: Respiratory Disorders Therapeutics Market, Global, Epidemiology, 2016 11 Table 2: Respiratory Disorders Therapeutics Market, Global, Classification of Asthma Severity in Children of 0-4 Years of Age 25 Table 3: Respiratory Disorders Therapeutics Market, Global, Classification of Asthma Severity in Children of 5-11 Years of Age 26 Table 4: Respiratory Disorders Therapeutics Market, Global, Classification of Asthma Severity in Youths of 12 Years or More and Adults 27 Table 5: Respiratory Disorders Therapeutics Market, Global, COPD Disease Severity, 2016 28 Table 6: Respiratory Disorders Therapeutics Market, Global, COPD Patient Risk Categories, 2016 29 Table 7: Respiratory Disorders Therapeutics Market, Global, IPF Severity Classification, 2016 29 Table 8: Respiratory Disorders Therapeutics Market, Global, CF Severity Classification, 2016 31 Table 9: Respiratory Disorders Therapeutics Market, Global, COPD Treatment Algorithm, 2016 33 Table 10: Respiratory Disorders Therapeutics Market, Global, CF Treatment Plan, 2016 35 Table 11: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Advair, 2016 38 Table 12: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Spiriva, 2016 40 Table 13: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Symbicort, 2016 42 Table 14: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Singulair, 2016 43 Table 15: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Flixotide, 2016 46 Table 16: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Ventolin, 2016 47 Table 17: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Kalydeco, 2016 48 Table 18: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Pulmozyme, 2016 50 Table 19: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Esbriet, 2016 51 Table 20: Respiratory Disorders Therapeutics Market, Global, Approved Indications for TOBI, 2016 53 Table 21: Respiratory DIsorders Therapeutics Market, Global, Usage of Generics Across Key Indications, 2016 78 Table 22: Respiratory Disorders Therapeutics Market, Global, Forecast Revenue by Company, 2016 94 Table 23: Respiratory Disorders Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2016 114 Table 24: Respiratory Disorders Therapeutics Market, Global, Co-development Deals Valued Above $100m, 2006-2016 121 Table 25: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Discovery, 2016 130 Table 26: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Preclinical, 2016 139 Table 27: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, IND/CTA filed/Phase 0, 2016 171 Table 28: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Phase I, 2016 172 Table 29: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Phase II, 2016 181 Table 30: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Phase III, 2016 191 Table 31: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Pre-registration, 2016 197 1.2 List of Figures Figure 1: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for Asthma, 2015-2023 12 Figure 2: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for COPD, 2015-2023 13 Figure 3: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for Idiopathic Pulmonary Fibrosis, 2015-2023 14 Figure 4: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for Cystic Fibrosis, 2015-2023 15 Figure 5: Respiratory Disorders Therapeutics Market, Clinical Courses of IPF 30 Figure 6: Respiratory Disorders Therapeutics Market, Progression of CF 31 Figure 7: Respiratory Disorders Therapeutics Market, Global, Key Marketed Products and Approved Indications, 2016 37 Figure 8: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for Advair ($bn), 2006-2022 39 Figure 9: Respiratory Disorders Therapeutic Market, Global, Annual Revenues for Spiriva ($bn), 2006-2022 41 Figure 10: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for Symbicort ($bn), 2006-2022 43 Figure 11: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for Singulair ($bn), 2006-2022 45 Figure 12: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for Flixotide ($m), 2006-2022 46 Figure 13: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for Ventolin ($m), 2006-2022 48 Figure 14: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for Kalydeco ($bn), 2012-2022 49 Figure 15: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Pulmozyme ($m), 2006-2022 51 Figure 16: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Esbriet ($bn), 2011-2022 52 Figure 17: Respiratory Disorders Therapeutics Market, Global, Annual Revenues for TOBI ($m), 2006-2020 54 Figure 18: Respiratory Disorders Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2016 56 Figure 19: Respiratory Disorders Therapeutics Market, Global, Pipeline by Stage of Development, Molecule Type and Program Type, 2016 57 Figure 20: Respiratory Disorders Therapeutics Market, Global, Pipeline by Key Indications and Stage of Development, 2016 58 Figure 21: Respiratory Disorders Therapeutics Market, Global, Pipeline by Key Indications and Molecule Type, 2016 59 Figure 22: Respiratory Disorders Therapeutics Market, Global, Pipeline by Molecular Targets and Stage of Development, 2016 60 Figure 23: Respiratory Disorders Therapeutics Market, Global, Pipeline by Key Indications and Molecular Targets, 2016 61 Figure 24: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2016 62 Figure 25: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2016 63 Figure 26: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2016 64 Figure 27: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2016 65 Figure 28: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2016 66 Figure 29 Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2016 66 Figure 30: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2016 67 Figure 31: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2016 68 Figure 32: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development, 2006-2016 69 Figure 33: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication, 2006-2016 69 Figure 34: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type, 2006-2016 70 Figure 35: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target, 2006-2016 71 Figure 36: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development, 2006-2016 72 Figure 37: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication, 2006-2016 72 Figure 38: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type, 2006-2016 73 Figure 39: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target, 2006-2016 74 Figure 40: Respiratory Disorders Therapeutics Market, Global, Market Size ($bn), 2015-2022 75 Figure 41: Respiratory DIsorders Therapeutics Market, Global, Annual Revenue Forecast for Key Products ($m), 2015-2022 76 Figure 42: Respiratory Disorders Therapeutics Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2015-2022 77 Figure 43: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for G Protein-Coupled Receptor Modulators ($bn), 2015-2022 80 Figure 44: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for Immune/Inflammatory System Targets ($bn), 2015-2022 81 Figure 45: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for Transcription Factor Therapies ($bn), 2015-2022 82 Figure 46: Respiratory DIsorders Therapeutics Market, Global, Annual Revenue Forecast for Signal Transduction Modulators ($bn), 2015-2022 83 Figure 47: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for CFTR Modulators ($bn), 2015-2022 84 Figure 48: Respiratory Disorders Therapeutics Market, Global, Revenue for Dupilumab ($bn), 2017-2022 85 Figure 49: Respiratory DIsorders Therapeutics Market, Global, Revenue for Benralizumab ($m), 2018-2022 86 Figure 50: Respiratory Disorders Therapeutics Market, Global, Revenue for Lebrizikumab ($m), 2017-2022 88 Figure 51: Respiratory Disorders Therapeutics Market, Global, Revenue for PT010 ($m), 2017-2022 89 Figure 52: Respiratory Disorders Therapeutics Market, Global, Revenue for Tralokinumab ($m), 2017-2022 90 Figure 53: Respiratory Disorders Therapeutics Market, Global, Revenue for Batefenterol ($m), 2019-2022 91 Figure 54: Respiratory Disorders Therapeutics Market, Global, Cluster Graph by Growth and Market Share, 2015-2022 92 Figure 55: Respiratory Disorders Therapeutics Market, Global, Forecast Market Share by Company (%), 2015-2022 95 Figure 56: Respiratory Disorders Therapeutics Market, Global, Companies by Compound Annual Growth Rate (%), 2015-2022 96 Figure 57: Respiratory Disorders Therapeutics Market, Global, Revenue by Product Type, 2015-2022 97 Figure 58: Respiratory Disorders Therapeutics Market, Global, GlaxoSmithKline Annual Revenue Forecast ($m), 2015-2022 98 Figure 59: Respiratory Disorders Therapeutics Market, Global, Vertex Annual Revenue Forecast ($m), 2015-2022 99 Figure 60: Respiratory DIsorders Therapeutics Market, Global, AstraZeneca Annual Revenue Forecast ($m), 2015-2022 101 Figure 61: Respiratory Disorders Therapeutics Market, Global, Roche Annual Revenue Forecast ($m), 2015-2022 102 Figure 62: Respiratory Disorders Therapeutics Market, Global, Novartis Annual Revenue Forecast ($m), 2015-2022 103 Figure 63: Respiratory Disorders Therapeutics Market, Global, Boehringer Ingelheim Annual Revenue Forecast ($m), 2015-2022 104 Figure 64: Respiratory Disorders Therapeutics Market, Global, Companies by Type, 2016 105 Figure 65: Respiratory Disorders Therapeutics Market, Global, High-Activity and Late-Stage Developers by Level of Respiratory Specialization, 2016 106 Figure 66: Respiratory Disorders Therapeutics Market, Global, Proportion of Total Company Revenue Attributed to Respiratory Disorders, 2015-2022 107 Figure 67: Respiratory Disorders Therapeutics Market, Global, Proportion of Total Company Revenue Attributed to Respiratory Disorders, Top Six Companies ($bn), 2015-2022 108 Figure 68: Respiratory Disorders Therapeutics Market, Global, Licensing Deals by Region, Year and Value, 2006-2016 110 Figure 69: Respiratory Disorders Therapeutics Market, Global, Licensing Deal Volume and Value by Indication, 2006-2016 111 Figure 70: Respiratory Disorders Therapeutics Market, Global, Licensing Deal Volume and Value by Stage of Development, 2006-2016 112 Figure 71: Respiratory Disorders Therapeutics Market, Global, Licensing Deals by Molecule Type and Target, 2006-2016 113 Figure 72: Respiratory Disorders Therapeutics Market, Global, Co-development Deals by Region, Year and Value, 2006-2016 117 Figure 73: Respiratory Disorders Therapeutics Market, Global, Co-development Deals by Indication, 2006-2016 118 Figure 74: Respiratory Disorders Therapeutics Market, Global, Co-development Deal Volume and Value by Stage of Development, 2006-2016 119 Figure 75: Respiratory Disorders Therapeutics Market, Global, Co-development Deals by Molecule Type and Target, 2006-2016 120