Global Respiratory Drugs Market to 2023 – A Changing Therapeutic Landscape as Key Patents Expire and Biologics, Targeted Therapies and CFTR Modulators for Asthma and Cystic Fibrosis Treatment Emerge as Market Growth Drivers

The respiratory therapy area consists of indications that affect the respiratory system in different ways, such as inflammation, the scarring of lung tissue and excessive production of mucus in the airways. This report focuses on the key therapy area indications of asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and cystic fibrosis (CF). The causes of respiratory disorders vary significantly across each indication, and include factors such as environment, occupation, genetic predisposition and aging.

The treatment landscape for respiratory disorders has traditionally been dominated by small molecule therapies that aim to treat the disease symptoms, rather than the underlying cause. This means that treatment options can be diverse in terms of their targets and mechanisms of action. However, over the past decade the treatment of respiratory disorders has developed significantly, with novel and targeted therapies emerging onto the market. The approval of the products Kalydeco and Orkambi, in 2012 and 2014 respectively, gave patients disease-modifying treatment options for CF. Targeted biologics have also emerged such as omalizumab and Nucala for the treatment of asthma.

Overall, 937 products are being actively developed in the respiratory pipeline. The pipelines of asthma, COPD, IPF and CF contain 261, 106, 79 and 131 products, respectively. Although the more traditional non-specific symptomatic therapies continue to have a strong presence in the respiratory disorder pipeline, the pipeline also contains promising targeted biologic therapies, which reflects their growing prominence in this therapy area.

Scope

– Global revenue from the respiratory market is forecast to increase from $30.9 billion in 2016 to $41.3 billion in 2023, at a compound annual growth rate of 4.23%. What is driving this growth?

– The leading companies in terms of market share are GSK, AstraZeneca and Boehringer Ingelheim. Which of these are forecast to experience the largest growth?

– There have been many new approvals in the therapy area. Which drugs will achieve blockbuster status?

– The market has been dominated by ICS/LABA therapies. What classes of drugs dominate the market and which will dominate over the forecast period?

– There are 930 respiratory products in the pipeline. What molecular targets are most abundant in the pipeline and what role will pipeline product approvals play in market growth?

– Respiratory disorders clinical trials have an overall attrition rate of around 70%, what can companies do to maximize their chance of success?

Reasons to buy

- Understand the current treatment landscape, with portfolios of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Analyze the respiratory pipeline through a comprehensive review of the pipeline segmented by stage of development, molecule type and molecular target. This review also provides a detailed look at respiratory product clinical trials to provide an insight into the risk associated with attempting to bring pipeline products to market.

- Predict growth in market size, with in-depth market forecasting from 2016 to 2023. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.

- Identify commercial opportunities in the respiratory deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 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 54

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

List of Tables

1.1 List of Tables

Table 1: Respiratory Disorders Therapeutics Market, Global, Epidemiology, 2017 24

Table 2: Respiratory Disorders Therapeutics Market, Global, Classification of Asthma Severity in Children of 0-4 Years of Age 29

Table 3: Respiratory Disorders Therapeutics Market, Global, Classification of Asthma Severity in Children of 5-11 Years of Age 29

Table 4: Respiratory Disorders Therapeutics Market, Global, Classification of Asthma Severity in Youths of 12 Years or More and Adults 30

Table 5: Respiratory Disorders Therapeutics Market, Global, COPD Disease Severity, 2016 31

Table 6: Respiratory Disorders Therapeutics Market, Global, COPD Patient Risk Categories, 2016 32

Table 7: Respiratory Disorders Therapeutics Market, Global, IPF Severity Classification, 2016 32

Table 8: Respiratory Disorders Therapeutics Market, Global, CF Severity Classification, 2016 34

Table 9: Respiratory Disorders Therapeutics Market, Global, COPD Treatment Algorithm, 2016 37

Table 10: Respiratory Disorders Therapeutics Market, Global, CF Treatment Plan, 2016 39

Table 11: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Advair, 2017 43

Table 12: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Symbicort, 2017 45

Table 13: Respiratory Disorders Therapeutics Market 47

Table 14: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Xolair, 2017 49

Table 15: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Ventolin, 2017 50

Table 16: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Pulmicort, 2017 51

Table 17: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Orkambi, 2017 53

Table 18: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Relvar/Breo Ellipta, 2017 54

Table 19: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Singulair, 2017 55

Table 20: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Esbriet, 2017 57

Table 21: Respiratory Disorders Therapeutics Market, Global, Approved Indications for Kalydeco, 2017 59

Table 22: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for Key Products ($m), 2016-2023 93

Table 23: Respiratory Disorders Therapeutics Market, Global, Usage of Generics Across Key Indications, 2017 96

Table 24: Respiratory Disorders Therapeutics Market, Global, Licensing Deals Valued Above $100m, 2006-2017 126

Table 25: Respiratory Disorders Therapeutics Market, Global, Co-development Deals Valued Above $100m, 2006-2017 136

List of Figures

1.1 List of Figures

Figure 1: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for Asthma, 2016-2023 25

Figure 2: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for COPD, 2016-2023 26

Figure 3: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for Idiopathic Pulmonary Fibrosis, 2016-2023 27

Figure 4: Respiratory Disorders Therapeutics Market, Global, Epidemiology Patterns for Cystic Fibrosis, 2016-2023 28

Figure 5: Respiratory Disorders Therapeutics Market, Schematic Representation of Potential Clinical Courses of IPF 33

Figure 6: Respiratory Disorders Therapeutics Market, Progression of CF 35

Figure 7: Respiratory Disorders Therapeutics Market, Global, Key Marketed Products and Approved Indications, 2017 42

Figure 8: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Advair ($bn), 2006-2023 44

Figure 9: Respiratory Disorders Therapeutics Market, Advair Market Share Within Asthma, Global, 2006-2023 44

Figure 10: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Symbicort ($bn), 2006-2023 46

Figure 11: Respiratory Disorders Therapeutics Market, Symbicort Market Share Within Asthma, Global, 2006-2023 47

Figure 12: Respiratory Disorders Therapeutic Market, Global, Annual Revenue for Spiriva ($bn), 2006-2023 48

Figure 13: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Xolair ($m), 2006-2023 49

Figure 14: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Ventolin ($bn), 2006-2023 51

Figure 15: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Pulmicort ($bn), 2006-2023 52

Figure 16: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Orkambi ($bn), 2015-2023 53

Figure 17: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Relvar/Breo Ellipta ($bn), 2013-2023 55

Figure 18: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Singulair ($bn), 2006-2023 57

Figure 19: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Esbriet ($m), 2008-2023 58

Figure 20: Respiratory Disorders Therapeutics Market, Global, Annual Revenue for Kalydeco ($m), 2012-2023 60

Figure 21: Respiratory Disorders Therapeutics Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 62

Figure 22: Respiratory Disorders Therapeutics Market, Global, Pipeline by Stage of Development, Molecule Type and Program Type, 2017 63

Figure 23: Respiratory Disorders Therapeutics Market, Global, Pipeline by Key Indications and Stage of Development, 2017 64

Figure 24: Respiratory Disorders Therapeutics Market, Global, Pipeline by Key Indications and Molecule Type, 2017 65

Figure 25: Respiratory Disorders Therapeutics Market, Global, Pipeline by Molecular Targets and Stage of Development, 2017 66

Figure 26: Respiratory Disorders Therapeutics Market, Global, Pipeline by Key Indications and Molecular Targets, 2017 67

Figure 27: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2017 68

Figure 28: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2017 69

Figure 29: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2017 70

Figure 30: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2017 71

Figure 31: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2017 72

Figure 32: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2017 73

Figure 33: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2017 74

Figure 34: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2017 75

Figure 35: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development, 2006-2017 76

Figure 36: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Indication, 2006-2017 77

Figure 37: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecule Type, 2006-2017 78

Figure 38: Respiratory Disorders Therapeutics Market, Global, Clinical Trial Size by Stage of Development and Molecular Target, 2006-2017 79

Figure 39: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development, 2006-2017 80

Figure 40: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development and Indication, 2006-2017 81

Figure 41: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecule Type, 2006-2017 82

Figure 42: Respiratory Disorders Therapeutics Market, Global, Clinical Program Size by Stage of Development and Molecular Target, 2006-2017 83

Figure 43: Respiratory Disorders Therapeutics Market, Global, Revenue for Ivacaftor/Tezacaftor ($bn), 2018-2023 84

Figure 44: Respiratory Disorders Therapeutics Market, Global, Revenue for (Fluticasone Furoate plus Umeclidinium Bromide plus Vilanterol Trifenatate) ($m), 2017-2023 85

Figure 45: Respiratory Disorders Therapeutics Market, Global, Revenue for Dupixent ($m), 2017-2023 86

Figure 46: Respiratory Disorders Therapeutics Market, Global, Revenue for Benralizumab ($m), 2017-2023 88

Figure 47: Respiratory Disorders Therapeutics Market, Global, Revenue for Tralokinumab ($m), 2017-2023 89

Figure 48: Respiratory Disorders Therapeutics Market, Global, Revenue for PT010 ($m), 2017-2023 90

Figure 49: Respiratory Disorders Therapeutics Market, Global, Market Size ($bn), 2016-2023 92

Figure 50: Respiratory Disorders Therapeutics Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2016-2023 95

Figure 51: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for G Protein-Coupled Receptor Modulators ($bn), 2016-2023 97

Figure 52: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for Immune/Inflammatory System Targets ($bn), 2016-2023 98

Figure 53: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for Transcription Factor Therapies ($bn), 2016-2023 99

Figure 54: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for Signal Transduction Modulators ($bn), 2016-2023 100

Figure 55: Respiratory Disorders Therapeutics Market, Global, Annual Revenue Forecast for CFTR Modulators ($bn), 2016-2023 101

Figure 56: Respiratory Disorders Therapeutics Market, Global, Company Analysis Matrix, 2016-2023 102

Figure 57: Respiratory Disorders Therapeutics Market, Global, Cluster Graph by Growth and Market Share, 2016-2023 103

Figure 58: Respiratory Disorders Therapeutics Market, Global, Forecast Revenue by Company, 2016-2023 105

Figure 59: Respiratory Disorders Therapeutics Market, Global, Forecast Market Share by Company (%), 2016-2023 106

Figure 60: Respiratory Disorders Therapeutics Market, Global, Companies by Compound Annual Growth Rate (%), 2016-2023 107

Figure 61: Respiratory Disorders Therapeutics Market, Global, Revenue by Product Type, 2016-2023 108

Figure 62: Respiratory Disorders Therapeutics Market, Global, GlaxoSmithKline Annual Revenue Forecast ($bn), 2016-2023 109

Figure 63: Respiratory Disorders Therapeutics Market, Global, Vertex Annual Revenue Forecast ($bn), 2016-2023 110

Figure 64: Respiratory Disorders Therapeutics Market, Global, AstraZeneca Annual Revenue Forecast ($bn), 2016-2023 111

Figure 65: Respiratory Disorders Therapeutics Market, Global, Roche Annual Revenue Forecast ($bn), 2016-2023 113

Figure 66: Respiratory Disorders Therapeutics Market, Global, Boehringer Ingelheim Annual Revenue Forecast ($bn), 2016-2023 114

Figure 67: Respiratory Disorders Therapeutics Market, Global, Novartis Annual Revenue Forecast ($m), 2016-2023 115

Figure 68: Respiratory Disorders Therapeutics Market, Global, Teva Annual Revenue Forecast ($bn), 2016-2023 116

Figure 69: Respiratory Disorders Therapeutics Market, Global, Sumitomo Dainippon Annual Revenue Forecast ($bn), 2016-2023 117

Figure 70: Respiratory Disorders Therapeutics Market, Global, Regeneron Annual Revenue Forecast ($bn), 2016-2023 117

Figure 71: Respiratory Disorders Therapeutics Market, Global, Merck & Co. Annual Revenue Forecast ($bn), 2016-2023 118

Figure 72: Respiratory Disorders Therapeutics Market, Global, Companies by Type, 2017 119

Figure 73: Respiratory Disorders Therapeutics Market, Global, High-Activity and Late-Stage Developers by Level of Respiratory Specialization, 2017 120

Figure 74: Respiratory Disorders Therapeutics Market, Global, Proportion of Total Company Revenue Attributed to Respiratory Disorders, 2016-2023 121

Figure 75: Respiratory Disorders Therapeutics Market, Global, Licensing Deals by Region, Year and Value, 2006-2017 122

Figure 76: Respiratory Disorders Therapeutics Market, Global, Licensing Deal Volume and Value by Indication, 2006-2017 123

Figure 77: Respiratory Disorders Therapeutics Market, Global, Licensing Deal Volume and Value by Stage of Development, 2006-2017 124

Figure 78: Respiratory Disorders Therapeutics Market, Global, Licensing Deals by Molecule Type and Target, 2006-2017 125

Figure 79: Respiratory Disorders Therapeutics Market, Global, Co-development Deals by Region, Year and Value, 2006-2017 133

Figure 80: Respiratory Disorders Therapeutics Market, Global, Co-development Deals by Indication, 2006-2017 133

Figure 81: Respiratory Disorders Therapeutics Market, Global, Co-development Deal Volume and Value by Stage of Development, 2006-2017 134

Figure 82: Respiratory Disorders Therapeutics Market, Global, Co-development Deals by Molecule Type and Target, 2006-2017 135

Figure 83: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Discovery, 2017 147

Figure 84: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Preclinical, 2017 148

Figure 85: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, IND/CTA-Filed/Phase 0, 2017 149

Figure 86: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Phase I, 2017 149

Figure 87: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Phase II, 2017 150

Figure 88: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Phase III, 2017 151

Figure 89: Respiratory Disorders Therapeutics Market, Global, Pipeline Products, Pre-registration, 2017 151

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