Global Respiratory Drugs Market to 2022 - Pipeline and Market Characterized by Growing Prominence of Targeted Therapies, with Asthma and Cystic Fibrosis Leading the Way

GBI Research
202 Pages - GBI10550
$4,995.00

Summary

The respiratory therapy area consists of indications that affect the respiratory system in different ways, such as the scarring of lung tissue, and excessive production of mucus in the airways, thereby decreasing lung function. Some of the key indications in this therapy area include asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and idiopathic pulmonary fibrosis (IPF). 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 cause. This means that treatment options can be diverse in terms of their targets and mechanisms of action. This is most notable in CF, where patients may be prescribed a combination of drugs from several treatment categories, including mucolytic agents, bronchodilators and antibiotics. The COPD and asthma treatment landscapes employ similar symptomatic treatments, including bronchodilators and inhaled corticosteroids.

However, over the past decade the treatment of respiratory disorders has developed significantly, as has the importance for novel therapies and targeted therapies. The approval of the products Orkambi and Kalydeco, in 2014 and 2012 respectively, gave patients disease-modifying treatment options for CF. Another important entry was the first biologic drug - omalizumab - approved in 2014 for the treatment of severe asthma. The trend of developing targeted therapies continued with the approval of the maintenance treatment Nucala (mepolizumab) in November 2015.

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. Overall, 908 products are currently in active in development for respiratory disorders.

Scope

The respiratory disorders market is characterized by entrenched, commercially successful therapies.
 - Which classes of drug dominate the market?
 - What additional benefits have newly approved therapies brought to the market?
 - What are the future prospects for the leading brands?
The pipeline contains a range of molecule types and molecular targets, with a growing presence of targeted therapies.
 - Which molecular targets appear most frequently in the pipeline?
 - What are the commercial prospects for the most promising late-stage pipeline products?
Respiratory disorders clinical trials have an overall attrition rate of 89.1%.
 - What are the failure rates at individual phases of clinical development?
 - How do the key respiratory disorders compare in terms of clinical trial failure rate?
The respiratory disorders market is forecast to rise from a value of $28.1 billion in 2015 to $46.6 billion in 2022, at a CAGR of 7.5%.
 - How much of a role will pipeline product approvals play in market growth?
 - Are the large number of recently approved products expected to drive market growth?
 - Will generic competition have a significant impact on the market over the forecast period?
 - Which products face generic competition?
Big pharma holds a notable presence in the market.
 - What are the leading companies in terms of market share?
 - Which companies are forecast to experience the greatest growth in market share?
 - Which company will hold the largest market share in 2022?
 - How dependent are the key companies on this disease cluster for revenue?
 - Which companies rely heavily on this disease cluster for revenue?

Reasons to buy

This report will allow you to -
- Understand the current clinical and commercial landscape through a comprehensive study of disease pathogenesis, diagnosis, prognosis, and the current treatment landscape in respiratory disorders.
Assess the current treatment landscape, with product profiles on prominent marketed therapies, including revenue forecasts.
- Analyze the respiratory disorders pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast.
- Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.
- Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from respiratory disorder products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market.
- Identify commercial opportunities in the respiratory disorder deals landscape by analyzing trends in licensing and co-development deals, and by profiling the most significant deals that have occurred in this indication in recent years.

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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

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