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Asthma Therapeutics in Major Developed Markets to 2020 - Personalized Treatment for Severe Asthma to Drive Market Growth despite Patent Expirations

Summary

GBI Research, a leading business intelligence provider, has released its latest research report,"Asthma Therapeutics in Major Developed Markets to 2020 - Personalized Treatment for Severe Asthma to Drive Market Growth despite Patent Expirations".The asthma therapeutics market is forecast to grow marginally over the forecast period across the top eight developed nations, from $18.4 billion in 2013 to a projected value of $21.7 billion by 2020 at a Compound Annual Growth Rate (CAGR) of 2.4%. This is in spite of generic erosion facing several of the leading asthma brands, such as Advair (fluticasone propionate/salmeterol xinafoate), Symbicort (budesonide/formoterol fumarate) and Xolair (omalizumab), and is a consequence of new market entrants and rising disease prevalence.

The global prevalence of asthma is significant, believed to affect approximately 300 million people worldwide. This burden is predicted to increase in future, reaching 400 million by 2025.

Although the majority of asthma patients are able to manage their symptoms effectively using currently marketed products, some remain inadequately controlled with these same products. This unmet need, coupled with rising global prevalence, has resulted in strong industry interest.

Consequently, the current asthma pipeline is highly innovative, featuring several promising molecules in late-stage drug development. Biologics and monoclonal antibodies, the latter in particular, are gaining prominence within the indication. Novel monoclonal antibodies such as mepolizumab, reslizumab, lebrikizumab, and dupilumab target Interleukins (IL), or IL receptors, and have demonstrated potential in severe and inadequately controlled eosinophilic asthma, in turn representing a shift towards personalized therapy. Despite the fact that they target only a small patient sub-set, they are likely to be priced highly and to drive market growth, offsetting the impact of generic erosion.

Scope

The report covers and includes -
- An introduction to asthma, including discussion of disease epidemiology, etiology pathophysiology, symptoms, diagnosis, and treatment, with clinical data for drugs featured in the current treatment algorithm discussed in detail
- In-depth analysis of the current marketed products landscape, including product profiles of the main drugs used and heat maps that compare their safety and efficacy parameters
- Comprehensive analysis of the asthma pipeline by phase of development, molecule type, and molecular target and novelty, and comparative analysis of the most promising late-stage pipeline drugs, as well as heat maps and a competitor matrix that compares safety and efficacy parameters
- Additional in-depth analysis of the asthma clinical trials landscape, including trends in size, duration and failure rate
- Forecast projections for the asthma market to 2020, including analysis of the global market and each of the eight major markets and incorporating projected, low, and high-variance scenarios based on treatment usage patterns and annual cost of therapy in each of the major markets
- Discussion of the strategic consolidations landscape, including trends in co-development and licensing deals relevant to asthma drug products

Reasons to buy

The report will assist business development and enable marketing executives to strategize their product launches by allowing them to -
- Gain a comprehensive understanding of asthma, including diagnosis, disease severity, and treatment algorithms
- Understand the current asthma marketed products landscape and recognize the dominant therapeutic agents and pharmaceutical players involved
- Identify trends, developments, and prominent molecule types and molecular targets within the asthma pipeline
- Gain an appreciation of the clinical and commercial aspects of the most promising late-stage pipeline molecules and their potential competitive impact on the future market
- Consider market opportunities and potential risks by examining trends in asthma clinical trial size, duration and failure rate, phase of development, molecule type, and molecular target
- Observe projections for treatment usage patterns, annual therapy costs, and market growth in the eight major markets and understand reasons for variance in projected patterns of growth

Table Of Contents

Asthma Therapeutics in Major Developed Markets to 2020 - Personalized Treatment for Severe Asthma to Drive Market Growth despite Patent Expirations
1 Table of Contents

1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 10
2.3 Etiology 11
2.4 Pathophysiology 12
2.5 Symptoms 12
2.6 Diagnosis 12
2.7 Assessment of Disease Severity 13
2.8 Treatment 15
2.9 Treatment Algorithm 16
2.10 Treatment Segments 18
2.10.1 ICS Monotherapy for the Maintenance Treatment of Asthma 19
2.10.2 Singulair (montelukast sodium) as First-Line Maintenance Therapy 21
2.10.3 ICS/LABA Combination Therapy 22
2.10.4 Add-on Therapies 27
3 Marketed Products 33
3.1 Overview 33
3.2 ICS for the Maintenance Treatment of Asthma 33
3.2.1 Arnuity (fluticasone furoate) - GSK 33
3.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 34
3.3.1 Advair (fluticasone propionate and salmeterol xinafoate) - GSK 34
3.3.2 Symbicort (budesonide and formoterol fumarate) - AstraZeneca, Co-Promotion with Astellas Pharma 35
3.3.3 Dulera (mometasone furoate and formoterol fumarate) - Merck 36
3.3.4 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) - GlaxoSmithKline/Theravance 37
3.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 38
3.4.1 Xolair (omalizumab) - Novartis and Genentech 38
3.4.2 Singulair (montelukast) - Merck 39
3.4.3 Spiriva (tiotropium bromide) - Boehringer Ingelheim 40
3.5 Heat Maps for Marketed Products 42
4 Asthma Pipeline 44
4.1 Overview 44
4.2 Pipeline Analysis by Stage of Development, Molecule Type and Program Type 44
4.3 Pipeline Analysis by Molecular Target 46
4.4 Asthma Clinical Trial Landscape 53
4.4.1 Clinical Trial Failure Rates 53
4.4.2 Clinical Trial Duration 58
4.4.3 Clinical Trial Size 62
4.4.4 Comparative Clinical Trial Metrics Analysis 69
4.5 Promising Pipeline Molecules 71
4.5.1 Mepolizumab - GSK 71
4.5.2 Reslizumab - Teva Pharmaceutical 73
4.5.3 Lebrikizumab - Roche/Genentech 75
4.5.4 Dupilumab - Regeneron Pharmaceuticals in Collaboration with Sanofi 77
4.5.5 Masitinib - AB Science 79
4.6 Heat Map and Competitor Matrix for Pipeline Products 81
5 Market Forecast to 2020 84
5.1 Geographical Markets 84
5.2 Global Market 85
5.3 North America 88
5.3.1 Treatment Usage Patterns 88
5.3.2 Annual Cost of Therapy 90
5.3.3 Market Size 92
5.4 Top Five Countries of Europe 94
5.4.1 Treatment Usage Patterns 94
5.4.2 Annual Cost of Therapy 95
5.4.3 Market Size 97
5.5 Japan 98
5.5.1 Treatment Usage Patterns 98
5.5.2 Annual Cost of Therapy 98
5.5.3 Market Size 99
5.6 Drivers and Barriers for the Asthma Market 100
5.6.1 Drivers 100
5.6.2 Barriers 100
6 Strategic Consolidations 102
6.1 Co-development Deals 102
6.1.1 Sepracor Enters into Co-Development Agreement with Nycomed for Ciclesonide 107
6.1.2 NeoStem Enters into Agreement with University of California to Develop Human Regulatory T Cells 108
6.1.3 Amgen Enters into Co-Development Agreement with AstraZeneca for Five Monoclonal Antibodies 108
6.2 Licensing Deals 108
6.2.1 Amgen Enters into Licensing Agreement with Kyowa Hakko Kirin - Terminated 115
6.2.2 Mundipharma Enters into Licensing Agreement with SkyePharma 116
6.2.3 MAP Pharmaceuticals Enters into Licensing Agreement with AstraZeneca - Terminated 116
6.2.4 Orexo Enters into Licensing Agreement with Janssen Pharmaceuticals - Terminated 116
6.2.5 Aslan Pharma Enters into Licensing Agreement with CSL for CSL-334 117
7 Appendix 118
7.1 All Pipeline Drugs by Phase of Development 118
7.1.1 Discovery 118
7.1.2 Preclinical 119
7.1.3 Phase I 124
7.1.4 Phase II 125
7.1.5 Phase III 127
7.1.6 Pre-registration 128
7.2 Market Forecasts to 2020 128
7.2.1 Global 128
7.2.2 US 129
7.2.3 Canada 129
7.2.4 UK 129
7.2.5 France 130
7.2.6 Germany 130
7.2.7 Italy 130
7.2.8 Spain 131
7.2.9 Japan 131
7.3 References 131
7.4 Abbreviations 137
7.5 Research Methodology 137
7.5.1 Secondary Research 138
7.5.2 Marketed Product Profiles 138
7.5.3 Late-Stage Pipeline Candidates 139
7.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 139
7.5.5 Product Competitiveness Framework 139
7.5.6 Pipeline Analysis 139
7.5.7 Forecasting Model 140
7.5.8 Deals Data Analysis 141
7.6 Expert Panel Validation 141
7.7 Contact Us 142
7.8 Disclaimer 142



1.1 List of Tables

Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 0-4 Years of Age 13
Table 2: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children of 5-11 Years of Age 14
Table 3: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Youths ? 12 Years of Age and Adults 15
Table 4: Management of Chronic Asthma 16
Table 5: Management of Acute Asthma 18
Table 6: Asthma Clinical Trial Endpoints 19
Table 7: Asthma Therapeutics, Global, All Pipeline Products, Discovery Phase, 2015 118
Table 8: Asthma Therapeutics, Global, All Pipeline Products, Preclinical Phase, 2015 119
Table 9: Asthma Therapeutics, Global, All Pipeline Products, Phase I, 2015 124
Table 10: Asthma Therapeutics, Global, All Pipeline Products, Phase II, 2015 125
Table 11: Asthma Therapeutics, Global, All Pipeline Products, Phase III, 2015 127
Table 12: Asthma Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2015 128
Table 13: Asthma Therapeutics Market, Global, Market Forecast, 2013-2020 128
Table 14: Asthma Therapeutics Market, US, Market Forecast, 2013-2020 129
Table 15: Asthma Therapeutics Market, Canada, Market Forecast, 2013-2020 129
Table 16: Asthma Therapeutics Market, UK, Market Forecast, 2013-2020 129
Table 17: Asthma Therapeutics Market, France, Market Forecast, 2013-2020 130
Table 18: Asthma Therapeutics Market, Germany, Market Forecast, 2013-2020 130
Table 19: Asthma Therapeutics Market, Italy, Market Forecast, 2013-2020 130
Table 20: Asthma Therapeutics Market, Spain, Market Forecast, 2013-2020 131
Table 21: Asthma Therapeutics Market, Japan, Market Forecast, 2013-2020 131



1.2 List of Figures

Figure 1: Asthma Therapeutics Market, Global, Heat Map for Marketed Products, 2015 42
Figure 2: Asthma Therapeutics Market, Global, Heat Map for Marketed Products (continued), 2015 42
Figure 3: Asthma Therapeutics Market, Global, Pipeline, 2015 45
Figure 4: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, 2015 48
Figure 5: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Immune/Inflammatory System Targets and Cytokine/Cytokine Receptor Targets, 2015 49
Figure 6: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Enzyme and Kinase Molecular Targets, 2015 51
Figure 7: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, Breakdown of Adrenergic and Cholinergic Receptors, 2015 52
Figure 8: Asthma Therapeutics Market, Global, Clinical Trial Failure Rate, 2006-2014 54
Figure 9: Asthma Therapeutics Market, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2014 55
Figure 10: Asthma Therapeutics Market, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2014 57
Figure 11: Asthma Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type, (months), 2006-2014 59
Figure 12: Asthma Therapeutics Market, Global, Phase I Clinical Trial Duration by Molecular Target (months), 2006-2014 60
Figure 13: Asthma Therapeutics Market, Global, Phase II Clinical Trial Duration by Molecular Target (months), 2006-2014 61
Figure 14: Asthma Therapeutics Market, Global, Phase III Clinical Trial Duration by Molecular Target (months), 2006-2014 62
Figure 15: Asthma Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type for Individual Asthma Products (participants), 2006-2014 63
Figure 16: Asthma Therapeutics Market, Global, Clinical Trial Recruitment Size by Stage of Development and Molecule Type for Individual Asthma Clinical Trials (participants), 2006-2014 65
Figure 17: Asthma Therapeutics Market, Global, Phase I Clinical Trial Recruitment Size by Molecular Target (participants), 2006-2014 67
Figure 18: Asthma Therapeutics Market, Global, Phase II Clinical Trial Recruitment Size by Molecular Target (participants), 2006-2014 68
Figure 19: Asthma Therapeutics Market, Global, Phase III Clinical Trial Recruitment Size by Molecular Target (participants), 2006-2014 69
Figure 20: Asthma Therapeutics Market, Global, Failure Rate (%), Average Clinical Trial Duration (months) and Average Recruitment Size for Asthma by Molecule Type, 2006-2014 70
Figure 21: Asthma Therapeutics Market, Global Failure Rate (%), Average Clinical Trial Duration (months) and Average Trial Recruitment Size (participants) for Asthma by Molecular Target, 2006-2014 70
Figure 22: Asthma Therapeutics Market, Global, Mepolizumab Forecast ($bn), 2015-2020 73
Figure 23: Asthma Therapeutics Market, Global, Reslizumab Forecast ($bn), 2016-2020 75
Figure 24: Asthma Therapeutics Market, Global, Lebrikizumab Forecast ($m), 2018-2020 76
Figure 25: Asthma Therapeutics Market, Global, Dupilumab Forecast ($m), 2018-2020 79
Figure 26: Asthma Therapeutics Market, Global, Masitinib Forecast ($m), 2017-2020 81
Figure 27: Asthma Therapeutics Market, Global, Heat Map for Pipeline Products, 2015 81
Figure 28: Asthma Therapeutics Market, Global, Competitor Matrix for Marketed and Pipeline Products, 2015 82
Figure 29: Asthma Therapeutics Market, Global, Treatment Patterns, 2013-2020 86
Figure 30: Asthma Therapeutics Market, Global, Market Size ($bn), 2013-2020 87
Figure 31: Asthma Therapeutics Market, North America, Treatment Patterns, 2013-2020 89
Figure 32: Asthma Therapeutics Market, North America, Annual Cost of Therapy ($), 2013-2020 91
Figure 33: Asthma Therapeutics Market, North America, Market Size, 2013-2020 93
Figure 34: Asthma Therapeutics Market, Top Five EU Countries, Treatment Patterns, 2013-2020 94
Figure 35: Asthma Therapeutics Market, Top Five EU Countries, Annual Cost of Therapy ($), 2013-2020 96
Figure 36: Asthma Therapeutics Market, Top Five EU Countries, Market Size, 2013-2020 97
Figure 37: Asthma Therapeutics Market, Japan, Treatment Patterns, 2013-2020 98
Figure 38: Asthma Therapeutics Market, Japan, Annual Cost of Therapy ($), 2013-2020 99
Figure 39: Asthma Therapeutics Market, Japan, Market Size ($bn), 2013-2020 99
Figure 40: Asthma Therapeutics Market, Global, Co-Development Deals by Region, 2006-2014 103
Figure 41: Asthma Therapeutics Market, Global, Co-Development Deals by Value ($m), 2006-2014 103
Figure 42: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2014 104
Figure 43: Asthma Therapeutics Market, Global, Co-Development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2014 105
Figure 44: Asthma Therapeutics Market, Global, Co-Development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2014 106
Figure 45: Asthma Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2014 107
Figure 46: Asthma Therapeutics Market, Global, Licensing Deals by Region, 2006-2014 109
Figure 47: Asthma Therapeutics Market, Global, Licensing Deals by Value ($m), 2006-2014 110
Figure 48: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2014 110
Figure 49: Asthma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2014 112
Figure 50: Asthma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2014 114
Figure 51: Asthma Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2014 115

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