Asthma therapeutics in major developed markets to 2020 personalized treatment for severe asthma to drive market growth despite patent expirations

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Asthma Therapeutics in Major Developed Markets to 2020 - Personalized Treatment for Severe
Asthma to Drive Market Growth despite Patent Expirations
YRH: Asthma Therapeutics in Major Developed Markets to 2020 -
Personalized Treatment for Severe Asthma to Drive Market Growth despite
Patent Expirations
Overview, Size, Share, Analysis, Technology Developments, Development
Status, Trends, Structure, Production Value and Forecast Research Report
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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:
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

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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
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
5.5 Japan 98
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
Table of Figures:
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
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Asthma therapeutics in major developed markets to 2020 personalized treatment for severe asthma to drive market growth despite patent expirations

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Asthma therapeutics in major developed markets to 2020 personalized treatment for severe asthma to drive market growth despite patent expirations