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

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


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Executive Summary

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

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 USD 18.4 billion in 2013 to a projected value of USD 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

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

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 (USD bn), 2015-2020 73

Figure 23: Asthma Therapeutics Market, Global, Reslizumab Forecast (USD bn), 2016-2020 75

Figure 24: Asthma Therapeutics Market, Global, Lebrikizumab Forecast (USD m), 2018-2020 76

Figure 25: Asthma Therapeutics Market, Global, Dupilumab Forecast (USD m), 2018-2020 79

Figure 26: Asthma Therapeutics Market, Global, Masitinib Forecast (USD 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 (USD 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 (USD ), 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 (USD ), 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 (USD ), 2013-2020 99

Figure 39: Asthma Therapeutics Market, Japan, Market Size (USD 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 (USD m), 2006-2014 103

Figure 42: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2014 104

Figure 43: Asthma Therapeutics Market, Global, Co-Development Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2014 105

Figure 44: Asthma Therapeutics Market, Global, Co-Development Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2014 106

Figure 45: Asthma Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value (USD 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 (USD m), 2006-2014 110

Figure 48: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2014 110

Figure 49: Asthma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2014 112

Figure 50: Asthma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2014 114

Figure 51: Asthma Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value (USD m), 2006-2014 115

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