Summary
Asthma is a common chronic inflammatory disease of the airways, characterized by recurrent attacks of breathlessness and wheezing, which vary in frequency and severity from patient to patient. The exact causes of asthma are currently unknown, and may be the result of a combination of factors, although two major factors thought to be involved are environmental exposure and host factors, particularly genes.
Asthma treatment can be classed as either a long-term control medication, aimed at controlling persistent asthma, or a quick-relief medication, for the relief of exacerbations and acute symptoms. Long-term control medication includes Inhaled Corticosteroids (ICS), immunomodulators, leukotriene modifiers, cromolyn sodium, nedocromil and methylxanthines. In addition, Long-Acting Beta-Adrenoceptor Agonists (LABAs) can be used in combination with ICSs – but not as monotherapies – for moderate or severe persistent asthma. Currently, only one biologic – Xolair (omalizumab) – is approved as an add-on therapy for the treatment of allergic asthma in the Asia-Pacific region. Nevertheless, significant unmet need remains for the treatment of severe eosinophilic asthma.
Scope
The current asthma market in the Asia-Pacific region contains novel products, including Xolair, a recombinant humanized monoclonal anti-IgE antibody; Seretide/Adoair, an ICS-LABA combination therapy; Relvar/Breo, an ICS-LABA combination therapy, and Spiriva, a LAMA.
- What are the competitive advantages of the existing novel drugs?
With over 274 active pipeline molecules, most of the late-stage investigational drug candidates are being evaluated, with improved dosing regimens and administration routes in comparison to currently marketed products.
- Which classes of novel drugs are most prominent within the pipeline?
- Is there strong potential for the pipeline to address unmet needs within the asthma market – specifically for severe eosinophilic asthma?
Analysis of clinical trials since 2006 has identified that the failure rates of asthma molecules were highest in Phase III (46%), with the overall attrition rate for asthma in development being 78%.
- How do failure rates vary by product stage of development, molecule type, and mechanism of action?
- How do other factors, such as average trial duration and trial size influence the costs and risks associated with product development?
Over the 2014–2021 forecast period, the asthma therapeutics market in the Asia-Pacific region is expected to increase in value at a Compound Annual Growth Rate (CAGR) of 7.2%, from $3.5 billion to over $5.6 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the five assessed Asia-Pacific markets?
Rising asthma prevalence and uptake of newer biologics will lead to significant market growth over the forecast period, in spite of affordability concerns.
- Will affordability threaten the commercial success of existing drugs as well as newer biologics?
- Which of the assessed countries have affordability concerns?
Reasons to buy
This report will enable you to -
- Understand the clinical context of asthma by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Identify key pipeline trends in molecule type, administration route, mechanism of action, and novelty.
- Consider market opportunities and potential risks by examining trends in asthma clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in asthma by examining clinical trial data and multi-scenario product forecast projections.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for China, India, Australia, South Korea and Japan.
- Discover trends in licensing and co-development deals concerning asthma products and identify the major strategic consolidations that have shaped the commercial landscape.
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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 9
2.1 Disease Introduction 9
2.2 Epidemiology 9
2.3 Symptoms 10
2.4 Etiology and Pathophysiology 10
2.5 Diagnosis 11
2.6 Classification 12
2.7 Treatment Guidelines and Options 13
2.7.1 ICS Monotherapy for the Maintenance Treatment of Asthma 16
2.7.2 Montelukast sodium as First-Line Maintenance Therapy 19
2.7.3 ICS/LABA Combination Therapy 20
2.7.4 Add-on Therapies 25
3 Marketed Products 30
3.1 Overview 30
3.2 ICS for the Maintenance Treatment of Asthma 30
3.2.1 Arnuity (fluticasone furoate) 30
3.3 ICS/LABA Combination Therapy for the Maintenance Treatment of Asthma 31
3.3.1 Seretide/Adoair (fluticasone propionate and salmeterol xinafoate) - GlaxoSmithKline 31
3.3.2 Symbicort (budesonide and formoterol fumarate) - AstraZeneca, Co-Promotion with Astellas Pharma 32
3.3.3 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) - GlaxoSmithKline 33
3.3.4 Flutiform (fluticasone propionate and formoterol fumarate) - SkyePharma 34
3.4 Add-on Therapy to ICS or ICS/LABA Therapies for the Maintenance Treatment of Asthma 35
3.4.1 Xolair (omalizumab) - Novartis and Genentech 35
3.4.2 Montelukast sodium 36
3.4.3 Spiriva (tiotropium bromide) - Boehringer Ingelheim 37
3.5 Comparative Efficacy and Safety of Marketed Products 38
4 Pipeline Analysis 41
4.1 Overview 41
4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 41
4.3 Pipeline by Molecular Target 43
4.4 Promising Pipeline Molecules 47
4.4.1 Mepolizumab - GlaxoSmithKline 47
4.4.2 Reslizumab - Teva Pharmaceutical 49
4.4.3 Lebrikizumab - Roche/Genentech 51
4.4.4 Dupilumab - Regeneron Pharmaceuticals in Collaboration with Sanofi 52
4.4.5 Tralokinumab - AstraZeneca 55
4.4.6 Benralizumab - AstraZeneca 56
4.5 Comparative Efficacy and Safety of Pipeline Products 58
5 Clinical Trial Analysis 62
5.1 Failure Rate 62
5.1.1 Overall Failure Rate 62
5.1.2 Failure Rate by Phase and Molecule Type 63
5.1.3 Failure Rate by Phase and Molecular Target 64
5.2 Clinical Trial Size 65
5.2.1 Patient Enrollment per Product by Stage of Development by Molecule Type and Molecular Target 65
5.2.2 Patient Enrollment per Trial by Stage of Development by Molecule Type and Molecular Target 67
5.3 Clinical Trial Duration 69
5.3.1 Trial Duration by Stage of Development by Molecule Type and Molecular Target 69
5.4 Summary of Clinical Trial Metrics 70
6 Multi-Scenario Forecast 72
6.1 Geographical Markets 72
6.2 Asia-Pacific Market 73
6.3 India 75
6.3.1 Treatment Usage Patterns 75
6.3.2 Annual Cost of Therapy 76
6.3.3 Market Size 76
6.4 China 77
6.4.1 Treatment Usage Patterns 77
6.4.2 Annual Cost of Therapy 78
6.4.3 Market Size 79
6.5 Australia 80
6.5.1 Treatment Usage Patterns 80
6.5.2 Annual Cost of Therapy 81
6.5.3 Market Size 82
6.6 South Korea 83
6.6.1 Treatment Usage Patterns 83
6.6.2 Annual Cost of Therapy 84
6.6.3 Market Size 85
6.7 Japan 86
6.7.1 Treatment Usage Patterns 86
6.7.2 Annual Cost of Therapy 87
6.7.3 Market Size 88
7 Drivers and Barriers 90
7.1 Drivers 90
7.1.1 Rising Prevalence 90
7.1.2 New Costly Market Entries 90
7.1.3 Growing Alternative Therapeutic Choices 90
7.2 Barriers 90
7.2.1 Usage of Traditional Medicines 90
7.2.2 Treatment Regimen Adherence 91
7.2.3 Limited Understanding of Underlying Causes 91
7.2.4 Lack of Awareness and Affordability of High-Cost Biological Products 91
8 Deals and Strategic Consolidations 92
8.1 Co-development Deals 92
8.1.1 Deals by Region and Value 92
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 93
8.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 94
8.1.4 Key Co-Development Deals 97
8.2 Licensing Deals 99
8.2.1 Deals by Region and Value 99
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 100
8.2.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 100
8.2.4 Key Licensing Deals 103
9 Appendix 106
9.1 All Pipeline Drugs by Phase of Development 106
9.1.1 Discovery 106
9.1.2 Preclinical 107
9.1.3 Phase I 112
9.1.4 Phase II 113
9.1.5 Phase III 115
9.1.6 Pre-registration 116
9.2 Summary of Multi-Scenario Market Forecasts to 2021 116
9.2.1 Asia-Pacific 116
9.2.2 China 117
9.2.3 India 117
9.2.4 Australia 118
9.2.5 South Korea 118
9.2.6 Japan 119
9.3 References 119
9.4 Abbreviations 124
9.5 Research Methodology 126
9.5.1 Secondary Research 127
9.5.2 Marketed Product Profiles 127
9.5.3 Late-Stage Pipeline Candidates 127
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 128
9.5.5 Product Competitiveness Framework 128
9.5.6 Pipeline Analysis 128
9.5.7 Forecasting Model 129
9.5.8 Deals Data Analysis 130
9.6 Contact Us 130
9.7 Disclaimer 130
1.1 List of Tables
Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity According to GINA Guidelines (2002) 12
Table 2: Asthma Therapeutics, Global, Management of Chronic Asthma in Adults and Children above Five Years 14
Table 3: Asthma Diagnosis, Global, Symptoms and Management of Acute Asthma 15
Table 4: Asthma Trials, Global, Clinical Trial Endpoints 16
Table 5: Asthma Therapeutics, Global, All Pipeline Products, Discovery, 2015 106
Table 6: Asthma Therapeutics, Global, All Pipeline Products, Preclinical, 2015 107
Table 7: Asthma Therapeutics, Global, All Pipeline Products, Phase I, 2015 112
Table 8: Asthma Therapeutics, Global, All Pipeline Products, Phase II, 2015 113
Table 9: Asthma Therapeutics, Global, All Pipeline Products, Phase III, 2015 115
Table 10: Asthma Therapeutics, Global, All Pipeline Products, Pre-registration Phase, 2015 116
Table 11: Asthma Therapeutics Market, Asia-Pacific, Market Forecast, 2014-2021 116
Table 12: Asthma Therapeutics Market, China, Market Forecast, 2014-2021 117
Table 13: Asthma Therapeutics Market, India, Market Forecast, 2014-2021 117
Table 14: Asthma Therapeutics Market, Australia, Market Forecast, 2014-2021 118
Table 15: Asthma Therapeutics Market, South Korea, Market Forecast, 2014-2021 118
Table 16: Asthma Therapeutics Market, Japan, Market Forecast, 2014-2021 119
1.2 List of Figures
Figure 1: Asthma Therapeutics Market, Asia-Pacific, Heat Map for Marketed Products, 2015 38
Figure 2: Asthma Therapeutics Market, Asia-Pacific, Heat Map for Marketed Products (continued), 2015 39
Figure 3: Asthma Therapeutics Market, Global, Pipeline, 2015 43
Figure 4: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, 2015 46
Figure 5: Asthma Therapeutics Market, Asia-Pacific, Mepolizumab Forecast ($m), 2016-2021 49
Figure 6: Asthma Therapeutics Market, Asia-Pacific, Reslizumab Forecast ($m), 2016-2021 51
Figure 7: Asthma Therapeutics Market, Asia-pacific, Lebrikizumab Forecast ($m), 2018-2021 52
Figure 8: Asthma Therapeutics Market, Asia-Pacific, Dupilumab Forecast ($m), 2019-2021 55
Figure 9: Asthma Therapeutics Market, Asia-Pacific, Tralokinumab Forecast ($m), 2019-2021 56
Figure 10: Asthma Therapeutics Market, Asia-Pacific, Benralizumab Forecast ($m), 2020-2021 58
Figure 11: Asthma Therapeutics Market, Global, Heat Map for Pipeline Products, 2015 59
Figure 12: Asthma Therapeutics Market, Global, Competitor Matrix for Marketed and Pipeline Products, 2015 60
Figure 13: Asthma Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2015 63
Figure 14: Asthma Therapeutics, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2015 64
Figure 15: Asthma Therapeutics, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2015 65
Figure 16: Asthma Therapeutics, Global, Clinical Trial Size per Product by Stage of Development and Molecule Type, 2006-2015 66
Figure 17: Asthma Therapeutics, Global, Clinical Trial Size per Product by Stage of Development and Molecular Target, 2006-2015 67
Figure 18: Asthma Therapeutics, Global, Clinical Trial Size per Individual Trial by Stage of Development and Molecule Type, 2006-2015 68
Figure 19: Asthma Therapeutics, Global, Clinical Trial Size per Individual Trial by Stage of Development and Molecular Target, 2006-2015 68
Figure 20: Asthma Therapeutics, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2015 69
Figure 21: Asthma Therapeutics, Global, Clinical Trial Duration by Phase and Molecular Target, 2006-2015 70
Figure 22: Asthma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 70
Figure 23: Asthma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 71
Figure 24: Asthma Therapeutics Market, Asia-Pacific, Treatment Patterns, 2014-2021 73
Figure 25: Asthma Therapeutics Market, Asia-Pacific, Market Size ($bn), 2014-2021 74
Figure 26: Asthma Therapeutics Market, India, Treatment Patterns, 2014-2021 75
Figure 27: Asthma Therapeutics Market, India, Annual Cost of Therapy ($), 2014-2021 76
Figure 28: Asthma Therapeutics Market, India, Market Size, 2014-2021 77
Figure 29: Asthma Therapeutics Market, China, Treatment Patterns, 2014-2021 78
Figure 30: Asthma Therapeutics Market, China, Annual Cost of Therapy ($), 2014-2021 79
Figure 31: Asthma Therapeutics Market, China, Market Size, 2014-2021 80
Figure 32: Asthma Therapeutics Market, Australia, Treatment Patterns, 2014-2021 81
Figure 33: Asthma Therapeutics Market, Australia, Annual Cost of Therapy ($), 2014-2021 82
Figure 34: Asthma Therapeutics Market, Australia, Market Size, 2014-2021 83
Figure 35: Asthma Therapeutics Market, South Korea, Treatment Patterns, 2014-2021 84
Figure 36: Asthma Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2014-2021 85
Figure 37: Asthma Therapeutics Market, South Korea, Market Size, 2014-2021 86
Figure 38: Asthma Therapeutics Market, Japan, Treatment Patterns, 2014-2021 87
Figure 39: Asthma Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021 88
Figure 40: Asthma Therapeutics Market, Japan, Market Size ($bn), 2014-2021 89
Figure 41: Asthma Therapeutics Market, Global, Co-Development Deals by Region, 2006-2015 92
Figure 42: Asthma Therapeutics Market, Global, Co-Development Deals by Value ($m), 2006-2015 93
Figure 43: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-Development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015 94
Figure 44: Asthma Therapeutics Market, Global, Co-Development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015 95
Figure 45: Asthma Therapeutics Market, Global, Co-Development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015 96
Figure 46: Asthma Therapeutics Market, Global, Co-Development Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2015 97
Figure 47: Asthma Therapeutics Market, Global, Licensing Deals by Region, 2006-2015 99
Figure 48: Asthma Therapeutics Market, Global, Licensing Deals by Value ($m), 2006-2015 99
Figure 49: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2015 100
Figure 50: Asthma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015 101
Figure 51: Asthma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2015 102
Figure 52: Asthma Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Deal Value ($m), 2006-2015 103
