Asthma Therapeutics in Asia-Pacific Markets to 2023 - High Prevalence and Highly Priced Existing & Upcoming Biologics will Drive the Market

Market: Pharmaceuticals and Healthcare

Asia Pacific, 134 pages report, published by GBI Research

Keywords : Asthma, breathlessness, chronic inflammatory disease, inhaled corticosteroid, immunomodulator, leukotriene modifier

Report ThumbnailJune-2017
Asthma Therapeutics in Asia-Pacific Markets to 2023 - High Prevalence and Highly Priced Existing & Upcoming Biologics will Drive the Market

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. The disease has significant global incidence and there is currently no cure. Pharmacotherapeutic intervention aims to provide patients with an increased level of disease control and reduce the severity of symptoms, and a number of inhalational therapeutic options are available.

Asthma treatment can be classed as either long-term control medication, aimed at controlling persistent asthma, or 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 (LABA) can be used in combination with ICSs - but not as monotherapies - for moderate or severe persistent asthma. Currently, only two biologics - Xolair (omalizumab) and Nucala (mepolizumab) - are approved as add-on therapy for the treatment of allergic and severe refractory eosinophilic asthma in the Asia-Pacific region. Unmet need therefore remains in the form of patients that do not respond well to current therapeutics.

The Asia-Pacific asthma market was valued at $4.1 billion in 2016. The large size of the market is driven by high prevalence rates, particularly among children and the aging population; the need for long-term reliever and maintenance medication; and the expected launch of high-cost biological therapies.

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, another ICS-LABA combination therapy; and Spiriva, a LAMA.
- What are the competitive advantages of the existing novel drugs?
With over 290 active pipeline molecules, most of the late-stage investigational drug candidates offer improved dosing regimens and administration routes in comparison to currently marketed products.
- Which classes of novel drugs are most prominent within the pipeline?
- How much potential is there for the pipeline to address unmet needs within the asthma market?
Analysis of clinical trials since 2006 has identified that the failure rates of asthma molecules were highest in Phase III (60%).
- 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 2016-2023 forecast period the asthma therapeutics market in the Asia-Pacific region is expected to increase in value at a compound annual growth rate of 5.4%, from $4.1 billion to over $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?

Reasons to buy

- 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. Analyze the asthma pipeline and stratify pipeline therapies by stage of development, molecule type and molecular target. There are signs in the pipeline that the industry is seeking novel approaches to meet unmet needs within asthma.
- 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.
  • 1.2 List of Figures
  • Figure 1: Asthma Therapeutics Market, Comparative Efficacy and Safety Heatmap for Marketed Products 38
  • Figure 2: Asthma Therapeutics Market, Global, Pipeline, 2016 41
  • Figure 3: Asthma Therapeutics Market, Global, Pipeline by Molecular Target, 2016 44
  • Figure 4: Asthma Therapeutics Market, Global, Pipeline by Molecular Target and Stage of Development, 2016 45
  • Figure 5: Asthma Therapeutics Market, Asia-Pacific, Reslizumab Forecast ($m), 2017-2023 47
  • Figure 6: Asthma Therapeutics Market, Asia-Pacific, Dupilumab Forecast ($m), 2019-2023 49
  • Figure 7: Asthma Therapeutics Market, Asia-Pacific, Tralokinumab Forecast ($m), 2019-2023 51
  • Figure 8: Asthma Therapeutics Market, Asia-Pacific, Benralizumab Forecast ($m), 2018-2023 53
  • Figure 9: Asthma Therapeutics Market, Asia-Pacific, Fevipiprant Forecast ($m), 2021-2023 54
  • Figure 10: Asthma Therapeutics Market, Comparative Efficacy and Safety Heatmap for Pipeline Products 55
  • Figure 11: Asthma Therapeutics Market, Competitor Matrix for Asthma Marketed and Pipeline Products, 2016 57
  • Figure 12: Asthma Therapeutics, Global, Average Clinical Trial Failure Rate (%), 2006-2016 59
  • Figure 13: Asthma Therapeutics, Global, Clinical Trial Failure Rate by Molecule Type, 2006-2016 60
  • Figure 14: Asthma Therapeutics, Global, Clinical Trial Failure Rate by Molecular Target, 2006-2016 61
  • Figure 15: Asthma Therapeutics, Global, Clinical Trial Duration by Phase and Molecule Type, 2006-2016 62
  • Figure 16: Asthma Therapeutics, Global, Clinical Trial Duration by Phase and Molecular Target, 2006-2016 63
  • Figure 17: Asthma Therapeutics, Global, Clinical Trial Size per Individual Trial by Stage of Development and Molecule Type, 2006-2016 64
  • Figure 18: Asthma Therapeutics, Global, Clinical Trial Size per Individual Trial by Stage of Development and Molecular Target, 2006-2016 65
  • Figure 19: Asthma Therapeutics, Global, Clinical Trial Size per Product by Stage of Development and Molecule Type, 2006-2016 66
  • Figure 20: Asthma Therapeutics, Global, Clinical Trial Size per Product by Stage of Development and Molecular Target, 2006-2016 67
  • Figure 21: Asthma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 68
  • Figure 22: Asthma Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 68
  • Figure 23: Asthma Therapeutics Market, Asia-Pacific, Treatment Patterns, 2016-2023 70
  • Figure 24: Asthma Therapeutics Market, Asia-Pacific, Market Size ($bn), 2016-2023 71
  • Figure 25: Asthma Therapeutics Market, India, Treatment Usage Patterns (million), 2016-2023 72
  • Figure 26: Asthma Therapeutics Market, India, Annual Cost of Therapy ($), 2016-2023 73
  • Figure 27: Asthma Therapeutics Market, India, Market Size ($m), 2016-2023 74
  • Figure 28: Asthma Therapeutics Market, China, Treatment Usage Patterns, 2016-2023 75
  • Figure 29: Asthma Therapeutics Market, China, Annual Cost of Therapy ($), 2016-2023 76
  • Figure 30: Asthma Therapeutics Market, China, Market Size ($m), 2016-2023 77
  • Figure 31: Asthma Therapeutics Market, Australia, Treatment Usage Patterns (million), 2016-2023 78
  • Figure 32: Asthma Therapeutics Market, Australia, Annual Cost of Therapy ($), 2016-2023 79
  • Figure 33: Asthma Therapeutics Market, Australia, Market Size ($m), 2016-2023 80
  • Figure 34: Asthma Therapeutics Market, South Korea, Treatment Usage Patterns (million), 2016-2023 81
  • Figure 35: Asthma Therapeutics Market, South Korea, Annual Cost of Therapy ($), 2016-2023 82
  • Figure 36: Asthma Therapeutics Market, South Korea, Market Size ($m), 2016-2023 83
  • Figure 37: Asthma Therapeutics Market, Japan, Treatment Usage Patterns (million), 2016-2023 84
  • Figure 38: Asthma Therapeutics Market, Japan, Annual Cost of Therapy ($), 2016-2023 85
  • Figure 39: Asthma Therapeutics Market, Japan, Market Size ($m), 2016-2023 86
  • Figure 40: Asthma Therapeutics Market, Global, Licensing Deals by Region and Value, 2006-2016 91
  • Figure 41: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2016 92
  • Figure 42: Asthma Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2016 93
  • Figure 43: Asthma Therapeutics Market, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2016 94
  • Figure 44: Asthma Therapeutics Market, Global, Licensing Deals by Molecular Target, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006-2016 95
  • Figure 45: Asthma Therapeutics Market, Global, Co-development Deals by Region, 2006-2016 99
  • Figure 46: Asthma Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006-2016 100
  • Figure 47: Asthma Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2016 101
  • Figure 48: Asthma Therapeutics Market, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006-2016 102
  • Figure 49: Asthma Therapeutics Market, Global, Co-development Deals by Molecular Target, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006-2016 103
  • 1.1 List of Tables
  • Table 1: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children Aged 0-4 15
  • Table 2: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Children Aged 5-11 16
  • Table 3: Asthma Therapeutics Market, Global, Classification of Asthma Severity in Those Aged 12 and over 16
  • Table 4: Asthma Therapeutics Market, Global, Classification of Asthma Severity According to GINA Guidelines (2002) 17
  • Table 5: Asthma Therapeutics, Global, Management of Chronic Asthma in Adults and Children Older than Five 19
  • Table 6: Asthma Diagnosis, Global, Symptoms and Management of Acute Asthma 20
  • Table 7: Asthma Trials, Global,Clinical Trial Endpoints 21
  • Table 8: Asthma Therapeutics Market, Global, Licensing Deals Valued Above $10m, 2006-2016 97
  • Table 9: Asthma Therapeutics Market, Global, Co-development Deals Valued Above $10m, 2006-2016 105
  • Table 10: Asthma Therapeutics Market, Global, All Pipeline Products, Discovery, 2016 106
  • Table 11: Asthma Therapeutics Market, Global, All Pipeline Products, Preclinical, 2016 108
  • Table 12: Asthma Therapeutics, Global, All Pipeline Products, IND/CTA-Filed, 2016 113
  • Table 13: Asthma Therapeutics Market, Global, All Pipeline Products, Phase I, 2016 114
  • Table 14: Asthma Therapeutics Market, Global, All Pipeline Products, Phase II, 2016 116
  • Table 15: Asthma Therapeutics Market, Global, All Pipeline Products, Phase III, 2016 118
  • Table 16: Asthma Therapeutics Market, Global, All Pipeline Products, Pre-registration, 2016 119
  • Table 17: Asthma Therapeutics Market, Asia-Pacific, Market Forecast, 2016-2023 119
  • Table 18: Asthma Therapeutics Market, China, Market Forecast, 2016-2023 119
  • Table 19: Asthma Therapeutics Market, India, Market Forecast, 2016-2023 120
  • Table 20: Asthma Therapeutics Market, Australia, Market Forecast, 2016-2023 120
  • Table 21: Asthma Therapeutics Market, South Korea, Market Forecast, 2016-2023 121
  • Table 22: Asthma Therapeutics Market, Japan, Market Forecast, 2016-2023 121
  • 1 Table of Contents
  • 1 Table of Contents 5
  • 1.1 List of Tables 8
  • 1.2 List of Figures 8
  • 2 Introduction 10
  • 2.1 Disease Introduction 10
  • 2.2 Epidemiology 10
  • 2.3 Symptoms 11
  • 2.4 Etiology and Pathophysiology 11
  • 2.4.1 Pathophysiology 12
  • 2.5 Diagnosis 14
  • 2.6 Disease Stages 15
  • 2.7 Prognosis 17
  • 2.8 Treatment Guidelines and Options 18
  • 2.8.1 Treatment Algorithm 18
  • 2.8.2 Pharmacological Treatments 21
  • 2.8.3 Non-Pharmacological Treatments 25
  • 3 Marketed Products 27
  • 3.1 Overview 27
  • 3.2 ICS for the Maintenance Treatment of Asthma 27
  • 3.2.1 Arnuity (fluticasone furoate) - GlaxoSmithKline 27
  • 3.3 ICS-LABA Combination Therapy for the Maintenance Treatment of Asthma 28
  • 3.3.1 Seretide/Adoair (fluticasone propionate and salmeterol xinafoate) - GlaxoSmithKline 28
  • 3.3.2 Symbicort (budesonide and formoterol fumarate) - AstraZeneca, Co-promotion with Astellas Pharma 29
  • 3.3.3 Relvar/Breo (vilanterol trifenatate and fluticasone furoate) - GlaxoSmithKline 30
  • 3.3.4 Flutiform (fluticasone propionate and formoterol fumarate) - SkyePharma 31
  • 3.4 Add-on Therapy to ICS or ICS-LABA Therapies for the Maintenance Treatment of Asthma 31
  • 3.4.1 Xolair (omalizumab) - Novartis and Genentech 31
  • 3.4.2 Montelukast Sodium - Merck & Co 33
  • 3.4.3 Spiriva (tiotropium bromide) - Boehringer Ingelheim 34
  • 3.4.4 Nucala (mepolizumab) - GlaxoSmithKline 35
  • 3.5 Comparative Efficacy and Safety of Marketed Products 36
  • 4 Pipeline Analysis 39
  • 4.1 Overview 39
  • 4.2 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 39
  • 4.3 Pipeline by Molecular Target 41
  • 4.4 Promising Pipeline Molecules 45
  • 4.4.1 Reslizumab - Teva Pharmaceutical 45
  • 4.4.2 Dupilumab - Regeneron/Sanofi 47
  • 4.4.3 Tralokinumab - AstraZeneca 49
  • 4.4.4 Benralizumab - AstraZeneca 51
  • 4.4.5 Fevipiprant - Novartis 53
  • 4.5 Comparative Efficacy and Safety of Pipeline Products 54
  • 4.6 Product Competitiveness Framework 56
  • 5 Clinical Trial Analysis 58
  • 5.1 Failure Rate 58
  • 5.1.1 Overall Failure Rate 58
  • 5.1.2 Failure Rate by Phase and Molecule Type 60
  • 5.1.3 Failure Rate by Phase and Molecular Target 61
  • 5.2 Clinical Trial Duration 61
  • 5.2.1 Clinical Trial Duration by Molecule Type 61
  • 5.2.2 Clinical Trial Duration by Molecular Target 62
  • 5.3 Clinical Trial Size 63
  • 5.3.1 Patient Enrollment per Trial by Molecule Type, Molecular Target and Stage of Development 64
  • 5.3.2 Patient Enrollment per Product by Molecule Type, Molecular Target and Stage of Development 65
  • 5.4 Summary of Clinical Trial Metrics 67
  • 6 Multi-Scenario Forecast 69
  • 6.1 Geographical Markets 69
  • 6.2 Asia-Pacific Market 70
  • 6.3 India 72
  • 6.3.1 Treatment Usage Patterns 72
  • 6.3.2 Annual Cost of Therapy 73
  • 6.3.3 Market Size 73
  • 6.4 China 74
  • 6.4.1 Treatment Usage Patterns 74
  • 6.4.2 Annual Cost of Therapy 75
  • 6.4.3 Market Size 76
  • 6.5 Australia 77
  • 6.5.1 Treatment Usage Patterns 77
  • 6.5.2 Annual Cost of Therapy 78
  • 6.5.3 Market Size 79
  • 6.6 South Korea 80
  • 6.6.1 Treatment Usage Patterns 80
  • 6.6.2 Annual Cost of Therapy 81
  • 6.6.3 Market Size 82
  • 6.7 Japan 83
  • 6.7.1 Treatment Usage Patterns 83
  • 6.7.2 Annual Cost of Therapy 84
  • 6.7.3 Market Size 85
  • 7 Drivers and Barriers 87
  • 7.1 Drivers 87
  • 7.1.1 Rising Aging Population and Asthma Risk Factors 87
  • 7.1.2 Promising Product Pipeline and Launch of First-in-Class Molecules 87
  • 7.1.3 New Costly Market Entries 87
  • 7.1.4 Diversified Healthcare Reform to Boost Market Growth 88
  • 7.2 Barriers 88
  • 7.2.1 Sales Erosion by Generics 88
  • 7.2.2 Competition from Traditional Medicines 88
  • 7.2.3 Treatment Regimen Adherence 88
  • 7.2.4 Limited Understanding of Underlying Causes 88
  • 7.2.5 Lack of Awareness and Affordability of High-Cost Biological Products 89
  • 8 Deals and Strategic Consolidations 90
  • 8.1 Licensing Deals 90
  • 8.1.1 Deals by Region and Value 90
  • 8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 91
  • 8.1.3 Deal Value by Stage of Development, Molecule Type and Molecular Target 92
  • 8.1.4 Key Licensing Deals 95
  • 8.2 Co-development 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 101
  • 8.2.4 Key Co-development Deals 103
  • 9 Appendix 106
  • 9.1 All Pipeline Drugs by Phase of Development 106
  • 9.1.1 Discovery 106
  • 9.1.2 Preclinical 108
  • 9.1.3 Investigational New Drug/ Clinical Trial Authorization-Filed 113
  • 9.1.4 Phase I 114
  • 9.1.5 Phase II 116
  • 9.1.6 Phase III 118
  • 9.1.7 Pre-registration 119
  • 9.2 Summary of Multi-Scenario Market Forecasts to 2023 119
  • 9.2.1 Asia-Pacific 119
  • 9.2.2 China 119
  • 9.2.3 India 120
  • 9.2.4 Australia 120
  • 9.2.5 South Korea 121
  • 9.2.6 Japan 121
  • 9.3 References 122
  • 9.4 Abbreviations 128
  • 9.5 Research Methodology 130
  • 9.5.1 Secondary Research 131
  • 9.5.2 Marketed Product Profiles 131
  • 9.5.3 Late-Stage Pipeline Candidates 131
  • 9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 131
  • 9.5.5 Product Competitiveness Framework 132
  • 9.5.6 Pipeline Analysis 132
  • 9.5.7 Forecasting Model 133
  • 9.5.8 Deals Data Analysis 134
  • 9.6 Contact Us 134
  • 9.7 Disclaimer 134

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