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PharmaPoint: Asthma - Japan Drug Forecast and Market Analysis to 2023

Summary

Asthma accounts for approximately 250,000 deaths around the world annually, deaths that otherwise could be easily prevented through appropriate treatment The asthma market saw very slow growth over the past decade, as it has become saturated with relatively efficacious standard therapies, such as short-acting beta-agonists (SABAs), inhaled corticosteroids (ICSs), inhaled corticosteroids and long-acting beta-agonists (ICS/LABAs), and leukotriene modifiers, and has also been facing increasing generic competition. However, the launch of seven novel targeted biologic agents and once-daily ICS and ICS/LABA therapies delivered by the next-generation inhalers will strongly drive the market growth over the next 10 years. The biologic agents will not only reshape the market growth, but will also mark the beginning of a new era of a personalized approach to asthma treatment. The realization that asthma is a very heterogeneous disease is highly reflected in the rich assortment of these targeted therapies in the late-stage pipeline.

The 2013 base-year market sales of asthma products in Japan were $1.7 billion. A dip in sales caused by the Singulair patent expiry in 2013, as well as the patent expiry of the best-selling ICS/LABA FDCs, GSK’s Advair and AstraZeneca’s Symbicort, will be offset by eight pipeline product launches, seven of which are targeted biologics. Despite the fact that the target patient pool for these biologic therapies will be relatively limited, as they will target only specific subpopulations of severe asthmatics, they will fulfill some of the major unmet needs for the treatment of severe asthmatics who do not respond to conventional treatment with the ICS and ICS/LABA therapies.

Scope

- Overview of Asthma including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan Asthma market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Asthma.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2013-2023 in Japan.

Table Of Contents

PharmaPoint: Asthma - Japan Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 13
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 18
3.1.3 Prognosis 20
3.1.4 Quality of Life 20
3.2 Symptoms 21
4 Disease Management 22
4.1 Diagnosis and Treatment Overview 22
4.1.1 Diagnosis 22
4.1.2 Treatment Guidelines, Clinical Practice, and Leading Prescribed Drugs 23
4.1.3 Clinical Practice 24
4.2 Japan 28
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 32
5.3 Inhaled Corticosteroids 36
5.3.1 Flovent (fluticasone propionate) 36
5.3.2 Pulmicort (budenoside) 40
5.3.3 Other Inhaled Corticosteroids 44
5.4 Long-Acting Beta-Agonists 45
5.4.1 Overview 45
5.5 Inhaled Corticosteroids/Long-Acting Beta-Agonists 46
5.5.1 Advair (fluticasone propionate/salmeterol xinafoate) 46
5.5.2 Symbicort (budenoside/formoterol fumarate) 52
5.5.3 Breo Ellipta (fluticasone furoate/vilanterol trifenatate) 55
5.5.4 Flutiform (fluticasone propionate/formoterol fumarate) 59
5.6 Leukotriene Modifiers 63
5.6.1 Singulair (montelukast) 63
5.6.2 Other Leukotriene Modifiers 67
5.7 Short-Acting Beta-Agonists 68
5.7.1 Overview 68
5.7.2 Efficacy 69
5.7.3 Safety 70
5.8 Targeted Therapies 71
5.8.1 Xolair (omalizumab) 71
5.9 Anticholinergics 74
5.9.1 Spiriva (tiotropium bromide) 74
6 Unmet Need and Opportunity 79
6.1 Overview 79
6.2 Personalized Therapies to Control Severe Asthma 80
6.2.1 Unmet Need 80
6.2.2 Gap Analysis 81
6.2.3 Opportunity 81
6.3 Better Patient Compliance 81
6.3.1 Unmet Need 81
6.3.2 Gap Analysis 82
6.3.3 Opportunity 83
6.4 Lower Cost of Asthma Medications 83
6.4.1 Unmet Need 83
6.4.2 Gap Analysis 84
6.4.3 Opportunity 84
6.5 Proper Diagnosis of Asthma in Children 84
6.5.1 Unmet Need 84
6.5.2 Gap Analysis 85
6.5.3 Opportunity 85
7 Pipeline Assessment 86
7.1 Overview 86
7.2 Promising Drugs in Clinical Development 88
7.2.1 Fluticasone furoate 89
7.2.2 Cinquil (reslizumab) 93
7.2.3 Bosatria (mepolizumab) 98
7.2.4 Lebrikizumab 103
7.2.5 Benralizumab 108
7.2.6 Dupilumab 113
7.2.7 Quilizumab 118
7.2.8 Tralokinumab 122
8 Market Outlook 127
8.1 Japan 127
8.1.1 Forecast 127
8.1.2 Key Events 132
8.1.3 Drivers and Barriers - Global Issues 132
8.1.4 Drivers and Barriers 135
9 Appendix 137
9.1 Bibliography 137
9.2 Abbreviations 147
9.3 Methodology 151
9.4 Forecasting Methodology 151
9.4.1 Diagnosed Asthma Patients 151
9.4.2 Percent Drug-Treated Patients 152
9.4.3 Drugs Included in Each Therapeutic Class 152
9.4.4 Key Launch and Patent Expiry Dates 153
9.4.5 General Pricing Assumptions 153
9.4.6 Individual Drug Assumptions 154
9.4.7 Generic Erosion 158
9.4.8 Pricing of Pipeline Agents 158
9.5 Physicians and Specialists Included in This Study 160
9.6 About the Authors 163
9.6.1 Author 163
9.6.2 Author/Reviewer 163
9.6.3 Reviewer 164
9.6.4 Global Head of Healthcare 165
9.7 About GlobalData 166
9.8 Disclaimer 166

1.1 List of Tables

Table 1: Symptoms of Asthma 21
Table 2: Treatment Guidelines for Asthma by Country 23
Table 3: Most Prescribed Drugs for Asthma by Class and Disease Severity in the Global Markets, 2013 23
Table 4: Dosing of Common ICSs for Adult Asthma Therapy to Achieve Equivalent Therapeutic Potency 25
Table 5: Recommended Low Daily Dose of ICSs in Children with Asthma Under Five Years of Age 28
Table 6: Country Profile, Asthma Management - Japan 29
Table 7: Leading Treatments for Asthma, 2014 35
Table 8: Product Profile - Flovent 37
Table 9: Efficacy - Flovent Diskus Versus Placebo 38
Table 10: Adverse Events Related to Flovent Diskus 39
Table 11: Flovent SWOT Analysis, 2014 39
Table 12: Product Profile - Pulmicort 41
Table 13: Pulmicort-Associated Adverse Events 43
Table 14: Pulmicort SWOT Analysis, 2014 44
Table 15: Summary of Other Marketed ICSs for Asthma Treatment, 2014 45
Table 16: Product Profile - Advair 49
Table 17: Efficacy - Advair Diskus Versus Its Individual Components 50
Table 18: Advair, Frequency of Drug-Related Adverse Events 50
Table 19: Advair SWOT Analysis, 2014 51
Table 20: Product Profile - Symbicort 53
Table 21: Efficacy - Symbicort Versus Its Individual Components 54
Table 22: Symbicort, Frequency of Drug-Related Adverse Events 54
Table 23: Symbicort SWOT Analysis, 2014 55
Table 24: Product Profile - Breo Ellipta 57
Table 25: Efficacy - Breo Ellipta Versus Flovent 58
Table 26: Safety - Breo Ellipta Versus Flovent 58
Table 27: Breo Ellipta SWOT Analysis, 2014 59
Table 28: Product Profile - Flutiform 61
Table 29: Efficacy - Flutiform Versus Advair 62
Table 30: Safety - Flutiform Versus Advair 62
Table 31: Flutiform SWOT Analysis, 2014 63
Table 32: Product Profile - Singulair 65
Table 33: Efficacy - Singulair+Pulmicort Versus Double-Dose of Pulmicort 66
Table 34: Safety of Singulair+Pulmicort Compared With a Double Dose of Pulmicort 66
Table 35: Singulair SWOT Analysis, 2014 67
Table 36: Overview of the Leading SABAs for Asthma Treatment, 2014 69
Table 37: Efficacy - Nebulized Levalbuterol Versus Nebulized Albuterol 70
Table 38: Adverse Events Related to Nebulized Levalbuterol and Nebulized Albuterol 70
Table 39: Product Profile - Xolair 72
Table 40: Efficacy - Xolair Versus Placebo 73
Table 41: Xolair SWOT Analysis, 2014 74
Table 42: Product Profile - Spiriva 76
Table 43: Efficacy - Spiriva's Versus LABA and Double-Dose ICS 77
Table 44: Adverse Events Related to the Use of Spiriva 77
Table 45: Spiriva SWOT Analysis, 2014 78
Table 46: Unmet Need and Opportunity in Asthma 79
Table 47: Asthma - Late Stage Pipeline, 2014 88
Table 48: Product Profile - Fluticasone Furoate 90
Table 49: Fluticasone Fuorate Efficacy Versus Placebo and Fluticasone Propionate 91
Table 50: Fluticasone Furoate Safety Profile 91
Table 51: Fluticasone Furoate SWOT Analysis, 2014 93
Table 52: Product Profile - Cinquil 94
Table 53: Efficacy of Cinquil Versus Placebo 95
Table 54: Cinquil's Safety Profile 96
Table 55: Cinquil SWOT Analysis, 2014 98
Table 56: Product Profile - Bosatria 100
Table 57: Efficacy of Bosatria Versus Placebo 100
Table 58: Bosatria's Safety Profile 101
Table 59: Bosatria SWOT Analysis, 2012 103
Table 60: Product Profile - Lebrikizumab 105
Table 61: Efficacy of Lebrikizumab Versus Placebo 105
Table 62: Lebrikizumab Safety Profile 106
Table 63: Lebrikizumab SWOT Analysis, 2014 108
Table 64: Product Profile - Benralizumab 110
Table 65: Efficacy of Benralizumab Versus Placebo 111
Table 66: Benralizumab SWOT Analysis, 2014 113
Table 67: Product Profile - Dupilumab 115
Table 68: Efficacy of Dupilumab Versus Placebo 115
Table 69: Dupilumab's Safety Profile 116
Table 70: Dupilumab SWOT Analysis, 2014 118
Table 71: Product Profile - Quilizumab 119
Table 72: Efficacy of Quilizumab Versus Placebo 120
Table 73: Quilizumab SWOT Analysis, 2014 122
Table 74: Product Profile - Tralokinumab 123
Table 75: Efficacy of Tralokinumab Versus Placebo 124
Table 76: Tralokinumab's Safety Profile 124
Table 77: Tralokinumab SWOT Analysis, 2014 126
Table 78: Sales Forecast ($m) for Asthma in Japan, 2013-2023 129
Table 79: Key Events Impacting Sales for Asthma in Japan, 2013-2023 132
Table 80: Global Asthma Market - Drivers and Barriers, 2014 132
Table 81: Asthma Market - Drivers and Barriers in Japan, 2013-2023 135
Table 82: Key Launch Dates 153
Table 83: Key Patent Expiries 153
Table 84: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 162

1.2 List of Figures

Figure 1:Stepwise Disease Management Approach for Asthma in Adults 24
Figure 2: Stepwise Disease Management Approach for Asthma in Children Age Five and Younger 27
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Asthma, 2013-2023 89
Figure 4: Sales for Asthma in Japan by Drug Class, 2013-2023 131

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