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PharmaPoint: Asthma - US 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 for asthma pharmaceuticals in the US were around $10.1 billion. As in the global market, this growth will be fueled mainly by the uptake of the new branded biologic drugs. A dip in sales caused by the Singulair patent expiry in 2012, as well as the patent expiry of numerous SABA, ICS, and ICS/LABA products over the forecast period, will be offset by eight pipeline product launches, seven of which are targeted biologics.

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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 US.

Table Of Contents

PharmaPoint: Asthma - US 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 US 29
5 Competitive Assessment 31
5.1 Overview 31
5.2 Strategic Competitor Assessment 33
5.3 Inhaled Corticosteroids 37
5.3.1 Flovent (fluticasone propionate) 37
5.3.2 Pulmicort (Budesonide) 41
5.3.3 Other Inhaled Corticosteroids 45
5.4 Long-Acting Beta-Agonists 46
5.4.1 Overview 46
5.5 Inhaled Corticosteroids/Long-Acting Beta-Agonists 47
5.5.1 Advair (fluticasone propionate/salmeterol xinafoate) 47
5.5.2 Symbicort (Budesonide/formoterol fumarate) 52
5.5.3 Breo Ellipta (fluticasone furoate/vilanterol trifenatate) 56
5.5.4 Dulera (mometasone furoate/formoterol fumarate) 59
5.6 Leukotriene Modifiers 62
5.6.1 Singulair (montelukast) 62
5.6.2 Other Leukotriene Modifiers 66
5.7 Short-Acting Beta-Agonists 67
5.7.1 Overview 67
5.7.2 Efficacy 68
5.7.3 Safety 69
5.8 Targeted Therapies 70
5.8.1 Xolair (omalizumab) 70
5.9 Anticholinergics 73
5.9.1 Spiriva (tiotropium bromide) 73
6 Unmet Need and Opportunity 78
6.1 Overview 78
6.2 Personalized Therapies to Control Severe Asthma 79
6.2.1 Unmet Need 79
6.2.2 Gap Analysis 80
6.2.3 Opportunity 80
6.3 Better Patient Compliance 80
6.3.1 Unmet Need 80
6.3.2 Gap Analysis 81
6.3.3 Opportunity 82
6.4 Lower Cost of Asthma Medications 82
6.4.1 Unmet Need 82
6.4.2 Gap Analysis 83
6.4.3 Opportunity 83
6.5 Proper Diagnosis of Asthma in Children 83
6.5.1 Unmet Need 83
6.5.2 Gap Analysis 84
6.5.3 Opportunity 84
7 Pipeline Assessment 85
7.1 Overview 85
7.2 Promising Drugs in Clinical Development 87
7.2.1 Fluticasone furoate 88
7.2.2 Cinquil (reslizumab) 92
7.2.3 Bosatria (mepolizumab) 97
7.2.4 Lebrikizumab 102
7.2.5 Benralizumab 108
7.2.6 Dupilumab 112
7.2.7 Quilizumab 118
7.2.8 Tralokinumab 122
8 Market Outlook 127
8.1 United States 127
8.1.1 Forecast 127
8.1.2 Key Events 132
8.1.3 Drivers and Barriers - Global Issues 133
8.1.4 Drivers and Barriers 135
9 Appendix 138
9.1 Bibliography 138
9.2 Abbreviations 148
9.3 Methodology 152
9.4 Forecasting Methodology 152
9.4.1 Diagnosed Asthma Patients 152
9.4.2 Percent Drug-Treated Patients 153
9.4.3 Drugs Included in Each Therapeutic Class 153
9.4.4 Key Launch and Patent Expiry Dates 154
9.4.5 General Pricing Assumptions 154
9.4.6 Individual Drug Assumptions 155
9.4.7 Generic Erosion 160
9.4.8 Pricing of Pipeline Agents 161
9.5 Physicians and Specialists Included in This Study 162
9.6 About the Authors 165
9.6.1 Author 165
9.6.2 Author/Reviewer 165
9.6.3 Reviewer 166
9.6.4 Global Head of Healthcare 166
9.7 About GlobalData 167
9.8 Disclaimer 167

1.1 List of Tables

Table 1: Symptoms of Asthma 21
Table 2: Treatment Guidelines for Asthma 23
Table 3: Most Prescribed Drugs for Asthma by Class and Disease Severity in the US Markets, 2013 24
Table 4: Dosing of Common ICSs for Adult Asthma Therapy to Achieve Equivalent Therapeutic Potency 26
Table 5: Recommended Low Daily Dose of ICSs in Children with Asthma Under Five Years of Age 29
Table 6: Country Profile, Asthma Management - US 30
Table 7: Leading Treatments for Asthma, 2014 36
Table 8: Product Profile - Flovent 38
Table 9: Efficacy - Flovent Diskus Versus Placebo 39
Table 10: Adverse Events Related to Flovent Diskus 40
Table 11: Flovent SWOT Analysis, 2014 40
Table 12: Product Profile - Pulmicort 42
Table 13: Pulmicort-Associated Adverse Events 44
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 - Dulera 60
Table 29: Efficacy - Dulera Versus Its Individual Components 61
Table 30: Dulera - Frequency of Drug-Related Adverse Events 61
Table 31: Dulera SWOT Analysis, 2014 62
Table 32: Product Profile - Singulair 64
Table 33: Efficacy - Singulair+Pulmicort Versus Double-Dose of Pulmicort 65
Table 34: Safety of Singulair+Pulmicort Compared With a Double Dose of Pulmicort 65
Table 35: Singulair SWOT Analysis, 2014 66
Table 36: Overview of the Leading SABAs for Asthma Treatment, 2014 68
Table 37: Efficacy - Nebulized Levalbuterol Versus Nebulized Albuterol 69
Table 38: Adverse Events Related to Nebulized Levalbuterol and Nebulized Albuterol 69
Table 39: Product Profile - Xolair 71
Table 40: Efficacy - Xolair Versus Placebo 72
Table 41: Xolair SWOT Analysis, 2014 73
Table 42: Product Profile - Spiriva 75
Table 43: Efficacy - Spiriva's Versus LABA and Double-Dose ICS 76
Table 44: Adverse Events Related to the Use of Spiriva 76
Table 45: Spiriva SWOT Analysis, 2014 77
Table 46: Unmet Need and Opportunity in Asthma 78
Table 47: Asthma - Late Stage Pipeline, 2014 87
Table 48: Product Profile - Fluticasone Furoate 89
Table 49: Fluticasone Fuorate Efficacy Versus Placebo and Fluticasone Propionate 90
Table 50: Fluticasone Furoate Safety Profile 90
Table 51: Fluticasone Furoate SWOT Analysis, 2014 92
Table 52: Product Profile - Cinquil 93
Table 53: Efficacy of Cinquil Versus Placebo 94
Table 54: Cinquil's Safety Profile 95
Table 55: Cinquil SWOT Analysis, 2014 97
Table 56: Product Profile - Bosatria 99
Table 57: Efficacy of Bosatria Versus Placebo 99
Table 58: Bosatria's Safety Profile 100
Table 59: Bosatria SWOT Analysis, 2012 102
Table 60: Product Profile - Lebrikizumab 104
Table 61: Efficacy of Lebrikizumab Versus Placebo 105
Table 62: Lebrikizumab Safety Profile 105
Table 63: Lebrikizumab SWOT Analysis, 2014 107
Table 64: Product Profile - Benralizumab 109
Table 65: Efficacy of Benralizumab Versus Placebo 109
Table 66: Benralizumab SWOT Analysis, 2014 112
Table 67: Product Profile - Dupilumab 114
Table 68: Efficacy of Dupilumab Versus Placebo 115
Table 69: Dupilumab's Safety Profile 115
Table 70: Dupilumab SWOT Analysis, 2014 117
Table 71: Product Profile - Quilizumab 119
Table 72: Efficacy of Quilizumab Versus Placebo 119
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 the US 2013-2023 129
Table 79: Key Events Impacting Sales for Asthma in the US, 2013-2023 132
Table 80: Global Asthma Market - Drivers and Barriers, 2014 133
Table 81: Asthma Market - Drivers and Barriers in the US, 2013-2023 135
Table 82: Key Launch Dates 154
Table 83: Key Patent Expiries 154

1.2 List of Figures

Figure 1:Stepwise Disease Management Approach for Asthma in Adults 25
Figure 2: Stepwise Disease Management Approach for Asthma in Children Age Five and Younger 28
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Asthma, 2013-2023 88
Figure 4: Sales for Asthma in the US by Drug Class, 2013-2023 131

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