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PharmaPoint: Asthma - Australia 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 Australia were $322m. 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 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.

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

Table Of Contents

PharmaPoint: Asthma - Australia 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 Australia 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 (budenoside) 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 (budenoside/formoterol fumarate) 52
5.5.3 Breo Ellipta (fluticasone furoate/vilanterol trifenatate) 56
5.5.4 Dulera (mometasone furoate/formoterol fumarate) 59
5.5.5 Flutiform (fluticasone propionate/formoterol fumarate) 62
5.6 Leukotriene Modifiers 66
5.6.1 Singulair (montelukast) 66
5.6.2 Other Leukotriene Modifiers 70
5.7 Short-Acting Beta-Agonists 71
5.7.1 Overview 71
5.7.2 Efficacy 72
5.7.3 Safety 73
5.8 Targeted Therapies 74
5.8.1 Xolair (omalizumab) 74
5.9 Anticholinergics 77
5.9.1 Spiriva (tiotropium bromide) 77
6 Unmet Need and Opportunity 82
6.1 Overview 82
6.2 Personalized Therapies to Control Severe Asthma 83
6.2.1 Unmet Need 83
6.2.2 Gap Analysis 84
6.2.3 Opportunity 84
6.3 Better Patient Compliance 84
6.3.1 Unmet Need 84
6.3.2 Gap Analysis 85
6.3.3 Opportunity 86
6.4 Lower Cost of Asthma Medications 86
6.4.1 Unmet Need 86
6.4.2 Gap Analysis 87
6.4.3 Opportunity 87
6.5 Proper Diagnosis of Asthma in Children 87
6.5.1 Unmet Need 87
6.5.2 Gap Analysis 88
6.5.3 Opportunity 88
7 Pipeline Assessment 89
7.1 Overview 89
7.2 Promising Drugs in Clinical Development 91
7.2.1 Fluticasone furoate 92
7.2.2 Cinquil (reslizumab) 96
7.2.3 Bosatria (mepolizumab) 101
7.2.4 Lebrikizumab 106
7.2.5 Benralizumab 111
7.2.6 Dupilumab 116
7.2.7 Quilizumab 122
7.2.8 Tralokinumab 126
8 Market Outlook 131
8.1 Australia 131
8.1.1 Forecast 131
8.1.2 Key Events 136
8.1.3 Drivers and Barriers - Global Issues 136
8.1.4 Drivers and Barriers 139
9 Appendix 141
9.1 Bibliography 141
9.2 Abbreviations 164
9.3 Methodology 168
9.4 Forecasting Methodology 168
9.4.1 Diagnosed Asthma Patients 168
9.4.2 Percent Drug-Treated Patients 169
9.4.3 Drugs Included in Each Therapeutic Class 169
9.4.4 Key Launch and Patent Expiry Dates 170
9.4.5 General Pricing Assumptions 170
9.4.6 Individual Drug Assumptions 171
9.4.7 Generic Erosion 175
9.4.8 Pricing of Pipeline Agents 176
9.5 Physicians and Specialists Included in This Study 177
9.6 About the Authors 180
9.6.1 Author 180
9.6.2 Author/Reviewer 180
9.6.3 Reviewer 181
9.6.4 Global Head of Healthcare 181
9.7 About GlobalData 182
9.8 Disclaimer 182

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 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 28
Table 6: Country Profile, Asthma Management - Australia 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 - Flutiform 64
Table 33: Efficacy - Flutiform Versus Advair 65
Table 34: Safety - Flutiform Versus Advair 65
Table 35: Flutiform SWOT Analysis, 2014 66
Table 36: Product Profile - Singulair 68
Table 37: Efficacy - Singulair+Pulmicort Versus Double-Dose of Pulmicort 69
Table 38: Safety of Singulair+Pulmicort Compared With a Double Dose of Pulmicort 69
Table 39: Singulair SWOT Analysis, 2014 70
Table 40: Overview of the Leading SABAs for Asthma Treatment, 2014 72
Table 41: Efficacy - Nebulized Levalbuterol Versus Nebulized Albuterol 73
Table 42: Adverse Events Related to Nebulized Levalbuterol and Nebulized Albuterol 73
Table 43: Product Profile - Xolair 75
Table 44: Efficacy - Xolair Versus Placebo 76
Table 45: Xolair SWOT Analysis, 2014 77
Table 46: Product Profile - Spiriva 79
Table 47: Efficacy - Spiriva's Versus LABA and Double-Dose ICS 80
Table 48: Adverse Events Related to the Use of Spiriva 80
Table 49: Spiriva SWOT Analysis, 2014 81
Table 50: Unmet Need and Opportunity in Asthma 82
Table 51: Asthma - Late Stage Pipeline, 2014 91
Table 52: Product Profile - Fluticasone Furoate 93
Table 53: Fluticasone Fuorate Efficacy Versus Placebo and Fluticasone Propionate 94
Table 54: Fluticasone Furoate Safety Profile 94
Table 55: Fluticasone Furoate SWOT Analysis, 2014 96
Table 56: Product Profile - Cinquil 98
Table 57: Efficacy of Cinquil Versus Placebo 98
Table 58: Cinquil's Safety Profile 99
Table 59: Cinquil SWOT Analysis, 2014 101
Table 60: Product Profile - Bosatria 103
Table 61: Efficacy of Bosatria Versus Placebo 103
Table 62: Bosatria's Safety Profile 104
Table 63: Bosatria SWOT Analysis, 2012 106
Table 64: Product Profile - Lebrikizumab 108
Table 65: Efficacy of Lebrikizumab Versus Placebo 108
Table 66: Lebrikizumab Safety Profile 109
Table 67: Lebrikizumab SWOT Analysis, 2014 111
Table 68: Product Profile - Benralizumab 113
Table 69: Efficacy of Benralizumab Versus Placebo 114
Table 70: Benralizumab SWOT Analysis, 2014 116
Table 71: Product Profile - Dupilumab 118
Table 72: Efficacy of Dupilumab Versus Placebo 119
Table 73: Dupilumab's Safety Profile 119
Table 74: Dupilumab SWOT Analysis, 2014 121
Table 75: Product Profile - Quilizumab 123
Table 76: Efficacy of Quilizumab Versus Placebo 123
Table 77: Quilizumab SWOT Analysis, 2014 126
Table 78: Product Profile - Tralokinumab 127
Table 79: Efficacy of Tralokinumab Versus Placebo 128
Table 80: Tralokinumab's Safety Profile 128
Table 81: Tralokinumab SWOT Analysis, 2014 130
Table 82: Sales Forecast ($m) for Asthma in Australia, 2013-2023 133
Table 83: Key Events Impacting Sales for Asthma in Australia, 2013-2023 136
Table 84: Global Asthma Market - Drivers and Barriers, 2014 136
Table 85: Asthma Market - Drivers and Barriers in Australia, 2013-2023 139
Table 86: Key Launch Dates 170
Table 87: Key Patent Expiries 170
Table 88: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 179

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 27
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Asthma, 2013-2023 92
Figure 4: Sales for Asthma in Australia by Drug Class, 2013-2023 135

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