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PharmaPoint: Major Depressive Disorder - Australia Drug Forecast and Market Analysis to 2023

Summary

Major depressive disorder (MDD) is one of the most common psychiatric diseases worldwide. The MDD market is a crowded and competitive market, with more than 30 marketed products available for the treatment of patients with MDD. The depression market is about to enter a dynamic phase with imminent patent expiries for top selling products, such as Eli Lilly’s Cymbalta, and Otsuka/BMS’s Abilify, along with the recent launch of the multimodal antidepressant, Lundbeck/Takeda’s Brintellix, in January 2014, and the potential introduction of seven promising late-stage pipeline products into the market during the forecast period, from 2013 to 2023.

Despite patent expiries for key products, Eli Lilly’s Cymbalta in 2013, Otsuka Pharmaceutical/BMS’s Abilify in 2016, and AstraZeneca’s Seroquel XR in 2017, the MDD market value in Australia is not anticipated to decline, as generic products are priced similarly to branded products and any loss of market value due to potential price discounts is expected to be offset by the increasing prevalent cases of MDD, the launch of Brintellix and the potential introduction of late-stage pipeline products during the forecast period.

Scope

- Overview of Major depressive disorder 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 Australia including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Australia from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the Australia Major depressive disorder 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 Major depressive disorder.
- 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: Major Depressive Disorder - Australia Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 12
2.3 Upcoming Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 15
3.2 Classification 17
3.3 Symptoms and Subtypes of Major Depressive Disorder 19
3.4 Prognosis 20
3.5 Quality of Life 20
4 Disease Management 21
4.1 Diagnosis and Treatment Overview 21
4.1.1 Diagnosis 21
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 22
4.1.3 Clinical Practice 23
4.2 Australia 26
5 Competitive Assessment 29
5.1 Overview 29
5.2 Product Profiles: Major Brands, Selective Serotonin Reuptake Inhibitors 31
5.2.1 Lexapro (Escitalopram) 31
5.2.2 Other Selective Serotonin Reuptake Inhibitors 35
5.3 Product Profiles: Major Brands, Serotonin-Norepinephrine Reuptake Inhibitors 38
5.3.1 Effexor (Venlafaxine) 38
5.3.2 Cymbalta (Duloxetine) 42
5.3.3 Pristiq (Desvenlafaxine) 46
5.4 Product Profiles: Major Brands, Other Antidepressants 50
5.4.1 Norepinephrine-Dopamine Reuptake Inhibitors 50
5.4.2 Noradrenaline and Specific Serotonergic Antidepressants 54
5.4.3 Monoamine Oxidase Inhibitors 58
5.4.4 Tricyclic Antidepressants 60
5.4.5 Brintellix (Vortioxetine) 62
5.5 Product Profiles: Major Brands, Antipsychotics 68
5.5.1 Abilify (Aripiprazole) 68
5.5.2 Seroquel XR (Quetiapine) 72
5.6 Other Therapeutic Classes 76
6 Unmet Needs and Opportunities 77
6.1 Overview 77
6.2 More Effective Pharmacotherapies 78
6.2.1 Unmet Needs 78
6.2.2 Gap Analysis 79
6.2.3 Opportunities 80
6.3 More Favorable Side Effect Profiles 80
6.3.1 Unmet Needs 80
6.3.2 Gap Analysis 81
6.3.3 Opportunities 81
6.4 Rapid Onset of Antidepressant Effects 82
6.4.1 Unmet Needs 82
6.4.2 Gap Analysis 82
6.4.3 Opportunities 82
6.5 Personalized Treatment Approach 83
6.5.1 Unmet Needs 83
6.5.2 Gap Analysis 84
6.5.3 Opportunities 84
7 Pipeline Assessment 85
7.1 Overview 85
7.2 Promising Drugs in Clinical Development 85
7.2.1 Brexpiprazole (OPC-34712) 88
7.2.2 Cariprazine (RGH-188) 94
7.2.3 ALKS-5461 99
7.2.4 Amitifadine (EB-1010) 104
7.2.5 GLYX-13 109
7.2.6 Tedatioxetine (Lu AA24530) 113
7.2.7 ETS6103 117
7.3 Other Drugs in Development 122
8 Market Outlook 124
8.1 Australia 124
8.1.1 Forecast 124
8.1.2 Key Events 127
8.1.3 Drivers and Barriers - Global Issues 127
8.1.4 Drivers and Barriers 129
9 Appendix 132
9.1 Bibliography 132
9.2 Abbreviations 137
9.3 Methodology 141
9.4 Forecasting Methodology 141
9.4.1 Diagnosed MDD Patients 141
9.4.2 Percent of Drug-Treated Patients 141
9.4.3 Drugs Included in Each Therapeutic Class 142
9.4.4 Launch and Patent Expiry Dates 142
9.4.5 General Pricing Assumptions 143
9.4.6 Individual Drug Assumptions 144
9.4.7 Generic Erosion 147
9.4.8 Pricing of Pipeline Agents 148
9.5 Physicians and Specialists Included in this Study 149
9.6 About the Authors 151
9.6.1 Analyst 151
9.6.2 Therapy Area Directors 151
9.6.3 Global Head of Healthcare 152
9.7 About GlobalData 153
9.8 Disclaimer 153

1.1 List of Tables

Table 1: Classification and Criteria of Major Depressive Disorder (DSM-IV) and Major Depressive Episode (ICD-10) 18
Table 2: Subtypes of Major Depressive Disorder 19
Table 3: Severity of Depressive Episodes according to ICD-10 and DSM-IV Diagnostic Criteria 21
Table 4: Treatment Guidelines for Major Depressive Disorder 22
Table 5: Most Prescribed Drugs for MDD by Class in Australia, 2013 22
Table 6: Country Profile - Australia 28
Table 7: Leading Treatments for MDD, 2013 30
Table 8: Product Profile - Lexapro 32
Table 9: Safety of Lexapro - Five Most Frequently Reported Adverse Events 34
Table 10: Lexapro SWOT Analysis, 2014 34
Table 11: Relative Frequency of Common Adverse Effects for Different SSRIs 38
Table 12: Product Profile - Effexor 40
Table 13: Effexor SWOT Analysis, 2014 42
Table 14: Product Profile - Cymbalta 44
Table 15: Cymbalta SWOT Analysis, 2023 46
Table 16: Product Profile - Pristiq 47
Table 17: Efficacy of Pristiq in short-term studies 48
Table 18: Pristiq SWOT Analysis, 2014 50
Table 19: Product Profile - Bupropion 52
Table 20: Safety of Bupropion - Five Most Frequently Reported Adverse Events 53
Table 21: Bupropion SWOT Analysis, 2014 54
Table 22: Product Profile - Mirtazapine 56
Table 23: Safety of Mirtazapine - Four Most Frequently Reported Adverse Events 57
Table 24: Mirtazapine SWOT Analysis, 2014 58
Table 25: MAOI SWOT Analysis, 2014 60
Table 26: TCAs SWOT Analysis, 2014 62
Table 27: Product Profile - Brintellix 64
Table 28: Efficacy of Brintellix in Six-Week to Eight-Week Clinical Trials 65
Table 29: Safety of Brintellix - Five Most Frequently Reported Adverse Events 67
Table 30: Brintellix SWOT Analysis, 2014 67
Table 31: Product Profile - Abilify 69
Table 32: Safety of Abilify - Five Most Frequently Reported Adverse Events 71
Table 33: Abilify SWOT Analysis, 2014 71
Table 34: Product Profile - Seroquel XR 73
Table 35: Efficacy of Seroquel XR as an Adjunctive Therapy to Antidepressants 74
Table 36: Safety of Seroquel XR- Five Most Frequently Reported Adverse Events 75
Table 37: Seroquel XR SWOT Analysis, 2014 75
Table 38: Summary of Minor Therapeutic Classes in MDD, 2013 76
Table 39: Unmet Needs and Opportunities in MDD 78
Table 40: Comparison of Therapeutic Classes in Development for MDD, 2013 87
Table 41: Product Profile - Brexpiprazole 90
Table 42: Safety of Brexpiprazole - Most Frequently Reported Adverse Events 92
Table 43: Brexpiprazole SWOT Analysis, 2014 94
Table 44: Product Profile - Cariprazine 96
Table 45: Cariprazine SWOT Analysis, 2014 99
Table 46: Product Profile - ALKS-5461 101
Table 47: ALKS-5461 SWOT Analysis, 2014 104
Table 48: Product Profile - Amitifadine 106
Table 49: Amitifadine SWOT Analysis, 2014 109
Table 50: Product Profile - GLYX-13 110
Table 51: GLYX-13 SWOT Analysis, 2014 113
Table 52: Product Profile - Tedatioxetine 115
Table 53: Tedatioxetine SWOT Analysis, 2014 117
Table 54: Product Profile - ETS6103 119
Table 55: ETS6103 SWOT Analysis, 2014 122
Table 56: Drugs in Development for MDD, 2014 123
Table 57: Sales Forecasts ($m) for MDD in Australia, 2013-2023 125
Table 58: Key Events Impacting Sales for MDD in Australia, 2013-2023 127
Table 59: MDD Market - Drivers and Barriers, 2013-2023 127
Table 60: MDD Market in Australia - Drivers and Barriers, 2013-2023 129
Table 61: Key Launch Dates 142
Table 62: Key Patent Expiries 143
Table 63: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 15

1.2 List of Figures

Figure 1: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons 17
Figure 2: Disease Management Model for Major Depressive Disorder 24
Figure 3: Major Depressive Disorder Treatment Algorithm 26
Figure 4: MDD - Phase IIb-III Pipeline, 2014 86
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013-2023 87
Figure 6: Clinical and Commercial Positioning of Brexpiprazole 93
Figure 7: Clinical and Commercial Positioning of Cariprazine 98
Figure 8: Clinical and Commercial Positioning of ALKS-5461 103
Figure 9: Clinical and Commercial Positioning of Amitifadine 108
Figure 10: Clinical and Commercial Positioning of GLYX-13 112
Figure 11: Clinical and Commercial Positioning of Tedatioxetine 116
Figure 12: Clinical and Commercial Positioning of ETS6103 121
Figure 13: Sales for MDD in Australia by Drug Class, 2013-2023 126

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