PharmaPoint: Major Depressive Disorder - 5EU 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.

The value of the depression market in France is expected to fall following patent expiries for Lundbeck’s Lexapro in 2014, Eli Lilly’s Cymbalta in 2014, Otsuka Pharmaceutical/BMS’s Abilify in 2014, and AstraZeneca’s Seroquel XR in 2017. GlobalData estimates the drug sales for MDD in Germany were approximately $236.7m in 2013. GlobalData expects Eli Lilly’s Cymbalta and Lundbeck’s Brintellix to be the top-selling products by the end of the forecast period in Italy. GlobalData anticipates seven products in the late-stage pipeline to enter the MDD market in Spain during the forecast period: four adjunctive therapies, and three other antidepressant therapies. If physicians in the UK become convinced from experience in clinical practice that Brintellix offers improvements in cognitive function, Lundbeck will be able to differentiate Brintellix from other available SSRI and SNRI treatments and subsequently drive higher patient share.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU.

Table Of Contents

1 Table of Contents

2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 15
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 18
3.1.2 Pathophysiology 18
3.2 Classification 20
3.3 Symptoms and Subtypes of Major Depressive Disorder 22
3.4 Prognosis 23
3.5 Quality of Life 23
4 Disease Management 24
4.1 Diagnosis and Treatment Overview 24
4.1.1 Diagnosis 24
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 25
4.1.3 Clinical Practice 27
4.2 France 30
4.3 Germany 32
4.4 Italy 34
4.5 Spain 37
4.6 UK 39
5 Competitive Assessment 41
5.1 Overview 41
5.2 Product Profiles: Major Brands, Selective Serotonin Reuptake Inhibitors 43
5.2.1 Lexapro (Escitalopram) 43
5.2.2 Other Selective Serotonin Reuptake Inhibitors 47
5.3 Product Profiles: Major Brands, Serotonin-Norepinephrine Reuptake Inhibitors 50
5.3.1 Effexor (Venlafaxine) 50
5.3.2 Cymbalta (Duloxetine) 54
5.3.3 Pristiq (Desvenlafaxine) 58
5.3.4 Savella (Milnacipran) 62
5.4 Product Profiles: Major Brands, Other Antidepressants 65
5.4.1 Norepinephrine-Dopamine Reuptake Inhibitors 65
5.4.2 Noradrenaline and Specific Serotonergic Antidepressants 68
5.4.3 Monoamine Oxidase Inhibitors 72
5.4.4 Tricyclic Antidepressants 74
5.4.5 Brintellix (Vortioxetine) 76
5.5 Product Profiles: Major Brands, Antipsychotics 82
5.5.1 Abilify (Aripiprazole) 82
5.5.2 Seroquel XR (Quetiapine) 86
5.6 Other Therapeutic Classes 90
6 Unmet Needs and Opportunities 91
6.1 Overview 91
6.2 More Effective Pharmacotherapies 92
6.2.1 Unmet Needs 92
6.2.2 Gap Analysis 93
6.2.3 Opportunities 94
6.3 More Favorable Side Effect Profiles 94
6.3.1 Unmet Needs 94
6.3.2 Gap Analysis 95
6.3.3 Opportunities 95
6.4 Rapid Onset of Antidepressant Effects 96
6.4.1 Unmet Needs 96
6.4.2 Gap Analysis 96
6.4.3 Opportunities 96
6.5 Personalized Treatment Approach 97
6.5.1 Unmet Needs 97
6.5.2 Gap Analysis 98
6.5.3 Opportunities 98
7 Pipeline Assessment 99
7.1 Overview 99
7.2 Promising Drugs in Clinical Development 99
7.2.1 Brexpiprazole (OPC-34712) 102
7.2.2 Cariprazine (RGH-188) 108
7.2.3 ALKS-5461 113
7.2.4 Amitifadine (EB-1010) 118
7.2.5 GLYX-13 123
7.2.6 Tedatioxetine (Lu AA24530) 127
7.2.7 ETS6103 131
7.3 Other Drugs in Development 135
8 Market Outlook 137
8.1 Global 137
8.1.1 Drivers and Barriers - Global Issues 137
8.2 France 140
8.2.1 Forecast 140
8.2.2 Key Events 143
8.2.3 Drivers and Barriers 143
8.3 Germany 145
8.3.1 Forecast 145
8.3.2 Key Events 149
8.3.3 Drivers and Barriers 149
8.4 Italy 151
8.4.1 Forecast 151
8.4.2 Key Events 155
8.4.3 Drivers and Barriers 155
8.5 Spain 157
8.5.1 Forecast 157
8.5.2 Key Events 161
8.5.3 Drivers and Barriers 161
8.6 UK 163
8.6.1 Forecast 163
8.6.2 Key Events 167
8.6.3 Drivers and Barriers 167
9 Appendix 170
9.1 Bibliography 170
9.2 Abbreviations 175
9.3 Methodology 179
9.4 Forecasting Methodology 179
9.4.1 Diagnosed MDD Patients 179
9.4.2 Percent of Drug-Treated Patients 179
9.4.3 Drugs Included in Each Therapeutic Class 180
9.4.4 Launch and Patent Expiry Dates 180
9.4.5 General Pricing Assumptions 181
9.4.6 Individual Drug Assumptions 182
9.4.7 Generic Erosion 186
9.4.8 Pricing of Pipeline Agents 186
9.5 Physicians and Specialists Included in this Study 188
9.6 About the Authors 190
9.6.1 Analyst 190
9.6.2 Therapy Area Directors 190
9.6.3 Global Head of Healthcare 191
9.7 About GlobalData 192
9.8 Disclaimer 192


1.1
List of Tables


Table 1: Classification and Criteria of Major Depressive Disorder (DSM-IV) and Major Depressive Episode (ICD-10) 21
Table 2: Subtypes of Major Depressive Disorder 22
Table 3: Severity of Depressive Episodes according to ICD-10 and DSM-IV Diagnostic Criteria 24
Table 4: Treatment Guidelines for Major Depressive Disorder 25
Table 5: Most Prescribed Drugs for MDD by Class in the 5EU, 2013 26
Table 6: Country Profile - France 32
Table 7: Country Profile - Germany 34
Table 8: Country Profile - Italy 36
Table 9: Country Profile - Spain 38
Table 10: Country Profile - UK 40
Table 11: Leading Treatments for MDD, 2013 42
Table 12: Product Profile - Lexapro 44
Table 13: Safety of Lexapro - Five Most Frequently Reported Adverse Events 46
Table 14: Lexapro SWOT Analysis, 2014 46
Table 15: Relative Frequency of Common Adverse Effects for Different SSRIs 50
Table 16: Product Profile - Effexor 52
Table 17: Effexor SWOT Analysis, 2014 54
Table 18: Product Profile - Cymbalta 56
Table 19: Cymbalta SWOT Analysis, 2023 58
Table 20: Product Profile - Pristiq 59
Table 21: Efficacy of Pristiq in short-term studies 60
Table 22: Pristiq SWOT Analysis, 2014 62
Table 23: Product Profile - Savella 63
Table 24: Savella SWOT Analysis, 2014 64
Table 25: Product Profile - Bupropion 66
Table 26: Safety of Bupropion - Five Most Frequently Reported Adverse Events 67
Table 27: Bupropion SWOT Analysis, 2014 68
Table 28: Product Profile - Mirtazapine 70
Table 29: Safety of Mirtazapine - Four Most Frequently Reported Adverse Events 71
Table 30: Mirtazapine SWOT Analysis, 2014 72
Table 31: MAOI SWOT Analysis, 2014 74
Table 32: TCAs SWOT Analysis, 2014 76
Table 33: Product Profile - Brintellix 78
Table 34: Efficacy of Brintellix in Six-Week to Eight-Week Clinical Trials 79
Table 35: Safety of Brintellix - Five Most Frequently Reported Adverse Events 81
Table 36: Brintellix SWOT Analysis, 2014 81
Table 37: Product Profile - Abilify 83
Table 38: Safety of Abilify - Five Most Frequently Reported Adverse Events 85
Table 39: Abilify SWOT Analysis, 2014 85
Table 40: Product Profile - Seroquel XR 87
Table 41: Efficacy of Seroquel XR as an Adjunctive Therapy to Antidepressants 88
Table 42: Safety of Seroquel XR- Five Most Frequently Reported Adverse Events 89
Table 43: Seroquel XR SWOT Analysis, 2014 89
Table 44: Summary of Minor Therapeutic Classes in MDD, 2013 90
Table 45: Unmet Needs and Opportunities in MDD 92
Table 46: Comparison of Therapeutic Classes in Development for MDD, 2013 101
Table 47: Product Profile - Brexpiprazole 104
Table 48: Safety of Brexpiprazole - Most Frequently Reported Adverse Events 106
Table 49: Brexpiprazole SWOT Analysis, 2014 108
Table 50: Product Profile - Cariprazine 110
Table 51: Cariprazine SWOT Analysis, 2014 113
Table 52: Product Profile - ALKS-5461 115
Table 53: ALKS-5461 SWOT Analysis, 2014 118
Table 54: Product Profile - Amitifadine 119
Table 55: Amitifadine SWOT Analysis, 2014 123
Table 56: Product Profile - GLYX-13 124
Table 57: GLYX-13 SWOT Analysis, 2014 127
Table 58: Product Profile - Tedatioxetine 129
Table 59: Tedatioxetine SWOT Analysis, 2014 131
Table 60: Product Profile - ETS6103 132
Table 61: ETS6103 SWOT Analysis, 2014 135
Table 62: Drugs in Development for MDD, 2014 136
Table 63: MDD Market - Drivers and Barriers, 2013-2023 137
Table 64: Sales Forecasts ($m) for MDD in France, 2013-2023 141
Table 65: Key Events Impacting Sales for MDD in France, 2013-2023 143
Table 66: MDD Market in France - Drivers and Barriers, 2013-2023 143
Table 67: Sales Forecasts ($m) for MDD in Germany, 2013-2023 147
Table 68: Key Events Impacting Sales for MDD in Germany, 2013-2023 149
Table 69: MDD Market in Germany - Drivers and Barriers, 2013-2023 149
Table 70: Sales Forecasts ($m) for MDD in Italy, 2013-2023 153
Table 71: Key Events Impacting Sales for MDD in Italy, 2013-2023 155
Table 72: MDD Market in Italy - Drivers and Barriers, 2013-2023 155
Table 73: Sales Forecasts ($m) for MDD in Spain, 2013-2023 159
Table 74: Key Events Impacting Sales for MDD in Spain, 2013-2023 161
Table 75: MDD Market in Spain - Drivers and Barriers, 2013-2023 161
Table 76: Sales Forecasts ($m) for MDD in the UK, 2013-2023 165
Table 77: Key Events Impacting Sales for MDD in the UK, 2013-2023 167
Table 78: MDD Market in the UK - Drivers and Barriers, 2013-2023 167
Table 79: Key Launch Dates 180
Table 80: Key Patent Expiries 181
Table 81: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 189

1.2
List of Figures

Figure 1: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons 20
Figure 2: Disease Management Model for Major Depressive Disorder 28
Figure 3: Major Depressive Disorder Treatment Algorithm 30
Figure 4: MDD - Phase IIb-III Pipeline, 2014 100
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013-2023 101
Figure 6: Clinical and Commercial Positioning of Brexpiprazole 107
Figure 7: Clinical and Commercial Positioning of Cariprazine 112
Figure 8: Clinical and Commercial Positioning of ALKS-5461 117
Figure 9: Clinical and Commercial Positioning of Amitifadine 122
Figure 10: Clinical and Commercial Positioning of GLYX-13 126
Figure 11: Clinical and Commercial Positioning of Tedatioxetine 130
Figure 12: Clinical and Commercial Positioning of ETS6103 134
Figure 13: Sales for MDD in France by Drug Class, 2013-2023 142
Figure 14: Sales for MDD in Germany by Drug Class, 2013-2023 148
Figure 15: Sales for MDD in Italy by Drug Class, 2013-2023 154
Figure 16: Sales for MDD in Spain by Drug Class, 2013-2023 160
Figure 17: Sales for MDD in the UK by Drug Class, 2013-2023 166

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