Summary
Major depressive disorder (MDD) is one of the most common psychiatric diseases worldwide. It is characterized by single or recurrent major depressive episodes (MDEs), where patients can typically experience periods of depressed mood, loss of energy, abnormal cognition, anxiety and suicidal ideation. Similar to other neuropsychiatric disorders, MDD has a multifaceted and varied etiology, and remains poorly understood. The MDD market is crowded and competitive, with more than 30 products available for the treatment of patients, the majority of which are now available as inexpensive generics. The MDD market is therefore in a dynamic phase where patent expiries for historically top-selling products such as Eli Lilly’s Cymbalta and Otsuka/BMS’ Abilify have occurred, and recent launches of Lundbeck/Takeda’s Trintellix and Otsuka/Lundbeck’s Rexulti will be a significant driver of growth in the 7MM. Growth in the MDD market is also expected to be driven by the potential introduction of six promising late-stage pipeline products into the market during the forecast period, all of which are directed towards treatment-resistant patients, a significant unmet need.
The recent launch of Lundbeck/Takeda’s Trintellix (in 2014) will be the main driver of growth in these markets, as well as the release of four late-stage pipeline drugs during the forecast period. The pipeline drugs will expand the 5EU MDD market substantially from 2018 onwards. Increases in diagnosed prevalent cases of MDD will also drive market growth throughout the 5EU, driven by increased public awareness of depressive disorders, and an increase in the routine screening for depressive disorders.
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Scope
- Overview of MDD 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 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting 5EU MDD 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 MDD.
- 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 2015-2025 in 5EU.
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 10
2 Introduction 11
2.1 Related Reports 11
2.2 Upcoming Related Reports 12
3 Disease Overview 13
3.1 Etiology and Pathophysiology 13
3.1.1 Etiology 13
3.1.2 Pathophysiology 14
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 22
4.1.3 Clinical Practice 24
4.2 5EU 28
5 Competitive Assessment 32
5.1 Overview 32
5.2 Selective Serotonin Reuptake Inhibitors 34
5.2.1 Lexapro (Escitalopram) 34
5.2.2 Viibryd (Vilazodone) 42
5.2.3 Other Selective Serotonin Reuptake Inhibitors 46
5.3 Serotonin-Norepinephrine Reuptake Inhibitors 60
5.3.1 Cymbalta (Duloxetine) 60
5.3.2 Effexor (Venlafaxine) 68
5.3.3 Fetzima (Levomilnacipran) 75
5.3.4 Savella (Milnacipran) 81
5.3.5 Pristiq (Desvenlafaxine) 86
5.4 Multimodal Antidepressants 91
5.4.1 Trintellix (Vortioxetine) 91
5.5 Other Antidepressants 100
5.5.1 Bupropion 100
5.5.2 Symbyax (Olanzapine/Fluoxetine) 106
5.5.3 Mirtazapine 111
5.5.4 Monoamine Oxidase Inhibitors 116
5.5.5 Tricyclic Antidepressants 120
5.6 Antipsychotics 124
5.6.1 Abilify (Aripiprazole) 124
5.6.2 Seroquel XR (Quetiapine XR) 131
5.6.3 Rexulti (Brexpiprazole) 136
5.7 Other Therapeutic Classes 142
6 Unmet Need and Opportunity 143
6.1 Overview 143
6.2 New Therapies with Better Efficacy 145
6.2.1 Unmet Need 145
6.2.2 Gap Analysis 147
6.2.3 Opportunity 148
6.3 Improved Safety Profiles 149
6.3.1 Unmet Need 149
6.3.2 Gap Analysis 151
6.3.3 Opportunity 152
6.4 Rapid Onset of Action 154
6.4.1 Unmet Need 154
6.4.2 Gap Analysis 155
6.4.3 Opportunity 157
6.5 Personalized Treatment Approach 158
6.5.1 Unmet Need 158
6.5.2 Gap Analysis 159
6.5.3 Opportunity 160
6.6 Manage Patient Outcome Expectations 162
6.6.1 Unmet Need 162
6.6.2 Gap Analysis 164
6.6.3 Opportunity 165
7 Pipeline Assessment 167
7.1 Overview 167
7.2 Clinical Trial Mapping 167
7.2.1 Clinical Trials by Class of Therapy 167
7.3 Promising Drugs in Clinical Development 168
7.3.1 ALKS-5461 172
7.3.2 Vraylar (Cariprazine) 181
7.3.3 ASC-01 188
7.3.4 AXS-05 191
7.3.5 Esketamine 198
7.3.6 Rapastinel (GLYX-13) 206
7.3.7 Strada (MSI-195) 214
7.3.8 Viotra (Tramadol) 220
7.4 Promising Drugs in Early-Stage Development 227
7.4.1 CGP3466B 227
7.4.2 NSI-189 228
7.5 Other Drugs in Development 229
8 Market Outlook 231
8.1 5EU 231
8.1.1 Forecast 231
8.1.2 Key Events 236
8.1.3 Drivers and Barriers 237
9 Appendix 239
9.1 Bibliography 239
9.2 Abbreviations 285
9.3 Methodology 296
9.4 Forecasting Methodology 296
9.4.1 Diagnosed NSCLC Patients 296
9.4.2 Percent Drug-Treated Patients 297
9.4.3 Drugs Included in Each Therapeutic Class 297
9.4.4 Launch and Patent Expiry Dates 300
9.4.5 General Pricing Assumptions 302
9.4.6 Individual Drug Assumptions 304
9.4.7 Generic Erosion 318
9.4.8 Pricing of Pipeline Agents 318
9.5 Primary Research - KOLs 323
9.5.1 KOLs 323
9.6 About the Authors 327
9.6.1 Analyst 327
9.6.2 Therapy Area Director 327
9.6.3 Epidemiologist 328
9.6.4 Global Head of Healthcare 328
9.7 About GlobalData 330
9.8 Disclaimer 330
1.1 List of Tables
Table 1: Classification and Criteria of MDD (DSM-IV) and MDE (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 22
Table 4: Treatment Guidelines for Major Depressive Disorder 23
Table 5: Most-Prescribed Drugs for MDD by Class in the 7MM, 2015 24
Table 6: Country Profile - 5EU 31
Table 7: Leading Treatments for MDD, 2016 34
Table 8: Product Profile - Lexapro 38
Table 9: Lexapro/Cipralex SWOT Analysis, 2016 41
Table 10: Product Profile - Viibryd 44
Table 11: Summary of Efficacy Results for the Primary Endpoint in Viibryd Clinical Trials 45
Table 12: Viibryd SWOT Analysis, 2016 46
Table 13: Summary of SSRIs, 2016 50
Table 14: SSRIs SWOT Analysis, 2016 60
Table 15: Product Profile - Cymbalta 65
Table 16: Cymbalta SWOT Analysis, 2016 67
Table 17: Product Profile - Effexor 72
Table 18: Effexor SWOT Analysis, 2016 74
Table 19: Product Profile - Fetzima 78
Table 20: Fetzima SWOT Analysis, 2016 80
Table 21: Product Profile - Savella 83
Table 22: Savella SWOT Analysis, 2016 85
Table 23: Product Profile - Pristiq 88
Table 24: Pristiq SWOT Analysis, 2016 90
Table 25: Product Profile - Trintellix 97
Table 26: Trintellix SWOT Analysis, 2016 99
Table 27: Product Profile - Bupropion 103
Table 28: Bupropion SWOT Analysis, 2016 105
Table 29: Product Profile - Symbyax 108
Table 30: Symbyax SWOT Analysis, 2016 110
Table 31: Product Profile - Mirtazapine 114
Table 32: Mirtazapine SWOT Analysis, 2016 116
Table 33: MAOIs SWOT Analysis, 2016 120
Table 34: TCAs SWOT Analysis, 2016 124
Table 35: Product Profile - Abilify 128
Table 36: Abilify SWOT Analysis, 2016 130
Table 37: Product Profile - Seroquel XR 133
Table 38: Seroquel XR SWOT Analysis, 2016 135
Table 39: Product Profile - Rexulti 139
Table 40: Rexulti SWOT Analysis, 2016 141
Table 41: Summary of Minor Therapeutic Classes in MDD, 2016 142
Table 42: Unmet Needs and Opportunities in MDD 144
Table 43: Promising Drugs in Clinical Development for MDD, 2016 169
Table 44: Comparison of Drugs in Development for MDD, 2016 171
Table 45: Product Profile - ALKS-5461 176
Table 46: SWOT Analysis - ALKS-5461, 2016 180
Table 47: Product Profile - Vraylar 184
Table 48: SWOT Analysis - Vraylar, 2016 187
Table 49: Product Profile - ASC-01 189
Table 50: SWOT Analysis - ASC-01, 2016 191
Table 51: Product Profile - AXS-05 195
Table 52: SWOT Analysis - AXS-05, 2016 197
Table 53: Product Profile - Esketamine 202
Table 54: SWOT Analysis - Esketamine, 2016 205
Table 55: Product Profile - Rapastinel 210
Table 56: SWOT Analysis - Rapastinel, 2016 213
Table 57: Product Profile - Strada 218
Table 58: SWOT Analysis - Strada, 2016 220
Table 59: Product Profile - Viotra 223
Table 60: SWOT Analysis - Viotra, 2015 226
Table 61: Drugs in Development, 2016 230
Table 62: Key Events Impacting Sales for MDD Therapies in the 5EU, 2015-2025 236
Table 63: MDD Market - Drivers and Barriers in the 5EU, 2015-2025 237
Table 64: National Healthcare Authorities and Governmental Drug Pricing Authorities in the 5EU 238
Table 65: Key Launch Dates - Part I 300
Table 66: Key Launch Dates - Part II 301
Table 67: Key Patent Expiries 302
Table 68 Average Body Weight and Surface Area Across the 8MM 303
Table 69: Average Cost of Therapy of Alimta in the 8MM 305
Table 70: Average Cost of Therapy of Alecensa in the 8MM 306
Table 71: Average Cost of Therapy of Avastin 307
Table 72: Average Cost of Therapy of Cyramza 307
Table 73: Average Cost of Therapy of Gilotrif 308
Table 74: Average Cost of Therapy of Iressa 309
Table 75: Average Cost of Therapy of Portrazza 310
Table 76: Average Cost of Therapy of Tagrisso 311
Table 77: Average Cost of Therapy of Tarceva 312
Table 78: Average Cost of Therapy of Vargatef 312
Table 79: Average Cost of Therapy of Xalkori 313
Table 80: Average Cost of Therapy of Zykadia 314
Table 81: Average Cost of Therapy of Keytruda 315
Table 82: Average Cost of Therapy of Opdivo 316
Table 83: Average Cost of Therapy of Tecentriq 317
Table 84: Average Cost of Therapy of Conmana 318
Table 85: High-Prescribing Physicians Surveyed by Country 326
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 25
Figure 3: Major Depressive Disorder Treatment Algorithm 27
Figure 4: MDD Therapeutics - Phase II and III Clinical Trials in the 7MM, 2016 168
Figure 5: MDD Phase II/Phase III Pipeline, 2016 170
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2015-2025 172
Figure 7: Clinical and Commercial Positioning of ALKS-5461 179
Figure 8: Clinical and Commercial Positioning of Vraylar 186
Figure 9: Clinical and Commercial Positioning of ASC-01 190
Figure 10: Clinical and Commercial Positioning of AXS-05 196
Figure 11: Clinical and Commercial Positioning of Esketamine 204
Figure 12: Clinical and Commercial Positioning of Rapastinel 212
Figure 13: Clinical and Commercial Positioning of Strada 219
Figure 14: Clinical and Commercial Positioning of Viotra 225
Figure 15: 5EU Sales by Drug Class for MDD Therapies, 2015 and 2025 233
Figure 16: 5EU Sales by Drug Class for MDD Therapies, 2015-2025 234
Figure 17: 5EU Sales by Region for MDD Therapies, 2015 and 2025 235
