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.
GlobalData estimates that the MDD market will undergo a period of steady growth from 2015 to 2025, mainly attributed to the growth in atypical antipsychotics and the expected launch of five pipeline products.GlobalData anticipates that five products in the late-stage pipeline will enter the MDD market in the US during the forecast period: Alkermes’ ALKS-5461, Allergan/Gedeon Richter/Mitsubishi Tanabe’s Vraylar, Axsome Therapeutics’ AXS-05, Janssen’s esketamine, and Allergan’s rapastinel.
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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 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 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 the US.
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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 US 28
5 Competitive Assessment 31
5.1 Overview 31
5.2 Selective Serotonin Reuptake Inhibitors 33
5.2.1 Lexapro (Escitalopram) 33
5.2.2 Viibryd (Vilazodone) 41
5.2.3 Other Selective Serotonin Reuptake Inhibitors 45
5.3 Serotonin-Norepinephrine Reuptake Inhibitors 59
5.3.1 Cymbalta (Duloxetine) 59
5.3.2 Effexor (Venlafaxine) 67
5.3.3 Fetzima (Levomilnacipran) 74
5.3.4 Savella (Milnacipran) 80
5.3.5 Pristiq (Desvenlafaxine) 85
5.4 Multimodal Antidepressants 90
5.4.1 Trintellix (Vortioxetine) 90
5.5 Other Antidepressants 99
5.5.1 Bupropion 99
5.5.2 Symbyax (Olanzapine/Fluoxetine) 105
5.5.3 Mirtazapine 110
5.5.4 Monoamine Oxidase Inhibitors 115
5.5.5 Tricyclic Antidepressants 119
5.6 Antipsychotics 123
5.6.1 Abilify (Aripiprazole) 123
5.6.2 Seroquel XR (Quetiapine XR) 130
5.6.3 Rexulti (Brexpiprazole) 135
5.7 Other Therapeutic Classes 141
6 Unmet Need and Opportunity 142
6.1 Overview 142
6.2 New Therapies with Better Efficacy 144
6.2.1 Unmet Need 144
6.2.2 Gap Analysis 146
6.2.3 Opportunity 147
6.3 Improved Safety Profiles 148
6.3.1 Unmet Need 148
6.3.2 Gap Analysis 150
6.3.3 Opportunity 151
6.4 Rapid Onset of Action 153
6.4.1 Unmet Need 153
6.4.2 Gap Analysis 154
6.4.3 Opportunity 156
6.5 Personalized Treatment Approach 157
6.5.1 Unmet Need 157
6.5.2 Gap Analysis 158
6.5.3 Opportunity 159
6.6 Manage Patient Outcome Expectations 161
6.6.1 Unmet Need 161
6.6.2 Gap Analysis 163
6.6.3 Opportunity 164
7 Pipeline Assessment 166
7.1 Overview 166
7.2 Clinical Trial Mapping 166
7.2.1 Clinical Trials by Class of Therapy 166
7.3 Promising Drugs in Clinical Development 167
7.3.1 ALKS-5461 171
7.3.2 Vraylar (Cariprazine) 180
7.3.3 ASC-01 187
7.3.4 AXS-05 190
7.3.5 Esketamine 197
7.3.6 Rapastinel (GLYX-13) 205
7.3.7 Strada (MSI-195) 213
7.3.8 Viotra (Tramadol) 219
7.4 Promising Drugs in Early-Stage Development 226
7.4.1 CGP3466B 226
7.4.2 NSI-189 227
7.5 Other Drugs in Development 228
8 Market Outlook 230
8.1 US 230
8.1.1 Forecast 230
8.1.2 Key Events 232
8.1.3 Drivers and Barriers 233
9 Appendix 234
9.1 Bibliography 234
9.2 Abbreviations 280
9.3 Methodology 291
9.4 Forecasting Methodology 291
9.4.1 Diagnosed NSCLC Patients 291
9.4.2 Percent Drug-Treated Patients 292
9.4.3 Drugs Included in Each Therapeutic Class 292
9.4.4 Launch and Patent Expiry Dates 295
9.4.5 General Pricing Assumptions 297
9.4.6 Individual Drug Assumptions 299
9.4.7 Generic Erosion 313
9.4.8 Pricing of Pipeline Agents 313
9.5 Primary Research - KOLs 318
9.5.1 KOLs 318
9.6 About the Authors 322
9.6.1 Analyst 322
9.6.2 Therapy Area Director 322
9.6.3 Epidemiologist 323
9.6.4 Global Head of Healthcare 323
9.7 About GlobalData 325
9.8 Disclaimer 325
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 - US 30
Table 7: Leading Treatments for MDD, 2016 33
Table 8: Product Profile - Lexapro 37
Table 9: Lexapro/Cipralex SWOT Analysis, 2016 40
Table 10: Product Profile - Viibryd 43
Table 11: Summary of Efficacy Results for the Primary Endpoint in Viibryd Clinical Trials 44
Table 12: Viibryd SWOT Analysis, 2016 45
Table 13: Summary of SSRIs, 2016 49
Table 14: SSRIs SWOT Analysis, 2016 59
Table 15: Product Profile - Cymbalta 64
Table 16: Cymbalta SWOT Analysis, 2016 66
Table 17: Product Profile - Effexor 71
Table 18: Effexor SWOT Analysis, 2016 73
Table 19: Product Profile - Fetzima 77
Table 20: Fetzima SWOT Analysis, 2016 79
Table 21: Product Profile - Savella 82
Table 22: Savella SWOT Analysis, 2016 84
Table 23: Product Profile - Pristiq 87
Table 24: Pristiq SWOT Analysis, 2016 89
Table 25: Product Profile - Trintellix 96
Table 26: Trintellix SWOT Analysis, 2016 98
Table 27: Product Profile - Bupropion 102
Table 28: Bupropion SWOT Analysis, 2016 104
Table 29: Product Profile - Symbyax 107
Table 30: Symbyax SWOT Analysis, 2016 109
Table 31: Product Profile - Mirtazapine 113
Table 32: Mirtazapine SWOT Analysis, 2016 115
Table 33: MAOIs SWOT Analysis, 2016 119
Table 34: TCAs SWOT Analysis, 2016 123
Table 35: Product Profile - Abilify 127
Table 36: Abilify SWOT Analysis, 2016 129
Table 37: Product Profile - Seroquel XR 132
Table 38: Seroquel XR SWOT Analysis, 2016 134
Table 39: Product Profile - Rexulti 138
Table 40: Rexulti SWOT Analysis, 2016 140
Table 41: Summary of Minor Therapeutic Classes in MDD, 2016 141
Table 42: Unmet Needs and Opportunities in MDD 143
Table 43: Promising Drugs in Clinical Development for MDD, 2016 168
Table 44: Comparison of Drugs in Development for MDD, 2016 170
Table 45: Product Profile - ALKS-5461 175
Table 46: SWOT Analysis - ALKS-5461, 2016 179
Table 47: Product Profile - Vraylar 183
Table 48: SWOT Analysis - Vraylar, 2016 186
Table 49: Product Profile - ASC-01 188
Table 50: SWOT Analysis - ASC-01, 2016 190
Table 51: Product Profile - AXS-05 194
Table 52: SWOT Analysis - AXS-05, 2016 196
Table 53: Product Profile - Esketamine 201
Table 54: SWOT Analysis - Esketamine, 2016 204
Table 55: Product Profile - Rapastinel 209
Table 56: SWOT Analysis - Rapastinel, 2016 212
Table 57: Product Profile - Strada 217
Table 58: SWOT Analysis - Strada, 2016 219
Table 59: Product Profile - Viotra 222
Table 60: SWOT Analysis - Viotra, 2015 225
Table 61: Drugs in Development, 2016 229
Table 62: Key Events Impacting Sales for MDD Therapies in the US, 2015-2025 232
Table 63: MDD Market - Drivers and Barriers in the US, 2015-2025 233
Table 64: Key Launch Dates - Part I 295
Table 65: Key Launch Dates - Part II 296
Table 66: Key Patent Expiries 297
Table 67 Average Body Weight and Surface Area Across the 8MM 298
Table 68: Average Cost of Therapy of Alimta in the 8MM 300
Table 69: Average Cost of Therapy of Alecensa in the 8MM 301
Table 70: Average Cost of Therapy of Avastin 302
Table 71: Average Cost of Therapy of Cyramza 302
Table 72: Average Cost of Therapy of Gilotrif 303
Table 73: Average Cost of Therapy of Iressa 304
Table 74: Average Cost of Therapy of Portrazza 305
Table 75: Average Cost of Therapy of Tagrisso 306
Table 76: Average Cost of Therapy of Tarceva 307
Table 77: Average Cost of Therapy of Vargatef 307
Table 78: Average Cost of Therapy of Xalkori 308
Table 79: Average Cost of Therapy of Zykadia 309
Table 80: Average Cost of Therapy of Keytruda 310
Table 81: Average Cost of Therapy of Opdivo 311
Table 82: Average Cost of Therapy of Tecentriq 312
Table 83: Average Cost of Therapy of Conmana 313
Table 84: High-Prescribing Physicians Surveyed by Country 321
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 167
Figure 5: MDD Phase II/Phase III Pipeline, 2016 169
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2015-2025 171
Figure 7: Clinical and Commercial Positioning of ALKS-5461 178
Figure 8: Clinical and Commercial Positioning of Vraylar 185
Figure 9: Clinical and Commercial Positioning of ASC-01 189
Figure 10: Clinical and Commercial Positioning of AXS-05 195
Figure 11: Clinical and Commercial Positioning of Esketamine 203
Figure 12: Clinical and Commercial Positioning of Rapastinel 211
Figure 13: Clinical and Commercial Positioning of Strada 218
Figure 14: Clinical and Commercial Positioning of Viotra 224
Figure 15: US Sales by Drug Class for MDD Therapies, 2015 and 2025 231
Figure 16: US Sales by Drug Class for MDD Therapies, 2015-2025 232
