PharmaPoint: Major Depressive Disorder-Global Drug Forecast and Market Assessment to 2025

PharmaPoint: Major Depressive Disorder-Global Drug Forecast and Market Assessment to 2025


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Executive Summary

PharmaPoint: Major Depressive Disorder-Global Drug Forecast and Market Assessment to 2025

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.

Highlights

Key Questions Answered

The MDD market is widely genericized. In light of this, what are the current clinical and environmental unmet needs? Will there be opportunities in this market for drug developers throughout the forecast period?

There are five substantial unmet needs that exist in the MDD market. Will pipeline drugs fulfil any of the unmet needs for MDD? Which unmet needs will continue to provide opportunity for drug developers during the forecast period?

Six late-stage pipeline products are expected to launch during the forecast period to 2025. What impact will these drugs have on the market? How will they affect the treatment algorithm for MDD?

Key Findings

The main drivers of growth in the MDD market will be the uptake of atypical antipsychotic products throughout the 7MM, most notably from Otsuka/Lundbeck's Rexulti. These agents are forecast to be the highest selling MDD products by 2025, accounting for 38.9% of the MDD market in the 7MM.

The six late-stage pipeline products are all adjunctive therapies aimed at treating treatment-resistant patients and aim to satisfy major unmet needs within the MDD market; providing therapies with better efficacy, improved safety profiles, and rapid onsets of action.

The biggest barrier for growth in the MDD market will be fierce competition from generic products. This limits market opportunities for new and existing players, as uptake of novel pipeline products would be hindered by their premium price point.

Growth in the MDD market is also expected to be driven by increasing diagnosed prevalence of MDD, due to increased public awareness and routine screening for depressive disorders, as well as an increase in socioeconomic stress.

Scope

Overview of MDD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized MDD market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the MDD therapeutics market.

Pipeline analysis: focus on eight late-stage pipeline MDD drugs, discussing emerging trends as well as an overview of earlier phase drugs.

Analysis of the current and future market competition in the global MDD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.

Develop business strategies by understanding the trends shaping and driving the global MDD therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MDD therapeutics market in future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Track drug sales in the global MDD therapeutics market from 2015-2025.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.



Read More



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1 Table of Contents

1 Table of Contents 10

1.1 List of Tables 15

1.2 List of Figures 20

2 Introduction 22

2.1 Related Reports 22

2.2 Upcoming Related Reports 23

3 Disease Overview 24

3.1 Etiology and Pathophysiology 24

3.1.1 Etiology 24

3.1.2 Pathophysiology 25

3.2 Classification 28

3.3 Symptoms and Subtypes of Major Depressive Disorder 30

3.4 Prognosis 31

3.5 Quality of Life 31

4 Epidemiology 32

4.1 Disease Background 32

4.2 Risk Factors and Comorbidities 33

4.3 Global Trends 35

4.4 Forecast Methodology 38

4.4.1 Sources Used Tables 38

4.4.2 Forecast Assumptions and Methods 40

4.4.3 Sources Not Used 44

4.5 Epidemiological Forecast for MDD (2015-2025) 46

4.5.1 12-Month Total Prevalent Cases of MDD 46

4.5.2 Age-Specific 12-Month Total Prevalent Cases of MDD 48

4.5.3 Sex-Specific 12-Month Total Prevalent Cases of MDD 49

4.5.4 Age-Standardized 12-Month Total Prevalence of MDD 51

4.5.5 12-Month Total Prevalent Cases of MDD by Severity 52

4.6 Discussion 53

4.6.1 Epidemiological Forecast Insight 53

4.6.2 Limitations of the Analysis 54

4.6.3 Strengths of the Analysis 55

5 Disease Management 56

5.1 Diagnosis and Treatment Overview 56

5.1.1 Diagnosis 56

5.1.2 Treatment Guidelines 57

5.1.3 Clinical Practice 59

5.2 US 63

5.3 5EU 66

5.4 Japan 70

6 Competitive Assessment 73

6.1 Overview 73

6.2 Selective Serotonin Reuptake Inhibitors 75

6.2.1 Lexapro (Escitalopram) 75

6.2.2 Viibryd (Vilazodone) 83

6.2.3 Other Selective Serotonin Reuptake Inhibitors 87

6.3 Serotonin-Norepinephrine Reuptake Inhibitors 101

6.3.1 Cymbalta (Duloxetine) 101

6.3.2 Effexor (Venlafaxine) 109

6.3.3 Fetzima (Levomilnacipran) 116

6.3.4 Savella (Milnacipran) 122

6.3.5 Pristiq (Desvenlafaxine) 127

6.4 Multimodal Antidepressants 132

6.4.1 Trintellix (Vortioxetine) 132

6.5 Other Antidepressants 141

6.5.1 Bupropion 141

6.5.2 Symbyax (Olanzapine/Fluoxetine) 147

6.5.3 Mirtazapine 152

6.5.4 Monoamine Oxidase Inhibitors 157

6.5.5 Tricyclic Antidepressants 161

6.6 Antipsychotics 165

6.6.1 Abilify (Aripiprazole) 165

6.6.2 Seroquel XR (Quetiapine XR) 172

6.6.3 Rexulti (Brexpiprazole) 177

6.7 Other Therapeutic Classes 183

7 Unmet Need and Opportunity 184

7.1 Overview 184

7.2 New Therapies with Better Efficacy 186

7.2.1 Unmet Need 186

7.2.2 Gap Analysis 188

7.2.3 Opportunity 189

7.3 Improved Safety Profiles 190

7.3.1 Unmet Need 190

7.3.2 Gap Analysis 192

7.3.3 Opportunity 193

7.4 Rapid Onset of Action 195

7.4.1 Unmet Need 195

7.4.2 Gap Analysis 196

7.4.3 Opportunity 198

7.5 Personalized Treatment Approach 199

7.5.1 Unmet Need 199

7.5.2 Gap Analysis 200

7.5.3 Opportunity 201

7.6 Manage Patient Outcome Expectations 203

7.6.1 Unmet Need 203

7.6.2 Gap Analysis 205

7.6.3 Opportunity 206

8 Pipeline Assessment 208

8.1 Overview 208

8.2 Clinical Trial Mapping 208

8.2.1 Clinical Trials by Class of Therapy 208

8.3 Promising Drugs in Clinical Development 209

8.3.1 ALKS-5461 213

8.3.2 Vraylar (Cariprazine) 222

8.3.3 ASC-01 229

8.3.4 AXS-05 232

8.3.5 Esketamine 239

8.3.6 Rapastinel (GLYX-13) 247

8.3.7 Strada (MSI-195) 255

8.3.8 Viotra (Tramadol) 261

8.4 Promising Drugs in Early-Stage Development 268

8.4.1 CGP3466B 268

8.4.2 NSI-189 269

8.5 Other Drugs in Development 270

9 Current and Future Players 272

9.1 Overview 272

9.2 Trends in Corporate Strategy 274

9.3 Company Profiles 275

9.3.1 Allergan 275

9.3.2 e-Therapeutics 278

9.3.3 Alkermes 280

9.3.4 Pfizer 282

9.3.5 Otsuka 284

9.3.6 Janssen 287

9.3.7 Eli Lilly 290

9.3.8 Lundbeck 292

9.3.9 Takeda 295

9.3.10 Axsome Therapeutics 297

10 Market Outlook 299

10.1 Global Markets 299

10.1.1 Forecast 299

10.1.2 Drivers and Barriers-Global Issues 306

10.2 US 306

10.2.1 Forecast 306

10.2.2 Key Events 309

10.2.3 Drivers and Barriers 310

10.3 5EU 310

10.3.1 Forecast 310

10.3.2 Key Events 315

10.3.3 Drivers and Barriers 316

10.4 Japan 318

10.4.1 Forecast 318

10.4.2 Key Events 320

10.4.3 Drivers and Barriers 321

11 Appendix 322

11.1 Bibliography 322

11.2 Abbreviations 365

11.3 Methodology 371

11.4 Forecasting Methodology 371

11.4.1 Diagnosed MDD Patients 371

11.4.2 Percent Drug-Treated Patients 372

11.4.3 Percent Treatment-Resistant Patients 372

11.4.4 Drugs Included in Each Therapeutic Class 372

11.4.5 Key Launch Dates and Patent Expiries 373

11.4.6 General Pricing Assumptions 373

11.4.7 Individual Drug Assumptions 374

11.4.8 Generic Erosion 384

11.4.9 Pricing of Pipeline Agents 385

11.5 Primary Research-KOLs Interviewed for this Report 386

11.6 Primary Research-High-Prescriber Survey 388

11.7 About the Authors 389

11.7.1 Analysts 389

11.7.2 Therapy Area Director 389

11.7.3 Epidemiologist 390

11.7.4 Global Director of Therapy Analysis and Epidemiology 390

11.8 About GlobalData 391

11.9 Disclaimer 391

1.2 List of Figures

Figure 1: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons 28

Figure 2: 7MM, 12-Month Total Prevalent Cases of MDD, Ages ?18 Years, Both Sexes, N, 2015-2025 47

Figure 3: 7MM, 12-Month Total Prevalent Cases of MDD, by Age, Both Sexes, N, 2015 49

Figure 4: 7MM, 12-Month Total Prevalent Cases of MDD, by Sex, Ages ?18 Years, N, 2015 51

Figure 5: 7MM, Age-Standardized 12-Month Total Prevalence (%) of MDD, by Sex, Ages ?18 Years, 2015 52

Figure 6: 7MM, 12-Month Total Prevalent Cases of MDD by Severity, Both Sexes, Ages ?18 Years, 2015 53

Figure 7: Disease Management Model for Major Depressive Disorder 60

Figure 8: Major Depressive Disorder Treatment Algorithm 62

Figure 9: MDD Therapeutics-Phase II and III Clinical Trials in the 7MM, 2016 209

Figure 10: MDD Phase II/Phase III Pipeline, 2016 211

Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2015-2025 213

Figure 12: Clinical and Commercial Positioning of ALKS-5461 220

Figure 13: Clinical and Commercial Positioning of Vraylar 227

Figure 14: Clinical and Commercial Positioning of ASC-01 231

Figure 15: Clinical and Commercial Positioning of AXS-05 237

Figure 16: Clinical and Commercial Positioning of Esketamine 245

Figure 17: Clinical and Commercial Positioning of Rapastinel 253

Figure 18: Clinical and Commercial Positioning of Strada 260

Figure 19: Clinical and Commercial Positioning of Viotra 266

Figure 20: Company Portfolio Gap Analysis in MDD, 2015-2025 274

Figure 21: Global Sales by Region for MDD Therapies, 2015 and 2025 302

Figure 22: Global Sales by Region for MDD Therapies, 2015-2025 303

Figure 23: Global Sales by Drug Class for MDD Therapies, 2015 and 2025 304

Figure 24: Global Sales by Drug Class for MDD Therapies, 2015-2025 305

Figure 25: US Sales by Drug Class for MDD Therapies, 2015 and 2025 308

Figure 26: US Sales by Drug Class for MDD Therapies, 2015-2025 309

Figure 27: 5EU Sales by Drug Class for MDD Therapies, 2015 and 2025 312

Figure 28: 5EU Sales by Drug Class for MDD Therapies, 2015-2025 313

Figure 29: 5EU Sales by Region for MDD Therapies, 2015 and 2025 314

Figure 30: Japan Sales by Drug Class for MDD Therapies, 2015 and 2025 319

Figure 31: Japan Sales by Drug Class for MDD Therapies, 2015-2025 320

1.1 List of Tables

Table 1: Classification and Criteria of MDD (DSM-IV) and MDE (ICD-10) 29

Table 2: Subtypes of Major Depressive Disorder 30

Table 3: DSM-IV Diagnostic Criteria for MDD 33

Table 4: Risk Factors and Comorbidities for MDD 34

Table 5: Prevalence of the Most Frequent Psychiatric Comorbidities in Individuals With and Without MDD, Ages 18-64 Years 35

Table 6: 7MM, Total Prevalence (%) of MDD According to the DSM-IV Criteria, ?18 Years 37

Table 7: 7MM, Total Prevalence (%) of MDD According to the DSM-III Criteria 37

Table 8: 7MM, Sources Used to Forecast the 12-Month Total Prevalence of MDD 39

Table 9: Sources Used to Forecast the 12-Month Total Prevalent Cases of MDD by Severity 40

Table 10: 7MM, Sources Not Used in Epidemiological Forecast for the 12-Month Total Prevalent Cases of MDD 45

Table 11: 7MM, 12-Month Total Prevalent Cases of MDD, Ages ?18 Years, Both Sexes, N, Selected Years 2015-2025 47

Table 12: 7MM, 12-Month Total Prevalent Cases of MDD, by Age, Both Sexes, N (Row %), 2015 48

Table 13: 7MM, 12-Month Total Prevalent Cases of MDD, by Sex, Ages ?18 Years, N (Row %), 2015 50

Table 14: Severity of Depressive Episodes According to ICD-10 and DSM-IV Diagnostic Criteria 57

Table 15: Treatment Guidelines for Major Depressive Disorder 58

Table 16: Most-Prescribed Drugs for MDD by Class in the 7MM, 2015 59

Table 17: Country Profile-US 66

Table 18: Country Profile-5EU 69

Table 19: Country Profile-Japan 72

Table 20: Leading Treatments for MDD, 2016 75

Table 21: Product Profile-Lexapro 79

Table 22: Lexapro/Cipralex SWOT Analysis, 2016 82

Table 23: Product Profile-Viibryd 85

Table 24: Summary of Efficacy Results for the Primary Endpoint in Viibryd Clinical Trials 86

Table 25: Viibryd SWOT Analysis, 2016 87

Table 26: Summary of SSRIs, 2016 91

Table 27: SSRIs SWOT Analysis, 2016 101

Table 28: Product Profile-Cymbalta 106

Table 29: Cymbalta SWOT Analysis, 2016 108

Table 30: Product Profile-Effexor 113

Table 31: Effexor SWOT Analysis, 2016 115

Table 32: Product Profile-Fetzima 119

Table 33: Fetzima SWOT Analysis, 2016 121

Table 34: Product Profile-Savella 124

Table 35: Savella SWOT Analysis, 2016 126

Table 36: Product Profile-Pristiq 129

Table 37: Pristiq SWOT Analysis, 2016 131

Table 38: Product Profile-Trintellix 138

Table 39: Trintellix SWOT Analysis, 2016 140

Table 40: Product Profile-Bupropion 144

Table 41: Bupropion SWOT Analysis, 2016 146

Table 42: Product Profile-Symbyax 149

Table 43: Symbyax SWOT Analysis, 2016 151

Table 44: Product Profile-Mirtazapine 155

Table 45: Mirtazapine SWOT Analysis, 2016 157

Table 46: MAOIs SWOT Analysis, 2016 161

Table 47: TCAs SWOT Analysis, 2016 165

Table 48: Product Profile-Abilify 169

Table 49: Abilify SWOT Analysis, 2016 171

Table 50: Product Profile-Seroquel XR 174

Table 51: Seroquel XR SWOT Analysis, 2016 176

Table 52: Product Profile-Rexulti 180

Table 53: Rexulti SWOT Analysis, 2016 182

Table 54: Summary of Minor Therapeutic Classes in MDD, 2016 183

Table 55: Unmet Needs and Opportunities in MDD 185

Table 56: Promising Drugs in Clinical Development for MDD, 2016 210

Table 57: Comparison of Drugs in Development for MDD, 2016 212

Table 58: Product Profile-ALKS-5461 217

Table 59: SWOT Analysis-ALKS-5461, 2016 221

Table 60: Product Profile-Vraylar 225

Table 61: SWOT Analysis-Vraylar, 2016 228

Table 62: Product Profile-ASC-01 230

Table 63: SWOT Analysis-ASC-01, 2016 232

Table 64: Product Profile-AXS-05 236

Table 65: SWOT Analysis-AXS-05, 2016 238

Table 66: Product Profile-Esketamine 243

Table 67: SWOT Analysis-Esketamine, 2016 246

Table 68: Product Profile-Rapastinel 251

Table 69: SWOT Analysis-Rapastinel, 2016 254

Table 70: Product Profile-Strada 259

Table 71: SWOT Analysis-Strada, 2016 261

Table 72: Product Profile-Viotra 264

Table 73: SWOT Analysis-Viotra, 2015 267

Table 74: Drugs in Development, 2016 271

Table 75: Key Companies in the MDD Market in the 7MM 273

Table 76: Allergan's MDD Portfolio Assessment, 2016 277

Table 77: Allergan SWOT Analysis in MDD, 2015-2025 278

Table 78: e-Therapeutics' MDD Portfolio Assessment, 2016 279

Table 79: e-Therapeutics SWOT Analysis in MDD, 2015-2025 280

Table 80: Alkermes' MDD Portfolio Assessment, 2016 282

Table 81: Alkermes SWOT Analysis in MDD, 2015-2025 282

Table 82: Pfizer's MDD Portfolio Assessment, 2016 283

Table 83: Pfizer SWOT Analysis in MDD, 2015-2025 284

Table 84: Otsuka's MDD Portfolio Assessment, 2016 286

Table 85: Otsuka SWOT Analysis in MDD, 2015-2025 287

Table 86: Janssen's MDD Portfolio Assessment, 2016 289

Table 87: Janssen SWOT Analysis in MDD, 2015-2025 290

Table 88: Eli Lilly's MDD Portfolio Assessment, 2016 291

Table 89: Eli Lilly SWOT Analysis in MDD, 2015-2025 292

Table 90: Lundbeck's MDD Portfolio Assessment, 2016 294

Table 91: Lundbeck SWOT Analysis in MDD, 2015-2025 295

Table 92: Takeda's MDD Portfolio Assessment, 2016 296

Table 93: Takeda SWOT Analysis in MDD, 2015-2025 296

Table 94: Axsome Therapeutics' MDD Portfolio Assessment, 2016 298

Table 95: Axsome Therapeutics SWOT Analysis in MDD, 2015-2025 298

Table 96: MDD Market-Drivers and Barriers, 2015-2025 306

Table 97: Key Events Impacting Sales for MDD Therapies in the US, 2015-2025 309

Table 98: MDD Market-Drivers and Barriers in the US, 2015-2025 310

Table 99: Key Events Impacting Sales for MDD Therapies in the 5EU, 2015-2025 315

Table 100: MDD Market-Drivers and Barriers in the 5EU, 2015-2025 316

Table 101: National Healthcare Authorities and Governmental Drug Pricing Authorities in the 5EU 317

Table 102: Key Events Impacting Sales for MDD Therapies in Japan, 2015-2025 320

Table 103: MDD Market-Drivers and Barriers in Japan, 2015-2025 321

Table 104: Key Launch Dates 373

Table 105: Key Patent Expiries 373

Table 106: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 388

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