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

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.

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.

Key Highlights

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?

Companies mentioned

AbbVie

Abbott Laboratories

Alkermes

Allergan

Asahi Kasei

Astellas

AstraZeneca

Avanir Pharmaceuticals

Axsome Therapeutics

Bristol-Myers Squibb

e-Therapeutics

Eli Lilly

GlaxoSmithKline

Gedeon Richter

Janssen

Lundbeck

Meiji Seika

Merck & Co.

Methylation Sciences

Minerva Neurosciences

Mitsubishi Tanabe Pharma

Mochida

Moksha8

Neuralstem Pharmaceuticals

Novartis

Otsuka

Pfizer

Pierre Fabre

Royalty Pharma

Sandoz

Shionogi

Takeda

Teva Pharmaceutical

Yoshitomi Yakuhin Corporation

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Related Reports

2.2Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification

3.3Symptoms and Subtypes of Major Depressive Disorder

3.4Prognosis

3.5Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for MDD (2015–2025)

4.5.112-Month Total Prevalent Cases of MDD

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

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

4.5.4Age-Standardized 12-Month Total Prevalence of MDD

4.5.512-Month Total Prevalent Cases of MDD by Severity

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines

5.1.3Clinical Practice

5.2US

5.35EU

5.4Japan

6Competitive Assessment

6.1Overview

6.2Selective Serotonin Reuptake Inhibitors

6.2.1Lexapro (Escitalopram)

6.2.2Viibryd (Vilazodone)

6.2.3Other Selective Serotonin Reuptake Inhibitors

6.3Serotonin-Norepinephrine Reuptake Inhibitors

6.3.1Cymbalta (Duloxetine)

6.3.2Effexor (Venlafaxine)

6.3.3Fetzima (Levomilnacipran)

6.3.4Savella (Milnacipran)

6.3.5Pristiq (Desvenlafaxine)

6.4Multimodal Antidepressants

6.4.1Trintellix (Vortioxetine)

6.5Other Antidepressants

6.5.1Bupropion

6.5.2Symbyax (Olanzapine/Fluoxetine)

6.5.3Mirtazapine

6.5.4Monoamine Oxidase Inhibitors

6.5.5Tricyclic Antidepressants

6.6Antipsychotics

6.6.1Abilify (Aripiprazole)

6.6.2Seroquel XR (Quetiapine XR)

6.6.3Rexulti (Brexpiprazole)

6.7Other Therapeutic Classes

7Unmet Need and Opportunity

7.1Overview

7.2New Therapies with Better Efficacy

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Improved Safety Profiles

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Rapid Onset of Action

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Personalized Treatment Approach

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Manage Patient Outcome Expectations

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Class of Therapy

8.3Promising Drugs in Clinical Development

8.3.1ALKS-5461

8.3.2Vraylar (Cariprazine)

8.3.3ASC-01

8.3.4AXS-05

8.3.5Esketamine

8.3.6Rapastinel (GLYX-13)

8.3.7Strada (MSI-195)

8.3.8Viotra (Tramadol)

8.4Promising Drugs in Early-Stage Development

8.4.1CGP3466B

8.4.2NSI-189

8.5Other Drugs in Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Allergan

9.3.2e-Therapeutics

9.3.3Alkermes

9.3.4Pfizer

9.3.5Otsuka

9.3.6Janssen

9.3.7Eli Lilly

9.3.8Lundbeck

9.3.9Takeda

9.3.10Axsome Therapeutics

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed MDD Patients

11.4.2Percent Drug-Treated Patients

11.4.3Percent Treatment-Resistant Patients

11.4.4Drugs Included in Each Therapeutic Class

11.4.5Key Launch Dates and Patent Expiries

11.4.6General Pricing Assumptions

11.4.7Individual Drug Assumptions

11.4.8Generic Erosion

11.4.9Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – High-Prescriber Survey

11.7About the Authors

11.7.1Analysts

11.7.2Therapy Area Director

11.7.3Epidemiologist

11.7.4Global Director of Therapy Analysis and Epidemiology

11.8About GlobalData

11.9Disclaimer

List of Tables

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

Table 2: Subtypes of Major Depressive Disorder

Table 3: DSM-IV Diagnostic Criteria for MDD

Table 4: Risk Factors and Comorbidities for MDD

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

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

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

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

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

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

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

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

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

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

Table 15: Treatment Guidelines for Major Depressive Disorder

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

Table 17: Country Profile – US

Table 18: Country Profile – 5EU

Table 19: Country Profile – Japan

Table 20: Leading Treatments for MDD, 2016

Table 21: Product Profile – Lexapro

Table 22: Lexapro/Cipralex SWOT Analysis, 2016

Table 23: Product Profile – Viibryd

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

Table 25: Viibryd SWOT Analysis, 2016

Table 26: Summary of SSRIs, 2016

Table 27: SSRIs SWOT Analysis, 2016

Table 28: Product Profile – Cymbalta

Table 29: Cymbalta SWOT Analysis, 2016

Table 30: Product Profile – Effexor

Table 31: Effexor SWOT Analysis, 2016

Table 32: Product Profile – Fetzima

Table 33: Fetzima SWOT Analysis, 2016

Table 34: Product Profile – Savella

Table 35: Savella SWOT Analysis, 2016

Table 36: Product Profile – Pristiq

Table 37: Pristiq SWOT Analysis, 2016

Table 38: Product Profile – Trintellix

Table 39: Trintellix SWOT Analysis, 2016

Table 40: Product Profile – Bupropion

Table 41: Bupropion SWOT Analysis, 2016

Table 42: Product Profile – Symbyax

Table 43: Symbyax SWOT Analysis, 2016

Table 44: Product Profile – Mirtazapine

Table 45: Mirtazapine SWOT Analysis, 2016

Table 46: MAOIs SWOT Analysis, 2016

Table 47: TCAs SWOT Analysis, 2016

Table 48: Product Profile – Abilify

Table 49: Abilify SWOT Analysis, 2016

Table 50: Product Profile – Seroquel XR

Table 51: Seroquel XR SWOT Analysis, 2016

Table 52: Product Profile – Rexulti

Table 53: Rexulti SWOT Analysis, 2016

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

Table 55: Unmet Needs and Opportunities in MDD

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

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

Table 58: Product Profile – ALKS-5461

Table 59: SWOT Analysis – ALKS-5461, 2016

Table 60: Product Profile – Vraylar

Table 61: SWOT Analysis – Vraylar, 2016

Table 62: Product Profile – ASC-01

Table 63: SWOT Analysis – ASC-01, 2016

Table 64: Product Profile – AXS-05

Table 65: SWOT Analysis – AXS-05, 2016

Table 66: Product Profile – Esketamine

Table 67: SWOT Analysis – Esketamine, 2016

Table 68: Product Profile – Rapastinel

Table 69: SWOT Analysis – Rapastinel, 2016

Table 70: Product Profile – Strada

Table 71: SWOT Analysis – Strada, 2016

Table 72: Product Profile – Viotra

Table 73: SWOT Analysis – Viotra, 2015

Table 74: Drugs in Development, 2016

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

Table 76: Allergan’s MDD Portfolio Assessment, 2016

Table 77: Allergan SWOT Analysis in MDD, 2015–2025

Table 78: e-Therapeutics’ MDD Portfolio Assessment, 2016

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

Table 80: Alkermes’ MDD Portfolio Assessment, 2016

Table 81: Alkermes SWOT Analysis in MDD, 2015–2025

Table 82: Pfizer’s MDD Portfolio Assessment, 2016

Table 83: Pfizer SWOT Analysis in MDD, 2015–2025

Table 84: Otsuka’s MDD Portfolio Assessment, 2016

Table 85: Otsuka SWOT Analysis in MDD, 2015–2025

Table 86: Janssen’s MDD Portfolio Assessment, 2016

Table 87: Janssen SWOT Analysis in MDD, 2015–2025

Table 88: Eli Lilly’s MDD Portfolio Assessment, 2016

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

Table 90: Lundbeck’s MDD Portfolio Assessment, 2016

Table 91: Lundbeck SWOT Analysis in MDD, 2015–2025

Table 92: Takeda’s MDD Portfolio Assessment, 2016

Table 93: Takeda SWOT Analysis in MDD, 2015–2025

Table 94: Axsome Therapeutics’ MDD Portfolio Assessment, 2016

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

Table 96: MDD Market – Drivers and Barriers, 2015–2025

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

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

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

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

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

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

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

Table 104: Key Launch Dates

Table 105: Key Patent Expiries

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

List of Figures

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

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

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

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

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

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

Figure 7: Disease Management Model for Major Depressive Disorder

Figure 8: Major Depressive Disorder Treatment Algorithm

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

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

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

Figure 12: Clinical and Commercial Positioning of ALKS-5461

Figure 13: Clinical and Commercial Positioning of Vraylar

Figure 14: Clinical and Commercial Positioning of ASC-01

Figure 15: Clinical and Commercial Positioning of AXS-05

Figure 16: Clinical and Commercial Positioning of Esketamine

Figure 17: Clinical and Commercial Positioning of Rapastinel

Figure 18: Clinical and Commercial Positioning of Strada

Figure 19: Clinical and Commercial Positioning of Viotra

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

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

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

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

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

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

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

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

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

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

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

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

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