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

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.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Related Reports
2.2 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification
3.3 Symptoms and Subtypes of Major Depressive Disorder
3.4 Prognosis
3.5 Quality of Life
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.3 Global Trends
4.4 Forecast Methodology
4.4.1 Sources Used Tables
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiological Forecast for MDD (2015-2025)
4.5.1 12-Month Total Prevalent Cases of MDD
4.5.2 Age-Specific 12-Month Total Prevalent Cases of MDD
4.5.3 Sex-Specific 12-Month Total Prevalent Cases of MDD
4.5.4 Age-Standardized 12-Month Total Prevalence of MDD
4.5.5 12-Month Total Prevalent Cases of MDD by Severity
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Disease Management
5.1 Diagnosis and Treatment Overview
5.1.1 Diagnosis
5.1.2 Treatment Guidelines
5.1.3 Clinical Practice
5.2 US
5.3 5EU
5.4 Japan
6 Competitive Assessment
6.1 Overview
6.2 Selective Serotonin Reuptake Inhibitors
6.2.1 Lexapro (Escitalopram)
6.2.2 Viibryd (Vilazodone)
6.2.3 Other Selective Serotonin Reuptake Inhibitors
6.3 Serotonin-Norepinephrine Reuptake Inhibitors
6.3.1 Cymbalta (Duloxetine)
6.3.2 Effexor (Venlafaxine)
6.3.3 Fetzima (Levomilnacipran)
6.3.4 Savella (Milnacipran)
6.3.5 Pristiq (Desvenlafaxine)
6.4 Multimodal Antidepressants
6.4.1 Trintellix (Vortioxetine)
6.5 Other Antidepressants
6.5.1 Bupropion
6.5.2 Symbyax (Olanzapine/Fluoxetine)
6.5.3 Mirtazapine
6.5.4 Monoamine Oxidase Inhibitors
6.5.5 Tricyclic Antidepressants
6.6 Antipsychotics
6.6.1 Abilify (Aripiprazole)
6.6.2 Seroquel XR (Quetiapine XR)
6.6.3 Rexulti (Brexpiprazole)
6.7 Other Therapeutic Classes
7 Unmet Need and Opportunity
7.1 Overview
7.2 New Therapies with Better Efficacy
7.2.1 Unmet Need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Improved Safety Profiles
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 Rapid Onset of Action
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Personalized Treatment Approach
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity
7.6 Manage Patient Outcome Expectations
7.6.1 Unmet Need
7.6.2 Gap Analysis
7.6.3 Opportunity
8 Pipeline Assessment
8.1 Overview
8.2 Clinical Trial Mapping
8.2.1 Clinical Trials by Class of Therapy
8.3 Promising Drugs in Clinical Development
8.3.1 ALKS-5461
8.3.2 Vraylar (Cariprazine)
8.3.3 ASC-01
8.3.4 AXS-05
8.3.5 Esketamine
8.3.6 Rapastinel (GLYX-13)
8.3.7 Strada (MSI-195)
8.3.8 Viotra (Tramadol)
8.4 Promising Drugs in Early-Stage Development
8.4.1 CGP3466B
8.4.2 NSI-189
8.5 Other Drugs in Development
9 Current and Future Players
9.1 Overview
9.2 Trends in Corporate Strategy
9.3 Company Profiles
9.3.1 Allergan
9.3.2 e-Therapeutics
9.3.3 Alkermes
9.3.4 Pfizer
9.3.5 Otsuka
9.3.6 Janssen
9.3.7 Eli Lilly
9.3.8 Lundbeck
9.3.9 Takeda
9.3.10 Axsome Therapeutics
10 Market Outlook
10.1 Global Markets
10.1.1 Forecast
10.1.2 Drivers and Barriers - Global Issues
10.2 US
10.2.1 Forecast
10.2.2 Key Events
10.2.3 Drivers and Barriers
10.3 5EU
10.3.1 Forecast
10.3.2 Key Events
10.3.3 Drivers and Barriers
10.4 Japan
10.4.1 Forecast
10.4.2 Key Events
10.4.3 Drivers and Barriers
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.4 Forecasting Methodology
11.4.1 Diagnosed MDD Patients
11.4.2 Percent Drug-Treated Patients
11.4.3 Percent Treatment-Resistant Patients
11.4.4 Drugs Included in Each Therapeutic Class
11.4.5 Key Launch Dates and Patent Expiries
11.4.6 General Pricing Assumptions
11.4.7 Individual Drug Assumptions
11.4.8 Generic Erosion
11.4.9 Pricing of Pipeline Agents
11.5 Primary Research - KOLs Interviewed for this Report
11.6 Primary Research - High-Prescriber Survey
11.7 About the Authors
11.7.1 Analysts
11.7.2 Therapy Area Director
11.7.3 Epidemiologist
11.7.4 Global Director of Therapy Analysis and Epidemiology
11.8 About GlobalData
11.9 Disclaimer
1.1 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
1.2 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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