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Brexpiprazole (Major Depressive Disorder) - Forecast and Market Analysis to 2023

Summary

Major depressive disorder (MDD) is one of the most common psychiatric diseases worldwide. The MDD market is a crowded and competitive market, with more than 30 marketed products available for the treatment of patients with MDD. The depression market is about to enter a dynamic phase with imminent patent expiries for top selling products, such as Eli Lilly’s Cymbalta, and Otsuka/BMS’s Abilify, along with the recent launch of the multimodal antidepressant, Lundbeck/Takeda’s Brintellix, in January 2014, and the potential introduction of seven promising late-stage pipeline products into the market during the forecast period, from 2013 to 2023.

Otsuka Pharmaceutical initially developed Brexpiprazole but in 2011, the pharmaceutical company entered an agreement with Lundbeck for the co-development and co-commercialization of this product. The product is in Phase III development as an adjunctive therapy for MDD in the US and Europe, and is also being developed for the treatment of schizophrenia, anxiety disorders, dementia, post-traumatic stress disorder (PTSD), sleep disorders, and ADHD.

Scope

- Overview of Major depressive disorder, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Brexpiprazole including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Brexpiprazole for the top eight countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and Australia.

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 Major depressive disorder
- 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 Brexpiprazole performance
- Obtain sales forecast for Brexpiprazole from 2013-2023 in the top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Australia)

Table Of Contents

Brexpiprazole (Major Depressive Disorder) - Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 9
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.2 Classification 14
3.3 Symptoms and Subtypes of Major Depressive Disorder 16
3.4 Prognosis 17
3.5 Quality of Life 17
4 Disease Management 18
4.1 Diagnosis and Treatment Overview 18
4.1.1 Diagnosis 18
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 19
4.1.3 Clinical Practice 22
5 Competitive Assessment 27
5.1 Overview 27
6 Unmet Needs and Opportunities 29
6.1 Overview 29
6.2 More Effective Pharmacotherapies 30
6.2.1 Unmet Needs 30
6.2.2 Gap Analysis 31
6.2.3 Opportunities 32
6.3 More Favorable Side Effect Profiles 32
6.3.1 Unmet Needs 32
6.3.2 Gap Analysis 33
6.3.3 Opportunities 33
6.4 Rapid Onset of Antidepressant Effects 34
6.4.1 Unmet Needs 34
6.4.2 Gap Analysis 34
6.4.3 Opportunities 34
6.5 Personalized Treatment Approach 35
6.5.1 Unmet Needs 35
6.5.2 Gap Analysis 36
6.5.3 Opportunities 36
7 Pipeline Assessment 37
7.1 Overview 37
7.2 Promising Drugs in Clinical Development 37
8 Brexpiprazole (OPC-34712) 40
8.1 Overview 40
8.2 Efficacy 42
8.3 Safety 43
8.4 Dosing and Formulation 44
8.5 Potential Clinical and Commercial Positioning 45
8.6 SWOT Analysis 46
8.7 Forecast 46
9 Appendix 48
9.1 Bibliography 48
9.2 Abbreviations 52
9.3 Methodology 55
9.4 Forecasting Methodology 55
9.4.1 Diagnosed MDD Patients 55
9.4.2 Percent of Drug-Treated Patients 55
9.4.3 General Pricing Assumptions 56
9.4.4 Generic Erosion 57
9.4.5 Pricing of Pipeline Agents 57
9.5 Physicians and Specialists Included in this Study 58
9.6 About the Authors 60
9.6.1 Analyst 60
9.6.2 Therapy Area Directors 60
9.6.3 Global Head of Healthcare 61
9.7 About GlobalData 62
9.8 Disclaimer 62

1.1 List of Tables

Table 1: Classification and Criteria of Major Depressive Disorder (DSM-IV) and Major Depressive Episode (ICD-10) 15
Table 2: Subtypes of Major Depressive Disorder 16
Table 3: Severity of Depressive Episodes according to ICD-10 and DSM-IV Diagnostic Criteria 18
Table 4: Treatment Guidelines for Major Depressive Disorder 20
Table 5: Most Prescribed Drugs for MDD by Class in the 7MM and Australia, 2013 22
Table 6: Leading Treatments for MDD, 2013 28
Table 7: Unmet Needs and Opportunities in MDD 30
Table 8: Comparison of Therapeutic Classes in Development for MDD, 2013 39
Table 9: Product Profile - Brexpiprazole 42
Table 10: Safety of Brexpiprazole - Most Frequently Reported Adverse Events 44
Table 11: Brexpiprazole SWOT Analysis, 2014 46
Table 12: Global MDD Sales Forecasts ($m) for Brexpiprazole, 2013-2023 47
Table 13: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 59

1.2 List of Figures

Figure 1: Overview of Targets of Antidepressant Action on Noradrenergic and Serotonergic Neurons 14
Figure 2: Disease Management Model for Major Depressive Disorder 24
Figure 3: Major Depressive Disorder Treatment Algorithm 26
Figure 4: MDD - Phase IIb-III Pipeline, 2014 38
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013-2023 39
Figure 6: Clinical and Commercial Positioning of Brexpiprazole 45

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