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Cariprazine (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.

Cariprazine (RGH-188) is being developed as an adjunctive treatment to antidepressant therapy in patients with MDD who had an inadequate response to antidepressant therapy, and as of April 2014, two Phase III clinical trials were ongoing (Forest Laboratories, NCT01715805; Forest Laboratories, NCT01838876). In addition, cariprazine is being developed for the treatment of schizophrenia and bipolar disorder.

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 Cariprazine including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Cariprazine 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 Cariprazine performance
- Obtain sales forecast for Cariprazine from 2013-2023 in the top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Australia)

Table Of Contents

Cariprazine (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 Cariprazine (RGH-188) 40
8.1 Overview 40
8.2 Efficacy 42
8.3 Safety 42
8.4 Dosing and Formulation 43
8.5 Potential Clinical and Commercial Positioning 43
8.6 SWOT Analysis 44
8.7 Forecast 44
9 Appendix 46
9.1 Bibliography 46
9.2 Abbreviations 50
9.3 Methodology 52
9.4 Forecasting Methodology 52
9.4.1 Diagnosed MDD Patients 52
9.4.2 Percent of Drug-Treated Patients 52
9.4.3 General Pricing Assumptions 53
9.4.4 Generic Erosion 54
9.4.5 Pricing of Pipeline Agents 54
9.5 Physicians and Specialists Included in this Study 55
9.6 About the Authors 57
9.6.1 Analyst 57
9.6.2 Therapy Area Directors 57
9.6.3 Global Head of Healthcare 58
9.7 About GlobalData 59
9.8 Disclaimer 59

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 - Cariprazine 41
Table 10: Cariprazine SWOT Analysis, 2014 44
Table 11: Global MDD Sales Forecasts ($m) for Cariprazine, 2013-2023 45
Table 12: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 56

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 Cariprazine 43

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