GLYX-13 (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.

GLYX-13 is being developed by Naurex as an adjunctive therapy for MDD in patients with an inadequate response to antidepressants. The exact MOA of GLYX-13 is not fully understood, but it is hypothesized that it exerts its antidepressant effects by enhancing synaptic plasticity (Naurex, press release, December 12, 2013). GLYX-13 is being developed for IV administration and there is evidence to suggest that the NMDA receptor ligands can demonstrate rapid antidepressant effects (Popp et al., 2013).

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 GLYX-13 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for GLYX-13 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 GLYX-13 performance
- Obtain sales forecast for GLYX-13 from 2013-2023 in the top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Australia)

Table Of Contents

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 GLYX-13 40
8.1 Overview 40
8.2 Efficacy 41
8.3 Safety 42
8.4 Dosing and Formulation 42
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 53
9.4 Forecasting Methodology 53
9.4.1 Diagnosed MDD Patients 53
9.4.2 Percent of Drug-Treated Patients 53
9.4.3 General Pricing Assumptions 54
9.4.4 Generic Erosion 55
9.4.5 Pricing of Pipeline Agents 55
9.5 Physicians and Specialists Included in this Study 56
9.6 About the Authors 58
9.6.1 Analyst 58
9.6.2 Therapy Area Directors 58
9.6.3 Global Head of Healthcare 59
9.7 About GlobalData 60
9.8 Disclaimer 60


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 - GLYX-13 41
Table 10: GLYX-13 SWOT Analysis, 2014 44
Table 11: Global MDD Sales Forecasts ($m) for GLYX-13, 2013-2023 45
Table 12: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 57

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 GLYX-13 43

Companies Mentioned

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