ALKS-5461 (Major Depressive Disorder) - Forecast and Market Analysis to 2023

NEW YORK, July 15, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

ALKS-5461 (Major Depressive Disorder) - Forecast and Market Analysis to 2023

http://www.reportlinker.com/p02166750/ALKS-5461-Major-Depressive-Disorder---Forecast-and-Market-Analysis-to-2023.html

ALKS-5461 (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.

ALKS-5461 is being developed by Alkermes as an adjunctive treatment for MDD in patients who have had an inadequate response to standard therapies. According to Alkermes, ALKS-5461 is expected to enter Phase III development during the first half of 2014. Following its very successful Phase II trial, the FDA granted Fast Track status for ALKS-5461 in order to facilitate its development and expedite its review by the regulatory authority (Alkermes, press release, October 10, 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 ALKS-5461 including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for ALKS-5461 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 ALKS-5461 performance
- Obtain sales forecast for ALKS-5461 from 2013-2023 in the top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and Australia)

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 21
5 Competitive Assessment 26
5.1 Overview 26
6 Unmet Needs and Opportunities 28
6.1 Overview 28
6.2 More Effective Pharmacotherapies 29
6.2.1 Unmet Needs 29
6.2.2 Gap Analysis 30
6.2.3 Opportunities 31
6.3 More Favorable Side Effect Profiles 31
6.3.1 Unmet Needs 31
6.3.2 Gap Analysis 32
6.3.3 Opportunities 32
6.4 Rapid Onset of Antidepressant Effects 33
6.4.1 Unmet Needs 33
6.4.2 Gap Analysis 33
6.4.3 Opportunities 33
6.5 Personalized Treatment Approach 34
6.5.1 Unmet Needs 34
6.5.2 Gap Analysis 35
6.5.3 Opportunities 35
7 Pipeline Assessment 36
7.1 Overview 36
7.2 Promising Drugs in Clinical Development 36
8 ALKS-5461 39
8.1 Overview 39
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 49
9.3 Methodology 51
9.4 Forecasting Methodology 51
9.4.1 Diagnosed MDD Patients 51
9.4.2 Percent of Drug-Treated Patients 51
9.4.3 General Pricing Assumptions 52
9.4.4 Generic Erosion 53
9.4.5 Pricing of Pipeline Agents 53
9.5 Physicians and Specialists Included in this Study 54
9.6 About the Authors 56
9.6.1 Analyst 56
9.6.2 Therapy Area Directors 56
9.6.3 Global Head of Healthcare 57
9.7 About GlobalData 58
9.8 Disclaimer 58

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 19
Table 5: Most Prescribed Drugs for MDD by Class in the 7MM and Australia, 2013 21
Table 6: Leading Treatments for MDD, 2013 27
Table 7: Unmet Needs and Opportunities in MDD 29
Table 8: Comparison of Therapeutic Classes in Development for MDD, 2013 38
Table 9: Product Profile - ALKS-5461 40
Table 10: ALKS-5461 SWOT Analysis, 2014 44
Table 11: Global MDD Sales Forecasts ($m) for ALKS-5461, 2013-2023 45
Table 12: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 55

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 23
Figure 3: Major Depressive Disorder Treatment Algorithm 25
Figure 4: MDD - Phase IIb-III Pipeline, 2014 37
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in MDD, 2013-2023 38
Figure 6: Clinical and Commercial Positioning of ALKS-5461 43

Companies Mentioned

To order this report: ALKS-5461 (Major Depressive Disorder) - Forecast and Market Analysis to 2023
http://www.reportlinker.com/p02166750/ALKS-5461-Major-Depressive-Disorder---Forecast-and-Market-Analysis-to-2023.html

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