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Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022

Summary

Schizophrenia is a persistent long-term brain disorder that causes severe, debilitating psychotic episodes. Its core symptoms, auditory or visual hallucinations, are often accompanied by fixed, false, and often paranoid beliefs, called delusions. These two features are often combined with learning and cognitive deficits. WHO experts have estimated that roughly 24 million people are affected by schizophrenia worldwide. While the arrival of atypical antipsychotics has greatly expanded pharmacologic treatment options over the past two decades, the current drug market does not treat the negative and cognitive symptoms that are associated with the disease. GlobalData expects that the growing popularity of long-acting injectable (LAI) antipsychotics, along with the arrival of novel treatments that achieve higher efficacy in negative- and cognitive-predominant patients, will serve to stimulate growth in the marketplace over the forecast period. Country-specific treatment recommendations and policy implementation will be an essential metric for determining future mental health services in the 7MM.

Brexpiprazole is a D2-preferring D3/D2 receptor partial agonist in development by Otsuka. As a partial agonist, like cariprazine (a D3 partial agonist), brexpiprazole helps to stabilize dopaminergic tone in periods of hyper- or hypoactivity. Brexpiprazole has broad activity across multiple monoamine systems, including 5-HT1A partial agonism and antagonism at 5-HT2A a1 receptors, which may lessen the occurrence of EPS, although it acts on D2 receptors (Stahl, 2013). Brexpiprazole is also an antagonist at 5-HT7 receptors, which may make it useful as an antidepressant. Given its diverse activity profile, it is also being investigated in dementia, ADHD, PTSD, sleep disorders, and MDD. As its name suggests, brexpiprazole may be considered as a successor to Otsuka’s Abilify (aripiprazole), which faces patent expiration in April 2015.

Scope

- Overview of Schizophrenia, 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 seven countries from 2012 to 2022.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan

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 Schizophrenia
- 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 2012-2022 in the top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)

Table Of Contents

Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
2.3 Upcoming Reports 10
3 Disease Overview 11
3.1 Etiology and Pathophysiology 11
3.1.1 Etiology 11
3.1.2 Pathophysiology 12
3.2 Symptoms 13
4 Disease Management 14
4.1 Diagnosis 14
4.1.1 Subjective Assessments 15
4.1.2 Disease Subtypes 16
4.2 Treatment Overview 18
4.2.1 Treatment of Acute Agitation Associated with Schizophrenia 21
4.2.2 Maintenance Treatment of Schizophrenia 22
5 Competitive Assessment 23
5.1 Overview 23
5.2 Strategic Competitor Assessment 24
6 Opportunity and Unmet Need 26
6.1 Unmet Needs Overview 26
6.1.1 Public Awareness 27
6.1.2 Early Diagnosis and Treatment 29
6.1.3 Long-Acting and Advanced Drug Delivery Systems 30
6.1.4 Effective Management of Negative and Cognitive Symptom Domains 31
6.2 Gap Analysis 32
6.2.1 Long-Acting Drug Delivery 33
6.2.2 Treatment of Negative and Cognitive Symptoms 33
7 Pipeline Assessment 34
7.1 Overview 34
7.2 Early-Stage Pipeline Assessment 34
7.3 Novel Therapeutic Approaches 35
7.3.1 Negative Symptoms 36
7.3.2 Cognitive Symptoms 36
7.4 Long-Acting Drug Delivery 36
7.5 Technology Trends Analysis 37
7.6 Key Drugs in Clinical Development 38
8 Brexpiprazole 40
8.1 Overview 40
8.2 Efficacy 40
8.3 Safety 41
8.3.1 Dosing and Formulation 41
8.3.2 Potential Clinical Positioning 41
8.3.3 Potential Commercial Positioning 41
8.3.4 Pricing and Reimbursement 42
8.4 SWOT Analysis 42
8.5 Forecast 42
9 Appendix 43
9.1 Bibliography 43
9.2 Abbreviations 48
9.3 Methodology 51
9.4 Forecasting Methodology 51
9.4.1 Diagnosis and Treatment Rates 51
9.4.2 Adherence Rates 52
9.4.3 General Pricing Assumptions 52
9.4.4 Generic Erosion 53
9.4.5 Pricing of Pipeline Agents 53
9.5 Key Opinion Leaders 54
9.6 About the Authors 55
9.6.1 Author 55
9.6.2 Reviewers 55
9.6.3 Global Head of Healthcare 56
9.7 About GlobalData 57
9.8 Disclaimer 57

1.1 List of Tables

Table 1: Symptom Clusters of Schizophrenia 13
Table 2: Common Subjective Rating Scales Employed in Schizophrenia Diagnosis 16
Table 3: Development-Based Classification of Antipsychotic Drugs 19
Table 4: Receptor Binding Profiles of Atypical Antipsychotics 20
Table 5: Guidelines for the Treatment of Schizophrenia 21
Table 6: Leading Branded Treatments for Schizophrenia, 2013 25
Table 7: Strategic Competitor Assessment of the Marketed Products in Schizophrenia, 2014 25
Table 8: Unmet Needs - Current Level of Attainment 27
Table 9: Clinical Unmet Needs - Gap Analysis, 2013 32
Table 10: Technological Trends Analytic Framework in the Schizophrenia Pipeline, 2014 37
Table 11: Pipeline Candidates in Development for Schizophrenia, 2014 38
Table 12: Comparison of Novel Therapeutic Classes in Development for Schizophrenia, 2013 39
Table 13: Product Profile - Brexpiprazole 40
Table 14: Brexpiprazole SWOT Analysis, 2014 42
Table 15: Global Sales Forecasts ($m) for Brexpiprazole, 2012-2022 42

1.2 List of Figures

Figure 1: Schizophrenia - Pipeline Drugs by Target, 2014 35
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012-2022 38

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