REFERENCE CODE GDHC367DFR | PUBLICATION DATE FEBRUARY 2014
BREXPIPRAZOLE (SCHIZOPHRENIA) – FORECAST AND MARKET ANALYSIS TO 2022
BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
Table below provides a summary of the key May have an effect on negative symptoms. metrics for Brexpiprazole in the seven major Otsuka has a strong presence in the pharmaceutical markets during the forecast period schizophrenia drug market. upto 2022. Conversely, the major barriers for the growth of Brexpiprazole : Key Metrics in the Seven Major Brexpiprazole in the schizophrenia market include: Pharmaceutical Markets, 2012–2022 Key Events (2012-2022) Level of Impact Higher cost of therapy compared to older Anticipated launch of Brexpiprazole in ↑↑↑ medications. US(2015) Anticipated launch of Brexpiprazole in ↑↑ Requires daily oral dosing. Japan (2016) 2022 Market Sales The figure below illustrates Brexpiprazole sales in US $1,648.9m the 7MM by region during the forecast period. 5EU $28.4m Japan $105.8m Sales for Brexpiprazole by Region, 2022 7MM $1,783.1m 5.9% 1.6% 2022 Source: GlobalData. Total : $1,783.1m 7MM = US, France, Germany, Italy, Spain, UK, Japan; 5EU = France, Germany, Italy, Spain, UK
US
Sales of Brexpiprazole in Global Schizophrenia 5EU
Market, 2022 Japan
Brexpiprazole sales are expected to increase from $176.2 million upon launch in 2015 to $1,783.1 92.5% million in 2022. Source: GlobalData. Major growth drivers for Brexpiprazole in the Schizophrenia market over the forecast period include:
Structurally similar to Otsuka’s Abilify, the current market leader in the schizophrenia drug market.
Improved tolerability and similar efficacy to Abilify demonstrated in clinical trials.
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BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022
Executive Summary
What Do the Physicians Think? in terms of epidemiology. But they have increased in terms of rate of prescribing because the “Unfortunately there is really nothing out there diagnosis has expanded to which these which would give me confidence that we will have medications are directed to.” something reasonably effective in the next several years. We are probably coming to one set of [EU] KOL, November 2013 results very soon, probably sometime early next “[We] treat them according to the presenting year or maybe the spring of next year, the syndrome. And even more specifically – in terms of glutamatergic compounds.” the positive symptoms, depression, affective [US] KOL, October 2013 symptoms, or cognitive symptoms, negative symptoms – they will be cueing in much more on “There isn’t that much coming out these days, so that rather than on the label of, ‘Is this that’s a fact which many of us have actually agreed schizoaffective, is it bipolar, is it a schizophrenic on is a major, major issue. We’ve had discussions patient?’ I think once it gets down to medications, with pharmaceutical companies as a group of then it gets much simpler. These discussions do pharmacologically oriented and research-oriented not reach into the medication decision-making psychiatrists and say, ‘Please come back and process.” reactivate your research and development sections and divisions. Don’t desert this group of patients, [EU] KOL, December 2013 because we need better drugs.’ There’s no doubt “Going systematically, you have the glutamatergic about it.” compounds, you have nicotinic acid agonists, you [US] KOL, September 2013 have the me-too drugs, which are the D2/5-HT2 antagonists, and of those we have plenty, we don’t “If you look at the utilization patterns of need anything more, that mechanism of action is antipsychotics you do see that once the atypicals entirely taken care of, so to speak.” were introduced, the usage of these medications went up significantly. And this is not at all because [US] KOL October, 2013 there are more schizophrenic patients around. In
fact, schizophrenia has actually decreased slightly
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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
1 Table of Contents
1 Table of Contents ...... 4
1.1 List of Tables...... 7
1.2 List of Figures ...... 7
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
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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
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
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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
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
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BREXPIPRAZOLE (SCHIZOPHRENIA) -
FORECAST AND MARKET ANALYSIS TO 2022
Table of Contents
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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BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2 Introduction
2.1 Catalyst
Schizophrenia is a chronic, severe, and disabling group of psychotic disorders characterized by fundamental disturbances of thinking such as hallucinations, delusions, disorganized communication and reduced motivation (NIMH, 2013; WHO, 2013). Globally, the condition is prevalent in approximately 7 persons per 1,000 of the adult population ages 15–35 years (WHO, 2013).
This report provides an overview of the risk factors, comorbidities, and the global and historical trends for schizophrenia in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). In addition, the report also includes a 10-year forecast of diagnosed prevalent cases of schizophrenia segmented by age and sex.
To forecast the diagnosed prevalent cases of schizophrenia in the 7MM, GlobalData epidemiologists selected nationally representative studies that provided diagnosed prevalence of schizophrenia using uniform diagnostic criteria and classification defined by the World Health Organization’s International Classification of Diseases 9th revision (ICD-9).
GlobalData epidemiologists forecast an increase in the diagnosed prevalent cases of schizophrenia in the 7MM from 2,495,903 diagnosed prevalent cases in 2012 to 2,643,660 diagnosed prevalent cases in 2022, with an annual growth rate (AGR) of 0.59% in the forecast period.
In 2022, the US will have the highest number of diagnosed prevalent cases of schizophrenia with 1,777,333 diagnosed prevalent cases, followed by Japan with 454,961 diagnosed prevalent cases, and Italy with 154,331 diagnosed prevalent cases.
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BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
2.2 Related Reports
GlobalData (2014). PharmaPoint: Schizophrenia - Global Drug Forecast and Market Analysis to 2022, February 2014, GDHC81PIDR
GlobalData (2014). Schizophrenia – US Drug Forecast and Market Analysis to 2022, February 2014, GDHC224CFR
GlobalData (2014). Schizophrenia – 5EU Drug Forecast and Market Analysis to 2022, February 2014, GDHC225CFR
GlobalData (2014). Schizophrenia – Japan Drug Forecast and Market Analysis to 2022, February 2014, GDHC226CFR
GlobalData (2014). Abilify (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC355DFR
GlobalData (2014). Saphris (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC356DFR
GlobalData (2014). Clozaril (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC357DFR
GlobalData (2014). Fanapt (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC358DFR
GlobalData (2014). Latuda (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC359DFR
GlobalData (2014). Zyprexa (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC360DFR
GlobalData (2014). Invega (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC361DFR
GlobalData (2014). Seroquel (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC362DFR
Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.
BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022
Introduction
GlobalData (2014). Risperdal (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC363DFR
GlobalData (2014). Geodon (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC364DFR
GlobalData (2014). Aripiprazole lauroxil (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC365DFR
GlobalData (2014). Cariprazine (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC366DFR
GlobalData (2014). Zicronapine (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC368DFR
GlobalData (2014). Bitopertin (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC369DFR
GlobalData (2014). EVP-6124 (Schizophrenia) – Forecast and Market Analysis to 2022, February 2014, GDHC370DFR
GlobalData (2014). Schizophrenia – Current and Future Players, February 2014, GDHC1030FPR
2.3 Upcoming Reports
GlobalData (2014). PharmaPoint Report: Major Depressive Disorders, 2014
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BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022
Appendix
9.7 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research, and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, Boston, London, India, and Singapore.
9.8 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData.
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