(Schizophrenia) – Forecast and Market Analysis to 2022

<ul style="display: flex;"><li style="flex:1">GDHC367DFR | </li><li style="flex:1">FEBRUARY 2014 </li></ul><ul style="display: flex;"><li style="flex:1">PUBLICATION DATE </li><li style="flex:1">REFERENCE CODE </li></ul>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 metrics for Brexpiprazole in the seven major pharmaceutical markets during the forecast period upto 2022. May have an effect on negative symptoms. <ul style="display: flex;"><li style="flex:1">Otsuka has </li><li style="flex:1">a</li><li style="flex:1">strong presence in the </li></ul>schizophrenia drug market. Conversely, the major barriers for the growth of Brexpiprazole in the schizophrenia market include: Brexpiprazole : Key Metrics in the Seven Major Pharmaceutical Markets, 2012–2022 <ul style="display: flex;"><li style="flex:1">Key Events (2012-2022) </li><li style="flex:1">Level of Impact </li></ul>Higher cost of therapy compared to older medications. Anticipated launch of Brexpiprazole in US(2015) ↑↑↑ Anticipated launch of Brexpiprazole in Japan (2016) Requires daily oral dosing. ↑↑ 2022 Market Sales The figure below illustrates Brexpiprazole sales in the 7MM by region during the forecast period. <ul style="display: flex;"><li style="flex:1">US </li><li style="flex:1">$1,648.9m </li></ul><ul style="display: flex;"><li style="flex:1">$28.4m </li><li style="flex:1">5EU </li></ul><ul style="display: flex;"><li style="flex:1">Japan </li><li style="flex:1">$105.8m </li></ul>$1,783.1m Sales for Brexpiprazole by Region, 2022 7MM 5.9% 2022 1.6% 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 Market, 2022 5EU Japan Brexpiprazole sales are expected to increase from $176.2 million upon launch in 2015 to $1,783.1 million in 2022. 92.5% 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. Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. 2BREXPIPRAZOLE (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 diagnosis has expanded to which these medications are directed to.” “Unfortunately there is really nothing out there which would give me confidence that we will have something reasonably effective in the next several years. We are probably coming to one set of results very soon, probably sometime early next year or maybe the spring of next year, the glutamatergic compounds.” [EU] KOL, November 2013 “[We] treat them according to the presenting syndrome. And even more specifically – in terms of the positive symptoms, depression, affective symptoms, or cognitive symptoms, negative symptoms – they will be cueing in much more on that rather than on the label of, ‘Is this schizoaffective, is it bipolar, is it a schizophrenic patient?’ I think once it gets down to medications, then it gets much simpler. These discussions do not reach into the medication decision-making process.” [US] KOL, October 2013 “There isn’t that much coming out these days, so that’s a fact which many of us have actually agreed on is a major, major issue. We’ve had discussions with pharmaceutical companies as a group of pharmacologically oriented and research-oriented psychiatrists and say, ‘Please come back and reactivate your research and development sections and divisions. Don’t desert this group of patients, because we need better drugs.’ There’s no doubt about it.” [EU] KOL, December 2013 “Going systematically, you have the glutamatergic compounds, you have nicotinic acid agonists, you have the me-too drugs, which are the D2/5-HT2 antagonists, and of those we have plenty, we don’t need anything more, that mechanism of action is entirely taken care of, so to speak.” [US] KOL, September 2013 “If you look at the utilization patterns of antipsychotics you do see that once the atypicals were introduced, the usage of these medications went up significantly. And this is not at all because there are more schizophrenic patients around. In fact, schizophrenia has actually decreased slightly [US] KOL October, 2013 Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. 3BREXPIPRAZOLE (SCHIZOPHRENIA) - FORECAST AND MARKET ANALYSIS TO 2022 Table of Contents <ul style="display: flex;"><li style="flex:1">1</li><li style="flex:1">Table of Contents </li></ul>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 Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 4© 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 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 Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 5© 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 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 Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 6© 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 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 Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 7© 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 <ul style="display: flex;"><li style="flex:1">2</li><li style="flex:1">Introduction </li></ul>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. Brexpiprazole (Schizophrenia) - Forecast and Market Analysis to 2022 8© 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 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

(Schizophrenia) – Forecast and Market Analysis to 2022

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