REFERENCE CODE GDHC224CFR PUBLICAT ION DATE FEBRUARY 2014 SCHIZOPHRENIA
Executive Summary Schizophrenia Sales in the US, 2012 The combined sales of medications carrying an indication in schizophrenia in the US were estimated at $5.23 billion in 2012. By, GlobalData projects these sales to grow to $6.13 billion, with a compound annual growth rate (CAGR) of 1.60% over the course of the decade. Major growth drivers in the US Schizophrenia market over the forecast period include: US healthcare reform the Affordable Care Act (ACA) will increase number of insured schizophrenia patients Patent expirations of several atypical agents will allow for these therapies to be more affordable Conversely, major barriers to the growth of the Schizophrenia market in the US include: Poorly designed healthcare infrastructure for mental health and patient support systems are inadequate Anosognosia, or the inability to recognize oneself as ill, is a significant characteristic of the schizophrenic patient and makes these patients less likely to seek medical attention than those with other conditions The figure below illustrates schizophrenia drug sales in the US by region during the forecast period. Schizophrenia Drug Sales in the US By Therapeutic Class, 2012 18% 74% Source: GlobalData. 8% 74% 8% 11% 7% 2012 Total: $5.23bn FGAs Atypical Antipsychotics Long-Acting Injectables Total: $6.13 bn FGAs What Do the Physicians Think? Atypical Antipsychotics Long-Acting Injectables Pipeline Drugs 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. [US] KOL, October 2013 Schizophrenia US Drug Forecast and Market Analysis to 2
Executive Summary 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. [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 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. [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. [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 D 2 /5-HT 2 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 October, 2013 [EU] KOL, November 2013 Schizophrenia - US Drug Forecast and Market Analysis to 3
Table of Contents 1 Table of Contents 1 Table of Contents... 4 1.1 List of Tables... 7 1.2 List of Figures... 9 2 Introduction... 10 2.1 Catalyst... 10 2.2 Related Reports... 11 2.3 Upcoming Reports... 12 3 Disease Overview... 13 3.1 Etiology and Pathophysiology... 13 3.1.1 Etiology... 13 3.1.2 Pathophysiology... 14 3.2 Symptoms... 15 4 Disease Management... 16 4.1 Diagnosis... 16 4.1.1 Subjective Assessments... 17 4.1.2 Disease Subtypes... 18 4.2 Treatment Overview... 21 4.2.1 Treatment of Acute Agitation Associated with Schizophrenia... 23 4.2.2 Maintenance Treatment of Schizophrenia... 24 4.3 US... 25 4.3.1 Diagnosis... 25 4.3.2 Clinical Practice... 25 5 Competitive Assessment... 27 5.1 Overview... 27 Schizophrenia - US Drug Forecast and Market Analysis to 4
Table of Contents 5.2 Strategic Competitor Assessment... 28 5.3 Product Profiles by Generation... 29 5.3.1 Conventional Antipsychotics... 29 5.3.2 Atypical Antipsychotics... 32 6 Opportunity and Unmet Need... 65 6.1 Unmet Needs Overview... 65 6.1.1 Public Awareness... 66 6.1.2 Early Diagnosis and Treatment... 68 6.1.3 Long-Acting and Advanced Drug Delivery Systems... 69 6.1.4 Effective Management of Negative and Cognitive Symptom Domains... 70 6.2 Gap Analysis... 71 6.2.1 Long-Acting Drug Delivery... 72 6.2.2 Treatment of Negative and Cognitive Symptoms... 72 7 Pipeline Assessment... 73 7.1 Overview... 73 7.2 Early-Stage Pipeline Assessment... 73 7.3 Novel Therapeutic Approaches... 74 7.3.1 Negative Symptoms... 75 7.3.2 Cognitive Symptoms... 75 7.4 Long-Acting Drug Delivery... 75 7.5 Technology Trends Analysis... 76 7.6 Key Drugs in Clinical Development... 77 7.6.1 Aripiprazole Lauroxil... 79 7.6.2 Cariprazine... 83 7.6.3 Brexpiprazole... 87 Schizophrenia - US Drug Forecast and Market Analysis to 5
Table of Contents 7.6.4 Zicronapine... 90 7.6.5 Bitopertin... 93 7.6.6 EVP-6124... 96 8 Market Outlook... 100 8.1 US... 100 8.1.1 Forecast... 100 8.1.2 Key Events... 103 8.1.3 Drivers and Barriers... 103 9 Appendix... 106 9.1 Bibliography... 106 9.2 Abbreviations... 115 9.3 Methodology... 120 9.4 Forecasting Methodology... 120 9.4.1 Diagnosis and Treatment Rates... 120 9.4.2 Adherence Rates... 121 9.4.3 Drugs Included in Each Therapeutic Class... 121 9.4.4 Launch and Patent Expiry Dates... 122 9.4.5 General Pricing Assumptions... 123 9.4.6 Drug Assumptions... 124 9.4.7 Generic Erosion... 129 9.4.8 Pricing of Pipeline Agents... 129 9.5 Key Opinion Leaders... 131 9.6 About the Authors... 132 9.6.1 Author... 132 9.7 About GlobalData... 133 9.8 Disclaimer... 133 Schizophrenia - US Drug Forecast and Market Analysis to 6
Table of Contents 1.1 List of Tables Table 1: Symptom Clusters of Schizophrenia... 15 Table 2: Common Subjective Rating Scales Employed in Schizophrenia Diagnosis... 18 Table 3: Development-Based Classification of Antipsychotic Drugs... 21 Table 4: Receptor Binding Profiles of Atypical Antipsychotics... 22 Table 5: Guidelines for the Treatment of Schizophrenia... 23 Table 6: Leading Branded Treatments for Schizophrenia, 2013... 29 Table 7: Strategic Competitor Assessment of the Marketed Products in Schizophrenia, 2014... 29 Table 8: Chemical Classifications of FGAs... 30 Table 9: Receptor Affinity Profiles for FGAs... 31 Table 10: First-Generation Antipsychotics SWOT Analysis, 2013... 32 Table 11: Product Profile Abilify... 35 Table 12: Abilify SWOT Analysis, 2014... 38 Table 13: Product Profile Saphris... 39 Table 14: Saphris SWOT Analysis, 2013... 41 Table 15: Product Profile Clozaril... 42 Table 16: Clozaril SWOT Analysis, 2014... 43 Table 17: Product Profile Fanapt... 44 Table 18: Fanapt SWOT Analysis, 2014... 46 Table 19: Product Profile Latuda... 47 Table 20: Latuda SWOT Analysis, 2014... 48 Table 21: Product Profile Zyprexa... 50 Table 22: Zyprexa SWOT Analysis, 2014... 53 Table 23: Product Profile Invega... 54 Schizophrenia - US Drug Forecast and Market Analysis to 7
Table of Contents Table 24: Invega SWOT Analysis, 2013... 56 Table 25: Product Profile Seroquel... 57 Table 26: Seroquel SWOT Analysis, 2013... 58 Table 27: Product Profile Risperdal... 60 Table 28: Risperdal SWOT Analysis, 2013... 62 Table 29: Product Profile Geodon... 63 Table 30: Geodon SWOT Analysis, 2013... 64 Table 31: Unmet Needs Current Level of Attainment... 66 Table 32: Clinical Unmet Needs Gap Analysis, 2013... 71 Table 33: Technological Trends Analytic Framework in the Schizophrenia Pipeline, 2014... 77 Table 34: Pipeline Candidates in Development for Schizophrenia, 2014... 77 Table 35: Comparison of Novel Therapeutic Classes in Development for Schizophrenia, 2013... 78 Table 36: Product Profile Aripiprazole Lauroxil... 79 Table 37: Aripiprazole Lauroxil SWOT Analysis, 2014... 83 Table 38: Product Profile Cariprazine... 84 Table 39: Cariprazine SWOT Analysis, 2014... 87 Table 40: Product Profile Brexpiprazole... 88 Table 41: Brexpiprazole SWOT Analysis, 2014... 90 Table 42: Product Profile Zicronapine... 91 Table 43: Zicronapine SWOT Analysis, 2014... 93 Table 44: Product Profile Bitopertin... 94 Table 45: Bitopertin SWOT Analysis, 2014... 96 Table 46: Product Profile EVP-6124... 97 Table 47: EVP-6124 SWOT Analysis, 2014... 99 Schizophrenia - US Drug Forecast and Market Analysis to 8
Table of Contents Table 48: Sales Forecast ($m) for Schizophrenia in the US, 2012... 101 Table 49: Key Events Impacting Sales for Schizophrenia in the US, 2012... 103 Table 50: Schizophrenia Market in the US Drivers and Barriers, 2012... 103 Table 51: Key Launch Dates... 122 Table 52: Key Patent Expirations... 123 1.2 List of Figures Figure 1: Schizophrenia Pipeline Drugs by Target, 2014... 74 Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012... 78 Figure 3: Sales for Schizophrenia in the US by Drug Class, 2012... 102 Schizophrenia - US Drug Forecast and Market Analysis to 9
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, with an annual growth rate (AGR) of 0.59% in the forecast period. In, 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. Schizophrenia US Drug Forecast and Market Analysis to 10
Introduction 2.2 Related Reports GlobalData (2014). PharmaPoint: Schizophrenia - Global Drug Forecast and Market Analysis to, February 2014, GDHC81PIDR GlobalData (2014). Schizophrenia 5EU Drug Forecast and Market Analysis to, February 2014, GDHC225CFR GlobalData (2014). Schizophrenia Japan Drug Forecast and Market Analysis to, February 2014, GDHC226CFR GlobalData (2014). Abilify (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC355DFR GlobalData (2014). Saphris (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC356DFR GlobalData (2014). Clozaril (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC357DFR GlobalData (2014). Fanapt (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC358DFR GlobalData (2014). Latuda (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC359DFR GlobalData (2014). Zyprexa (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC360DFR GlobalData (2014). Invega (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC361DFR GlobalData (2014). Seroquel (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC362DFR GlobalData (2014). Risperdal (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC363DFR Schizophrenia US Drug Forecast and Market Analysis to 11
Introduction GlobalData (2014). Geodon (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC364DFR GlobalData (2014). Aripiprazole lauroxil (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC365DFR GlobalData (2014). Cariprazine (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC366DFR GlobalData (2014). Brexpiprazole (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC367DFR GlobalData (2014). Zicronapine (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC368DFR GlobalData (2014). Bitopertin (Schizophrenia) Forecast and Market Analysis to, February 2014, GDHC369DFR GlobalData (2014). EVP-6124 (Schizophrenia) Forecast and Market Analysis to, 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 Schizophrenia US Drug Forecast and Market Analysis to 12
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. Schizophrenia US Drug Forecast and Market Analysis to 133