PharmaPoint: Schizophrenia – Global Drug 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.

Highlights

Key Questions Answered

– What are the preferred antipsychotic therapies for each country?
– The developmental pipeline consists of LAI antipsychotics that address medication compliance concerns. Which of these LAIs will attain high sales revenues during 2012-2022 and in which markets?
– Will LAI antipsychotics face adoption challenges in the market? What is the projected uptake of new LAIs, such as Otsuka/Lundbeck’s Abilify Maintena and Alkermes’ Aripiprazole lauroxil, over the forecast period?
– How large an impact will bitopertin and EVP-6124 have on the schizophrenia market? What do key opinion leaders think of these treatment approaches?
– What governmental and industry developments are likely to affect healthcare access and treatment rates in the markets researched? Which is the largest growth market globally?

Key Findings

– Country-specific mental health policy heavily influences antipsychotics prescribing patterns and sales in the marketplace.
– The impact of negative and cognitive symptom therapies in the marketplace will be challenging without the use of biomarkers and laboratory measurements that can demonstrate a patient’s response to treatment.
– Patient and prescriber endorsements of new and existing LAIs, in particular, atypical LAI antipsychotics, are anticipated to dramatically influence market growth.
– Major players will leverage their R&D, manufacturing, and distribution networks to maintain their stakes in the market.

Scope

– Overview of schizophrenia, including etiology, general symptoms, and country-specific treatment recommendations and compliance data.
– Annualized schizophrenia market revenue, annual cost of vaccination and treatment usage pattern data from 2012 and forecast for ten years to 2022.
– Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the schizophrenia market.
– Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically as Otsuka/Lundbeck’s Abilify Maintena and Alkermes’ Aripiprazole lauroxil.
– Analysis of the current and future market competition in the global schizophrenia drug market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

– Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
– Develop business strategies by understanding the trends shaping and driving the schizophrenia market.
– Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global schizophrenia market in the future.
– Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
– Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
– Track drug sales in the global schizophrenia market from 2012-2022.
– Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 16
1.2 List of Figures 21
2 Introduction 22
2.1 Catalyst 22
2.2 Upcoming Reports 22
3 Disease Overview 23
3.1 Etiology and Pathophysiology 23
3.1.1 Etiology 23
3.1.2 Pathophysiology 24
3.2 Symptoms 25
4 Epidemiology 26
4.1 Disease Background 26
4.2 Risk Factors and Comorbidities 27
4.2.1 Psychiatric illness in first-degree relatives is a strong predictor of schizophrenia 28
4.2.2 Advancing paternal age increases the risk of schizophrenia in offspring 29
4.2.3 Psychiatric comorbidities are common in patients with schizophrenia 30
4.2.4 People with schizophrenia suffer from several medical comorbidities 31
4.3 Global Trends 34
4.3.1 US 37
4.3.2 5EU 38
4.3.3 Japan 41
4.4 Forecast Methodology 42
4.4.1 Sources Used 42
4.4.2 Sources Not Used 45
4.4.3 Forecast Assumptions and Methods, Prevalent Cases 45
4.5 Epidemiological Forecast of Schizophrenia (2012-2022) 47
4.5.1 Diagnosed Prevalent Cases of Schizophrenia 47
4.5.2 Age-Specific Prevalent Cases of Schizophrenia 49
4.5.3 Sex-Specific Prevalent Cases of Schizophrenia 51
4.5.4 Age-Standardized Diagnosed Prevalence of Schizophrenia 53
4.6 Discussion 54
4.6.1 Epidemiological Forecast Insight 54
4.6.2 Limitations of the Analysis 55
4.6.3 Strengths of the Analysis 56
5 Disease Management 57
5.1 Diagnosis 57
5.1.1 Subjective Assessments 58
5.1.2 Disease Subtypes 59
5.2 Treatment Overview 62
5.2.1 Treatment of Acute Agitation Associated with Schizophrenia 64
5.2.2 Maintenance Treatment of Schizophrenia 65
5.3 US 66
5.3.1 Diagnosis 66
5.3.2 Clinical Practice 66
5.4 France 67
5.4.1 Diagnosis 67
5.4.2 Clinical Practice 68
5.5 Germany 69
5.5.1 Diagnosis 69
5.5.2 Clinical Practice 69
5.6 Italy 71
5.6.1 Diagnosis 71
5.6.2 Clinical Practice 71
5.7 Spain 72
5.7.1 Diagnosis 72
5.7.2 Clinical Practice 72
5.8 UK 73
5.8.1 Diagnosis 73
5.8.2 Clinical Practice 74
5.9 Japan 75
5.9.1 Diagnosis 75
5.9.2 Clinical Practice 75
6 Competitive Assessment 77
6.1 Overview 77
6.2 Strategic Competitor Assessment 78
6.3 Product Profiles by Generation 79
6.3.1 Conventional Antipsychotics 79
6.3.2 Atypical Antipsychotics 83
7 Opportunity and Unmet Need 120
7.1 Unmet Needs Overview 120
7.1.1 Public Awareness 121
7.1.2 Early Diagnosis and Treatment 123
7.1.3 Long-Acting and Advanced Drug Delivery Systems 124
7.1.4 Effective Management of Negative and Cognitive Symptom Domains 125
7.2 Gap Analysis 126
7.2.1 Long-Acting Drug Delivery 127
7.2.2 Treatment of Negative and Cognitive Symptoms 127
8 Pipeline Assessment 128
8.1 Overview 128
8.2 Clinical Trial Mapping 129
8.2.1 Clinical Trials by Country 129
8.2.2 Clinical Trials by Phase and Trial Status 130
8.3 Early-Stage Pipeline Assessment 131
8.4 Novel Therapeutic Approaches 132
8.4.1 Negative Symptoms 132
8.4.2 Cognitive Symptoms 132
8.5 Long-Acting Drug Delivery 133
8.6 Technology Trends Analysis 133
8.7 Key Drugs in Clinical Development 134
8.7.1 Aripiprazole Lauroxil 136
8.7.2 Cariprazine 141
8.7.3 Brexpiprazole 145
8.7.4 Zicronapine 149
8.7.5 Bitopertin 152
8.7.6 EVP-6124 156
9 Current and Future Players 160
9.1 Overview 160
9.2 Trends in Corporate Strategy 161
9.3 Company Profiles 161
9.3.1 Janssen Pharmaceuticals 161
9.3.2 Eli Lilly and Company 164
9.3.3 Roche 166
9.3.4 Alkermes 168
9.3.5 EnVivo Pharmaceuticals 170
10 Market Outlook 172
10.1 Global Markets 172
10.1.1 Forecast 172
10.1.2 Global Drivers and Barriers 176
10.2 US 177
10.2.1 Forecast 177
10.2.2 Key Events 181
10.2.3 Drivers and Barriers 181
10.3 France 184
10.3.1 Forecast 184
10.3.2 Key Events 187
10.3.3 Drivers and Barriers 187
10.4 Germany 189
10.4.1 Forecast 189
10.4.2 Key Events 193
10.4.3 Drivers and Barriers 193
10.5 Italy 195
10.5.1 Forecast 195
10.5.2 Key Events 198
10.5.3 Drivers and Barriers 199
10.6 Spain 201
10.6.1 Forecast 201
10.6.2 Key Events 204
10.6.3 Drivers and Barriers 204
10.7 UK 205
10.7.1 Forecast 205
10.7.2 Key Events 208
10.7.3 Drivers and Barriers 208
10.8 Japan 210
10.8.1 Forecast 210
10.8.2 Key Events 213
10.8.3 Drivers and Barriers 213
11 Appendix 216
11.1 Bibliography 216
11.2 Abbreviations 231
11.3 Methodology 236
11.4 Forecasting Methodology 236
11.4.1 Diagnosis and Treatment Rates 236
11.4.2 Adherence Rates 237
11.4.3 Drugs Included in Each Therapeutic Class 237
11.4.4 Launch and Patent Expiry Dates 238
11.4.5 General Pricing Assumptions 239
11.4.6 Drug Assumptions 240
11.4.7 Generic Erosion 247
11.4.8 Pricing of Pipeline Agents 247
11.5 Key Opinion Leaders 249
11.6 About the Authors 250
11.6.1 Author 250
11.6.2 Epidemiology 250
11.6.3 Reviewers 251
11.6.4 Global Head of Healthcare 251
11.7 About GlobalData 252
11.8 Disclaimer 252

1.1 List of Tables
Table 1: Symptom Clusters of Schizophrenia 25
Table 2: ICD-9 Codes and Classification of Schizophrenia 27
Table 3: Risk Factors and Comorbidities for Schizophrenia 28
Table 4: Prevalence of Most Frequent Comorbidities in People with Schizophrenia and People without Schizophrenia, Both Sexes, Ages ?18 Years, 2007 32
Table 5: Prevalence of Most Frequent Comorbidities in People with Schizophrenia and People without Schizophrenia, 1996-2001 33
Table 6: Distribution of Estimates of Schizophrenia from Three Meta-Analysis Studies of Incidence, Prevalence, and Mortality, by Sex 36
Table 7: Trends in the Annual Incidence of Schizophrenia (per 100,000 Population), Portogruaro, Italy, 1982-1989 38
Table 8: Trends in the Prevalence of Schizophrenia (per 1,000 Population), Portogruaro, Italy, 1982-1989 39
Table 9: Trends in the Prevalence of Schizophrenia (per 1,000 Population), Japan, 1984-2008 41
Table 10: Sources of Schizophrenia Prevalence Data 42
Table 11: 7MM, Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, Ages ?15 Years, N, 2012-2022 48
Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, N (Row %), 2012 50
Table 13: 7MM, Sex-Specific Diagnosed Prevalent Cases of Schizophrenia, Ages ?15 Years, N (Row %), 2012 52
Table 14: Common Subjective Rating Scales Employed in Schizophrenia Diagnosis 59
Table 15: Development-Based Classification of Antipsychotic Drugs 62
Table 16: Receptor Binding Profiles of Atypical Antipsychotics 63
Table 17: Guidelines for the Treatment of Schizophrenia 64
Table 18: Leading Branded Treatments for Schizophrenia, 2013 79
Table 19: Strategic Competitor Assessment of the Marketed Products in Schizophrenia, 2014 79
Table 20: Chemical Classifications of FGAs 80
Table 21: Receptor Affinity Profiles for FGAs 81
Table 22: First-Generation Antipsychotics SWOT Analysis, 2013 82
Table 23: Global Sales Forecast ($m) for First-Generation Antipsychotics, 2012-2022 83
Table 24: Product Profile - Abilify 86
Table 25: Abilify SWOT Analysis, 2014 89
Table 26: Global Sales Forecast ($m) for Abilify, 2012-2022 90
Table 27: Product Profile - Saphris 91
Table 28: Saphris SWOT Analysis, 2013 93
Table 29: Global Sales Forecast ($m) for Saphris, 2012-2022 94
Table 30: Product Profile - Clozaril 95
Table 31: Clozaril SWOT Analysis, 2014 96
Table 32: Global Sales Forecast ($m) for Clozaril, 2012-2022 96
Table 33: Product Profile - Fanapt 97
Table 34: Fanapt SWOT Analysis, 2014 99
Table 35: Global Sales Forecast ($m) for Fanapt, 2012-2022 99
Table 36: Product Profile - Latuda 100
Table 37: Latuda SWOT Analysis, 2014 102
Table 38: Global Sales Forecasts ($m) for Latuda, 2012-2022 102
Table 39: Product Profile - Zyprexa 104
Table 40: Zyprexa SWOT Analysis, 2014 107
Table 41: Global Sales Forecast ($m) for Zyprexa, 2012-2022 107
Table 42: Product Profile - Invega 108
Table 43: Invega SWOT Analysis, 2013 110
Table 44: Global Sales Forecast ($m) for Invega, 2012-2022 110
Table 45: Product Profile - Seroquel 111
Table 46: Seroquel SWOT Analysis, 2013 112
Table 47: Global Sales Forecast ($m) for Seroquel, 2012-2022 113
Table 48: Product Profile - Risperdal 114
Table 49: Risperdal SWOT Analysis, 2013 116
Table 50: Global Sales Forecast ($m) for Risperdal, 2012-2022 116
Table 51: Product Profile - Geodon 117
Table 52: Geodon SWOT Analysis, 2013 118
Table 53: Global Sales Forecasts ($m) for Geodon, 2012-2022 119
Table 54: Unmet Needs - Current Level of Attainment 121
Table 55: Clinical Unmet Needs - Gap Analysis, 2013 126
Table 56: Schizophrenia - Clinical Trials by Phase and Status, Global, 2014 130
Table 57: Technological Trends Analytic Framework in the Schizophrenia Pipeline, 2014 134
Table 58: Pipeline Candidates in Development for Schizophrenia, 2014 134
Table 59: Comparison of Novel Therapeutic Classes in Development for Schizophrenia, 2013 135
Table 60: Product Profile - Aripiprazole Lauroxil 136
Table 61: Aripiprazole Lauroxil SWOT Analysis, 2014 140
Table 62: Global Sales Forecast ($m) for Aripiprazole Lauroxil, 2012-2022 140
Table 63: Product Profile - Cariprazine 141
Table 64: Cariprazine SWOT Analysis, 2014 144
Table 65: Global Sales Forecast ($m) for Cariprazine, 2012-2022 145
Table 66: Product Profile - Brexpiprazole 146
Table 67: Brexpiprazole SWOT Analysis, 2014 148
Table 68: Global Sales Forecasts ($m) for Brexpiprazole, 2012-2022 148
Table 69: Product Profile - Zicronapine 149
Table 70: Zicronapine SWOT Analysis, 2014 151
Table 71: Global Sales Forecast ($m) for Zicronapine, 2012-2022 152
Table 72: Product Profile - Bitopertin 153
Table 73: Bitopertin SWOT Analysis, 2014 155
Table 74: Global Sales Forecast ($m) for Bitopertin, 2012-2022 156
Table 75: Product Profile - EVP-6124 157
Table 76: EVP-6124 SWOT Analysis, 2014 159
Table 77: Global Sales Forecast ($m) for EVP-6124, 2012-2022 159
Table 78: Janssen Schizophrenia Portfolio Assessment, 2014 163
Table 79: Janssen SWOT Analysis, 2014 164
Table 80: Eli Lilly Schizophrenia Portfolio Assessment, 2014 166
Table 81: Eli Lilly SWOT Analysis, 2014 166
Table 82: Roche Schizophrenia Portfolio Assessment, 2014 167
Table 83: Roche SWOT Analysis, 2014 168
Table 84: Alkermes Schizophrenia Portfolio Assessment, 2014 169
Table 85: Alkermes SWOT Analysis, 2014 169
Table 86: EnVivo Schizophrenia Portfolio Assessment, 2014 170
Table 87: EnVivo Pharmaceuticals SWOT Analysis, 2014 171
Table 88: Global Sales Forecast ($m) for Schizophrenia, 2012-2022 174
Table 89: Global Schizophrenia Market, Drivers and Barriers, 2012-2022 176
Table 90: Sales Forecast ($m) for Schizophrenia in the US, 2012-2022 179
Table 91: Key Events Impacting Sales for Schizophrenia in the US, 2012-2022 181
Table 92: Schizophrenia Market in the US - Drivers and Barriers, 2012-2022 181
Table 93: Sales Forecast ($m) for Schizophrenia in France, 2012-2022 185
Table 94: Key Events Impacting Sales for Schizophrenia in France, 2012-2022 187
Table 95: Schizophrenia Market in France - Drivers and Barriers, 2012-2022 187
Table 96: Sales Forecast ($m) for Schizophrenia in Germany, 2012-2022 191
Table 97: Key Events Impacting Sales for Schizophrenia in Germany, 2012-2022 193
Table 98: Schizophrenia Market in Germany - Drivers and Barriers, 2012-2022 193
Table 99: Sales Forecast ($m) for Schizophrenia in Italy, 2012-2022 196
Table 100: Key Events Impacting Sales for Schizophrenia in Italy, 2012-2022 198
Table 101: Schizophrenia Market in Italy - Drivers and Barriers, 2012-2022 199
Table 102: Sales Forecast ($m) for Schizophrenia in Spain, 2012-2022 202
Table 103: Key Events Impacting Sales for Schizophrenia in Spain, 2012-2022 204
Table 104: Schizophrenia Market in Spain - Drivers and Barriers, 2012-2022 204
Table 105: Sales Forecast ($m) for Schizophrenia in the UK, 2012-2022 206
Table 106: Key Events Impacting Sales for Schizophrenia in the UK, 2012-2022 208
Table 107: Schizophrenia Market in the UK - Drivers and Barriers, 2012-2022 208
Table 108: Sales Forecast ($m) for Schizophrenia in Japan, 2012-2022 211
Table 109: Key Events Impacting Sales for Schizophrenia in Japan, 2012-2022 213
Table 110: Schizophrenia Market in Japan - Drivers and Barriers, 2012-2022 213
Table 111: Key Launch Dates 238
Table 112: Key Patent Expirations 239

1.2 List of Figures
Figure 1: 7MM, Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, Ages ?15 Years, N, 2012-2022 48
Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, N, 2012 51
Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of Schizophrenia, Ages ?15 Years, N, 2012 53
Figure 4: 6MM, Age-Standardized Diagnosed Prevalence (%) of Schizophrenia, Ages ?15 Years, by Sex, 2012 54
Figure 5: Active Schizophrenia Clinical Trials by Location in the 7MM, 2014 129
Figure 6: Schizophrenia - Pipeline Drugs by Target, 2014 131
Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012-2022 135
Figure 8: Schizophrenia Therapeutics - Pipeline by Company, 2014 160
Figure 9: Global Schizophrenia Drug Sales by Region, 2012-2022 175
Figure 10: Sales for Schizophrenia in the US by Drug Class, 2012-2022 180
Figure 11: Sales for Schizophrenia in France by Drug Class, 2012-2022 186
Figure 12: Sales for Schizophrenia in Germany by Drug Class, 2012-2022 192
Figure 13: Sales for Schizophrenia in Italy by Drug Class, 2012-2022 197
Figure 14: Sales for Schizophrenia in Spain by Drug Class, 2012-2022 203
Figure 15: Sales for Schizophrenia in the UK by Drug Class, 2012-2022 207
Figure 16: Sales for Schizophrenia in Japan by Drug Class, 2012-2022 212