ABOUT DATAMONITOR HEALTHCARE 2
About the Central Nervous System pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Datamonitor insight into the schizophrenia market 3
Contributing experts 6
Related reports 7
Upcoming reports 8
CHAPTER 2 PATIENT POTENTIAL 10
Definition of schizophrenia 11
Classification of schizophrenia 11
DSM-IV defined symptoms of schizophrenia 12
A - Characteristic symptoms 12
B - Social/occupational dysfunction 13
C - Duration 13
D - Schizoaffective and mood disorder exclusion 13
E - Substance/general medical condition exclusion 13
F - Relationship to a pervasive developmental disorder 14
Characterization of symptoms 14
Array of symptoms characterize the disorder 14
Symptoms subdivided into positive and negative 14
Ongoing discussion of symptom categories 14
Epidemiology of schizophrenia 16
Schizophrenia affects approximately 0.6% of the population 16
Etiology and course of schizophrenia 18
Age of onset 18
Risk factors 19
Co-morbidities of schizophrenia 19
Anxiety is the most prevalent co-morbidity of schizophrenia 21
Unmet needs in schizophrenia 21
Improving patient compliance 22
Innovative solutions for partial responders or refractory patients 24
Improving cognitive functioning 26
Treating negative symptoms 26
Reducing adverse events 27
CHAPTER 3 MARKET OVERVIEW 29
Seven major markets 30
Current market assessment 30
Sales revenue is dominated by atypical antipsychotics 30
Typical antipsychotics still constitute a significant share of the total volume of antipsychotic prescriptions 31
Comparison between regions 32
Future market assessment 36
Market value stagnation expected over forecast period 36
Genericization becomes a major issue in the schizophrenia market 37
Market value is sustained through uptake of depot atypicals 37
Opportunities and threats 42
Opportunities 42
Threats 43
CHAPTER 4 BRAND DYNAMICS 48
Overview of competitive landscape 49
Lack of gold standard antipsychotic 49
Leading brands and their evolution 49
Impact of generics on the current leading companies 50
Oral pipeline drugs offer limited competition for the current market leaders 51
Drivers of brand choice 53
Zyprexa 55
Zypadhera: olanzapine depot in pre-registration 56
Drug profile 56
Product positioning 57
Marketing mix 58
Brand forecast to 2017 59
Zyprexa: market leader over the last 4 years 2004-07 59
Zyprexa's sales widely reduced by market genericization from 2008 59
Zyprexa's sales affected by pipeline drug launch 60
Strategic recommendations 61
Risperdal 62
Drug profile 63
Product positioning 63
Marketing mix 64
Brand forecast to 2017 65
Risperdal second leading brand in 2007 65
Risperdal Oral widely affected by risperidone generics 66
Strategic recommendations 68
Risperdal Consta 68
Drug profile 71
Product positioning 72
Marketing mix 72
Brand forecast to 2017 74
Historical trends and geographic expansion 74
Risperdal Consta sales widely impacted by second generation depot's 74
Risperdal Consta generics 75
Strategic recommendations 76
Abilify 77
Drug profile 77
Product positioning 78
Marketing mix 80
Brand forecast to 2017 81
Strong Abilify sales growth from 2004 to 2007 81
Abilify forecast sales revenue benefits from a late genericization 82
Strategic recommendations 83
Seroquel 84
Drug profile 85
Product positioning 85
Marketing mix 86
Brand forecast to 2017 88
Seroquel XR likely to relieve Seroquel in schizophrenia treatment 88
Quetiapine generics are expected to threaten both version sales 88
Strategic recommendations 90
Geodon 90
Drug profile 91
Product positioning 92
Marketing mix 94
Brand forecast to 2017 95
Geodon's moderate success over the past 4 years will continue until 2012 95
Ziprasidone generics arrival in 2012: the major event likely to impact Geodon's sales revenue 95
Strategic recommendations 97
Invega 97
Drug profile 98
Product positioning 99
Marketing mix 100
Brand forecast to 2017 101
Strategic recommendations 103
Other recently launched atypical antipsychotics 104
Serdolect 104
Serdolect history 105
Brand forecast to 2017 106
Lonasen 106
Brand forecast to 2017 107
CHAPTER 5 PIPELINE OVERVIEW AND CLASSIFICATION 109
Pipeline overview 110
Classification of pipeline products 115
Serotonergic and dopaminergic receptor antipsychotics 115
Others 116
Glutamate (AMPA and NMDA) and glycine receptor modulators 116
Muscarinic M1 receptor agonist 116
Alpha 2 adrenoceptor antagonist 116
Nicotinic acetylcholine receptor modulators 117
CHAPTER 6 LATE STAGE DRUG ANALYSIS AND FORECASTS 118
Key late stage pipeline summary 119
Comparative forecasts 119
Comparative drug assessment 119
Definition of current comparator therapy 120
Zyprexa: leading brand on the schizophrenia market 120
Drugs in pre-registration 122
Zypadhera (olanzapine depot) 122
Drug overview 122
Forecasts to 2017 123
Datamonitor drug assessment summary 126
Marketing factors 126
Patient potential 127
Satisfaction of unmet needs 130
Clinical trial data 132
Paliperidone palmitate depot 135
Drug overview 135
Forecasts to 2017 135
Datamonitor drug assessment summary 138
Marketing factors 139
Patient potential 142
Satisfaction of unmet needs 143
Clinical trial data 144
Asenapine 149
Drug overview 149
Forecasts to 2017 150
Datamonitor drug assessment summary 152
Marketing factors 153
Patient potential 154
Satisfaction of unmet needs 155
Clinical trial data 157
Drugs in Phase III clinical trial 164
Bifeprunox 164
Drug overview 164
Forecasts to 2017 166
Marketing factors 168
Patient potential 169
Satisfaction of unmet needs 170
Clinical trial data 171
Lurasidone 176
Drug overview 176
Forecasts to 2017 177
Datamonitor drug assessment summary 179
Marketing factors 179
Patient potential 180
Satisfaction of unmet needs 181
Clinical trial data 182
Staccato loxapine (AZ-004) 189
Drug overview 189
Forecasts to 2017 190
Datamonitor drug assessment summary 192
Marketing factors 192
Patient potential 193
Satisfaction of unmet needs 195
Clinical trial data 197
Drugs in Phase II clinical trial 201
LY-2140023 201
Drug overview 201
Forecast to 2017 201
Datamonitor drug assessment 202
Marketing factor 203
Patient potential 204
Satisfaction of unmet needs 204
Clinical trial data 205
Unforecasted late-stage drug 207
Iloperidone 207
Drug overview 207
Forecasts to 2017 209
Marketing factors 210
Patient potential 210
Satisfaction of unmet needs 211
Clinical trial data for iloperidone oral 211
Clinical trial data for iloperidone depot 216
Other unforecasted drugs 217
Pimavanserin tartrate (ACP-103) 217
Drug overview 217
Clinical trial data 218
BL-1020 221
Drug overview 221
Clinical trial data 222
RGH-188 cariprazine 226
Drug overview 226
Clinical trial data 227
Erythropoietin - NTx-028 230
Drug overview 230
Clinical trial data 230
SAM-101 232
Drug overview 232
Clinical trial data 232
Preclinical study comparing minocycline and haloperidol 234
Sabcomeline 234
Drug overview 234
PF-02545920 235
Drug overview 235
Clinical trial data 235
PNB-02 237
Drug overview 237
BIBLIOGRAPHY 238
Journal papers, books, and conference abstracts 238
Websites 247
Datamonitor reports 254
Annual reports 254
APPENDIX A - MARKET ASSUMPTIONS 256
New product launches 256
Patent expiries 256
Data definitions, limitations and assumptions 258
Standard units 258
Japanese market data 258
Derivation of sales forecasts and pricing trends 258
Indication-specific sales methodology 259
Schizophrenia-specific sales calculations 259
ICD-10 codes used to define current schizophrenia market 259
Diagnosis values for key brands 260
Datamonitor drug assessment summary 260
Forecast methodology 262
APPENDIX B 263
Contributing experts 263
About Datamonitor 263
About Datamonitor Healthcare 264
Datamonitor Healthcare's therapy area capabilities 264
About the Disease analysis team 265
Disclaimer 266
List of Tables
Table 1: Diagnostic criteria for schizophrenia and its subtypes 11
Table 2: Prevalence studies of schizophrenia 17
Table 3: Prevalence of schizophrenia in the seven major markets, 2008 18
Table 4: Prevalence of patients with schizophrenia exhibiting co-morbid psychiatric disorders across the US, EU and Japan (%), 2005 20
Figure 3: Unmet needs in schizophrenia, 2008 22
Table 5: Sales forecasts for schizophrenia market in the seven major markets ($m), 2007-2017 39
Table 6: Key branded atypical antipsychotics patent's expiry dates across the US, the 5EU and Japan (1/2) 44
Table 7: Summary of opportunities and threats in the schizophrenia market across the seven major markets, 2008 47
Table 8: Leading branded drug sales revenue ($m) for schizophrenia in the seven major markets, 2007 and 2017 50
Table 9: Key products in late-stage R&D pipeline for schizophrenia, 2008 51
Table 10: Comparison of leading brands for schizophrenia, 2008 52
Table 11: Zyprexa - Drug profile, 2008 57
Table 12: Impacting factors on Zyprexa revenues, 2007-2017 61
Table 13: Risperdal - Drug profile, 2008 63
Table 14: Impacting factors on Risperdal Oral revenues, 2007-2017 67
Table 15: Risperdal Consta - Drug profile, 2008 71
Table 16: Factors impacting on Risperdal Consta revenues, 2007-2017 76
Table 17: Abilify - Drug profile, 2008 78
Table 18: Impacting factors on Abilify revenues, 2007-2017 83
Table 19: Seroquel - Drug profile, 2008 85
Table 20: Impacting factors on Seroquel's revenues, 2007-2017 90
Table 21: Geodon - Drug profile, 2008 92
Table 22: Impacting factors on Geodon's revenues, 2007-2017 96
Table 23: Invega - Drug profile, 2008 99
Table 24: Impacting factors on Invega revenues, 2007-2017 103
Table 25: Number of key schizophrenia drugs by type of mechanism of action and phase of development, 2008 110
Table 26: Pipeline drugs in pre-registration for the treatment of schizophrenia, 2008 111
Table 27: Pipeline drugs in Phase III development for the treatment of schizophrenia, 2008 112
Table 28: Pipeline drugs in Phase II development for the treatment of schizophrenia, 2008 112
Table 29: Pipeline drugs in Phase II development for the treatment of cognitive disorder associated with schizophrenia, 2008 115
Table 30: Eli Lilly's Zyprexa: key facts 121
Table 31: Impacting factors on Zypadhera sales revenue, 2009-2017 125
Table 32: Satisfaction of unmet needs assessment - Zypadhera (olanzapine depot), 2008 130
Table 33: Clinical trial summary - Zypadhera 132
Table 34: Impacting factors on paliperidone palmitate revenues, 2009-2017 137
Table 35: Comparison of paliperidone palmitate depot versus Risperdal Consta 141
Table 36: Satisfaction of unmet needs assessment - paliperidone palmitate depot, 2008 144
Table 37: Clinical trial summary - paliperidone palmitate 145
Table 38: Ongoing Phase III Clinical trial summary - paliperidone palmitate 146
Table 39: Impacting factors on asenapine revenues, 2009-2017 151
Table 40: Satisfaction of unmet needs assessment - asenapine, 2008 156
Table 41: Phase III clinical trial summary - asenapine, 2008 157
Table 42: Phase I and II clinical trial summary - asenapine, 2008 158
Table 43: Satisfaction of unmet needs assessment - bifeprunox, 2008 170
Table 44: Completed clinical trial summary - bifeprunox (DU127090) 172
Table 45: Ongoing clinical trial summary - bifeprunox 173
Table 46: Impacting factors on lurasidone revenues, 2011-2017 178
Table 47: Satisfaction of unmet needs assessment - lurasidone, 2008 182
Table 48: Ongoing clinical trial summary Lurasidone 183
Table 49: Completed clinical trial summary Lurasidone 184
Table 50: Satisfaction of unmet needs assessment - Staccato loxapine, 2008 197
Table 51: Clinical trial summary - Staccato™ Loxapine, AZ-004 198
Table 52: Impacting factors on LY-2140023revenues, 2014-17 202
Table 53: Satisfaction of unmet needs assessment - LY-2140023, 2008 205
Table 54: Clinical trial summary - LY-2140023 206
Table 55: Satisfaction of unmet needs assessment - iloperidone, 2008 211
Table 56: Phase III Clinical trial summary - Iloperidone oral 212
Table 57: Clinical trial summary - pimavanserin tartrate (ACP-103) 219
Table 58: Phase I clinical trial summary - BL-1020 223
Table 59: Phase II clinical trial summary - BL-1020 224
Table 60: Clinical trial summary - RGH-188 (cariprazine) 228
Table 61: Clinical trial summary - SAM-101 233
Table 62: Clinical trial summary - PF-254592 236
Table 63: Datamonitor's launch dates for schizophrenia products across the US, 5EU and Japan, 2008-2017 256
Table 64: Key branded atypical antipsychotics patent's expiry dates across the US, the 5EU and Japan (1/2) 257
Table 65: ICD-10 and DSM-IV codes for schizophrenia 260
Table 66: Schizophrenia diagnosis values (%) for key brands sales ($) in the US, 2005-07 260
Table 67: Datamonitor drug assessment parameters 261
List of Figures
Figure 1: Schizophrenia-specific sales revenue distribution by drug type across the seven major markets ($m), 2004-2017 5
Figure 2: Datamonitor drug competitive positioning analysis of pipeline drugs in development for schizophrenia in the seven major markets over the forecast period, 2008-2017 6
Figure 4: Schizophrenia sales revenue distribution between typical and atypical antipsychotics in the US, 5EU and Japan ($m), 2004-07 31
Figure 5: Schizophrenia sales volume distribution between typical and atypical antipsychotics (standard units million) in the US, 5EU and Japan, 2004-07 32
Figure 6: Schizophrenia sales revenue ($m) in the US, 5EU and Japan, 2004-07 33
Figure 7: Schizophrenia sales volume (standard units million; SUm) in the US and 5EU, 2004-07 34
Figure 8: Schizophrenia sales revenue distribution between atypical antipsychotics brands and conventional antipsychotics in the US, 5EU and Japan ($m), 2007 35
Figure 9: Key events impacting the schizophrenia market, 2004-08 36
Figure 10: Schizophrenia-specific sales revenue distribution by drug type across the seven major markets ($m), 2004-2017 37
Figure 11: Schizophrenia-specific sales volume distribution by drug type across the seven major markets (SUm), 2004-2017 38
Figure 12: Market share of drug type for schizophrenia across the seven major markets, 2007 and 2017 40
Figure 13: Key events impacting the schizophrenia market, 2007-2017 41
Figure 14: Drivers of brand choice for the treatment of schizophrenia, 2008 53
Figure 15: Zyprexa all-indication promotional spend in the US and 5EU ($m), 2005-07 59
Figure 16: The effect of patent expiry on the sales of Eli Lilly's Zyprexa (olanzapine) for schizophrenia in the seven major markets ($m), 2004-2017 60
Figure 17: Risperdal Oral all-indication promotional spend ($m) in the US and 5EU, 2005-07 65
Figure 18: The effect of patent expiry on the sales of Johnson & Johnson's Risperdal Oral (risperidone) for schizophrenia in the seven major markets ($m), 2004-2017 67
Figure 19: Risperdal Consta all-indication promotional spend in the US and 5EU ($m), 2005-07. 73
Figure 20: The effect of patent expiry and paliperidone palmitate depot launch on the sales of Johnson & Johnson's Risperdal Consta (risperidone depot) for schizophrenia in the seven major markets ($m), 2004-2017 75
Figure 21: Abilify all-indication promotional spend in the US and 5EU ($m), 2005-07 81
Figure 22: The effect of patent expiry on the sales of Otsuka/Bristol-Myers Squibb's Abilify (aripiprazole) for schizophrenia in the seven major markets ($m), 2004-2017 82
Figure 23: Seroquel franchise all-indication promotional spend in the US and 5EU ($m), 2005-07 87
Figure 24: Seroquel all-indication promotional expenses by channel in the US and 5EU ($m), 2007 88
Figure 25: The effect of the extended release version and patent expiry on the sales of AstraZeneca's Seroquel (quetiapine) for schizophrenia in the seven major markets ($m), 2004-2017 89
Figure 26: Geodon all-indication promotional spend in the US and 5EU ($m), 2005-07 94
Figure 27: The effect of patent expiry on the sales of Pfizer's Geodon (ziprasidone) for schizophrenia in the seven major markets ($m), 2004-2017 96
Figure 28: Invega all-indication promotional spend in the US and 5EU ($m), 2005-07 101
Figure 29: The effect of patent expiry on the sales of Johnson & Johnson's Invega (paliperidone) for schizophrenia in the seven major markets ($m), 2004-2017 102
Figure 30: The effect of US launch and patent expiry on the sales of Lundbeck's Serdolect for schizophrenia in the 7MM ($m), 2004-2017 106
Figure 31: Forecast sales of Dainippon-Sumitomo's Lonasen for schizophrenia in the 7MM ($m), 2004-2017 107
Figure 32: Comparative schizophrenia-specific sales ($m) forecast for key late-stage pipeline drugs in the seven major markets, 2008-2017 119
Figure 33: Datamonitor drug assessment summary of pipeline drugs in development for schizophrenia across the seven major markets,2008-2017 120
Figure 34: Sales forecast for Zypadhera in schizophrenia to 2017 across the seven major markets 124
Figure 35: Eli Lilly's schizophrenia sales revenue across the seven major markets, 2004-2017 125
Figure 36: Datamonitor's competitive positioning analysis of Zypadhera in schizophrenia across the seven major markets, 2008-2017 126
Figure 37: Sales forecast for paliperidone palmitate in schizophrenia to 2017 across the seven major markets 136
Figure 38: Johnson & Johnson's schizophrenia-specific sales revenue across the seven major markets, 2004-2017 138
Figure 39: Datamonitor's competitive positioning analysis of paliperidone palmitate in schizophrenia across the seven major markets, 2008-2017 139
Figure 40: Sales forecast for asenapine in schizophrenia to 2017 across the seven major markets 151
Figure 41: Datamonitor's competitive positioning analysis of asenapine in schizophrenia across the seven major markets, 2007-2017 153
Figure 42: Sales forecast for bifeprunox in schizophrenia to 2017, 5EU 167
Figure 43: Datamonitor's competitive positioning analysis of bifeprunox in schizophrenia across the 7MM, 2008-17 168
Figure 44: Sales forecast for lurasidone in schizophrenia to 2017 across the seven major markets 178
Figure 45: Datamonitor's competitive positioning analysis of lurasidone in schizophrenia across the seven major markets, 2007-2017 179
Figure 46: Staccato system - single dose platform 190
Figure 47: Sales forecast for Staccato loxapine in schizophrenia to 2017 across the seven major markets 191
Figure 48: Datamonitor's competitive positioning analysis of Staccato loxapine in schizophrenia across the seven major markets, 2007-2017 192
Figure 49: Sales forecast for LY-2140023 in schizophrenia to 2017across the seven major markets 202
Figure 50: Datamonitor's competitive positioning analysis of LY-2140023 in schizophrenia across the seven major markets, 2008-2017 203
Figure 51: Datamonitor drug assessment summary of pipeline drugs in development for schizophrenia over the forecast period 2008-2017 across the seven major markets. 262