Summary
Schizophrenia is a heterogeneous behavioral and cognitive syndrome involving chronic or recurrent psychosis. The disorder is characterized by several symptom domains including positive symptoms (such as hallucinations or delusions and disorganized speech), negative symptoms (such as a flat affect and poverty of speech), and cognitive deficits (including attention, memory, and executive functions). A multitude of antipsychotic products are currently available for the pharmacological management of schizophrenia, many of which are already available as inexpensive generics. Further patent and exclusivity losses in key franchises throughout the forecast period will act as a barrier to growth in the 7MM, making the schizophrenia market more competitive and crowded. Growth in the schizophrenia market is expected to be driven by the potential introduction of six promising late-stage pipeline products into the market during the forecast period, all of which are directed towards significant unmet needs.
GlobalData estimates that drug sales for schizophrenia in the 5EU reached $806.5m in 2015. As with the US market, a number of brands available in the 5EU are expected to face generic erosion following patent expiry during the forecast period. The patents protecting Janssen’s Invega, Invega Sustenna (known as Xeplion within the 5EU), and Risperdal Consta; AstraZeneca’s Seroquel; Eli Lilly’s Zyprexa (known as Zypadhera); and Allergan’s Vraylar (marketed by Gedeon Richter in the 5EU) are all due to expire throughout the forecast period, leaving the 5EU to become widely genericized and limiting sales growth in these markets.
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Scope
- Overview of Schizophrenia including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the 5EU from 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU Schizophrenia market.
Reasons to buy
- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for Schizophrenia.
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of drug performance
- Obtain sales forecast for drugs from 2015-2025 in the 5EU.
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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 12
2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology 15
3.1.1 Etiology 15
3.1.2 Pathophysiology 17
3.2 Classification 19
3.3 Symptoms 23
3.4 Course 26
3.5 Prognosis 27
4 Disease Management 29
4.1 Diagnosis Overview 29
4.1.1 Clinical Evaluation 29
4.2 Treatment Overview 31
4.2.1 Treatment Initiation 31
4.2.2 Maintenance Treatment 33
4.2.3 Treatment of Breakthrough Episodes 34
4.2.4 Long-Acting Injectables 35
4.2.5 Treatment-Resistance 37
4.2.6 Acute Agitation 41
4.2.7 Adjunctive Psychotherapy 42
4.3 Treatment Guidelines and Leading Prescribed Drugs 43
4.4 5EU 45
5 Competitive Assessment 49
5.1 Overview 49
5.2 Product Profiles - Atypical Antipsychotics 52
5.2.1 Abilify (aripiprazole) 52
5.2.2 Aristada (aripiprazole lauroxil) 65
5.2.3 Clozapine (widely genericized) 72
5.2.4 Fanapt (iloperidone) 79
5.2.5 Geodon (ziprasidone) 86
5.2.6 Invega (paliperidone) 91
5.2.7 Latuda (lurasidone) 105
5.2.8 Lonasen (blonanserin) 112
5.2.9 Rexulti (brexpiprazole) 117
5.2.10 Risperdal (risperidone) 123
5.2.11 Saphris (asenapine) 136
5.2.12 Seroquel (quetiapine) 143
5.2.13 Vraylar (cariprazine) 156
5.2.14 Zyprexa (olanzapine) 163
5.3 Product Profiles - Typical Antipsychotics 176
5.3.1 Typical Antipsychotics 176
5.3.2 Adasuve (Staccato loxapine) 180
5.4 Other Therapeutic Classes 186
6 Unmet Needs and Opportunities 187
6.1 Overview 187
6.2 Development of Cognitive-Enhancing Drugs 189
6.2.1 Unmet Need 189
6.2.2 Gap Analysis 190
6.2.3 Opportunity 190
6.3 Development of Drugs to Treat Negative Symptoms 190
6.3.1 Unmet Need 190
6.3.2 Gap Analysis 191
6.3.3 Opportunity 192
6.4 Improved Treatment Options for Treatment-Resistant Patients 192
6.4.1 Unmet Need 192
6.4.2 Gap Analysis 193
6.4.3 Opportunity 193
6.5 Development of Drugs with Enhanced Safety Profiles 194
6.5.1 Unmet Need 194
6.5.2 Gap Analysis 195
6.5.3 Opportunity 195
6.6 Development of Drugs to Increase Compliance 195
6.6.1 Unmet Need 195
6.6.2 Gap Analysis 197
6.6.3 Opportunity 197
7 Pipeline Assessment 198
7.1 Overview 198
7.1.1 Clinical Trials by Class of Therapy 198
7.2 Promising Drugs in Clinical Development 199
7.2.1 ALKS-3831 201
7.2.2 ITI-007 209
7.2.3 Lu AF35700 218
7.2.4 MIN-101 221
7.2.5 Risperidone implant 230
7.2.6 Risperidone ISM 237
7.2.7 RBP-7000 242
7.2.8 AVN-211 251
7.2.9 NaBen 259
7.3 Other Drugs in Development 267
8 Market Outlook 270
8.1 5EU 270
8.1.1 Forecast 270
8.1.2 Key Events 273
8.1.3 Drivers and Barriers 274
9 Appendix 275
9.1 Bibliography 275
9.2 Abbreviations 317
9.3 Methodology 323
9.4 Forecasting Methodology 323
9.4.1 Diagnosed Schizophrenia Patients 323
9.4.2 Percent Drug-Treated Patients 324
9.4.3 Launch and Patent Expiry Dates 324
9.4.4 General Pricing Assumptions 325
9.4.5 Individual Drug Assumptions 326
9.4.6 Generic Erosion 341
9.4.7 Pricing of Pipeline Agents 341
9.5 Primary Research - KOLs Interviewed for this Report 343
9.6 Primary Research - Prescriber Survey 345
9.7 About the Authors 346
9.7.1 Analyst 346
9.7.2 Therapy Area Director 347
9.7.3 Epidemiologist 347
9.7.4 Managing Epidemiologist 347
9.7.5 Global Director of Therapy Analysis and Epidemiology 348
9.8 About GlobalData 349
9.9 Disclaimer 349
1.1 List of Tables
Table 1: DSM-V Schizophrenia Specifiers 20
Table 2: Classification of Schizophrenia According to DSM-IV and ICD-10 22
Table 3: Other Schizophrenia Spectrum Disorders, 2015 23
Table 4: Symptoms of Schizophrenia 25
Table 5: Treatment Guidelines for Schizophrenia 44
Table 6: Most Prescribed Drugs for Schizophrenia in the 7MM, 2015 45
Table 7: Country Profile - 5EU 48
Table 8: Leading Treatments for Schizophrenia, 2015 51
Table 9: Product Profile - Abilify 55
Table 10: Efficacy Results for Abilify in Schizophrenia Trials 57
Table 11: Efficacy Results for Abilify in Schizophrenia Trials 59
Table 12: AEs at ≥2% Incidence in Schizophrenia and Bipolar I Disorder Trials of Abilify 61
Table 13: AEs at ≥2% Incidence in a Schizophrenia Trial of Abilify Maintena 63
Table 14: Abilify SWOT Analysis, 2016 64
Table 15: Product Profile - Aristada 68
Table 16: Efficacy Results for Aristada in Schizophrenia Trial 69
Table 17: AEs at ≥2% Incidence in a Schizophrenia Trial of Aristada 70
Table 18: Aristada SWOT Analysis, 2016 71
Table 19: Product Profile - Clozapine 74
Table 20: Efficacy Results for Clozapine in Treatment-Resistant Schizophrenia Patients 75
Table 21: AEs at ≥5% Incidence in a Short-Term Trial of Clozapine 76
Table 22: AEs at ≥2% Incidence in All Clinical Trials of Clozapine (Excluding InterSePT) 77
Table 23: AEs at ≥10% Incidence During the InterSePT Trial of Clozapine 78
Table 24: Clozapine SWOT Analysis, 2016 79
Table 25: Product Profile - Fanapt 82
Table 26: AEs at ≥2% Incidence in Short-Term Trials of Fanapt 84
Table 27: Fanapt SWOT Analysis, 2016 85
Table 28: Product Profile - Geodon 87
Table 29: AEs at ≥2% Incidence in Schizophrenia Trials of Geodon 89
Table 30: Geodon SWOT Analysis, 2016 90
Table 31: Product Profile - Invega 94
Table 32: Efficacy of Invega Sustenna in Adult Schizophrenia Short-Term Trials 96
Table 33: AEs at ≥2% Incidence in Adult Schizophrenia Trials of Invega 98
Table 34: AEs at ≥2% Incidence in an Adolescent Schizophrenia Trial of Invega 99
Table 35: AEs at ≥2% Incidence in Schizophrenia Trials of Invega Sustenna 101
Table 36: AEs at ≥2% Incidence in a Long-Term Maintenance Trial of Invega Trinza in Schizophrenic Patients 103
Table 37: Invega SWOT Analysis, 2016 104
Table 38: Product Profile - Latuda 107
Table 39: Efficacy Results for Latuda in Schizophrenia Trials 109
Table 40: AEs at ≥2% Incidence in Schizophrenia Trials of Latuda 111
Table 41: Latuda SWOT Analysis, 2016 112
Table 42: Product Profile - Lonasen 114
Table 43: Efficacy Results for Lonasen in Haloperidol-Controlled Clinical Trial 114
Table 44: Efficacy Results for Lonasen in Risperidone-Controlled Clinical Trial 115
Table 45: AEs at ≥5% Incidence in a Short-Term Trial of Lonasen 116
Table 46: Lonasen SWOT Analysis, 2016 116
Table 47: Product Profile - Rexulti 119
Table 48: Efficacy Results for Rexulti in Short-Term Schizophrenia Trials 120
Table 49: AEs at ≥2% Incidence in Schizophrenia Trials of Rexulti 121
Table 50: Rexulti SWOT Analysis, 2016 122
Table 51: Product Profile - Risperdal 126
Table 52: Efficacy Results for Risperdal Consta in a 12-Week Schizophrenia Study 129
Table 53: AEs at ≥2% Incidence in Adult Schizophrenia Trials of Risperdal 131
Table 54: AEs at ≥5% Incidence in a Pediatric Schizophrenia Trial of Risperdal 133
Table 55: AEs at ≥5% Incidence in an Adult Schizophrenia Trial of Risperdal Consta 134
Table 56: Risperdal SWOT Analysis, 2016 135
Table 57: Product Profile - Saphris 138
Table 58: Efficacy Results for Saphris in Short-Term Schizophrenia Trials 139
Table 59: AEs at ≥2% Incidence in Schizophrenia Trials of Saphris 141
Table 60: Saphris SWOT Analysis, 2016 142
Table 61: Product Profile - Seroquel 146
Table 62: Efficacy Results for Seroquel in a Six-Week Schizophrenia Study 147
Table 63: Efficacy Results for Seroquel in Short-Term Schizophrenia Studies 149
Table 64: Efficacy Results for Seroquel XR in Schizophrenia Trials 150
Table 65: AEs at ≥2% Incidence in Adult Schizophrenia and Bipolar Mania Trials of Seroquel 152
Table 66: AEs at ≥2% Incidence in a Short-Term Trial of Seroquel in Schizophrenic Adolescents 153
Table 67: AEs at ≥2% Incidence in Six-Week Trials of Seroquel XR in Schizophrenic Adults 154
Table 68: Seroquel SWOT Analysis, 2016 155
Table 69: Product Profile - Vraylar 158
Table 70: Efficacy Results for Vraylar in a Six-Week Schizophrenia Study 159
Table 71: Efficacy Results for Vraylar in Short-Term Schizophrenia Studies 160
Table 72: AEs at ≥2% Incidence in Short-Term Schizophrenia Trials of Vraylar 161
Table 73: Vraylar SWOT Analysis, 2016 162
Table 74: Product Profile - Zyprexa 166
Table 75: AEs at ≥5% Incidence in Adult Schizophrenia Trials of Zyprexa 169
Table 76: AEs at ≥2% Incidence in Short-Term Trials of Zyprexa 170
Table 77: AEs at ≥1% Incidence in Adult Schizophrenia Trials of Zyprexa IntraMusular 171
Table 78: AEs at ≥5% Incidence in Adolescent Schizophrenia Trials of Zyprexa 172
Table 79: AEs Reported at ≥2% Incidence in a Schizophrenia Trial of Zyprexa Relprevv 173
Table 80: Zyprexa SWOT Analysis, 2016 175
Table 81: Typical antipsychotics SWOT Analysis, 2016 179
Table 82: Product Profile - Adasuve 182
Table 83: Efficacy Results for Adasuve in Agitation Trial of Schizophrenia Patients 183
Table 84: Decrease in FEV1 in Pulmonary Safety Trials of Adasuve 184
Table 85: Adasuve SWOT Analysis, 2016 185
Table 86: Summary of Minor Therapeutic Classes, 2015 186
Table 87: Unmet Need and Opportunity in Schizophrenia 189
Table 88: Product Profile - ALKS-3831 205
Table 89: ALKS-3831 SWOT Analysis, 2016 209
Table 90: Product Profile - ITI-007 212
Table 91: Efficacy Results for ITI-007 in a Phase II Schizophrenia Trial 213
Table 92: Key Safety Data From a Phase II in a Schizophrenia Trial of ITI-007 215
Table 93: ITI-007 SWOT Analysis, 2016 217
Table 94: Product Profile - Lu AF35700 219
Table 95: Lu AF35700 SWOT Analysis, 2016 221
Table 96: Product Profile - MIN-101 223
Table 97: Efficacy Results for MIN-101 in a 12-Week Phase IIb Schizophrenia Study 225
Table 98: Safety Evaluation of MIN-101 Phase IIa Clinical Trial in Schizophrenia 226
Table 99: AEs at ≥5% Incidence in a Phase IIb Schizophrenia Trial of MIN-101 227
Table 100: Safety Evaluation of MIN-101 Phase IIb Clinical Trial in Schizophrenia 227
Table 101: MIN-101 SWOT Analysis, 2016 230
Table 102: Product Profile - Risperidone Implant 233
Table 103: Risperidone Implant SWOT Analysis, 2016 236
Table 104: Product Profile - Risperidone ISM 238
Table 105: Risperidone ISM SWOT Analysis, 2016 241
Table 106: Product Profile - RBP-7000 244
Table 107: Efficacy Results for RBP-7000 in a Phase III Schizophrenia Trial 245
Table 108: AEs reported in a Phase III Schizophrenia Trial of RBP-7000A 247
Table 109: RBP-7000 SWOT Analysis, 2016 250
Table 110: Product Profile - AVN-211 252
Table 111: Attention tests and measures evaluated in a Phase IIa Schizophrenia Trial of AVN-211 253
Table 112: Psychometric Results in a Phase IIa Schizophrenia Trial of AVN-211 255
Table 113: Results of the Attention Measures that Showed Significant Changes in a Phase IIa Schizophrenia Trial of AVN-211 256
Table 114: AVN-211 SWOT Analysis, 2016 258
Table 115: Product Profile - NaBen 260
Table 116: PANSS Clinical Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia 262
Table 117: Other Clinical Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia 263
Table 118: Cognitive Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia 264
Table 119: NaBen SWOT Analysis, 2016 266
Table 120: Drugs in Development for Schizophrenia, 2015 268
Table 121: Key Events Impacting Sales for Schizophrenia in the 5EU, 2015-2025 273
Table 122: Schizophrenia Market in the 5EU - Drivers and Barriers, 2015-2025 274
Table 123: Key Launch Dates 324
Table 124: Key Patent/Exclusivity Expiries 325
Table 125: High-Prescribing Psychiatrists (Non-KOLs) Surveyed, By Country 345
1.2 List of Figures
Figure 1: Longitudinal Course of Schizophrenia 27
Figure 2: Schizophrenia Therapeutics - Class of Therapy, 2016 199
Figure 3: Schizophrenia - Promising Late-Stage Phase IIb-III Pipeline Drugs, 2016 200
Figure 4: Competitive Assessment of Promising Late-Stage Pipeline Agents in Schizophrenia, 2015-2025 201
Figure 5: Clinical and Commercial Positioning of ALKS-3831 208
Figure 6: Clinical and Commercial Positioning of ITI-007 216
Figure 7: Clinical and Commercial Positioning of Lu AF35700 220
Figure 8: Clinical and Commercial Positioning of MIN-101 229
Figure 9: Clinical and Commercial Positioning of the Risperidone Implant 235
Figure 10: Clinical and Commercial Positioning of Risperidone ISM 240
Figure 11: Clinical and Commercial Positioning of RBP-7000 249
Figure 12: Clinical and Commercial Positioning of AVN-211 258
Figure 13: Clinical and Commercial Positioning of NaBen 266
Figure 14: Sales for Schizophrenia in the 5EU by Drug Class, 2015-2025 272
