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市場調查報告書

PharmaPoint:精神分裂症 - 日本的醫藥品的預測與市場分析

Schizophrenia - Japan Drug Forecast and Market Analysis to 2025

出版商 GlobalData 商品編碼 299164
出版日期 內容資訊 英文 349 Pages
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PharmaPoint:精神分裂症 - 日本的醫藥品的預測與市場分析 Schizophrenia - Japan Drug Forecast and Market Analysis to 2025
出版日期: 2016年11月01日 內容資訊: 英文 349 Pages
簡介

精神分裂症是持續性的長期性腦功能障礙,造成嚴重的神經衰弱發作。其核心症狀為聽覺或視覺性幻覺(幻聽或幻視),許多時候還會伴隨妄想。也常發生學習障礙或認知障礙。根WHO專家推測全球約2,400萬人患有精神分裂症。

本報告提供日本精神分裂症的治療藥市場相關調查分析,提供疾病的概要與指南,競爭情形,主要藥物的詳細資訊(產品說明,安全性,有效性),以及SWOT分析,銷售額預測,影響分析(趨勢,推動因素·阻礙因素)等,為您概述為以下內容。

第1章 目錄

第2章 簡介

第3章 疾病概要

  • 病因·病理生理學
  • 症狀

第4章 疾病的管理

  • 診斷
  • 治療概要
  • 日本
    • 診斷
    • 臨床診療

第5章 競爭評估

  • 概要
  • 策略性競爭企業的評估
  • 按產品簡介:世代

第6章 機會及未滿足需求

  • 未滿足需求概要
  • 差距分析

第7章 開發平台評估

  • 概要
  • 初期階段開發平台的評估
  • 新的治療方法
  • 長效型藥物遞輸
  • 技術趨勢分析
  • 臨床開發中的潛力藥物
    • Aripiprazole Lauroxil
    • Cariprazine
    • Brexpiprazole
    • Zicronapine
    • Bitopertin
    • EVP-6124

第8章 市場預測

  • 日本
    • 預測
    • 主要的活動
    • 推動因素與阻礙

第9章 附錄

圖表

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目錄
Product Code: GDHC371CFR

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 Japan reached approximately $659.3m during 2015, making it the second largest market within the 7MM. Similar to the US and 5EU markets, the increase in Japan's market value will mainly be a result of emerging pipeline assets that are expected to launch from early to midway through the forecast period, which will likely have a high ACOT compared to the widely available generic drugs.

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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in the Japan from 2015-2025.
  • Analysis of the impact of key events as well the drivers and restraints affecting the Japan 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 Japan.

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 Japan 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 Japan 270
    • 8.1.1 Forecast 270
    • 8.1.2 Key Events 272
    • 8.1.3 Drivers and Barriers 273

9 Appendix 274

  • 9.1 Bibliography 274
  • 9.2 Abbreviations 316
  • 9.3 Methodology 322
  • 9.4 Forecasting Methodology 322
    • 9.4.1 Diagnosed Schizophrenia Patients 322
    • 9.4.2 Percent Drug-Treated Patients 323
    • 9.4.3 Launch and Patent Expiry Dates 323
    • 9.4.4 General Pricing Assumptions 324
    • 9.4.5 Individual Drug Assumptions 325
    • 9.4.6 Generic Erosion 340
    • 9.4.7 Pricing of Pipeline Agents 340
  • 9.5 Primary Research - KOLs Interviewed for this Report 342
  • 9.6 Primary Research - Prescriber Survey 344
  • 9.7 About the Authors 345
    • 9.7.1 Analyst 345
    • 9.7.2 Therapy Area Director 346
    • 9.7.3 Epidemiologist 346
    • 9.7.4 Managing Epidemiologist 346
    • 9.7.5 Global Director of Therapy Analysis and Epidemiology 347
  • 9.8 About GlobalData 348
  • 9.9 Disclaimer 348

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 - Japan 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 Japan, 2015-2025 272
  • Table 122: Schizophrenia Market in Japan - Drivers and Barriers, 2015-2025 273
  • Table 123: Key Launch Dates 323
  • Table 124: Key Patent/Exclusivity Expiries 324
  • Table 125: High-Prescribing Psychiatrists (Non-KOLs) Surveyed, By Country 344

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 Japan by Drug Class, 2015-2025 271
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