自閉症障害：市場機会分析及び予測（～2018）...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 15
2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
2.3 Upcoming Related Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 18
3.2 Symptoms 19
3.2.1 Core Symptoms 20
3.2.2 Associated Non-Core Symptoms 22
3.3 Diagnosis 28
3.3.1 DSM-IV and DSM-V 28
3.3.2 ICD-10 Diagnosis 32
3.3.3 Diagnostic Tests 33
4 Epidemiology 36
4.1 Disease Background 36
4.2 Risk Factors and Comorbidities 37
4.2.1 Intake of certain drugs during pregnancy increases the risk of ASD in children 38
4.2.2 Gestational complications elevate the risk of ASD 40
4.2.3 Familial history of psychiatric disorders in first-degree relatives is a strong predictor of ASD 41
4.2.4 Increasing maternal age raises the risk of ASD compared with increasing paternal age 44
4.2.5 Boys are more likely to develop ASD than girls 46
4.2.6 Neuropsychiatric disorders are highly prevalent in autistic patients 47
4.3 Global Trends 49
4.3.1 US 49
4.3.2 5EU 50
4.4 Forecast Methodology 51
4.4.1 Sources Used 52
4.4.2 Sources Not Used 54
4.4.3 Forecast Assumptions and Methods, Prevalent Cases 55
4.5 Epidemiological Forecast for ASD (2012-2022) 57
4.5.1 Diagnosed Prevalent Cases of ASD 57
4.5.2 Age-Specific Diagnosed Prevalent Cases of ASD 59
4.5.3 Sex-Specific Diagnosed Prevalent Cases of ASD 61
4.5.4 Age-Standardized Diagnosed Prevalence of ASD 62
4.5.5 Diagnosed Prevalent Cases of ASD by Subtype 63
4.6 Discussion 65
4.6.1 Epidemiological Forecast Insight 65
4.6.2 Limitations of the Analysis 67
4.6.3 Strengths of the Analysis 68
5 Current Treatment Options 69
5.1 Overview 69
5.1.1 Psychotropic Medication 71
5.2 Product Profiles – Major Brands 79
5.2.1 Risperidone 79
5.2.2 Abilify (aripiprazole) 82
6 Unmet Needs Assessment and Opportunity Analysis 86
6.1 Overview 86
6.2 Unmet Needs Analysis 87
6.2.1 Lack of Efficacious Therapies for the Core ASD Symptoms 87
6.2.2 More approved treatment options for the associated non-core symptoms of ASD 92
6.2.3 Improved early diagnosis in high-functioning autistic children 94
6.2.4 Poor Diagnosis of Autistic Females and Adult Males 97
6.2.5 Diagnostic Biomarkers for ASD 99
6.3 Opportunity Analysis 101
6.3.1 Development of Alternative Antipsychotic Drugs for ASD 101
6.3.2 Label Expansion of Other CNS Drugs 103
6.3.3 Treatments to Improve Language Skills 104
6.3.4 Treatments Targeting Sleep Problems, Sensory Overload, and Anxiety 105
6.3.5 Medications Suitable for Young Autistic Children 106
7 Research and Development Strategies 109
7.1 Overview 109
7.1.1 Correcting an Excitation-Inhibition Imbalance at the Synapse 110
7.1.2 The Oxytocin-Vasopressin Pathway 112
7.1.3 Alternative Therapies and Digestive Aids 115
7.2 Patient-Compatible Drug Formulations 117
7.3 EU-AIMS 119
7.4 Clinical Trial Design 120
7.4.1 Diagnosis and Relevant Inclusion Criteria 120
7.4.2 Current Clinical Trial Design 121
7.4.3 Recruiting Trial Participants 123
8 Pipeline Assessment 125
8.1 Overview 125
8.2 Promising Drugs in Clinical Development 126
8.2.1 CM-AT 126
8.2.2 Latuda 133
8.2.3 Serelsa/AT-001 140
8.2.4 Namenda 145
8.2.5 RG-7314 149
8.3 Innovative Early-Stage Approaches 153
8.3.1 NMDAR Modulation 154
8.3.2 TSO 155
8.3.3 Syntocinon 157
8.3.4 Stem Cell Therapy 158
9 Pipeline Valuation Analysis 159
9.1 Clinical Benchmarking of Key ASD Pipeline Drugs 160
9.2 Commercial Benchmarking of Key ASD Pipeline Drugs 162
9.3 Competitive Assessment 164
9.4 Top-Line Five-Year Forecast 164
9.4.1 US 168
9.4.2 5EU 170
10 Appendix 172
10.1 Bibliography 172
10.2 Abbreviations 197
10.3 Methodology 202
10.4 Forecasting Methodology 202
10.4.1 Diagnosed and Drug-Treated Autistic Patients 202
10.4.2 Drugs Included in Each Therapeutic Class 203
10.4.3 Key Launch and Patent Expiry Dates 203
10.4.4 General Pricing Assumptions 204
10.4.5 Individual Drug Assumptions 204
10.4.6 Generic Erosion 208
10.4.7 Drug Dosage Assumptions 208
10.5 Physicians and Specialists Included in This Study 210
10.6 About the Authors 211
10.6.1 Authors 211
10.6.2 Epidemiologist 212
10.6.3 Global Head of Healthcare 212
10.7 About GlobalData 213
10.8 Disclaimer 213