成長ホルモン分泌不全症治療薬の世界市場機会分析...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 15
1.2 List of Figures 17
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Symptoms 22
3.3 Diagnosis 22
3.4 Prognosis 23
3.5 Quality of Life 23
4 Epidemiology 25
4.1 Disease Background 25
4.1.1 GHD in Children 25
4.1.2 GHD in Adults 26
4.2 Risk Factors and Comorbidities 26
4.3 Global Trends 28
4.3.1 GHD in Children 29
4.3.2 GHD in Adults 31
4.4 Forecast Methodology 32
4.4.1 Sources Used 36
4.4.1.1 7MM 36
4.4.1.2 Diagnosed Cases of GHD in Children 37
4.4.1.3 Diagnosed Cases of GHD in Adults 38
4.4.1.4 GHD Etiological Classification in Children 38
4.4.1.5 GHD Etiological Classification in Adults 39
4.4.2 Sources Not Used 40
4.4.3 Forecast Assumptions and Methods 41
4.4.3.1 Temporal Trends 41
4.4.3.2 Sex-Specific Trends 41
4.4.3.3 Diagnosed Prevalent Cases of GHD in Children 41
4.4.3.4 Diagnosed Prevalent Cases of GHD in Adults 42
4.4.3.5 GHD Etiological Classification in Children 43
4.4.3.6 GHD Etiological Classification in Adults 43
4.5 Epidemiological Forecast of GHD (2014-2024) 44
4.5.1 Diagnosed Prevalent Cases of GHD 44
4.5.2 Diagnosed Prevalent Cases of GHD by Sex 46
4.5.3 Diagnosed Prevalent Cases of GHD by Age 47
4.5.3.1 Diagnosed Prevalent Cases of GHD in Children 47
4.5.3.2 Diagnosed Prevalent Cases of GHD in Adults 49
4.5.4 Age-Adjusted Diagnosed Prevalence of GHD 50
4.5.5 Diagnosed Prevalent Cases of GHD in Children by Etiological Classification 51
4.5.6 Diagnosed Prevalent Cases of GHD in Adults by Etiological Classification 52
4.6 Discussion 53
4.6.1 Epidemiological Forecast Insight 53
4.6.2 Limitations of the Analysis 54
4.6.3 Strengths of the Analysis 55
5 Competitive Assessment 56
5.1 Overview 56
5.2 Treatment Algorithm 56
5.3 Market Access, Reimbursement, and Clinical Practice 58
5.4 Product Profiles — Recombinant Human Growth Hormones 60
5.4.1 Overview 60
5.4.1.1 Genotropin 61
5.4.1.2 Humatrope 62
5.4.1.3 Norditropin 62
5.4.1.4 Nutropin AQ 63
5.4.1.5 Saizen 64
5.4.1.6 Tev-Tropin/Zomacton/Growject 64
5.4.1.7 Omnitrope Biosimilar 65
5.4.2 Efficacy 68
5.4.2.1 Pediatric GHD 68
5.4.2.2 Adult GHD 68
5.4.3 Safety 69
5.4.3.1 Pediatric GHD 69
5.4.3.2 Adult GHD 69
5.4.4 SWOT Analysis 70
6 Unmet Needs Assessment and Opportunity Analysis 71
6.1 Overview 71
6.2 Improved Adherence and Compliance 72
6.2.1 Unmet Needs 72
6.2.2 Gap Analysis 74
6.2.3 Opportunity 74
6.3 Early Diagnosis 75
6.3.1 Unmet Needs 75
6.3.2 Gap Analysis 75
6.3.3 Opportunity 76
6.4 Disease Awareness and Regulatory Policy in Japan 76
6.4.1 Unmet Needs 76
6.4.2 Gap Analysis 77
6.4.3 Opportunity 77
6.5 Insurance Policies that Impact Patient Access 78
6.5.1 Unmet Needs 78
6.5.2 Gap Analysis 79
6.5.3 Opportunity Analysis 79
6.6 Safer Treatments for Cancer Survivors 79
6.6.1 Unmet needs 79
6.6.2 Gap Analysis 80
6.6.3 Opportunity Analysis 80
7 R&D Strategies 81
7.1 Overview 81
7.1.1 Development of Long-Acting Biobetter Growth Hormones 81
7.1.2 Novel Drug Delivery Strategies 82
7.1.3 Targeting the Growth Hormone Releasing Hormone 83
7.1.4 Licensing and Acquisitions 83
7.2 Clinical Trial Design 84
7.2.1 Current Clinical Trial Design 84
7.2.2 Future Clinical Trial Design 85
8 Pipeline Assessment 88
8.1 Overview 88
8.2 Promising Drugs in Clinical Development 89
8.2.1 Somatropin Biopartners 91
8.2.1.1 Overview 91
8.2.1.2 Efficacy 92
8.2.1.3 Safety 92
8.2.1.4 SWOT Analysis 93
8.2.2 NNC0195-0092 93
8.2.2.1 Overview 93
8.2.2.2 Efficacy 95
8.2.2.3 Safety 95
8.2.2.4 SWOT Analysis 95
8.2.3 MOD-4023 96
8.2.3.1 Overview 96
8.2.3.2 Efficacy 97
8.2.3.3 Safety 97
8.2.3.4 SWOT Analysis 98
8.2.4 VRS-317 98
8.2.4.1 Overview 98
8.2.4.2 Efficacy 99
8.2.4.3 Safety 99
8.2.4.4 SWOT Analysis 100
8.2.5 ACP-001 100
8.2.5.1 Overview 100
8.2.5.2 Efficacy 101
8.2.5.3 Safety 101
8.2.5.4 SWOT Analysis 102
8.2.6 TV-1106 102
8.2.6.1 Overview 102
8.2.6.2 Efficacy 103
8.2.6.3 Safety 103
8.2.6.4 SWOT Analysis 104
8.3 Innovative Early-Stage Approaches 104
9 Pipeline Valuation Analysis 107
9.1 Clinical Benchmark of Key Pipeline Drugs 107
9.2 Commercial Benchmark of Key Pipeline Drugs 109
9.3 Competitive Assessment 112
9.4 Top Line Ten Year Forecast 113
9.4.1 US 118
9.4.2 5EU 119
9.4.3 Japan 120
10 Appendix 122
10.1 Bibliography 122
10.2 Abbreviations 130
10.3 Methodology 133
10.4 Forecasting Methodology 133
10.4.1 Diagnosed GHD patients 133
10.4.2 Percent Drug-Treated Patients 133
10.4.3 Drugs Included in Each Therapeutic Class 134
10.4.4 Launch and Patent Expiry Dates 134
10.4.5 General Pricing Assumptions 135
10.4.6 Individual Drug Assumptions 136
10.4.7 Pricing of Pipeline agents 139
10.5 Physicians Included in This Study 141
10.6 Payers Included in This Study 142
10.7 Primary Research – Prescriber Survey 143
10.8 About the Authors 144
10.8.1 Analyst 144
10.8.2 Epidemiologist 144
10.8.3 Therapy Director – CVMD 145
10.8.4 Global Head of Healthcare 145
10.9 About GlobalData 146
10.10 Disclaimer 146