小児脂肪便症（セリアック病）治療薬の市場機会分析...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 14
1.2 List of Figures 16

2 Introduction 17
2.1 Catalyst 17
2.2 Related Reports 18
2.3 Upcoming Related Reports 18

3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.2 Prognosis and Quality of Life 21
3.3 Symptoms 22

4 Epidemiology 24
4.1 Disease Background 24
4.2 Risk Factors and Comorbidities 24
4.3 Global Trends 27
4.3.1 US 30
4.3.2 5EU 30
4.4 Forecast Methodology 31
4.4.1 Sources Used 32
4.4.2 Sources Not Used 35
4.4.3 Forecast Assumptions and Methods – Total Prevalent Cases of Celiac Disease 37
4.4.4 Forecast Assumptions – Diagnosed Prevalent Cases of Celiac Disease 40
4.5 Epidemiological Forecast for Celiac Disease (2013–2023) 41
4.5.1 Total Prevalent Cases of Celiac Disease 41
4.5.2 Age-Specific Total Prevalent Cases of Celiac Disease 43
4.5.3 Sex-Specific Total Prevalent Cases of Celiac Disease 44
4.5.4 Age-Standardized Total Prevalence of Celiac Disease 46
4.5.5 Diagnosed Prevalent Cases of Celiac Disease 47
4.6 Discussion 49
4.6.1 Epidemiological Forecast Insight 49
4.6.2 Limitations of the Analysis 50
4.6.3 Strengths of the Analysis 51

5 Current Treatment Options 52
5.1 Overview 52
5.2 Product Profiles – Major Therapies 57
5.2.1 Steroids (Numerous Brands and Generic Names) 57
5.2.2 Immunosuppressants (Azathioprine) 63

6 Unmet Need and Opportunity 68
6.1 Overview 68
6.2 Reliable Diagnosis 71
6.2.1 Unmet Need 71
6.2.2 Gap Analysis 72
6.2.3 Opportunity 72
6.3 Improved Physician Knowledge of Celiac Disease Diagnosis 73
6.3.1 Unmet Need 73
6.3.2 Gap Analysis 74
6.3.3 Opportunity 75
6.4 Increased Patient Awareness of a Gluten-Free Diet 76
6.4.1 Unmet Need 76
6.4.2 Gap Analysis 77
6.4.3 Opportunity 78
6.5 Lack of Approved Pharmacological Therapies 78
6.5.1 Unmet Need 78
6.5.2 Gap Analysis 80
6.5.3 Opportunity 80
6.6 Improved Compliance to a Gluten-Free Diet 81
6.6.1 Unmet Need 81
6.6.2 Gap Analysis 81
6.6.3 Opportunity 82
6.7 Improved Therapies for Refractory Celiac Disease Type I 82
6.7.1 Unmet Need 82
6.7.2 Gap Analysis 83
6.7.3 Opportunity 83
6.8 Available Therapies for Refractory Celiac Disease Type II 83
6.8.1 Unmet Need 83
6.8.2 Gap Analysis 84
6.8.3 Opportunity 85

7 R&D Strategies 86
7.1 Overview 86
7.1.1 Development of Pharmacological Interventions with Novel MOAs 86
7.1.2 Diverse Preclinical Research 87
7.1.3 Licensing and Alliances 88
7.2 Clinical Trial Design 89
7.2.1 No Standardized Clinical Trial Design Exists in Celiac Disease 89
7.2.2 Trial Outcome Measures are Tailored to the Pipeline Drug Being Investigated 90
7.2.3 Trial Designs for Early-Stage Pipeline Drugs Likely to be Dictated by Their MOA 90

8 Pipeline Assessment 92
8.1 Overview 92
8.2 Promising Drugs in Clinical Development 93
8.2.1 Larazotide Acetate 93
8.2.2 Latiglutenase 101
8.2.3 BL-7010 107
8.2.4 NexVax-2 111
8.3 Innovative Early-Stage Approaches 115

9 Pipeline Valuation Analysis 121
9.1 Clinical Benchmark of Key Pipeline Drugs 121
9.2 Commercial Benchmark of Key Pipeline Drugs 123
9.3 Competitive Assessment 126
9.4 Top-Line Five-Year Forecast 128
9.4.1 US 131
9.4.2 5EU 132
9.5 Case Study: Top-Line-Ten Year Forecast 133
9.5.1 US 137
9.5.2 5EU 138

10 Appendix 140
10.1 Bibliography 140
10.2 Abbreviations 151
10.3 Methodology 154
10.4 Forecasting Methodology 154
10.4.1 Diagnosed Celiac Disease Patients 154
10.4.2 Percent Drug-Treated Patients 155
10.4.3 Drugs Included in Each Therapeutic Class 155
10.4.4 Launch Dates 156
10.4.5 General Pricing Assumptions 156
10.4.6 Individual Drug Assumptions 157
10.4.7 Pricing of Pipeline Agents 159
10.5 Physicians and Specialists Included in This Study 160
10.6 About the Authors 161
10.6.1 Author 161
10.6.2 Reviewers 161
10.6.3 Epidemiologist 162
10.6.4 Global Head of Healthcare 163
10.7 About GlobalData 164
10.8 Disclaimer 164