Diabetic Foot Ulcers：市場分析及び予測（～2017）...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 17
3.2 Assessment of DFUs 18
3.2.1 Patient History and Visual Examination 19
3.2.2 Testing for Neuropathy 19
3.2.3 Testing Vascular Status 19
3.2.4 Identifying Infection 20
3.3 Classification of Diabetic Foot Ulcers 20
3.4 Prognosis 22
4 Epidemiology 23
4.1 Disease Background 23
4.2 Risk Factors and Comorbidities 23
4.2.1 An increased duration of diabetes triples the risk of DFUs 24
4.2.2 Men diabetics are at higher risk for DFUs than women diabetics 25
4.3 Global Trends 25
4.3.1 US 26
4.3.2 5EU 27
4.4 Forecast Methodology 28
4.4.1 Sources Used 29
4.4.2 Sources Not Used 31
4.4.3 Forecast Assumptions and Methods, Diagnosed Prevalent Cases of Diabetes 32
4.4.4 Forecast Assumptions and Methods, Diabetic Foot Ulcers 35
4.5 Epidemiological Forecast for DFUs (2012-2022) 38
4.5.1 Total Prevalent Cases of DFUs 38
4.5.2 Age-Specific Total Prevalent Cases of DFUs 40
4.5.3 Sex-Specific Total Prevalent Cases of DFUs 42
4.5.4 Total Prevalent Cases of Diabetic Foot Infections 43
4.6 Discussion 45
4.6.1 Epidemiological Forecast Insight 45
4.6.2 Limitations of the Analysis 45
4.6.3 Strengths of the Analysis 46
5 Current Treatment Options 47
5.1 Overview 47
5.2 Product Profiles – Wound-Healing Agents 51
5.2.1 Regranex (becaplermin) Gel 51
5.3 Product Profiles – Cell-Based Skin Substitutes 58
5.3.1 Dermagraft (human fibroblast-derived dermal substitute) 58
5.3.2 Apligraf (bi-layered skin substitute) 62
5.3.3 Grafix (human cellular repair matrix) 65
6 Unmet Needs Assessment and Opportunity Analysis 70
6.1 Overview 70
6.2 Unmet Needs Analysis 71
6.2.1 Improved Patient and Physician Education: Emphasis on the Importance of Off-Loading 71
6.2.2 Improved Multidisciplinary Approach to Patient Treatment with Common Protocols 73
6.2.3 More Effective Treatments for Neuroischemic Wounds 75
6.2.4 More Effective Antibacterial Treatments for Infected DFUs 76
6.2.5 Affordable Products and Improved Reimbursement 76
6.2.6 In-Home Sensing Systems for the Early Prevention of DFUs 78
6.3 Opportunity Analysis 79
6.3.1 Wound-Healing Agents for the Treatment of Neuroischemic Ulcers 79
6.3.2 Topical Antibiotics for the Treatment of DFUs 79
6.3.3 Enzymatic Debriding Agents 80
7 Research and Development Strategies 82
7.1 Overview 82
7.1.1 Local Administration of Growth Factors and Bioactive Peptides 82
7.1.2 Cellular Therapies: Leukocytes, Platelets, and Stem Cells 83
7.1.3 Acquisitions and Licensing Agreements Between Wound Care Companies 84
7.2 Clinical Trial Design 85
7.2.1 Current Clinical Trial Design 86
7.2.2 Standardization of Debridement and Off-Loading 87
7.2.3 Inclusion of Representative Patient Populations in Clinical Trials 89
8 Pipeline Assessment 91
8.1 Overview 91
8.2 Promising Wound-Healing Agents in Clinical Development 92
8.2.1 CureXcell (activated leukocyte suspension) 92
8.2.2 DSC127 (NorLeu3-angiotensin[1-7]) 98
8.2.3 Trafermin (recombinant human basic fibroblast growth factor spray) 103
8.2.4 CVBT-141B (topical human fibroblast growth factor-1) 108
8.3 Promising Antimicrobial Agents in Clinical Development 109
8.3.1 Cogenzia (gentamicin-collagen sponge) 109
8.3.2 Locilex (pexiganan acetate cream) 115
8.3.3 Innovative Early-Stage Approaches 120
9 Pipeline Valuation Analysis 123
9.1 Clinical Benchmark of Key Pipeline Drugs 123
9.2 Commercial Benchmark of Key Pipeline Drugs 125
9.3 Competitive Assessment 126
9.4 Top-Line Five-Year Forecast 130
9.4.1 US 132
9.4.2 5EU 133
10 Appendix 134
10.1 Bibliography 134
10.2 Abbreviations 145
10.3 Methodology 148
10.4 Forecast Methodology 148
10.4.1 Percent Diagnosed Patients 149
10.4.2 Percent Drug-Treated Patients 149
10.4.3 Drugs Included in Each Therapeutic Class 149
10.4.4 Launch Dates 150
10.4.5 General Pricing Assumptions 150
10.4.6 Individual Drug Assumptions 151
10.5 Physicians and Specialists Included in This Study 155
10.6 About the Authors 156
10.6.1 Analyst, Cardiovascular and Metabolic Disorders 156
10.6.2 Senior Epidemiologist 156
10.6.3 Therapy Director – CVMD and Infectious Disease 157
10.6.4 Global Head of Healthcare 157
10.7 About GlobalData 158
10.8 Disclaimer 158