Late-Stage Chronic Kidney Disease (CKD)：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 10
1.1 List of Tables 14
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 21
3.2 Symptoms 24
3.3 Disease Management 25
3.3.1 Diagnosis 25
3.3.2 Drug Treatment for Underlying Causes of CKD 26
4 Epidemiology 40
4.1 Disease Overview 40
4.2 Risk Factors and Comorbidities 41
4.2.1 Diabetic CKD patients are more likely to have complications of CKD 43
4.2.2 Hypertensive patients are three times more likely to develop ESRD 45
4.2.3 Obesity at a younger age significantly increases the risk for CKD later in life 46
4.2.4 Women are twice as likely to develop CKD as men 47
4.2.5 Family history increases the risk of developing CKD by up to 10 times 48
4.2.6 CVD is prevalent in almost 40% of CKD patients in stages 4 and 5 49
4.3 Global Trends 50
4.3.1 US 51
4.3.2 5EU 55
4.4 Forecast Methodology 71
4.4.1 Sources Used 73
4.4.2 Forecast Assumptions and Methods 77
4.4.3 Sources Not Used 82
4.5 Epidemiology Forecast for CKD (2012-2022) 84
4.5.1 Prevalent Cases of CKD 84
4.5.2 Age-Specific Prevalent Cases of CKD 86
4.5.3 Sex-Specific Prevalent Cases of CKD 87
4.5.4 Age-Standardized Prevalence of CKD 89
4.5.5 Prevalent Cases of CKD by Stage 90
4.6 Discussion 92
4.6.1 Conclusions on Epidemiological Trends 92
4.6.2 Limitations of the Analysis 93
4.6.3 Strengths of the Analysis 94
5 Current Treatment Options 96
5.1 Overview 96
5.2 Product Profiles – Major Brands 99
5.2.1 Renvela (sevelamer carbonate) 99
5.2.2 Renagel (sevelamer hydrochloride) 103
5.2.3 Fosrenol (lanthanum carbonate) 107
5.2.4 BindRen (colestilan) 112
5.2.5 Zemplar (paricalcitol) 116
5.2.6 Sensipar/Mimpara (cinacalcet hydrochloride) 120
6 Unmet Needs Assessment and Opportunity Analysis 125
6.1 Overview 125
6.2 Unmet Needs Analysis 127
6.2.1 Unmet Need: Therapies that Provide Improved Efficacy 127
6.2.2 Unmet Need: Therapies that Provide Improved Compliance 128
6.2.3 Unmet Need: Safety and Tolerability 130
6.2.4 Unmet Need: Earlier Identification and Treatment of Patients Requiring Phosphate Control 131
6.2.5 Unmet Need: Lower Cost of Therapy 132
6.2.6 Unmet Need: Guidelines 134
6.3 Opportunity Analysis 135
6.3.1 Opportunity: Novel Treatments Targeting Phosphate Absorption 135
6.3.2 Opportunity: Flexibility in Formulation 137
6.3.3 Opportunity: Efficacious Treatments for iPTH Control in Pre-Dialysis Late-Stage CKD Patients 138
6.3.4 Opportunity: Phosphate Binders Targeted at Pre-Dialysis Late-Stage CKD Patients 139
7 R&D Strategies 141
7.1 Overview 141
7.1.1 Targeting Patients on Hemodialysis 141
7.1.2 Licensing and Alliances 142
7.1.3 Iron-Based Phosphate Binders 144
7.2 Clinical Trial Design 146
7.2.1 Hyperphosphatemia 146
7.2.2 Secondary Hyperparathyroidism 150
8 Pipeline Assessment 153
8.1 Overview 153
8.2 Promising Drugs in Clinical Development 154
8.2.1 PA-21 155
8.2.2 Zerenex (ferric citrate) 160
8.2.3 Velcalcetide (AMG-416) 165
8.3 Innovative Early-Stage Approaches 171
8.3.1 Hyperphosphatemia 172
8.3.2 Secondary Hyperparathyroidism 175
9 Pipeline Valuation Analysis 178
9.1 Clinical Benchmark of Key Pipeline Drugs 178
9.2 Commercial Benchmark of Key Pipeline Drugs 181
9.3 Competitive Assessment 182
9.4 Top-Line Five-Year Forecast 184
9.4.1 US 187
9.4.2 5EU 189
10 Appendix 191
10.1 Bibliography 191
10.2 Abbreviations 212
10.3 Methodology 214
10.4 Forecasting Methodology 214
10.4.1 Diagnosed Late-Stage CKD Patients 214
10.4.2 Percent Drug-Treated Patients 215
10.4.3 Drugs Included in Each Therapeutic Class 215
10.4.4 Launch and Patent Expiry Dates 215
10.4.5 General Pricing Assumptions 216
10.4.6 Individual Drug Assumptions 217
10.4.7 Generic Erosion 220
10.5 Physicians and Specialists Included in this Study 221
10.6 About the Authors 222
10.6.1 Authors 222
10.6.2 Epidemiologist 223
10.6.3 Global Head of Healthcare 224
10.7 About GlobalData 225
10.8 Disclaimer 225