1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 6
2 Introduction 7
2.1 Overview 7
2.1.1 Chronic Kidney Disease 7
2.2 Epidemiology of End-stage Renal Disease 9
2.3 Etiology 10
2.4 Pathophysiology 12
2.5 Signs and Symptoms 12
2.6 Diagnosis 13
2.7 Treatment and Management Pattern 13
2.7.1 Drug Therapy 13
2.7.2 Renal Replacement Therapies 15
2.7.3 Treatment Flow 19
2.8 Referral Pathway for End-stage Renal Disease 19
2.9 GlobalData Pipeline Report Guidance 21
3 End-stage Renal Disease Therapeutics - Market Characterization 22
3.1 End-stage Renal Disease Therapeutics Market Size (2006-2011) - Global 22
3.2 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - Global 24
3.3 End-stage Renal Disease Therapeutics Market Size (2006-2011) - The US 26
3.4 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - The US 27
3.5 End-stage Renal Disease Therapeutics Market Size (2006-2011) - The UK 28
3.6 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - The UK 29
3.7 End-stage Renal Disease Therapeutics Market Size (2006-2011) - France 30
3.8 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - France 31
3.9 End-stage Renal Disease Therapeutics Market Size (2006-2011) - Germany 32
3.10 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - Germany 33
3.11 End-stage Renal Disease Therapeutics Market Size (2006-2011) - Italy 34
3.12 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - Italy 35
3.13 End-stage Renal Disease Therapeutics Market Size (2006-2011) - Spain 36
3.14 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - Spain 37
3.15 End-stage Renal Disease Therapeutics Market Size (2006-2011) - Japan 38
3.16 End-stage Renal Disease Therapeutics Market Forecast (2011-2019) - Japan 39
3.17 Drivers and Barriers for the End-stage Renal Disease Therapeutics Market 40
3.17.1 Drivers for the End-stage Renal Disease Therapeutics Market 40
3.17.2 Barriers for the End-stage Renal Disease Therapeutics Market 40
3.18 Opportunity and Unmet Need 41
3.18.1 Opportunity and Unmet Need for Phosphate Binders Class in the End-stage Renal Disease Market 42
3.18.2 Opportunity and Unmet need for the Anti-hyperparathyroidism Class in the End-stage Renal Disease Market 43
3.19 Key Takeaway 43
4 End-stage Renal Disease Market - Competitive Assessment 44
4.1 Overview 44
4.1.1 Strategic Competitor Assessment 44
4.1.2 Competitor Assessment within the Classes Considered in the Treatment of End-stage Renal Disease 45
4.2 Marketed Product Profiles 47
4.2.1 Renagel (sevelamer hydrochloride) 47
4.2.2 Renvela (sevelamer carbonate) 48
4.2.3 Fosrenol (lanthanum carbonate hydrate) 49
4.2.4 Phoslo Gelcaps (calcium acetate) 50
4.2.5 Zemplar (paricalcitol) 50
4.2.6 Hectorol (doxercalciferol) 51
4.2.7 Sensipar (cinacalcet) 52
4.2.8 Omontys (peginesatide injection) 52
4.2.9 Antihypertensive Agents 53
4.2.10 Immunosuppressants 54
4.3 Key Takeaway 54
5 End-stage Renal Disease Therapeutics Market - Pipeline Assessment 55
5.1 Overview 55
5.2 Strategic Pipeline Assessment 55
5.3 End-stage Renal Disease Pipeline Analysis - Pipeline by Phase of Clinical Development 56
5.3.1 End-stage Renal Disease Therapeutics - Phase III Pipeline 56
5.3.2 End-stage Renal Disease Therapeutics - Phase II/III Pipeline 56
5.3.3 End-stage Renal Disease Therapeutics - Phase II Pipeline 57
5.3.4 End-stage Renal Disease Therapeutics - Phase I Pipeline 57
5.4 End-stage Renal Disease Pipeline by Mechanism of Action 58
5.5 End-stage Renal Disease Technology Trends Analytical Framework 59
5.6 End-stage Renal Disease Key Late-stage Pipeline Drugs under Clinical Development 61
5.7 Molecule Profile for Key Late-stage Pipeline Drugs under Clinical Development 62
5.7.1 MP-146 (AST-120) 62
5.7.2 Soluble Ferric Pyrophosphate 63
5.7.3 Zerenex (ferric citrate, KRX-0502) 63
5.8 Key Takeaway 64
6 End-stage Renal Disease Therapeutics - Clinical Trial Mapping 65
6.1 Clinical Trial Mapping by Region/Country 65
6.2 Clinical Trial Mapping by Phase 66
6.3 Clinical Trial Mapping by Trial Status 67
6.4 Overall Sponsors 68
6.5 Prominent Sponsors 69
6.6 Participants in Therapeutic Clinical Trials - Companies 70
7 End-stage Renal Disease Therapeutics - Strategic Assessment 71
7.1 Future Market Competition Scenario 71
8 End-stage Renal Disease - Future Market Players 72
8.1 Introduction 72
8.2 Company Profiles 72
8.2.1 Mitsubishi Tanabe Pharma Corporation 72
8.2.2 Rockwell Medical Technologies Inc. 74
8.2.3 Pharmacosmos 75
8.2.4 Keryx Biopharmaceuticals 75
8.3 Other Companies in the End-stage Renal Disease Therapeutics Market 77
9 End-stage Renal Disease Therapeutics - Licensing and Partnership Deals 79
10 End-stage Renal Disease Market - Appendix 80
10.1 Market Definitions 80
10.2 Abbreviations 80
10.3 Bibliography 81
10.4 Research Methodology 83
10.4.1 Coverage 83
10.4.2 Secondary Research 83
10.4.3 Forecasting 84
10.4.4 Primary Research 86
10.4.5 Expert Panel Validation 87
10.5 Contact Us 87
10.6 Disclaimer 87
List of Tables
Table 1: Stages of Chronic Kidney Disease 7
Table 2: Stage-wise Prevalence of Chronic Kidney Disease in the US, 2011 8
Table 3: Historical Prevalence for End-stage Renal Disease in Seven Major Markets, 2006-2011 9
Table 4: Forecast Prevalence for End-stage Renal Disease in Seven Major Markets, 2011-2019 10
Table 5: Dosage Chart for End-stage Renal Disease Drug Therapy 14
Table 6: Dialysis Solutions 17
Table 7: End-stage Renal Disease Therapeutics, Major Markets, Market Revenue ($m), 2006-2011 23
Table 8: End-stage Renal Disease Therapeutics, Global, Revenue Forecasts ($m), 2011-2019 24
Table 9: End-stage Renal Disease Therapeutics, The US, Market Historical Revenue ($m), 2006-2011 26
Table 10: End-stage Renal Disease Therapeutics, The US, Revenue Forecasts ($m), 2011-2019 27
Table 11: End-stage Renal Disease Therapeutics, The UK, Market Revenue ($m), 2006-2011 28
Table 12: End-stage Renal Disease Therapeutics, The UK, Revenue Forecasts ($m), 2011-2019 29
Table 13: End-stage Renal Disease Therapeutics, France, Market Historical Revenue ($m), 2006-2011 30
Table 14: End-stage Renal Disease Therapeutics, France, Revenue Forecasts ($m), 2011-2019 31
Table 15: End-stage Renal Disease Therapeutics, Germany, Market Revenue ($m), 2006-2011 32
Table 16: End-stage Renal Disease Therapeutics, Germany, Revenue Forecasts ($m), 2011-2019 33
Table 17: End-stage Renal Disease Therapeutics, Italy, Market Revenue ($m), 2006-2011 34
Table 18: End-stage Renal Disease Therapeutics, Italy, Revenue Forecasts ($m), 2011-2019 35
Table 19: End-stage Renal Disease Therapeutics, Spain, Market Revenue ($m), 2006-2011 36
Table 20: End-stage Renal Disease Therapeutics, Spain, Revenue Forecasts ($m), 2011-2019 37
Table 21: End-stage Renal Disease Therapeutics, Japan, Market Revenue ($m), 2006-2011 38
Table 22: End-stage Renal Disease Therapeutics, Japan, Revenue Forecasts ($m), 2011-2019 39
Table 23: End-stage Renal Disease Therapeutics - Phase III Pipeline 56
Table 24: End-stage Renal Disease Therapeutics - Phase II/III Pipeline 56
Table 25: End-stage Renal Disease Therapeutics - Phase II Pipeline 57
Table 26: End-stage Renal Disease Therapeutics - Phase I Pipeline 57
Table 27: End-stage Renal Disease Therapeutics - Preclinical Pipeline 57
Table 28: Mechanisms of Action that Constitute ‘Others’ in Figure 35 58
Table 29: End-stage Renal Disease Therapeutics - Promising Drugs under Clinical Development, 2012 61
Table 30: End-stage Renal Disease Therapeutics - Clinical Trials by Region, 2012 65
Table 31: End-stage Renal Disease Therapeutics - Clinical Trials by Phase, 2012 66
Table 32: End-stage Renal Disease Therapeutics - Clinical Trials by Region, 2012 67
Table 33: End-stage Renal Disease Therapeutics - Clinical Trials, by Sponsor, 2012 68
Table 34: End-stage Renal Disease Therapeutics - Clinical Trials by Sponsors, 2012 69
Table 35: End-stage Renal Disease Therapeutics - Top Companies Participating in Clinical Trials, 2012 70
Table 36: Mitsubishi Tanabe- End-stage Renal Disease Therapeutics Pipeline, 2012 73
Table 37: Rockwell Medical Technologies - End-stage Renal Disease Therapeutics Pipeline, 2012 74
Table 38: Pharmacosmos - End-stage Renal Disease Therapeutics Pipeline, 2012 75
Table 39: Keryx Biopharmaceuticals - End-stage Renal Disease Therapeutics Pipeline, 2012 76
Table 40: End-stage Renal Disease Therapeutics Market, Future Players 77
Table 41: End-stage Renal Disease Therapeutics, Global, Deals ($m), 2012 79
List of Figures
Figure 1: Chronic Kidney Disease - Stage Distribution in the US, 2011 8
Figure 2: Patient Share of End-stage Renal Disease in Seven Major Markets, 2011 9
Figure 3: Common Causes of End-stage Renal Disease 11
Figure 4: End-stage Renal Disease - Treatment Analysis in the US 15
Figure 5: Hemodialysis 16
Figure 6: Peritoneal Dialysis 17
Figure 7: Kidney Transplantation 18
Figure 8: End-stage Renal Disease Treatment Model 19
Figure 9: Referral Pathway for End-stage Renal Disease 20
Figure 10: End-stage Renal Disease Therapeutics, Major Markets, Market Revenue ($m), 2006-2011 22
Figure 11: End-stage Renal Disease Therapeutics, Market Share ($m,%), 2011 23
Figure 12: End-stage Renal Disease Therapeutics, Major Markets, Revenue Forecasts ($m), 2011-2019 24
Figure 13: End-stage Renal Disease Therapeutics, Forecast Market Share ($m,%), 2019 25
Figure 14: End-stage Renal Disease Therapeutics, The US, Market Revenue ($m), 2006-2011 26
Figure 15: End-stage Renal Disease Therapeutics, The US, Revenue Forecasts ($m), 2011-2019 27
Figure 16: End-stage Renal Disease Therapeutics, The UK, Market Revenue ($m), 2006-2011 28
Figure 17: End-stage Renal Disease Therapeutics, The UK, Revenue Forecasts ($m), 2011-2019 29
Figure 18: End-stage Renal Disease Therapeutics, France, Market Revenue ($m), 2006-2011 30
Figure 19: End-stage Renal Disease Therapeutics, France, Revenue Forecasts ($m), 2011-2019 31
Figure 20: End-stage Renal Disease Therapeutics, Germany, Market Revenue ($m), 2006-2011 32
Figure 21: End-stage Renal Disease Therapeutics, Germany, Revenue Forecasts ($m), 2011-2019 33
Figure 22: End-stage Renal Disease Therapeutics, Italy, Market Revenue ($m), 2006-2011 34
Figure 23: End-stage Renal Disease Therapeutics, Italy, Revenue Forecasts ($m), 2011-2019 35
Figure 24: End-stage Renal Disease Therapeutics, Spain, Market Revenue ($m), 2006-2011 36
Figure 25: End-stage Renal Disease Therapeutics, Spain, Revenue Forecasts ($m), 2011-2019 37
Figure 26: End-stage Renal Disease Therapeutics, Japan, Market Revenue ($m), 2006-2011 38
Figure 27: End-stage Renal Disease Therapeutics, Japan, Revenue Forecasts ($m), 2011-2019 39
Figure 28: End-stage Renal Disease Therapeutics - Key Events Impacting Future Market, 2012 41
Figure 29: Opportunity and Unmet Need for Phosphate Binders Class in the End-stage Renal Disease Market, 2012 42
Figure 30: Opportunity and Unmet Need for the Anti-hyperparathyroidism Class in the End-stage Renal Disease Market, 2012 43
Figure 31: Strategic Competitor Assessment of the Phosphate Binders Class in End-stage Renal Disease Therapeutics Market, 2012 45
Figure 32: Strategic Competitor Assessment of Anti-hyperparathyroidism Class in End-stage Renal Disease Therapeutics Market, 2012 46
Figure 33: End-stage Renal Disease Therapeutics Pipeline by Phase of Clinical Development, 2012 56
Figure 34: End-stage Renal Disease Therapeutics - Clinical Pipeline by Mechanism of Action, 2012 58
Figure 35: End-stage Renal Disease Therapeutics - Technology Trends Analytical Framework, 2012 59
Figure 36: End-stage Renal Disease Therapeutics - Technology Trends Analytical Framework, 2012 60
Figure 37: End-stage Renal Disease Therapeutics - Clinical Trials by Region, 2012 65
Figure 38: End-stage Renal Disease Therapeutics - Clinical Trials by Phase, 2012 66
Figure 39: End-stage Renal Disease Therapeutics - Clinical Trials by Status, 2012 67
Figure 40: End-stage Renal Disease Therapeutics - Clinical Trials by Overall Sponsors, 2012 68
Figure 41: End-stage Renal Disease Therapeutics - Clinical Trials by Prominent Sponsors, 2012 69
Figure 42: Top Companies Participating in End-stage Renal Disease Therapeutics Clinical Trials, 2012 70
Figure 43: End-stage Renal Disease Therapeutics - Strategic Assessment, 2012 71
Figure 44: End-stage Renal Disease Therapeutics, Clinical Pipeline by Company, 2012 72
Companies mentioned
Mitsubishi Tanabe Pharma Corporation
Rockwell Medical Technologies Inc.
Pharmacosmos
Keryx Biopharmaceuticals