OpportunityAnalyzer: Late - Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026

OpportunityAnalyzer: Late - Stage Chronic Kidney Disease - Opportunity Analysis and Forecasts to 2026

Summary

The late-stage chronic kidney disease (CKD) - Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia market is expected to undergo significant growth over the next ten years across the seven major markets (7MM) covered in this report (US, France, Germany, Italy, Spain, UK, and Japan). The main driver of this expansion will be the dramatic increase in disease prevalence. According to primary research, GlobalData has determined that there is a high level of unmet need remaining for CKD patients. Despite the launch of new agents, GlobalData expects significant opportunities to remain for developers of drugs with novel mechanisms of action. The challenge for new entrants will be getting a foothold in the dialysis care setting; in this regard, GlobalData anticipates that partnerships and agreements between manufacturers and dialysis centers will continue to be a key strategy to maintain dominance in this market.

This report will specifically focus on three major CKD-induced comorbidities: hyperparathyroidism (HPT), hyperphosphatemia (HP), and hyperkalemia (HK). The major barrier to CKD market growth over the 2016-2026 forecast period is the loss of patent exclusivity of major drugs in the HPT, HP space. However, the decline in sales will be countered by the launch of pipeline contenders, particularly Amgens Parsabiv (etelcalcetide), and Ardelyxs tenapanor, which will aid global sales growth throughout the forecast period. Lastly, the arrival of new HK agents with preferable onsets of action, effectiveness, and safety, along with reduced compliance-associated issues, will steal significant market share from SOC HK therapies.

Scope

- Overview of CKD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global Late-Stage CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global T2D therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global T2D therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global T2D therapeutics market from 2016-2026.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1.1 List of Tables 6
1.2 List of Figures 8
2 Executive Summary 9
2.1 Combined Sales for CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia to Double by 2026 10
2.2 A Continued Focus on Improving the Compliance and Safety of Phosphate Binder Drugs 12
2.3 Novel Therapies Finally Begin to Address Long-Standing Key Unmet Needs in Hyperkalemia 13
2.4 IV Calcimimetic, Parsabiv Expected to Revolutionize the Treatment of Dialysis-Dependent Hyperparathyroidism Patients 14
2.5 What Do Physicians Think? 14
3 Introduction 16
3.1 Catalyst 16
3.2 Related Reports 17
4 Disease Overview 18
4.1 Etiology and Pathophysiology 18
4.1.1 Etiology 18
4.1.2 Pathophysiology 19
4.2 Symptoms 25
4.3 Diagnosis and Monitoring 27
4.4 Prognosis and Quality of Life 31
5 Epidemiology 32
5.1 Disease Background 32
5.2 Risk Factors and Comorbidities 33
5.3 Global and Historical Trends 34
5.4 Forecast Methodology 35
5.4.1 Sources 36
5.4.2 Forecast Assumptions and Methods 40
5.5 Epidemiological Forecast for CKD (2016-2026) 46
5.5.1 Total Prevalent Cases of CKD, Stages I-IV 46
5.5.2 Age-Specific Total Prevalent Cases of CKD, Stages I-IV 47
5.5.3 Sex-Specific Total Prevalent Cases of CKD, Stages I-IV 48
5.5.4 Total Prevalent Cases of CKD by Stage 49
5.5.5 Diagnosed Prevalent Cases of CKD, Stages I-V 50
5.5.6 Diagnosed Prevalent Cases of CKD by Stage 51
5.6 Discussion 52
5.6.1 Epidemiological Forecast Insight 52
5.6.2 Limitations of the Analysis 53
5.6.3 Strengths of the Analysis 54
6 Current Treatment Options 55
6.1 Overview 55
6.2 Treatment Guidelines and Leading Prescribed Drugs 56
6.2.1 Hyperparathyroidism and Hyperphosphatemia 56
6.2.2 Hyperkalaemia 58
6.3 Clinical Practice 60
6.3.1 Hyperparathyroidism and Hyperphosphatemia 60
6.3.2 Hyperkalemia 61
6.4 Calcimimetics 63
6.4.1 Sensipar (cinacalcet hydrochloride) 63
6.5 Vitamin D Sterols 67
6.5.1 Nutritional/Native Vitamin D 67
6.5.2 Vitamin D Receptor Agonists 71
6.6 Phosphate Binding Therapies 75
6.6.1 Overview 75
6.6.2 Calcium-Based Phosphate Binders 76
6.6.3 Aluminum-Containing Phosphate Binders 77
6.6.4 Magnesium-Containing Phosphate Binders 77
6.6.5 Renvela/Renagel (sevelamer carbonate/hydrochloride) 77
6.6.6 Fosrenol (lanthanum carbonate) 81
6.6.7 Velphoro (sucroferric oxyhydroxide) 85
6.6.8 Auryxia (ferric citrate) 88
6.7 Potassium Binding Therapies 93
6.7.1 Resins 93
6.7.2 Veltassa (patiromer sorbitex calcium) 95
7 Unmet Needs and Opportunity Assessment 99
7.1 Overview 99
7.2 Optimal Management of Phosphate in Hyperparathyroidism 100
7.2.1 Unmet Need 100
7.2.2 Gap Analysis 101
7.2.3 Opportunity 102
7.3 Novel Hyperkalemia Treatments 102
7.3.1 Unmet Need 102
7.3.2 Gap Analysis 103
7.3.3 Opportunity 103
7.4 Improved Compliance 104
7.4.1 Unmet Need 104
7.4.2 Gap Analysis 104
7.4.3 Opportunity 105
7.5 Drug Cost and Market Access 105
7.5.1 Unmet Need 105
7.5.2 Gap Analysis 106
7.5.3 Opportunity 107
8 R&D Strategies 108
8.1 Overview 108
8.1.1 Licensing and Alliances 108
8.1.2 Optimizing Treatment Safety and Compliance in Both the Pre-dialysis and Dialysis Setting 109
8.1.3 Development of Various Novel Phosphate Binders Continues as Unmet Needs Remian 111
8.2 Clinical Trial Design 113
8.2.1 Hyperparathyroidism 113
8.2.2 Hyperphosphatemia 114
8.2.3 Hyperkalemia 115
9 Pipeline Assessment 117
9.1 Overview 117
9.2 Promising Drugs in Clinical Development 119
9.2.1 Parsabiv (etelcalcetide hydrochloride) 119
9.2.2 Evocalcet 123
9.2.3 DP-001 124
9.2.4 PT20 128
9.2.5 Tenapanor hydrochloride 131
9.2.6 Alpharen (fermagate) 134
9.2.7 Lokelma (sodium zirconium cyclosilicate) 136
9.3 Innovative Early Stage Approaches 139
9.3.1 Renazorb (SPI-014) 141
10 Pipeline Valuation Analysis 142
10.1 Clinical Benchmark of Key Pipeline Drugs 142
10.2 Commercial Benchmark of Key Pipeline Drugs 146
10.3 Competitive Assessment 150
10.4 Top-Line 10-Year Forecast 153
10.4.1 US 158
10.4.2 5EU 158
10.4.3 Japan 159
11 Appendix 161
11.1 Bibliography 161
11.2 Abbreviations 178
11.3 Methodology 181
11.3.1 Forecasting Methodology 181
11.3.2 Diagnosed Patients 181
11.3.3 Percent Drug-Treated Patients 182
11.3.4 Drugs Included in Each Therapeutic Class 182
11.3.5 Launch and Patent Expiry Dates 183
11.3.6 General Pricing Assumptions 184
11.3.7 Individual Drug Assumptions 184
11.3.8 Generic Erosion 187
11.3.9 Pricing of Pipeline Agents 187
11.4 Primary Research - KOLs Interviewed for This Report 187
11.5 Primary Research - Prescriber Survey 190
11.6 About the Authors 190
11.6.1 Managing Analyst 190
11.6.2 Analyst 191
11.6.3 Therapy Area Director 191
11.6.4 Epidemiologist 191
11.6.5 Director of Epidemiology 192
11.6.6 Global Director of Therapy Analysis and Epidemiology 192
11.6.7 Global Head of Healthcare 192
11.7 About GlobalData 194
11.8 Contact Us 194
11.9 Disclaimer 195

List Of Tables

1.1 List of Tables
Table 1: Late-Stage Chronic Kidney Disease-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia, Key Metrics in the 7MM 9
Table 2: Stages of CKD 20
Table 3: Common Comorbidities of CKD and ESRD 21
Table 4: Degree of HK 23
Table 5: Factors Influencing Renal Potassium Excretion 24
Table 6: Factors Influencing Potassium Plasma Levels 24
Table 7: Symptoms of CKD 26
Table 8: Main Conditions Associated with HPT 26
Table 9: Common Diagnostic Tests for CKD and Associated Comorbidities 27
Table 10: Common Monitoring Procedures for HPT patients. 28
Table 11: Recommended Phosphate Maintenance Levels for CKD Patients 28
Table 12: Cardiac Monitoring Recommendations in HK Patients 29
Table 13: ECG Changes Indicative of Increasing Serum Potassium Levels 30
Table 14: Acute versus Chronic HK 30
Table 15: KDIGO Classification of CKD 32
Table 16: Risk Factors and Comorbidities for CKD 33
Table 17: 7MM, Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages 20 Years, N, Selected Years from 2016-2026 47
Table 18: 7MM, Diagnosed Prevalent Cases of CKD, Stages I-V, Both Sexes, Ages 20 Years, N, Selected Years from 2016-2026 51
Table 19: Treatment Guidelines for CKD, HPT 57
Table 20: Leading Treatments for HPT and HP, 2016 58
Table 21: Treatment Guidelines for CKD, HPT 59
Table 22: Interventions for the treatment of acute or chronic HK 60
Table 23: Product Profile - Sensipar 65
Table 24: Sensipar SWOT Analysis 67
Table 25: Nutritional Vitamin D Sterols 69
Table 26: Product Profile - Rayaldee 69
Table 27: Rayaldee SWOT Analysis 70
Table 28: Common VDRAs 72
Table 29: Product Profile - VDRAs 73
Table 30: Paricalcitol SWOT Analysis 75
Table 31: Product Profile - Sevelamer 79
Table 32: Sevelamer SWOT Analysis 81
Table 33: Product Profile - Fosrenol 83
Table 34: Fosrenol SWOT Analysis 84
Table 35: Product Profile - Velphoro 86
Table 36: Velphoro SWOT Analysis 88
Table 37: Product Profile - Auryxia 90
Table 38: Auryxia SWOT Analysis 92
Table 39: Product Profile - Resins 93
Table 40: Auryxia SWOT Sodium polystyrene sulfonate 95
Table 41: Product Profile - Veltassa 96
Table 42: Veltassa SWOT Analysis 98
Table 43: Key Late-Stage Pipeline Agents for HPT 119
Table 44: Product Profile - Parsabiv 121
Table 45: Etelcalcetide SWOT Analysis 122
Table 46: Product Profile - Evocalcet 123
Table 47: Evocalcet SWOT Analysis 124
Table 48: Product Profile - DP-001 126
Table 49: DP-001 SWOT Analysis 128
Table 50: Product Profile - PT20 130
Table 51: PT20 SWOT Analysis 131
Table 52: Product Profile - Tenpanor 133
Table 53: Tenapanor SWOT Analysis 134
Table 54: Product Profile - Alpharen 135
Table 55: Alpharen SWOT Analysis 136
Table 56: Product Profile - Lokelma 137
Table 57: Lokelma SWOT Analysis 139
Table 58: Early Stage Pipeline Products for HPT, HP, and HK. 140
Table 59: Clinical Benchmarking of Key Marketed & Pipeline Products (Phosphate binders) 143
Table 60: Clinical Benchmarking of Key Marketed and Pipeline Products (calcimimetics) 144
Table 61: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols) 145
Table 62: Clinical Benchmarking of Key Marketed and Pipeline Products (potassium binders) 146
Table 63: Commercial Benchmarking of Key Marketed & Pipeline Products (Phosphate binders) 147
Table 64: Commercial Benchmarking of Key Marketed & Pipeline Products (calcimimetics) 148
Table 65: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols) 149
Table 66: Commercial benchmarking of SOC and newly launched/pipeline potassium binders. 149
Table 67: Key Events Impacting Sales for HPT, HP, and HK, 2016-2026 157
Table 68: HPT Market - Global Drivers and Barriers, 20162026 157
Table 69: Key Launch Dates for HPT, HP, and HK 183
Table 70: Key Patent Expirations for HPT, HP, and HK 183
Table 71: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 190

List Of Figures

1.2 List of Figures
Figure 1: Global Sales Forecast by Country in 2016 and 2026 11
Figure 2: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026 12
Figure 3: The Pathogenesis of HPT 22
Figure 4: The Pathogenesis of HK 25
Figure 5: 7MM, Age-Standardized Total Prevalence of CKD, Stages I-IV, Ages 20 Years, 2016 35
Figure 6: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD Stages I-IV 36
Figure 7: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD by Stage 37
Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD Stages I-IV 38
Figure 9: 7MM, Sources Used to Forecast the Number of CKD Cases on Dialysis 39
Figure 10: 7MM, Sources Used to Forecast the Number of New Kidney Transplants 40
Figure 11: 7MM, Age-Specific Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages 20 Years, N, 2016 48
Figure 12: 7MM, Sex-Specific Total Prevalent Cases of CKD, Stages I-IV, Both Sexes, Ages 20 Years, N, 2016 49
Figure 13: 7MM, Total Prevalent Cases of CKD by Stage, Both Sexes, Ages 20 Years, N, 2016 50
Figure 14: 7MM, Diagnosed Prevalent Cases of CKD by Stage, Both Sexes, Ages 20 Years, N, 2016 52
Figure 15: Unmet Need and Opportunity in CKD 99
Figure 16: Overview of the Development Pipeline in CKD-Induced HPT, HP, and HK 118
Figure 17: Competitive Assessment of Key Pipeline Phosphate Binders 150
Figure 18: Competitive Assessment of Key Pipeline Calcimimetics 151
Figure 19: Competitive Assessment of Key Pipeline Vitamin D Sterols 152
Figure 20: Competitive Assessment of Key Pipeline Potassium Binders 153
Figure 21: Global Sales Forecast by Country in 2016 and 2026 155
Figure 22: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026 156

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