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

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Combined Sales for CKD-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia to Double by 2026

2.2 A Continued Focus on Improving the Compliance and Safety of Phosphate Binder Drugs

2.3 Novel Therapies Finally Begin to Address Long-Standing Key Unmet Needs in Hyperkalemia

2.4 IV Calcimimetic, Parsabiv Expected to Revolutionize the Treatment of Dialysis-Dependent Hyperparathyroidism Patients

2.5 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Symptoms

4.3 Diagnosis and Monitoring

4.4 Prognosis and Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for CKD (2016–2026)

5.5.1 Total Prevalent Cases of CKD, Stages I–IV

5.5.2 Age-Specific Total Prevalent Cases of CKD, Stages I–IV

5.5.3 Sex-Specific Total Prevalent Cases of CKD, Stages I–IV

5.5.4 Total Prevalent Cases of CKD by Stage

5.5.5 Diagnosed Prevalent Cases of CKD, Stages I–V

5.5.6 Diagnosed Prevalent Cases of CKD by Stage

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Current Treatment Options

6.1 Overview

6.2 Treatment Guidelines and Leading Prescribed Drugs

6.2.1 Hyperparathyroidism and Hyperphosphatemia

6.2.2 Hyperkalaemia

6.3 Clinical Practice

6.3.1 Hyperparathyroidism and Hyperphosphatemia

6.3.2 Hyperkalemia

6.4 Calcimimetics

6.4.1 Sensipar (cinacalcet hydrochloride)

6.5 Vitamin D Sterols

6.5.1 Nutritional/Native Vitamin D

6.5.2 Vitamin D Receptor Agonists

6.6 Phosphate Binding Therapies

6.6.1 Overview

6.6.2 Calcium-Based Phosphate Binders

6.6.3 Aluminum-Containing Phosphate Binders

6.6.4 Magnesium-Containing Phosphate Binders

6.6.5 Renvela/Renagel (sevelamer carbonate/hydrochloride)

6.6.6 Fosrenol (lanthanum carbonate)

6.6.7 Velphoro (sucroferric oxyhydroxide)

6.6.8 Auryxia (ferric citrate)

6.7 Potassium Binding Therapies

6.7.1 Resins

6.7.2 Veltassa (patiromer sorbitex calcium)

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Optimal Management of Phosphate in Hyperparathyroidism

7.2.1 Unmet Need

7.2.2 Gap Analysis

7.2.3 Opportunity

7.3 Novel Hyperkalemia Treatments

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Improved Compliance

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

7.5 Drug Cost and Market Access

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

8 R&D Strategies

8.1 Overview

8.1.1 Licensing and Alliances

8.1.2 Optimizing Treatment Safety and Compliance in Both the Pre-dialysis and Dialysis Setting

8.1.3 Development of Various Novel Phosphate Binders Continues as Unmet Needs Remian

8.2 Clinical Trial Design

8.2.1 Hyperparathyroidism

8.2.2 Hyperphosphatemia

8.2.3 Hyperkalemia

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.2.1 Parsabiv (etelcalcetide hydrochloride)

9.2.2 Evocalcet

9.2.3 DP-001

9.2.4 PT20

9.2.5 Tenapanor hydrochloride

9.2.6 Alpharen (fermagate)

9.2.7 Lokelma (sodium zirconium cyclosilicate)

9.3 Innovative Early Stage Approaches

9.3.1 Renazorb (SPI-014)

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Drugs

10.2 Commercial Benchmark of Key Pipeline Drugs

10.3 Competitive Assessment

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 Diagnosed Patients

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Managing Analyst

11.6.2 Analyst

11.6.3 Therapy Area Director

11.6.4 Epidemiologist

11.6.5 Director of Epidemiology

11.6.6 Global Director of Therapy Analysis and Epidemiology

11.6.7 Global Head of Healthcare

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table 1: Late-Stage Chronic Kidney Disease-Induced Hyperparathyroidism, Hyperphosphatemia, and Hyperkalemia, Key Metrics in the 7MM

Table 2: Stages of CKD

Table 3: Common Comorbidities of CKD and ESRD

Table 4: Degree of HK

Table 5: Factors Influencing Renal Potassium Excretion

Table 6: Factors Influencing Potassium Plasma Levels

Table 7: Symptoms of CKD

Table 8: Main Conditions Associated with HPT

Table 9: Common Diagnostic Tests for CKD and Associated Comorbidities

Table 10: Common Monitoring Procedures for HPT patients.

Table 11: Recommended Phosphate Maintenance Levels for CKD Patients

Table 12: Cardiac Monitoring Recommendations in HK Patients

Table 13: ECG Changes Indicative of Increasing Serum Potassium Levels

Table 14: Acute versus Chronic HK

Table 15: KDIGO Classification of CKD

Table 16: Risk Factors and Comorbidities for CKD

Table 17: 7MM, Total Prevalent Cases of CKD, Stages I–IV, Both Sexes, Ages ≥20 Years, N, Selected Years from 2016–2026

Table 18: 7MM, Diagnosed Prevalent Cases of CKD, Stages I–V, Both Sexes, Ages ≥20 Years, N, Selected Years from 2016–2026

Table 19: Treatment Guidelines for CKD, HPT

Table 20: Leading Treatments for HPT and HP, 2016

Table 21: Treatment Guidelines for CKD, HPT

Table 22: Interventions for the treatment of acute or chronic HK

Table 23: Product Profile – Sensipar

Table 24: Sensipar SWOT Analysis

Table 25: Nutritional Vitamin D Sterols

Table 26: Product Profile – Rayaldee

Table 27: Rayaldee SWOT Analysis

Table 28: Common VDRAs

Table 29: Product Profile – VDRAs

Table 30: Paricalcitol SWOT Analysis

Table 31: Product Profile – Sevelamer

Table 32: Sevelamer SWOT Analysis

Table 33: Product Profile – Fosrenol

Table 34: Fosrenol SWOT Analysis

Table 35: Product Profile – Velphoro

Table 36: Velphoro SWOT Analysis

Table 37: Product Profile – Auryxia

Table 38: Auryxia SWOT Analysis

Table 39: Product Profile – Resins

Table 40: Auryxia SWOT Sodium polystyrene sulfonate

Table 41: Product Profile – Veltassa

Table 42: Veltassa SWOT Analysis

Table 43: Key Late-Stage Pipeline Agents for HPT

Table 44: Product Profile – Parsabiv

Table 45: Etelcalcetide SWOT Analysis

Table 46: Product Profile – Evocalcet

Table 47: Evocalcet SWOT Analysis

Table 48: Product Profile – DP-001

Table 49: DP-001 SWOT Analysis

Table 50: Product Profile – PT20

Table 51: PT20 SWOT Analysis

Table 52: Product Profile – Tenpanor

Table 53: Tenapanor SWOT Analysis

Table 54: Product Profile – Alpharen

Table 55: Alpharen SWOT Analysis

Table 56: Product Profile – Lokelma

Table 57: Lokelma SWOT Analysis

Table 58: Early Stage Pipeline Products for HPT, HP, and HK.

Table 59: Clinical Benchmarking of Key Marketed & Pipeline Products (Phosphate binders)

Table 60: Clinical Benchmarking of Key Marketed and Pipeline Products (calcimimetics)

Table 61: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols)

Table 62: Clinical Benchmarking of Key Marketed and Pipeline Products (potassium binders)

Table 63: Commercial Benchmarking of Key Marketed & Pipeline Products (Phosphate binders)

Table 64: Commercial Benchmarking of Key Marketed & Pipeline Products (calcimimetics)

Table 65: Clinical Benchmarking of Key Marketed and Pipeline Products (Vitamin D sterols)

Table 66: Commercial benchmarking of SOC and newly launched/pipeline potassium binders.

Table 67: Key Events Impacting Sales for HPT, HP, and HK, 2016–2026

Table 68: HPT Market – Global Drivers and Barriers, 2016‒2026

Table 69: Key Launch Dates for HPT, HP, and HK

Table 70: Key Patent Expirations for HPT, HP, and HK

Table 71: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

Figure 1: Global Sales Forecast by Country in 2016 and 2026

Figure 2: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026

Figure 3: The Pathogenesis of HPT

Figure 4: The Pathogenesis of HK

Figure 5: 7MM, Age-Standardized Total Prevalence of CKD, Stages I–IV, Ages ≥20 Years, 2016

Figure 6: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD Stages I–IV

Figure 7: 7MM, Sources Used to Forecast the Total Prevalent Cases of CKD by Stage

Figure 8: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of CKD Stages I–IV

Figure 9: 7MM, Sources Used to Forecast the Number of CKD Cases on Dialysis

Figure 10: 7MM, Sources Used to Forecast the Number of New Kidney Transplants

Figure 11: 7MM, Age-Specific Total Prevalent Cases of CKD, Stages I–IV, Both Sexes, Ages ≥20 Years, N, 2016

Figure 12: 7MM, Sex-Specific Total Prevalent Cases of CKD, Stages I–IV, Both Sexes, Ages ≥20 Years, N, 2016

Figure 13: 7MM, Total Prevalent Cases of CKD by Stage, Both Sexes, Ages ≥20 Years, N, 2016

Figure 14: 7MM, Diagnosed Prevalent Cases of CKD by Stage, Both Sexes, Ages ≥20 Years, N, 2016

Figure 15: Unmet Need and Opportunity in CKD

Figure 16: Overview of the Development Pipeline in CKD-Induced HPT, HP, and HK

Figure 17: Competitive Assessment of Key Pipeline Phosphate Binders

Figure 18: Competitive Assessment of Key Pipeline Calcimimetics

Figure 19: Competitive Assessment of Key Pipeline Vitamin D Sterols

Figure 20: Competitive Assessment of Key Pipeline Potassium Binders

Figure 21: Global Sales Forecast by Country in 2016 and 2026

Figure 22: Global Sales Forecast by CKD-Induced HPT, HP, and HK in 2016 and 2026