Chronic kidney disease (CKD) is a general term for a set of heterogeneous disorders that negatively affect the function and structure of the kidney. CKD is characterized by a progressive loss of function and can lead to end-stage renal disease (ESRD), necessitating dialysis. The most common causes of CKD are diabetes and hypertension. As the prevalence of hypertension and diabetes continues to increase, so too does the prevalence of CKD and the cost to national healthcare systems for treating these patients. Thus, the commercial opportunity for drugs with proven efficacy in delaying the progression of this condition and/or treating its symptoms is considerable.

Because of the lack of disease-modifying agents for CKD, treatment is aimed at minimizing the symptoms and complications arising from progressively diminished kidney function. The most common complications are renal anemia, hyperphosphatemia, and secondary hyperparathyroidism. This content takes a comprehensive look at the CKD therapy market, including treatment practices, unmet need, the early- and late-stage therapy pipelines, the likely impact of emerging therapies, and reimbursement and access restrictions.

Table of contents

  • Chronic Kidney Disease - Landscape & Forecast - Disease Landscape & Forecast
    • Executive Summary
      • Introduction
        • Key Findings
        • Market Share of Chronic Kidney Disease Drug Classes in 2015
        • Market Share of Chronic Kidney Disease Drug Classes in 2025
        • Chronic Kidney Disease SWOT Analysis
    • Market Outlook
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Chronic Kidney Disease?
        • What Factors Are Constraining the Market for Chronic Kidney Disease?
        • Key Market Events for Chronic Kidney Disease, 2015-2025
      • Drug-Class-Specific Trends
        • Annual Sales of Erythropoietin-Stimulating Agents in Chronic Kidney Disease Nondialysis, Major Markets, 2015 - 2025
        • Annual Sales of Erythropoietin-Stimulating Agents in Chronic Kidney Disease Dialysis, Major Markets, 2015 - 2025
        • Patient Share of Select Erythropoietin-Stimulating Agents in Chronic Kidney Disease Nondialysis, Major Markets, 2015-2025
        • Patient Share of Select Erythropoietin-Stimulating Agents in Dialysis, Major Markets, 2015-2025
        • Annual Sales of Phosphate Binders in Chronic Kidney Disease Nondialysis, Major Markets, 2015 - 2025
        • Annual Sales of Phosphate Binders in Chronic Kidney Disease Dialysis, Major Markets, 2015 - 2025
        • Patient Share of Select Phosphate Binders in Chronic Kidney Disease Nondialysis, Major Markets, 2015-2025
        • Patient Share of Select Phosphate Binders in Chronic Kidney Disease Dialysis, Major Markets, 2015-2025
        • Annual Sales of Select Calcium Mimetics in Chronic Kidney Disease Dialysis, Major Markets, 2015 - 2025
        • Patient Share of Select Calcium Mimetics in Chronic Kidney Disease Dialysis, Major Markets, 2015 - 2025
        • Annual Sales of Potassium Binders in Chronic Kidney Disease, Major Markets, 2015-2025
        • Patient Shares of Potassium Binders in Chronic Kidney Disease, Major Markets, 2015-2025
        • Annual Sales of HIF-PH Inhibitors in Chronic Kidney Disease, Major Markets, 2015-2025
        • Patient Share of HIF-PH Inhibitors in Chronic Kidney Disease, Major Markets, 2015 - 2025
        • Patient Share of Atrasentan by Subpopulation in Chronic Kidney Disease, Major Markets, 2015-2025
        • Patient Share of Finerenone by Subpopulation in Chronic Kidney Disease, Major Markets, 2015-2025
        • Patient Share of Canagliflozin by Subpopulation in Chronic Kidney Disease, Major Markets, 2015-2025
    • Forecast
      • Sales of Drugs to Treat Chronic Kidney Disease Nondialysis in the Major Pharmaceutical Markets, 2015-2025
      • Sales of Drugs to Treat Dialysis in the Major Pharmaceutical Markets, 2015-2025
    • Etiology and Pathophysiology
      • Epidemiology Overview
        • Introduction
          • Key Findings
          • Expert Insights
          • Prevalence of Chronic Kidney Disease per 1,000 People Aged 20+ in 2015 and 2025
          • Relative Sizes of the Contributing Factors to the Trend in Prevalent Cases of Chronic Kidney Disease over the Next Ten Years
          • Analysis of the Prevalent Cases of Chronic Kidney Disease in 2015 by Stage
        • Epidemiology Populations
          • Disease Definition
          • Methods
          • Sources Used for Prevalent Cases of Chronic Kidney Disease and Staging
          • Number of Total Prevalent Cases of Chronic Kidney Disease in the Major Pharmaceutical Markets by Chronic Kidney Disease Stages 1-5, 2015-2025 (in thousands)
          • Sources Used for Diagnosed Prevalent Cases of Chronic Kidney Disease
          • Diagnosed Prevalent Cases of Stage 3 Chronic Kidney Disease (thousands)
          • Diagnosed Prevalent Cases of Stage 4 Chronic Kidney Disease (thousands)
          • Diagnosed Prevalent Cases of Stage 5 Chronic Kidney Disease-Nondialysis
          • Diagnosed Prevalent Cases of Chronic Kidney Disease-Dialysis
          • Sources Used for Drug-Treated Prevalent Cases of Chronic Kidney Disease
          • Drug-Treated Prevalent Cases of Stage 3 Chronic Kidney Disease (thousands)
          • Drug-Treated Prevalent Cases of Stage 4 Chronic Kidney Disease (thousands)
          • Drug-Treated Prevalent Cases of Stage 5 Chronic Kidney Disease-Nondialysis
          • Drug-Treated Prevalent Cases of Chronic Kidney Disease-Dialysis
      • Current Treatment Overview
        • Introduction
          • Key Findings
          • Expert Insight
          • Treatment Overview
        • Treatment Goals
          • Key End Points Used in Clinical Trials for Chronic Kidney Disease
          • Key End Points Used in Clinical Trials for Complications Associated with Chronic Kidney Disease
          • Key Physician Insights on Clinical Trial End Points for Chronic Kidney Disease
        • Key Current Therapies
          • Overview
          • Mechanism of Action of Key Current Drug Classes Used for Chronic Kidney Disease
          • Current Treatments Used for Chronic Kidney Disease
          • Market Events Impacting the Use of Key Current Therapies in Chronic Kidney Disease
          • Advantages and Disadvantages of Renin-Angiotensin-Aldosterone System Inhibitors
          • Expert Insight: Epoetin Alfa
          • Advantages and Disadvantages of Short-Acting Erythropoietin-Stimulating Agents
          • Advantages and Disadvantages of Long-Acting Erythropoietin-Stimulating Agents
          • Iron Supplementation for the Treatment of Renal Anemia
          • Advantages and Disadvantages of Iron Dextran
          • Advantages and Disadvantages of Iron Sucrose
          • Advantages and Disadvantages of Ferric Carboxymaltose
          • Advantages and Disadvantages of Soluble Ferric Pyrophosphate
          • Expert Insight: Soluble Ferric Pyrophosphate
          • Expert Insight: Phosphate Binders
          • Advantages and Disadvantages of Calcium Carbonate/Calcium Acetate
          • Advantages and Disadvantages of Calcium Acetate/Magnesium Carbonate
          • Expert Insight: Sevelamer Carbonate
          • Advantages and Disadvantages of Sevelamer Hydrochloride/Sevelamer Carbonate
          • Advantages and Disadvantages of Lanthanum Carbonate
          • Advantages and Disadvantages of Colestilan
          • Advantages and Disadvantages of Bixalomer
          • Advantages and Disadvantages of Ferric Citrate
          • Expert Insight: Ferric Citrate
          • Advantages and Disadvantages of Sucroferric Oxyhydroxide
          • Expert Insight: Sucroferric Oxyhydroxide
          • Advantages and Disadvantages of Active Vitamin D Analogues
          • Advantages and Disadvantages of Cinacalcet
          • Expert Insight: Potassium Binders
          • Advantages and Disadvantages of Sodium/Calcium Polystyrene Sulfonate
          • Expert Insight: Sodium/Calcium Polystyrene Sulfonate
          • Advantages and Disadvantages of Patiromer
          • Expert Insight: Patiromer
          • Largest Dialysis Providers in 2016
        • Medical Practice
          • Overview
          • Treatment Guidelines
          • Chronic Kidney Disease Treatment Guidelines, by Market
          • Drug Selection
          • Factors Influencing Drug Selection in Chronic Kidney Disease
          • Treatment Decision Tree for Chronic Kidney Disease: United States
          • Treatment Decision Tree for Chronic Kidney Disease: France
          • Treatment Decision Tree for Chronic Kidney Disease: Germany
          • Treatment Decision Tree for Chronic Kidney Disease: Italy
          • Treatment Decision Tree for Chronic Kidney Disease: Spain
          • Treatment Decision Tree for Chronic Kidney Disease: United Kingdom
          • Treatment Decision Tree for Chronic Kidney Disease: Japan
      • Unmet Need Overview
        • Introduction
          • Key Findings
          • Expert Insight
        • Attainment of Unmet Needs
          • Current Attainment of Unmet Needs in Chronic Kidney Disease
          • Future Attainment of Unmet Needs in Chronic Kidney Disease
          • Top Unmet Needs in Chronic Kidney Disease: Current and Future Attainment
          • Expert Insight on Unmet Needs in Chronic Kidney Disease Treatment
      • Emerging Therapies Overview
        • Introduction
          • Key Findings
          • Expert Insight
          • Pipeline Overview
          • Pipeline Trends for Chronic Kidney Disease
        • Late-Phase Pipeline Analysis
          • Notable Developments in the Late-Phase Pipeline for Chronic Kidney Disease
          • Therapies in Late-Phase Development for Chronic Kidney Disease
          • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Chronic Kidney Disease
        • Key Emerging Therapies
          • Etelcalcetide Profile
          • Etelcalcetide's Clinical Development
          • Expert Insight: Use of Etelcalcetide in the Treatment of Chronic Kidney Disease
          • Expert Insight: Etelcalcetide
          • Expectations for Launch and Sales Opportunity of Etelcalcetide in Chronic Kidney Disease
          • Key Development Milestones for Etelcalcetide in the Treatment of Chronic Kidney Disease
          • KHK-7580 Profile
          • KHK-7580's Clinical Development
          • Expectations for Launch and Sales Opportunity of KHK-7580 in Chronic Kidney Disease
          • Calcifediol Modified-Release Profile
          • Calcifediol Modified-Release's Clinical Development
          • Expert Insight: Use of Calcifediol Modified-Release in the Treatment of Chronic Kidney Disease
          • Expert Insight: Calcifediol Modified-Release
          • Expectations for Launch and Sales Opportunity of Calcifediol in Chronic Kidney Disease
          • Expert Insight: Use of Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitors in the Treatment of Chronic Kidney Disease
          • Expert Insight: Hypoxia-Inducible Factor-Prolyl Inhibitors
          • Likely Uses of Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitors for the Treatment of Chronic Kidney Disease
          • Roxadustat Profile
          • Roxadustat's Clinical Development
          • Expert Insight: Use of Roxadustat in the Treatment of Chronic Kidney Disease
          • Expectations for Launch and Sales Opportunity of Roxadustat in Chronic Kidney Disease
          • Expectations for Launch and Sales Opportunity of Roxadustat in Chronic Kidney Disease
          • Key Development Milestones for Roxadustat in the Treatment of Chronic Kidney Disease
          • Vadadustat Profile
          • Vadadustat's Clinical Development
          • Expert Insight: Use of Vadadustat in the Treatment of Chronic Kidney Disease
          • Expectations for Launch and Sales Opportunity of Vadadustat in Chronic Kidney Disease
          • Key Development Milestones for Vadadustat in the Treatment of Chronic Kidney Disease
          • Daprodustat Profile
          • Daprodustat's Clinical Development
          • Expert Insight: Use of Daprodustat in the Treatment of CKD
          • Expectations for Launch and Sales Opportunity of Daprodustat in Chronic Kidney Disease
          • Key Development Milestones for Daprodustat in the Treatment of Chronic Kidney Disease
          • Expert Insight: Use of Potassium Binders in the Treatment of Chronic Kidney Disease
          • Expert Insight: Potassium Binders
          • Sodium Zirconium Cyclosilicate Profile
          • Sodium Zirconium Cyclosilicate's Clinical Development
          • Expert Insight: Use of Sodium Zirconium Cyclosilicate in the Treatment of Chronic Kidney Disease
          • Expert Insight: Sodium Zirconium Cyclosilicate
          • Expectations for Launch and Sales Opportunity of Sodium Zirconium Cyclosilicate in Chronic Kidney Disease
          • Key Development Milestones for Sodium Zirconium Cyclosilicate in the Treatment of Chronic Kidney Disease
          • Polystyrene Sulfonate Polymer's Clinical Development
          • Expectations for Launch and Sales Opportunity of Polystyrene Sulfonate Polymer in Chronic Kidney Disease
          • Atrasentan Profile
          • Atrasentan's Clinical Development
          • Expert Insight: Use of Atrasentan in the Treatment of Chronic Kidney Disease
          • Expert Insight: Atrasentan
          • Expectations for Launch and Sales Opportunity of Atrasentan in Chronic Kidney Disease
          • Key Development Milestones for Atrasentan in the Treatment of Chronic Kidney Disease
          • Finerenone Profile
          • Finerenone's Clinical Development
          • Expert Insight: Use of Finerenone in the Treatment of Chronic Kidney Disease
          • Expert Insight: Finerenone
          • Expectations for Launch and Sales Opportunity of Finerenone in Chronic Kidney Disease
          • Key Development Milestones for Finerenone in the Treatment of Chronic Kidney Disease
          • Expert Insight: Use of Sodium-Glucose Co-Transporter 2 Inhibitors to Treat Chronic Kidney Disease
          • Expert Insight: Sodium-Glucose Co-Transporter 2 Inhibitors
          • Canagliflozin Profile
          • Canagliflozin's Clinical Development
          • Expectations for Launch and Sales Opportunity of Canagliflozin in Chronic Kidney Disease
          • Likely Uses of Canagliflozin in the Treatment of Chronic Kidney Disease
          • Likely Uses of Canagliflozin in the Treatment of Chronic Kidney Disease
          • Empagliflozin's Clinical Development
          • Dapagliflozin's Clinical Development
          • Tenapanor Profile
          • Tenapanor's Clinical Development
          • Expert Insight: Use of Tenapanor in the Treatment of Chronic Kidney Disease
          • Expert Insight: Tenapanor
          • Expectations for Launch and Sales Opportunity of Tenapanor in Chronic Kidney Disease
        • Early-Phase Pipeline Analysis
          • Notable Developments in the Early-Phase Pipeline for Chronic Kidney Disease
          • Select Phase II Compounds in Development for Chronic Kidney Disease
          • Select Phase I and Preclinical Development Programs for Chronic Kidney Disease
      • Access and Reimbursement Overview
        • Region-Specific Reimbursement Practices
          • Reimbursement Environment for Chronic Kidney Disease Therapies in the United States
          • Reimbursement Environment for Chronic Kidney Disease Therapies in France
          • Reimbursement Environment for Chronic Kidney Disease Therapies in Germany
          • Reimbursement Environment for Chronic Kidney Disease Therapies in Italy
          • Reimbursement Environment for Chronic Kidney Disease Therapies in Spain
          • Reimbursement Environment for Chronic Kidney Disease Therapies in the United Kingdom
          • Reimbursement Environment for Chronic Kidney Disease Therapies in Japan
        • U.S. Reimbursement Dynamics
          • Reimbursement Dynamics in Renal Anemia in the United States: Current and Future
          • Current Commercial MCO Coverage in the United States
          • Commercial MCO Coverage in Next 12 Months in the United States
        • U.S. Access & Reimbursement Considerations for Emerging Therapies
          • Access & Reimbursement Considerations for Emerging Renal Anemia Therapies in the United States
          • Potential Formulary Placement of Roxadustat at Various Price Points in the United States
      • Methodology
        • Appendix
          • Key Abbreviations Related to Chronic Kidney Disease
          • Brands, Marketers, and Generic Availability of Current Therapies Used for Chronic Kidney Disease, by Market
          • Experts Interviewed
          • Chronic Kidney Disease Bibliography

      Author(s): Caitlin Koris, MSPH

      Caitlin Koris, MSPH, is a business insights analyst on the cardiovascular, metabolic, and renal disorders team at Decision Resources Group. She has developed expertise in chronic kidney disease and related disorders such as bone and mineral metabolism, renal anemia, hyperkalemia, diabetic nephropathy, and kidney transplant.

      Prior to joining DRG, Caitlin was a clinical research monitor for oncology phase I and II trials. She obtained her M.S. in public health/health services research (MSPH) from Emory University, where she focused on pharmacoeconomics/outcomes research and healthcare policy. She has conducted research at the U.S. Centers for Disease Control and at the Food and Drug Administration.


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