Market Outlook

Elevated serum potassium, commonly known as hyperkalemia, is a condition common in patients with decreased renal function and heart failure and is often exacerbated by those receiving RAAS inhibitors or NSAIDs. Although largely asymptomatic, if left untreated hyperkalemia can result in cardiac dysfunction and even death. Drug development has been minimal over the past 50 years; however, new potassium-binding products from Relypsa/Vifor Fresenius Medical Care Renal Pharma and ZS Pharma/AstraZeneca are anticipated in the major markets under study. These therapies compete directly with an existing binder by offering improvements in safety and efficacy and are expected to significantly increase the value of the hyperkalemia market over the next decade. With these changing market dynamics, companies investing in the space need to understand the competing factors that will influence the commercial success, or failure, of new product launches.

Questions Answered

  • What market access and reimbursement challenges will the emerging potassium binders face in the G7? Will this influence patient share?
  • Will patiromer and zirconium cyclosilicate become blockbusters in the major markets?
  • What do key opinion leaders think will be the most promising new therapy to treat chronic and/or acute hyperkalemia?
  • What challenges will potassium binders face as a chronic treatment for hyperkalemia?

Product Description

Disease Landscape & Forecast: Comprehensive market intelligence providing world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Hyperkalemia - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • December 2017
      • August 2017
    • Executive Summary
      • Key Findings
        • Market Share of Hyperkalemia Drug Classes: 2016
        • Market Share of Hyperkalemia Drug Classes: 2026
        • Hyperkalemia SWOT Analysis
    • Market Outlook
      • Key Findings
        • Expert Insight
        • Market Overview
        • Major-Market Sales of Chronic Hyperkalemia Therapies by Region and Drug Class: 2016-2026
        • Major-Market Sales of Acute Hyperkalemia Therapies by Region and Drug Class: 2016-2026
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Hyperkalemia?
        • What Factors Are Constraining the Market for Hyperkalemia?
        • Key Market Events for Hyperkalemia
        • Major-Market Patient Share and Drug-Treated Population: 2016-2026
      • Drug Class Specific Trends
        • Patient Share of Cation-Exchange Resins in Chronic Hyperkalemia in the United States: 2016-2026
        • Patient Share of Cation-Exchange Resins in Chronic Hyperkalemia in Europe: 2016-2026
        • Patient Share of Cation-Exchange Resins in Chronic Hyperkalemia in Japan: 2016-2026
        • Sales of Cation-Exchange Resins in Chronic Hyperkalemia in the G7: 2016-2026
        • Patient Share of Cation-Exchange Resins in Acute Hyperkalemia in the United States: 2016-2026
        • Patient Share of Cation-Exchange Resins in Acute Hyperkalemia in Europe: 2016-2026
        • Patient Share of Cation-Exchange Resins in Acute Hyperkalemia in Japan: 2016-2026
        • Sales of Cation-Exchange Resins in Acute Hyperkalemia in the G7: 2016-2026
        • Patient Share of Other Drug Classes in Chronic Hyperkalemia in the G7: 2016-2026
        • Sales of Other Drug Classes in Chronic Hyperkalemia in the G7: 2016-2026
        • Patient Share of Other Drug Classes in Acute Hyperkalemia in the G7: 2016-2026
        • Sales of Other Drug Classes in Acute Hyperkalemia in the G7: 2016-2026
    • Forecast
      • Sales of Drugs to Treat Chronic Hyperkalemia in the Major Pharmaceutical Markets: 2016-2026
      • Sales of Drugs to Treat Acute Hyperkalemia in the Major Pharmaceutical Markets: 2016-2026
    • Etiology and Pathophysiology
      • Key Findings
        • Expert Insight
        • Disease Overview
      • Etiology
        • Underlying Causes of Hyperkalemia
        • Hyperkalemia Associated with RAAS Inhibitor Use in Select Clinical Trials in Chronic Kidney Disease Patients
        • Risk Factors for Hyperkalemia
      • Pathophysiology
        • Maintaining Potassium Homeostasis
        • Potassium Homeostasis
      • Key Pathways and Drug Targets
        • Summary of Drug Targets for Hyperkalemia
    • Epidemiology Overview
      • Key Findings
        • Epidemiology Populations
          • Disease Definition
          • Methods
          • Sources Used for Total Prevalence of Hyperkalemia
          • Number of Total Prevalent Cases of Chronic Hyperkalemia in the Major Pharmaceutical Markets: 2016-2026
          • Disease Definition
          • Methods
          • Sources Used for Diagnosed Acute Events of Hyperkalemia
          • Number of Diagnosed Acute Events of Hyperkalemia in the Major Pharmaceutical Markets: 2016-2026
          • Sources Used for Drug-Treated Prevalent Cases of Hyperkalemia
          • Number of Drug-Treated Prevalent Cases of Hyperkalemia in the Major Pharmaceutical Markets: 2016-2026
          • Disease Definition
          • Methods
          • Sources Used for Severity of Hyperkalemia
          • Number of Total Prevalent Cases of Hyperkalemia in the Major Pharmaceutical Markets by Severity: 2016-2026
      • Current Treatment Overview
        • Key Findings
          • Expert Insight
        • Treatment Goals
          • Key End Points Used in Clinical Trials for Hyperkalemia
          • Physician Insights on Clinical End Points
          • Expert Insight: Clinical End Points
        • Key Current Therapies
          • Overview
          • Mechanism of Action of Key Current Drug Classes Used for Hyperkalemia
          • Current Treatments Used for Hyperkalemia
          • Market Events Impacting the Use of Key Current Therapies in Hyperkalemia
          • Advantages and Disadvantages of Sodium/Calcium Polystyrene Sulfonate
          • Expert Insight: Use of Sodium/Calcium Polystyrene Sulfonate in the Treatment of Hyperkalemia
          • Expert Insight: Sodium/Calcium Polystyrene Sulfonate
          • Advantages and Disadvantages of Patiromer
          • Ongoing Clinical Development
          • Key Ongoing Clinical Trials of Patiromer in the Treatment of Hyperkalemia
          • Expert Insight: Use of Patiromer in the Treatment of Hyperkalemia
          • Expert Insight: Patiromer
          • Advantages and Disadvantages of Insulin
          • Expert Insight: Insulin
          • Advantages and Disadvantages of Beta 2 Adrenoreceptor Agonists
          • Advantages and Disadvantages of Diuretics
          • Advantages and Disadvantages of Sodium Bicarbonate
          • Expert Insight: Sodium Bicarbonate
          • Hemodialysis and Peritoneal Dialysis
          • Advantages and Disadvantages of Renal Replacement Therapy
          • Expert Insight: Use of Renal Replacement Therapy in the Treatment of Hyperkalemia
          • Expert Insight: Renal Replacement Therapy
        • Medical Practice
          • Overview
          • Treatment Guidelines
          • Regional Hyperkalemia Treatment Guidelines
          • Drug Selection
          • Factors Influencing Drug Selection in Hyperkalemia
          • Treatment Decision Tree for Hyperkalemia: United States
          • Treatment Decision Tree for Hyperkalemia: Europe
          • Treatment Decision Tree for Hyperkalemia: Japan
      • Unmet Need Overview
        • Key Findings
          • Expert Insight
        • Attainment of Unmet Needs
          • Current Attainment of Unmet Needs in Hyperkalemia
          • Future Attainment of Unmet Needs in Hyperkalemia
          • Top Unmet Needs in Hyperkalemia: Current and Future Attainment
          • Expert Insight: Unmet Needs in Hyperkalemia
      • Emerging Therapies Overview
        • Key Findings
          • Expert Insight
          • Pipeline Trends for Hyperkalemia
        • Key Emerging Therapies
          • Notable Developments Among Key Emerging Therapies for Hyperkalemia
          • Key Emerging Therapies in Development for Hyperkalemia
          • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Hyperkalemia
          • Potassium Binders
          • Key Results from Select Clinical Trials Investigating Zirconium Cyclosilicate for the Treatment of Hyperkalemia
          • Key Ongoing Clinical Trials of Zirconium Cyclosilicate in the Treatment of Hyperkalemia
          • Zirconium Cyclosilicate Clinical Development
          • Key Development Milestones for Zirconium Cyclosilicate in the Treatment of Hyperkalemia
          • Expert Insight: Use of Zirconium Cyclosilicate in the Treatment of Hyperkalemia
          • Expert Insight: Zirconium Cyclosilicate
          • Expectations for Launch and Sales Opportunity of Zirconium Cyclosilicate in Hyperkalemia
          • Key Clinical Trials of RDX-7675 in the Treatment of Hyperkalemia
          • RDX-7675 Clinical Development
          • Expectations for Launch and Sales Opportunity of RDX-7675 in Hyperkalemia
        • Early-Phase Pipeline Analysis
          • Notable Developments in the Early-Phase Pipeline for Hyperkalemia
          • Select Compounds in Early-Phase Development for Hyperkalemia
      • Access & Reimbursement Overview
        • Region-Specific Reimbursement Practices
          • Key Market Access Considerations in Hyperkalemia: United States
          • Key Market Access Considerations in Hyperkalemia: EU5
          • Key Market Access Considerations in Hyperkalemia: Japan
          • General Reimbursement Environment: Japan
      • Methodology
        • Bottom-Up Forecasting Overview
          • Patient Populations
          • Drug-Specific Assumptions
        • Bottom-Up Forecast Assumptions
          • General Sources of Data
          • Agents Included in Our Market Analysis
          • General Statements About Pricing
          • Sources for Drug Prices
          • 2016 Exchange Rates
          • Dosing, Days of Therapy, and Compliance
          • Generic Erosion
          • Biosimilar Erosion
          • Out-Year Forecasting
          • Emerging Therapy Prices
        • Primary Market Research
          • Experts Interviewed
      • Appendix
        • Brands, Marketers, and Generic Availability of Key Therapies for Hyperkalemia by Market
        • Key Abbreviations Related to Hyperkalemia
        • Hyperkalemia 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.