Diabetic nephropathy (DN), also referred to as diabetic kidney disease, is a common complication of diabetes. The current standard of care fails to halt the frequent progression of DN to kidney disease and, ultimately, kidney failure—a condition associated with severe morbidity / mortality and high costs to patients and payers. As a result, key opinion leaders (KOLs) indicate that efficacious therapies for DN are a major unmet need. KOLs weigh in on the anticipated nephroprotective effects that endothelin receptor antagonists, mineralocorticoid receptor antagonists, and SGLT-2 inhibitors may offer. These therapies represent the first potentially disease-modifying therapies, should they prove efficacious and safe. The increasing prevalence of DN, exacerbated by the dynamics between clinicians seeking to prescribe new, premium-priced therapies and payers seeking to control costs among an already expensive population, will help shape the changing DN market over the next ten years.

Questions answered

  • Will the inclusion of cardiovascular endpoints in the clinical trials for select therapies be a competitive advantage once commercially available?
  • How do KOLs view the different mechanisms of action of the therapies in early- and late-phase clinical development?
  • What are the key remaining unmet needs in DN? Which drugs in development will fulfill these unmet needs?
  • What market access and reimbursement challenges will the emerging therapies face in the G7? How will these challenges influence their uptake?

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

  • Diabetic Nephropathy - Landscape & Forecast - Disease Landscape & Forecast
    • COVID-19
      • Key Findings
        • Diabetic Nephropathy - Key Findings - January 2021
      • Key Updates
        • March 2021
        • February 2021
        • January 2021
        • December 2020
        • July 2020
        • April 2020
        • March 2020
      • Market Outlook
        • Key Findings
          • Market Share of Diabetic Nephropathy Drug Classes: 2019
          • Market Share of Diabetic Nephropathy Drug Classes: 2029
          • Diabetic Nephropathy SWOT Analysis
        • COVID-19: Areas of Potential Forecast Impact
          • Market Drivers and Constraints
            • What Factors Are Driving the Market for Diabetic Nephropathy?
            • What Factors Are Constraining the Market for Diabetic Nephropathy?
          • Drug Class-Specific Trends
            • Annual Sales of SGLT-2 Inhibitors in Diabetic Nephropathy in the United States: 2019-2029
            • Annual Patient Share of SGLT-2 Inhibitors in Diabetic Nephropathy in the United States: 2019-2029
            • Annual Sales of SGLT-2 Inhibitors in Diabetic Nephropathy in Europe: 2019-2029
            • Annual Patient Share of SGLT-2 Inhibitors in Diabetic Nephropathy in Europe: 2019-2029
            • Annual Sales of SGLT-2 Inhibitors in Diabetic Nephropathy in Japan: 2019-2029
            • Annual Patient Share of SGLT-2 Inhibitors in Diabetic Nephropathy in Japan: 2019-2029
            • Annual Sales of Antidiabetic Drug Classes in Diabetic Nephropathy in the Major Markets: 2019-2029
            • Annual Patient Share of Insulins in Diabetic Nephropathy in the Major Markets: 2019-2029
            • Annual Patient Share of Noninsulins in Diabetic Nephropathy in the Major Markets: 2019-2029
            • Annual Sales of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in the Major Markets: 2019-2029
            • Annual Patient Share of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in the Major Markets: 2019-2029
            • Annual Patient Share of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in Japan: 2019-2029
            • Annual Sales of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in Japan: 2019-2029
            • Annual Patient Share of Antihypertensive Drug Classes in Diabetic Nephropathy in the Major Markets: 2019-2029
        • Forecast
          • Market Forecast Assumptions
          • Market Forecast Dashboard
        • Etiology and Pathophysiology
          • Disease Overview
            • Pathophysiology
              • Diabetic Nephropathy Pathophysiology
            • Natural History of Diabetic Nephropathy
              • Natural History
              • Stages of Natural Disease Progression: Diabetic Nephropathy
            • Risk Factors
              • Diabetic Nephropathy Risk Factors
            • Key Pathways and Drug Targets
              • Key Therapeutic Targets
          • Epidemiology
            • Key Findings
              • Epidemiology Populations
                • Disease Definition
                • Methods
                • Sources Used for Diagnosed Diabetes within Total Prevalent CKD
                • Number of Diagnosed Diabetes Within Total Prevalent CKD: 2019-2029 (Thousands)
                • Sources Used for Diagnosed Prevalence of Diabetic Nephropathy
                • Number of Diagnosed Prevalent Cases of Diabetic Nephropathy: 2019-2029 (Thousands)
            • Current Treatment
              • Key Findings
                • Treatment Goals
                  • Key Endpoints Used in Clinical Trials for Diabetic Nephropathy
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drug Classes Used for Diabetic Nephropathy
                  • Current Treatments Used for Glycemic Control in Diabetic Nephropathy
                  • Current Treatments for Blood Pressure Control Used in Diabetic Nephropathy
                  • Market Events Impacting the Use of Key Current Therapies in Diabetic Nephropathy
                  • Advantages and Disadvantages of Renin-Angiotensin-Aldosterone System Inhibitors
                  • Expert Insight: RAAS Inhibitors
                  • Esaxerenone
                  • Advantages and Disadvantages of Esaxerenone
                  • Key Results from Select Clinical Trials Investigating Esaxerenone for the Treatment of Diabetic Nephropathy
                  • Key Ongoing Clinical Trials of Esaxerenone in the Treatment of Diabetic Nephropathy
                  • Expert Insight: Esaxerenone
                  • Other Antihypertensive Drug Classes
                  • Expert Insight: Other Antihypertensives Used for Diabetic Nephropathy
                  • Advantages and Disadvantages of Dapagliflozin
                  • Key Results from Select Clinical Trials Investigating Dapagliflozin for the Treatment of Diabetic Nephropathy
                  • Expert Insight: Dapagliflozin
                  • Advantages and Disadvantages of Canagliflozin
                  • Key Results from Select Clinical Trials Investigating Canagliflozin for the Treatment of Diabetic Nephropathy
                  • Key Ongoing Clinical Trials of Canagliflozin in the Treatment of Diabetic Nephropathy
                  • Expert Insight: Canagliflozin
                  • Advantages and Disadvantages of Empagliflozin
                  • Key Results from Select Clinical Trials Investigating Empagliflozin for the Treatment of Diabetic Nephropathy
                  • Key Ongoing Clinical Trials of Empagliflozin in the Treatment of Diabetic Nephropathy
                  • Expert Insight: Empagliflozin
                  • Advantages and Disadvantages of Ertugliflozin
                  • Key Results from Select Clinical Trials Investigating Ertugliflozin for the Treatment of Diabetic Nephropathy
                  • Key Ongoing Clinical Trials of Ertugliflozin in the Treatment of Diabetic Nephropathy
                  • Expert Insight: Ertugliflozin
                  • Other Antidiabetics
                  • Expert Insight: Use of Other Antidiabetics in the Treatment of Diabetic Nephropathy
                • Medical Practice
                  • Overview
                  • Country-Specific Diabetic Nephropathy Treatment Guidelines
                  • Drug Selection
                  • Factors Influencing Drug Selection in Diabetic Nephropathy
                  • Treatment Decision Tree for Diabetic Nephropathy: United States
                  • Treatment Decision Tree for Diabetic Nephropathy: Europe
                  • Treatment Decision Tree for Diabetic Nephropathy: Japan
              • Unmet Need Overview
                • Current and Future Attainment of Unmet Needs in Diabetic Nephropathy
                • Top Unmet Needs in Diabetic Nephropathy: Current and Future Attainment
                • Expert Insight: Unmet Need in Diabetic Nephropathy
              • Emerging Therapies
                • Key Findings
                  • Pipeline Trends for Diabetic Nephropathy
                • Key Emerging Therapies
                  • Key Emerging Therapies in Development for Diabetic Nephropathy
                  • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Diabetic Nephropathy
                  • Likely Uses of SGLT-2 Inhibitors in the Treatment of Diabetic Patients with Renal Dysfunction
                  • Key Results from Select Clinical Trials Investigating Sotagliflozin for the Treatment of Diabetic Nephropathy
                  • Key Ongoing Clinical Trials of Sotagliflozin in the Treatment of Diabetic Nephropathy
                  • Analysis of the Clinical Development Program for Sotagliflozin
                  • Expert Insight: Sotagliflozin
                  • Expectations for Launch and Sales Opportunity of Sotagliflozin in Diabetic Nephropathy
                  • Key Development Milestones for Sotagliflozin in the Treatment of Diabetic Nephropathy
                  • Key Results from Select Clinical Trials Investigating Finerenone for the Treatment of Diabetic Nephropathy
                  • Key Ongoing Clinical Trials of Finerenone in the Treatment of Diabetic Nephropathy
                  • Analysis of the Clinical Development Program for Finerenone
                  • Expectations for Market Authorization and Sales Opportunity of Finerenone in Diabetic Nephropathy
                  • Key Development Milestones for Finerenone in the Treatment of Diabetic Nephropathy
                • Early-Phase Pipeline Analysis
                  • Notable Developments in the Early-Phase Pipeline for Diabetic Nephropathy / Diabetic Kidney Disease
                  • Select Phase II Compounds in Development for Diabetic Nephropathy / Diabetic Kidney Disease
                  • Select Phase I and Preclinical Development Programs for Diabetic Nephropathy / Diabetic Kidney Disease
                • Key Discontinuations and Failures in Diabetic Nephropathy
                  • Key Discontinuations and Failures
              • Access & Reimbursement Overview
                • Region-Specific Reimbursement Practices
                  • Key Market Access Considerations in Diabetic Nephropathy: United States
                  • General Reimbursement Environment: United States
                  • Key Market Access Considerations in Diabetic Nephropathy: EU5
                  • General Reimbursement Environment: EU5
                  • Key Market Access Considerations in Diabetic Nephropathy: Japan
                  • General Reimbursement Environment: Japan
              • Appendix
                • Key Abbreviations Related to Diabetic Nephropathy
                • Brands, Marketers, and Generic Availability of Current Therapies Used for Diabetic Nephropathy by Market
                • Diabetic Nephropathy Bibliography

            Author(s): Dwaipayan Chatterjee, M.Pharm.; Brynna Izquierdo, M.P.H.

            Dwaipayan Chatterjee, M.Pharm., is an analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at DRG, part of Clarivate. He has authored reports focusing on metabolic and cardiovascular indications. Prior to joining DRG, he was an equity analyst for the U.S. healthcare sector with Market Realist, where he worked on competitive intelligence and analysis of financial data. He was also a market research analyst for Mordor Intelligence, where he gained experience in market sizing, forecasting, and analyzing market dynamics. He holds a master’s degree with a specialization in pharmaceutical chemistry from the Birla Institute of Technology & Science in Pilani, India.

            Brynna Izquierdo, M.P.H., is an associate epidemiologist at DRG, part of Clarivate. Prior to joining DRG, she held various research assistant positions conducting secondary data analyses in the fields of psycho-oncology and chronic disease. She earned her M.P.H. in epidemiology and B.S. in public health from Temple University in Philadelphia.