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 will feature continuous updates in 2021 to provide timely insights and analyses as meaningful indication-specific news and events unfold.
Diabetic Nephropathy - Key Findings - January 2021
Key Updates
Q4 2021
November 2021
Q3 2021
September 2021
August 2021
July 2021
Q2 2021
June 2021
May 2021
April 2021
Q1 2021
March 2021
February 2021
January 2021
Q4 2020
December 2020
Market Outlook
Key Findings
Market Share of Diabetic Nephropathy Drug Classes: 2020
Market Share of Diabetic Nephropathy Drug Classes: 2030
Diabetic Nephropathy SWOT Analysis
Market Drivers and Constraints
What Factors Are Driving the Market for Diabetic Nephropathy?
What Factors Are Constraining the Market for Diabetic Nephropathy?
Annual Patient Share of Drug Classes for Diabetic Nephropathy: 2020-2030
Drug Class-Specific Trends
Annual Sales of SGLT-2 Inhibitors in Diabetic Nephropathy in the United States: 2020-2030
Annual Patient Share of SGLT-2 Inhibitors in Diabetic Nephropathy in the United States: 2020-2030
Annual Sales of SGLT-2 Inhibitors in Diabetic Nephropathy in Europe: 2020-2030
Annual Patient Share of SGLT-2 Inhibitors in Diabetic Nephropathy in Europe: 2020-2030
Annual Sales of SGLT-2 Inhibitors in Diabetic Nephropathy in Japan: 2020-2030
Annual Patient Share of SGLT-2 Inhibitors in Diabetic Nephropathy in Japan: 2020-2030
Annual Patient Share of Antidiabetic Drug Classes in Diabetic Nephropathy in the Major Markets: 2020-2030
Annual Sales of Antidiabetic Drug Classes in Diabetic Nephropathy in the Major Markets: 2020-2030
Annual Patient Share of Insulins in Diabetic Nephropathy in the Major Markets: 2020-2030
Annual Sales of Insulins in Diabetic Nephropathy in the Major Markets: 2020-2030
Annual Sales of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in the United States: 2020-2030
Annual Patient Share of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in the United States: 2020-2030
Annual Patient Share of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in Japan: 2020-2030
Annual Sales of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in Japan: 2020-2030
Annual Sales of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in the Europe: 2020-2030
Annual Patient Share of Mineralocorticoid Receptor Antagonists in Diabetic Nephropathy in the Europe: 2020-2030
Annual Patient Share of Antihypertensive Drug Classes in Diabetic Nephropathy in the Major Markets: 2020-2030
Annual Sales of Antihypertensives in Diabetic Nephropathy in the Major Markets: 2020-2030
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 Cases of Diabetes Within Total Prevalent CKD
Number of Diagnosed Cases of Diabetes Within Total Prevalent CKD: 2020-2030 (Thousands)
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
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
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
Key Emerging Therapies
Key Emerging Therapies in Development for Diabetic Nephropathy
Estimated Launch Dates of Key Emerging Therapies for the Treatment of Diabetic Nephropathy
Key Results From Select Clinical Trials Investigating Sotagliflozin for the Treatment of Diabetic Nephropathy
Analysis of the Clinical Development Program for Sotagliflozin
Expectations for Launch and Sales Opportunity of Sotagliflozin in Diabetic Nephropathy
Key Results From Select Clinical Trials Investigating Finerenone for 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
Early-Phase Pipeline Analysis
Notable Developments in the Early-Phase Pipeline 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
Diabetic Nephropathy Bibliography
Dwaipayan Chatterjee, M.Pharm.
Dwaipayan Chatterjee, M.Pharm., is an analyst on the Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders team at Clarivate. He has authored reports focusing on metabolic and cardiovascular indications. Previously, 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.
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.