Diabetic Macular Edema / Diabetic Retinopathy – Landscape & Forecast – Disease Landscape & Forecast

Diabetic macular edema (DME) is a complication of diabetic retinopathy (DR) derived from chronically high blood sugar levels, resulting in vision loss and blindness, if left untreated. The standards of care for DME include the anti-VEGFs Eylea, Lucentis, and off-label Avastin. Other approved agents for this indication are the long-acting corticosteroid implants Ozurdex and Iluvien, and the anti-VEGF / Ang-2 bispecific antibody Vabysmo; Beovu—marketed for treating wet age-related macular degeneration (AMD)—also got a label expansion and became the latest anti-VEGF approved for DME. Of note, Lucentis 0.3 mg and Eylea are also approved for DR without DME in the United States, whereas Lucentis 0.5 mg is approved for DR in Europe. Competition will increase in the DR / DME market, not only with the launch of ranibizumab (Lucentis) and aflibercept (Eylea) biosimilars but also with the potential approval of key emerging therapies such as Roche’s ranibizumab port delivery system (Susvimo, launched in the United States in November 2021 for wet AMD) and Kodiak Sciences' KSI-301, promising longer dosing intervals.

QUESTIONS ANSWERED

  • How large is the treatable DR / DME population, and how will diagnosis / drug-treatment rates change over time?
  • Do KOLs perceive any differences between Avastin, Eylea, and Lucentis? How is the use of these drugs expected to change over the next 10 years as emerging therapies enter the market? How are Iluvien and Ozurdex being used to treat DME?
  • How will Vabysmo and emerging therapies such as Roche's ranibizumab port delivery system capitalize on the need for therapies with longer dosing schedules than those currently in the market?
  • How will market dynamics be impacted by the launch of biosimilars of Lucentis 0.5 mg and Eylea?
  • How have Lucentis and Eylea been incorporated into the treatment algorithm for DR exclusive of DME in the United States? What would be the impact of Novartis’s Beovu if it is successfully launched for PDR?

PRODUCT DESCRIPTION

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

SOLUTION ENHANCEMENT

Disease Landscape & Forecast will feature continuous updates in 2022 to provide timely insights and analyses as meaningful indication-specific news and events unfold.

Geographies: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 17 country-specific interviews with thought-leading retinal specialists and supported by survey data collected for this and other Clarivate research.

Epidemiology: Prevalence of severe NPDR, PDR, and DME, by country, including diagnosed / drug-treated populations.

Forecast: 10-year, annualized, drug-level sales and patient share of key DR and DME therapies through 2030, segmented by brands / biosimilars and epidemiological subpopulations.

Emerging therapies: Phase III / PR: 4 drugs; Phase II: 11 drugs.

Table of contents

  • Diabetic Macular Edema / Diabetic Retinopathy - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q3 2022
        • July 2022
      • Q2 2022
        • June 2022
        • May 2022
        • April 2022
      • Q1 2022
        • March 2022
        • February 2022
        • January 2022
      • Q4 2021
        • December 2021
      • Q3 2021
        • September 2021
        • July 2021
    • Key Findings
      • DR / DME Key Findings June 2022
        • September 2021
        • July 2021
    • Market Outlook
      • Key Findings
        • Market Share of DME, Severe NPDR, and PDR: 2020
        • Market Share of DME, Severe NPDR, and PDR: 2030
        • Market Share of DME, Severe NPDR, and PDR Drug Classes: 2020
        • Market Share of DME, Severe NPDR, and PDR Drug Classes: 2030
        • DR / DME SWOT Analysis
      • COVID-19: Market Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for DR / DME?
          • What Factors Are Constraining the Market for DR / DME?
          • Major-Market Sales and Drug-Treated Patients in DME: 2020-2030
          • Major-Market Brand and Generic / Biosimilar Sales and Drug-Treated Patients for DME: 2020-2030
        • Drug-Class-Specific Trends
          • Major-Market Sales of VEGF Inhibitors in DME, Severe NPDR, and PDR: 2020-2030
          • Major-Market Sales of VEGF Inhibitors in DME: 2020-2030
          • Patient Share of VEGF Inhibitors in DME in the United States: 2020-2030
          • Patient Share of VEGF Inhibitors in DME in the EU5: 2020-2030
          • Patient Share of VEGF Inhibitors in DME in Japan: 2020-2030
          • Major-Market Sales of Corticosteroids in DME: 2020-2030
          • Patient Share of Corticosteroid Implants in the United States: 2020-2030
          • Patient Share of Corticosteroids in the EU5: 2020-2030
          • Major-Market Sales and Patient Share of Faricimab in DME: 2020-2030
      • Forecast
        • Market Forecast Assumptions
        • Market Forecast Dashboard
      • Etiology and Pathophysiology
        • Disease Overview
          • Etiology
            • Key Risk Factors for DR / DME
          • Pathophysiology
            • Disease Classification
            • Differences Between the Normal Retina, Retina with NPDR, and Retina with PDR
            • International Clinical Diabetic Retinopathy Disease Severity Scale
            • International Clinical Diabetic Macular Edema Disease Severity Scale
            • Pathogenesis
            • Key Pathways Associated with the Pathogenesis of DR / DME
            • Pathogenesis of DR / DME
          • Key Pathways and Drug Targets
            • Potential Drug Targets for DR / DME
        • Epidemiology
          • Key Findings
            • Note About Our Epidemiology Populations
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for Total Prevalent Cases of DME
            • Number of Total Prevalent Cases of DME in the Major Pharmaceutical Markets: 2020-2030 (Thousands)
            • Diagnosed Prevalent Cases of DME
            • Drug-Treated Prevalent Cases of DME
            • Diagnosed Prevalent Cases of DME: 2020-2030 (Thousands)
            • Drug-Treated Prevalent Cases of DME: 2020-2030 (Thousands)
            • Disease Definition
            • Methods
            • Sources Used for Diabetic Retinopathy by Severity
            • Number of Total Prevalent Cases of Diabetic Retinopathy by Severity in the Major Pharmaceutical Markets: 2020-2030 (Thousands)
            • Diagnosed Prevalent Cases of Diabetic Retinopathy by Severity
            • Drug-Treated Prevalent Cases of Diabetic Retinopathy by Severity
            • Diagnosed Prevalent Cases of PDR: 2020-2030 (Thousands)
            • Drug-Treated Prevalent Cases of PDR (Without Coexisting DME): 2020-2030
            • Diagnosed Prevalent Cases of Severe NPDR: 2020-2030 (Thousands)
            • Drug-Treated Prevalent Cases of Severe NPDR (Without Coexisting DME): 2020-2030 (Thousands)
        • Current Treatment
          • Key Findings
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for DR / DME
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for DR / DME
              • Current Treatments Used for DR / DME
              • Market Events Impacting the Use of Key Current Therapies for DR / DME
              • Advantages and Disadvantages of Lucentis
              • Advantages and Disadvantages of Eylea
              • Expert Insight: Eylea
              • Advantages and Disadvantages of Avastin
              • Expert Insight: Avastin
              • Beovu
              • Advantages and Disadvantages of Beovu
              • Key Results from Select Clinical Trials Investigating Beovu for the Treatment of DME
              • Ongoing Clinical Development of Beovu
              • Expert Insight: Beovu
              • Advantages and Disadvantages of Ozurdex
              • Expert Insight: Ozurdex
              • Advantages and Disadvantages of Iluvien
              • Expert Insight: Iluvien
              • Advantages and Disadvantages of Corticosteroid Injections
              • Vabysmo
              • Advantages and Disadvantages of Vabysmo
              • Key Results from Select Clinical Trials Investigating Vabysmo for the Treatment of DME
              • Ongoing Clinical Development of Vabysmo
              • Key Ongoing Clinical Trials of Vabysmo in the Treatment of DME
              • Expert Insight: Vabysmo
            • Medical Practice
              • Overview
              • Factors Influencing Drug Selection in DR / DME
              • Treatment Decision Tree for DR / DME: United States
              • Treatment Decision Tree for DR / DME: Europe
              • Treatment Decision Tree for DR / DME: Japan
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in DR / DME
            • Top Unmet Needs in DR / DME: Current and Future Attainment
            • Expert Insight: Unmet Need in DR / DME
          • Drug Pipeline
            • Pipeline
            • Regulatory Milestones
            • Indication Comparison
          • Emerging Therapies
            • Key Findings
              • Pipeline Trends in DR / DME
            • Key Emerging Therapies
              • Key Therapies in Development for DR / DME
              • Estimated Launch Dates of Key Emerging Therapies for the Treatment of DR / DME
              • Brolucizumab Profile
              • Analysis of Clinical Development Program for Brolucizumab
              • Expert Insight: Brolucizumab
              • Expectation for Launch and Sales Opportunity of Brolucizumab in DR
              • Ranibizumab Port Delivery System Profile
              • Analysis of the Clinical Program for the Ranibizumab Port Delivery System
              • Expert Insight: Ranibizumab Port Delivery System for DR / DME
              • Expectations for Launch and Sales Opportunity for Ranibizumab Port Delivery System in DME
              • Aflibercept (High-Dose) Profile
              • Analysis of the Clinical Program for Aflibercept (High-Dose)
              • Expert Insight: Aflibercept (High-Dose) for DME
              • Expectations for Launch and Sales Opportunity for Aflibercept (High-Dose) in DME
              • KSI-301 Profile
              • Analysis of the Clinical Program for KSI-301
              • Expert Insight: KSI-301 for DME
              • Expectations for Sales and Market Launch of KSI-301
            • Early-Phase Pipeline Analysis
              • Select Compounds in Early-Phase Development for DR / DME
          • Access & Reimbursement Overview
            • Region-Specific Reimbursement Practices
              • Key Market Access Considerations in DR / DME: United States
              • General Reimbursement Environment: United States
              • Key Market Access Considerations in DR / DME: EU5
              • General Reimbursement Environment: EU5
              • Key Market Access Considerations in DR / DME: Japan
              • General Reimbursement Environment: Japan
          • Appendix
            • Brands, Marketers, and Generic Availability of Key Therapies for DR / DME by Market
            • Bibliography

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