Patients with proliferative diabetic retinopathy (PDR) experience retinal damage that can eventually lead to debilitating vision deficits and blindness, especially with the development of diabetic macular edema (DME). The DME therapy market became more competitive with the launch of vascular endothelial growth factor (VEGF) inhibitors—approved agents Eylea and Lucentis—which are the standards of care for center-involved DME. Ozurdex and Iluvien, both long-acting corticosteroid implants, are also approved for DME in some markets. Of note, Lucentis 0.3 mg (0.5 mg in Europe) and Eylea are now both approved for DR without DME. Factoring in the near-term launch of biosimilars of Lucentis 0.5 mg and Eylea, growing clinical data supporting the treatment of some DR patients without DME with pharmacotherapies, and a dynamic development pipeline, competition is expected to increase in this space.

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 ten years as emerging therapies enter the market? How are Iluvien and Ozurdex being used to treat DME?
  • 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 brolucizumab if it is successfully launched for DME and 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 2021 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: Approximately 20 country-specific interviews with thought-leading retinal specialists and supported by survey data collected for this and other DRG research.

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

Forecast: Ten-year, annualized, drug-level sales and patient share of key DR and DME therapies through 2029, segmented by brands / biosimilars and epidemiological subpopulations.

Emerging therapies: Phase III / PR: 5 drugs; Phase II: 12 drugs.

Table of contents

  • Diabetic Macular Edema / Diabetic Retinopathy - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • Q3 2021
        • July 2021
      • Q2 2021
        • June 2021
        • May 2021
        • April 2021
      • Q1 2021
        • March 2021
        • February 2021
        • January 2021
      • Q4 2020
        • November 2020
        • September 2020
    • Key Findings
      • DR / DME Key Findings November 2020
        • November 2020
        • September 2020
    • Market Outlook
      • Key Findings
        • Market Share of DME, Severe NPDR, and PDR: 2019
        • Market Share of DME, Severe NPDR, and PDR: 2029
        • Market Share of DME, Severe NPDR, and PDR Drug Classes: 2019
        • Market Share of DME, Severe NPDR, and PDR Drug Classes: 2029
        • DR / DME SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for DR / DME?
          • What Factors Are Constraining the Market for DR / DME?
          • Key Market Events for DR / DME: 2019-2029
          • Major-Market Sales and Drug-Treated Patients in DME: 2019-2029
          • Major-Market Brand and Generic / Biosimilar Sales for DME: 2019-2029
          • Brand / Biosimilar Sales and Drug-Treated Patients in Severe NPDR (Without Coexisting DME) in the United States and EU5: 2019-2029
          • Brand / Biosimilar Sales and Drug-Treated Patients in PDR (Without Coexisting DME) in the United States and EU5: 2019-2029
        • Drug-Class-Specific Trends
          • Major-Market Sales of VEGF Inhibitors in DME, Severe NPDR, and PDR: 2019-2029
          • Major-Market Sales of VEGF Inhibitors in DME: 2019-2029
          • Patient Share of VEGF Inhibitors in DME in the United States: 2019-2029
          • Patient Share of VEGF Inhibitors in DME in the EU5: 2019-2029
          • Patient Share of VEGF Inhibitors in DME in Japan: 2019-2029
          • Major-Market Sales of Corticosteroids in DME: 2019-2029
          • Patient Share of Corticosteroid Implants in the United States: 2019-2029
          • Patient Share of Corticosteroids in the EU5: 2019-2029
          • Major-Market Sales of Faricimab in DME: 2019-2029
          • Major-Market Patient Share of Faricimab in DME: 2019-2029
      • 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: 2019-2029 (Thousands)
            • Diagnosed Prevalent Cases of DME
            • Drug-Treated Prevalent Cases of DME
            • Diagnosed Prevalent Cases of DME: 2019-2029 (Thousands)
            • Drug-Treated Prevalent Cases of DME: 2019-2029 (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: 2019-2029 (Thousands)
            • Diagnosed Prevalent Cases of Diabetic Retinopathy by Severity
            • Drug-Treated Prevalent Cases of Diabetic Retinopathy by Severity
            • Diagnosed Prevalent Cases of Severe NPDR: 2019-2029 (Thousands)
            • Drug-Treated Prevalent Cases of Severe NPDR (Without Coexisting DME): 2019-2029 (thousands)
            • Diagnosed Prevalent Cases of PDR: 2019-2029 (Thousands)
            • Drug-Treated Prevalent Cases of PDR (Without Coexisting DME): 2019-2029
        • 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
              • Advantages and Disadvantages of Ozurdex
              • Expert Insight: Ozurdex
              • Advantages and Disadvantages of Iluvien
              • Expert Insight: Iluvien
              • Advantages and Disadvantages of Corticosteroid Injections
            • Medical Practice
              • Overview
              • Country-Specific DR and DME Treatment Guidelines
              • 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
          • 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 for DME
              • Expectation for Launch and Sales Opportunity of Brolucizumab in DME
              • Likely Use of Brolucizumab in the Treatment of DME
              • Likely Use of Brolucizumab in the Treatment of 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
              • Likely Uses of Ranibizumab Port Delivery System for the Treatment of DME
              • Likely Use of Ranibizumab Port Delivery System for DR
              • 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
              • Likely Uses of Aflibercept (High-Dose) for DME
              • KSI-301 Profile
              • Analysis of the Clinical Program for KSI-301
              • Expectations for Sales and Market Launch of KSI-301
              • Likely Uses of KSI-301 for DME
              • Faricimab Profile
              • Analysis of Clinical Development Program for Faricimab
              • Expert Insight: Faricimab for DME
              • Expectation for Launch and Sales Opportunity of Faricimab in DME
              • Likely Uses of Faricimab in the Treatment of DME
            • 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
            • Key Abbreviations Related to DR / DME
            • Brands, Marketers, and Generic Availability of Key Therapies for DR / DME by Market
            • Bibliography

        Author(s): Natalie Taylor, Ph.D.; Emma McFadden, Ph.D.; Fjoralba Kristo, M.D., M.P.H. ; Himanshu Jain, M.S. Pharm.; Ruchita Kumar, Ph.D.

        Natalie Taylor, Ph.D., is a principal business insights analyst on the CNS/Ophthalmology Disorders team at Clarivate. She has more than ten years of experience authoring primary and market research reports for pharmaceutical industry clients in the fields of psychiatry, pain, neurology, and ophthalmology. Previously, Dr. Taylor worked at QuintilesIMS as manager of its CNS portfolio. She completed her Ph.D. in physiology at Dartmouth College in New Hampshire, where she studied the role of serotonergic neurons in the medullary raphe on modulating respiratory responses in mammals. She holds a B.S. in biology from Dickinson College in Pennsylvania.

        Emma McFadden, Ph.D., is a director on the CNS/Ophthalmology Disorders team at Clarivate. Her focus is on ophthalmic indications, such as age-related macular degeneration, diabetic retinopathy, and diabetic macular edema, although she has authored reports in a number of other indications, including multiple sclerosis and epilepsy. Dr. McFadden earned a B.A. in neuroscience and a Ph.D. in biochemistry from Trinity College in Dublin.

         

        Fjoralba Kristo, M.D., M.P.H., is an epidemiologist at DRG, part of Clarivate. Prior to joining DRG, she completed a postdoctoral fellowship at the University of Kentucky, Division of Cardiovascular Medicine, and more recently worked as a research scientist at Massachusetts General Hospital, where she investigated mechanisms of inflammation in cardiovascular diseases. Dr. Kristo holds an M.P.H. degree from Boston University School of Public Health, with a concentration in epidemiology and biostatistics, and a medical degree from the University of Medicine in Bucharest, Romania.

        Himanshu Jain, M.S.(Pharm.), is a manager on the CNS/Ophthalmology Disorders team at Clarivate. He has authored content for ophthalmology (retinal / nonretinal) and psychiatry indications, including age-related macular degeneration, diabetic retinopathy / diabetic macular edema, glaucoma, uveitis, and schizophrenia. He has more than ten years of experience working in market research and consulting firms. He earned his master’s degree from the National Institute of Pharmacological Education and Research and holds an Executive Post-Graduate Diploma in international business from the Indian Institute of Foreign Trade.

        Ruchita Kumar, M.Pharm., Ph.D., is a manager on the CNS/Ophthalmology Disorders team at Clarivate. Her specialties are migraine and Alzheimer’s disease. She has worked on a variety of opportunity assessment and market intelligence projects involving the preparation of disease narratives, epi-based forecasts, and building brand performance reports across different therapy areas. She holds a Ph.D. in the design and development of modified-release dosing forms of antidiabetic drugs from the University Institute of Pharmaceutical Sciences at Panjab University in Chandigarh, India.


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