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. DME treatments 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 also got a label expansion for DME, and upon FDA approval in August 2023, high-dose aflibercept (Eylea HD) was added to the treatment armamentarium. Of note, Lucentis 0.3 mg, Eylea, and Eylea HD are also approved for all forms of 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 with the launch of ranibizumab (Lucentis) and aflibercept (Eylea) biosimilars and with the potential approval of key emerging therapies such as Roche’s ranibizumab port delivery system (Susvimo), promising longer dosing intervals. Non-IVT agents like Oculis’s OCS-01, a topical eye drop formulation of dexamethasone, will likely constitute a paradigm shift and may revolutionize the management of DME patients in the future.

​​​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, Beovu, Lucentis, and Vabysmo? How is the use of these drugs expected to change over the next 10 years as agents with distinct MOAs and ROAs enter the market? How are the corticosteroid implants Iluvien and Ozurdex being used to treat DME?
  • How will Vabysmo, Eylea HD, and emerging therapies such as the ranibizumab port delivery system capitalize on the need for therapies with longer dosing schedules than those currently available in the market?
  • How will market dynamics be impacted by the launch of biosimilars of Lucentis and Eylea?
  • How have Lucentis and Eylea been incorporated into the treatment algorithm for DR exclusive of DME in the United States? What will be the impact of Eylea HD and of 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.

Additionally, Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.

SOLUTION ENHANCEMENT

Disease Landscape & Forecast will feature continuous updates in 2023 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: 19 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 2032, segmented by brands / biosimilars and generics and epidemiological subpopulations.

Emerging therapies: Phase 3 / PR: 4 drugs; Phase 2: 10 drugs.

Table of contents

  • Diabetic Macular Edema / Diabetic Retinopathy - Landscape & Forecast - Disease Landscape & Forecast
    • Key Findings
      • DR / DME Key Findings September 2023
    • Key Updates
      • September 2023
      • July 2023
      • May 2023
      • April 2023
      • Q4 2022
        • December 2022
        • November 2022
        • October 2022
      • Q3 2022
        • July 2022
    • Market Outlook
      • Key findings
        • Market share of DME, PDR, and severe NPDR: 2022
        • Market share of DME, PDR, and severe NPDR: 2032
        • Market share of DME, PDR, and severe NPDR drug classes: 2022
        • Market share of DME, PDR, and severe NPDR drug classes: 2032
        • DR / DME SWOT analysis
      • 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: 2022-2032
        • Major-market brand and generic / biosimilar sales and drug-treated patients for DME: 2022-2032
      • Drug-class-specific trends
        • Major-market sales of VEGF inhibitors in DME, PDR, and severe NPDR: 2022-2032
        • Major-market sales of VEGF inhibitors in DME: 2022-2032
        • Patient share of VEGF inhibitors in DME in the United States: 2022-2032
        • Patient share of VEGF inhibitors in DME in the EU5: 2022-2032
        • Patient share of VEGF inhibitors in DME in Japan: 2022-2032
        • Major-market sales of corticosteroids in DME: 2022-2032
        • Patient share of corticosteroids in DME in the United States: 2022-2032
        • Patient share of corticosteroids in DME in the EU5: 2022-2032
        • Major-market sales and patient share of VEGF / Ang-2 inhibitors in DME: 2022-2032
    • 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 and sources used
          • Number of total prevalent cases of DME: 2022-2032
          • Diagnosed prevalent cases of DME
          • Drug-treated prevalent cases of DME
          • Diagnosed prevalent cases of DME: 2022-2032 (thousands)
          • Drug-treated prevalent cases of DME: 2022-2032 (thousands)
          • Disease definition
          • Methods and sources used
          • Number of total prevalent cases of diabetic retinopathy by severity 2022-2032
          • Diagnosed prevalent cases of diabetic retinopathy, by severity
          • Drug-treated prevalent cases of diabetic retinopathy, by severity
          • Diagnosed prevalent cases of PDR: 2022-2032 (thousands)
          • Drug-treated prevalent cases of PDR (without coexisting DME): 2022-2032
          • Diagnosed prevalent cases of severe NPDR: 2022-2032 (thousands)
          • Drug-treated prevalent cases of severe NPDR (without coexisting DME): 2022-2032
      • 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 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
            • 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
            • 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 the clinical development program for brolucizumab
              • Expert insight: brolucizumab for DR
              • 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 DR / DME
              • High-dose aflibercept profile
              • Analysis of the clinical program for high-dose aflibercept
              • Expert insight: high-dose aflibercept for DME
              • Expectations for launch and sales opportunity for high-dose aflibercept in DME
              • OCS-01 profile
              • Analysis of the clinical development program for OCS-01
              • Expectations for launch and sales opportunity of OCS-01 in 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
            • Abbreviations
            • Bibliography

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