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Research & Reports

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

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

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Diabetic retinopathy (DR) patients experience retinal damage that can eventually lead to debilitating vision deficits and blindness, especially if proliferative DR (PDR) and diabetic macular edema (DME) develop. The DME therapy market has become more competitive with the launch of multiple new therapies. Vascular endothelial growth factor (VEGF) inhibitors—approved agents Eylea and Lucentis and off-label Avastin—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 became the first drug approved for DR without DME in 2017, following label expansion in the United States; Eylea is also expected to be approved for DR without DME in the United States in 2019, followed by expanded approval of Lucentis 0.5 mg for this indication in Europe in 2020. Based on the latest pipeline developments, we forecast two new therapies launching for DME: Novartis’s brolucizumab, a VEGF inhibitor, and Roche’s faricimab, a VEGF/Ang-2 inhibitor. They will help offset declining sales because of the launch of biosimilars of Eylea and Lucentis 0.5 mg. With growing clinical evidence supporting the treatment of some DR patients without DME with VEGF inhibitors and the expanding DR/DME pipeline, competition in this space will increase.

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 for DME? How is the use of current therapies expected to change, if at all, over the next ten years?
  • What is the commercial potential of key late-phase therapies for DME (brolucizumab, faricimab)? How will market dynamics be affected by the launch of biosimilars of Lucentis 0.5 mg and Eylea?
  • How has Lucentis 0.3 mg been incorporated into the treatment algorithm for DR without DME in the United States? What is the likely impact of Eylea (in the United States) and Lucentis 0.5 mg (in the EU5) if approved for DR without DME?

PRODUCT DESCRIPTION

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.

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 2027, segmented by brands/biosimilars and epidemiological subpopulations.

Emerging therapies: Phase III/PR: 4 drugs. Phase II: 13 drugs. Coverage of select preclinical and Phase I products.

Table of contents

  • Disease Landscape & Forecast
    • Key Updates
      • December 2018
      • September 2018
      • June 2018
      • March 2018
    • Market Outlook
      • Key Findings
        • Market Overview
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for DR/DME?
        • What Factors Are Constraining the Market for DR/DME?
      • Drug-Class-Specific Trends
        • VEGF Inhibitors
        • Corticosteroid Implants
        • VEGF/Ang-2 Inhibitors
    • Forecast
      • Market Forecast Assumptions
      • Market Forecast Dashboard
    • Etiology and Pathophysiology
      • Etiology
      • Pathophysiology
        • Disease Classification
        • Pathogenesis
      • Key Pathways and Drug Targets
      • Disease Overview
    • Epidemiology
      • Key findings
        • Expert Insights
        • Note About Our Epidemiology Populations
      • Epidemiology Populations
        • Total Prevalent Cases of DME
        • Diagnosed and Drug-Treated Cases of DME
        • Total Prevalent Cases of Diabetic Retinopathy by Severity
        • Diagnosed and Drug-Treated Cases of Diabetic Retinopathy by Severity
    • Current Treatment
      • Key Findings
        • Expert Insight
      • Treatment Goals
      • Key Current Therapies
        • Overview
        • VEGF Inhibitors
        • Corticosteroid Implants
        • Corticosteroid Injections
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Drug Selection
        • Region-Specific Treatment Practices
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in DR/DME
    • Emerging Therapies
      • Key Findings
      • Key Emerging Therapies
        • Notable Developments Among Key Emerging Therapies for DR/DME
        • VEGF Inhibitors
        • VEGF/Ang-2 Inhibitors
      • Early-Phase Pipeline Analysis
        • Notable Developments in the Early-Phase Pipeline for DR/DME
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
        • Japan
      • Looking for More?
    • Methodology
      • Market Forecast Assumptions File
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Generic Erosion
        • Biosimilar Erosion
        • Out-Year Forecasting
        • Emerging Therapy Prices
      • Primary Market Research
        • Experts Interviewed
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
    • Appendix
      • DR/DME Bibliography

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  • Pub Date: December 2018
  • Author(s): Ruchita Kumar, Ph.D; Emma McFadden, PhD; Himanshu Jain, M.S. Pharm; Fjoralba Kristo, MD, MPH
  • Ruchita has joined as a Lead Analyst in the Central Nervous System and Ophthalmology team at Decision Resources Group. She comes with eight years of experience in handling various types of commercial assessment projects. She has worked on variety of opportunity assessment and market intelligence projects involving preparation of disease narratives, epi-based forecasts, patent landscapes, social media analysis and building brand performance reports across different therapy areas. She earned a in design and development of modified release dosage forms of anti-diabetic drugs from the University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh.

  • Emma McFadden, is a  Director within the Central Nervous System/Ophthalmology disorders group. Her main focus is on ophthalmic indications, such as age-related macular degeneration, diabetic retinopathy, and diabetic macular edema, although she has authored research across a number of other indications, including multiple sclerosis and ; Prior to joining Decision Resources Group, Emma earned a in neuroscience and a in biochemistry from Trinity College Dublin.  

  • Himanshu is a Lead Analyst in the CNS/Ophthalmology team at Decision Resources Group, and has authored content for indications including age-related macular degeneration, diabetic retinopathy/diabetic macular edema, and unipolar depression. He comes with eight years of experience working on commercial assessment projects, including opportunity assessments, market intelligence, disease narratives, epi-based forecasts, patent research, and social media analysis, across multiple therapy areas. He holds a degree in Pharmacology from the National Institute of Pharmaceutical Education and Research (NIPER) in India and an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.

  • Fjoralba Kristo has expertise in forecasting infectious diseases and chronic diseases in both the mature and global markets. She has extensive academic experience with quantitative and qualitative research methods. Prior to joining Decision Resources Group, she completed a postdoctoral fellowship at University of Kentucky, Division of Cardiovascular Medicine, and more recently worked as Research Scientist at Massachusetts General Hospital, where she investigated mechanisms of inflammation in cardiovascular diseases. Fjoralba holds an MPH degree from Boston University School of Public Health, concentrating in Epidemiology and Biostatistics, and a medical degree from University of Medicine, Bucharest, Romania.

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