加齢黄斑変性市場

The secondary research process involved comprehensive analysis of regulatory databases, peer-reviewed ophthalmology journals, clinical trial registries, and authoritative vision health organizations. Key sources included the US Food & Drug Administration (FDA) Center for Drug Evaluation and Research, European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), National Institute for Health and Care Excellence (NICE) UK, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, and Health Canada. Ophthalmology-specific authorities comprised the National Eye Institute (NEI) of the National Institutes of Health (NIH), American Academy of Ophthalmology (AAO), American Society of Retinal Specialists (ASRS), European Society of Retina Specialists (EURETINA), Royal College of Ophthalmologists (UK), and Asia-Pacific Vitreo-retina Society (APVRS). Clinical and epidemiological data were sourced from ClinicalTrials.gov, Cochrane Library, PubMed/NCBI, WHO World Report on Vision, CDC Vision Health Initiative, National Health and Nutrition Examination Survey (NHANES), and national blindness registries from key markets. These sources provided prevalence/incidence statistics of wet and dry AMD, regulatory approval pathways for intravitreal injections, biosimilar guidance documents, real-world evidence studies, and reimbursement frameworks across public and private payers.

To gather both qualitative and quantitative insights, supply-side and demand-side stakeholders were interviewed during the primary research phase. Global Heads of Ophthalmology/Retina Therapeutics, Vice Presidents of Clinical Development, leaders of regulatory strategies, and directors of market access from biopharmaceutical companies creating gene therapies, biosimilars, and anti-VEGF biologics were among the supply-side sources. Board-certified vitreoretinal surgeons, retinal specialists, medical retina fellows, hospital pharmacy directors, and procurement leads from academic medical centers, ambulatory surgery centers, specialized retina clinics, and hospital outpatient departments were among the demand-side sources. Primary research confirmed clinical trial timelines and regulatory submissions, validated patient segmentation (early dry, geographic atrophy, neovascular wet AMD), and collected information on treatment switching patterns, injection frequency trends, the adoption of anti-VEGF biosimilars, and payer management strategies (prior authorization criteria, step therapy protocols).

Primary Respondent Breakdown:

• By Designation: C-level Primaries (30%), Director Level (40%), Others (30%)

• By Region: North America (40%), Europe (25%), Asia-Pacific (28%), Rest of World (7%)

Global market valuation was derived through revenue mapping and patient volume analysis. The methodology included:

• Identification of 30+ key biopharmaceutical manufacturers across North America, Europe, Asia-Pacific, and Latin America specializing in retinal therapeutics

• Product mapping across anti-VEGF biologics (ranibizumab, aflibercept, brolucizumab, faricimab), emerging biosimilars (SB11, FYB201, CT-P42), gene therapy candidates (RGX-314, ADVM-022), complement inhibitors for geographic atrophy (pegcetacoplan, avacincaptad pegol), and sustained-release delivery systems

• Analysis of reported and modeled annual revenues specific to ophthalmology/retina portfolios, including intravitreal injection procedure volumes and average selling prices (ASPs) net of rebates and discounts

• Coverage of manufacturers representing 80-85% of global market share in 2024 (reflecting high market concentration among established anti-VEGF innovators and early biosimilar entrants)

• Extrapolation using bottom-up (diagnosed prevalent cases × treatment penetration rates × annual injection frequency × ASP by country) and top-down (manufacturer reported revenue validation against IMS/Evaluate Pharma data) approaches to derive segment-specific valuations for wet AMD and dry AMD (Geographic Atrophy) submarkets