Last updated: February 24, 2026
What is the Drug Associated with NDC 54092-0519?
NDC 54092-0519 corresponds to Aflibercept Injection, marketed under the brand name Eylea. Approved by the FDA for treating various retinal diseases, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Market Overview
Therapeutic Area and Indication Penetration
Eylea is a dominant drug in anti-vascular endothelial growth factor (anti-VEGF) therapies for retinal vascular diseases. The global retinal disease market reached approximately $9.7 billion in 2022, with anti-VEGF agents representing about 80% of the market. Eylea's market share within this class stood at approximately 60% in 2022, according to industry data.
Competitor Landscape
Primarily competing with:
- Ranibizumab (Lucentis)
- Bevacizumab (Off-label use, Avastin)
Eylea maintained higher usage due to extended dosing intervals and clinical efficacy.
Market Dynamics
- Increasing prevalence of AMD and diabetic retinopathy, driven by aging populations and rising diabetes rates.
- Innovations in delivery methods and combination therapies.
- Elevated off-label use of bevacizumab affecting branded product sales.
Sales Data
- Global Eylea sales in 2022: Approximately $4.0 billion.
- U.S. sales: Roughly $2.6 billion, representing about 65% of global sales.
- Projections indicate a compounded annual growth rate (CAGR) of 4-6% for the next five years, driven by demographic trends and expanded indications.
Price Trends and Projections
Current Pricing Structure
In the U.S., the average wholesale price (AWP) for a 2 mg/0.05 mL vial of Eylea is approximately $1,900, with actual acquisition costs lower due to discounts and rebates. For treatment, multiple doses are administered, typically every 8-12 weeks after initial loading doses.
Historical Price Changes
- Average wholesale price increased marginally by 2-3% annually over the past five years.
- Pricing remains stable, with modest adjustments reflecting inflation and market factors.
Price Forecast (2023-2028)
Assumptions:
- No significant regulatory changes impact pricing.
- Continued market dominance of Eylea.
- Competition and biosimilar entry are expected to be limited over the next five years.
Projected Trends:
| Year |
Estimated Wholesale Price per Dose |
Key Notes |
| 2023 |
$1,950 |
Slight inflation-based increase |
| 2024 |
$1,985 |
Market stability |
| 2025 |
$2,025 |
Potential slight uptick due to inflation |
| 2026 |
$2,065 |
Cost adjustments for new formulations |
| 2027 |
$2,100 |
Anticipated stabilizing market |
| 2028 |
$2,135 |
Continued incremental growth |
Note: Actual net prices to payers are often lower due to rebates and discounts.
Future Impact Factors
- Biosimilar development could exert downward pressure, but current data suggests limited immediate market entry.
- Pricing adjustments from health insurers and government payers based on formulary decisions.
- Potential for extended dosing intervals reducing per-patient treatment costs.
Strategic Implications
- Price stability supports steady revenue streams.
- Investment in research for extended duration formulations could influence future pricing.
- Monitoring biosimilar timelines is critical; biosimilar entry may commence around 2025-2026, increasing price competition.
Key Takeaways
- Eylea remains the market leader in retinal VEGF inhibition, with stable pricing and consistent growth.
- Pricing is expected to increase modestly over the next five years, driven by inflation and market dynamics.
- Market expansion hinges on demographic trends and potential new indications.
- Biosimilar competition remains a risk but is currently limited; entry is projected around 2025-2026.
- Pricing strategies from healthcare payers could impact effective revenue and access.
FAQs
1. How does biosimilar entry affect Eylea prices?
Biosimilar entries typically reduce prices through competition, but initial impact on Eylea's market share remains limited due to patent protections and clinical preferences.
2. What are the primary drivers of treatment costs for Eylea?
Treatment costs depend on dosing frequency, injection costs, and patient adherence. Extended dosing intervals can reduce per-treatment expenses.
3. Are there upcoming regulatory or patent challenges?
Patent protections extend into the mid-2020s, with potential patent cliffs around 2025-2026. Regulatory pathways for biosimilars are matured but vary globally.
4. How is demographic change influencing the market?
An aging population and rising diabetes prevalence increase indications for Eylea, expanding the patient base.
5. What is the outlook for new indications or formulations?
Research continues on longer-acting formulations and combination therapies, which could modify pricing and market dynamics.
References
- Evaluate Pharma. (2023). Global Ophthalmic Drugs Market Report.
- IQVIA. (2022). National Prescription Audit Data.
- FDA. (2020). Eylea (Aflibercept) Approval Documents.
- MarketWatch. (2023). Anti-VEGF Market Trends.
- CEFAR. (2022). Biosimilar Landscape Report.
Note: All data are estimates based on industry reports and market analysis as of early 2023.
