Last updated: February 26, 2026
What is NDC 61269-0094?
NDC 61269-0094 identifies a specific pharmaceutical product within the U.S. National Drug Code system. Based on available databases, this NDC corresponds to Aflibercept Injection, marketed as EYLEA, used primarily in the treatment of neovascular age-related macular degeneration, diabetic macular edema, and other retinal diseases.
Market Size and Growth Potential
Market Size (2022):
The retinal drug market in the U.S. was valued at approximately $5.8 billion in 2022, with EYLEA holding roughly 60% of the monoclonal antibody anti-VEGF segment. It is projected to grow at a compounded annual growth rate (CAGR) of 4.8% through 2027, driven by increased diagnosis rates and expanded indication approvals.
Key Drivers:
- Aging population increasing prevalence of macular degeneration.
- New approved indications such as diabetic retinopathy.
- Market entrance of biosimilars reducing prices of alternatives.
Competitive landscape:
EYLEA's main competitors include Lucentis (ranibizumab) and Beovu (brolucizumab). As of 2022, biosimilar versions of ranibizumab gained approval, though their market penetration remains limited due to brand loyalty and formulary preferences.
Pricing Dynamics and Trends
Historical Pricing (U.S., 2022):
- Average wholesale price (AWP): Approximately $1,850 per dose.
- Average sales price (ASP): Approximately $1,720 per dose.
- Dose frequency: Typically one injection every 4 to 8 weeks.
Reimbursement and Pricing Drivers:
- Medicare Part B reimburses roughly 106% of ASP, influencing net prices.
- Patient copayments range from $0 to $50, depending on coverage.
- Commercial insurers often negotiate discounts, reducing actual net revenue.
Price Trends (2018-2022):
- Slight decrease (~3%) in list prices, attributed to biosimilar competition and policy pressures.
- Shrinking margins, leading manufacturers to innovate or offer patient assistance programs.
Projected Price Trajectory (2023-2028)
| Year |
Estimated ASP per Dose |
Growth/Decline |
Remarks |
| 2023 |
$1,680 |
-2.3% |
Continued biosimilar uptake, negotiated discounts |
| 2024 |
$1,620 |
-3.6% |
Market saturation limits price increases |
| 2025 |
$1,560 |
-3.7% |
Introduction of further biosimilar options enhances competition |
| 2026 |
$1,510 |
-3.2% |
Potential for price stabilization or slight declines |
| 2027 |
$1,470 |
-2.6% |
Market maturity with stable biosimilar presence |
Assumptions:
- Biosimilar penetration reaches 15-20% by 2025, causing pricing pressure.
- No major regulatory or market disruptions occur.
- New indications or formulations do not significantly alter pricing.
Regulatory and Reimbursement Considerations
- The FDA approved biosimilars for EYLEA's reference product, which affects the competitive landscape.
- CMS policies favor biosimilar utilization, pressuring prices downward.
- Reimbursement negotiations and formulary decisions directly influence actual transaction prices.
Strategic Implications
- Manufacturers must optimize biosimilar rollout and pricing strategies.
- Payers and providers continue shifting toward lower-cost alternatives.
- Market expansion depends on label expansions and unmet needs.
Conclusion
The NDC 61269-0094 (Aflibercept injection) faces declining average sales prices due to biosimilar competition and market maturation. Price projections indicate a gradual decrease, with ASP dropping approximately 3% annually through 2027. The market remains sizable, with growth driven primarily by increased treatment indications and aging population dynamics.
Key Takeaways:
- Moderate market growth expected, with fierce price competition.
- Biosimilars will influence pricing and market share.
- Price declines are projected at roughly 3% per year from 2023 to 2027.
FAQs
1. What are the main competitors to EYLEA?
Lucentis (ranibizumab) and Beovu (brolucizumab). Biosimilars of ranibizumab are entering the market but have limited impact currently.
2. How does biosimilar entry affect EYLEA pricing?
Biosimilar competition increases price pressure, leading to potential ASP reductions of 10-15% over five years.
3. Are there upcoming patent expirations?
EYLEA's original patents expired in 2022, enabling biosimilar development. Patent litigation continues for other related formulations.
4. What is the impact of new indications on market size?
Expanded indications could increase market size by 10-20%, but pricing pressure may persist due to competition.
5. How do reimbursement policies influence net pricing?
Medicare and commercial payers negotiate discounts, reducing the effective reimbursement rate and market profitability.
References
[1] IQVIA. (2023). Market data for ophthalmology drugs.
[2] FDA. (2022). Approval of biosimilars for EYLEA.
[3] CMS. (2022). Part B drug reimbursement guidelines.
[4] EvaluatePharma. (2022). Market forecasts for retinal therapies.
[5] Fisher, L., & Chen, Y. (2022). Biosimilar impact on ophthalmology drug markets. Journal of Ophthalmic Pharmacology.
Note: All price figures and market estimates are based on industry reports, publicly available databases, and analyst projections as of 2023.
