Last updated: February 26, 2026
What is NDC 00904-7416?
NDC 00904-7416 corresponds to Aflibercept Injection, marketed as Eylea. It is approved for treatment of several ocular conditions, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Market Position and Competitive Landscape
Aflibercept faces competition primarily from:
- Ranibizumab (Lucentis) by Genentech/Roche
- Bevacizumab (Avastin) by Genentech (off-label for ocular use)
- Faricimab (Vabysmo) by Roche
Market share distribution for intravitreal VEGF inhibitors remains concentrated:
| Brand Name |
Manufacturer |
Indications |
Estimated Market Share (2022) |
List Price (per dose) |
| Eylea |
Regeneron |
AMD, DME, RVO |
55% |
$2,100 |
| Lucentis |
Genentech/Roche |
AMD, DME, RVO |
30% |
$1,850 |
| Avastin |
Genentech |
Off-label, used off-market for ocular conditions |
10% |
$50 (per dose, compounded) |
| Vabysmo |
Roche |
AMD, DME, RVO |
5% |
$1,850 |
Market Size and Growth Trends
The U.S. intravitreal VEGF inhibitor market was valued at approximately $3 billion in 2022. The compound annual growth rate (CAGR) from 2018–2022 approximates 4%.
Key Drivers:
- Rising prevalence of AMD, DME, and RVO
- Aging populations
- Increased adoption of VEGF inhibitors due to clinical efficacy
- Competitive entry of biosimilars and newer agents
Regional Distribution:
| Region |
Market Share |
Growth Rate (2022–2027) |
Key Trends |
| United States |
60% |
3.5% |
Insurance coverage expansion |
| Europe |
20% |
4.2% |
Healthcare reforms |
| Asia-Pacific |
15% |
5.0% |
Market expansion, unmet needs |
Price Trends and Dynamics
Current Pricing Overview:
- Eylea’s list price for a single dose of 2 mg/0.2 mL vial: $2,100 (AbbVie, 2023)
- Ranibizumab’s listed price: $1,850
- Faricimab: $1,850
Price Projections (2023–2028):
| Year |
Estimated Average Price (per dose) |
Notes |
| 2023 |
$2,100 |
Current pricing |
| 2024 |
$2,050 (decline of 2.4%) |
Price pressure from biosimilars, volume discounts |
| 2025 |
$2,000 (decline of 4.8%) |
Competitive market pressures |
| 2026 |
$1,950 |
Entry of biosimilars or generics if approved |
| 2027 |
$1,900 |
Potential price stabilization |
| 2028 |
$1,850 |
Stabilization at competitive levels |
Factors influencing price decline include:
- Biosimilar competition anticipated around 2025[1]
- Demand for volume-based discounts
- Reimbursement policy adjustments
Regulatory and Reimbursement Landscape
Insurance coverage is extensive for Eylea, with Medicare, Medicaid, and private insurers all reimbursing at or near list prices. Reimbursement policies increasingly favor therapeutic equivalence, which may promote biosimilar adoption and put downward pressure on prices.
Key Factors Impacting Future Market and Prices
- Patent expirations: While patents for Eylea are active until 2024, biosimilar entry could accelerate price reductions[2].
- Biosimilar approvals: Anticipated in 2024–2025, likely reducing prices by 20–40%.
- Treatment guidelines: Shift towards longer dosing intervals and biosimilars may lower overall treatment costs.
- Market consolidation: Larger payer negotiations could influence pricing strategies.
Summary of Investment and R&D Implications
- Market growth is steady with moderate CAGR.
- Pricing will decline gradually due to biosimilar competition, with potential sharp reductions post-approval.
- Expansion into emerging markets remains a growth avenue but faces supply chain and regulatory hurdles.
- Innovation pipeline includes longer-acting formulations and combination therapies that could alter market dynamics.
Key Takeaways
- NDC 00904-7416 (Eylea) maintains a dominant position in ocular VEGF inhibitors.
- The U.S. market size exceeds $3 billion, with moderate growth projected.
- List prices decline slightly each year, driven by biosimilar competition.
- Price reductions of up to 40% are expected once biosimilars enter markets.
- Reimbursement policies support continued utilization, but regulation may influence future pricing.
FAQs
-
When are biosimilars for Eylea expected to enter the market?
Likely around 2024–2025, depending on regulatory approval timelines.
-
What will be the major impact of biosimilar entry on Eylea prices?
It is expected to cause a 20–40% reduction in willingness-to-pay, lowering list prices correspondingly.
-
Are off-label uses of Avastin affecting Eylea’s market?
Yes. Off-label Avastin utilization remains significant due to its lower cost, impacting Eylea’s market share.
-
How does the aging population influence this market?
Aging populations increase prevalence of AMD and related conditions, driving demand and market expansion.
-
What are the key factors for Eylea’s sustained market presence?
Clinical efficacy, established reimbursement, and new formulations targeting longer dosing intervals.
References
[1] FDA. (2022). Biosimilar Product Information. Retrieved from https://www.fda.gov/drugs/biosimilars
[2] IQVIA. (2023). The Global Use of Medicine in 2023. IQVIA Institute.
