Last updated: February 23, 2026
What is NDC 10631-0122?
NDC 10631-0122 corresponds to Aflibercept Injection (brand: Eylea), indicated primarily for ophthalmic conditions, including neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal diseases. It is a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF).
Market Landscape Overview
Competitive Position
- Major Competitors: Ranibizumab (Lucentis), Bevacizumab (Avastin), and Faricimab (Vabysmo) are primary alternatives.
- Market Share (2022): Eylea maintained approximately 70% in the U.S. intravitreal VEGF inhibitor market, with Lucentis at 20% and Avastin at 10% (EvaluatePharma, 2022).
- Market Size (2022): The U.S. retinal disease market for VEGF inhibitors was estimated at $4 billion, driven by AMD, DME, and retinopathy indications.
Market Dynamics
- The growing prevalence of AMD, DME, and proliferative diabetic retinopathy (PDR) boosts demand.
- Expansion into new indications such as myopic choroidal neovascularization and retinal vein occlusion widens revenue streams.
- There is increasing adoption of biosimilars and off-label Bevacizumab use, pressuring pricing.
Market Projections
Key Drivers
- Aging Population: U.S. adults over 65 account for roughly 16% of the population, with AMD prevalence reaching approximately 20% among those over 70 (NEI, 2021).
- Rising Diabetes Rates: 37 million Americans are diabetic, with DME affecting nearly half of them over time (CDC, 2022).
- Innovative Approvals: Additional indications and extended dosing regimens extend market penetration.
- Pricing Trends: Increased safety profile and efficacy favor continued premium pricing.
Revenue Projections
| Year |
Estimated U.S. Market Penetration |
Expected Revenue (USD billions) |
Notes |
| 2023 |
75% of market share |
$2.8 billion |
Slow uptake of biosimilars; price stability maintained |
| 2025 |
75-80% market share |
$3.2 billion |
Biosimilar entry begins to exert pressure |
| 2027 |
75% market share |
$3.1 billion |
Slight price erosion due to biosimilar competition |
Price Trends
- Average Wholesale Price (AWP): Currently approximately $1,950 – $2,100 per injection.
- Pricing Pressure: Biosimilar competition introduced in 2024-2025 may reduce prices by up to 20% over five years.
- Injectable Cost Structure: Cost of goods (COGS) remains low, allowing for sustained margins.
Pricing Forecasts (Next 3-5 Years)
| Year |
Estimated Average Price per Dose |
Change from Previous Year |
Total Estimated Revenue (USD) |
| 2023 |
$2,000 |
0% |
$2.8B |
| 2024 |
$1,950 |
-2.5% |
$2.7B |
| 2025 |
$1,900 |
-2.6% |
$2.75B |
| 2027 |
$1,850 |
-2.6% annually |
$3.1B |
Strategic Implications
- Patent Cliff: Patents expire in 2024-2025, opening the market to biosimilars that could erode pricing power.
- Market Expansion: Approval of new indications and dosing regimens may compensate for pricing pressures.
- Pricing Strategies: Fenestration of pricing models to differentiate from biosimilars is essential.
- Regulatory Factors: FDA's evolving biosimilar policies will influence market entry and pricing.
Key Takeaways
- NDC 10631-0122 (Eylea) dominates the U.S. VEGF inhibitor market with approximately 70% share.
- The market is expected to grow from $2.8 billion in 2023 to around $3.1 billion by 2027.
- Prices are projected to decline gradually due to biosimilar competition, with a potential 20% reduction by 2027.
- The competitive landscape is intensifying, driven by biosimilar entrants and new therapeutics.
- Continued product differentiation and expansion into new indications are critical for maintaining market position.
FAQs
1. When will biosimilars for Eylea enter the market?
Biosimilars are expected to launch around 2024-2025, following patent expiry and FDA approval processes.
2. How will biosimilars impact Eylea’s pricing?
They will likely reduce prices by up to 20%, leading to revenue pressure but could also expand overall market size through increased accessibility.
3. Are there upcoming indications that could boost Eylea’s sales?
Yes. FDA approvals for additional retinal conditions and improved dosing regimens can expand the target patient base.
4. How does Eylea compare to its competitors in terms of market share?
It captures roughly 70% of the intravitreal VEGF market in the U.S., significantly outperforming Lucentis and Avastin.
5. What strategies can preserve Eylea’s market share?
Investing in new indications, optimizing dosing schedules, and leveraging brand loyalty are vital.
References
- EvaluatePharma. (2022). World Market Share Data.
- National Eye Institute (NEI). (2021). Prevalence of AMD.
- Centers for Disease Control and Prevention (CDC). (2022). Diabetes Statistics.
