Last updated: March 13, 2026
What is the drug associated with NDC 82009-0165?
The National Drug Code (NDC) 82009-0165 corresponds to Aflibercept Injection (marketed as Eylea by Regeneron Pharmaceuticals). It is an anti-VEGF agent used in treating various retinal vascular disorders.
Market Overview
Indications and Revenue Drivers
Aflibercept primarily treats neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), central retinal vein occlusion (CRVO), and diabetic retinopathy. Its indications make it a critical product in ophthalmology, a growing sector due to increasing diabetes and aging populations.
Market Size
- The global ophthalmic drugs market exceeded USD 49 billion in 2022.
- Aflibercept accounted for approximately 15-20% of this segment, translating to a market size of roughly USD 7.35-9.8 billion.
- The U.S. remains the largest market, constituting 45-50% of sales.
Key Competitors
- Ranibizumab (Lucentis): Pfizer/Genentech
- Bevacizumab (Off-label use): Roche, widely used off-label
- Faricimab: Novo Nordisk and Roche (emerging)
Market Dynamics
- Growth driven by expanding patient base due to aging populations.
- Increasing adoption of intravitreal injections.
- Off-label use of bevacizumab offering price competition.
- New entrants like faricimab threaten market share.
Price Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Estimated at USD 1,900–2,200 per injection.
- Average Sales Price (ASP): USD 1,500–1,700 per dose.
- Patient Access Considerations: Payers often negotiate discounts, reducing the effective price to USD 1,200–1,500 per injection.
Dosing & Administration
- Dosing frequency varies from monthly to quarterly.
- Typical treatment involves 8-12 injections annually.
Cost Drivers
- Manufacturing complexity of biologics elevates costs.
- Market competition influences pricing.
- Reimbursement policies impact net pricing in different regions.
Price Projection Projections (2023–2028)
| Year |
Estimated Price per Injection |
Market Dynamics |
Notes |
| 2023 |
USD 1,500 |
Stable, but price pressures emerge |
Increased discounting due to biosimilars and alternative therapies |
| 2024 |
USD 1,400 |
Entry of biosimilars, payer negotiations |
Biosimilars gaining approval and market share, pressuring list prices |
| 2025 |
USD 1,300 |
Enhanced biosimilar competition |
Use of biosimilars increases, reducing average prices |
| 2026 |
USD 1,200 |
Expanded biosimilar market penetration |
Price erosion accelerates with multiple biosimilar options |
| 2027 |
USD 1,150 |
Market saturation; value-based pricing |
Manufacturers focus on differentiation, potential premium pricing for innovation |
| 2028 |
USD 1,100 |
Market stabilization |
Price declines plateau as biosimilar competition consolidates |
Note: Prices assume typical reimbursement and discounting patterns across major markets; regional variations may impact actual prices.
Key Factors Influencing Market and Pricing
- Patent Litigation & Biosimilar Approvals: Biosimilar approvals in the U.S. and Europe could reduce prices by 20-40%.
- Regulatory Changes: Accelerated pathway approvals may introduce new competitors more rapidly.
- Reimbursement Policies: CMS and private insurers' negotiation leverage impacts net pricing.
- Long-term Therapeutic Efficacy: Demonstrable superior efficacy or safety profile can sustain premium pricing.
Strategic Positioning
- Regeneron maintains a leading position through patent protection and established clinical data.
- Diversifying indications and geographical expansion can buffer pricing pressures.
- Partnering for biosimilar development or pursuing biomarker-driven patient stratification can mitigate market contraction effects.
Summary
Aflibercept (NDC 82009-0165) remains a significant revenue generator in ophthalmology. Prices are expected to decline gradually over the next five years due to biosimilar entry and market competition, with per-injection costs projected to decrease from approximately USD 1,500 in 2023 to around USD 1,100 by 2028. The market's growth hinges on demographic trends and technological advances, with pricing dynamics closely linked to regulatory and reimbursement environments.
Key Takeaways
- The global ophthalmology market is currently USD 49 billion, with Aflibercept representing a sizable segment.
- The current average wholesale price per injection is USD 1,900–2,200; net prices are lower.
- Prices are projected to decline by about 27% over the next five years due to biosimilar competition.
- Reimbursement strategies and regulatory developments will significantly influence future pricing.
- Growth remains robust but faces headwinds from biosimilars and alternative therapies.
FAQs
1. How does biosimilar entry affect the pricing of Aflibercept?
Biosimilar approvals typically lead to price reductions of 20–40%, driven by increased competition and payer negotiations.
2. Which markets are most influential for Aflibercept sales?
The U.S. accounts for roughly half of sales; Europe and emerging markets also contribute significantly.
3. Are there innovative therapies that could disrupt the Aflibercept market?
Yes. Emerging treatments like faricimab and gene therapies could shift market share if they demonstrate superior efficacy or safety.
4. How does treatment frequency influence cost projections?
Higher frequency treatments increase overall drug spend; price reductions per injection can offset some cost increases due to volume.
5. What legal or regulatory factors could impact future pricing?
Patent litigations, biosimilar approvals, and reimbursement policy changes each influence pricing dynamics and market share.
References
- Grand View Research. (2022). Ophthalmology Drugs Market Size & Trends.
- IQVIA. (2022). Global Ophthalmic Drugs Market Report.
- FDA. (2022). Biosimilar Approval Database.
- Regeneron Pharmaceuticals. (2022). Eylea Product Monograph.
- Statista. (2022). Market share data for ophthalmology drugs.
