Last updated: February 24, 2026
What Is NDC 43547-0378?
NDC 43547-0378 corresponds to Aflibercept injection (Eylea), approved by the FDA for multiple indications, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal diseases. Marketed primarily by Bayer and Regeneron, it is a leading anti-VEGF therapy. The drug's global revenue reached approximately $4.2 billion in 2022.
Market Overview
Key Market Segments
| Segment |
Details |
| Indications |
AMD, DME, diabetic retinopathy, myopic choroidal neovascularization, and retinal vein occlusion |
| Treatment Setting |
Intravitreal injections administered in ophthalmology clinics |
| Competition |
Ranibizumab (Lucentis), Bevacizumab (Off-label), Faricimab (Vabysmo) |
| Regulatory Status |
FDA approved since 2011; multiple indications expanded over time |
Market Trends
- Increasing prevalence of AMD and diabetic eye diseases due to aging populations and diabetes mellitus.
- Growing adoption of anti-VEGF therapies as standard of care.
- Entry of biosimilars is unlikely soon, given patent protections and market dynamics.
Competitors
| Drug |
Market Share (2022) |
Price per Dose |
Key Differentiators |
| Eylea (Aflibercept) |
45% |
$2,000 |
Broad indication profile |
| Lucentis (Ranibizumab) |
40% |
$2,200 |
Established presence |
| Bevacizumab |
10% |
$50–$100 |
Cost-effective, off-label use |
| Vabysmo (Faricimab) |
5% |
Not yet established |
New candidate, dual mechanism |
Price Projections
Current Pricing Overview
- Average wholesale price (AWP) for Eylea: approximately $2,000 per injection.
- Rebate and discount adjustments typically lower net price to approximately $1,600–$1,800 per dose.
Short-term (Next 1–2 Years)
- No major price changes projected; pricing for branded anti-VEGF therapies remains stable.
- Increased utilization driven by broader indications and higher patient demand.
- No generic or biosimilar competition expected before 2030 due to patent protections.
Long-term (3–5 Years)
- Potential for slight price erosion (~5% annually) as competition intensifies.
- Expansion of biosimilar pipelines may eventually influence pricing.
- Performance-based pricing models could influence average transaction prices, contingent on efficacy outcomes.
External Factors Influencing Pricing
- Reimbursement policies: CMS and private insurers increasingly scrutinize drug prices.
- Market access strategies: Differentiation through improved formulations or delivery methods.
- Patent litigation and exclusivity periods: Patent expiry for key patents scheduled around 2027–2030, potentially opening the market for biosimilars.
Revenue Projections
| Year |
Estimated Revenue |
Assumptions |
| 2023 |
$4.2 billion |
Continuation of current utilization and pricing stability |
| 2024 |
$4.3–$4.4 billion |
Slight increase due to broader indications and adoption |
| 2025 |
$4.2–$4.3 billion |
Stabilization as market reaches saturation |
| 2026 |
$4.0–$4.2 billion |
Potential introduction of biosimilar competition |
| 2027+ |
Decline expected |
Biosimilar entry, patent expirations, price competition |
Key Takeaways
- The anti-VEGF sector remains a high-value, high-demand market with stable price points due to patent protections.
- Eylea holds approximately 45% market share with an approximate cost of $2,000 per injection.
- Revenue likely to plateau through 2024 and face decline beginning 2027 with biosimilar entry.
- Pricing models will increasingly reflect value-based approaches, impacting future reimbursement.
FAQs
What factors could significantly alter Eylea's pricing over the next five years?
Patent expirations, biosimilar entries, regulatory changes, and reimbursement policies.
How does Eylea's price compare to key competitors?
It is comparable in cost to Lucentis but generally slightly less expensive; Bevacizumab remains significantly cheaper due to off-label use.
Are biosimilars expected to enter the market soon?
Probably not before 2027, given current patent protections and pipeline status.
What indications have contributed most to Eylea's revenue growth?
Wet AMD and diabetic macular edema (DME) are the primary drivers.
How might new therapies impact Eylea’s market share?
Emerging treatments like Vabysmo with dual mechanisms could erode share, but widespread adoption requires more data on efficacy and safety.
References
- IQVIA. (2022). Global Ophthalmic Drugs Market Report.
- Bayer. (2022). Eylea Prescribing Information.
- Regeneron Pharmaceuticals. (2022). Financial Report.
- EvaluatePharma. (2022). Anti-VEGF Market Outlook.
- U.S. Food and Drug Administration. (2011). Eylea Approval Letter.
