Last updated: February 24, 2026
What is NDC 42291-0560?
NDC 42291-0560 corresponds to Aflibercept injection, marketed as Eylea, used primarily for ocular neovascularization conditions such as wet age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal diseases.
Market Size and Demand Drivers
Current Market Landscape
- The global ophthalmic drugs market was valued at approximately USD 36 billion in 2022.
- The anti-VEGF segment, which includes aflibercept, dominates with a share exceeding 60% of the ocular therapeutics market.
- The primary indications for aflibercept include wet AMD, DME, diabetic retinopathy, and myopic choroidal neovascularization.
Key Market Players and Competition
| Company |
Product |
Annual Revenue (2022) |
Market Share (Estimated) |
| Regeneron Pharmaceuticals |
Eylea |
USD 5.8 billion |
48% |
| Bayer |
Aflibercept (generic or biosimilar entries expected) |
Pending |
0% (brand dominant) |
| Novartis |
Beovu |
USD 1.4 billion |
12% |
Demand Trends
- The aging global population increases prevalence of AMD and DME.
- Growing adoption in emerging markets due to increased healthcare access.
- The shift in treatment paradigms toward anti-VEGF injections sustains high demand.
Pricing Analysis
Current Price Benchmarks
- United States: The average wholesale price (AWP) for a 0.25 mL vial of Eylea is approximately USD 1,950.
- Reimbursement: Via Medicare and private insurers, effective prices are lower due to negotiated discounts and reimbursements.
Price Dynamics
- The US retail price for aflibercept has remained relatively stable over recent years.
- Biosimilar competition is absent in the US but emerging in Europe, which could pressure prices over the next 3-5 years.
Cost Considerations
- Manufacturing costs are estimated around USD 150–300 per dose.
- The high price reflects R&D, clinical trial investments, and patent protections expiring around 2027–2030.
Regulatory and Patent Landscape
- U.S. patent for Eylea expires in 2027, opening potential for biosimilar entry.
- The European Medicines Agency (EMA) approved biosimilars in 2022, with commercial availability expected in 2023-2024.
- Patent litigations may prolong exclusivity in certain markets.
Price Projection Outlook (2023–2028)
| Year |
Estimated Price Range (USD per dose) |
Key Assumptions |
| 2023 |
USD 1,950 – 2,100 |
Stable demand, no biosimilar competition |
| 2024 |
USD 1,900 – 2,050 |
Biosimilar approvals in the US remain delayed |
| 2025 |
USD 1,850 – 2,000 |
Biosimilar market entry in Europe accelerates |
| 2026 |
USD 1,750 – 1,950 |
Biosimilar adoption reduces pricing |
| 2027 |
USD 1,700 – 1,900 |
Patent expiry, biosimilars gain market share |
Factors Influencing Prices
- Biosimilar competition starting in 2024-2025 could drive prices down by 15–25%.
- Reimbursement policies and payer negotiations heavily influence net prices.
- Clinical advancements or new indications could either sustain premiums or decrease prices if warranted.
Key Takeaways
- The current US market for aflibercept (NDC 42291-0560) holds high revenue potential driven by aging populations and disease prevalence.
- Prices are stable in the near term but are susceptible to decline post-2027 due to patent expirations and biosimilar entries.
- Biosimilar competition in Europe may influence global pricing trends before the US market adapts.
FAQs
-
What factors could accelerate biosimilar entry in the US?
Patent expiry in 2027 and regulatory pathways, such as the Biologics Price Competition and Innovation Act, facilitate biosimilar approval. Litigation and patent protections can slow entry.
-
How do reimbursement policies impact effective prices?
Negotiated discounts, formularies, and payer policies lower actual costs for providers, impacting net prices received by manufacturers.
-
What is the forecasted impact of biosimilars on prices?
Biosimilar entry could reduce prices by 15–25% in the US and Europe within two years of market entry.
-
Are there any recent regulatory updates affecting aflibercept?
The EMA approved biosimilar versions of aflibercept in 2022, and regulatory review continues in other markets.
-
How might new therapies influence the market?
Innovator companies developing longer-acting formulations, gene therapies, or alternative mechanisms could shift demand away from current anti-VEGF products.
References
[1] MarketWatch. (2023). "Ophthalmic Drugs Market Size and Trends." Retrieved from https://www.marketwatch.com
[2] IQVIA. (2022). "Global Ophthalmic Market Reports." Retrieved from https://www.iqvia.com
[3] FDA. (2022). "Biologics Price Competition and Innovation Act." Retrieved from https://www.fda.gov
[4] EMA. (2022). "Approval of biosimilar aflibercept." Retrieved from https://www.ema.europa.eu
[5] Regeneron Pharmaceuticals. (2022). "Eylea Sales Data." Retrieved from https://www.regeneron.com
