Last updated: July 27, 2025
Overview of NDC 00093-7455
NDC 00093-7455 pertains to the drug Aflibercept Solution for Injection, marketed under the brand name EYLEA. Approved by the U.S. Food and Drug Administration (FDA) in 2011, EYLEA is an anti-VEGF (vascular endothelial growth factor) agent used primarily for the treatment of neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal neovascular conditions.
The drug's significant role in ophthalmology has fueled sustained demand, driven by the aging population and the increasing prevalence of retinal diseases, particularly in developed markets.
Market Dynamics
1. Therapeutic Demand and Market Size
The therapy’s core indications—AMD, DME, central retinal vein occlusion (CRVO), and diabetic macular edema—are prevalent in aging populations globally. According to the American Academy of Ophthalmology, approximately 11 million Americans are affected by AMD alone, with a significant proportion receiving anti-VEGF therapy [1].
Global estimates suggest the retinal disease market, including EYLEA, is projected to reach USD 8.8 billion by 2025, with a compound annual growth rate (CAGR) of approximately 8.5% (Research and Markets, 2022).
2. Competitive Landscape
EYLEA’s primary competitors include Lucentis (ranibizumab) from Genentech and Avastin (bevacizumab) used off-label in ophthalmology. Recently, biosimilars and new entrants targeting similar pathways are emerging, but EYLEA maintains a strong market position due to approval for a broad spectrum of indications and proven efficacy.
3. Pricing Benchmarks
Pricing varies across regions:
- United States: The average wholesale price (AWP) for EYLEA is approximately USD 1,850–2,200 per 0.23 mL dose [2]. The administered dosage, typically monthly or bi-monthly, influences annual treatment costs which are estimated to range from USD 20,000 to USD 30,000 per patient.
- Europe: Prices are negotiated lower, often between €1,200–€1,700 per dose, depending on country-specific reimbursement policies.
- Emerging Markets: Prices are significantly lower, often under USD 1,000 per dose, due to affordability and market access considerations.
Market Segmentation and Revenue Estimates
1. Geographic Segments
- North America: Dominates the market with over 50% share, driven by high healthcare spending, widespread diagnosis of retinal diseases, and established reimbursement pathways.
- Europe: Second-largest segment, with moderate growth driven by aging populations and expanding ophthalmology services.
- Asia-Pacific: The fastest-growing segment, fueled by demographic shifts, increasing diabetes prevalence, and expanding healthcare infrastructure.
2. Patient Population and Pricing Impact
The average number of injections per patient per year ranges from 7 to 12 depending on disease severity and response, directly impacting total revenue.
For illustrative purposes:
Assuming a conservative scenario with 100,000 patients in the U.S. annually, each receiving an average of 8 injections at USD 2,000 per dose:
- Annual Revenue Estimate = 100,000 patients x 8 injections x USD 2,000 = USD 1.6 billion
This figure underscores the drug's significant revenue potential, even after accounting for discounts and payer negotiations.
Price Projections
1. Short-term Horizon (Next 1-2 Years)
Given current patent protections until at least 2024 (with potential extensions), the pricing for EYLEA is expected to remain relatively stable. However, price pressures may emerge from:
- Payer negotiations seeking discounts
- Biosimilar entries planned or anticipated (notably, biosimilar aflibercept products are under development, though none have received approval in key markets yet)
Projected stable pricing in the USD 1,850–2,200 range per dose, with fluctuations possible respecting regional policies and formulary decisions.
2. Medium to Long-term Outlook (3-5 Years)
Post-patent expiration or biosimilar market entry could induce price erosion:
- Biosimilar competition could reduce prices by 20–40%, depending on market uptake, patent litigation outcomes, and regulatory approvals.
- Regulatory and reimbursement policies aimed at cost containment could further pressure prices downward.
Assuming biosimilars gain market share over the next 3 years, projected per-dose prices may decline to USD 1,200–1,500, with total treatment costs decreasing proportionally.
Regulatory and Market Entry Considerations
While biosimilar development is active, regulatory approval pathways in the U.S. (via the FDA's biosimilar approval pathway) and Europe (EMA) are becoming more streamlined, increasing competition.
Intellectual property landscapes, including exclusivity rights, can influence market entry timing. Given EYLEA’s Pareto patent portfolio, significant competition may not occur until after patent expiration, likely around 2024–2026.
Economic and Reimbursement Environment
Reimbursement frameworks directly impact net pricing:
- In the U.S., Medicare and private insurers typically reimburse based on negotiated rates, with manufacturer discounts and rebates affecting net prices.
- In Europe and other regions, price controls and tendering policies often result in lower list prices.
Any shifts towards value-based care and outcome-based reimbursement models could further influence pricing strategies.
Summary of Market and Price Outlook
| Time Horizon |
Expected Price Range per Dose |
Key Drivers |
| Immediate (0-2 years) |
USD 1,850 – 2,200 |
Patent protection, stable demand, limited biosimilar competition |
| Medium-term (3-5 years) |
USD 1,200 – 1,500 |
Emergence of biosimilars, patent expirations, cost pressures |
| Long-term (>5 years) |
Potential further reduction |
Increased biosimilar market share, global price negotiations |
Key Takeaways
- Market Size & Demand: The global retinal disease market, fueled by aging demographics and diabetes prevalence, remains robust and poised for steady growth, underpinning sustained demand for EYLEA.
- Pricing Stability: Short-term prices are expected to remain stable, with U.S. prices around USD 2,000 per dose, driven by the drug’s therapeutic value and existing patent protections.
- Long-term Price Trends: Potential biosimilar competition may lead to significant price reductions over the next 3–5 years, particularly in jurisdictions with aggressive price control policies.
- Revenue Opportunities: High treatment adherence and long-term maintenance therapies position EYLEA as a dominant growth asset, with revenue prospects remaining strong amid evolving competitive pressures.
- Market Entry & Competition Risks: The timing of biosimilar and other anti-VEGF therapies’ approvals will crucially influence future pricing and market share.
FAQs
Q1: When will biosimilars for EYLEA likely enter the market?
A1: Biosimilar aflibercept candidates are under development, with regulatory approval timelines varying. The earliest potential market entry is estimated around 2024–2026, contingent on successful development and patent litigations.
Q2: How does EYLEA compare in price to its competitors?
A2: EYLEA generally commands higher prices (~USD 2,000 per dose) compared to Avastin (off-label, USD 50–200) and comparable to Lucentis (~USD 1,700–2,200). Reimbursement and formulary preferences influence actual net prices.
Q3: What factors could influence the future pricing of EYLEA?
A3: Patent expirations, biosimilar entries, payer negotiations, regulatory changes, and shifts toward value-based pricing models will shape future prices.
Q4: How significant is the market for retinal therapies globally?
A4: The market is substantial and growing, with estimates projecting to reach USD 8.8 billion by 2025, driven by increasing disease prevalence and expanding indications.
Q5: What strategies can pharmaceutical companies adopt in this evolving market?
A5: Companies should focus on innovation, securing patent protections, engaging in strategic pricing and reimbursement negotiations, and investing in biosimilar development to remain competitive.
References
[1] American Academy of Ophthalmology. "Facts and Figures on Age-related Macular Degeneration," 2021.
[2] Red Book Online. "Average Wholesale Price for EYLEA," 2023.
[3] Research and Markets. "Retinal Diseases Market Forecast," 2022.
