Last updated: February 27, 2026
What is NDC 72578-0004?
NDC 72578-0004 corresponds to Regeneron’s Eylea (aflibercept) 40 mg/0.5 mL injection. Approved for the treatment of various ocular diseases, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Eylea is one of the leading anti-VEGF therapies with a significant market share in ophthalmology.
Market Size and Growth
Current Sales Volume
- Estimated global sales for Eylea reached approximately $4.3 billion in 2022.
- U.S. market accounts for roughly 60% of sales (~$2.58 billion).
- Employed in over 50 countries, with penetration growing across emerging markets.
Market Drivers
- Increasing prevalence of AMD, DME, and RVO.
- Aging population in developed countries.
- Advancements in delivery methods reducing injection frequency.
- Competitive landscape with alternatives like Lucentis and Avastin.
Competitive Landscape
| Drug |
Manufacturer |
Indication Coverage |
Market Share (2022) |
Price Range ($ per injection) |
| Eylea |
Regeneron |
AMD, DME, RVO |
55% |
$1,850-$2,150 |
| Lucentis |
Genentech/Roche |
AMD, DME, RVO |
30% |
$2,000-$2,500 |
| Beovu |
Bayer |
AMD |
10% |
$1,900-$2,100 |
| Avastin |
Genentech (off-label) |
AMD, DME, RVO |
Variable |
$50-$100 (off-label use) |
Market Growth Projections
- Compound annual growth rate (CAGR) expected at 6% from 2023 to 2028.
- Market size projected to reach approximately $6.0 billion globally in 2028.
Price Analysis and Projections
Current Pricing Trends
- Average list price in the U.S. is approximately $2,000 per injection.
- Negotiated prices for insurers and pharmacy benefit managers (PBMs) are 20%–25% lower.
- European prices range from €1,800 to €2,100 per dose, depending on country.
Price Drivers
- Entry of biosimilars could reduce prices.
- Patent exclusivity for Eylea extends until 2025 in key markets; patent challenges ongoing.
- Regulatory approvals for sustained-release formulations may influence pricing strategies.
Future Price Trends (2023–2028)
| Year |
Estimated Average Price Per Injection |
Notes |
| 2023 |
$2,000 |
Current market conditions |
| 2024 |
$1,950 |
Slight decline amid biosimilar development |
| 2025 |
$1,850 |
Patent expiration, biosimilar entry expected |
| 2026 |
$1,700 |
Increased biosimilar competition, price pressure |
| 2027 |
$1,600 |
Market stabilization, reduced pricing |
| 2028 |
$1,550 |
Biosimilars mainstream, constant innovation |
Impact of Biosimilars
- Biosimilar versions available by 2025 could reduce Eylea prices by 30%-50%.
- Price erosion impact varies based on regional adoption and regulatory approvals.
Strategic Considerations
- Regeneron invests in developing next-generation formulations and delivery systems.
- Pricing strategies likely to adjust competitively in response to biosimilar competition and market demand.
- Establishing strong payer relationships is critical for maintaining prices and market share.
Summary
The Eylea market exhibits steady growth fueled by increasing ophthalmologic disease prevalence. Prices remain high with slight downward pressure anticipated from biosimilars by 2025. Long-term, prices are expected to decline but remain attractive due to the drug’s market leadership and expanding indications.
Key Takeaways
- The global Eylea market is projected to grow at 6% CAGR until 2028, reaching $6 billion.
- U.S. prices currently average around $2,000 per injection, with negotiated discounts reducing actual costs.
- Biosimilar competition set to emerge by 2025 could halve prices, impacting revenue.
- Regeneron’s innovation pipeline and strategic pricing will influence future market dynamics.
- Regional disparities in pricing and market penetration remain significant for global expansion.
FAQs
1. How will biosimilars affect the pricing of Eylea?
Biosimilars licensed by 2025 are expected to reduce Eylea prices by 30%-50%, mainly through increased competition in mature markets.
2. What are the main indications driving Eylea sales?
Wet AMD, DME, and RVO collectively account for the majority of Eylea’s revenue, due to high prevalence and ongoing treatment adoption.
3. How does Eylea compare price-wise with competitors?
Eylea’s list prices are comparable or slightly lower than Lucentis but higher than off-label Avastin, which remains a cost-effective alternative.
4. What are the prospects for Eylea in emerging markets?
While growth potential exists, pricing and reimbursement barriers limit immediate expansion. Generics may have less impact due to regulatory constraints.
5. What innovations could influence Eylea’s future market position?
Sustained-release formulations, improved delivery systems, and expanded indications could sustain or increase market share.
References
[1] IQVIA, "Worldwide Rx & OTC sales data," 2022.
[2] Evaluate Pharma, "Market forecasts for ophthalmology drugs," 2022.
[3] U.S. Food and Drug Administration, "Eylea (aflibercept) approval details," 2011.
[4] European Medicines Agency, "Regulatory status for Eylea," 2012.
[5] GlobalData, "Biosimilar market analysis," 2022.
