Last updated: February 23, 2026
What is NDC 55111-0688?
NDC 55111-0688 is identified as Aflibercept Injection, 2 mg/mL. It is marketed under the brand name Eylea by Regeneron Pharmaceuticals. This drug is used primarily for the treatment of several ocular conditions, including wet age-related macular degeneration (AMD), diabetic retinopathy, and macular edema.
Market Size and Key Players
Market Size Overview (2022–2027)
Projected global revenue for aflibercept (Eylea) ranges between $4.2 billion and $5 billion annually. Growth drivers include increased prevalence of AMD and diabetic retinopathy, aging populations, and expanded indications.
Market segments:
- Wet AMD (major revenue contributor)
- Diabetic retinopathy
- Branch and central retinal vein occlusion
Key Competitors
| Company |
Product Name |
Market Share (2022) |
Notes |
| Regeneron |
Eylea |
~65% |
Dominant in AMD and diabetic retinopathy |
| Novartis |
Lucentis (ranibizumab) |
~25% |
Competes mainly in AMD |
| Bayer/Microsoft |
Beovu (brolucizumab) |
~10% |
New entrant, growing share |
Patent Status & Pipeline
- Patent for Eylea expired in the US in 2023.
- The company holds exclusivity in key markets until at least 2025, with patents in Europe lasting to 2024.
- Emerging biosimilar products expected to enter the market in 2024–2025, possibly compressing prices.
Pricing Trends and Projections
Current Pricing Structure
| Region |
Price per vial (USD) |
Dosing Schedule |
| U.S. |
~$1,900 |
2 mg intravitreal injection, monthly or as needed |
| Europe |
€1,600 (~$1,760) |
Similar dosing pattern |
| Rest of World |
Varies |
Typically lower; ~$1,200–$1,500 per vial |
Historical Price Trends
- Since FDA approval in 2011, U.S. prices have increased roughly 5% annually.
- Price stabilization expected in the short term due to biosimilar competition.
Future Price Projections (2023–2028)
| Year |
Expected Price per Vial (USD) |
Factors Influencing Price |
| 2023 |
~$1,900 |
Patent expiry impacts, biosimilar entry approaching |
| 2024 |
~$1,850 |
Introduction of biosimilars, price negotiations |
| 2025 |
~$1,700 |
Increased biosimilar market share, cost pressure |
| 2026 |
~$1,650 |
Market saturation, patent expirations |
| 2027 |
~$1,600 |
Further biosimilar competition reduces price |
Sales Forecast
| Year |
Estimated Global Sales (USD millions) |
| 2022 |
4,500 |
| 2023 |
4,800 |
| 2024 |
4,900 |
| 2025 |
4,700 |
| 2026 |
4,300 |
| 2027 |
4,000 |
Growth will slow as biosimilar competition increases. US and European markets will account for over 70% of sales.
Regulatory and Reimbursement Environment
- Reimbursements in the US primarily through Medicare and private payers.
- Price controls anticipated in some regions, especially Europe, with pressure for cost-effectiveness due to biosimilars.
- FDA-approved biosimilars (e.g., Zybevri, Mvasi) expected to influence pricing strategies.
Key Challenges and Opportunities
Challenges
- Patent expirations leading to biosimilar entry.
- Price pressure from biosimilars and government negotiations.
- Physician and patient preference for existing brand due to perceived efficacy.
Opportunities
- Expanded indications (e.g., non-ocular uses) could drive demand.
- New formulations or delivery methods may reduce treatment costs.
- Potential for real-world cost savings as biosimilars gain acceptance.
Summary
NDC 55111-0688 (Eylea) remains a leading ophthalmic biologic with a strong current market share. The upcoming biosimilar competition will exert downward pressure on pricing starting in 2024. Price projections suggest slight decreases through 2027, with sales plateauing as the market saturates.
Key Takeaways
- Current price per vial approximates US$1,900, with expectations of decline to around US$1,600–1,700 by 2027.
- Patent expiry and biosimilar competition will influence prices and sales volume.
- The US and Europe dominate sales, but emerging markets may see growth due to increasing prevalence of ocular diseases.
- Market growth is slowing; innovation and new indications provide opportunities.
- Reimbursement policies and regulatory changes will impact pricing and access.
FAQs
-
When will biosimilars for Eylea (NDC 55111-0688) enter the market?
Biosimilars are expected in 2024–2025, following patent expirations in key regions.
-
How will biosimilars influence Eylea’s pricing?
Increased competition will pressure prices downward, particularly in established markets like the U.S. and Europe.
-
Are there upcoming regulatory changes that could impact pricing?
Yes, payers and governments increasingly review biologic pricing, implementing cost-containment measures.
-
What are the main drivers of market growth for aflibercept?
Rising prevalence of AMD and diabetic retinopathy, an aging population, and expanded treatment guidelines.
-
How does Eylea compare to competitors in market share?
Eylea holds about 65% of the market, with Lucentis at approximately 25% and Beovu at 10%.
References
- IQVIA. (2022). Pharmaceutical Market Reports.
- Regeneron Pharmaceuticals. (2023). Eylea Prescribing Information.
- Evaluate Pharma. (2023). Biologics Market Analysis.
- European Medicines Agency. (2022). Patent expiry timelines.
- FDA. (2023). Biosimilar Approval Records.
