Last updated: February 24, 2026
What is NDC 46122-0637?
NDC 46122-0637 corresponds to the drug Aflibercept Injection, marketed under the brand Eylea by Regeneron Pharmaceuticals. It is used primarily for treating age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal diseases.
Current Market Position
Eylea dominates the intravitreal anti-VEGF market, with sales exceeding $6 billion in 2022 globally. Its key competitors include:
- Ranibizumab (Lucentis)
- Bevacizumab (Off-label for ophthalmic uses)
Regeneron holds approximately 55% of the US intravitreal VEGF inhibitor market (2022 data), driven by efficacy, dosing schedule, and established clinical reputation.
Market Size and Growth Drivers
Global Ophthalmic Drugs Market
Projected CAGR (2022-2028): 4.8% (Fortune Business Insights, 2023)
Key Drivers
- Aging population increasing incidence of AMD and DME.
- Increasing diagnosis rates with advanced imaging techniques.
- Expanding treatment adherence due to Eylea’s dosing schedule (every 8 weeks post-loading phase).
- Patent protections extending until at least 2027 in the US; biosimilar entry expected thereafter.
US Market
- 2022 sales: approximately $4.2 billion (EvaluatePharma)
- Expected Compound Annual Growth Rate: 4.5-6% over five years, driven by indications expansion and competitive launches.
Price Dynamics and Cost Structure
Current Pricing
- Eylea (per injection): Approximately $2,100 (based on wholesaler data)
- Market Average for Ophthalmic injections: $1,800–$2,200
Reimbursement Environment
- Mediated mostly through private insurers and Medicare.
- The average WAC (Wholesale Acquisition Cost) has increased annually at ~2% since 2020.
- Formularies favor Eylea for chronic treatment due to dosing frequency and clinical data.
Biosimilar Impact
- Biosimilar versions are expected post-2027.
- Price erosion anticipated: 25-35% reduction upon biosimilar entry.
- Early biosimilars in development with potential launch by 2027–2028.
Price Projections (2023-2030)
| Year |
Estimated Injection Price |
Key Assumptions |
| 2023 |
$2,100 |
Stable market, no biosimilars |
| 2024 |
$2,100 |
Minor adjustments; reimbursement pressures remain stable |
| 2025 |
$2,200 |
Slight cost increase; patent protection persists |
| 2026 |
$2,200 |
Market stable; preparing for upcoming biosimilar threat |
| 2027 |
$1,850 |
Biosimilar launch; expected 25% price reduction |
| 2028 |
$1,860 |
Slight recovery due to market adjustments |
| 2029 |
$1,860 |
Biosimilar competition stabilizes pricing |
| 2030 |
$1,860 |
Long-term stabilization at a lower price point |
Note: Prices are in nominal USD; biosimilar market entry is the primary variable impacting price declines.
Revenue Projections
Assuming approximately 10 million injections annually in the US pre-biosimilar entry:
- 2023-2026 (pre-biosimilar): Revenue remains around $22–$24 billion annually.
- 2027 onward: Revenue drops to approximately $16–$17 billion with biosimilar competition.
Strategic Considerations
- Patent expiry in the US occurs in 2027. Competitors are developing biosimilars.
- Regeneron may introduce further formulations or combination therapies to defend revenue.
- Pricing will likely decline more sharply in emerging markets without strong patent protections.
Key Takeaways
- Eylea maintains a dominant market share, with stable prices until patent expiration.
- Biosimilar competition expected around 2027 will reduce prices by at least 25%.
- Revenue forecasts anticipate a post-2027 decline, but the total market size will remain sizable due to high prevalence of target indications.
- Pricing adjustments in response to market pressures will influence ongoing profitability and R&D strategies.
- Expansion into new indications or delivery methods can offset price erosion.
FAQs
Q1: When do biosimilars for Eylea become commercially available?
A1: No biosimilars are approved as of 2023; launch is projected post-2027 based on patent expiry.
Q2: How will patent expiry affect Eylea’s pricing?
A2: Prices are expected to decrease by 25-35%, driven by biosimilar competition and market dynamics.
Q3: Are there any approved therapies to replace Eylea before biosimilars arrive?
A3: Several emerging therapies are in late-stage trials, but none have yet replaced Eylea's market position.
Q4: How does Eylea’s pricing compare internationally?
A4: U.S. prices are higher than in Europe and Asia due to different reimbursement systems and market regulations.
Q5: What are the main drivers for future growth in the Eylea market?
A5: Expanding indications, improving treatment adherence, and increasing diagnosis rates.
References
- Fortune Business Insights. (2023). Ophthalmic Drugs Market Size, Share & Industry Analysis.
- EvaluatePharma. (2023). Ophthalmic Drugs Market Data.
- U.S. Food and Drug Administration. (2023). Biosimilar Resources and Approvals.
- Regeneron Pharmaceuticals. (2022). Eylea Product Sales Data.
- Market Research Future. (2022). Ophthalmology Market Trends & Forecasts.
