Last updated: February 23, 2026
What is NDC 13668-0453?
NDC 13668-0453 corresponds to Aflibercept Injection, marketed under the brand name Eylea. It is used for treating wet age-related macular degeneration, diabetic macular edema, and other retinal vascular conditions. It is a monoclonal antibody that inhibits vascular endothelial growth factor (VEGF).
Market Overview
Market Size and Adoption
The global market for anti-VEGF therapies, including aflibercept, was valued at approximately $8.2 billion in 2022 and is projected to reach $15.4 billion by 2030, with a compound annual growth rate (CAGR) of 8.1%. The primary drivers include increasing prevalence of retinal diseases, aging populations, and expanding indications.
Key Market Players:
| Company |
Product Name |
Estimated Market Share (2022) |
Notes |
| Regeneron |
Eylea |
~65% |
Dominant among anti-VEGF therapies |
| Bayer |
Bayer's version of Eylea |
~20% |
Competitive pricing, expanding globally |
| Novartis |
Lucentis |
~10% |
Used for similar indications but declining since Eylea's market entry |
| Others |
Bevacizumab |
~5% |
Off-label use, lower cost |
Pricing Context
In the United States, Eylea’s average wholesale price (AWP) is approximately $1,850 per injection (2023). The cost varies by dosage, indication, and payer reimbursement policies.
Market Dynamics
- The primary growth factor is increased diagnosis of retinal vascular diseases.
- Patent expirations for some formulations may introduce biosimilars, affecting pricing and market share.
- Off-label use of cheaper alternatives like bevacizumab influences market competition.
Price Projections
Short-Term Outlook (Next 2 Years)
- Pricing stability: Maintained around $1,850 per injection for brand-name Eylea.
- Insurance and reimbursement policies: Coverages remain stable; no significant discounts expected.
- Market penetration: Slight growth anticipated due to expanded indications and global reach.
Medium to Long-Term Outlook (Next 5-10 Years)
- Patents and biosimilar entry: Biosimilars could enter by 2025-2027, potentially reducing prices by 20%-40%.
- Pricing adjustments: Major payers may negotiate discounts, leading to decreases in net prices.
- Emergence of alternative therapies: New agents targeting retinal diseases may limit growth and exert downward pressure on prices.
Price Impact Factors
| Factor |
Effect on Price |
Estimated Timeline |
| Biosimilar Competition |
20-40% reduction |
2025-2027 |
| Regulatory Changes |
Potential price controls |
2024-2026 |
| Market Expansion |
Slight price increases due to higher volume |
Ongoing |
| Innovation in Treatment |
Might introduce more effective or less costly options |
2024-2030 |
Market Entry and Competition Strategies
- Biosimilar Development: Several companies (e.g., Samsung Bioepis, Coherus) are working on aflibercept biosimilars targeting regulatory approval by 2025.
- Pricing strategies: Brand manufacturers may implement rebates and discounts to retain market share.
- Global Pricing Variability: Prices differ widely outside the US and Europe, influenced by healthcare systems and policy.
Critical Considerations
- Patent litigation and exclusivity periods significantly influence market dynamics.
- Cost-effectiveness assessments impact payer coverage and formulary placements.
- Patient access programs influence utilization rates, especially in emerging markets.
Key Takeaways
- The current market for aflibercept (NDC 13668-0453) is largely driven by the US and Europe, with significant growth expected elsewhere.
- Brand-name prices are stable near $1,850 per injection, with potential decreases once biosimilars enter the market around 2025.
- Competitive pressure from biosimilars, regulatory changes, and emerging therapies will shape future pricing.
- Market expansion in emerging markets, driven by increasing retinal disease prevalence, sustains growth prospects.
- Cost control efforts and innovation may lead to pricing adjustments in the coming years.
FAQs
Q1: When are biosimilars for aflibercept expected to enter the market?
A1: Biosimilars are projected to seek regulatory approval by 2025-2027, with potential market entry shortly thereafter.
Q2: How much could biosimilars reduce the price of aflibercept?
A2: Biosimilars could reduce the price by 20%-40%, depending on manufacturing costs, market competition, and payer negotiations.
Q3: What are the main competitors to aflibercept?
A3: The main competitors are ranibizumab (Lucentis) and off-label bevacizumab, along with emerging therapies and biosimilars.
Q4: How does geographic variation impact pricing?
A4: Prices generally decrease outside the US and Europe due to differing healthcare policies, negotiation power, and local regulations.
Q5: Will new treatments replace aflibercept?
A5: Not immediately. While new therapies are under development, aflibercept remains a leading treatment, with adoption dependent on efficacy and cost.
References
[1] IQVIA. (2022). Global ophthalmology market report.
[2] Drugs.com. (2023). Eylea Pricing Information.
[3] EvaluatePharma. (2022). Ophthalmology drug trends.
[4] U.S. Food and Drug Administration. (2023). Biosimilar Approval timeline.
[5] MarketWatch. (2023). Anti-VEGF therapy market analysis.
