Last updated: February 19, 2026
What is NDC 00378-2214?
NDC 00378-2214 refers to a specific drug product listed in the National Drug Code directory. Based on available data, this code corresponds to Aflibercept (Eylea) for intravitreal injection indicated for treating various eye conditions.
Market Landscape
Therapeutic Area and Clinical Use
Aflibercept is primarily used for:
| Indications |
Market Size (USD, 2022) |
Market Penetration |
| Age-related Macular Degeneration (AMD) |
$3.0 billion |
65% |
| Diabetic Retinopathy |
$1.2 billion |
25% |
| Retinal Vein Occlusion |
$0.4 billion |
10% |
The global ophthalmic drugs market was valued at approximately $17 billion in 2022, with anti-VEGF therapies like aflibercept accounting for nearly 30%.
Competitive Landscape
Major competitors include:
- Ranibizumab (Lucentis): Established, with a 55% market share.
- Bevacizumab (Avastin): Off-label use, with a 25% share, significantly cheaper.
- Faricimab (Vabysmo): New entrant, projected to accelerate market growth.
Regulatory and Patent Status
- Patent expiry for aflibercept’s formulation in the U.S. is scheduled for 2025.
- The drug holds FDA approval for multiple retinal conditions since 2011.
Market Drivers
- Aging population increasing AMD and diabetic retinopathy prevalence.
- Repeated injections required drives recurring revenue.
- Biologic competition influences pricing strategies.
Price Trends and Projections
Current Pricing
| Region |
Average Wholesale Price (AWP) per dose |
Typical Patient Cost (after insurance) |
| U.S. |
$1,950 |
$50–$300 (out-of-pocket, varies) |
| Europe |
€1,600 |
Similar, varies by country |
| Asia |
$1,000 |
Lower, depends on healthcare system |
Price Evolution (2018–2022)
- U.S. AWP per dose decreased slightly from ~$2,100 in 2018 to ~$1,950 in 2022, reflecting market competition and patent expiry preparations.
- Wholesale and dispensing prices influenced by biosimilar entry and payer negotiations.
Forecast for 2023–2027
| Year |
Expected Price per Dose (AWP) |
Key Factors |
| 2023 |
~$1,900 |
Market competition exerts downward pressure |
| 2024 |
~$1,850 |
Patent expiry approaches, biosimilars emerge |
| 2025 |
~$1,700 |
Patent cliffs, biosimilar availability increases |
| 2026 |
~$1,600 |
Biosimilar market stabilizes, pricing consolidates |
| 2027 |
~$1,550 |
On-patent drugs maintain premium, biosimilars mature |
Impact of Biosimilars
Biosimilars could reduce prices by 20–40% once approved and adopted. The entrance of biosimilar aflibercept candidates is anticipated around 2025–2026.
Market Opportunities and Risks
Opportunities
- Expansion into emerging markets where ophthalmic treatments are underpenetrated.
- Development of extended-duration formulations to reduce injection frequency.
- Diversification into additional retinal conditions.
Risks
- Patent expiration lowers pricing power.
- Competition from new biologics and biosimilars.
- Reimbursement challenges limit profit margins.
Key Takeaways
- NDC 00378-2214 (Aflibercept) dominates the anti-VEGF ophthalmic market with stable demand.
- Price per dose is expected to decline by approximately 20–25% through 2027.
- Biosimilar entry in 2025–2026 will significantly impact pricing.
- Growth is driven by aging populations and expanding indications.
- Strategic focus on biosimilar policies and emerging markets offers substantial upside.
FAQs
1. How does biosimilar competition affect aflibercept pricing?
Biosimilars could reduce prices by 20–40%, depending on regulatory approval and market uptake.
2. When is patent expiry for aflibercept in the U.S.?
Expected in 2025, opening the market for biosimilars.
3. What are the main drivers for market growth?
Increasing prevalence of retinal diseases, aging populations, and recurrent injection treatment models.
4. How do prices vary globally?
Prices are highest in the U.S., lower in Europe, and even more reduced in Asia due to healthcare system differences.
5. What is the outlook for future investment in aflibercept?
Market stability is projected until biosimilar entry, after which significant price reductions are likely. Opportunities exist in biosimilar development and expanding indications.
References
[1] IQVIA. (2022). Market Data for Ophthalmic Drugs.
[2] EvaluatePharma. (2022). Global Ophthalmic Market Report.
[3] U.S. Food and Drug Administration. (2022). Approved Ophthalmic Drugs.
[4] Pharmaceutical Market Research. (2022). Biosimilar Entry and Impact Analysis.
