Last updated: February 22, 2026
What is the Drug Associated with NDC 59676-0310?
The NDC 59676-0310 refers to Aflibercept Injection, marketed under the brand name Eylea. It is used primarily to treat retinal vein occlusion, diabetic macular edema, and neovascular age-related macular degeneration.
Market Overview
Market Size and Growth
The ophthalmic therapeutics market, particularly anti-VEGF agents, has experienced rapid growth. Eylea's major competitors include Lucentis (ranibizumab) and Beovu (brolucizumab), both targeting similar indications.
- The global ophthalmic drugs market was valued at approximately USD 12 billion in 2022.
- CAGR from 2022-2027 is estimated at 4-6%, driven by aging populations and increased diagnosis rates.
Market Penetration
Eylea maintains a dominant position in the US ophthalmic injection market, capturing roughly 50-60% market share among anti-VEGF treatments as of 2022.
- In the US, approximately 3 million patients are eligible for anti-VEGF therapies annually.
- Eylea's sales in 2022 reached USD 4.5 billion globally, with the US accounting for ~70%.
Competitive Landscape
| Drug |
Indication |
Market Share (2022) |
Approval Year |
| Eylea |
AMD, RVO, DME |
50-60% |
2011 |
| Lucentis |
AMD, RVO, DME |
20-30% |
2006 |
| Beovu |
AMD |
10-15% |
2019 |
Patent and Exclusivity
- Eylea's primary patent expired in 2020 but has been extended through formulation and method patents to 2023-2025.
- Biosimilar competition is anticipated post-patent expiry, with multiple biosimilar candidates under development.
Price Projections
Current Pricing Dynamics
- The average wholesale price (AWP) for a single injection of Eylea ranges from USD 1,300 to USD 1,600.
- Reimbursement rates vary, with commercial insurers reimbursing approximately USD 1,400 per injection.
- The average treatment course involves 7-8 injections annually per patient.
Projected Market Trends and Pricing
| Year |
Expected Average Price per Injection |
Rationale |
| 2023 |
USD 1,400 |
Stabilization post patent expiry, biosimilar entry delays |
| 2024 |
USD 1,200 - USD 1,300 |
Biosimilar competition begins to impact pricing |
| 2025 |
USD 1,100 - USD 1,200 |
Increased biosimilar market penetration |
| 2026+ |
USD 900 - USD 1,000 |
Increased biosimilar availability, policy-driven price pressures |
Price Impact Factors
- Biosimilar Entry: Initiates in late 2023, expected to reduce prices by 20-30%.
- Healthcare Policies: Cost-containment policies could further pressure prices.
- Reimbursement Trends: Shifts towards value-based payments may incentivize price reductions.
- Volume Growth: Steady increase in diagnosed patients and treatment rates supports volume sales even amid price declines.
Revenue Projections
Assuming the prevalence remains steady, and treatment rates increase modestly:
| Year |
Estimated Number of Patients |
Approximate Annual Revenue (USD) |
Comments |
| 2023 |
3 million |
USD 4.2 billion |
Stable prices, high market share |
| 2024 |
3.2 million |
USD 3.84 billion |
Biosimilar entry, price competition |
| 2025 |
3.3 million |
USD 3.5 billion |
Continued biosimilar proliferation |
| 2026+ |
3.5 million |
USD 3.15 billion |
Market stabilization at lower prices |
Risks to Price and Market Stability
- Biosimilar Development: Potential to significantly lower prices sooner.
- Regulatory Changes: Policies favoring generics/biosimilars could accelerate price erosion.
- Market Saturation: Slower-than-expected adoption of new indications might limit growth.
Key Takeaways
- Eylea dominates the US anti-VEGF ophthalmic market but faces increasing biosimilar competition post-2023.
- Prices are expected to decline gradually, with a possible decrease of up to 30% over the next three years.
- Market growth depends on increasing diagnosis and treatment rates, especially in aging populations.
- Revenue will remain substantial despite falling prices, owing to high treatment volumes.
- Policy and patent landscapes will heavily influence pricing trends.
FAQs
1. When will biosimilar versions of Eylea enter the market?
Multiple biosimilar candidates are in late-stage development, expected to launch between late 2023 and 2024.
2. How much can prices decline with biosimilar competition?
Prices could decrease by 20-30% compared to current levels.
3. What are the primary indications for Eylea?
Age-related macular degeneration, diabetic macular edema, and retinal vein occlusion.
4. Is the market expected to grow in the coming years?
Yes, driven by aging populations and increased awareness, but at a slower rate as market saturation approaches.
5. How might healthcare policy changes impact prices?
Policy shifts favoring biosimilars and value-based reimbursement could accelerate price reductions.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] EvaluatePharma. (2022). Top 10 Global Ophthalmic Drugs.
[3] FDA. (2022). Biosimilar Development and Market Entry Status.
[4] MarketResearch.com. (2023). Ophthalmic Drugs Market Outlook.
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies and Trends.
