Last updated: March 5, 2026
What is NDC 71288-0554?
NDC 71288-0554 refers to a specific drug product listed by the U.S. Food and Drug Administration. Based on data from the FDA and industry reports, this code corresponds to Aflibercept (Eylea) for intravitreal injection, used primarily in the treatment of neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal diseases.
Market Size and Domain
Current Market Landscape
- Global Retina Drugs Market was valued at USD 3.5 billion in 2022 (source: MarketsandMarkets).
- U.S. Market Share constitutes approximately 50% of this, driven by a high prevalence of AMD and DME.
- Key Competitors: Regeneron’s Eylea, Roche’s Lucentis, and Bayer’s Eyelea.
Incidence and Prevalence Factors
- AMD affects approximately 11 million Americans aged 50+.
- DME impacts 750,000 to 1 million Americans, with increasing prevalence due to diabetes rates.
- The rising aging population and diabetic prevalence support growing demand.
Revenue Data for Eylea (as of 2022)
| Company |
Product |
Revenue (USD) |
Market Share |
Growth Rate (YoY) |
| Regeneron |
Eylea |
2.3 billion |
~65% |
8% |
| Roche |
Lucentis |
1.2 billion |
~34% |
1% |
| Bayer |
Eyelea |
400 million |
~11% |
2% |
Note: Some revenue overlaps exist, and these figures are approximate.
Price Trends and Projections
Historic Pricing Data
- Average Wholesale Price (AWP) for a single dose of Eylea (2 mg/0.05 mL) was approximately USD 1,800 in 2020.
- Pricing Trends for intravitreal drugs have remained relatively stable, with minimal annual increases (~2-3%) to account for inflation and manufacturing costs.
Factors Influencing Future Pricing
- Introduction of biosimilars or generics — currently limited due to patent protections.
- Potential for value-based pricing models based on patient outcomes.
- Manufacturing cost reductions from process innovations.
- Regulatory or policy changes affecting drug pricing.
Price Projection (Next 5 Years)
| Year |
Expected Average Price per Dose (USD) |
Comments |
| 2023 |
1,800 |
Stable, slight inflation |
| 2024 |
1,860 |
Industry standard increase |
| 2025 |
1,920 |
No major market disruptions |
| 2026 |
1,980 |
Potential biosimilar entry delay |
| 2027 |
2,040 |
Patent protection continues, no biosamoids |
Market Dynamics Impacting Prices
- Patent Expirations: Patents for Eylea are set to expire around 2024-2025, opening opportunities for biosimilars, which could reduce prices 20-30% upon market entry.
- Regulatory Approvals: Biosimilars approved in Europe and now entering U.S. markets may influence price downward.
- Reimbursement Policies: CMS and private insurers are shifting towards value-based care, pressing for price negotiations.
Regulatory and Policy Environment
- FDA Approval Timeline: Original approvals issued in 2011-2012.
- Biosimilar Approvals: First U.S. biosimilar for Eylea approved in 2021 (by Coherus Biosciences).
- Pricing Regulations: The no-quotas approach by Medicare and Medicaid could limit price increases.
Investment and Commercialization Outlook
- Market Entry of Biosimilars: Estimated to occur by 2024-2026, with price reductions impacting revenues.
- Pipeline Products: Emerging treatments (e.g., RG7716) could alter market share dynamics.
- M&A Activity: Expect consolidation among biotech firms seeking to expand retina drug portfolios.
Summary Table: Key Data Points
| Parameter |
2022 Data |
Projected Trends |
| Market Size (USD) |
USD 3.5 billion |
Growth to USD 4.5 billion by 2027 |
| Average Dose Price (USD) |
1,800 |
Slight increase to 2,040 by 2027 |
| Patent Expiry |
2024-2025 |
Biosimilar market entry possible |
| Key Competitors |
Eylea, Lucentis, Eyelea |
Biosimilar emergence influencing prices |
Key Takeaways
- NDC 71288-0554 (Eylea) dominates the retinal injection market with USD 2.3 billion in revenue (2022).
- Price per dose has averaged USD 1,800 with a projection of USD 2,040 by 2027.
- Patent expirations pose risks and opportunities, likely leading to biosimilar competition and price reductions.
- Industry trends favor gradual price increases through 2023, followed by stabilization or decline post-biosimilar entry.
- The market’s growth is driven by the rising prevalence of AMD and DME, with an expected CAGR of approximately 5-6% through 2027.
FAQs
What is the primary driver of Eylea's market value?
The primary driver is its widespread approval for retinal diseases, combined with a strong brand presence and limited biosimilar competition until recent patent expiries.
How will biosimilar competition affect prices?
Biosimilars are expected to lower prices by 20-30%, with discounts occurring approximately 1-2 years after patent expiry.
Are there upcoming regulatory changes that could impact Eylea pricing?
Changes favoring value-based reimbursement and increased biosimilar approvals are on the horizon, which could put downward pressure on prices.
What is the outlook for future revenue?
Revenue is projected to grow modestly to USD 4.5 billion globally by 2027, tempered by biosimilar entry.
Which factors could accelerate or slow down market growth?
Accelerators include increased diagnosis rates and new indications; delays result from regulatory hurdles for biosimilars or policy interventions limiting drug costs.
References
- MarketsandMarkets. (2022). Retina Drugs Market by Disease, Molecule, and Region. [Report]
- FDA. (2022). Application approval and patent information for Eylea. [Data]
- Coherus Biosciences. (2021). Biosimilar approval for Eylea. [Press release]
- IQVIA. (2022). U.S. Prescription Drug Market Data. [Data sources]
- Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement policies and value-based initiatives.
