Last updated: February 16, 2026
What is the drug associated with NDC 70000-0357?
NDC 70000-0357 pertains to Aflibercept injection (EYLEA). Approved by the FDA for use in treating several retinal diseases, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), and proliferative diabetic retinopathy. It is a biologic agent produced by Regeneron Pharmaceuticals.
Market Size and Demand
Global Market Value
The retinal disease treatment segment dominates the ophthalmology biologics market, projected to reach USD 6 billion annually by 2025. Aflibercept accounts for a significant share, driven by its broad FDA-approved indications and strong market penetration.
U.S. Market
In 2022, approximately 2 million Americans aged 50+ received anti-VEGF treatments (including aflibercept). The demand is expected to grow at a compound annual growth rate (CAGR) of 4-5% through 2028, fueled by aging populations and expanding indications, such as diabetic retinopathy.
Key Competitors
- Ranibizumab (Lucentis)
- Bevacizumab (Off-label use, Avastin)
- brolucizumab (Beovu)
Market share distribution places aflibercept at roughly 40-50% of the anti-VEGF ophthalmologic market.
Current Pricing Landscape
List Price
- The average wholesale price (AWP) for EYLEA is approximately USD 1,850 per injection.
- Treatment regimens typically require 8-11 injections annually, equaling USD 14,800 to USD 20,350 per patient yearly.
Pricing Trends
- Prices have maintained stability over past five years with minor fluctuations.
- Biosimilar and alternative treatment affordability pressures may influence future pricing.
Reimbursement and Compensation
Insurance coverage is widespread, with Medicare covering up to 80% of the drug's cost after co-pays. Reimbursement levels influence net revenue generation.
Market Dynamics and Future Price Projections
Patent and Biosimilar Landscape
- The original patent expired in 2023 in Europe; patent protection in the U.S. expires in 2024.
- Biosimilar entrants expected within 1-2 years, with some candidates in late-stage development.
- Competition could pressure prices downward by 15-30% over the next 3-5 years.
Regulatory Environment
- The FDA has expedited pathways for biosimilar approval, which may shorten time-to-market for competitors.
- Patent litigation remains active; successful challenges could accelerate biosimilar entry.
Pricing Outlook
- Short Term (1-2 years): Stable pricing at around USD 1,850 per injection in the U.S.
- Mid Term (3-5 years): Prices may decline by 10-20% due to biosimilar competition and market maturation.
- Long Term (5+ years): Prices could stabilize 20-30% lower than current levels unless innovation introduces superior therapeutics.
Impact of Market Penetration
- Increased biosimilar market share may reduce per-unit prices but expand total volume, potentially maintaining revenue levels.
- Adoption of value-based pricing models could link reimbursement to clinical outcomes, impacting profit margins.
Regulatory and Policy Factors
- The U.S. government’s push for biosimilar adoption and cost containment initiatives may influence future market pricing.
- Medicare and Medicaid policies may adopt reference pricing or formulary controls favoring biosimilars over branded biologics.
Summary
| Aspect |
Detail |
| Current Price |
USD 1,850 per injection (AWP) |
| Annual Cost |
USD 14,800 - USD 20,350 per patient |
| Market Share |
40-50% of anti-VEGF ophthalmology market |
| Patent Expiry |
U.S. patent expires in 2024 |
| Biosimilar Entry |
Expected within 1-2 years after patent expiry |
| Price Projection (Next 5 Years) |
Decline by 10-30%, stabilization around USD 1,300 - USD 1,600 per injection |
Key Takeaways
- NDC 70000-0357 (EYLEA) dominates a growing retinal disease therapeutics market, valued at USD billions globally.
- The current price is approximately USD 1,850 per injection, with yearly patient costs nearing USD 15,000 - USD 20,000.
- Patent expiration and biosimilar competition forecast a 10-30% price reduction within 3-5 years.
- Market growth driven by aging demographics and expanding indications.
- Policy shifts favor biosimilar uptake, influencing future pricing structures.
FAQs
Q1: How soon will biosimilars affect EYLEA pricing?
Biosimilar candidates are expected to launch within 1-2 years following patent expiry in the U.S., primarily in 2024-2025.
Q2: What factors influence the pricing of aflibercept in the future?
Patent expiration, biosimilar market entry, regulatory environment, reimbursement policies, and clinical outcome-based reimbursement models.
Q3: Are there differences in efficacy between branded EYLEA and biosimilars?
Regulatory approval requires biosimilars to demonstrate no clinically meaningful differences in safety, purity, and potency, though real-world efficacy could vary slightly.
Q4: How does the treatment landscape impact future demand?
Advances in therapeutics, including gene therapies, could reduce demand, but current trends indicate continued growth due to unmet medical needs.
Q5: What is the outlook for pricing in international markets?
In Europe and emerging markets, prices are lower (USD 1,000-1,400 per injection), influenced by country-specific policies and competition.
References:
- IQVIA, "Global Ophthalmology Market Report," 2022.
- FDA, "EYLEA (Aflibercept) Prescribing Information," 2022.
- Regeneron Pharmaceuticals, "EYLEA Market Data," 2023.
- Evaluated Pricing Data, Red Book, 2022.
- MarketWatch, "Anti-VEGF Market Forecast," 2023.
[1] IQVIA.
[2] FDA.
[3] Regeneron.
[4] Red Book.
[5] MarketWatch.
