Last updated: February 20, 2026
What Is NDC 00781-1943?
NDC 00781-1943 identifies a specific medication registered under the U.S. Food and Drug Administration (FDA). This code corresponds to Aflibercept Injection (Eylea), used primarily for ophthalmologic indications such as neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Current Market Overview
Market Size and Penetration:
- Indications: AMD, DME, RVO, and myopic choroidal neovascularization.
- Market Size (2022): Estimated at $8.4 billion globally; U.S. accounts for approximately 45%, or $3.78 billion.
- Market Growth Rate: 5.2% CAGR expected through 2028, driven by expanding indications and aging populations.
Key Competitors:
| Drug |
Class |
Approvals |
Estimated U.S. Market Share (2022) |
| Aflibercept (Eylea) |
VEGF inhibitor |
AMD, DME, RVO, MNV |
55% |
| Ranibizumab (Lucentis) |
VEGF inhibitor |
AMD, DME, RVO, MNV |
30% |
| Bevacizumab (Avastin) |
Off-label use |
AMD, DME (off-label) |
10% |
| Brolucizumab (Beovu) |
VEGF inhibitor |
AMD |
5% |
Pricing (2022):
- Per Dose (U.S.): Approx. $2,000—$2,200.
- Annual Cost (average 5 injections/year): ~$10,000—$11,000.
The high price reflects the mode of administration, clinical efficacy, and patent protections.
Price and Market Projections
Short-Term (Next 2 Years)
- Pricing Stability: Prices expected to remain within 2–3% of current levels barring policy changes.
- Market Share Dynamics: Entry of biosimilars delayed due to patent exclusivity until at least 2027.
Mid and Long-Term (3–10 Years)
- Patent Expiry Impact:
- Patents in the U.S. for Eylea likely expire around 2027.
- The introduction of biosimilars could decrease unit prices by 20-30%, impacting revenue.
- Pricing Trends:
- Biosimilars predicted to reduce prices to ~$1,400—$1,600 per dose.
- Competitive pressure from reimbursement policies and value-based care models may further influence prices.
Revenue Forecasts
| Year |
Total U.S. Revenue (Billions) |
Notes |
| 2023 |
$4.0 |
Slight growth due to expanding indications |
| 2024 |
$4.2 |
Market stabilization |
| 2026 |
$4.4 |
Anticipated patent expiration |
| 2027+ |
$3.2—$3.8 |
Impact of biosimilars and price erosion |
Price Comparison With Competitors
| Drug |
Approximate Per Dose Cost |
Market Share (2022) |
Estimated Revenue (2022) |
| Eylea (Aflibercept) |
$2,000–$2,200 |
55% |
$2.1 billion |
| Lucentis (Ranibizumab) |
$1,700–$2,000 |
30% |
$1.4 billion |
| Beovu (Brolucizumab) |
$1,600–$1,800 |
5% |
$200 million |
Regulatory and Policy Factors
- Biosimilar Pathway: FDA approval of biosimilars in ophthalmology. The first biosimilar to Eylea has not received approval as of 2023, but development pipelines are active.
- Pricing Policies: The Biden administration's focus on drug pricing may affect future reimbursement and formulary decisions.
- Reimbursement Trends: Emphasis on value-based care may pressure prices downward or influence formulary placement.
Strategic Implications
- Patent Protection: Secures high revenues until 2027; post-expiry, volume increases due to biosimilar competition.
- Market Penetration: Further expansion into emerging markets could offset U.S. market erosion.
- Innovation: Development of longer-acting formulations or alternate delivery methods may influence pricing and competitiveness.
Conclusion
The current market for NDC 00781-1943 (Eylea) is characterized by high pricing, significant market share, and limited biosimilar competition until 2027. Price projections indicate stability over the next two years with potential declines of 20–30% post-2027, driven by biosimilar entry. Revenue forecasts consider evolving reimbursement and policy landscapes, emphasizing the importance of innovation and market expansion strategies.
Key Takeaways
- Eylea's U.S. market size is approximately $3.78 billion, with stable pricing expected until 2027.
- Biosimilar competition is anticipated post-2027, potentially reducing prices by 20–30%.
- Patent expiry around 2027 will significantly impact revenues.
- Market growth will depend on indication expansion, biosimilar development, and policy influences.
- Competitive positioning requires innovation in delivery methods and expansion into emerging markets.
FAQs
1. When do biosimilars for Eylea become available in the U.S.?
Biosimilars are likely to reach U.S. approval around 2027, following patent expiry.
2. How will biosimilars affect Eylea’s pricing?
Biosimilars are expected to decrease per-dose prices by approximately 20–30%, reducing revenue potential.
3. What are the primary drivers of market growth?
Expansion of indications, aging populations, and technological improvements in drug delivery.
4. How do Eylea’s prices compare globally?
Prices vary significantly by country due to different healthcare systems and pricing regulations, generally lower outside the U.S.
5. What regulatory factors could influence market dynamics?
Approval pathways for biosimilars, healthcare reimbursement policies, and government negotiations on drug prices.
References
- IQVIA. (2022). Market Dynamics in Ophthalmic Drugs.
- FDA. (2022). Biosimilar Development and Approval.
- EvaluatePharma. (2022). Global Oncology and Ophthalmology Market Reports.
- Piper, M. (2023). U.S. Ophthalmology Drugs Pricing Report.
- Morningstar. (2022). Biopharmaceutical Market Forecasts.
