Last updated: March 3, 2026
What is NDC 49348-0981?
NDC 49348-0981 refers to a specific drug product listed in the National Drug Code (NDC) database. Based on the manufacturer and product details, this NDC corresponds to Aflibercept injection (Eylea) used for treating neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and other retinal vascular conditions. The drug is marketed by Regeneron Pharmaceuticals.
Market Size and Adoption
Current Market Landscape
- Indications: Wet AMD, DME, retinal vein occlusion (RVO), myopic chorioretinal atrophy.
- Market Position: Eylea holds the second-largest share in wet AMD treatments, behind Lucentis (ranibizumab), with a notable growth trajectory.
- Patient Population:
- Estimated 10 million globally with wet AMD.
- Approximately 1 million diagnosed in the U.S. (as of 2021).
Market Penetration
- U.S. Market:
- Estimated sales revenue in 2022: ~$2.2 billion.
- Year-over-year growth: ~8.5% (Evaluate when compared to prior years: 2020 at ~$1.6 billion).
- Global Market:
- Expected to reach over $4 billion in revenue by 2025, with compound annual growth rate (CAGR) of around 10%.
Key Competitors
| Product |
Market Share (2022) |
Annual Revenue |
Administration |
Approved Indications |
| Eylea (Aflibercept) |
44% |
~$2.2 billion |
Intravitreal injection |
Wet AMD, DME, RVO |
| Lucentis |
35% |
~$1.6 billion |
Intravitreal injection |
Wet AMD, Diabetic Retinopathy |
| Beovu |
8% |
~$450 million |
Intravitreal injection |
Wet AMD |
| Others |
13% |
<$500 million |
Various |
Various retinal conditions |
Market Trends
- Increasing prevalence of AMD and diabetic retinopathy.
- Advancements in sustained-release delivery systems.
- Growing acceptance of biosimilars (though none approved yet for aflibercept in this indication).
Pricing Overview
Current Pricing
- U.S. Wholesale Acquisition Cost (WAC) for a 2-milliliter vial (40 mg/0.8 mL): approximately $1,900 to $2,200 per administration.
- Reimbursement rates vary depending on insurance plans and geographic regions.
Pricing Dynamics
- The list price has remained relatively stable over recent years, with minor inflation adjustments.
- Cost negotiations and patient assistance programs impact net prices.
Pricing Compared with Competitors
| Product |
List Price per Dose |
Dosing Frequency |
Total Annual Cost (Approximate) |
| Aflibercept |
$2,000 |
Every 8 weeks after initial loading |
$12,000–$15,000 (assuming 7-8 injections/year) |
| Ranibizumab |
$2,000 |
Monthly or PRN |
Similar to aflibercept |
| Brolucizumab |
$1,200 |
Every 12 weeks |
Less costly per year, but with safety considerations |
Future Price and Market Projections
Price Trends
- Expected patent exclusivity to expire around 2023–2024, possibly enabling biosimilar entries.
- Biosimilar competition could reduce prices by 20%-40% within 2 years of biosimilar approval.
- Price stabilization anticipated until biosimilars gain approval, then potential discounts.
Sales Projections
| Year |
Estimated Global Sales |
Notes |
| 2023 |
~$4.3 billion |
Growth driven by increased adoption |
| 2024 |
~$4.7 billion |
Introduction of biosimilars possible |
| 2025 |
~$5.2 billion |
Market expansion continues |
Strategic Influences
- Increased use of high-dose options may influence price points.
- Expansion into emerging markets could slightly lower average selling prices but increase revenue volume.
Regulatory and Policy Influences
- Pending biosimilar approvals in the U.S. FDA could impact prices.
- CMS and private payers' formulary decisions may influence net reimbursement.
Key Takeaways
- NDC 49348-0981 (Aflibercept) is a leading treatment for retinal vascular diseases with a strong market presence.
- The U.S. market generated over $2 billion annually, with growth driven by aging populations.
- Pricing remains stable but faces potential reduction post-biosimilar entry.
- Future growth hinges on biosimilar development, expanding indications, and market penetration in emerging regions.
- Competitive landscape is consolidated, but innovation in delivery methods may create pricing shifts.
Frequently Asked Questions
Q1: When are biosimilars for aflibercept expected to enter the market?
A1: Biosimilar applications are currently under review, with FDA approvals expected between 2023 and 2024.
Q2: How might biosimilar competition affect prices?
A2: Biosimilars could reduce prices by 20–40% within 2 years of approval.
Q3: What are the primary drivers of market growth?
A3: Increasing prevalence of AMD and diabetic retinopathy, aging populations, and expanded treatment indications.
Q4: What is the outlook for international expansion?
A4: Emerging markets offer growth opportunities, though pricing will be influenced by local reimbursement policies.
Q5: Are there any notable safety or efficacy concerns impacting market dynamics?
A5: Safety concerns related to intraocular inflammation with newer agents like Brolucizumab impact prescribing, but aflibercept maintains a strong safety profile.
References
- MarketWatch. (2022). Aflibercept (Eylea) market analysis and forecast.
- IQVIA. (2022). Global ophthalmology drug sales report.
- U.S. Food and Drug Administration (FDA). (2023). Pending biosimilar approvals list.
- Regeneron Pharmaceuticals. (2022). Annual Report 2022.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement data for retinal therapies.
