Last updated: February 28, 2026
What Is NDC 00378-8056?
NDC 00378-8056 is a specific drug identified under the National Drug Code (NDC) system. This code corresponds to Aflibercept (Eylea), a biologic used primarily to treat retinal vascular diseases such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Market Size and Dynamics
Global Market Size
The ophthalmic biologics segment, including aflibercept, has experienced consistent growth due to increasing prevalence of retinal diseases, aging populations, and technological advancements. The global market for ophthalmic drugs was valued at approximately $8.4 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 6.0% over the next five years, reaching $11.3 billion by 2027 (Research and Markets, 2022).
U.S. Market Overview
In the United States, the market for aflibercept specifically is estimated at $2.5 billion in 2022, driven by routine administration in ophthalmology clinics. The largest segment comprises AMD treatments, accounting for around 70% of the market. Growth is supported by:
- Increasing diagnosis and screening.
- Limited biosimilar competition until recent entries.
- Reimbursement coverage by Medicare and private insurers.
Competitive Landscape
Main competitors include:
- Ranibizumab (Lucentis): Another anti-VEGF agent.
- Biosimilars: The first biosimilar, Mila, gained FDA approval in 2022, introducing potential price competition.
- New entrants and next-generation biologics: Pipeline drugs aim to improve upon current efficacy and dosing.
Pricing Trends and Projections
Current Pricing
The average wholesale price (AWP) for a single injection of aflibercept (Eylea) is approximately $2,100. Payers negotiate discounts lowering actual reimbursement rates. Typical outpatient injection therapy involves:
- Three initial monthly injections.
- Follow-up injections every 8 to 12 weeks.
Price Drivers
- Biosimilar competition: Entry of biosimilars in 2022 has driven unit prices downward. Prices for biosimilars range from $1,300 to $1,700 per injection.
- Volume-based discounts: Larger health systems negotiate lower prices.
- Regulatory policies: U.S. administration initiatives supporting biosimilars aim to reduce biologics costs by 20-40% over five years.
Future Price Projection
Based on current trends, prices are expected to decline by approximately 10-15% annually over the next five years due to biosimilar competition and price negotiations:
| Year |
Estimated Price per Injection |
Notes |
| 2023 |
$2,100 |
Current average wholesale price |
| 2024 |
$1,890 |
10% decrease from 2023 |
| 2025 |
$1,701 |
10% decrease from 2024 |
| 2026 |
$1,531 |
10% decrease from 2025 |
| 2027 |
$1,378 |
10% decrease from 2026 |
Revenue Outlook
Assuming an average of 4 injections annually per patient, with an estimated 250,000 patients in the U.S.:
- 2022: $2.5 billion
- 2027 projection: roughly $1.9 billion, factoring in price declines and steady patient volume.
Regulatory and Policy Impact
Biosimilar Approval and Adoption
- The FDA approved the first biosimilar of aflibercept in 2022. Adoption rates are projected to increase to 40% of the market by 2027.
- The Biosimilar Price Competition and Innovation Act (BPCIA) incentivizes biosimilar entry, likely accelerating price reductions.
Reimbursement Policies
- The Centers for Medicare & Medicaid Services (CMS) and private insurers increasingly favor biosimilar integration.
- Payment models adjusting for biosimilar discounts put pressure on branded biologics.
Key Market Risks
- Biosimilar market penetration: Rapid adoption could accelerate price declines.
- Patent litigation: Potential patent disputes delaying biosimilar entry.
- Technological advancements: Next-generation therapies may replace current biologics earlier than expected, reducing revenue.
Summary of Market Drivers & Challenges
| Drivers |
Challenges |
| Aging population increases retinal disease prevalence |
Biosimilar patent litigation delays entry |
| Growing diagnosis rates |
Resistance from established providers to biosimilars |
| Reimbursement structures favoring biosims |
Rapid technological advancements in therapies |
Key Takeaways
- The U.S. market for aflibercept (NDC 00378-8056) is approximately $2.5 billion, with steady growth expected through 2027.
- Prices for the drug are projected to decline 10-15% annually, driven mainly by biosimilar competition.
- Biosimilars are expected to capture up to 40% of the market by 2027, further pressuring prices.
- Revenue projections indicate a potential decrease to around $1.9 billion in the U.S. market by 2027, assuming stable patient volume.
- Regulatory policies are increasingly supportive of biosimilar adoption, which could accelerate price erosion.
FAQs
1. How does biosimilar entry impact the price of aflibercept?
Biosimilar entry leads to price competition that can reduce biologic prices by 20-40%. This accelerates price declines for the branded product.
2. What is the current reimbursement landscape for aflibercept?
Reimbursements are negotiated between providers and payers, with Medicare covering most outpatient injections at negotiated rates, often discounted from AWP.
3. Are there upcoming patent expirations for aflibercept?
Patent protections generally extend into the late 2020s; patent litigations and settlements influence biosimilar entry timing.
4. Which emerging therapies could influence the market?
Gene therapies and longer-acting biologics are in development, potentially reducing the demand for repeated biologic injections.
5. How does patient volume affect revenue projections?
Steady or increasing patient volume moderates the impact of price declines, sustaining revenue levels—if patient volume diminishes, revenue drops further.
References
[1] Research and Markets. (2022). Ophthalmic Drugs Market Report.
[2] IQVIA. (2022). US Market Data for Ophthalmic Biologics.
[3] FDA. (2022). Biosimilar Approval Announcements.
