Last updated: October 31, 2025
Introduction
The drug identified by the National Drug Code (NDC) 62135-0191 refers to Aflibercept Injection, marketed under brand names such as Eylea. Aflibercept is a recombinant fusion protein used primarily to treat various retinal disorders, including age-related macular degeneration (AMD), diabetic macular edema (DME), and central retinal vein occlusion (CRVO). Since its FDA approval in 2011, Aflibercept has established itself as a prominent entrant in ophthalmology treatments, experiencing consistent demand due to its proven efficacy. This report provides a comprehensive market analysis and price projections for NDC 62135-0191, considering factors like current market dynamics, competitive landscape, regulatory environment, and pricing trends.
Market Overview
Therapeutic Area and Clinical Demand
Aflibercept addresses critical unmet needs in ophthalmologic care, with an expanding patient population driven by aging demographics and rising prevalence of retinal diseases:
- Age-related Macular Degeneration (AMD): The primary marketed indication, affecting over 196 million worldwide as of 2020, projected to reach 288 million by 2040 [1].
- Diabetic Retinal Disorders: Increasing diabetes prevalence, notably in North America and Europe, fuels demand for anti-VEGF therapies.
- Retinal Vein Occlusions: A subset of indications with consistent treatment needs.
Market Size and Growth
The global intravitreal anti-VEGF market, estimated at approximately $8.0 billion in 2022 [2], is projected to grow at a CAGR of around 5-7% over the next five years, driven by technological innovations, expanded indications, and increasing healthcare access. Aflibercept’s segment share is substantial, often competing with Bevacizumab and Ranibizumab, with revenue estimations for Aflibercept reaching $2.5-3.0 billion globally in 2022.
Competitive Landscape
Key Competitors
- Ranibizumab (Lucentis): FDA-approved for similar indications; established market presence.
- Bevacizumab (Avastin): Widely used off-label due to lower cost.
- Faricimab (Vabysmo): A newer bispecific antibody approved in 2022, targeting multiple pathways, showing promising efficacy.
Market Dynamics
- Pricing strategies are influenced by manufacturer competition, formulary inclusions, and reimbursement policies.
- Biosimilars and generics are yet to significantly impact Aflibercept’s market due to patent protections, but are anticipated post patent expiry.
Regulatory and Reimbursement Factors
- FDA approvals: Maintained for multiple indications, contributing to sustained demand.
- Reimbursement landscape: Favorable, with Medicare and private insurers covering anti-VEGF therapies substantially, although cost containment pressures prompt negotiations and formulary management.
Pricing Policies and Cost Considerations
Pricing variations reflect regional differences, healthcare system negotiations, and list prices. The average wholesale price (AWP) for Aflibercept injections fluctuates around $1,200 to $1,700 per dose (for a standard 2 mg dose), but actual reimbursement and net prices are often lower due to discounts and negotiated rates.
Price Projections
Historical Pricing Trends
Since its market introduction, the list price of Aflibercept has exhibited modest annual increases, generally aligned with inflation and R&D recovery costs. No significant price reductions have been observed due to its patent exclusivity and critical clinical role.
Short-term (Next 1-2 Years) Outlook
- Stable or slight increase in list prices, consistent with inflation and market dynamics.
- Reimbursement adjustments may influence net prices, potentially leading to modest discounts.
Medium- to Long-term (3-5 Years) Outlook
- Patent expiration anticipation: Since the original patents for Aflibercept are expected to expire around 2024-2025 [3], generics or biosimilars could enter the market.
- Potential price erosion: Entry of biosimilars is likely to reduce prices by 20-40%, contingent on regulatory pathways and market acceptance.
- Market share shifts: As biosimilars gain adoption, the legacy drug’s annual revenue could decline correspondingly.
Factors Influencing Future Pricing
- Regulatory approvals of biosimilars could catalyze price competition.
- Pricing regulation by governments, notably in Europe and North America, may cap price hikes.
- Market acceptance and physician preference influence uptake of biosimilars versus the originator.
Implications for Stakeholders
- Pharmaceutical companies: Need to strategize around patent cliffs and biosimilar development to maintain revenue streams.
- Healthcare providers: Can expect pricing pressures with the advent of biosimilars—decision-making will pivot on maintaining efficacy and cost-effectiveness.
- Payers: Will leverage biosimilar options to optimize budgets, emphasizing the importance of comparative pricing and real-world outcomes.
- Investors: Should monitor patent expiry timelines and biosimilar approval pathways for valuation adjustments.
Key Takeaways
- Aflibercept (NDC 62135-0191) remains a pivotal drug in retinal disease management, with a robust current market presence.
- Market growth is fueled by expanding indication scope, increasing prevalence of retinal disorders, and aging populations.
- Pricing trends have been relatively stable but are poised for potential reductions post-patent expiry due to biosimilar competition.
- The entry of biosimilars, anticipated around 2024-2025, could lead to a 20-40% decrease in net prices, drastically altering revenue prospects.
- Stakeholders must prepare for price competition, regulatory changes, and evolving reimbursement policies to optimize strategic planning.
FAQs
Q1. When is patent expiration expected for Aflibercept, and how will it impact pricing?
A1. Patents for Aflibercept are expected to expire around 2024-2025 in key markets. Post-expiry, biosimilar entries are likely, potentially reducing prices by 20-40%, thus influencing revenue and market dynamics.
Q2. How does the pricing of Aflibercept compare to its competitors?
A2. Aflibercept's list price per dose is generally higher than off-label Bevacizumab but comparable or slightly higher than Ranibizumab. Actual net prices vary due to negotiations, rebates, and discounts.
Q3. Will biosimilars fully replace Aflibercept in clinical use?
A3. Biosimilars are expected to capture significant market share, especially in cost-sensitive settings. However, clinicians may prefer the originator for certain indications due to familiarity, efficacy data, or regulatory reasons.
Q4. What factors influence the future price of Aflibercept?
A4. Patent status, biosimilar competition, regulatory policies, reimbursement negotiations, and market acceptance will heavily influence future pricing trajectories.
Q5. Are there new therapies that could disrupt the current market for retinal disease treatments?
A5. Yes. Innovations such as bispecific antibodies (e.g., Faricimab) and gene therapies are emerging, promising more durable or targeted treatments, which could shift market preferences and pricing strategies.
Sources
[1] Wong, T. Y., et al. (2020). "Global prevalence of age-related macular degeneration and disease burden projection." The British Journal of Ophthalmology.
[2] Market Research Future. (2022). "Anti-VEGF Market Analysis."
[3] FDA Patent and Exclusivity Information. (2023).
Note: Data may evolve, and stakeholders should continuously monitor regulatory filings, scientific literature, and market reports.
