Aflibercept - Biologic Drug Details

Summary for aflibercept

Tradenames:	2
High Confidence Patents:	13
Applicants:	1
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for aflibercept

Recent Clinical Trials for aflibercept

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Federation Francophone de Cancerologie Digestive	PHASE2
Tanta University	EARLY_PHASE1
EyeBiotech Ltd.	PHASE2

See all aflibercept clinical trials

Pharmacology for aflibercept

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for aflibercept Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for aflibercept Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2037-03-28	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-03-10	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-10-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for aflibercept Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2037-12-21	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2035-11-23	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2036-11-15	Patent claims search

International Patents for aflibercept

Country	Patent Number	Estimated Expiration
European Patent Office	3790532
Singapore	10202107444X
South Korea	20240124434

Supplementary Protection Certificates for aflibercept

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1391020-3	Sweden		PRODUCT NAME: AFLIBERCEPT; EU/1/12/797/001, 2012-11-22; EU/1/12/797/001, 2012-11-22;
C01183353/01	Switzerland		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: SWISSMEDIC 62397 29.10.2012
122013000041	Germany		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122

Market Dynamics and Financial Trajectory for the Biologic Drug Aflibercept

Last updated: November 9, 2025

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Introduction

Aflibercept, marketed as Eylea among other names, is a recombinant fusion protein developed by Regeneron Pharmaceuticals and Bayer. Its mechanism involves acting as a decoy receptor for vascular endothelial growth factors (VEGF), thereby inhibiting abnormal angiogenesis associated with retinal diseases and certain cancers. Since its FDA approval in 2011 for ophthalmic indications, aflibercept’s market positioning has evolved amid intense competition, technological advancements, and shifting healthcare economics. This report analyses the current market dynamics and project financial trajectories to equip stakeholders with a comprehensive understanding of aflibercept’s commercial outlook.

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Market Landscape and Competitive Environment

Therapeutic Indications and Market Scope

Aflibercept's primary approved indication is for ocular diseases such as neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and proliferation diabetic retinopathy (PDR). These retinal conditions affect millions globally, with increasing prevalence driven by aging populations and rising diabetes incidence [1]. Additionally, aflibercept is approved for certain oncology indications, including metastatic colorectal cancer (mCRC), expanding its therapeutic portal.

Competitive Positioning

In ocular therapeutics, aflibercept faces stiff competition from ranibizumab (Lucentis) and bevacizumab (Avastin). While ranibizumab has a robust market presence, aflibercept’s longer dosing intervals and possibly superior efficacy for some patient subgroups have sustained its market share. The oncology segment is more nascent, with emerging biosimilars and new biologics competing for limited indications.

Market Penetration and Adoption Dynamics

The adoption of aflibercept hinges upon factors such as improved visual outcomes, dosing convenience, and healthcare provider familiarity. Payer reimbursement policies and healthcare access influence treatment choices, with cost-effectiveness playing a pivotal role, especially in markets like the United States and Europe.

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Market Drivers

• Growing Prevalence of Retinal Diseases: The global increase in aging populations and diabetes prevalence predicts sustained growth. According to The Market Research Future, the age-related macular degeneration (AMD) market alone is expected to reach $10 billion globally by 2025 [2].

• Treatment Paradigm Shifts: The transition from frequent intravitreal injections to extended dosing (e.g., every 8 weeks vs. monthly) boosts patient compliance and reduces treatment costs, benefiting aflibercept’s market penetration.

• Regulatory Approvals for New Indications: Continued approval of aflibercept for additional ocular and oncology indications will broaden its revenue base. For instance, its use in pediatric retinopathy and metastatic cancers holds potential.

• Technological Innovations: Advances in drug delivery systems, including sustained-release implants, could reduce treatment burden, improving market adoption.

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Market Challenges

• Pricing Pressures: Payer negotiations and the rising adoption of biosimilars (specifically for bevacizumab) threaten to compress prices and margins.

• Competition from Biosimilars and Small Molecule Alternatives: Biosimilars for aflibercept, though limited, are entering the market as patent protections fade, intensifying price competition.

• Clinical Data and Efficacy Competition: Head-to-head clinical trials and real-world data demonstrating superiority or niche efficacy influence prescribing patterns.

• Manufacturing and Supply Chain Risks: Biologics' complexity heightens susceptibility to supply disruptions, impacting revenue streams.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

Since launch, aflibercept has demonstrated consistent revenue growth driven by the ophthalmology segment. In 2022, Regeneron reported Eylea sales of approximately $4.25 billion globally, constituting a significant portion of its portfolio [3]. The revenue growth rate has averaged around 10-12% annually, though recent trends indicate potential deceleration due to market saturation and emerging competitors.

Forecasted Revenue Dynamics

• Short to Medium Term (2023-2027):
  Given the rising prevalence of retinal diseases, continued approval of new indications, and improvements in dosing regimens, revenues are projected to grow at a compound annual growth rate (CAGR) of 5-7%. Market penetration in emerging economies, facilitated by cost-effective biosimilars and local manufacturing, could further support growth.

• Long-Term Outlook:
  The eventual pipeline maturation, including biosimilar entries and novel biologics, could compress revenues post-2028 unless differentiated clinical benefits emerge. Nonetheless, expansion into oncology and pediatric indications can provide additional revenue streams, potentially offsetting decline risks.

Impact of Biosimilars and Pricing

European and U.S. patent cliffs set the stage for biosimilar competition by 2025-2026. Biosimilar versions of aflibercept are under development with potential to lower price points by 20-40%. This dynamic will likely pressure gross margins but could expand overall volume, especially in price-sensitive markets.

R&D Investment and Pipeline Potential

Significant R&D expenditures support the development of next-generation biologics, combination therapies, and innovative delivery methods. While these investments may transiently suppress margins, they are integral to maintaining competitive advantage and capturing future growth.

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Global Market Opportunities and Risks

Opportunities:

• Growing adoption in emerging markets with expanded healthcare infrastructure.
• Off-label uses and expanding indications, notably in oncology.
• Strategic collaborations, licensing deals, and regional manufacturing to optimize costs.

Risks:

• Regulatory delays or rejections for new indications.
• Pricing and reimbursement hurdles in highly regulated markets.
• Technological disruptions from gene therapies and oral biologics.

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Regulatory and Policy Environment

Reimbursement frameworks, patent laws, and government R&D incentives significantly influence market dynamics. The increasing emphasis on value-based healthcare may favor biologics demonstrating superior outcomes, which could benefit aflibercept if comparative advantages are established.

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Key Takeaways

• Market Growth is Driven by Demographic and Disease Trends: Aging populations and diabetes prevalence underpin sustained demand for aflibercept in retinal conditions.

• Competitive Landscape is Intense: Aflibercept faces key proprietary and biosimilar competitors, requiring continuous innovation and strategic pricing.

• Revenue Projections Remain Favorable but Challenge-Infused: CAGR of 5-7% anticipated through 2027; long-term growth depends on pipeline execution and market expansion.

• Price Competition and Biosimilar Entry Will Reshape Margins: Price erosion expected post-patent expiry; strategic approaches to offset include cost management and value demonstration.

• Geographic Expansion Offers Growth Potential: Particularly in emerging economies, where access to affordable biologics could accelerate uptake.

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FAQs

1. What are the primary drivers of aflibercept’s market growth?
   The increasing prevalence of retinal diseases, improved treatment regimens, and expanded regulatory approvals underpin growth.

2. How will biosimilar competition affect aflibercept’s revenues?
   Biosimilar entries are expected to exert downward pressure on prices, potentially reducing margins but increasing volume, especially in price-sensitive markets.

3. What strategies can companies adopt to maintain market share amid increasing competition?
   Differentiation through superior clinical outcomes, patient-friendly dosing, cost-effective manufacturing, and expanding indications can sustain market presence.

4. Are there upcoming indications that could significantly impact aflibercept’s revenue?
   Yes, ongoing research into oncology applications and pediatric retinal diseases may drive future growth if approved.

5. How does Regeneron plan to address biosimilar threats?
   Likely strategies include pipeline diversification, licensing, collaborations, and emphasizing clinical differentiation to retain competitive advantages.

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References

[1] International Diabetes Federation. “IDF Diabetes Atlas, 9th Edition,” 2019.
[2] Market Research Future. “Global Macular Degeneration Market Analysis,” 2021.
[3] Regeneron Pharmaceuticals. “2022 Annual Report.”