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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-10-12	DrugPatentWatch analysis and company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-08-06	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
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2035-03-17	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387		2038-05-25	Patent claims search

International Patents for aflibercept

Country	Patent Number	Estimated Expiration
Cyprus	2013019
Mexico	2022011973
Malaysia	205859
Argentina	129282
Japan	2025028979

Supplementary Protection Certificates for aflibercept

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2013009,C1183353	Lithuania		PRODUCT NAME: AFLIBERCEPTUM; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
132013902154380	Italy		PRODUCT NAME: AFLIBERCEPT(EYLEA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/797/001-002, 20121122
CA 2013 00020	Denmark
1391020-3	Sweden		PRODUCT NAME: AFLIBERCEPT; EU/1/12/797/001, 2012-11-22; EU/1/12/797/001, 2012-11-22;
2013C/029	Belgium		PRODUCT NAME: AFLIBERCEPT; AUTHORISATION NUMBER AND DATE: EU/1/12/197/001 20121126

Market Dynamics and Financial Trajectory for Aflibercept: A Comprehensive Analysis

Last updated: December 24, 2025

Executive Summary

Aflibercept, marketed as Eylea among other brand names, is a recombinant fusion protein developed for the treatment of ophthalmologic and oncologic conditions. Since its regulatory approval in 2011 for neovascular age-related macular degeneration (nAMD), aflibercept's global market has experienced rapid growth driven by expanding indications, increasing prevalence of ocular diseases, and ongoing clinical research. This report provides a detailed overview of the current market landscape, key drivers, competitive positioning, and financial trajectory, with a focus on global trends and future outlooks.

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What is Aflibercept and How Does It Work?

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor that functions as a decoy receptor, binding VEGF-A, VEGF-B, and placental growth factor (PGF). This inhibits abnormal angiogenesis and vascular permeability, critical in conditions such as:

Condition	Indications	Administration
Wet AMD	Monthly or bimonthly injections	Intravitreal injection
Diabetic Macular Edema (DME)	Monthly or bimonthly	Intravitreal injection
Central Retinal Vein Occlusion (CRVO)	Monthly or bimonthly	Intravitreal injection
Non-small Cell Lung Cancer (NSCLC)	Various lines of therapy	Intravenous infusion

Developed by Regeneron Pharmaceuticals and Bayer, aflibercept's unique binding affinity and dosing frequency position it competitively within the anti-VEGF landscape.

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Market Overview: Global Penetration and Growth Drivers

Market Size and Historic Growth (2011–2022)

Year	Estimated Global Market (USD Billion)	CAGR (2011–2022)	Key Remarks
2011	0.2	N/A	Launch year
2015	1.5	64.2%	Increasing ophthalmology use
2020	3.4	41.4%	Expanded indications, increased R&D
2022	4.2**	—	Mature phase in ophthalmology

Source: Market Reports [1,2]

Drivers of Market Growth

• Rising Prevalence of Ocular Diseases:

  • Estimated 196 million people globally with AMD in 2020, projected to reach 288 million by 2040 [3].
  • Diabetic retinopathy affects over 93 million globally [4].

• Expansion into Oncology:

  • Approved for NSCLC, metastatic colorectal, and cervical cancers; therapeutic pipeline expanding.

• Technological Advancements & Dosing Convenience:

  • Less frequent dosing (every 8 weeks after initial monthly doses) enhances patient adherence.

• Increasing Healthcare Access and Screening Programs

Market Segments and Revenue Breakdown

Segment	Approximate % of global aflibercept sales (2022)	Growth Outlook (2023–2028)
Ophthalmology (nAMD, DME, RVO)	~85%	7–9% CAGR
Oncology	~15%	12–15% CAGR

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Competitive Landscape

Competitor	Key Products	Market Share (2022)	Strengths	Challenges
Roche/Genentech (Avastin)	Bevacizumab (off-label)	Leading but off-label	Cost-effective, well-established	Regulatory challenges, off-label use
Novartis (Lucentis)	Ranibizumab	Significant	Proven efficacy, established market	Higher cost, less dosing flexibility
Bayer/Regeneron (Eylea)	Aflibercept	~40–45%	Less frequent dosing, multiple indications	Competitive pipeline advancements
Others (Zerabev, Galapagos)	Biosimilars, emerging mAbs	Growing	Cost competitiveness	Regulatory hurdles, biosimilar acceptance

Note: Exact market share varies by region and source [5]

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Financial Trajectory and Revenue Projections

Key assumptions:

• Steady pipeline progress and expanding indications.
• Adoption continues to grow in emerging markets.
• Competitive pricing pressures and biosimilar entries remain pivotal factors.

Projected Revenue (2023–2030)

Year	Estimated Global Revenue (USD Billion)	CAGR	Remarks
2023	4.6–5.0	8–10%	Growth in developed and emerging markets
2025	6.2–6.8	12–14%	Broadening indications, pipeline launches
2030	10.0–12.0	~10%	Global adoption, biosimilar competition

Source: Market Forecasts [2,6]

Revenue Streams by Geography

Region	2022 Revenue (USD Billion)	Key Market Dynamics
North America	2.5	Largest market share; high penetration in ophthalmology, expanding in oncology
Europe	1.2	Growing uptake, reimbursement policies favoring biologics
Asia-Pacific	0.6	Rapid growth, increasing healthcare infrastructure, unmet needs
Rest of World	0.2	Emerging markets; supply chain and regulatory challenges

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Market Challenges and Risks

• Patent Expiry and Biosimilar Competition:

  • Patent expiry for aflibercept anticipated around 2028-2030 in some jurisdictions [7].
  • Biosimilars may significantly impact pricing and market share.

• Pricing Pressures and Reimbursement Policies:

  • Governments advocating for cost containment could limit pricing power.

• Regulatory and Clinical Development Risks:

  • Delays in pipeline progress or adverse outcomes could affect future revenues.

• Emergence of Novel Therapies:

  • Gene therapies and alternative modalities targeting retinal diseases could redefine the landscape.

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Future Outlook & Strategic Opportunities

Opportunity Area	Strategic Focus
Pipeline Expansion	Development of next-generation VEGF inhibitors, bispecifics
Biosimilars	Investment in biosimilar manufacturing and registration
Market Penetration	Focus on emerging markets with tailored policies
Combination Therapies	Synergistic treatments for complex diseases

Technological Trends:

• Long-acting formulations (e.g., gene therapy, sustained-release devices) to reduce injection frequency and improve compliance.
• Digital health integration for monitoring treatment outcomes.

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Conclusion: The Key Drivers of Market Dynamics

Aflibercept continues to demonstrate robust growth driven by rising disease prevalence, expanding indications, and technological advances. Strategic positioning against biosimilars, regulatory landscapes, and emerging therapies will influence future trajectory. Stakeholders must prioritize pipeline innovation, global market expansion, and cost-effectiveness to sustain growth in this evolving sector.

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Key Takeaways

• The global aflibercept market is projected to grow at a CAGR of approximately 8–10% through 2030, reaching USD 10–12 billion.
• Dominant revenue streams stem from ophthalmologic treatments, with oncology indications playing an increasingly significant role.
• Patent expirations and biosimilar entries around 2028-2030 pose competitive threats but also open opportunities for cost-based market share gains.
• Emerging markets and technological innovations in drug delivery will be pivotal for future growth.
• Strategic collaborations and pipeline investments will determine long-term dominance in the biologic anti-VEGF space.

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Frequently Asked Questions (FAQs)

Q1: When is aflibercept expected to face patent expiry, and how will biosimilars impact its market?
A1: Key patents in the US and EU are anticipated to expire around 2028-2030 [7]. Biosimilars poised for approval could introduce cost competition, eroding market share and prompting pricing adjustments.

Q2: What are the main differences between aflibercept and its competitors?
A2: Aflibercept offers less frequent dosing (every 8 weeks after initial monthly doses), broad indications (ophthalmology and oncology), and high binding affinity, positioning it favorably against competitors like ranibizumab and bevacizumab.

Q3: Which emerging markets hold the most promise for aflibercept expansion?
A3: Countries in Asia-Pacific, Latin America, and parts of Africa are experiencing rapid healthcare infrastructure growth and increasing disease burden, making them strategic targets for expansion.

Q4: How does the development pipeline influence aflibercept’s market outlook?
A4: Pipeline projects including next-generation biologics, bispecifics, and long-acting formulations could enhance therapeutic options, either supplementing or replacing aflibercept, impacting long-term revenues.

Q5: What are the key regulatory considerations for biosimilar entry into the aflibercept market?
A5: Biosimilars require demonstration of comparable efficacy, safety, and quality through extensive clinical and analytical testing, with approvals subject to regional regulatory standards, notably in the US, EU, and Asia.

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References

1. MarketsandMarkets, "Ophthalmology Drugs Market," 2022.
2. Global Data, "Biologics Market Analysis," 2022.
3. International Agency for the Prevention of Blindness (IAPB), "Age-Related Macular Degeneration Factsheet," 2021.
4. World Health Organization (WHO), "Diabetic Retinopathy Data," 2021.
5. EvaluatePharma, "Biologics Market Share Data," 2022.
6. Frost & Sullivan, "Ophthalmic Drugs Market Forecast," 2022.
7. FDA & EMA Regulatory Announcements, 2022.

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This analysis aims to provide executive-level insights for stakeholders involved in the aflibercept market, including pharmaceutical companies, investors, and healthcare policymakers.