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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aflibercept

Recent Clinical Trials for aflibercept

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
H. Lee Moffitt Cancer Center and Research Institute	Phase 2
Genzyme, a Sanofi Company	Phase 2
Aerie Pharmaceuticals	Phase 1/Phase 2

See all aflibercept clinical trials

Recent Litigation for aflibercept

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.	2024-09-24
Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.	2024-06-20
Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc.	2023-01-05

See all aflibercept litigation

PTAB Litigation

Petitioner	Date
Regeneron Pharmaceuticals, Inc. et al.	2021-04-16
Regeneron Pharmaceuticals, Inc.	2020-07-16
Regeneron Pharmaceuticals, Inc. et al.	2020-07-16

See all aflibercept litigation

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. General 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 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	10,130,681	2037-03-28	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,828,345	2038-10-12	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,888,601	2039-04-29	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11,066,458	2039-09-25	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11,084,865	2040-01-10	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11,253,572	2041-06-21	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	10,004,788	2032-05-15	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,047,096	2034-11-25	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,077,280	2036-04-22	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,086,010	2034-03-18	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,093,689	2036-04-22	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	10,106,605	2032-12-05	Patent claims search

International Patents for aflibercept

Country	Patent Number	Estimated Expiration
Slovenia	2944306
Germany	602004020474
Austria	E486091
Poland	1639007
Slovenia	2364691
World Intellectual Property Organization (WIPO)	0075319

Supplementary Protection Certificates for aflibercept

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1390020-4	Sweden		PRODUCT NAME: AFLIBERCEPT; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/12/797/001, 2012-11-22
13C0028	France		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001 20121122
300588	Netherlands		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
122013000041	Germany		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
PA2013009,C1183353	Lithuania		PRODUCT NAME: AFLIBERCEPTUM; REGISTRATION NO/DATE: EU/1/12/797/001-002 20121122
20/2013	Austria		PRODUCT NAME: AFLIBERCEPT; REGISTRATION NO/DATE: EU/1/12/797/001 UND 002 20121122

Market Dynamics and Financial Trajectory for the Biologic Drug: Aflibercept

Introduction to Aflibercept

Aflibercept, a biologic drug, is primarily used to treat various ophthalmic conditions, including neovascular age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy. It is also utilized in the treatment of metastatic colorectal cancer. The drug, marketed under the brand name EYLEA among others, has seen significant growth and is expected to continue its upward trajectory.

Market Size and Forecast

The global aflibercept market is projected to experience substantial growth over the coming years. As of 2024, the market size is estimated to be around USD 8,787.6 million, with forecasts indicating it will reach approximately USD 12,365.03 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.00% from 2024 to 2031[5].

Drivers of Market Growth

Increasing Prevalence of Ophthalmic Conditions

The rising incidence of eye diseases such as wet macular degeneration, diabetic macular edema, and diabetic retinopathy is a significant driver of the aflibercept market. According to the World Health Organization, age-related macular degeneration (AMD) affects approximately 196 million people worldwide, with over 10.4 million cases involving moderate to severe vision impairment[3].

Rising Geriatric Population

The increasing geriatric population is another key factor contributing to the growth of the aflibercept market. Older adults are more prone to eye diseases, and the advancement of therapies for these conditions is expected to drive demand for aflibercept[3].

Advancements in Therapies

Continuous research and development in the field of ophthalmology are leading to the development of novel treatments, including improved formulations of aflibercept. For instance, the introduction of EYLEA HD (aflibercept) Injection 8 mg has shown promising results with extended dosing intervals, which could drive preference over competitors and increase market share[4].

Government Support and Funding

Increased government funds and support for research and development in the healthcare sector are also boosting the market. Regions like North America and Asia-Pacific are benefiting from these initiatives, which are enhancing the availability and accessibility of aflibercept treatments[3][5].

Market Segmentation

By Type

The aflibercept market is segmented by type into prefilled syringe packages and vial packages. Each type has its own market dynamics, with prefilled syringes often preferred for their convenience and reduced risk of contamination[3].

By Application

Aflibercept is used in various applications, including wet macular degeneration, diabetic macular edema, diabetic retinopathy, and metastatic colorectal cancer. The demand for aflibercept is highest in the treatment of ophthalmic conditions due to their prevalence and the drug's efficacy[3].

By Route of Administration

The drug is administered via intravitreal injection, which is a key factor in its market growth. The intravitreal route ensures direct delivery to the eye, enhancing the drug's effectiveness in treating eye diseases[3].

By End-Users

Hospitals dominate the end-user segment of the aflibercept market due to the growing demand for the drug in these settings. Clinics, diagnostic centers, and other healthcare facilities also contribute to the market, but hospitals remain the primary users[3].

Financial Trajectory

Revenue Growth

Regeneron Pharmaceuticals, the manufacturer of EYLEA and EYLEA HD, has seen significant revenue growth driven by the sales of these drugs. In the second quarter of 2024, Regeneron's overall revenue surged by 12% year-over-year to $3.55 billion, with EYLEA and EYLEA HD contributing substantially to this growth[2].

Market Share Potential

The extended dosing intervals of EYLEA HD could drive preference over competitors, potentially increasing Regeneron's market share in the DME treatment segment. This could lead to broader adoption and offset any potential reduction in revenue due to fewer injections per patient[4].

Cost Efficiency

Reduced treatment frequency with EYLEA HD may lower healthcare system costs, making the drug more attractive to payers and potentially expanding access. This cost efficiency is a financial advantage that could further boost the market trajectory of aflibercept[4].

R&D Investments

Regeneron's successful long-term data for EYLEA HD validates the company's R&D investments in ophthalmology, supporting investor confidence in the company's pipeline. This validation is crucial for sustaining long-term growth and innovation in the biopharmaceutical sector[4].

Geographical Trends

North America

North America holds a significant market share, driven by the presence of major key players, high prevalence rates of eye diseases, and well-developed healthcare sectors. The region's market size was estimated at USD 3,515.04 million in 2024 and is expected to grow at a CAGR of 3.2% from 2024 to 2031[5].

Asia-Pacific

The Asia-Pacific region is expected to grow at the highest CAGR during the forecast period due to increasing awareness of eye diseases, rising healthcare expenditures, and government initiatives to improve healthcare access and infrastructure. Rapid urbanization and an expanding aging population are also driving demand for effective treatments in this region[3][5].

Key Financial Metrics

• Revenue: The global aflibercept market is projected to reach USD 12,365.03 million by 2031.
• CAGR: Expected to grow at a CAGR of 5.00% from 2024 to 2031.
• Market Share: North America holds over 40% of the global revenue, while Asia-Pacific is expected to grow at the highest rate[5].

Quotes from Industry Experts

"Regeneron had a strong quarter, with total revenue up 12%, driven by notable growth for EYLEA HD, Dupixent, and Libtayo. Importantly, Dupixent was granted its first regulatory approval for COPD by the European Commission, with FDA action anticipated in the third quarter, presenting an opportunity to help even more patients around the globe." - Leonard S. Schleifer, M.D., Ph.D., President and CEO of Regeneron[2].

Illustrative Statistics

• Prevalence of AMD: Affects approximately 196 million people worldwide, with over 10.4 million cases involving moderate to severe vision impairment[3].
• Dosing Intervals: 88% of EYLEA HD patients maintained ≥12-week dosing intervals at week 156, and 48% achieved ≥20-week intervals[4].
• Revenue Growth: Regeneron's overall revenue surged by 12% year-over-year to $3.55 billion in Q2 2024[2].

Safety and Efficacy

The safety data for EYLEA HD remains consistent with the known safety profiles of both EYLEA HD and EYLEA. The drug has demonstrated sustained visual gains and anatomic improvements, supporting its long-term efficacy in treating diabetic macular edema[4].

Conclusion

The aflibercept market is poised for significant growth driven by increasing prevalence of ophthalmic conditions, advancements in therapies, and government support. Regeneron's financial trajectory, particularly with the success of EYLEA HD, indicates a strong market position and potential for further growth.

Key Takeaways

• Market Growth: The global aflibercept market is expected to grow at a CAGR of 5.00% from 2024 to 2031.
• Revenue: Projected to reach USD 12,365.03 million by 2031.
• Geographical Trends: North America and Asia-Pacific are key regions driving market growth.
• Drivers: Increasing prevalence of eye diseases, rising geriatric population, and advancements in therapies.
• Financial Metrics: Regeneron's revenue surged by 12% year-over-year in Q2 2024, driven by EYLEA HD and other key products.

FAQs

What is the primary use of aflibercept?

Aflibercept is primarily used to treat neovascular age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy, as well as metastatic colorectal cancer.

What is the expected market size of aflibercept by 2031?

The global aflibercept market is expected to reach approximately USD 12,365.03 million by 2031[5].

Which region is expected to grow at the highest CAGR?

The Asia-Pacific region is expected to grow at the highest CAGR during the forecast period due to increasing awareness of eye diseases and rising healthcare expenditures[3][5].

What are the key drivers of the aflibercept market?

Key drivers include the increasing prevalence of ophthalmic conditions, rising geriatric population, advancements in therapies, and government support for research and development[3].

How does EYLEA HD impact the market?

EYLEA HD's extended dosing intervals could drive preference over competitors, potentially increasing Regeneron's market share and offsetting any reduction in revenue due to fewer injections per patient[4].

What is the safety profile of EYLEA HD?

The safety data for EYLEA HD remains consistent with the known safety profiles of both EYLEA HD and EYLEA, demonstrating sustained visual gains and anatomic improvements[4].

Sources

1. Market Research Intellect: Aflibercept Drug Sales Market Size And Forecast[1].
2. Regeneron Pharmaceuticals: Regeneron Announces Q2 2024 Financial and Operating Results[2].
3. Data Bridge Market Research: Global Aflibercept Market – Industry Trends and Forecast to 2030[3].
4. Stock Titan: Three-year Results for EYLEA HD® (aflibercept) Injection 8 mg[4].
5. Cognitive Market Research: Global Aflibercept Market Report[5].