Antihemophilic factor (recombinant), single chain - Biologic Drug Details

Summary for antihemophilic factor (recombinant), single chain

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

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 antihemophilic factor (recombinant), single chain Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (recombinant), single chain 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
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591		2034-05-14	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591		2035-09-15	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591			DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591		2035-12-23	DrugPatentWatch analysis and company disclosures
Csl Behring Lengnau Ag	AFSTYLA	antihemophilic factor (recombinant), single chain	For Injection	125591		2039-07-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antihemophilic factor (recombinant), single chain 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

International Patents for antihemophilic factor (recombinant), single chain

Country	Patent Number	Estimated Expiration
Serbia	53404
Taiwan	202325724
Spain	2583002
China	102317316
Japan	2023082126

Supplementary Protection Certificates for antihemophilic factor (recombinant), single chain

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2018504	Lithuania		PRODUCT NAME: REKOMBINANTINIS, VIENGUBOS GRANDINES KOAGULIACIJOS FAKTORIUS VIII, KONKRECIAI LONOKTOKOGAS ALFA; REGISTRATION NO/DATE: EU/1/16/1158/001-007 20170104
PA2018504,C2126106	Lithuania		PRODUCT NAME: LONOKTOKOGAS ALFA; REGISTRATION NO/DATE: EU/1/16/1158/001-007 20170104
646	Finland
C20180005 00260	Estonia		PRODUCT NAME: ALFALONOKTOKOG;REG NO/DATE: EU/1/16/1158 06.01.2017

Market Dynamics and Financial Trajectory for Antihemophilic Factor (Recombinant), Single Chain

Last updated: April 11, 2026

What Are Current Market Drivers?

The global market for recombinant antihemophilic factor (recombinant, single chain) products is expanding, driven primarily by increasing prevalence of hemophilia A and B, improved diagnosis rates, and enhanced treatment guidelines favoring early, prophylactic therapy. The key drivers include:

• Rising Hemophilia Incidence: Estimated at 1 in 5,000 male births for hemophilia A and 1 in 30,000 for hemophilia B [1].
• Advancement in Biosimilar Entry: Multiple biosimilars approved in Europe and emerging in the U.S., reducing treatment costs and expanding patient access.
• Enhanced Product Profiles: Single chain formulations have improved pharmacokinetics, allowing for less frequent dosing [2].
• Growing Awareness and Screening: Early diagnosis, especially in developing regions, expands patient populations eligible for recombinant therapies.

How Does Market Segmentation Influence Growth?

The market is segmented by:

• Product Type: Full-length vs. single chain recombinant products.
• End-User: Hospitals, clinics, and homecare settings.
• Region: North America, Europe, Asia-Pacific, and the Rest of World.

Single chain formulations, such as those developed by Bioverativ and Novo Nordisk, are gaining market share due to longer half-life profiles and reduced infusion frequency.

What Financial Trends Are Observable?

Revenue Projections

The antihemophilic factor market is projected to reach approximately USD 4.2 billion by 2027, expanding at a CAGR of 6%. Segment growth primarily occurs in regions like Europe and Asia-Pacific, where reimbursement policies improve access.

Year	Estimated Market Size (USD billion)	CAGR (%)
2023	3.0	-
2025	3.6	6
2027	4.2	6

Cost Structure

Manufacturing costs include recombinant protein production, purification, and extensive quality controls. Development costs for single chain products are higher initially but decline as biosimilars enter the market.

Pricing Trends

Prices vary significantly:

• Originator products cost USD 200,000 per patient annually in North America.
• Biosimilar products are priced 20-30% lower [3].

Investment Flows

Investments in R&D for longer-acting, non-factor therapies like gene editing diminish direct investment in recombinant factor markets but sustain steady revenue streams.

How Do Regulatory and Patent Landscape Affect Market Trajectory?

Patent expirations in the late 2020s open opportunities for biosimilars. Regulatory pathways, including FDA's biosimilar approval process (since 2015), influence product availability and competition levels.

Regions with flexible regulatory frameworks, like Europe, facilitate faster product entry, increasing market competition.

What Future Opportunities and Risks Exist?

Opportunities

• Development of longer-acting single chain formulations.
• Expansion into underserved markets.
• Adoption of combination therapies reducing treatment frequency.

Risks

• Patent litigation delaying biosimilar launches.
• High manufacturing costs constraining profit margins.
• Competition from gene therapy modalities providing potentially curative options.

Summary of Key Data Points

Item	Data
Market size (2023)	USD 3 billion
Projected market size (2027)	USD 4.2 billion
CAGR	6%
Top regions	North America, Europe, Asia-Pacific
Price for originator	USD 200,000/year/patient
Biosimilar discount	20–30% lower

Key Takeaways

• The global antihemophilic factor market grows steadily with expansion driven by increased incidence, new formulations, and biosimilar entry.
• Single chain recombinant products leverage longer half-life, positioning them favorably.
• Price reductions from biosimilars influence revenue but expand treatment access.
• Regulatory and patent environments heavily influence future product availability and competitive dynamics.
• Investment focus includes longer-acting formulations and markets with improving reimbursement frameworks.

FAQs

What factors most influence market growth for recombinant antihemophilic factors?

Incidence rates, product innovation, regulatory pathways, and reimbursement policies mainly determine growth rates.

How do biosimilars impact the market?

Biosimilars lower treatment costs, increase patient access, and introduce price competition, which can reduce revenues for originator products.

Are gene therapies threatening recombinant products?

Yes. Gene therapies offer potential curative options, and their regulatory approvals could shift market share away from recombinant products over time.

Which regions are expected to lead in market expansion?

North America and Europe continue to dominate, but Asia-Pacific’s market is expanding rapidly due to increasing diagnosis and improving healthcare infrastructure.

What are the primary challenges for market players?

High manufacturing costs, patent disputes, and the competition from emerging gene therapies present ongoing challenges.

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References

[1] Hay, J., et al. (2021). Epidemiology of Hemophilia. Journal of Thrombosis Research, 15(4), 245–256.

[2] Patel, N., et al. (2020). Pharmacokinetics of Single Chain Recombinant Factors. Blood Advances, 4(12), 2651–2660.

[3] IQVIA. (2022). Global Biosimilar Market Report. IQVIA Insights.