Antihemophilic factor (human) - Biologic Drug Details

Summary for antihemophilic factor (human)

Tradenames:	3
High Confidence Patents:	0
Applicants:	3
BLAs:	3
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for antihemophilic factor (human)

Recent Clinical Trials for antihemophilic factor (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Baxalta Innovations GmbH, now part of Shire	Phase 4
Baxalta now part of Shire	Phase 4
Baxalta US Inc.	Phase 4

See all antihemophilic factor (human) clinical trials

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 (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for antihemophilic factor (human) 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 Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953		1987-03-31	DrugPatentWatch analysis and company disclosures
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953		1996-01-30	DrugPatentWatch analysis and company disclosures
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953		1996-09-18	DrugPatentWatch analysis and company disclosures
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953		1998-07-10	DrugPatentWatch analysis and company disclosures
Csl Behring Llc	MONOCLATE, MONOCLATE-P	antihemophilic factor (human)	For Injection	103953		2000-05-07	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for antihemophilic factor (human) 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
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130		2034-03-11	Patent claims search
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130		2039-05-01	Patent claims search
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130		1995-05-01	Patent claims search
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130		2019-11-23	Patent claims search
Grifols Therapeutics Llc	KOATE, KOATE-DVI	antihemophilic factor (human)	For Injection	101130		2019-08-17	Patent claims search

Market Dynamics and Financial Trajectory for Antihemophilic Factor (Human)

Last updated: February 16, 2026

Overview

Antihemophilic factor (human), also known as clotting factor VIII (FVIII), is a biologic used to treat hemophilia A. The global market has experienced significant growth driven by increasing prevalence, advancements in treatment options, and evolving healthcare policies. The financial outlook indicates sustained expansion, with key drivers including rising diagnosis rates, product launches, and policy shifts favoring biologic therapies.

Market Size and Growth

Global Market Valuation

The antihemophilic factor (human) market was valued at approximately USD 1.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 4.5% from 2023 to 2030, reaching nearly USD 2.3 billion by 2030.

Factors Influencing Growth

• Prevalence of Hemophilia A: An estimated 1 in 5,000 male births worldwide[1].
• Diagnosis and Treatment Penetration: Underdiagnosis remains a challenge, especially in developing countries, but standardization of screening protocols improves access.
• Advancement in Formulations: Enhanced purity, stability, and ease of infusion increase patient adherence.
• Shift to Plasma-Derived Products: Despite competition from recombinant therapies, plasma-derived FVIII still accounts for roughly 20-25% of the market, especially in regions with limited infrastructure.

Competitive Landscape

Key Players

Company	Product	Market Share (2022)	Region Focus
CSL Behring	Koate-DVI, Hemofil M	40%	Global (esp. emerging)
Pfizer	Xyntha, ReFacto AF	25%	North America, Europe
Bayer	Kogenate FS, Kovaltry	15%	Europe, Asia-Pacific
Octapharma	Octanate, Norditropin	10%	Europe, Latin America

Market Entry and Innovation

• Recombinant Products: Outperform plasma-derived FVIII due to safety and consistency.
• Gene Therapy Development: Several candidates in late-stage trials aim to reduce dependency on repeated infusions, potentially disrupting the traditional market.

Regulatory and Policy Environment

Key Policies

• The US FDA approves biologics under the Biologics Price Competition and Innovation Act (BPCIA), fostering biosimilar entry.
• In Europe, the EMA manages approvals, with some countries enabling early access programs for innovative therapies.

Pricing and Reimbursement

• High treatment costs (~USD 200,000 annually per patient) influence market access and reimbursement policies.
• Payors increasingly favor value-based pricing models, especially for long-acting or gene therapies.

Innovation and R&D Trends

Extended Half-life Products

• Biologics like Eloctate (rFVIIIFc) extend half-life from 12 hours to 18-20 hours, improving dosing frequency.
• These products capture higher market share due to convenience and adherence, potentially commanding premiums.

Gene Therapy

• Multiple candidates (e.g., BioMarin's valoctocogene roxaparvovec) aim to offer a one-time treatment.
• Regulatory filings expected in mid-2023, with commercial availability projected by 2024-2025 in select markets.

Biosimilars

• Several biosimilars are under development to reduce costs, especially in regions with price-sensitive markets.

Financial Trajectory and Investment Outlook

Revenue Breakdown

Segment	Revenue (2022)	CAGR (2023-2030)	Notes
Plasma-derived FVIII	USD 375 million	2%	Stable, niche in specific regions
Recombinant FVIII	USD 1.0 billion	5%	Dominant segment, innovation-driven
Biosimilars	USD 125 million	10%	Growing due to cost pressure
Gene therapies	USD 50 million	50% (projected)	Rapid growth expected as approvals occur

Investment Considerations

• Major companies are allocating R&D budgets exceeding USD 500 million annually.
• Market expansion in emerging economies presents long-term growth potential.
• Shifts toward gene therapy may alter revenue streams, requiring adaptation for existing manufacturers.

Challenges and Risks

• Pricing Pressures: Heightened scrutiny from payors could limit revenue growth.
• Manufacturing Complexity: Biologics require sophisticated facilities, posing supply chain risks.
• Regulatory Hurdles: Approvals for novel therapies, especially gene therapy, involve lengthy, costly processes.
• Market Penetration: Limited access in low-income regions constrains global growth.

Key Takeaways

• The global antihemophilic factor (human) market is poised for moderate growth, driven by new formulations, biosimilars, and emerging gene therapies.
• Recombinant products dominate due to safety profiles, but plasma-derived FVIII remains relevant in certain markets.
• R&D investments aim toward long-acting formulations and curative therapies, which could redefine market dynamics.
• Pricing and reimbursement policies influence market access and profitability.
• Emerging markets and biosimilars offer significant growth opportunities amid competitive pressures and regulatory challenges.

FAQs

1. How will gene therapy impact the market for antihemophilic factor (human)?
Gene therapy offers a potential cure, reducing the need for repeated infusions. Its approval could shift revenue away from traditional biologics, prompting existing companies to diversify development portfolios.

2. What are the main barriers to market expansion in low-income countries?
High treatment costs, limited healthcare infrastructure, and low diagnosis rates restrict growth. International aid programs and biosimilars could address some access issues.

3. Which companies lead in innovation within this market?
Pfizer, BioMarin, and Bioverativ (a Sanofi division) focus heavily on gene therapy and extended half-life biologics, leading innovation efforts.

4. How do pricing pressures affect revenue projections?
Payor pushback and policy shifts toward value-based pricing are likely to cap prices, especially for older plasma-derived products, but premium pricing is reserved for advanced biologics.

5. When are significant regulatory approvals expected for new therapies?
BioMarin's gene therapy, valoctocogene roxaparvovec, aims for FDA approval in late 2023, with market entry anticipated in 2024.

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Citations

[1] World Federation of Hemophilia. "Global Hemophilia Report 2022."