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 US Inc.	Phase 4
Baxalta now part of Shire	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 the Biologic Drug: Antihemophilic Factor (Human)

Last updated: July 30, 2025

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Introduction

The antihemophilic factor (human) represents a cornerstone in the treatment of hemophilia A, a hereditary bleeding disorder characterized by deficiency of clotting factor VIII. This biologic therapy has evolved significantly over the past decades, driven by advancements in bioprocessing technologies, regulatory frameworks, and an expanding global patient base. Understanding the market dynamics and financial trajectory of this biologic provides critical insights into its current landscape and future potential.

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Market Overview

The global market for antihemophilic factor (human) is experiencing sustained growth, underpinned by increasing diagnosis rates, improved treatment accessibility, and expanding awareness. According to recent estimates, the overall market size was valued at approximately USD 1.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-6% through 2030 [1].

Key drivers include:

• Rising incidence of hemophilia: Diagnosis of hemophilia, particularly in developing regions, is improving, expanding the patient pool.
• Enhanced manufacturing and safety profile: Recombinant formulations and plasma-derived products balance efficacy with safety, broadening treatment adoption.
• Healthcare policy and reimbursement: Supportive reimbursement policies in developed countries facilitate broader access.
• Patient advocacy and awareness: Increasing patient and clinician awareness encourages early diagnosis and treatment adherence.

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Market Dynamics

Manufacturing and Supply Chain Considerations

Biologics production, especially for plasma-derived and recombinant factors, requires complex manufacturing infrastructure. The risk of plasma shortages historically affected supply stability; however, advancements in recombinant technology and plasma pooling have mitigated such risks, ensuring more reliable supply chains [2].

Regulatory Environment

Stringent regulatory pathways, such as those outlined by the FDA and EMA, require extensive clinical trial data demonstrating safety and efficacy. Recent approvals of innovative formulations, including extended half-life products, indicate a proactive regulatory stance towards improving patient outcomes [3].

Competitive Landscape

The market features established players like CSL Behring, Shire (now part of Takeda), Bayer, and Bioverativ (a Sanofi entity). The introduction of biosimilar and second-generation recombinant products increases competition, presenting both challenges and opportunities for differentiation based on efficacy, safety, and convenience [4].

Pricing and Reimbursement

Pricing strategies for antihemophilic factors are influenced by manufacturing costs, patent protections, and reimbursement policies. Developed countries often exhibit premium pricing justified by safety and efficacy, while emerging markets face pricing pressures, prompting tiered pricing models [5].

Technological Innovations

Innovations include:

• Extended half-life (EHL) products: Prolonged dosing intervals improve patient compliance and reduce treatment burden.
• Gene therapy: Emerging gene therapies promise potential cures, threatening traditional biologic sales but also opening new market segments.

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Financial Trajectory Analysis

Historical Revenue Trends

From groundbreaking plasma-derived products to recombinant formulations, revenue has steadily increased. The launch of EHL products in the late 2010s catalyzed growth, with revenue from antihemophilic factor (human) products reaching USD 1 billion globally by 2022 [1].

Forecasted Growth Factors

• Market penetration of EHL products: Expected to capture significant market share due to better patient adherence.
• Geographical expansion: Emerging markets, particularly in Asia-Pacific, are projected to exhibit higher CAGR (up to 7%), driven by urbanization and healthcare improvements.
• Pipeline innovations: Biosimilars are poised to disrupt pricing, increasing accessibility and volume sales.
• Gene therapy developments: Potential to dramatically alter market size and revenue, though commercial availability remains nascent.

Financial Risks and Opportunities

• Intellectual property expiration: Patent cliffs threaten revenue streams, prompting investments in pipeline diversification.
• Pricing pressure: Growing biosimilar adoption may compress margins.
• Regulatory risks: Delays or denials could impact revenue projections.
• Pipeline success: Approval of new therapies, especially gene therapies, offers revenue uplift but also competition.

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Market Challenges

• Access and affordability: High prices limit access in low- and middle-income countries.
• Supply chain vulnerabilities: Plasma shortages and manufacturing complexities pose risks.
• Emergence of alternative therapeutics: Gene therapy and novel modalities threaten traditional biologic dominance.
• Regulatory hurdles: Navigating evolving global standards requires strategic agility.

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Future Outlook and Strategic Implications

The trajectory of antihemophilic factor (human) remains positive, driven by technological advancement and escalating demand. Companies must prioritize innovation, geographic expansion, and strategic collaborations to capture growth opportunities and mitigate competitive threats. The convergence of biologics with gene therapy innovations suggests a transitional landscape, where traditional products may decline or evolve into adjuncts to curative treatments.

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Key Takeaways

• The global antihemophilic factor (human) market is expected to grow at a CAGR of 4-6% through 2030, reaching approximately USD 1.8-2.0 billion.
• Technological advancements, particularly extended half-life formulations, will significantly bolster revenue streams and improve patient compliance.
• Emerging markets present substantial growth opportunities, driven by increasing diagnosis and healthcare investments.
• Biosimilar competition and gene therapy innovations pose both risks and transformative opportunities.
• Strategic focus on manufacturing efficiencies, regulatory navigation, and market access will determine long-term profitability and market share.

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FAQs

1. What factors are driving growth in the antihemophilic factor (human) market?
Increased diagnosis rates, technological advances like extended half-life products, expanding access in emerging markets, and supportive healthcare policies are primary growth drivers.

2. How are biosimilars affecting the market’s financial trajectory?
Biosimilars introduce pricing competition, potentially reducing revenue margins and market share for originator companies, but they also expand overall market volume due to increased accessibility.

3. What role does gene therapy play in the future of hemophilia treatment?
Gene therapy offers the promise of a one-time curative treatment, which could significantly reduce reliance on biologic products. While still emerging, it may disrupt traditional revenue streams once commercially viable.

4. How significant is the impact of manufacturing complexity on the market?
High manufacturing complexity and supply chain risks can constrain supply, influence pricing, and increase development costs, affecting overall market stability and profitability.

5. Which regions are expected to see the fastest growth in the upcoming years?
The Asia-Pacific region is poised for rapid expansion, driven by growing awareness, improved healthcare infrastructure, and the increasing affordability of treatments.

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References

[1] Market Research Future, "Global Hemophilia Treatment Market," 2022.
[2] World Federation of Hemophilia, "Annual Global Hemophilia Report," 2022.
[3] U.S. Food and Drug Administration, "Regulatory Approaches to Hemophilia A Therapies," 2022.
[4] EvaluatePharma, "Biologics and Biosimilars in Hemophilia," 2022.
[5] IQVIA, "Healthcare Access and Pricing Dynamics," 2022.