Von willebrand factor/coagulation factor viii complex (human) - Biologic Drug Details

Summary for von willebrand factor/coagulation factor viii complex (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for von willebrand factor/coagulation factor viii complex (human)

Recent Clinical Trials for von willebrand factor/coagulation factor viii complex (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Johns Hopkins Aramco Healthcare	PHASE3
Imam Abdulrahman Bin Faisal University	PHASE3
BeiGene	PHASE2

See all von willebrand factor/coagulation factor viii complex (human) clinical trials

Pharmacology for von willebrand factor/coagulation factor viii complex (human)

Physiological Effect	Increased Coagulation Activity Increased Platelet Aggregation
Established Pharmacologic Class	Human Antihemophilic Factor Human Blood Coagulation Factor
Chemical Structure	Blood Coagulation Factors Factor VIII von Willebrand Factor

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 von willebrand factor/coagulation factor viii complex (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for von willebrand factor/coagulation factor viii complex (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
Octapharma Pharmazeutika Produktionsges.m.b.h.	WILATE	von willebrand factor/coagulation factor viii complex (human)	For Injection	125251		2034-04-18	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	WILATE	von willebrand factor/coagulation factor viii complex (human)	For Injection	125251		2036-10-06	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	WILATE	von willebrand factor/coagulation factor viii complex (human)	For Injection	125251		2038-07-24	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	WILATE	von willebrand factor/coagulation factor viii complex (human)	For Injection	125251		2027-08-10	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	WILATE	von willebrand factor/coagulation factor viii complex (human)	For Injection	125251		2026-04-05	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for von willebrand factor/coagulation factor viii complex (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

International Patents for von willebrand factor/coagulation factor viii complex (human)

Country	Patent Number	Estimated Expiration
South Korea	102720834
Spain	2950570
Japan	2008113663
Spain	2620359
China	108290845

Supplementary Protection Certificates for von willebrand factor/coagulation factor viii complex (human)

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C 2016 020	Romania		PRODUCT NAME: ALEMTUZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/13/869; DATE OF NATIONAL AUTHORISATIOST AUTHORISATION IN EEA: 20130912 N: 20130912; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/869; DATE OF FIR
C20160023	Finland
PA2016019,C2066352	Lithuania		PRODUCT NAME: ALEMTUZUMABAS; REGISTRATION NO/DATE: EU/1/13/869 20130912
122016000041	Germany		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 20130912
300816	Netherlands		PRODUCT NAME: ALEMTUZUMAB; REGISTRATION NO/DATE: EU/1/13/869 20130916

Market Dynamics and Financial Trajectory for the Biologic Drug: Von Willebrand Factor/Coagulation Factor VIII Complex (Human)

Last updated: July 29, 2025

Introduction

The biologic combination of von Willebrand factor (vWF) and coagulation factor VIII (FVIII) represents a critical therapeutic intervention in managing von Willebrand disease (VWD) and hemophilia A. As both disorders primarily affect bleeding mechanisms, the development, commercialization, and adoption of vWF/FVIII complexes shape a dynamic pharmaceutical landscape. This article explores the market drivers, competitive forces, regulatory environment, and financial prospects of this biologic product, offering insights essential for stakeholders and investors.

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Market Overview

Von Willebrand Disease (VWD) and hemophilia A are inherited bleeding disorders primarily caused by deficiencies in vWF and FVIII, respectively. Hemophilia A affects approximately 1 in 5,000 male births globally, while VWD is more prevalent, affecting up to 1% of the population depending on severity (1). The biologic combination of vWF and FVIII offers a recombinant or plasma-derived therapeutic option, restoring deficiency and normalizing bleeding risk.

Historically, therapeutic options have included plasma-derived concentrates and recombinant products. Recently, the emphasis has shifted towards more effective, safer, and longer-acting formulations, impacting the market landscape significantly (2).

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Market Drivers

1. Rising Prevalence and Improved Diagnosis

Increasing awareness and advanced diagnostic capabilities have led to higher detection rates for VWD and hemophilia A (3). Early diagnosis facilitates timely treatment, expanding the patient base eligible for vWF/FVIII therapy.

2. Advances in Biologic Technologies

Innovations such as recombinant technology and improved purification processes have enhanced product safety and efficacy, driving adoption (4). The development of plasma-free recombinant complexes reduces pathogen transmission risk, boosting confidence among clinicians and patients.

3. Therapeutic Innovation and Extended Half-Life Products

Next-generation formulations with extended half-life (EHL) capabilities enable less frequent dosing, improving patient adherence and reducing healthcare costs (5). These innovations foster competitive differentiation and growth.

4. Favorable Regulatory Environment

Regulatory agencies, including the FDA and EMA, have streamlined approval pathways for breakthrough therapies and biosimilars, simplifying market entry for novel vWF/FVIII products (6).

5. Growing Patient and Healthcare System Demand

An aging population and increased healthcare spending globally sustain the demand for effective bleeding disorder treatments. Healthcare systems’ emphasis on reducing hospitalizations from bleeding episodes further boosts demand for prophylactic therapies (7).

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Competitive Landscape

Major players include CSL Behring, Shire (Takeda), Baxter, and emerging biotech firms advancing biosimilar and biosuperior formulations. Their strategic focus centers on:

• Developing long-acting therapeutics for better compliance.
• Enhancing safety profiles through recombinant and plasma-free products.
• Expanding geographic reach, especially in emerging markets with rising healthcare infrastructure (8).

The entry of biosimilars and biobetters introduces pricing pressures, potentially transforming the financial landscape by increasing accessibility and reducing costs.

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Regulatory and Reimbursement Factors

Regulatory approval processes focus on demonstrating biosimilarity, safety, and efficacy. The pathway for biosimilar vWF/FVIII may offer accelerated routes, reducing time-to-market (9). Conversely, reimbursement policies vary greatly by region; nations prioritizing cost-effective care may impose strict pricing controls, impacting revenue trajectories (10).

The increasing prevalence of biosimilar vWF/FVIII could challenge established brands' market shares but may also create opportunities for cost leadership and expanded access.

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Financial Trajectory and Revenue Forecasts

The global hemophilia therapeutics market, valued at approximately $10 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 5-7% over the next five years (11). A similar trend applies to vWF/FVIII complexes, driven by:

• Market Penetration of Extended Half-Life Products: These are anticipated to account for over 50% of new prescriptions by 2025, providing a significant revenue boost (12).

• Geographical Expansion: Emerging markets such as China and India are witnessing rapid growth, driven by expanding healthcare infrastructure and increasing diagnosis rates (13). These markets present both opportunities and challenges in price sensitivity and regulatory approval pipelines.

• Product Innovation and Pipeline Developments: Next-generation formulations, gene therapies, and personalized medicine approaches could disrupt traditional revenue streams, either through direct competition or by improving treatment outcomes—thus, extending market lifespan.

Financial Risks and Opportunities

While the market exhibits robustness, factors such as high R&D costs, manufacturing complexities, and regulatory hurdles pose risks. Pricing pressures from biosimilar competition and healthcare payers' emphasis on cost containment threaten profit margins.

Conversely, partnerships, licensing agreements, and strategic investments in pipeline candidates could amplify growth. Multibillion-dollar valuations for specialized hemophilia therapies reflect the high-value potential of novel vWF/FVIII complexes (14).

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Impact of Biologic and Market Trends

The wave of biologic innovations—such as gene therapies and non-factor products—may reshape the vWF/FVIII landscape. Gene therapies that potentially offer lifelong correction could markedly reduce reliance on replacement therapies, impacting revenue forecasts for traditional biologics. Yet, the current pipeline indicates that biologic complexes will remain relevant for at least the next decade, especially as they serve acute and prophylactic needs.

Furthermore, real-world evidence and pharmacoeconomic studies emphasizing long-term cost savings will influence reimbursement eligibility, affecting the financial trajectory of vWF/FVIII products.

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Conclusion

The biologic drug combining von Willebrand factor and coagulation factor VIII stands at the intersection of technological innovation, evolving regulatory standards, and expanding global markets. The market is characterized by steady growth driven by increased diagnosis, improved treatment modalities, and emerging markets. However, pricing pressures, biosimilar competition, and the advent of alternative therapies introduce complexity into its financial outlook.

Executives and investors should monitor regulatory developments, technological advances, and market expansion opportunities, especially in emerging regions. Strategically, differentiation through long-acting formulations and enhanced safety profiles remains critical to capturing and sustaining market share.

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Key Takeaways

• The global vWF/FVIII market is projected to grow at a CAGR of 5-7%, driven by increased diagnosis, innovation, and expanding markets.
• Biologics with extended half-life formulations are key growth drivers due to improved patient adherence and reduced treatment burden.
• Biosimilar entry and healthcare cost containment policies may pressure pricing, demanding strategic agility.
• Emerging markets present significant growth opportunities, requiring tailored regulatory and operational strategies.
• Advancements in gene therapy and non-factor treatments will influence long-term revenue streams for traditional biologics within the next decade.

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FAQs

1. What factors influence the pricing of vWF/FVIII biologics?
Pricing depends on manufacturing complexity, patent status, regulatory approval, competition from biosimilars, and healthcare reimbursement policies. Innovations like extended half-life formulations also justify premium pricing.

2. How will biosimilars impact the market for vWF/FVIII products?
Biosimilars may reduce prices and increase accessibility, pressuring established brands. They can expand market share but may also lead to pricing consolidation and reduced profit margins.

3. What is the role of gene therapy in the future of bleeding disorder treatments?
Gene therapy offers potential lifelong correction of hemophilia A and VWD, possibly replacing replacement therapies. However, widespread adoption depends on long-term safety, efficacy, and cost-effectiveness, which are still under evaluation.

4. Which emerging markets offer the most growth potential for vWF/FVIII biologics?
China, India, and Brazil stand out due to expanding healthcare infrastructure, increased awareness, and high prevalence, making them attractive for market entry despite regulatory and pricing challenges.

5. How do regulatory pathways for biosimilars differ across regions?
Regions like the US and Europe have established biosimilar approval processes emphasizing comparability and pharmacovigilance. Emerging markets may have less defined pathways, potentially leading to delays or additional requirements.

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References

[1] National Hemophilia Foundation. "World Prevalence Data."2022.

[2] Hoots, K., et al. "Hemophilia and Von Willebrand Disease: Advances in Diagnosis and Management." Blood Reviews, 2020.

[3] Soucie, J.M., et al. "Worldwide Prevalence of Bleeding Disorders." Blood, 2018.

[4] Peyvandi, F., et al. "Recombinant vs. Plasma-Derived FVIII: Comparative Safety." Hematology, 2019.

[5] Lu, H., et al. "Extended Half-Life Hemophilia Treatments." J Thromb Haemost, 2021.

[6] European Medicines Agency. "Regulatory Pathways for Biologics." 2022.

[7] Peyvandi, F., et al. "Economic Impact of Bleeding Disorders." Orphanet Journal of Rare Diseases, 2018.

[8] MarketWatch. "Leading Companies in Hemophilia Therapeutics." 2022.

[9] FDA Guidance. "Biosimilar Development." 2021.

[10] World Health Organization. "Pricing and Reimbursement Policies." 2020.

[11] Grand View Research. "Hemophilia Market Size & Trends." 2022.

[12] IQVIA. "Extended Half-Life Hemophilia Products Outlook." 2021.

[13] Deloitte. "Emerging Markets Healthcare Trends." 2022.

[14] EvaluatePharma. "Valuations of Hemophilia Therapies." 2022.