Von willebrand factor (recombinant) - Biologic Drug Details

Summary for von willebrand factor (recombinant)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for von willebrand factor (recombinant)
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for von willebrand factor (recombinant)

Recent Clinical Trials for von willebrand factor (recombinant)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Virginia	Phase 1
Swedish Orphan Biovitrum	Phase 3
Syneos Health	Phase 3

See all von willebrand factor (recombinant) clinical trials

Recent Litigation for von willebrand factor (recombinant)

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.	2016-10-31
Network Protection Sciences, LLC v. Juniper Networks, Inc.	2012-03-06

See all von willebrand factor (recombinant) litigation

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 von willebrand factor (recombinant) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for von willebrand factor (recombinant) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for von willebrand factor (recombinant) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Recombinant Von Willebrand Factor

Introduction

Von Willebrand disease (VWD) is a common inherited bleeding disorder, and the market for its treatment is undergoing significant transformations. The introduction and expanding use of recombinant von Willebrand factor (rVWF) are key drivers of these changes. Here, we delve into the market dynamics and financial trajectory of rVWF, highlighting the current state, future projections, and factors influencing its growth.

Current Market State

The global von Willebrand disease treatment market has been growing steadily, driven by increasing disease prevalence and the introduction of novel therapies. As of 2020, the market was valued at approximately $309 million and is expected to grow significantly over the next decade[1][3].

Key Drivers of Market Growth

Several factors are driving the growth of the rVWF market:

Increasing Disease Prevalence

The diagnosed prevalence of VWD is on the rise, which is expected to fuel the demand for effective treatments. This increase in prevalence, combined with better diagnostic techniques, is expanding the patient pool for rVWF therapies[1][3].

Expanded Use of Recombinant Therapies

Recombinant von Willebrand factor, such as Vonvendi (BAX 111) and Veyvondi, has been approved for both adult and pediatric use. The expanded approval for pediatric therapies is particularly significant, as it addresses a previously undertreated segment of the patient population[1][4].

Clinical Efficacy and Safety

Studies have shown that rVWF prophylaxis can significantly reduce the frequency of treated spontaneous bleeding events in patients with severe VWD. The safety profile of rVWF has been consistent with previous findings, with no new adverse drug reactions identified. This efficacy and safety profile are crucial for market acceptance and growth[5].

Government Initiatives and Awareness

Government initiatives and awareness programs are increasing, which helps in educating both healthcare providers and patients about VWD and its treatments. This heightened awareness is expected to drive market growth by increasing the demand for recombinant therapies[3].

Financial Projections

The financial trajectory for rVWF is promising:

Market Value Projections

The global VWD treatment market is projected to expand at a compound annual growth rate (CAGR) of around 6% from 2020 to 2030, reaching a market value of approximately $900 million by the end of 2030[3].

Regional Market Growth

The US, Germany, and the UK are expected to be major markets, with the combined market size in these regions growing from $893 million in 2022 to $2.04 billion in 2032, at a CAGR of 8.6%[4].

Sales Forecasts for New Therapies

New therapies, such as the recombinant vWF for pediatric use and BT-200, an aptamer-based therapy, are forecasted to launch in the coming years. These therapies are expected to achieve significant sales, with the recombinant vWF for pediatric use projected to reach $282.98 million in sales across the major markets by 2032[4].

Economic Impact and Cost Analysis

The economic impact of using rVWF versus other treatments is significant:

Cost Savings

A cost analysis comparing plasma-derived factor VIII/von Willebrand factor (pdFVIII/VWF) with recombinant-DNA-derived factor VIII (rFVIII) showed that initiating treatment with pdFVIII/VWF in severe hemophilia A patients can offer substantial cost savings to healthcare payers, amounting to a one-third reduction in costs over a 5-year period[2].

Total Cumulative Costs

The total cumulative costs per patient over 5 years were $834,621 for pdFVIII/VWF patients and $1,237,163 for rFVIII patients, highlighting the economic benefits of using plasma-derived products in certain cases. However, the cost-effectiveness of rVWF will depend on its specific use cases and patient populations[2].

Market Segmentation

The VWD treatment market is segmented based on several factors:

Disease Type

The market is segmented into different types of VWD, with type 2M being a focus area for new therapies like BT-200[4].

Drug Type

The market includes various drug types such as desmopressin, clot-stabilizing medications, replacement therapies, and contraceptives. Recombinant vWF is gaining prominence within the replacement therapies segment[3].

Route of Administration

The route of administration is another key segment, with intravenous administration being the primary method for rVWF[3].

Competitive Landscape

The competitive landscape for VWD treatments is dynamic:

Key Players

Major players such as Octapharma AG, Grifols, S.A., Shire plc, Bayer AG, CSL Behring, Pfizer, Inc., Akorn, Inc., and Ferring B.V. are actively involved in drug development and market expansion[3].

New Entrants and Pipeline Therapies

New therapies, including BT-200 and the expanded use of recombinant vWF, are expected to enter the market, potentially disrupting the existing market share of established drugs[4].

Regulatory and Research Environment

The regulatory and research environment is supportive of market growth:

Clinical Guidelines and Research

Clinical guidelines from the World Federation of Hemophilia (WFH) and ongoing research activities are crucial for maintaining state-of-the-art treatments and developing new therapies. Efforts to refine existing therapies and gain FDA approvals are ongoing[3].

Late-Stage Pipeline Therapies

Therapies in the late-stage pipeline, such as BT-200 and the pediatric use of recombinant vWF, are expected to launch in the coming years, further boosting market growth[4].

Conclusion

The market for recombinant von Willebrand factor is poised for significant growth driven by increasing disease prevalence, expanded use of recombinant therapies, and favorable clinical efficacy and safety profiles. Financial projections indicate a substantial increase in market value, with major regions and new therapies contributing to this growth. The economic impact, market segmentation, competitive landscape, and regulatory environment all support a positive outlook for the rVWF market.

Key Takeaways

• Market Growth: The global VWD treatment market is expected to grow at a CAGR of around 6% from 2020 to 2030.
• New Therapies: Recombinant vWF for pediatric use and BT-200 are expected to launch and achieve significant sales.
• Economic Impact: Using pdFVIII/VWF can offer substantial cost savings compared to rFVIII.
• Market Segmentation: The market is segmented by disease type, drug type, and route of administration.
• Competitive Landscape: Major players are involved in drug development, and new entrants are expected to disrupt the market.

FAQs

Q: What is the projected market value of the VWD treatment market by 2030? A: The global VWD treatment market is expected to attain a market value of approximately $900 million by the end of 2030[3].

Q: Which regions are expected to drive the growth of the rVWF market? A: The US, Germany, and the UK are expected to be major markets, with the combined market size growing from $893 million in 2022 to $2.04 billion in 2032[4].

Q: What are the key drivers of the rVWF market growth? A: Increasing disease prevalence, expanded use of recombinant therapies, and favorable clinical efficacy and safety profiles are key drivers of market growth[1][3].

Q: How does the cost of rVWF compare to other treatments? A: The cost analysis shows that using pdFVIII/VWF can offer substantial cost savings compared to rFVIII, but the cost-effectiveness of rVWF depends on specific use cases and patient populations[2].

Q: What new therapies are expected to enter the VWD treatment market? A: New therapies such as BT-200 and the expanded use of recombinant vWF for pediatric use are expected to launch in the coming years[4].

Sources

1. The Evolving Market Dynamics of Factor-based Bleeding Disorders - DelveInsight[1].
2. Cost analysis of plasma-derived factor VIII/von Willebrand ... - PubMed[2].
3. Von Willebrand Disease Treatment Market - Transparency Market Research[3].
4. vWD Market Growth Driven by the Increasing Use of Recombinant ... - Pharmaceutical Technology[4].
5. Recombinant von Willebrand factor prophylaxis in patients with ... - Blood[5].