VONVENDI Drug Profile

Summary for Tradename: VONVENDI

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for VONVENDI

Recent Clinical Trials for VONVENDI

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of North Carolina	Phase 3
University of Pittsburgh	Phase 3
Duke University	Phase 3

See all VONVENDI 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. 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 VONVENDI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for VONVENDI Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for VONVENDI 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
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	10,232,015	2032-05-08	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	6,100,061	2017-06-20	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	6,114,146	2014-11-14	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	6,960,352	2021-09-12	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	9,120,873	2028-08-21	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	VONVENDI	von willebrand factor (recombinant)	For Injection	125577	9,707,269	2032-05-08	Patent claims search

Market Dynamics and Financial Trajectory for VONVENDI

Introduction to VONVENDI

VONVENDI, developed by Takeda Pharmaceutical Company Ltd, is a recombinant von Willebrand factor (VWF) used for the treatment of von Willebrand disease (VWD), a common inherited bleeding disorder. This drug has marked a significant milestone in the treatment landscape of VWD, especially with its approval for routine prophylaxis and on-demand therapy.

Market Size and Growth Projections

The von Willebrand disease market, in which VONVENDI plays a crucial role, is anticipated to experience substantial growth over the coming years. Here are some key projections:

• The global VWD market is expected to reach USD 793.55 million by 2030, growing at a compound annual growth rate (CAGR) of 6.2% from 2022 to 2030[2].
• In the major markets of the US, Germany, and the UK, the VWD market is forecasted to grow from USD 893 million in 2022 to USD 2.04 billion by 2032, at a CAGR of 8.6%[5].

Role of VONVENDI in Market Growth

VONVENDI is a key driver of this market growth due to its innovative recombinant technology:

• Approval and Expansion: VONVENDI was approved by the FDA in January 2022 for routine prophylaxis alongside on-demand therapy for patients with severe type 3 VWD. This approval has expanded its use, particularly for pediatric therapies, which is expected to raise awareness and treatment rates among undertreated patients[1][4].
• Prophylactic and On-Demand Use: The drug's efficacy in both prophylactic and on-demand treatment settings has made it a preferred choice, contributing significantly to market growth. It is forecasted to launch for pediatric use in the US by 2026 and in the EU by 2024, with projected sales of USD 282.98 million for pediatric use and a total of USD 740.15 million for both adult and pediatric use across the major markets[5].

Competitive Landscape

The VWD market is competitive, with several key players:

• Major Players: Takeda, Octapharma, CSL Behring, Grifols, S.A., and Bio Products Laboratory Ltd. are among the major companies operating in this market. These companies are engaged in continuous R&D and strategic initiatives to capture market share[4].
• Pipeline Therapies: Besides VONVENDI, other therapies like BT-200, an aptamer-based therapy, and other recombinant VWF products are in the late-stage pipeline, which will further diversify the treatment options and drive market growth[5].

Regional Market Dynamics

The regional dynamics of the VWD market are significant:

• North America: This region holds the largest market share due to the consistent focus on innovative and cost-effective drugs, as well as the increasing prevalence of VWD. The United States, in particular, has seen significant growth driven by rising incidence rates and strategic initiatives by market players[4].
• Asia Pacific: This region is expected to be the fastest-growing market, driven by increasing healthcare expenditure and growing awareness of VWD[4].

Financial Impact and Sales Projections

The financial trajectory of VONVENDI is promising:

• Sales Projections: By 2032, VONVENDI is expected to achieve significant sales, particularly with its expanded use in pediatric therapies. The total sales value for VONVENDI and other new therapies like BT-200 is forecasted to be around USD 503 million across the major markets[5].
• Market Share: The launch of VONVENDI for pediatric use and other novel therapies is expected to gain a significant market share, estimated to be around 17% by 2031, replacing some of the incumbent therapies whose patents have expired[5].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

• Awareness and Cost: The high cost of treatment and the need for more awareness about VWD are factors hindering market growth. However, increasing patient assistance programs and healthcare expenditure are expected to mitigate these challenges[4].
• Innovative Therapies: The development of novel agents, such as BT-200 and other recombinant VWF products, presents opportunities for further market expansion and improved patient outcomes[5].

Key Takeaways

• VONVENDI is a pivotal drug in the VWD treatment market, driving growth with its approval for routine prophylaxis and on-demand therapy.
• The global VWD market is projected to grow significantly, with major markets in the US, Germany, and the UK expected to reach USD 2.04 billion by 2032.
• North America holds the largest market share, while Asia Pacific is the fastest-growing region.
• The launch of VONVENDI for pediatric use and other novel therapies will significantly impact the market, gaining a substantial share by 2031.
• Challenges include high treatment costs and the need for greater awareness, but these are being addressed through patient assistance programs and increasing healthcare expenditure.

FAQs

What is the current market size of the VWD treatment market?

The VWD treatment market was valued at USD 491.87 million in 2022 and is expected to reach USD 793.55 million by 2030[2].

Who are the key players in the VWD treatment market?

Key players include Takeda Pharmaceutical Company Ltd, Octapharma AG, CSL Behring, Grifols, S.A., and Bio Products Laboratory Ltd[4].

What is the significance of VONVENDI in the VWD market?

VONVENDI is the only recombinant VWF replacement therapy approved for routine prophylaxis and on-demand therapy, significantly impacting the treatment landscape of VWD[4].

Which region is expected to grow the fastest in the VWD treatment market?

The Asia Pacific region is estimated to grow at the highest CAGR over the forecast period[4].

What are the challenges facing the VWD treatment market?

The high cost of treatment and the need for more awareness about VWD are significant challenges, although patient assistance programs and increasing healthcare expenditure are helping to address these issues[4].

Cited Sources

1. The Evolving Market Dynamics of Factor-based Bleeding Disorders - DelveInsight[1]
2. Von Willebrand Disease Market Size Worth US$ 793.55 Mn By 2030 - Reports Insights[2]
3. Biologics Market Dynamics: Setting the Stage for Biosimilars - FTC[3]
4. Von Willebrand Disease Treatment Market Size & Share Analysis - Mordor Intelligence[4]
5. vWD Market Growth Driven by the Increasing Use of Recombinant vWF - Pharmaceutical Technology[5]