Von Willebrand Disease Market Outlook to 2034: Expanded FDA Approval of Takeda's VONVENDI Strengthens Treatment Landscape | DelveInsight

DelveInsight's latest report, "Von Willebrand Disease (VWD) - Market Insight, Epidemiology, and Market Forecast - 2034," highlights how evolving therapies, regulatory milestones, and competition are shaping the VWD market across the 7MM (the US, EU4, the UK, and Japan). Alongside Takeda's VONVENDI, companies such as Band Therapeutics, TagCyx Biotechnologies, China Biologic Products, Thrombotargets Corporation, and Sanofi are driving innovation in the rare bleeding disorders landscape.
On September 5, 2025, Takeda announced that the FDA approved an expanded label for VONVENDI, broadening its use to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with Type 1 and 2 VWD, as well as on-demand and perioperative management of bleeding in pediatric patients. This milestone makes VONVENDI the only recombinant von Willebrand factor (rVWF) replacement therapy with approved indications in both adults and children with VWD, reinforcing its differentiated position in a rare bleeding disorder space long dominated by plasma-derived products.

The expansion is expected to significantly impact treatment practices by offering physicians a recombinant alternative that reduces reliance on plasma-derived therapies, addressing long-standing safety and supply challenges. Moreover, the pediatric approval underscores a growing focus on comprehensive disease management across age groups, which may influence treatment algorithms, payer decisions, and patient outcomes.

Against this backdrop, DelveInsight's Von Willebrand Disease (VWD) - Market Insight, Epidemiology, and Market Forecast - 2034 [https://www.delveinsight.com/report-store/von-willebrand-disease-vwd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr] report provides an in-depth analysis of epidemiology trends, therapeutic adoption, and the evolving competitive landscape. With the VWD market poised for steady growth driven by innovative therapies and broader patient coverage, stakeholders are entering a transformative period where regulatory decisions and clinical advancements will shape future opportunities.

Key Insights into the Von Willebrand Market

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The Von Willebrand market size across the 7MM is expected to witness steady growth through 2034.

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The growth of the Von Willebrand Disease market is driven by multiple factors, including a rising prevalence, advancements in research, improved diagnostic testing, and the introduction of novel systemic therapies.

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In 2023, the US had ~13K diagnosed prevalent cases of Von Willebrand Disease, with numbers expected to rise through 2034.

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Females made up ~55% of cases in 2023, totaling over 7K.

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In September 2025, the FDA approved Takeda's sBLA for VONVENDI (recombinant von Willebrand factor), expanding its use to include routine prophylaxis in adults with Type 1 and 2 VWD, and on-demand/perioperative treatment in pediatric patients. Previously approved for limited adult use, VONVENDI is now the only recombinant VWF therapy approved for both adults and children with VWD.

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In August 2025, insights from the "Bleeding Disorders Care" sessions highlighted innovative approaches being explored for bleeding disorders, notably including studies on emicizumab, a bispecific antibody originally for hemophilia A, now under investigation for potential use in severe VWD-offering a novel therapeutic angle beyond factor replacement

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In January 2025, Star Therapeutics, a clinical-stage biotechnology company focused on developing best-in-class antibodies, announced that the FDA granted Fast Track designation for VGA039 in the treatment of von Willebrand disease (VWD).

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Several promising Von Willebrand pipeline therapies are under development, including VGA039 and others, which aim to address unmet needs such as treatment durability and efficacy in non-responders.

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A diverse pool of players, including Band Therapeutics, TagCyx Biotechnologies, China Biologic Products, Thrombotargets Corporation, Sanofi, Frequently A, and others are actively contributing to the innovation within the Von Willebrand market landscape.

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Advancements in genetic testing and proteomics present a significant opportunity for earlier and more accurate diagnosis of von Willebrand Disease, helping to overcome current challenges caused by often mild and easily overlooked symptoms.

Request a sample and uncover the latest breakthroughs shaping the Von Willebrand market landscape and future outlook [https://www.delveinsight.com/report-store/von-willebrand-disease-vwd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr].

What's New in the Von Willebrand Treatment Market?

On September 5, 2025, Takeda (TSE:4502/NYSE:TAK) announced that the FDA approved a supplemental Biologics License Application (sBLA) for VONVENDI [recombinant von Willebrand factor], expanding its use in the von Willebrand disease (VWD) treatment landscape.

VONVENDI is now approved for:

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Routine prophylaxis in adults with Type 1 and 2 VWD

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On-demand and perioperative bleeding management in pediatric patients

This makes VONVENDI the only recombinant von Willebrand factor (rVWF) therapy approved for both adults and children with VWD, strengthening its position in the VWD treatment market.

VONVENDI, an infused replacement therapy for missing or defective VWF, has a long half-life (22.6 hours in adults, 14.3 hours in children). In clinical trials, most bleeds were managed with a single infusion in both adults and children.

The expanded approval is backed by three Phase 3 trials (NCT02973087, NCT02932618, NCT03879135) and real-world evidence, further supporting VONVENDI's clinical profile in the VWD market.

Takeda has also submitted regulatory applications in Japan and the EU for expanded pediatric indications under the brand names VONVENDI and VEYVONDI (vonicog alfa), signaling continued growth in the global VWD treatment landscape.

Von Willebrand Overview

Von Willebrand Disease (VWD) is the most common inherited bleeding disorder, caused by a deficiency or dysfunction of von Willebrand factor (VWF), a protein essential for normal blood clotting. It is classified into three main types: Type 1 (partial quantitative deficiency), Type 2 (qualitative defects), and Type 3 (near-complete or complete deficiency), with Type 1 being the most prevalent. Symptoms vary from mild to severe and include frequent nosebleeds, easy bruising, heavy menstrual bleeding, and prolonged bleeding after injury or surgery. While many cases are mild and may go undiagnosed, more severe forms require medical management.

Diagnosis of VWD involves a combination of clinical assessment, family history, and specialized blood tests to evaluate clotting function and VWF levels. Treatment depends on the type and severity of the disease and may include desmopressin (DDAVP), antifibrinolytics, or VWF replacement therapies such as recombinant products. Advances in diagnostic tools and therapeutic options, including routine prophylaxis and targeted recombinant therapies, are improving disease management and patient outcomes, especially for those with moderate to severe forms of VWD.

Get a free sample for the Von Willebrand market forecast, size & share analysis report: https://www.delveinsight.com/report-store/von-willebrand-disease-vwd-market [https://www.delveinsight.com/report-store/von-willebrand-disease-vwd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr]

Von Willebrand Epidemiology

The epidemiology section offers an overview of historical, current, and projected trends in the seven major markets (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends.

Von Willebrand Epidemiology Segmentation:

The Von Willebrand market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:

- Total Diagnosed Prevalent Population of Von Willebrand Disease

- Gender-Specific Diagnosed Prevalent Population of Von Willebrand Disease

- Type-Specific Diagnosed Prevalent Population of Von Willebrand Disease

- Age-Specific Diagnosed Prevalent Population of Von Willebrand Disease

Drugs Uptake & Pipeline Development Activities in Von Willebrand

The Von Willebrand Disease market is entering a new era of innovation, with novel gene therapies, oral drugs, and biologics poised to reshape treatment standards. These advancements aim to address unmet needs, improve patient outcomes, and offer more convenient and effective treatment options.

DelveInsight's Drug Uptake analysis provides a comprehensive evaluation of the adoption trends for newly launched and upcoming Von Willebrand Disease therapies, assessing patient acceptance, market penetration, and commercial performance. It highlights the key drivers behind rapid uptake, compares market shares, and identifies therapies gaining meaningful traction.

Von Willebrand Emerging Therapies

VGA039: Vega Therapeutics/Star TherapeuticsVGA039 is a first-in-class antibody therapy targeting Protein S, a key co-factor in thrombin generation. It offers a novel mechanism of action and has shown preclinical efficacy across several congenital bleeding disorders, including von Willebrand disease (VWD).

Currently in a Phase I/II trial, VGA039 is being developed as a subcutaneous treatment for VWD. Star Therapeutics shared clinical data in June 2024 and presented interim results at ASH 2024 in December, supporting its potential in the VWD treatment landscape.

Explore how emerging Von Willebrand therapies [https://www.delveinsight.com/report-store/von-willebrand-disease-vwd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr] are aligning with evolving patient populations.

Von Willebrand Market Outlook

The current von Willebrand disease treatment landscape in the U.S. is segmented into three main categories: non-replacement therapy, replacement therapy, and adjunctive therapy. Non-replacement therapy primarily involves desmopressin (DDAVP), used as a first-line treatment for most Type 1 and select Type 2 patients. Intravenous and intranasal forms (e.g., STIMATE, OCTOSTIM) are commonly used, though careful selection of dosage and formulation is essential for therapeutic efficacy.

Replacement therapies have evolved from plasma-derived products like HUMATE-P, WILATE, ALPHANATE, and IMMUNATE, to newer recombinant options like VONVENDI (Takeda), now gaining traction in the market. These are typically used for more severe VWD cases or during surgery. Adjunctive therapies, such as tranexamic acid (CYCLOKAPRON) and amiocaproic acid (AMICAR), provide supportive care by preventing clot breakdown, particularly for mucocutaneous bleeds. However, the frequent use of treatment at non-HTC (Hemophilia Treatment Center) sites without proper monitoring infrastructure remains a concern, highlighting the need for broader access to specialized care and further outcome studies.

Scope of the Von Willebrand Market Report

- Study Period: 2020-2034

- Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan].

- Key Von Willebrand Companies: Band Therapeutics, TagCyx Biotechnologies, China Biologic Products, Thrombotargets Corporation, Sanofi, Frequently A, and others.

- Key Von Willebrand Therapies: VGA039, and others.

- Von Willebrand Therapeutic Assessment: Von Willebrand currently marketed, and Von Willebrand emerging therapies.

- Von Willebrand Market Dynamics: Von Willebrand market drivers and Von Willebrand market barriers.

- Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies.

- Von Willebrand Unmet Needs, KOL's views, Analyst's views, Von Willebrand Market Access and Reimbursement.

To learn more about Von Willebrand companies working in the treatment market, check out our Von Willebrand Market Report [https://www.delveinsight.com/report-store/von-willebrand-disease-vwd-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=jpr].

Table of Contents

1. Von Willebrand Market Report Introduction

2. Executive Summary for Von Willebrand

3. SWOT analysis of Von Willebrand

4. Von Willebrand Patient Share (%) Overview at a Glance

5. Von Willebrand Market Overview at a Glance

6. Von Willebrand Disease Background and Overview

7. Von Willebrand Epidemiology and Patient Population

8. Country-Specific Patient Population of Von Willebrand

9. Von Willebrand Current Treatment and Medical Practices

10. Von Willebrand Unmet Needs

11. Von Willebrand Emerging Therapies

12. Von Willebrand Market Outlook

13. Country-Wise Von Willebrand Market Analysis (2020-2034)

14. Von Willebrand Market Access and Reimbursement of Therapies

15. Von Willebrand Market Drivers

16. Von Willebrand Market Barriers

17. Von Willebrand Appendix

18. Von Willebrand Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

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