Von Willebrand disease Market

• The Von Willebrand Disease Market Size in the United States was estimated to be more than USD 350 million in 2023.
• Overall, the increasing diagnosed Von Willebrand Disease Prevalence of the disease along with the promising expanded recombinant therapies will fuel the Von Willebrand Disease market during the forecasted period of (2024–2034) with some of the major players in the Von Willebrand disease treatment market being CSL Behring, LFB Biomedicaments SA, Octapharma AG, and Grifols SA.
• The Von Willebrand Disease Market dynamics is anticipated to change in the coming years owing to the improvement in the diagnosis methodologies, raising awareness of the disease, incremental healthcare spending across the world during the forecast period (2024-2034). However, the current pipeline is limited to early phase development. Key Von Willebrand Disease companies such as Vega Therapeutics and Sanofi are involved in developing treatments for von willebrand disease.
• In December 2023, the United States Food and Drug Administration (US FDA) granted expanded approval to WILATE as the first VWF concentrate for prophylaxis in all types of von willebrand disease.
• In May 2023, the US FDA granted Orphan Drug Designation to VGA039 for the treatment of the rare bleeding disorder, von Willebrand disease.
• The dynamics of the Von Willebrand disease market is anticipated to change in the coming years owing to the expanded use of VONVENDI (BAX 111) for prophylactic as well as pediatric therapies in the US. Its expanded approval (by US FDA in April 2018 for perioperative management of bleeding in adults) is also expected to raise awareness among a large section of von Willebrand disease patients who have VWF defects and have moderate disease but are currently undertreated.

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DelveInsight's “Von Willebrand Disease Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of von willebrand disease, historical and forecasted epidemiology as well as the von willebrand disease therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Von Willebrand Disease Treatment Market Report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM von willebrand disease market size from 2020 to 2034. The report also covers current von willebrand disease treatment market practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Von Willebrand Disease Treatment Market

Von Willebrand Disease Overview, Country-Specific Treatment Guidelines and Diagnosis

Von Willebrand disease is a genetic disorder caused by missing or defective von Willebrand factor (VWF), a clotting protein. VWF binds factor VIII, a key clotting protein, and platelets in blood vessel walls, which help form a platelet plug during the clotting process. Von Willebrand disease is a heterogeneous disorder and is usually classified into two main types, according to inheritance or acquired forms.

A combination of blood tests are used to diagnose Von Willebrand disease, including a VWF antigen test, which measures the amount of VWF in the blood, tests that measure clotting time and ability to form a clot, and tests measuring platelet function.

The Von Willebrand Disease market report provides an overview of Von Willebrand Disease pathophysiology, diagnostic approaches, and detailed treatment algorithm along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report...

Von Willebrand Disease Treatment

The most common treatment for Von Willebrand disease is DDAVP (desmopressin acetate), which stimulates the release of VWF from cells. This also increases the level of FVIII (factor 8). Recombinant VWF (such as Vonvendi) and medicines rich in VWF and factor VIII (for example, Humate P, Wilate, Alphanate, etc.) are used to treat people with more severe forms of Von Willebrand Disease or people with milder forms of Von Willebrand Disease who do not respond well to the nasal spray. The treatment patterns of Von Willebrand Disease differs between countries and geographical regions. Unlike hemophilia, the bleed patterns and treatment details are not very well defined.

Von Willebrand Disease Epidemiology

The Von Willebrand Disease epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034. The Von Willebrand Disease epidemiology is segmented with detailed insights into total diagnosed prevalent cases of von willebrand disease, gender-specific diagnosed prevalent cases of von willebrand disease, type-specific diagnosed prevalent cases of von willebrand disease, and age-specific diagnosed prevalent cases of von willebrand disease.

• In 2023, the total Von Willebrand Disease diagnosed prevalent cases in the US were approximately 13,000, cases, which are expected to increase during the study period (2020–2034).
• Females predominantly account for around 55% of Von Willebrand Disease diagnosed prevalent cases in the US, making up more than 7,000 cases in 2023.
• Age group 5–13 years and 14–18 years accounts for around 32% and 22% of all Von Willebrand Disease diagnosed prevalent cases in the US, in 2023. Whereas, age groups 0–4, 19–44, and >45 years reported around 6%, 23%, and 17% cases, respectively, in 2023.
• Von Willebrand disease Type 2 and Type 3 accounts for around 11% and 6% of all Von Willebrand Disease diagnosed prevalent cases in the US, in 2023. Whereas, von willebrand disease Type 1 reported around 83% cases alone, in 2023.

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Von Willebrand Disease Recent Developments

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

Von Willebrand Disease Drug Chapters

The drug chapter segment of the Von Willebrand Disease drugs market report encloses a detailed analysis of Von Willebrand Disease marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Von Willebrand Disease clinical trial details, recent and expected market approvals, patent details, the latest Von Willebrand Disease news, and recent deals and collaborations.

Von Willebrand Disease Marketed Drugs

• WILATE: OctaPharma

WILATE is the first von Willebrand factor (VWF) concentrate indicated for prophylactic treatment across all forms of Von Willebrand disease, marking a significant milestone in the field. In December 2023, Octapharma USA announced the expansion of the US FDA approval for WILATE, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label now includes routine prophylaxis aimed at reducing the frequency of bleeding episodes in adults and children aged 6 and older with any type of von Willebrand disease, the most prevalent bleeding disorder in the United States. The FDA approval is  supported by Octapharma’s WIL-31 study, a prospective, non-controlled, international, multicenter Phase III trial that investigated the efficacy and safety of wilate prophylaxis over 12 months in people aged 6 and older with severe Von Willebrand disease of any type.

• VONVENDI: Takeda Pharmaceuticals

VONVENDI is a recombinant von Willebrand factor replacement therapy. It is approved for the treatment to reduce the frequency of bleeding episodes for severe type 3 von Willebrand disease. In January 2022, US FDA approved VONVENDI [von Willebrand Factor (Recombinant)] for routine prophylaxis treatment in patients with severe Type 3 von Willebrand disease receiving on-demand therapy. The approval was based on data from a prospective, open-label, international multicenter study that evaluated efficacy and safety of prophylactic treatment. Investigators observed whether frequency of bleeding episodes were reduced in 10 adult patients diagnosed with severe Type 3 von Willebrand disease, who were previously treated on-demand.

Note: Detailed current therapies assessment will be provided in the full report of Von Willebrand Disease...

Von Willebrand Disease Emerging Drugs

• VGA039: Vega Therapeutics

Vega Therapeutics’ VGA039 is a first-in-class antibody therapy with a novel mechanism of action that modulates Protein S – a key co-factor involved in thrombin generation during both initiation and propagation of coagulation – with preclinical data demonstrating efficacy in numerous congenital bleeding disorders, including von Willebrand disease. By promoting thrombin generation through targeting Protein S, VGA039 addresses a fundamental mechanism of clot formation in Von Willebrand disease and, as a subcutaneously self-administered antibody therapy, has potential to transform von Willebrand disease treatment. It is currently recruiting in a Phase I study to assess safety, tolerability, pharmacokinetic, and pharmacodynamics study of VGA039 following IV or SC administration of single ascending doses in healthy adults and subcutaneous adult patients with von willebrand disease. In May 2023, the US FDA granted VGA039 Orphan Drug Designation.

Von Willebrand Disease Market Outlook

The current Von Willebrand Disease therapeutics market landscape in the United States can be divided into three major categories based on the class of drugs administered, they are; Non-replacement Therapy using desmopressin (DDAVP) to increase the plasma concentration of vWF, Replacement Therapy using plasma-derived coagulation factor concentrates (HUMATE-P, ALPHANATE, IMMUNATE, and WILATE) and Adjunct Therapy using primarily anti-fibrinolytics, such as Tranexamic Acid (CYCLOKAPRON).

A new category of recombinant coagulation factor concentrates -VONVENDI has recently entered the replacement therapy segment. The approved (and their generic versions) as well as off-label products that are being used for the treatment of von Willebrand Disease, and contributing toward the Von Willebrand Disease market revenue, belong to either of these above-mentioned therapeutic classes.

The gradual emergence of virally-inactivated FVIII concentrates containing VWF for the treatment of hemophilia A proved a more optimal replacement therapeutic option for patients with Von Willebrand disease.  Currently, they form the second line of treatment especially during severe bleeding episodes of Type 1 variant as well as Type 2 and Type 3. In the United States, Von Willebrand disease is typically treated with either HUMATE-P (CSL Behring) or WILATE (Octapharma) or ALPHANATE (Grifols), which is identical to FANHDI, made in Spain.

Key Von Willebrand Disease Companies, such as Sanofi, OctoPharma, Vega Therapeutics and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Von Willebrand Disease.

Von Willebrand Disease Drugs Uptake

This section focuses on the uptake rate of potential Von Willebrand Disease drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key Von Willebrand Disease Companies evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Von Willebrand Disease Pipeline Development Activities

The Von Willebrand Disease therapeutics market report provides insights into different Von Willebrand Disease clinical trials within Phase III and Phase II stages. It also analyzes key Von Willebrand Disease Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The Von Willebrand Disease therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Von Willebrand Disease emerging therapies.

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KOL Views

To keep up with the real-world scenario in current and emerging Von Willebrand Disease market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.

DelveInsight’s analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as UT Southwestern medical center, Boston hemophilia center etc., were contacted. Their opinion helps understand and validate current and emerging treatment patterns of Von Willebrand Disease. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Von Willebrand Disease Therapeutics Market: Qualitative Analysis

We perform Qualitative and Von Willebrand Disease Therapeutics Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging Von Willebrand Disease therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Von Willebrand Disease Therapeutics Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers’ concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

The Von Willebrand Disease therapeutics market report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Von Willebrand Disease Treatment Market Report Scope

• The Von Willebrand Disease treatment market report covers a segment of key events, an executive summary, descriptive overview, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the Von Willebrand Disease epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging Von Willebrand Disease therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current Von Willebrand Disease treatment market landscape.
• A detailed review of the Von Willebrand Disease drugs market, historical and forecasted Von Willebrand Disease market size, Von Willebrand Disease drugs market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Von Willebrand Disease therapeutics market report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM Von Willebrand Disease drugs market.

Von Willebrand Disease Treatment Market Report Insights

• Patient-based Von Willebrand Disease Market Forecasting
• Von Willebrand Disease Therapeutic Approaches
• Von Willebrand Disease Pipeline Drugs Analysis
• Von Willebrand Disease Market Size
• Von Willebrand Disease Market Trends
• Existing and future Von Willebrand Disease Drugs Market Opportunity

Von Willebrand Disease Treatment Market Report Key Strengths

• 11 Years Von Willebrand Disease Market Forecast
• 7MM Coverage
• Von Willebrand Disease Epidemiology Segmentation
• Inclusion of Country specific treatment guidelines
• KOL’s feedback on approved and emerging therapies
• Key Cross Competition
• Conjoint analysis
• Von Willebrand Disease Drugs Uptake
• Key Von Willebrand Disease Market Forecast Assumptions

Von Willebrand Disease Treatment Market Report Assessment

• Current Von Willebrand Disease Treatment Practices
• Von Willebrand Disease Unmet Needs
• Von Willebrand Disease Pipeline Product Profiles
• Von Willebrand Disease Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Von Willebrand Disease Market Drivers
• Von Willebrand Disease Market Barriers

FAQs

• What is the growth rate of the 7MM Von Willebrand Disease treatment market?
• What was the Von Willebrand Disease treatment market size, the Von Willebrand Disease treatment market size by therapies, Von Willebrand Disease drugs market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
• Is there any unexplored patient setting that can open the window for growth in the future?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the Von Willebrand Disease market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for the treatment of Von Willebrand Disease?
• How many Von Willebrand Disease companies are developing therapies for the treatment of Von Willebrand Disease?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved Von Willebrand Disease therapies?

Reasons to Buy

• The Von Willebrand Disease therapeutics market report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Von Willebrand Disease Drugs Market.
• Insights on patient burden/disease Von Willebrand Disease Prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• Understand the existing Von Willebrand Disease market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the Von Willebrand Disease Therapeutics Market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing Von Willebrand Disease market so that the upcoming players can strengthen their development and launch strategy.

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