Tuesday, 02 January 2024 12:17 GMT

Von Willebrand Disease Market Insight, Epidemiology, And Market Forecast To 2036, See How VONVENDI's Expanded Prophylaxis Approval Is Reshaping Treatment For The Most Common Inherited Bleeding Disorder


(MENAFN- GlobeNewsWire - Nasdaq) 200-Page Report Tracks Vega's VGA039 and Hemab's HMB-002 as Long-Acting Biologics Challenge Decades of On-Demand VWF Replacement Therapy

Dublin, Sept. 08, 2026 (GLOBE NEWSWIRE) -- The "Von Willebrand Disease - Market Insight, Epidemiology, and Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.

The "Von Willebrand Disease (VWD) - Market Insights, Epidemiology and Market Forecast - 2036" report provides a comprehensive assessment of the VWD market across the seven major markets (7MM): the United States, Germany, France, Italy, Spain, the United Kingdom, and Japan. Covering historical and forecast data from 2022 to 2036, the report examines diagnosed prevalence, treatment practices, market dynamics, therapy uptake, competitive developments, and emerging commercial opportunities.

The United States is expected to retain the largest share of the Von Willebrand disease market during the forecast period, supported by stronger diagnosis rates, broader access to treatment, expanded prophylactic indications, and continued therapeutic innovation. The EU4 and the United Kingdom represent another significant commercial region, while Japan offers additional growth potential as diagnostic awareness and access to advanced therapies improve.

Von Willebrand Disease Epidemiology and Patient Burden

Diagnosed VWD prevalence across the 7MM is projected to increase through 2036, driven by improved clinical recognition, advances in laboratory testing, and greater awareness among healthcare professionals and patients. Females account for approximately 55% of diagnosed prevalent cases in the United States, reflecting a substantial clinical burden associated with menstrual and pregnancy-related bleeding.

Children and adolescents represent a considerable proportion of diagnosed cases in the United States. In 2025, patients aged 5-13 years and 14-18 years accounted for approximately 32% and 22% of diagnosed prevalent cases, respectively. Type 1 VWD represented about 83% of diagnosed cases, compared with approximately 11% for Type 2 and 6% for Type 3.

Important unmet needs remain, including delayed diagnosis, variability in diagnostic testing, difficulties in subtype classification, limited access to specialized care, and persistent breakthrough bleeding. These challenges reinforce the need for more reliable diagnostic pathways, broader prophylactic treatment access, and therapies capable of providing sustained hemostatic protection.

Current Von Willebrand Disease Treatment Landscape

VWD management includes desmopressin, antifibrinolytic agents, and von Willebrand factor replacement therapies. Established products such as WILATE from Octapharma and VONVENDI/VEYVONDI (vonicog alfa) from Takeda Pharmaceuticals support on-demand treatment, perioperative management, and routine prophylaxis in eligible patients.

WILATE is a plasma-derived VWF and factor VIII concentrate. Its regulatory position was strengthened by the approval of routine prophylaxis for reducing bleeding episodes in adults and children aged six years and older. In April 2024, the US Food and Drug Administration granted orphan drug exclusivity for this prophylactic indication.

VONVENDI/VEYVONDI is a recombinant VWF replacement therapy with indications covering bleeding control and perioperative management. In September 2025, the FDA approved an expanded indication that included routine prophylaxis in adults across major VWD types, as well as on-demand treatment and perioperative management in pediatric patients. Takeda also submitted applications in Japan and the European Union to expand pediatric indications.

Emerging VWD Pipeline and Competitive Landscape

The emerging Von Willebrand disease pipeline is focused on long-acting biologics, monoclonal antibodies, and RNA-based therapies intended to improve bleed prevention while reducing infusion frequency and overall treatment burden. Leading investigational candidates include:

  • VGA039 - Vega Therapeutics: An investigational subcutaneous monoclonal antibody targeting Protein S and designed to enhance thrombin generation. The candidate is being evaluated as prophylaxis across VWD types and received FDA Orphan Drug Designation in May 2023.
  • HMB-002 - Hemab ApS: An investigational monoclonal antibody designed to increase VWF and factor VIII activity and provide sustained protection from bleeding. Preliminary VELORA Pioneer study data reported dose-dependent increases in VWF and factor VIII levels, with activity maintained for approximately 8-10 days.
  • ALN-6400 - Alnylam Pharmaceuticals: An investigational RNA interference therapy targeting plasminogen, with the goal of reducing fibrinolysis, improving clot stability, and supporting longer-term bleeding control.

Octapharma, Takeda Pharmaceuticals, Vega Therapeutics, Hemab ApS, and Alnylam Pharmaceuticals are among the companies shaping the VWD competitive landscape. Pipeline progress, differentiated administration routes, duration of effect, safety, efficacy, and pricing will influence future market positioning and patient uptake.

VWD Market Outlook and Growth Drivers

The VWD therapeutics market is transitioning from predominantly on-demand treatment toward routine prophylaxis and targeted long-term management. Increasing diagnosed prevalence, greater adoption of prophylactic therapy, expanded product indications, and investment in next-generation treatments are expected to support market growth through 2036.

WILATE and VONVENDI are anticipated to maintain strong uptake because of their established clinical use and expanding prophylactic roles. VONVENDI may achieve particularly strong adoption among newer options due to its recombinant formulation and broader approved indications. Emerging therapies could secure future market share by offering subcutaneous administration, longer dosing intervals, sustained bleed protection, and improved treatment convenience.

Comprehensive Market Intelligence and Strategic Analysis

The report evaluates VWD market size and therapy-level market share, patient uptake, peak patient share, pricing trends, analogue assessment, treatment accessibility, and commercial opportunity across the 7MM. It also includes epidemiology-based bottom-up forecasting, patient journey analysis, treatment guidelines, clinical development profiles, regulatory milestones, partnerships, patents, and market access considerations.

Primary research incorporates insights from key opinion leaders and subject matter experts across leading academic and medical institutions in the United States, Europe, and Japan. These perspectives help validate epidemiological assumptions, treatment trends, adherence challenges, prescribing behavior, and expectations for emerging VWD therapies.

SWOT and conjoint analyses further assess marketed and pipeline therapies based on efficacy, safety, route and frequency of administration, market entry timing, probability of success, and addressable patient populations. The resulting insights are designed to support pharmaceutical companies, investors, healthcare organizations, and other stakeholders in clinical development, portfolio planning, market access, launch strategy, and competitive positioning within the global Von Willebrand disease market.

Key Report Benefits

  • Eleven-year VWD epidemiology and market forecasts through 2036
  • Analysis of diagnosed patient populations across the United States, EU4, United Kingdom, and Japan
  • Market share, drug uptake, pricing, and peak patient share assessments
  • Profiles of approved and emerging Von Willebrand disease therapies
  • Evaluation of unmet needs, treatment practices, and market attractiveness
  • Competitive intelligence covering leading VWD companies and pipeline candidates
  • Expert insights supporting evidence-based commercial and development strategies

Overall, the Von Willebrand disease market is positioned for continued expansion as diagnosis improves, prophylaxis becomes more widely adopted, and innovative biologic and RNA-based therapies progress through clinical development. Companies that address diagnostic delays, breakthrough bleeding, treatment burden, and access barriers are expected to be best placed to capture emerging opportunities through 2036.

Key Topics Covered:
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
4.1. Upcoming Key Catalysts
4.2. Key Transactions And Collaborations
4.3. News Flow
5. Epidemiology and Market Forecast Methodology of Von Willebrand Disease (VWD)
6. Von Willebrand Disease (VWD) Market Overview at a Glance
6.1. Emerging Landscape Analysis (by Phase, Molecule Type, and RoA)
6.2. Market Share (%) Distribution of VWD by Therapies in the 7MM, in 2025
6.3. Market Share (%) Distribution of VWD by Therapies in the 7MM, in 2036
7. Disease Background and Overview of Von Willebrand Disease (VWD)
7.1. Introduction
7.2. Symptoms of Von Willebrand Disease (VWD)
7.3. Classification of Von Willebrand Disease (VWD)
7.3.1. Causes of Von Willebrand Disease (VWD)
7.4. Clinical Manifestations of Von Willebrand Disease (VWD)
7.4.1. Genetic Basis of Von Willebrand Disease (VWD)
7.5. Pathophysiology of Von Willebrand Disease (VWD)
7.6. Diagnosis of Von Willebrand Disease (VWD)
7.6.1. Diagnosis Guidelines of Von Willebrand Disease (VWD)
7.6.2. The Diagnosis, Evaluation, and Management of Von Willebrand Disease (VWD) from the National Heart, Lung and Blood Institute, National Institutes of Health
7.6.3. The Diagnosis of Von Willebrand Disease (VWD): a guideline from the UK Hemophilia Centre Doctors' Organization
7.6.4. The Diagnosis, Evaluation, and Management of Von Willebrand Disease (VWD) from the National Heart, Lung and Blood Institute, National Institutes of Health
7.6.5. The Diagnosis and Management of Von Willebrand Disease (VWD): a United Kingdom Hemophilia Centre
8. Treatment
8.1. Clinical Practice Guideline on the Evaluation and Management of Von Willebrand Disease (VWD)
9. Epidemiology and Patient Population of Von Willebrand Disease (VWD)
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in the 7MM
9.4. The United States
9.4.1. Total Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in the United States
9.4.2. Gender-Specific Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in the United States
9.4.3. Type-Specific Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in the United States
9.4.4. Age-specific Diagnosed Prevalent cases of Von Willebrand Disease (VWD) in the United States
9.4.5. Total Treated Cases of Von Willebrand Disease (VWD) in the United States
9.5. EU4 and the UK
9.5.1. Total Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in EU4 and the UK
9.5.2. Gender-Specific Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in EU4 and the UK
9.5.3. Type-Specific Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in EU4 and the UK
9.5.4. Age-specific Diagnosed Prevalent cases of Von Willebrand Disease (VWD) in EU4 and the UK
9.5.5. Total Treated Cases of Von Willebrand Disease (VWD) in EU4 and the UK
9.6. Japan
9.6.1. Total Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in Japan
9.6.2. Gender-Specific Diagnosed Prevalent Cases of Von Willebrand Disease (VWD) in Japan
9.6.3. Type-Specific Diagnosed Prevalent Cases of Von Willebrand Disease (VWD ) in Japan
9.6.4. Age-specific Diagnosed Prevalent cases of Von Willebrand Disease (VWD) in Japan
9.6.5. Total Treated Cases of Von Willebrand Disease (VWD) in Japan
10. Patient Journey of Von Willebrand Disease (VWD)
11. Marketed Therapies
11.1. Competitive landscape of marketed therapies
11.2. WILATE: OctaPharma
11.2.1. Drug Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Summary of Pivotal Trials
11.2.5. Clinical Development
11.2.5.1. Clinical Trial Information
11.2.6. Analyst's Views
11.3. VONVENDI/VEYVONDI (vonicog alfa): Takeda Pharmaceuticals
11.3.1. Drug Description
11.3.2. Regulatory Milestones
11.3.3. Other Developmental Activities
11.3.4. Summary of Pivotal Trials
11.3.5. Clinical Development
11.3.5.1. Clinical Trial Information
11.3.6. Analyst's Views
. Note: List to be continued in the report
12. Emerging Drugs
11.1. Competitive landscape of emerging therapies
11.2. VGA039: Vega Therapeutics
11.2.1. Drug Description
11.2.2. Other Developmental Activities
11.2.3. Clinical Development
11.2.3.1. Clinical Trials Information
11.2.4. Analyst's Views
11.3. HMB-002: HemaBiologics (Hemab ApS)
11.3.1. Drug Description
11.3.2. Other Developmental Activities
11.3.3. Clinical Development
11.3.3.1. Clinical Trials Information
11.3.4. Analyst's Views
. Note: List to be continued in the report
13. Von Willebrand Disease (VWD): 7MM Analysis
13.1. Key Findings
13.2. Market Outlook of Von Willebrand Disease (VWD)
13.3. Conjoint Analysis of Von Willebrand Disease (VWD)
13.4. Key Market Forecast Assumptions
13.4.1. Cost Assumptions
13.4.2. Pricing Trends
13.4.3. Analogue Assessment
13.4.4. Launch Year and Therapy Uptakes
13.5. Total Market Size of Von Willebrand Disease (VWD) in the 7MM
13.6. Total Market Size of Von Willebrand Disease (VWD) by Therapies in the 7MM
13.7. The United States
13.7.1. Total Market Size of Von Willebrand Disease (VWD) in the United States
13.7.2. Total Market Size of Von Willebrand Disease (VWD) by Therapies in the United States
13.8. EU4 and the UK
13.8.1. Total Market Size of Von Willebrand Disease (VWD) in EU4 and the UK
13.8.2. Total Market Size of Von Willebrand Disease (VWD) by Therapies in EU4 and the UK
13.9. Japan
13.1. Total Market Size of Von Willebrand Disease (VWD) in Japan
13.9.2. Total Market Size of Von Willebrand Disease (VWD) by Therapies in Japan
14. Unmet Needs of Von Willebrand Disease (VWD)
15. SWOT Analysis of Von Willebrand Disease (VWD)
16. KOL Views of Von Willebrand Disease (VWD)
17. Market Access and Reimbursement of Von Willebrand Disease (VWD)
17.1. The United States
17.2. EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. United Kingdom
17.3. Japan
17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
17.5. Market Access and Reimbursement of Von Willebrand Disease (VWD) Therapies
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. Analyst's Capabilities
20. Disclaimer
21. About the Publisher
List of Tables
Table 1: 7MM Von Willebrand Disease (VWD) Epidemiology (2022-2036)
Table 2: 7MM Von Willebrand Disease (VWD) Diagnosed and Treatable Cases (2022-2036)
Table 3: Von Willebrand Disease (VWD) Epidemiology in the United States (2022-2036)
Table 4: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in the United States (2022-2036)
Table 5: Von Willebrand Disease (VWD) Epidemiology in Germany (2022-2036)
Table 6: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Germany (2022-2036)
Table 7: Von Willebrand Disease (VWD) Epidemiology in France (2022-2036)
Table 8: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in France (2022-2036)
Table 9: Von Willebrand Disease (VWD) Epidemiology in Italy (2022-2036)
Table 10: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Italy (2022-2036)
Table 11: Von Willebrand Disease (VWD) Epidemiology in Spain (2022-2036)
Table 12: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Spain (2022-2036)
Table 13: Von Willebrand Disease (VWD) Epidemiology in the UK (2022-2036)
Table 14: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in the UK (2022-2036)
Table 15: Von Willebrand Disease (VWD) Epidemiology in Japan (2022-2036)
Table 16: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Japan (2022-2036)
Table 17: Drug Name, Clinical Trials by Recruitment status
Table 18: Drug Name, Clinical Trials by Zone
Table 19: Total Seven Major Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 20: Region-wise Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 21: 7MM-Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 22: United States Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 23: United States Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 24: Germany Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 25: Germany Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 26: France Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 27: France Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 28: Italy Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 29: Italy Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 30: Spain Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 31: Spain Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 32: United Kingdom Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 33: United Kingdom Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Table 34: Japan Von Willebrand Disease Market Size in USD, Million (2022-2036)
Table 35: Japan Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
*The list of tables is not exhaustive; the final content may vary
List of Figures
Figure 1: 7MM Von Willebrand Disease (VWD) Epidemiology (2022-2036)
Figure 2: 7MM Von Willebrand Disease (VWD) Diagnosed and Treatable Cases (2022-2036)
Figure 3: Von Willebrand Disease (VWD) Epidemiology in the United States (2022-2036)
Figure 4: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in the United States (2022-2036)
Figure 5: Von Willebrand Disease (VWD) Epidemiology in Germany (2022-2036)
Figure 6: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Germany (2022-2036)
Figure 7: Von Willebrand Disease (VWD) Epidemiology in France (2022-2036)
Figure 8: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in France (2022-2036)
Figure 9: Von Willebrand Disease (VWD) Epidemiology in Italy (2022-2036)
Figure 10: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Italy (2022-2036)
Figure 11: Von Willebrand Disease (VWD) Epidemiology in Spain (2022-2036)
Figure 12: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Spain (2022-2036)
Figure 13: Von Willebrand Disease (VWD) Epidemiology in the UK (2022-2036)
Figure 14: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in the UK (2022-2036)
Figure 15: Von Willebrand Disease (VWD) Epidemiology in Japan (2022-2036)
Figure 16: Von Willebrand Disease (VWD) Diagnosed and Treatable Cases in Japan (2022-2036)
Figure 17: Drug Name, Clinical Trials by Recruitment status
Figure 18: Drug Name, Clinical Trials by Zone
Figure 19: Total Seven Major Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 20: Region-wise Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 21: 7MM-Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 22: United States Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 23: United States Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 24: Germany Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 25: Germany Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 26: France Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 27: France Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 28: Italy Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 29: Italy Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 30: Spain Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 31: Spain Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 32: United Kingdom Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 33: United Kingdom Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
Figure 34: Japan Von Willebrand Disease Market Size in USD, Million (2022-2036)
Figure 35: Japan Von Willebrand Disease Market Size by Therapy in USD, Million (2022-2036)
*The list of figures is not exhaustive; the final content may vary
A selection of companies mentioned in this report includes, but is not limited to:

  • OctaPharma
  • Takeda Pharmaceuticals
  • Vega Therapeutics
  • Hemab ApS
  • Alnylam Pharmaceuticals

For more information about this report visit

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