DelveInsight’s “Hemophilia A Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Hemophilia A, historical and forecasted epidemiology as well as the Hemophilia A market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Discover which therapies are expected to grab the Hemophilia A Market Share @ Hemophilia A Market Outlook

Key Takeaways from the Hemophilia A Market Report

• In March 2025, CSL Behring announced a study in China is to investigate the pharmacokinetics (PK) of rVIII-SingleChain after an initial and repeat dose and to assess efficacy and safety during 2 to 3 times weekly prophylaxis treatment with rVIII-SingleChain in male Chinese PTPs with severe hemophilia A (FVIII activity less than [<] 1%).
• In March 2025, Novo Nordisk A/S conducted a study is looking at how Mim8 works in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used to avoid bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often the participants will receive Mim8 in this study depends on the treatment participant receives in the current Mim8 study participant is taking part in.
• In March 2025, Octapharma, Female patients with mild to moderate haemophilia A will often need FVIII concentrates to provide haemostatic cover during major surgery. This prospective, open-label, non-controlled, single-arm, multinational, multicentre study aims to evaluate the overall perioperative haemostatic efficacy of Nuwiq in women/girls over 12 with haemophilia A undergoing major surgery requiring FVIII treatment
• The Hemophilia A epidemiology segment also provides the Hemophilia A epidemiology data and findings across the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• The total Hemophilia A Prevalence in the 7MM comprised nearly 45,500 cases in 2023 and is projected to increase during the forecast period.
• The total Hemophilia A prevalence in the United States was nearly 14,300 in 2023.
• The United States contributed to the largest Hemophilia A prevalent population, accounting for ~30% of the 7MM in 2023.
• In EU4 and the UK, the Hemophilia A diagnosed prevalence was found to be maximum in France, followed by the UK. While the least number of cases were found in Spain in 2023.
• In Japan, the total prevalence of Hemophilia A was nearly 5,600 in 2023 and is anticipated to rise during the forecast period.
• In 2023, the prevalent cases of mild Hemophilia A in the United States were identified to be ~3,600, moderate as ~2,900, and severe as ~7,900.
• In the US, nearly 2,400 cases accounted for inhibitors and ~12,000 cases for non-inhibitors in 2023.
• The leading Hemophilia A Companies such as BioMarin Pharmaceutical, Roche (Spark Therapeutics), ApcinteX, Novo Nordisk, Sanofi (Genzyme), Alnylam Pharmaceuticals, Pfizer, Sangamo Therapeutics, Bayer, Ultragenyx Pharmaceutical, and others.
• Promising Hemophilia A Therapies such as RG6357 (SPK-8011), RG6358 (SPK-8016), SerpinPC, Concizumab (NN7415), Fitusiran (ALN-AT3, SAR-439774), BIVV001 (Efanesoctocog alfa) (rFVIIIFc-VWF-XTEN), Marstacimab (PF-06741086), NNC0365-3769 A (Mim8), Giroctocogene fitelparvovec (SB-525 or PF-07055480), BAY2599023 (DTX201 AAV FVIII), and others.

Stay ahead in the Hemophilia A Therapeutics Market with DelveInsight’s Strategic Report @ Hemophilia A Market Outlook

Hemophilia A Epidemiology Segmentation in the 7MM

• Total Hemophilia A Diagnosed Prevalent Pool
• Hemophilia A Severity-specific Prevalent Pool
• Hemophilia A Inhibitor-specific Prevalent Pool
• Hemophilia A Treated Prevalent Pool

Download the report to understand which factors are driving Hemophilia A Epidemiology trends @ Hemophilia A Prevalence

Marketed Hemophilia A Drugs

• ROCTAVIAN (valoctocogene roxaparvovec)

ROCTAVIAN (valoctocogene roxaparvovec) is an AAV5 gene therapy for treating severe hemophilia A. It delivers a functional gene designed to enable the body to produce Factor VIII independently without needing continued hemophilia prophylaxis, thus relieving patients of their treatment burden relative to currently available therapies. People with hemophilia A have a mutation in the gene responsible for producing Factor VIII, a protein necessary for blood clotting. The expressed hFVIII-SQ replaces the missing coagulation factor VIII needed for effective hemostasis. Following valoctocogene roxaparvovec infusion, vector DNA is processed in vivo to form full-length, episomal transgenes that persist as the stable DNA forms that support the long-term production of hFVIII-SQ.

• OBIZUR (susoctocog alfa): Takeda

OBIZUR treats bleeding episodes in adults with acquired hemophilia (a bleeding disorder caused by a lack of Factor VIII activity due to antibody development). These antibodies have a less neutralizing effect against OBIZUR than against human Factor VIII. OBIZUR contains the active substance susoctocog alfa, antihemophilic Factor VIII, and porcine sequence.

Emerging Hemophilia A Drugs

• Fitusiran: Sanofi

Fitusiran, currently under development by Sanofi (Genzyme)/Alnylam Pharmaceuticals, is a subcutaneously administered small interfering RNA (siRNA) technology to target antithrombin. In Q2 2022, the company announced data with lower doses expected in the second half of 2023. The company anticipates the first filing by 2024. The Pediatric (age 1–11) study is ongoing, and the company expects the first filing by 2026.

• Marstacimab: Pfizer

Marstacimab, which is currently under development by Pfizer, is a Tissue Factor Pathway Inhibitor monoclonal antibody to treat Hemophilia A and B with or without Inhibitors. Currently, it is in Phase III clinical trial for the treatment of severe Hemophilia A and B with or without Inhibitors. The company also projected a pivotal readout in Q2 2023 and projected submission for non-inhibitor indication in Q3 2023.

To learn more about Hemophilia A treatment guidelines, visit @ Hemophilia A Treatment Market Landscape

Hemophilia A Drugs Market Insights

In the Hemophilia A market, there are several third-generation products available; ADVATE (Baxter) and XYNTHA (Pfizer) are examples of recombinant factor VIII products. There are several other products approved under this category; however, these products were approved a long time ago, and since then, short and longer-acting recombinant (not derived from human plasma) factor therapies have entered the market, of which ELOCTATE and ADVATE have gained the popularity, in terms of treatment horizon of Hemophilia A. ELOCTATE is a recombinant fusion protein that temporarily replaces the missing Coagulation Factor VIII needed for effective hemostasis. KOGENATE FS is a new formulation of recombinant factor VIII formulated with sucrose, as opposed to human plasma protein (Albumin). Another class of factor concentrate is plasma-derived factor concentrate FVIII products that are produced by utilizing human plasma.

Hemophilia A Market Outlook

In the Hemophilia A Market, several recombinant factor VIII (FVIII) products are available with high-specific activities (the amount of desired clotting factor per mg of total protein). Plasma-derived clotting factors products are also available. However, the current market is mainly dominated by the recombinants of several generations (recombinant third-generation and recombinant second-generation).

Learn more about the FDA-approved drugs for Hemophilia A @ Drugs for Hemophilia A Treatment

Scope of the Hemophilia A Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Hemophilia A Companies- BioMarin Pharmaceutical, Roche (Spark Therapeutics), ApcinteX, Novo Nordisk, Sanofi (Genzyme), Alnylam Pharmaceuticals, Pfizer, Sangamo Therapeutics, Bayer, Ultragenyx Pharmaceutical, and others.
• Hemophilia A Therapies- RG6357 (SPK-8011), RG6358 (SPK-8016), SerpinPC, Concizumab (NN7415), Fitusiran (ALN-AT3, SAR-439774), BIVV001 (Efanesoctocog alfa) (rFVIIIFc-VWF-XTEN), Marstacimab (PF-06741086), NNC0365-3769 A (Mim8), Giroctocogene fitelparvovec (SB-525 or PF-07055480), BAY2599023 (DTX201 AAV FVIII), and others.
• Hemophilia A Market Dynamics: Hemophilia A Market Drivers and Barriers
• Hemophilia A Market Access and Reimbursement, Unmet Needs and Future Perspectives

Table of Content

1. Key Insights

2. Hemophilia A Report Introduction

3. Hemophilia A Market Overview at a Glance

4. Executive Summary of Hemophilia A

5. Key Events

6. Hemophilia A SWOT Analysis

7. Hemophilia A Epidemiology and Market Methodology

8. Hemophilia A: Disease Background and Overview

9. Hemophilia A Treatment Algorithm, Current Treatment, and Medical Practices

10. Hemophilia A Epidemiology and Patient Population

11. Patient Journey of Hemophilia A

12. Key Endpoints in Hemophilia A Clinical Trials

13. Hemophilia A Marketed Drugs

14. Hemophilia A Emerging Drugs

15. Hemophilia A: Seven Major Market Analysis

16. Hemophilia A Market Access and Reimbursement

17. Hemophilia A Unmet Needs

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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