The Hemophilia A Market Size in the 7MM is projected to grow at a CAGR of 2.9% by 2034, estimates DelveInsight

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.

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Key Takeaways from the Hemophilia A Market Report
• On February 05, 2026- Hoffmann-La Roche conducted a phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A.
• On February 05, 2026- Pfizer announced a study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008.
• The total diagnosed prevalent population of Hemophilia A in the 7MM comprised nearly 49,500 cases in 2024 and is projected to increase during the forecast period.
• The total diagnosed prevalent population of Hemophilia A in the United States was nearly 14,900 in 2024.
• EU4 and the UK contributed to the largest prevalent population of Hemophilia A, accounting for ~58% of the 7MM in 2024.
• In EU4 and the UK, the diagnosed prevalence of Hemophilia A was found to be maximum in France, followed by the UK. While the least number of cases were found in Spain in 2024.
• In 2024, the prevalent cases of mild Hemophilia A in the United States were identified to be ~35%, moderate as ~15%, and severe as ~50%.
• In the US, nearly 2,000 cases accounted for inhibitors and ~12,700 cases for non-inhibitors in 2024.
• 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 dirloctocogene samoparvovec (RG6357 or SPK-8011), fitusiran (ALN-AT3, SAR-439774), marstacimab (PF-06741086), and others

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Hemophilia A Epidemiology Segmentation in the 7MM
• Total Diagnosed Prevalent Pool
• Severity-specific Prevalent Pool
• Inhibitor-specific Prevalent Pool
• Treated Prevalent Pool

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Hemophilia A Drug 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. But this class of products acquires less market share because of their less usage in comparison to the recombinant-derived factor concentrates. Several drugs are approved under this category, such as FEIBA (Pfizer), MONOCLATEP (CSL Behring), and HEMOFIL-M (Baxter).

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). Although several products are available at present, then again, none of these products might be able to cure or manage this situation, completely. HEMLIBRA-a product of "Genentech/Chugai/Roche," is a novel bispecific antibody that was first approved in 2017 for patients with Hemophilia A with FVIII inhibitors in the US.

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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.

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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- dirloctocogene samoparvovec (RG6357 or SPK-8011), fitusiran (ALN-AT3, SAR-439774), marstacimab (PF-06741086), and others.
• Hemophilia A Market Dynamics: Hemophilia A Market drivers and Hemophilia A Market Barriers
• Hemophilia A Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Hemophilia A Unmet Needs, KOL's views, Analyst's views, Hemophilia A Market Access and Reimbursement

Table of Contents
1. Key Insights
2. Report Introduction
3. Hemophilia A Market Overview at a Glance
4. Executive Summary of Hemophilia A
5. Key Events
6. SWOT Analysis
7. Epidemiology and Market Methodology
8. Hemophilia A: Disease Background and Overview
9. Treatment Algorithm, Current Treatment, and Medical Practices
10. Epidemiology and Patient Population
11. Patient Journey of Hemophilia A
12. Key Endpoints in Hemophilia A Clinical Trials
13. Marketed Drugs
14. Emerging Drugs
15. Hemophilia A: Seven Major Market Analysis
16. Market Access and Reimbursement
17. Unmet Needs
18. Appendix
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

About Us

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This release was published on openPR.