Hemophilia B Therapeutics Market Size in 7MM is expected to grow at a decent CAGR by 2034, estimates DelveInsight | UniQure Biopharma B.V., CSL Behring, Pfizer/Spark Therapeutics, Genzyme Sanofi

DelveInsight's "Hemophilia B Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Hemophilia B, historical and forecasted epidemiology as well as the Hemophilia B 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 B Market Report

* In April 2025, Regeneron Pharmaceuticals announced a study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B. This study is researching an experimental gene insertion therapy (the adding of a gene into your DNA) called REGV131-LNP1265, also called the "study drug". Gene insertion therapy aims to teach the body how to produce clotting factor long-term, without the need for factor replacement therapy.
* In April 2025, Pfizer conducted a study to learn about the long-term safety and efficacy of giroctocogene fitelparvovec or fidanacogene elaparvovec in patients with hemophilia A or hemophilia B respectively, who have received treatment through prior participation in a Pfizer-sponsored clinical trial. Data collection and participant visits will be based on standard of care.
* In April 2025, Novo Nordisk A/S organized study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B without inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use.
* In March 2025, Alnylam Pharmaceuticals announced the FDA's approval of Qfitlia Trademark (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in the U.S. It is the first and only treatment to lower antithrombin (AT), aiming to promote thrombin generation, rebalance hemostasis, and prevent bleeds.
* Among the 7MM, the US accounted for the highest hemophilia B Diagnosed Prevalent Cases in 2023, with approximately 4000 cases; these cases are expected to increase during the forecast period.
* Amongst EU4 and the UK, the Hemophilia B Diagnosed Prevalent Cases were highest in France, while the lowest number of cases was in Germany in 2023.
* According to the estimates, in the US, it is observed that hemophilia B was most prevalent in the 19-44 years age group, accounting for ~35% of the total cases.
* On the basis of severity, the majority of cases in the United States were classified as mild, i.e. nearly 40%.
* The leading Hemophilia B Companies such as UniQure Biopharma B.V., CSL Behring, Pfizer/Spark Therapeutics, Genzyme, a Sanofi Company, Alnylam Pharmaceuticals, Novo Nordisk, Pfizer, UniQure Biopharma B.V., ApcinteX Ltd, Freeline Therapeutics, Sangamo Therapeutics and others.
* Promising Hemophilia B Drugs such as Nonacog beta pegol, BE-101, REGV131, LNP1265, Recombinant Factor IX Coagulation, APVO101, BeneFIX, SPK-9001 and others.

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Hemophilia B Epidemiology Segmentation in the 7MM

* Total Hemophilia B Diagnosed Prevalent Cases
* Hemophilia B Severity-specific Prevalent Cases
* Hemophilia B Age-specific Prevalent Cases
* Hemophilia B Prevalent Cases with or without Inhibitors
* Hemophilia B Treated Patient Pool

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Marketed Hemophilia B Drugs

* BEQVEZ (fidanacogene elaparvovec-dzkt): Pfizer

BEQVEZ is a product of Pfizer that is an adeno-associated viral (AAV) vector-based gene therapy. This therapy was recently approved in April 2024 for the treatment of adults with moderate to severe hemophilia B who currently use factor IX (FIX) prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes, and do not have neutralizing antibodies to adeno-associated virus serotype Rh74var (AAVRh74var) capsid as detected by an FDA-approved test. BEQVEZ is a one-time treatment that is designed to enable people living with hemophilia B to produce FIX themselves rather than the current standard of care, which requires regular intravenous infusions of FIX that are often administered multiple times a week or multiple times a month.

* HEMGENIX (etranacogene dezaparvovec-drlb): CSL Behring/uniQure

HEMGENIX by CSL Behring and uniQure is an AAV5-based gene therapy. AAV5 gene therapies has experienced any confirmed cytotoxic T-cell-mediated immune response to the capsid. Additionally, pre-clinical and clinical data show that AAV5-based gene therapies may be viable treatments in patients with pre-existing antibodies to AAV5, thereby potentially increasing patient eligibility for treatment compared to other gene therapy product candidates. This therapy was approved in November 2022 to treat adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy or have a current or historical life-threatening hemorrhage or have repeated, serious spontaneous bleeding episodes. HEMGENIX also has been granted conditional marketing authorization by the European Commission (EC) for the European Union and European Economic Area, and the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA).

Emerging Hemophilia B Drugs

* Fitusiran: Sanofi (Genzyme)/ Alnylam Pharmaceuticals

Fitusiran, currently under development by Sanofi (Genzyme)/Alnylam Pharmaceuticals, is a subcutaneously administered small interfering RNA (siRNA) technology to target antithrombin. The therapy works by silencing the gene responsible for antithrombin, which inhibits the protein's anticoagulant function, which further compensates for the imbalance caused by deficiencies in other clotting proteins, such as factor VIII (hemophilia A) or factor IX (hemophilia B). According to the companies, this candidate is based on an Alnylam delivery technology that enables increased potency and durability with SC (under-the-skin) injection.

* PF-06741086 (Marstacimab): Pfizer

Marstacimab, currently under development by Pfizer, is a human monoclonal immunoglobulin G isotype, subclass 1 (IgG1) that targets the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI). Marstacimab is in development as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in individuals with severe hemophilia A or B (defined as factor VIII or factor IX activity



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