Hemophilia B Market: Rapid Increment Driven by Innovation by 2034 - DelveInsight | Pfizer, Spark Therapeutics, Sanofi, Alnylam Pharma, CSL Behring, uniQure, Novo Nordisk

The Key Hemophilia B Companies in the market include - Belief Biomed, ISU ABXIS, TiumBio, Be Biopharma, Regeneron Pharmaceuticals, Pfizer, Biocad, CSL Behring, Shanghai Vitalgen BioPharma, Baxalta, Amarna therapeutics, Catalyst Biosciences, Freeline Therapeutics, Belief BioMed, Centessa Pharmaceuticals, Novo Nordisk, Sanofi, Pfizer, and others.
The Hemophilia B market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Hemophilia B pipeline products will significantly revolutionize the Hemophilia B market dynamics.

DelveInsight's "Hemophilia B Market Insights, Epidemiology, and Market Forecast-2034 report offers an in-depth understanding of the Hemophilia B, historical and forecasted epidemiology as well as the Hemophilia B market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Hemophilia B market report covers emerging drugs, current treatment practices, market share of the individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current treatment practice/algorithm, market drivers & barriers, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

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Some of the key facts of the Hemophilia B Market Report:

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The Hemophilia B market size was valued ~USD 3,400 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034).

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In March 2026, The Barbara Ann Karmanos Cancer Institute has become the first and only independent cancer center in the United States to offer a newly approved hemophilia therapy. Etranacogene dezaparvovec-drlb, marketed as Hemegenix Registered , is a one-time gene therapy authorized by the U.S. Food and Drug Administration (FDA) for adults with hemophilia B. Steve W., a resident of Clinton Township, became the first patient to receive this treatment at the Karmanos Cancer Center in Detroit on October 28, 2025. Across the U.S., he is the 52nd individual to undergo this therapy following its clinical trials.

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In March 2026, A single-dose gene therapy has demonstrated encouraging safety, effectiveness, and patient-reported outcomes in Hemophilia B. According to a recent study, a one-time infusion of fidanacogene elaparvovec sustained factor IX activity and enhanced patient-reported outcomes, while maintaining a favorable safety profile for up to six years in adult patients with Hemophilia B.

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In February 2026, Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to its supplemental Biologics License Application (sBLA) for HYMPAVZI. The application seeks to broaden the drug's approved use to include patients aged 6 years and older with hemophilia A or B who have inhibitors, as well as pediatric patients aged 6 to 11 years with hemophilia A or B without inhibitors. Currently in the United States, HYMPAVZI is approved for patients aged 12 years and older with hemophilia A without factor VIII (FVIII) inhibitors or hemophilia B without factor IX (FIX) inhibitors.

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In January 2026, At the 67th American Society of Hematology (ASH) Annual Meeting and Exposition held in Florida, end-of-study results from the pivotal Phase 3 HOPE-B clinical trial (NCT03569891) were presented. These data underpinned the FDA's 2022 approval of CSL Behring and uniQure's etranacogene dezaparvovec, marketed as Hemgenix, an AAV vector-based gene therapy approved for the treatment of hemophilia B.

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In September 2025, Pfizer announced a long-term safety and efficacy follow-up for Hemophilia B patients previously enrolled in the C0371005 (formerly SPK-9001-101) trial. Additionally, the company is launching a dose-escalation sub-study to assess the safety, tolerability, and kinetics of a higher dose, along with extended safety and efficacy monitoring. Importantly, participation in the original C0371005 trial is not a requirement for this sub-study.

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In August 2025, Concizumab-mtci (Alhemo Registered ) has been approved by the US FDA as the first once-daily subcutaneous prophylactic therapy for patients aged 12 and above with hemophilia A or B without inhibitors, broadening its use beyond those previously limited to inhibitor cases.

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In July 2025, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Alhemo Registered (concizumab-mtci) injection as a once-daily prophylactic therapy to prevent or reduce bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B (HA/HB) without inhibitors. This decision expands on the December 2024 approval for patients with HA/HB with inhibitors. Currently, many therapies for HA/HB without inhibitors require intravenous administration; with this approval, Alhemo Registered provides a subcutaneous treatment alternative for this patient population.

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In April 2025, The FDA approved Qfitlia (fitusiran) for routine prophylaxis to help prevent or reduce bleeding episodes in patients aged 12 years and older with hemophilia A or B, regardless of the presence of factor VIII or IX inhibitors.

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In December 2024, Biopharma initiated the first-in-human Phase 1/2 clinical trial of BE-101, its innovative B-cell therapy for hemophilia B, with patient enrollment underway at two U.S. sites. BE-101, a first-of-its-kind treatment, seeks to address ongoing challenges faced by hemophilia B patients, including the burden of regular treatment and disease management, as many still experience frequent bleeding episodes. The two-part Phase 1/2 trial, named BeCoMe-9 (NCT06611436), is designed to evaluate the safety and clinical activity of a single intravenous infusion of BE-101 in adults with moderately severe to severe hemophilia B.

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In July 2024, CSL Behring has reported the treatment of two patients with HEMGENIX (etranacogene dezaparvovec) gene therapy for haemophilia B, a hereditary bleeding condition. The treatments were administered at haemophilia centres in France. HEMGENIX underwent extensive clinical development led by UniQure, with CSL Behring assuming sponsorship of the trials after acquiring global commercial rights to the therapy.

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Replacement therapy is the most widely used treatment for hemophilia B. In the U.S., several recombinant factor IX products are available, including BeneFIX, RIXUBIS, IXINITY, ALPROLIX, IDELVION, and REBINYN. Additionally, bypassing agents like Feiba, Novoseven, and SEVENFACT, along with human plasma-derived coagulation factor IX products such as AlphaNine SD and Mononine, have also received FDA approval.

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In 2023, the United States had the highest number of diagnosed prevalent cases of hemophilia B among the 7MM, with an estimated 4,000 cases. This number is anticipated to rise over the forecast period.

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In 2023, France reported the highest number of diagnosed prevalent cases of hemophilia B among the EU4 and the UK, whereas Germany had the lowest number of cases.

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Estimates show that in the US, hemophilia B was most commonly found in the 19-44 years age group, representing approximately 35% of the total cases.

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Key Hemophilia B Companies: Belief Biomed, ISU ABXIS, TiumBio, Be Biopharma, Regeneron Pharmaceuticals, Pfizer, Biocad, CSL Behring, Shanghai Vitalgen BioPharma, Baxalta, Amarna therapeutics, Catalyst Biosciences, Freeline Therapeutics, Belief BioMed, Centessa Pharmaceuticals, Novo Nordisk, Sanofi, Pfizer, and others

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Key Hemophilia B Therapies: BBM-H901, ISU304, TU7710, BE-101, REGV131, PF-06838435, ANB-002, AAV5-hFIXco-Padua, VGB-R04, AskBio009, AMA005, CB 2679d-GT, FLT180a, BBM-H901, SerpinPC, Concizumab, Fitusiran , PF-06, and others

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The lowest prevalent population of Hemophilia B were recorded in Spain

Hemophilia B Overview

Hemophilia B is a rare genetic bleeding disorder caused by a deficiency or dysfunction of clotting factor IX, a protein essential for blood clotting. It is an inherited condition, typically passed down through the X chromosome, affecting mostly males, while females are usually carriers. Individuals with Hemophilia B experience prolonged bleeding after injuries, surgeries, or spontaneously in severe cases. Common symptoms include frequent bruising, joint bleeds, and internal bleeding. Treatment involves replacing the missing factor IX through regular infusions or advanced gene therapies. Early diagnosis and proper management are crucial to improving quality of life and preventing complications.

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Hemophilia B Market

The dynamics of the Hemophilia B market are anticipated to change in the coming years owing to the expected launch of emerging therapies and others during the forecasted period 2020-2034.

Hemophilia B Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Hemophilia B Epidemiology Segmentation:

The Hemophilia B market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Total Prevalence of Hemophilia B

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Prevalent Cases of Hemophilia B by severity

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Gender-specific Prevalence of Hemophilia B

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Diagnosed Cases of Episodic and Chronic Hemophilia B

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Hemophilia B Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Hemophilia B market or expected to get launched during the study period. The analysis covers Hemophilia B market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Hemophilia B Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Hemophilia B Therapies and Key Companies

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BBM-H901: Belief Biomed

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ISU304: ISU ABXIS

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TU7710: TiumBio

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BE-101: Be Biopharma

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REGV131: Regeneron Pharmaceuticals

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PF-06838435: Pfizer

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ANB-002: Biocad

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AAV5-hFIXco-Padua: CSL Behring

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VGB-R04: Shanghai Vitalgen BioPharma

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AskBio009: Baxalta

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AMA005: Amarna therapeutics

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CB 2679d-GT: Catalyst Biosciences

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FLT180a: Freeline Therapeutics

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BBM-H901: Belief BioMed

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SerpinPC: Centessa Pharmaceuticals

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Concizumab: Novo Nordisk

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Fitusiran: Sanofi

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PF-06741086: Pfizer

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Hemophilia B Market Drivers

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Popularity of Gene Therapy

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Increased Focus on Prophylactic Treatment

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Development of Novel Treatments with extended half-life

Hemophilia B Market Barriers

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High Cost of Treatment

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Inconvenience and Scheduling Barriers

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Lack of Skilled Healthcare Professionals

Scope of the Hemophilia B Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Hemophilia B Companies: Belief Biomed, ISU ABXIS, TiumBio, Be Biopharma, Regeneron Pharmaceuticals, Pfizer, Biocad, CSL Behring, Shanghai Vitalgen BioPharma, Baxalta, Amarna therapeutics, Catalyst Biosciences, Freeline Therapeutics, Belief BioMed, Centessa Pharmaceuticals, Novo Nordisk, Sanofi, Pfizer, and others

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Key Hemophilia B Therapies: BBM-H901, ISU304, TU7710, BE-101, REGV131, PF-06838435, ANB-002, AAV5-hFIXco-Padua, VGB-R04, AskBio009, AMA005, CB 2679d-GT, FLT180a, BBM-H901, SerpinPC, Concizumab, Fitusiran , PF-06, and others

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Hemophilia B Therapeutic Assessment: Hemophilia B current marketed and Hemophilia B emerging therapies

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Hemophilia B Market Dynamics: Hemophilia B market drivers and Hemophilia B market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Hemophilia B Unmet Needs, KOL's views, Analyst's views, Hemophilia B Market Access and Reimbursement

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Table of Contents

1. Hemophilia B Market Report Introduction

2. Executive Summary for Hemophilia B

3. SWOT analysis of Hemophilia B

4. Hemophilia B Patient Share (%) Overview at a Glance

5. Hemophilia B Market Overview at a Glance

6. Hemophilia B Disease Background and Overview

7. Hemophilia B Epidemiology and Patient Population

8. Country-Specific Patient Population of Hemophilia B

9. Hemophilia B Current Treatment and Medical Practices

10. Hemophilia B Unmet Needs

11. Hemophilia B Emerging Therapies

12. Hemophilia B Market Outlook

13. Country-Wise Hemophilia B Market Analysis (2020-2034)

14. Hemophilia B Market Access and Reimbursement of Therapies

15. Hemophilia B Market Drivers

16. Hemophilia B Market Barriers

17. Hemophilia B Appendix

18. Hemophilia B Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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