Hemophilia B Market Outlook 2034 - Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

Hemophilia B companies include 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.
Hemophilia B Market Summary

The Hemophilia B market size in the 7MM was ~USD 3.4 billion in 2023, with the US as the largest contributor. Current treatments mainly include replacement therapy with recombinant factor IX products (e.g., BeneFIX, RIXUBIS, IXINITY, ALPROLIX, IDELVION, REBINYN), bypassing agents (Feiba, Novoseven, SEVENFACT), and plasma-derived options (AlphaNine SD, Mononine).

The gene therapy space has transformed the market, led by CSL/uniQure's HEMGENIX, approved in November 2022 as the first gene therapy for hemophilia B, priced at USD 3.5M per dose. In April 2024, Pfizer's BEQVEZ became the second approved gene therapy, priced at the same level.

The pipeline is diverse, with extended half-life therapies, siRNA, antibodies, and additional gene therapies in development. Key players include Centessa, Sanofi/Alnylam, Pfizer/Spark, Novo Nordisk, among others. Recent milestones include Pfizer's Marstacimab, with FDA and EMA reviews ongoing, and a PDUFA decision expected in late 2024. Other upcoming therapies like FITUSIRAN (Sanofi), Marstacimab (Pfizer), and SerpinPC (Centessa) are expected to expand the market. Driven by new launches, rising prevalence, prophylactic use, and the adoption of gene therapies, the Hemophilia B market in the 7MM is set for strong growth through 2034.

DelveInsight's "Hemophilia B Market Insight, 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 the United Kingdom) and Japan. The hemophilia B market is steadily advancing, driven by evolving treatment strategies and ongoing research. DelveInsight's latest 7MM report offers in-depth insights into key epidemiology trends and market dynamics.

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

* The Hemophilia B market size is anticipated to grow with a significant CAGR during the study period (2020-2034).
* In 2023, Hemophilia B Market size was ~USD 3400 Million in 7MM. Among the 7MM, the United States accounted for the highest market size.
* The most common treatment for hemophilia B is replacement therapy. BeneFIX, RIXUBIS, IXINITY, ALPROLIX, IDELVION, and REBINYN are the some available recombinant factor IX products in the US.
* Apart from these, bypassing agents such as Feiba, Novoseven, and SEVENFACT and human plasma-derived coagulation factor IX - AlphaNine SD and Mononine have bagged the FDA approval as well.
* The advent of gene therapies brings the potential for curing patients with Hemophilia B. HEMGENIX, an approved gene therapy for Hemophilia B in November 2022, carries an astonishing price tag of USD 3.5 million per dosage, making it the most expensive medication worldwide and marking the first gene therapy to be approved for this rare disease.
* The most recent development in hemophilia B is the addition of Pfizer's BEQVEZ, another gene therapy approved in April 2024 for the treatment of hemophilia B.
* Pfizer is the second company in the indication, trailing CSL and uniQure's HEMGENIX for hemophilia B treatment. Despite having the opportunity to offer a lower price than its competitor, Pfizer opted to price its drug, BEQVEZ, at the same USD 3.5 million.
* Hemophilia B market has diverse pipeline such as extended half-life therapies, siRNA, antibodies and gene therapy. These therapies are expected to provide the patient convenient route of administration and longer treatment duration.
* Recently, in December 2023, the US FDA has accepted BLA for Pfizer's Marstacimab treating hemophilia A or B without inhibitors to Factor VIII (FVIII) or Factor IX (FIX). The European MAA for marstacimab also passed validation and is currently under review by the EMA. The Prescription Drug User Fee Act (PDUFA) action date is in the fourth quarter of 2024, and the decision from the European Commission is anticipated by the first quarter of 2025.
* Expected launch of potential therapies, FITUSIRAN (Sanofi), Marstacimab (Pfizer), SerpinPC (Centessa Pharmaceuticals and others may increase the market size in the coming years, assisted by an increase in the prevalent population of hemophilia B. In addition to this, gaining popularity of gene therapies and increased focus on prophylactic treatment will boast the market 7MM during the forecast period (20242034).
* Leading companies in the Hemophilia B market include 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.
* Key Hemophilia B Therapies: BEQVEZ (fidanacogene elaparvovec-dzkt), HEMGENIX (etranacogene dezaparvovec-drlb), Fitusiran, PF-06741086 (Marstacimab), 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.
* In April 2025, the FDA approved Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 and older with hemophilia A or B, with or without factor VIII or IX inhibitors.
* 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.
* In December 2024, Novo announced that the FDA approved concizumab, its tissue factor pathway inhibitor (TFPI) antagonist, as a once-daily treatment to prevent or reduce bleeding episodes in patients aged 12 and older with hemophilia A or B with inhibitors.
* In October 2024, Pfizer Inc. announced that the FDA has approved HYMPAVZI Trademark (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A or B, without FVIII or FIX inhibitors.
* In October 2024, Novo Nordisk received support from European regulators for the approval of its anti-TFPI antibody, Alhemo (concizumab), as a preventive treatment for hemophilia. The company stated that, if approved, this therapy would provide the first subcutaneous prophylactic treatment to be administered once daily for individuals with hemophilia A or B who have inhibitors.

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Hemophilia B Overview

Hemophilia B (Christmas disease) is a rare genetic bleeding disorder caused by a factor IX deficiency, inherited in an X-linked recessive pattern, mainly affecting males.

* Symptoms: Easy bruising, frequent nosebleeds, prolonged bleeding, and in severe cases, spontaneous bleeding into joints and muscles. Severity depends on factor IX levels.
* Treatment: Primarily replacement therapy with factor IX concentrates (prophylactic or on-demand). Gene therapy is an emerging option offering long-term potential.
* Management: No permanent cure yet, but advancements in therapies and preventive strategies (avoiding high-risk activities, regular follow-ups) greatly improve quality of life.

Hemophilia B Epidemiology

In 2023, the US had the highest number of diagnosed prevalent Hemophilia B cases (~4,000) among the 7MM, with numbers expected to rise. Within the EU4 and the UK, France reported the most cases, while Germany had the fewest. In the US, the 19-44 age group accounted for ~35% of cases, and ~40% were classified as mild.

Hemophilia B Epidemiology Segmentation:

The Hemophilia B epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by:

* Total Diagnosed Prevalent Cases of Hemophilia B in the 7MM
* Severity-Specific Prevalent Cases of Hemophilia B in the 7MM
* Age-Specific Prevalent Cases of Hemophilia B in the 7MM
* Prevalent Cases of Hemophilia B with or without Inhibitors in the 7MM
* Treated Patient Pool of Hemophilia B in the 7MM

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Hemophilia B Drugs Uptake, and Pipeline Development Activities

Fitusiran (Sanofi/Alnylam)

* Type: Subcutaneous siRNA therapy targeting antithrombin.
* Mechanism: Silences the antithrombin gene, reducing its anticoagulant effect and restoring clotting balance in hemophilia A & B.
* Advantage: Increased potency & durability via Alnylam delivery tech, with under-the-skin injection.
* Clinical Status: Phase III studies (published Apr 2023, The Lancet) - achieved primary & secondary endpoints, showing potential across all hemophilia types.

Marstacimab (Pfizer, PF-06741086)

* Type: Subcutaneous monoclonal antibody (IgG1) targeting TFPI (Kunitz 2 domain).
* Mechanism: Preventive non-factor therapy to reduce bleeding frequency in severe hemophilia A & B, with or without inhibitors.
* Administration: Mainly subcutaneous; Phase II tested SC & IV routes.
* Clinical Status: Phase III trial (NCT03938792) ongoing. Expected to show clinically meaningful benefit vs. factor replacement, especially in patients with inhibitors.

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Hemophilia B Market Drivers

* Rising Prevalence & Diagnosis - Increasing diagnosed cases across the 7MM, with improved awareness and screening.
* Advances in Treatment Options - Expansion of recombinant factor IX, extended half-life therapies, and prophylactic treatment adoption.
* Gene Therapy Innovation - Approvals like HEMGENIX and BEQVEZ highlight curative potential and long-term treatment benefits.
* Pipeline Expansion - Active R&D in siRNA, antibodies, and novel therapies from major players (Pfizer, Sanofi, Novo Nordisk, Centessa).
* Regulatory Support & Fast-Track Approvals - BLA/MAA acceptances (e.g., Pfizer's Marstacimab) accelerate market access.
* Improved Quality of Life - Focus on reducing bleeding frequency and offering patient-convenient routes of administration.

Hemophilia B Market Barriers

* High Cost of Therapies - Gene therapies priced at USD 3.5M per dose (HEMGENIX, BEQVEZ) pose affordability and access challenges.
* Limited Patient Pool - Being a rare disease, the overall prevalence is low, restricting market size despite high per-patient costs.
* Treatment Burden - Replacement therapies require frequent infusions, impacting compliance and patient convenience.
* Uncertain Long-Term Outcomes of Gene Therapy - Durability of effect and potential safety issues remain under scrutiny.
* Healthcare System Constraints - Reimbursement hurdles and varied access across geographies slow widespread adoption.
* Competition & Market Saturation - Multiple players and similar pricing strategies may limit differentiation and uptake.

Scope of the Hemophilia B Market Report

* Study Period: 2020-2034
* Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
* Key Hemophilia B Therapies: Fitusiran, Marstacimab, SerpinPC, and others.
* Key Hemophilia B Companies: 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.
* Hemophilia B Therapeutic Assessment: Hemophilia B currently marketed and Hemophilia B emerging therapies
* Hemophilia B Market Dynamics: Hemophilia B market drivers and Hemophilia B market barriers
* Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
* 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 business growth and overcome challenges with a practical approach.

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