Hemophilia B Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Pipeline, Revenue, Statistics, Epidemiology and Companies by DelveInsight

Hemophilia B companies are 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.
(Albany, USA) 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.

Request for sample report @ Hemophilia B Market Forecast [https://www.delveinsight.com/report-store/hemophilia-b-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

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.

To know in detail about the Hemophilia B market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: Hemophilia B Market Forecast [https://www.delveinsight.com/sample-request/hemophilia-b-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

Hemophilia B Overview

Hemophilia B, also known as Christmas disease, is a genetic bleeding disorder caused by a deficiency in clotting factor IX, a protein crucial for blood clotting. This condition is inherited in an X-linked recessive pattern, primarily affecting males while females typically carry the genetic mutation without displaying symptoms. Individuals with hemophilia B are prone to prolonged bleeding episodes, particularly after injury or surgery, due to the impaired ability of their blood to clot properly.

Symptoms of hemophilia B may include frequent nosebleeds, easy bruising, prolonged bleeding from cuts or injuries, and in severe cases, spontaneous bleeding into joints and muscles. The severity of symptoms varies depending on the level of factor IX deficiency, with those severely affected experiencing more frequent and severe bleeding episodes.

Treatment for hemophilia B typically involves replacement therapy with clotting factor IX concentrates to restore the missing or deficient clotting factor in the blood. This can be administered preventively to reduce the risk of bleeding (prophylactic therapy) or on-demand to manage bleeding episodes. In recent years, gene therapy has emerged as a promising approach for treating hemophilia B by introducing functional factor IX genes into the body to produce the missing clotting factor.

While there is currently no cure for hemophilia B, ongoing advancements in treatment options and management strategies have significantly improved the quality of life for individuals living with this condition. Additionally, preventive measures such as avoiding activities with a high risk of injury and maintaining regular medical follow-ups can help minimize complications associated with hemophilia B.

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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 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

The Hemophilia B drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Hemophilia B market or expected to be launched during the study period. The analysis covers the 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 collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Hemophilia B Market Strengths

* Continuous innovation in hemophilia B drugs, including gene therapies and extended half-life treatments, is improving patient outcomes and reducing treatment burden. These advancements drive market growth by offering more effective and long-lasting solutions.
* The hemophilia B market benefits from a robust pipeline of novel therapies, with multiple drug candidates receiving regulatory approvals. The introduction of breakthrough treatments enhances market expansion and provides patients with more therapeutic options.

Hemophilia B Market Weaknesses

* Hemophilia B drugs, particularly gene therapies and recombinant factor IX treatments, are expensive, limiting access for many patients. The high cost of lifelong treatment poses a significant economic burden on healthcare systems and individuals.
* Despite advancements, hemophilia B remains underdiagnosed in many regions due to limited awareness and access to specialized healthcare. Delayed diagnosis and inadequate treatment can lead to severe complications, impacting disease management and market penetration.

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

To learn more about the key players and advancements in the Hemophilia B Treatment Landscape, visit the Hemophilia B Market Analysis Report [https://www.delveinsight.com/sample-request/hemophilia-b-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=apr]

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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