Hemophilia B Pipeline Analysis Report 2026

Report Coverage

The Hemophilia B Pipeline Analysis Report by Expert Market Research gives comprehensive insights into hemophilia B therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for hemophilia B. The hemophilia B report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hemophilia B pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with hemophilia B treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to hemophilia B.

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Hemophilia B Pipeline Outlook

Hemophilia B is a rare, inherited bleeding disorder caused by a deficiency or dysfunction of coagulation factor IX. It occurs due to mutations in the F9 gene, leading to impaired blood clot formation. Affected individuals experience prolonged bleeding after injury, surgery, or spontaneous bleeding episodes.

Hemophilia B treatment includes factor IX replacement therapies, non-factor prophylactic agents, and emerging gene therapies to prevent bleeding, reduce complications, and improve long-term disease management. In March 2025, the U.S. Food and Drug Administration approved Qfitlia (fitusiran) for prophylactic treatment of hemophilia B, including patients with factor inhibitors. This RNA-based therapy reduces antithrombin levels, enabling sustained thrombin generation with less frequent subcutaneous dosing.

Hemophilia B Epidemiology

The pipeline continues to advance, supported by a well-defined epidemiological burden and unmet clinical needs. According to Alfarooq Alshaikhli et al., 2023, hemophilia occurs globally at a rate of 1 in 125,000, with Hemophilia B affecting 3.8 per 100,000 live males. As per the Great Lakes Hemophilia Foundation, the incidence in the United States is 1 in 19,283 male births. Additionally, Renuka Vasava et al., 2024 report a hemophilia B prevalence of 0.1 per 100,000 in India. These figures underscore sustained pipeline activity.

Hemophilia B – Pipeline Therapeutic Assessment

Hemophilia B Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase III covers a major share of the total hemophilia B clinical trials, accounting for 47%, highlighting strong late-stage development momentum that can accelerate market readiness. Phase I and phase II each contribute 22%, supporting innovation continuity.

Hemophilia B Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the hemophilia B pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides, and polymers. The hemophilia B report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hemophilia B. Gene therapy–based drugs are gaining significant traction in the Hemophilia B drug pipeline due to their potential for long-term disease control. For instance, BEQVEZ™ (fidanacogene elaparvovec-dzkt), an adeno-associated virus–based gene therapy, has been approved to enable endogenous factor IX production through a one-time administration, thereby reducing bleeding episodes and long-term prophylaxis burden.

Hemophilia B Clinical Trials – Key Players

The EMR report for the hemophilia B pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hemophilia B therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hemophilia B clinical trials:

• Biocad
• Be Biopharma
• Equilibra Bioscience LLC
• Pfizer
• CSL Behring
• Suzhou Alphamab Co., Ltd.
• Shanghai Xinzhi BioMed Co., Ltd.
• Regeneron Pharmaceuticals
• Novo Nordisk A/S
• Genzyme
• Sanofi

Hemophilia B – Emerging Drugs Profile

Key Questions Answered in the Hemophilia B Pipeline Insight Report

• Which companies/institutions are leading hemophilia B drug development?
• Which company is leading the hemophilia B pipeline development activities?
• What is the current hemophilia B commercial assessment?
• What are the opportunities and challenges present in the hemophilia B pipeline landscape?
• What is the efficacy and safety profile of hemophilia B pipeline drugs?
• Which company is conducting major trials for hemophilia B drugs?
• Which companies/institutions are involved in hemophilia B collaborations aimed at providing enhanced therapeutic alternatives for patients?
• What are the geographies covered for clinical trials in hemophilia B?

Reasons To Buy This Report

The Hemophilia B Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for hemophilia B. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into hemophilia B collaborations, regulatory environments, and potential growth opportunities.

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