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Hemophilia B Market is projected to reach USD 9.81 billion by 2034

12-09-2025 12:05 PM CET | Health & Medicine

Press release from: Exactitude Consultancy

Hemophilia B

Hemophilia B

The global Hemophilia B Market was valued at USD 4.76 billion in 2024 and is projected to reach USD 9.81 billion by 2034, growing at a CAGR of 7.5% during the forecast period (2025-2034). The market is expanding rapidly due to increasing access to factor IX replacement therapies, adoption of long-acting recombinant products, significant improvements in diagnostic capabilities, and strong momentum in curative gene therapy.

Download Full PDF Sample Copy of Market Report @ https://exactitudeconsultancy.com/request-sample/71654

Hemophilia B is a rare X-linked recessive bleeding disorder caused by deficiency or dysfunction of coagulation factor IX. The condition affects approximately 1 in 25,000-30,000 male births globally. Improved newborn screening, enhanced global hemophilia registry coverage, and better clinical awareness have expanded the diagnosed patient pool. Treatment primarily involves factor IX replacement therapy, prophylactic dosing, and management of bleeding episodes, while gene therapy is emerging as a transformative approach with long-term factor expression.

Key Market Highlights
• 2024 Market Size: USD 4.76 billion
• 2034 Forecast: USD 9.81 billion
• CAGR (2025-2034): 7.5%
• Highest Revenue Segment: Extended half-life (EHL) recombinant factor IX therapies
• Breakthrough Area: AAV gene therapy

Market Growth Drivers
1. Increasing Global Access to Factor IX Replacement Therapy
The introduction of:
• Standard half-life (SHL) factor IX
• Extended half-life (EHL) factor IX
• Recombinant factor IX (rFIX)
has significantly improved treatment outcomes and prophylaxis adoption.
2. Breakthrough of Gene Therapy for Hemophilia B
AAV-based FIX gene therapies can provide sustained endogenous factor production, reducing or eliminating the need for frequent infusions.
3. Strong Improvements in Diagnosis & Screening
Early diagnosis through:
• Newborn screening programs
• Coagulation testing
• Genetic testing for FIX mutations
has expanded the treatment-eligible population.
4. Rising Healthcare Spending in Developing Regions
Emerging markets are increasingly adopting prophylactic therapy as part of national rare-disease programs.
5. Improved Patient Survival & Long-Term Management
Advances in treatment have improved quality of life and increased lifespan, expanding demand for lifelong care.

Market Restraints
• Very high cost of recombinant factor IX and gene therapy
• Limited access to prophylaxis in low-resource regions
• Complications including inhibitor development (rare in Hemophilia B but clinically significant)
• Safety and long-term durability concerns regarding gene therapy
• Reimbursement challenges for innovative therapies

Market Opportunities
1. Expansion of Gene Therapy Programs
With additional late-stage trials underway, the next decade will see significant commercialization opportunities.
2. Ultra-Long-Acting FIX Therapies
Novel albumin-fusion and Fc-fusion technologies aim to reduce dosing frequency dramatically.
3. Growth in Home Infusion & Digital Monitoring
Remote patient monitoring and self-infusion therapy models improve adherence and disease control.
4. Increasing Adoption of Personalized Prophylaxis
PK-driven individualized dosing strategies are gaining acceptance.
5. Untapped Potential in Asia, Latin America & Africa
Improving healthcare infrastructure is creating new markets for prophylaxis.

Segmentation Overview
By Therapy Type
• Recombinant FIX (rFIX)
• Plasma-derived FIX
• Extended half-life FIX therapies
• Non-factor therapies (pipeline)
• Gene therapy (AAV)

By Severity
• Mild Hemophilia B
• Moderate Hemophilia B
• Severe Hemophilia B

By Treatment Approach
• On-demand treatment
• Prophylaxis therapy
• Gene therapy

By End User
• Hospitals
• Hemophilia treatment centers (HTCs)
• Specialty infusion clinics
• Homecare settings

Explore Full Report here: https://exactitudeconsultancy.com/reports/71654/hemophilia-b-market

Regional Insights
North America - Largest Market
High diagnosis rates, strong reimbursement systems, availability of advanced rFIX products, and early adoption of gene therapy support dominance.
Europe - Strong Clinical Infrastructure
Well-established HTCs, standardized care protocols, and active rare-disease research networks drive growth.
Asia Pacific - Fastest-Growing Region
Large undiagnosed populations, improving diagnosis, and rising healthcare funding create strong future demand.
Latin America & Middle East/Africa - Emerging Markets
Limited access remains a challenge, but government support and partnerships with global hemophilia foundations are expanding therapy reach.

Competitive Landscape
Key companies active in the Hemophilia B market include:
• Pfizer (BeneFIX)
• CSL Behring (Idelvion)
• Novo Nordisk (Rebinyn)
• Takeda
• Sanofi
• Bayer
• BioMarin
• UniQure (gene therapy)
• Spark Therapeutics
• Catalyst Biosciences
• Roche (non-factor therapy research)
These companies lead in rFIX development, long-acting factor engineering, gene therapy programs, and inhibitor management.

Recent Market Developments
• Commercialization of AAV-mediated factor IX gene therapies
• Launch of novel extended half-life rFIX products
• Expansion of global hemophilia registries for real-world evidence
• Progress in non-factor therapies targeting coagulation pathways
• Increased government support for rare hematology disorders

Future Outlook (2025-2034)
The Hemophilia B Market is heading toward a transformative decade characterized by:
• Broader access to gene therapy and long-term follow-up data
• Evolution toward ultra-long-acting FIX therapies enabling monthly or less frequent dosing
• Growth in home infusion and digital treatment monitoring
• Improved diagnosis in emerging markets
• Integration of pharmacokinetic modeling for personalized prophylaxis
With high unmet need and rapidly advancing treatment innovation, the market is expected to nearly double-from USD 4.76 billion in 2024 to USD 9.81 billion by 2034-signaling strong growth potential across the global hematology landscape.

This report is also available in the following languages : Japanese (血友病B市場), Korean (혈우병 B 시장), Chinese (B型血友病市场), French (Marché de l'hémophilie B), German (Hämophilie-B-Markt), and Italian (Mercato dell'emofilia B), etc.

Request for a sample of this research report at (Use Corporate Mail ID for Quick Response) @ https://exactitudeconsultancy.com/request-sample/71654

Our More Reports:

Von Willebrand disease Market
https://exactitudeconsultancy.com/reports/71676/von-willebrand-disease-market

Acquired hemophilia A Market
https://exactitudeconsultancy.com/reports/71070/acquired-hemophilia-a-market

Hemophilia Market
https://exactitudeconsultancy.com/reports/71268/hemophilia-market

Coagulation Factor Deficiency Market
https://exactitudeconsultancy.com/reports/71276/coagulation-factor-deficiency-market

About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
https://bulletin.exactitudeconsultancy.com/

https://www.thehealthanalytics.com/

https://www.analytica.global/

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https://www.marketinsightsreports.com/

https://exactitudeconsultancy.com/

Connect Us:
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PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com

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