Press release
Hypofibrinogenemia Market Trends: FDA Approval of Cryoprecipitate Alternatives Boosts Market Potential
Hypofibrinogenemia
Pfizer, Teva, Horizon Therapeutics, and Viatris lead with established fibrinogen concentrate and plasma derivative portfolios. Emerging players like Atamyo Therapeutics, Sarepta Therapeutics, and Asklepios BioPharmaceutical focus on advanced recombinant fibrinogen solutions. Companies including ML Bio Solutions, Genethon, and Edgewise Therapeutics are advancing novel gene and protein therapies through R&D investments and orphan drug development.
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Hypofibrinogenemia Market M&A & Strategic Collaborations
1. Pfizer-Atamyo Recombinant Fibrinogen Licensing Agreement
In June 2025, Pfizer secured exclusive rights to commercialize Atamyo's recombinant fibrinogen candidate, expanding its rare bleeding disorder portfolio through strategic licensing.
2. Horizon Partnerships for Global Access to Fibrinogen Concentrates
In May 2025, Horizon Therapeutics partnered with regional distributors across APAC and LATAM to scale the supply of fibrinogen products under compassionate use programs.
3. Sarepta Therapeutics Acquires Rare Hemostatic Startup
In July 2025, Sarepta acquired a small biotech specializing in gene-based fibrinogen replacement, strengthening its pipeline in rare coagulation disorders.
As per our analysis, these moves reflect a clear industry focus on strengthening recombinant fibrinogen access, expanding global distribution networks, and enhancing gene therapy innovation over traditional large-scale M&As.
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Key Growth Drivers & Emerging Opportunities in the Hypofibrinogenemia Market
• Rising incidence of trauma and surgical blood loss is increasing demand for rapid fibrinogen replacement therapy.
• Regulatory approvals of recombinant and concentrated fibrinogen products are offering safer, virus-free treatment alternatives.
• Advancement of point-of-care diagnostic tools and biomarker assays enables early detection and tailored therapy.
• Expansion of fibrinogen therapies in rare inherited bleeding disorders is supported by orphan drug incentives and patient advocacy.
• Strategic licensing and global distribution partnerships are improving market access in emerging regions and enhancing supply chain reach.
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Regional Market Drivers for the Hypofibrinogenemia Market
North America leads due to advanced surgical protocols, strong reimbursement frameworks, and widespread fibrinogen concentrate use.
Europe benefits from centralized blood product regulations, widespread adoption of recombinant alternatives, and strong donor networks.
Asia-Pacific shows rapid growth driven by expanding trauma and surgical care, regional manufacturing of plasma derivatives, and improving healthcare infrastructure.
Latin America sees increasing fibrinogen adoption through public-private collaborations and improved hospital supply chains.
The Middle East & Africa are emerging markets, supported by partnerships with global health agencies to enhance access to essential blood products.
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