Press release
Future of Hypofibrinogenemia Market Growth Trends & Research Highlights | Most Leading Companies - Kedrion Biopharma Inc., Octapharma AG, LFB S.A., Shanghai RAAS Blood Products Co., Ltd, Hualan Biological Engineering Inc, China Biologic Products Holdings,
Hypofibrinogenemia
Bleeding disorders are conditions where the blood does not clot properly. In the UK, about 1 in 2,000 people are diagnosed with a bleeding disorder, most of which are inherited.
The most common type is von Willebrand disorder (VWD), which is more prevalent in women, with 7,625 women and 4,310 men diagnosed-though many more cases likely remain undiagnosed.
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Latest M&A & Investments
Major pharmaceutical M&A in 2025 includes Merck's acquisition of Verona Pharma and other biopharma deals that may indirectly impact the hypofibrinogenemia treatment landscape through expanded hemostasis portfolios.
Venture funding continues toward improved fibrinogen concentrates and rapid-acting hemostatic agents to address inherited and acquired fibrinogen deficiencie
List of Top Key Player:
CSL Behring, Grifols, S.A., Kedrion Biopharma Inc., Octapharma AG, LFB S.A., Shanghai RAAS Blood Products Co., Ltd, Hualan Biological Engineering Inc, China Biologic Products Holdings, Inc, Baxter International Inc, Sanquin among others
Latest Product Launches & Developments
Grifols announced its fibrinogen concentrate therapy BT524 is set for EU commercial launch in late 2025 and US approval anticipated in early 2026, offering a rapid, standardized alternative to cryoprecipitate and fresh-frozen plasma for acquired fibrinogen deficiency in surgery.
The therapy met primary endpoints in Phase III trials (AdFIrst study), showing non-inferiority to standard care and improved dosing accuracy and response times.
Novel fibrinogen replacement therapies and formulations for congenital and acquired hypofibrinogenemia are under development, focusing on better safety profiles and ease of administration.
Forecast Projection:
The Global Hypofibrinogenemia Market is poised for significant growth between 2025 and 2032. In 2024, the market maintained a steady upward trajectory, and with strategic initiatives by leading players accelerating adoption, the market is expected to soar throughout the forecast period. Companies leveraging these trends are well-positioned to capture emerging opportunities and maximize revenue potential.
Market Intelligence Research Process:
The Hypofibrinogenemia Market research report by DataM Intelligence combines primary and secondary data to deliver deep, actionable insights. It examines the full spectrum of factors shaping the industry, from government regulations and market conditions to competitive dynamics, historical trends, technological breakthroughs, upcoming innovations, and potential challenges. This comprehensive analysis not only highlights growth prospects but also identifies barriers, equipping businesses to navigate market volatility and capitalize on emerging opportunities.
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Key Segmentation:
Fibrinogen concentrates held 47.3% market share
By Treatment Type: (Fibrinogen Concentrates, Cryoprecipitate, Fresh Frozen Plasma (FFP))
By Application: (Congenital Hypofibrinogenemia, Acquired Hypofibrinogenemia, Others)
By End User: (Hospitals, Specialty Clinics, Research and Academic Institutes)
Global Growth Regional Analysis:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
Benefits of the Report:
Chapter 1 - Market Overview: Kickstarts the report with a comprehensive snapshot of the Hypofibrinogenemia Market, summarizing key segments by region, product type, and application. Highlights include market size, segment growth potential, and short- & long-term industry outlook.
Chapter 2 - Emerging Trends: Uncovers the game-changing trends and high-impact innovations shaping the future of the industry.
Chapter 3 - Competitive Landscape: Offers a deep dive into market competition, detailing revenue shares, strategic initiatives, and recent mergers & acquisitions.
Chapter 4 - Top Player Profiles: Features detailed company profiles, covering revenue, profit margins, product lines, and major milestones for leading market players.
Chapters 5 & 6 - Regional & Country Analysis: Breaks down revenue performance across global regions, providing insights on market sizes, opportunities, and growth prospects worldwide.
Chapter 7 - Segmentation Analysis: Explores market segmentation by type, revealing high-potential categories and guiding businesses towards lucrative areas.
Chapter 8 - Application Insights: Examines downstream markets and identifies promising sectors for expansion, showing how different applications are driving growth.
Chapter 9 - Supply Chain Mapping: Maps the entire industry supply chain, highlighting upstream and downstream activities for a holistic market perspective.
Chapter 10 - Key Takeaways: Concludes with critical insights and actionable strategies, equipping stakeholders to make informed decisions and stay ahead in the market.
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FAQ's
Q1: How fast is the Hypofibrinogenemia Market expected to grow in the coming years?
A: The market is forecast to expand at a robust High CAGR between 2025 and 2032, signaling strong global growth and investment potential.
Q2: Which regions are dominating the Hypofibrinogenemia Market and which are fastest-growing?
A: North America to capture 38.4% market share
Latest FDA Approvals & Pipeline Updates
No new hypofibrinogenemia-specific FDA approvals were recorded in the last 3 months; however, important fibrinogen repletion therapies like Grifols BT524 are advancing regulatory submissions and expected approvals in 2025-2026.
Selected novel hemostatic drugs and supportive therapies are in clinical phases for bleeding disorders, with regulatory discussions ongoing.
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Hypofibrinogenemia is a rare inherited or acquired bleeding disorder characterized by abnormally low levels of fibrinogen, a crucial protein involved in blood clot formation. Patients with this condition face prolonged bleeding, recurrent hemorrhages, and complications during surgery or childbirth. Although rare, the market for hypofibrinogenemia treatment is steadily growing due to advancements in fibrinogen replacement therapy, improved genetic diagnostics, and supportive healthcare policies for rare diseases.
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