Market Overview The market size for fibrinogen concentrate reached USD 2.80 Billion in 2021, with an anticipated revenue Compound Annual Growth Rate (CAGR) of 6.1% throughout the forecast period. The growth is primarily fueled by the increasing utilization of fibrinogen concentrates in treating bleeding disorders, such as Congenital Fibrinogen Deficiencies (CFD), and the surge in approvals related to fibrinogen concentrate. Fibrinogen, a glycoprotein crucial in the blood clotting process, is converted into fibrin through enzymes like thrombin, preventing excessive bleeding. Fibrinogen concentrate is employed to address bleeding issues in patients lacking congenital fibrinogen, offering a standardized dose with lower risk compared to alternatives like Fresh Frozen Plasma (FFP) or cryoprecipitate.
Furthermore, a noteworthy trend in the market involves the growing use of fibrinogen concentrate to treat Acquired Fibrinogen Deficiency (AFD). A clinical program initiated in 2011 explored the efficacy of high-purity human fibrinogen concentrate in treating AFD, leading to successful approval for AFD treatment in 15 EU countries after eight years of comprehensive development.
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Market Dynamics
Driver: The rise in awareness and health concerns is a key factor propelling market growth. As health needs evolve, there is a heightened demand for high-quality treatments, including fibrinogen concentrate, driving market revenue.
Restraint: Adverse reactions such as arterial thrombosis, chills, dyspnea, nausea, vomiting, and pulmonary embolism are limiting market growth. These reactions emphasize the importance of careful administration and monitoring during fibrinogen concentrate use.
Type Insights
The global fibrinogen concentrate market is segmented into human fibrinogen concentrates and animal fibrinogen concentrates.
- The human fibrinogen concentrates segment is expected to witness rapid revenue growth, driven by its effectiveness in treating congenital fibrinogen deficiency and its safety profile.
- The animal fibrinogen concentrates segment is projected to experience swift revenue growth due to the increasing use of bovine fibrinogen, particularly in hemostatic therapy research.
Application Insights
The market is categorized based on application into congenital fibrinogen deficiency and surgical procedures.
- The congenital fibrinogen deficiency segment is anticipated to exhibit rapid revenue growth, with fibrinogen supplementation being a predominant treatment for CFD. This condition is characterized by decreased levels or malfunctioning fibrinogen, and human fibrinogen concentrate has proven effective for on-demand therapy and surgical prophylaxis.
- The surgical procedures segment is expected to see accelerated revenue growth, especially in major surgeries where human fibrinogen concentrate is effective in managing blood loss and maintaining hemostasis.
Regional Insights
- North America is poised to account for the largest revenue share, attributed to increased activities incorporating fibrinogen concentrate in treatments. The National Hemophilia Foundation in the U.S. has updated treatment guidelines to include fibrinogen concentrate, reinforcing its prominence.
- The Asia Pacific market is expected to register rapid revenue growth due to escalating research and development activities, such as the extraction of human fibrinogen from blood plasma, improving manufacturing procedures.
- Europe is projected to witness steady revenue growth, with key market players actively engaged in clinical trials and initiatives. Biotest AG's successful completion of the Adjusted Fibrinogen Replacement Strategy (AdFIrst) experiment for acquired fibrinogen insufficiency is a notable development.
Competitive Landscape
The global fibrinogen concentrate market's competitive landscape is fragmented, with key players such as CSI, Baxter, LFB Group, ProFibrix BV, Shanghai RAAS, Jiangxi Boya Bio Pharmaceutical, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical Co., Ltd., Green Cross, and Shanghai Xinxing Medicine Co. Ltd. actively participating in product development and strategic alliances to expand their market presence.
Initiatives such as FDA approvals for pediatric critical care products and the rebranding of business divisions by CSL contribute to market growth. Overall, the market showcases a dynamic and evolving landscape with key players adapting to emerging trends and demands.
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