The Fibrinogen Concentrate Market size in 2021 was USD 2.80 Billion, and it is projected to achieve a revenue CAGR of 6.1% during the forecast period. The growth of the market revenue is primarily attributed to factors such as the increasing utilization of fibrinogen concentrates in patients for the treatment of bleeding and Congenital Fibrinogen Deficiencies (CFD), as well as the rise in the number of approvals related to fibrinogen concentrate. Fibrinogen, a glycoprotein involved in the blood clotting process, is converted into fibrin using enzymes like thrombin, which promotes blood clotting to prevent excessive bleeding and hemorrhages. Fibrinogen concentrate is employed to address bleeding issues in patients lacking congenital fibrinogen. It can be individually tailored to prevent bleeding during surgical procedures and manage spontaneous or traumatic bleeding events in individuals with CFD. Previously, Fresh Frozen Plasma (FFP) or cryoprecipitate were used as substitutes for fibrinogen, but Human Fibrinogen Concentrate (FCH) has largely replaced them. Compared to FFP or cryoprecipitate, FCH offers the advantage of delivering a standardized dose of human plasma-derived fibrinogen in a small volume, reducing the risk of volume overload. Additionally, it decreases the risk of transfusion-related acute lung injury compared to FFP and undergoes viral inactivation, thus minimizing the likelihood of viral transmission. Guidelines recommend administering 50-100 mg/kg of FCH for significant bleeding/major surgery in CFD patients to maintain plasma fibrinogen levels above 1.0 g/L. Furthermore, individuals with a personal or family history of severe bleeding or fibrinogen levels below 0.1 g/L should consider long-term prophylaxis with FCH to maintain plasma fibrinogen levels above 0.5 g/L.

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Major Companies and Competitive Landscape:

Major players in the market include 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.

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The driving factors of the fibrinogen market include:

1. Increasing use in the treatment of bleeding and Congenital Fibrinogen Deficiencies (CFD): Fibrinogen concentrates are being increasingly used to address bleeding issues in patients with CFD, driving market growth.
2. Growth in approvals related to fibrinogen concentrate: The market is witnessing growth due to the rising number of approvals for fibrinogen concentrate, indicating its acceptance and effectiveness in medical practice.
3. Advantages over previous alternatives: Fibrinogen concentrates, such as Human Fibrinogen Concentrate (FCH), offer benefits over previous substitutes like Fresh Frozen Plasma (FFP) or cryoprecipitate. FCH provides a standardized dose in a smaller volume, reducing the risk of volume overload. It also lowers the risk of transfusion-related acute lung injury and undergoes viral inactivation, improving safety.
4. Individualized fibrinogen supplementation: Fibrinogen concentrates can be tailored to individual patients, allowing for personalized treatment plans. This individualization enhances the effectiveness of fibrinogen supplementation in preventing and treating bleeding events.

The restraints of the fibrinogen market include:

1. Limited awareness and accessibility: Despite the benefits of fibrinogen concentrates, there may be limited awareness among healthcare professionals and patients about their availability and usage. This lack of awareness can hinder market growth.
2. High cost: Fibrinogen concentrates can be expensive, which may limit their adoption, particularly in regions with budget constraints or healthcare systems that prioritize cost-effective treatments.
3. Regulatory challenges: Meeting regulatory requirements and obtaining approvals for fibrinogen concentrate products can be time-consuming and complex, potentially slowing down market growth.
4. Competing treatment options: While fibrinogen concentrates offer advantages over previous alternatives, other treatment options, such as cryoprecipitate, may still be available and widely used. The presence of competing options can pose challenges to the adoption and market penetration of fibrinogen concentrates.

It's important to note that market dynamics can change over time, and additional factors may emerge as driving forces or restraints in the future.

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An emerging trend in the market is the increasing use of fibrinogen concentrate for the treatment of Acquired Fibrinogen Deficiency (AFD). For instance, a clinical development program was initiated in 2011 to investigate the usage of high-purity human fibrinogen concentrate in congenital fibrinogen deficiency, serving as the initial step in Octapharma's ambitious clinical program aimed at treating AFD. AFD is caused by substantial blood loss resulting from major surgery or trauma, and there is a significant medical need for a licensed fibrinogen concentrate for this indication since cryoprecipitate is the only available option. The objective of this program was to demonstrate that their high-purity human fibrinogen concentrate is a more viable and reliable alternative to cryoprecipitate for AFD. After eight years of careful design, planning, and clinical trial execution by Octapharma's team, their high-purity human fibrinogen concentrate has now obtained approval for the treatment of AFD in 15 EU countries.

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