Fibrinogen Concentrate Market

Fibrinogen Concentrate Market by Product Type (Human Fibrinogen Concentrate and Animal Derived Fibrinogen Concentrate), Application (Congenital Fibrinogen Deficiency, Surgical Procedures, and Research), End-User (Hospitals, Ambulatory Surgical Centers, and Research Institutes), and Geography (United States, Japan, United Kingdom, Germany, France, Italy, and Spain) is expected to grow at a CAGR of 6.14% forecast till 2032 owing to the rising cases of bleeding disorders, such as congenital fibrinogen deficiencies and acquired conditions like postpartum hemorrhage (PPH) and liver diseases, are driving the demand for fibrinogen concentrate as a reliable treatment to restore clotting function.

7MM fibrinogen concentrate market was valued at USD 618.73 million in 2024 and will grow at a CAGR of 6.14% during the forecast period from 2025 to 2032 to reach USD 992.23 million by 2032. The rising cases of bleeding disorders, such as congenital fibrinogen deficiencies and acquired conditions like postpartum hemorrhage (PPH) and liver diseases, are driving the demand for fibrinogen concentrate as a reliable treatment to restore clotting function. Additionally, the increase in trauma incidents and the growing number of complex surgeries, including cardiac procedures and organ transplants, heighten the need for effective bleeding management solutions. Fibrinogen concentrate offers a rapid, targeted response, making it a preferred choice in critical care settings. Together, these factors contribute to the expanding use and development of fibrinogen concentrate during the forecast period from 2025 to 2032.

Fibrinogen Concentrate Market Dynamics:

The rising cases of bleeding disorders is driving the growth of the fibrinogen concentrate market, as these conditions require effective management to prevent life-threatening hemorrhages. Congenital disorders like afibrinogenemia and hypofibrinogenemia need lifelong fibrinogen replacement, ensuring consistent demand. As per the data provided by the National Organization for Rare Disorders (2023), congenital afibrinogenemia is a very rare disorder that affected approximately one in a million people. Males and females are equally affected. 

According to the study published, entitled, “Congenital fibrinogen disorders: a retrospective clinical and genetic analysis of the Prospective Rare Bleeding Disorders Database”, (2024), a total of 166 CFD cases from 16 countries were included, of whom 123 (30 afibrinogenemia, 33 hypofibrinogenemia, 55 dysfibrinogenemia, and 5 hypodysfibrinogenemia) were well characterized. 86 patients received treatment (69 on-demand and/or 17 on prophylaxis), with fibrinogen concentrates being the most frequently used product. 

Afibrinogenemia and hypofibrinogenemia are rare bleeding disorders where fibrinogen is either absent or deficient, leading to severe bleeding episodes, especially during birth, surgery, or trauma. These conditions require lifelong fibrinogen replacement therapy to prevent life-threatening hemorrhages. The consistent need for effective management and timely treatment of these disorders is driving the growth of the fibrinogen concentrate market.

Thus, the fibrinogen concentrate offers a faster, more reliable, and pathogen-free solution compared to traditional treatments like fresh frozen plasma (FFP) or cryoprecipitate, making it the preferred choice in many hospitals and trauma centers.

Additionally, the increase in trauma cases and surgical procedures is significantly boosting the growth of the fibrinogen concentrate market due to the critical role fibrinogen plays in achieving hemostasis and preventing excessive blood loss. Trauma and major surgeries often lead to massive bleeding, rapidly depleting fibrinogen levels and requiring immediate fibrinogen replacement to restore proper clot formation and prevent life-threatening hemorrhages.

According to the data provided by the Government of UK (2023), in 2023, there were 1,624 fatalities, 29,711 killed or seriously injured (KSI) casualties, and 132,977 casualties of all severities.

Additionally, according to the World Health Organization (WHO) 2023 data, road traffic crashes cause non-fatal injuries in approximately 20 to 50 million people globally each year. Severe trauma, including road accidents, industrial injuries, and battlefield injuries, often leads to massive blood loss, resulting in acute fibrinogen depletion. 

Since fibrinogen is the first clotting factor to drop to critically low levels, this increases the risk of uncontrolled bleeding and mortality. Early fibrinogen replacement using fibrinogen concentrate plays a pivotal role in trauma resuscitation, significantly improving survival rates.

Additionally, the World Health Organization (2023), estimates that over 300 million surgical procedures are performed annually worldwide, including cardiac, orthopedic, and trauma-related surgeries. These procedures present a high risk of intraoperative and postoperative bleeding, frequently leading to acquired fibrinogen deficiency. Given fibrinogen's crucial role in blood clot formation, its rapid replacement is essential for preventing excessive bleeding and ensuring better patient recovery.

Furthermore, organ transplantation is a complex surgical process that often involves extensive blood loss, making fibrinogen replacement essential for improving patient outcomes. According to the data provided by the United Network for Organ Sharing Organization (2025), in the United States approximately, 104,501 people need a lifesaving organ transplant (total waiting list candidates). Of those, 58,453 people are active waiting list. Additionally, as per the same source, 10,000 liver transplant were performed in 2023.

Organ transplants, especially liver transplants, carry a high risk of severe bleeding due to the liver’s crucial role in producing fibrinogen. When the liver is damaged or removed, fibrinogen levels drop sharply, leading to impaired clotting and life-threatening hemorrhage. In such cases, fibrinogen concentrate is administered to quickly restore clotting function, reducing bleeding risks. As the number of organ transplants rises, the demand for fibrinogen concentrate is increasing, driving market growth.

Thus, the above mentioned factors are expected to boost the market of fibrinogen concentrate as the increasing adoption of fibrinogen concentrate over traditional blood products (such as cryoprecipitate) due to its pathogen safety, faster preparation time, and standardized fibrinogen content is also contributing to market expansion.

Thus, the factors mentioned above are expected to boost the overall market of fibrinogen concentrate across the globe during the forecast period from 2025 to 2032.

However, Several alternatives to fibrinogen concentrate may hinder its market growth by offering different approaches to managing bleeding disorders and fibrinogen deficiencies. Key alternatives are Fresh Frozen Plasma (FFP), Cryoprecipitate, Recombinant Clotting Factors, Tranexamic Acid (TXA), and Prothrombin Complex Concentrate (PCC).

Fibrinogen Concentrate Market Segment Analysis:

Fibrinogen Concentrate Market by Product Type (Human Fibrinogen Concentrate and Animal Derived Fibrinogen Concentrate), Application (Congenital Fibrinogen Deficiency, Surgical Procedures, and Research), End-User (Hospitals, Ambulatory Surgical Centers, and Research Institutes), and Geography (United States, Japan, United Kingdom, Germany, France, Italy, and Spain)  

The human fibrinogen concentrate category in the fibrinogen concentrate market was holds the largest share of 86.72% in 2024 and will grow at a CAGR of 6.20% during the forecast period from 2025 to 2032. 

This growth is primarily driven by the widespread clinical applications, advantages, and established use of human fibrinogen concentrate in managing bleeding disorders. Unlike fresh frozen plasma (FFP) or cryoprecipitate, fibrinogen concentrate offers a precise, rapid, and controlled increase in fibrinogen levels, eliminating variability in fibrinogen content. Additionally, it does not require blood type matching, allowing for immediate administration in emergency settings.

Another key factor contributing to its adoption is its safety profile. Human fibrinogen concentrate is derived from screened human plasma and undergoes viral inactivation steps, significantly reducing the risk of infections compared to traditional blood-derived products.

The product is widely used in managing trauma-induced coagulopathy, postpartum hemorrhage, cardiac surgery, congenital fibrinogen deficiencies, and other coagulation disorders, underscoring its broad clinical utility. Furthermore, the growing number of regulatory approvals is expected to expand market penetration.

For instance, in September 2024, Octapharma USA, Inc. received expanded FDA approval for Fibryga® (Fibrinogen [Human] Lyophilized Powder for Reconstitution) for treating acquired fibrinogen deficiency (AFD) in bleeding patients. This regulatory milestone strengthens the availability and accessibility of fibrinogen concentrate in clinical practice.

Given these factors, the human fibrinogen concentrate segment is expected to drive substantial revenue growth, reinforcing its dominant position in the overall fibrinogen concentrate market during the forecast period.

United States is expected to dominate the overall fibrinogen concentrate market:

Among all regions, United States is estimated to hold the largest share of 63.88% in the 7MM fibrinogen concentrate market in 2024, growing at a CAGR of 5.79% during the forecast period from 2025 to 2032. The United States is poised to lead the fibrinogen concentrate market, driven by the increasing number of road accidents and surgical procedures, along with rising product approvals and launches.

According to the Centers for Disease Control and Prevention (CDC, 2024), over 2.6 million emergency department visits in 2022 were attributed to motor vehicle crash-related injuries. Additionally, data from the Registry of Transplant Recipients indicates that liver transplant procedures in the U.S. reached an all-time high of 9,527 in 2022 marking a 52% increase over the past decade (2012–2022).

The rising incidence of road injuries and liver transplants leads to severe blood loss and coagulopathy, often resulting in fibrinogen depletion, which is critical for blood clot formation. Fibrinogen concentrate plays a crucial role in trauma and emergency care by enabling rapid bleeding control and improving survival rates. As road accidents continue to rise, the demand for fibrinogen concentrate in hospitals and trauma centers is expected to grow significantly.

Furthermore, increasing regulatory approvals are set to drive market expansion. In August 2024, the U.S. Food and Drug Administration (FDA) granted expanded approval for fibryga®, a fibrinogen (human) lyophilized powder for reconstitution manufactured by Octapharma USA, Inc. This approval extends fibryga®'s use to include fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD).

Considering these factors, the U.S. fibrinogen concentrate market is projected to experience substantial growth throughout the forecast period from 2025 to 2032.

Fibrinogen Concentrate Market Key Players:

Some of the key market players operating in the fibrinogen concentrate market include CSL Behring, Octapharma, Innovative Research, Valiant Co., LTD. (MP Biomedicals), Enzo Biochem Inc., and Intas Pharmaceuticals Ltd.

Recent Developmental Activities in the Fibrinogen Concentrate Market:

• In September, 2024: Octapharma USA, Inc. announced that the U.S. FDA has expanded the approval of fibryga® (Fibrinogen [Human] Lyophilized Powder for Reconstitution) for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD). As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate, fibryga® offers a faster, more precise alternative to the current standard of care, cryoprecipitate, in severe bleeding situations.

Key Takeaways From the Fibrinogen Concentrate Market Report Study

• Market size analysis for current fibrinogen concentrate size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies operating in the fibrinogen concentrate market.
• Various opportunities available for the other competitors in the fibrinogen concentrate market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing countries in the current fibrinogen concentrate market scenario?
• Which are the countries where companies should have concentrated on opportunities for fibrinogen concentrate market growth in the coming future?

Target Audience Who Can be Benefited from this Fibrinogen Concentrate Market Report Study

• Fibrinogen Concentrate product providers
• Research organizations and consulting companies 
• Fibrinogen Concentrate -related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in fibrinogen concentrate 
• Various end-users who want to know more about the fibrinogen concentrate market and the latest technological developments in the fibrinogen concentrate market.

Frequently Asked Questions for the Fibrinogen Concentrate Market:

1. What are fibrinogen concentrate?

• Fibrinogen Concentrate is a purified, plasma-derived medication used to replace fibrinogen (Factor I) in patients with congenital or acquired fibrinogen deficiency. Fibrinogen is a key protein in the blood clotting process, and its deficiency can lead to excessive bleeding.

2. What is the market for fibrinogen concentrate?

• 7MM fibrinogen concentrate market was valued at USD 618.73 million in 2024 and will grow at a CAGR of 6.14% during the forecast period from 2025 to 2032 to reach USD 992.23 million by 2032. 

3. What are the drivers for the 7MM fibrinogen concentrate market?

• The rising cases of bleeding disorders, such as congenital fibrinogen deficiencies and acquired conditions like postpartum hemorrhage (PPH) and liver diseases, are driving the demand for fibrinogen concentrate as a reliable treatment to restore clotting function. Additionally, the increase in trauma incidents and the growing number of complex surgeries, including cardiac procedures and organ transplants, heighten the need for effective bleeding management solutions. Fibrinogen concentrate offers a rapid, targeted response, making it a preferred choice in critical care settings, thereby boosting its market growth. Together, these factors contribute to the expanding use and development of fibrinogen concentrate worldwide during the forecast period from 2025 to 2032.

4. Who are the key players operating in the 7MM fibrinogen concentrate market?

• Some of the key market players operating in the fibrinogen concentrate market include CSL Behring, Octapharma, Innovative Research, Valiant Co., LTD. (MP Biomedicals), Enzo Biochem Inc., and Intas Pharmaceuticals Ltd.

5. Which country has the highest share in the 7MM fibrinogen concentrate market?

• Among all regions, United States is estimated to hold the largest share of 63.88% in the 7MM fibrinogen concentrate market in 2024, growing at a CAGR of 5.79% during the forecast period from 2025 to 2032. The United States is poised to lead the fibrinogen concentrate market, driven by the increasing number of road accidents and surgical procedures, along with rising product approvals and launches.