U.S. Human Fibrinogen Concentrates Market Size, Share & Industry Analysis, By Application (Congenital Fibrinogen Deficiency, Acquired Fibrinogen Deficiency & Surgical Procedures, and Others), By End-user (Hospitals, Specialty Clinics, and Others), and Regional Forecast, 2025-2032

The U.S. human fibrinogen concentrates market size was valued at USD 171.8 million in 2024. The market is projected to grow from USD 196.7 million in 2025 to USD 530.7 million by 2032, exhibiting a CAGR of 15.2% during the forecast period.

Human fibrinogen concentrate is a medication used to treat bleeding disorders caused by low levels of fibrinogen, a protein crucial for blood clotting. It's a purified, lyophilized (freeze-dried) form of fibrinogen derived from human plasma, offering a standardized and convenient way to replenish this clotting factor. This market space is witnessing an upward growth trajectory driven by rising prevalence of bleeding disorders, increasing awareness, and growing number of surgical procedures in the U.S. Key players are also emphasizing on increasing investment in innovation in turn driving the market growth.

• For instance, according to the a research study published in National Center for Biotechnology Information (NCBI) in November 2023, in the U.S. every years traumatic injuries account for around 40 million emergency department (ED) visits.

Furthermore, the market is anticipated to observe a strong growth owing to the active involvement of key players such as CSL, Octapharma AG, and Grifols S.A. These entities are focusing on various strategic initiatives to capture the untapped opportunities of the market.

MARKET DYNAMICS

MARKET DRIVERS

Rising Incidence of Bleeding Disorders to Propel Market Growth

Rising incidence of bleeding disorders is one of the prominent factors driving the U.S. human fibrinogen concentrates market growth. Bleeding disorders are a group of conditions in which there is a problem with the body's blood clotting process. Thus, individuals with these conditions have a compromised ability to form blood clots, which increases their risk of excessive bleeding during surgeries and traumatic injuries. Thus, for patients with bleeding disorders, the use of fibrinogen concentrates is essential to manage intraoperative and postoperative bleeding effectively, minimizing complications and improving surgical outcomes.

This prevalence rate, combined with the high-unmet patient population in emerging countries, is expected to increase the demand for fibrinogen products. Consequently, this surge in demand is projected to drive market growth.

MARKET RESTRAINTS

Stringent Regulatory Framework May Impact Product Availability

A stringent regulatory framework for fibrinogen concentrate focuses on ensuring its safety and efficacy, particularly regarding viral inactivation, quality control, and appropriate use. This framework involves rigorous testing and manufacturing standards, as well as guidelines for dosing and administration based on patient-specific factors. Thus, such scenarios hamper the market entry of the new products resulting in slower market growth.

Moreover, the use of fibrinogen in surgical procedures is also yet not approved in the U.S, which in addition increases the burden on the manufacturers.

MARKET OPPORTUNITIES

Emphasis on Expansion of Product Offerings by Key Players to Offer Lucrative Growth Opportunities

Currently, only two products are approved by the U.S. FDA to treat disorders associated with fibrinogen deficiency. This offers growth opportunity for the operating players to focus on the untapped avenues of the market. Such increased focus by key players also indicates a competitive landscape that can foster price competitiveness and product quality improvements. Overall, this expansion is expected to benefit manufacturers, healthcare providers, and patients alike through enhanced treatment options.

MARKET CHALLENGES

High Cost and Supply Chain Issues to Hinder Market Growth

The market faces challenges due to high cost of production and issues relating to supply chain resulting in slower market growth. These factors can hinder broader access and utilization of fibrinogen, especially in resource-constrained environments. Fibrinogen concentrates and testing procedures can be expensive, limiting access, particularly in some regions.

Additionally, decrease in plasma donations further impacts the supply chain. The pandemic caused a sharp drop in donations, and while there was a partial recovery, levels have remained below pre-pandemic levels. This led to a significant decrease in blood and plasma donations, impacting the supply of plasma-derived therapies that are vital for patients with serious conditions.

U.S. HUMAN FIBRINOGEN CONCENTRATES MARKET TRENDS

Expanding Applications of Human Fibrinogen Concentrates

One of the prominent trend witnessed in the this market is the increased focus of key market players and research institutes to provide adequate clinical evidence for adoption of fibrinogen in trauma care practices. Fibrinogen administration in trauma care is increasingly recognized for its role in managing traumatic hemorrhage and improving outcomes. Low fibrinogen levels are common in severe trauma and are associated with impaired hemostasis, massive bleeding, and poor survival. Early fibrinogen supplementation, often through fibrinogen concentrate is being adopted in trauma protocols to address this coagulopathy.

Fibrinogen is crucial for clot formation and stabilization. Trauma-induced coagulopathy, characterized by fibrinogen depletion, contributes to uncontrolled bleeding. Many trauma guidelines now recommend early fibrinogen administration, even before lab results are available, based on clinical criteria such as severe bleeding and shock.

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SEGMENTATION ANALYSIS

By Application

Wide Adoption of Human Fibrinogen Concentrates Due to its Effectiveness to Treat AFD Propelled Segment Growth

On the basis of application, the U.S. market is divided into congenital fibrinogen deficiency, acquired fibrinogen deficiency (AFD) & surgical procedures, and others.

In 2024, the acquired fibrinogen deficiency (AFD) & surgical procedures dominated the U.S. market with highest market share. The rise in prevalence of acquired fibrinogen deficiency (AFD) increases the demand for effective treatment options, which increases product approval rate and R&D initiatives. Additionally, increasing number of surgical procedures in the U.S also boosts the demand for these products, in turn driving the segment growth.

On the other hand, congenital fibrinogen deficiency (CFD) segment captured a significant share of the U.S. market in 2024. Rising prevalence of this disorder is majorly driving the segment growth.

• In May 2022, as per the data published by the HHS Public Access report on the occurrence rates of inherited bleeding disorders among people receiving care in specialized treatment centers in the U.S., stated that the U.S. Hemophilia Treatment Centers Network (USHTCN) estimated the prevalence of Factor I (Fibrinogen) disorder i.e. around 1.13 per 1,000.000 population.

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By End-user

Hospitals Segment Dominated Due to Increasing Demand in Treatment of Acquired Fibrinogen Deficiency (AFD)

The market is categorized by end-user into hospitals, specialty clinics, and others.

In 2024, the hospitals segment captured the largest U.S. human fibrinogen concentrates market share. The use of human fibrinogen concentrate (HFC) in hospitals is increasing, particularly for managing bleeding and surgical prophylaxis. HFC is used in various clinical settings, including cardiac surgery, obstetrics (especially postpartum hemorrhage), and trauma. Additionally, increasing awareness programs and collaboration between the health centers further propels the segment’s growth.

• For instance, in July 2023, Tulane University partnered with Louisiana Center for Bleeding and Clotting Disorders (LCBCD) and Acadian Health, with an aim to reduce unnecessary emergency department (ED) visits and hospitalizations for individuals with bleeding disorders.

On the other hand, specialty clinics segment is anticipated to witness a moderate growth in the coming years. This is owing to the effectiveness and safety of human fibrinogen in treating bleeding disorders and surgical bleeding. This is due to the products becoming a preferred alternative to traditional sources such as fresh frozen plasma (FFP) and cryoprecipitate in certain situations.

U.S. HUMAN FIBRINOGEN CONCENTRATES MARKET REGIONAL OUTLOOK

Based on region, the market is divided into West U.S., South U.S., Midwest U.S., and Northeast U.S.

In terms of region, the south U.S. region captured the dominating share of the market in 2024. Increasing number of patients with bleeding disorders coupled with rising cases of trauma where fibrinogen concentrates are required have driven the market growth in the region.

The west U.S. region captured the second-highest share of the U.S. human fibrinogen concentrates market in 2024. Significant investment in research and development of human fibrinogen along with availability of developed healthcare infrastructure in the region support the market growth.

• For instance, in July 2025, the University of Colorado Anschutz Medical Campus initiated the EFFECT Trial, with a grant of USD 29.0 million from Octapharma.

COMPETITIVE LANDSCAPE

Key Industry Players

Emphasis of Key Players on Expansion and Regulatory Approvals to Boost their Market Presence

The competitive landscape of the U.S. human fibrinogen concentrates market is highly consolidated in nature. This is primarily due to the fact that only two products manufactured by CSL and Octapharma AG are approved in the U.S. by the Food and Drugs Administration (FDA). Growing focus of these companies on research and development activity to launch innovative products in the market is likely to favor the expansion of the market presence of these companies.

Moreover, Grifols S.A. is another prominent player in the market with anticipated regulatory approval for its pipeline candidate in near future. The company is focusing on getting the U.S. FDA approval for its human fibrinogen product by demonstrating its effectiveness for acquired fibrinogen deficiency (AFD).

LIST OF KEY HUMAN FIBRINOGEN CONCENTRATE COMPANIES PROFILED

• CSL (Australia)
• Octapharma AG (Switzerland)
• Grifols S.A. (Spain)

KEY INDUSTRY DEVELOPMENTS

• July 2025: The University of Colorado Anschutz Medical Campus initiated the EFFECT Trial, with a grant of USD 29.0 million from Octapharma.
• January 2025: Grifols S.A., submitted a Biologics License Application (BLA) for its new potential fibrinogen treatment to the U.S. Food and Drug Administration (FDA).
• September 2024: Octapharma AG (U.S.) announced the expanded approval of Fibryga, Fibrinogen) by the U.S. Food and Drug Administration (FDA). It is the Human Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD).
• April 2021: CSL collaborated with Terumo Blood and Cell Technologies. This collaboration was aimed to deliver a new plasma collection platform at CSL Plasma U.S. collection centers.

REPORT COVERAGE

The U.S. human fibrinogen concentrate market report provides detailed analysis of the current market scenario. The report focuses on several key aspects related to the market such as growth drivers, market challenges, regulatory framework, and others. Additionally, the report also encompasses several key insights such as consumer preference analysis, industry policies & regulations, impact of tariff on the market, and others. Besides these, the U.S. human fibrinogen concentrates market analysis offers insights into the market trends and comprises a detailed company profiling of key players in the market.

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Report Scope & Segmentation