U.S. Human Fibrinogen Concentrates Market Size, Share, Growth and Industry Analysis By Type & Application, Regional Insights and Forecast to 2024-2032

Growth Factors of U.S. human fibrinogen concentrates Market

The U.S. human fibrinogen concentrates market is experiencing accelerated growth driven by the rising prevalence of bleeding disorders, increasing trauma cases, and a growing number of surgical procedures across the country. As per the latest industry report, the market was valued at USD 171.8 million in 2024, is projected to rise to USD 196.7 million in 2025, and is expected to reach USD 530.7 million by 2032, reflecting a strong CAGR of 15.2%. This upward trajectory reflects the importance of fibrinogen concentrates in managing congenital and acquired fibrinogen deficiencies amid increasing clinical reliance on rapid and reliable methods of clotting management.

Human fibrinogen concentrate (HFC) is a purified, freeze-dried product derived from human plasma, widely used to treat bleeding caused by low fibrinogen levels. Its growing clinical adoption is linked to its convenience, safety, and effectiveness in critical scenarios. The high number of trauma cases in the U.S. further strengthens demand. According to an NCBI study published in November 2023, traumatic injuries lead to 40 million emergency department visits annually, highlighting the scale of need for fibrinogen supplementation in trauma care. Key players such as CSL, Octapharma AG, and Grifols S.A. are increasing investments in research, regulatory approvals, and product innovation, fueling market expansion.

Market Dynamics

Market Drivers

The increasing incidence of bleeding disorders-including congenital fibrinogen deficiency (CFD) and acquired fibrinogen deficiency (AFD)-remains a major driver. Patients suffering from coagulation challenges face severe complications during surgery or trauma, requiring immediate fibrinogen replacement. As the unmet patient population grows, so does the demand for effective fibrinogen products. Combined with rising surgical volumes, the market is poised for sustained growth throughout the forecast period.

Market Restraints

Stringent regulatory frameworks present a notable barrier to market entry. Fibrinogen concentrates require advanced viral inactivation processes, strict quality control, and compliance with rigorous FDA standards before approval. Additionally, fibrinogen use in surgical procedures is not yet FDA-approved in the U.S., creating added complexity for manufacturers seeking expanded indications. These factors slow down new product introductions and limit competitive diversity.

Market Opportunities

Only two fibrinogen products currently have U.S. FDA approval, creating significant opportunities for new entrants. Key manufacturers are increasingly exploring untapped applications and expanding pipeline development. Enhanced R&D efforts are expected to broaden clinical adoption, foster price competitiveness, and improve treatment accessibility. With companies expanding product portfolios and investing in clinical trials, the market holds substantial potential for innovation between 2025 and 2032.

Market Challenges

High manufacturing costs and ongoing supply chain disruptions present challenges. Plasma-derived therapies depend heavily on donor availability, and the pandemic caused a significant decline in plasma donations. Although levels have partially recovered, they remain below pre-pandemic averages, stressing supply chains. Production costs and shortages increase the burden on hospitals and patients, hindering broader access across certain regions.

Segmentation Analysis

By Application

In 2024, the acquired fibrinogen deficiency (AFD) & surgical procedures segment held the dominant market share due to rising prevalence of AFD and increasing number of surgeries requiring fibrinogen supplementation. The congenital fibrinogen deficiency (CFD) segment also held a significant share. HHS data from 2022 estimated the prevalence of Factor I disorder at 1.13 per 1,000,000 population in the U.S., supporting consistent clinical demand.

By End-user

Hospitals dominated the market in 2024, as fibrinogen concentrates are vital for emergency care, cardiac surgeries, obstetric procedures, postpartum hemorrhage, and trauma management. Rising awareness initiatives, such as the 2023 partnership between Tulane University and LCBCD, further strengthen hospital-based adoption. Specialty clinics are projected to grow moderately as HFC becomes a preferred alternative to FFP and cryoprecipitate in select cases.

Regional Analysis

The South U.S. captured the largest share of the market in 2024 due to a high number of trauma cases and bleeding disorders requiring fibrinogen supplementation. The West U.S. held the second-largest share, supported by strong research infrastructure and high healthcare investment. In July 2025, the University of Colorado Anschutz Medical Campus initiated the EFFECT Trial with a USD 29.0 million grant from Octapharma, underscoring regional R&D momentum.

Conclusion

Projected to grow from USD 171.8 million in 2024 to USD 530.7 million by 2032, the U.S. human fibrinogen concentrates market is poised for rapid expansion. Continued clinical adoption, rising trauma cases, regulatory advancements, and strong manufacturer engagement are expected to accelerate market growth in the years ahead.

Segmentation By Application

• Congenital Fibrinogen Deficiency
• Acquired Fibrinogen Deficiency & Surgical Procedures
• Others

By End-user

• Hospitals
• Specialty Clinics
• Others

By Region

• West U.S.
• South U.S.
• Midwest U.S.
• Northeast U.S.