The congenital fibrinogen deficiency (CFD) market is forecast to increase from $673 million in 2021 to over $800 million in 2031 at a compound annual growth rate (CAGR) of 1.7% across the three major markets (3MM*). Growth will be driven by the launch of improved human fibrinogen concentrate (HFC) products, the large market potential for HFC in treating acquired fibrinogen deficiency (AFD), and recent demand for blood plasma, says GlobalData, a leading data and analytics company.

GlobalData’s latest report, ‘Congenital Fibrinogen Deficiency Market Size and Trend Report, 2021-2031’, reveals that current treatment options for CFD are limited to the use of four HFC products, which serve as intravenous (IV) replacement therapy for fibrinogen (factor I) to control and prevent bleeding episodes in symptomatic patients. An urgent unmet need exists among the CFD population for differentiated therapies with lower risks of thrombosis, guaranteed viral safety, and more convenient routes of administration.

Nancy Jaser, PharmD/MBA, Pharma Analyst at GlobalData, comments: “Major interest has sparked across the HFC drug space as more experts are becoming aware of the clinical benefits of using fibrinogen concentrate to treat patients that ‘acquire’ fibrinogen deficiency (AFD) during surgeries or trauma involving massive blood loss. Since the drug treated CFD population is very small, drug developers are not heavily invested in the space and clinical trials frequently struggle with recruitment, leaving patients with few treatment options.

“While the CFD market is projected to grow steadily as the prevalent population increases, sales will eventually reach a cap given the rarity of the disease. The large market potential of using HFC in patients who “acquire” fibrinogen deficiency during surgery or unexpected trauma will likely drive an increase in drug development of more innovative fibrinogen replacement therapies, advancing the HFC drug space for both CFD and AFD patients. Furthermore, the COVID-19 pandemic led to a decrease in blood donations, which has increased demand for human plasma and facilitated higher usage of HFC.”

Currently, all four marketed products available across the 3MM to treat CFD belong to the therapeutic class of HFC replacement therapy. HFCs are derived from human plasma and carry risks of infection and blood clots. Two HCFs are marketed in the US (RiaSTAP and Fibryga), while three products are available in Germany (RiaSTAP/Haemocomplettan P, Fibryga, and FibCLOT), with only one marketed product available for use in Japan (Fibrinogen HT).

HFC products must be administered intravenously in a healthcare setting and carry risks of thrombosis. While they treat the symptoms of CFD, they are not curative. Therefore, there is also a significant need for new therapies that target the underlying cause of CFD that may offer a cure for patients living with severe disease, or for patients with genotypes such as dysfibrinogenemia, who are often ineligible for treatment with HCFs.

Jaser adds: “Given the huge market potential for HFC use in AFD patients, the development of fibrinogen-based therapies is expected to increase dramatically in the near future, fulfilling many unmet needs for CFD patients. Other indications remain largely unexplored in the HFC drug space, leaving ample opportunities for companies to invest in this area for a variety of blood disorders and surgical complications. As the field becomes more understood and demand continues to increase, GlobalData anticipates a dynamic market with a variety of fibrinogen-based treatment options for CFD patients in the near future.”

*3MM: US, Germany, and Japan