PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1887196
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1887196
The global coagulation factors market is experiencing strong growth as demand rises for advanced therapies that treat bleeding disorders such as hemophilia A, hemophilia B, and von Willebrand disease. According to the latest industry analysis, the global market was valued at USD 6.40 billion in 2024, is projected to increase to USD 6.89 billion in 2025, and is expected to reach USD 12.19 billion by 2032, driven by technological innovations, expanding plasma collection capacity, and increased awareness of hereditary bleeding disorders. In 2024, North America dominated the market with a 58.44% share, supported by strong healthcare infrastructure and rising adoption of plasma-derived therapies.
Coagulation factors play a crucial role in supporting normal blood clotting. With the rising prevalence of bleeding disorders and trauma cases globally, demand for plasma-derived and recombinant coagulation products continues to accelerate. Key industry leaders-such as CSL, Octapharma AG, Kedrion S.p.A., and Takeda Pharmaceuticals-are strengthening their research pipelines while expanding manufacturing capacity to meet global therapeutic needs.
Market Drivers
A primary driver of market expansion is the growing incidence of hereditary bleeding disorders worldwide. According to the CDC, approximately 33,000 males in the U.S. live with hemophilia, and von Willebrand disease affects nearly 1% of the U.S. population. Rising diagnostic rates, improved patient awareness, and increased clinician focus on early-stage treatment continue to boost demand for coagulation therapies.
Rising trauma and accident rates globally also contribute significantly to market expansion. In India alone, 461,312 road accidents occurred in 2022, representing an 11.9% increase over the previous year. Emergency and critical care facilities rely heavily on coagulation factors for immediate treatment, further supporting the market's upward momentum.
Market Restraints
Despite strong growth potential, stringent regulatory frameworks pose challenges for manufacturers. Plasma collection and processing must comply with rigorous safety and quality standards enforced by agencies such as the FDA, which monitors plasma therapies under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Lengthy approval cycles and strict operational requirements can slow product launches and limit market expansion, especially in emerging economies.
High production costs also restrict new market entrants, as plasma fractionation and manufacturing infrastructure require significant capital investment. Limited reimbursement coverage in developing regions further restricts treatment accessibility.
Market Opportunities
Increasing investments in R&D for advanced therapies offer significant opportunities for market players. New plasma fractionation facilities, expanded treatment indications, targeted delivery systems, and long-acting factor products are shaping the next wave of innovation. For example, CSL Behring opened a new plasma fractionation facility in Australia in 2022 to support treatments for hemophilia and other critical disorders, illustrating the industry's commitment to expanding global capacity.
Advancements in AI and IoT are improving manufacturing efficiency, supply chain visibility, and patient support, accelerating the adoption of next-generation therapies.
Segment Analysis
By Type
The Factor VIII segment held the largest market share in 2024, supported by high hemophilia A prevalence-estimated at over 1.1 million cases globally. The fibrinogen concentrates segment ranked second, fueled by regulatory approvals such as Octapharma's 2024 U.S. FDA approval for Fibryga.
By Application
The hematology segment dominated in 2024, driven by advancements in hemostasis technologies and a high global burden of congenital bleeding disorders. Prevalence of hemophilia is estimated at 1 in 6,000 to 10,000 males, highlighting the large clinical need.
By End User
Hospitals & clinics held the majority share in 2024 due to high patient preference for specialized treatment, increasing hospital admissions, and industry collaboration with healthcare institutions. Clinical research laboratories are expected to grow steadily with rising demand for plasma-derived R&D applications.
North America
North America led the global market in 2024 with USD 3.74 billion, driven by strong plasma collection networks, growing product approvals, and high adoption of advanced therapies. The U.S. continues to expand plasma banking capacity, with Takeda's BioLife Plasma Services opening its 200th donation center in 2023.
Europe
Europe holds the second-largest share, supported by expanded plasma fractionation facilities and strong regulatory backing. CSL's 2023 plasma plant expansion in Germany strengthens regional supply capabilities.
Asia Pacific
The region is projected to witness strong growth due to rising mergers, facility expansions, and increasing affordability of plasma-based products. Companies such as PlasmaGen Biosciences are expanding manufacturing operations to meet regional demand.
Conclusion
With a strong rise from USD 6.40 billion in 2024 to USD 6.89 billion in 2025, and a projected USD 12.19 billion market size by 2032, the coagulation factors industry is poised for sustained long-term growth. Strategic investments, technological innovation, and expanding treatment needs will continue to shape the global market landscape.
Segmentation By Type
By Application
By End User
By Geography