PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930140
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1930140
The global coagulation factors market is witnessing robust growth, driven by the increasing prevalence of bleeding disorders, advancements in plasma-derived therapies, and expanding research and development activities by key market players. According to Fortune Business Insights, the market was valued at USD 6.89 billion in 2025 and is projected to grow to USD 7.43 billion in 2026. By 2034, the market is expected to reach USD 14.61 billion, registering a compound annual growth rate (CAGR) of 8.81% from 2026 to 2034.
In 2025, North America dominated the market with a 58.17% share, supported by strong plasma collection infrastructure and advanced treatment availability.
Market Drivers
Rising Incidence of Bleeding Disorders
The growing prevalence of hereditary bleeding disorders such as hemophilia A, hemophilia B, and von Willebrand disease is a major factor driving market growth. According to the Centers for Disease Control & Prevention (CDC), approximately 33,000 males in the U.S. live with hemophilia, while von Willebrand disease affects nearly 1% of the population. The rising patient pool has significantly increased demand for plasma-derived coagulation products.
Increasing Trauma and Accident Cases
The rising number of accidents and trauma cases globally is further contributing to market expansion. For instance, India recorded over 461,312 road accidents in 2022, as reported by the Ministry of Road Transport and Highways, leading to increased demand for coagulation factors in emergency and critical care settings.
Market Restraints
Stringent Regulatory Frameworks
The coagulation factors market faces challenges due to stringent regulatory requirements governing plasma collection, processing, and distribution. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) enforce strict compliance under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, which can delay approvals and increase operational complexity for manufacturers.
Market Opportunities
Growing Investments in Research and Development
Increasing investments in research and development are creating new growth opportunities. Expansion of plasma fractionation facilities and development of next-generation therapies are strengthening market prospects. In December 2022, CSL Behring opened a new plasma fractionation facility in Australia to support treatments for hemophilia and immune disorders, reinforcing long-term market growth potential.
Market Trends
Introduction of Innovative and Long-Acting Therapies
The launch of longer-acting coagulation factors, advanced plasma fractionation technologies, and targeted delivery systems is a key market trend. Additionally, integration of artificial intelligence (AI) and Internet of Things (IoT) technologies is improving operational efficiency, supply chain management, and patient engagement, contributing to market expansion.
Market Challenges
High Initial Investment and Treatment Costs
High capital requirements for plasma-derived manufacturing facilities and complex processing technologies remain a significant challenge. Limited reimbursement coverage in some regions and high therapy costs restrict broader adoption, particularly in emerging markets, thereby affecting overall market penetration.
By type, the Factor VIII segment held the largest market share, driven by the high prevalence of hemophilia A. According to the Hemophilia Federation of America (2025), more than 1.1 million individuals worldwide suffer from hemophilia A.
By application, the hematology segment dominated due to advancements in hemostasis technologies and rising cases of blood-related disorders.
By end user, hospitals and clinics accounted for the majority share, supported by higher patient admissions and collaboration between healthcare providers and manufacturers.
North America generated USD 4.01 billion in revenue in 2025, driven by rising plasma collection activities and strong regulatory support.
Europe held the second-largest share due to expansion of plasma fractionation facilities and strategic partnerships.
Asia Pacific is projected to witness strong growth during the forecast period, supported by capacity expansion and affordable plasma-based therapies.
Latin America and the Middle East & Africa are expected to grow steadily with improving healthcare infrastructure and rising awareness.
Competitive Landscape
The market is moderately consolidated, with leading players such as CSL, Takeda Pharmaceutical Company, Kedrion S.p.A., and Octapharma AG focusing on capacity expansion, product innovation, and strategic collaborations. Continuous FDA approvals and new facility investments are strengthening their global market presence.
Conclusion
In conclusion, the global coagulation factors market is set for significant growth, expanding from USD 6.89 billion in 2025 to USD 14.61 billion by 2034. Rising prevalence of bleeding disorders, technological advancements, and increased investments in plasma-derived therapies are key growth drivers. Although regulatory complexities and high costs remain challenges, ongoing innovation, facility expansion, and strong demand across developed and emerging regions are expected to sustain long-term market growth during the forecast period.
Segmentation By Type
By Application
By End User
By Geography