United States Blood Clotting Factors Market Surges at 7.5% CAGR - $18.5 Billion Milestone by 2031, Led by Takeda and CSL Behring as Top Competitors | DataM Intelligence

Leander, Texas and TOKYO, Japan - Dec. 01, 2025. According to DataM Intelligence, the United States Blood Clotting Factors Market Size is growing from USD 9.5 billion in 2023 to USD 18.5 billion by 2031, registering a robust CAGR of 7.5% during 2024-2031. The surging demand for prophylactic treatments in haemophilia patients, the expansion of extended half-life recombinant products, and advancements in gene therapy integrations are fueling the need for enhanced blood clotting factor formulations that restore coagulation cascades effectively while minimizing immunogenicity and infusion frequency. Blood clotting factors, including recombinant Factor VIII, IX, and VIIa derived from plasma or biotech processes, revolutionise hematology by enabling on-demand and preventive dosing for bleeding disorders, reducing spontaneous hemorrhages and joint damage while supporting patients with inhibitors compliant with FDA biologics licensing and USP sterility standards. By combining pegylated long-acting concentrates, monoclonal antibody hybrids like emicizumab, and precision pharmacokinetic monitoring, this market provides potent, stable solutions for hemophilia A and B management, von Willebrand disease therapy, and perioperative hemostasis throughout hemophilia treatment centers, urban infusion clinics, and rural specialty pharmacies across the United States and beyond.

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Recent Developments

1. Takeda Pharmaceutical Company Limited received FDA expanded approval for its extended half-life Adynovate Factor VIII at the American Society of Hematology (ASH) 2024 Annual Meeting in San Diego, demonstrating 1.7-fold longer half-life in pediatric trials as endorsed by hematologist Dr. Guy Young of the Hemostasis and Thrombosis Center at Children's Hospital Los Angeles (December 2024).

2. CSL Behring acquired ViroPharma for USD 675 million to enhance its plasma-derived factor portfolio, targeting US inhibitor patients and integrating with Afstyla for 20% improved prophylaxis efficacy per clinical data from the Journal of Thrombosis and Haemostasis (August 2024).

3. Pfizer Inc. launched Beqvez gene therapy for hemophilia B at the International Society on Thrombosis and Haemostasis (ISTH) 2025 Congress in Toronto, reducing Factor IX dosing needs by 90% in Phase III trials validated by expert Dr. Margaret Ragni of the University of Pittsburgh Hemophilia Center (July 2025).

4. Novo Nordisk A/S debuted Esperoct with next-gen pegylation for hemophilia A, partnering with the National Hemophilia Foundation for access programs and showing 25% fewer bleeds in a multicenter study published in Blood Advances (April 2025).

5. Sanofi SA collaborated on Fitussiran RNA interference therapy for hemophilia variants, achieving 30% sustained factor level elevation in pilot data presented at the European Hematology Association (EHA) Congress, with specialists noting its potential for non-factor replacement (February 2025).

Competitive Landscape

The market is highly competitive among global biopharma leaders, plasma fractionators, and gene therapy innovators.

1️⃣Takeda Pharmaceutical Company Limited expanded its US manufacturing in Lexington, Massachusetts, operational since mid-2025, enhancing supply for treatment centers with 35% improved inhibitor neutralization rates.

2️⃣CSL Behring acquired ViroPharma, bolstering its North American recombinant pipeline and reporting a 22% revenue boost in hemophilia segments per insights from Barclays analysts.

3️⃣Pfizer Inc. partnered with six hemophilia networks to deploy gene therapy kits for Factor IX deficiency, attaining 95% sustained efficacy and capturing 28% of premium biologic contracts.

4️⃣Novo Nordisk A/S introduced AI-optimized dosing variants with superior stability, securing deals with major payer groups and fueling 26% growth in domestic prophylaxis sales.

5️⃣Sanofi SA rolled out RNA-based factor mimics optimized for home infusion, slashing administration times by 40% and collaborating with telehealth platforms for personalized regimens.

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Growth Drivers

✦ The global hemophilia market surpassed USD 15 billion in 2024, with clotting factors accounting for 70% of therapy spends, underscoring the drive for extended half-life formulations amid rising inhibitor challenges.

✦ US rare disease sales exceeded USD 200 billion in 2024, driving over 20,000 annual hemophilia infusions and accelerating factor integration for lifelong management.

✦ Biologics regulations spurred USD 500 billion in gene therapy investments by 2025, prioritising FDA-approved, low-immunogenic factors that meet payer orphan drug demands.

✦ North American coagulation revenues climbed 18% recently, utilizing more than 5 million factor units yearly as genetic screening fuels early diagnosis adoption.

✦ Prophylaxis innovations trimmed treatment costs by 25%, forecasting USD 1.5 billion in yearly efficiencies for US providers by 2030 through long-acting and non-factor systems.

🌍Regional Insights

United States (North America): The U.S. Blood Clotting Factors market was valued at USD 9.5 billion in 2023, projected to reach USD 18.5 billion by 2031 at a 7.5% CAGR. It holds nearly 50% of the global market share, driven by high hemophilia prevalence (20,000 cases per CDC) and strong FDA approvals. Key players like Takeda and CSL Behring lead through innovation, recombinant launches, and expanded access networks. Adoption of gene therapies and multiple reimbursement channels strengthens its dominance. Recent strategic acquisitions and product approvals keep the U.S. as the global market leader.

Canada (North America): Canada's market size was USD 1.8 billion in 2023, expected to grow to USD 3.5 billion by 2031 at a 7.2% CAGR, holding roughly 11% of the global market share. Growth is fueled by government funding and regulatory clarity that boost premium, extended half-life factor demand. Leading U.S. brands are investing in Canadian hemophilia clinics, accelerating market maturity. Patient preference for home-based, evidence-based therapies continues to mount. Canada complements U.S. leadership with a strong adjacent presence.

Europe (Key countries: UK, Germany, France): Europe constitutes 20% of the global Blood Clotting Factors market and is rapidly growing due to expanding regulatory acceptance and rising orphan disease awareness. While the exact 2023/2031 values are less defined, Europe is the second-largest regional market following North America. The UK, Germany, and France drive expansion through hybrid recombinant-gene formulations and diversified therapy launches. Market growth is supported by established hematology demand and the increased entry of North American brands. Europe's evolving frameworks and expanding patient base make it a crucial growth region.

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Market Segmentation Analysis

By Product: Factor VIII concentrates dominate with a 50% market share, valued at USD 4.75 billion in 2023 and projected to grow to USD 9.25 billion by 2031 at a 7.6% CAGR. Factor IX holds 30% of the market, valued at USD 2.85 billion in 2023 and expected to reach USD 5.55 billion by 2031 at a 7.4% CAGR. The Factor VIII segment's growth is driven by increasing demand for haemophilia A treatments compliant with FDA and EMA standards, while the Factor IX segment sustains demand through cost-effective applications in haemophilia B prophylaxis.

By Type: Recombinant factors lead with a commanding 65% market share, valued at USD 6.175 billion in 2023 and forecasted to reach USD 12.025 billion by 2031, favoured for their purity and reduced pathogen risk. Plasma-derived holds a 35% share, worth USD 3.325 billion in 2023 and projected to grow to USD 6.475 billion by 2031, attracting providers for von Willebrand applications. The recombinant segment grows fastest at 7.7% CAGR, catering to niche demands for extended half-life and innovative gene integrations.

By Application: Haemophilia A constitutes the largest segment with 55% market share, valued at USD 5.225 billion in 2023 and expected to expand to USD 10.175 billion by 2031, powered by prevalence research and prophylaxis trends. Haemophilia B holds a 25% share, valued at USD 2.375 billion in 2023 and projected to reach USD 4.625 billion by 2031, fueled by Factor IX therapies. Von Willebrand disease and others each account for 10% of the market, reflecting growing awareness of holistic coagulation benefits and targeted bleeding control.

Innovation and Consumer Trends Fueling Market Expansion

Manufacturers are investing heavily in advanced biotech technologies, such as pegylation and RNA interference, to improve half-life, reduce inhibitor formation by an estimated 25%, and comply with regulatory expectations. Patient growth is driven by expanding awareness of prophylactic benefits, integration into home care routines, and market education on premium, recombinant factor products. North American markets, particularly the U.S., exhibit the highest adoption rates, supported by clinical research, strategic partnerships, and haematologist-backed gene therapy blends.

Market Outlook and Opportunities: The Global blood clotting factors market is at a tipping point, driven by haemophilia-conscious mandates and every ounce of scientific evolution in recombinant biologics. Valued at USD 19.0 billion in 2023, it is projected to reach USD 37.0 billion by 2031 at a steady 7.6% CAGR. North America, capturing nearly half the global share, spearheads expansion powered by orphan drug demand, while the Asia Pacific benefits from prevalence rises. Progress in gene therapy sourcing and enhanced prophylaxis align with FDA accessibility aims, although hurdles like inhibitor volatility, cost challenges, and supply shortages remain. Post-pandemic focus on thrombosis prevention and rising embrace of non-factor mimics and digital infusion tracking unlock vast potential for bleeding management and hemostasis enhancement in haematology, surgery, and rare disease sectors.

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