U.S. Hemophilia Treatment Market Expected to reach USD 6.92 Billion by 2032

The U.S. hemophilia treatment market, projected to reach a valuation of USD 4.48 Billion in 2025, is poised for steady growth. Estimates suggest the market will expand to USD 6.92 Billion by 2032, registering a CAGR of 6.4% during the forecast period. Current market dynamics highlight the increasing prevalence of hemophilia A and B, along with growing awareness and early diagnosis, as primary growth drivers. Advancements in recombinant therapies, extended half-life factor concentrates, and gene therapies are reshaping treatment paradigms. Additionally, rising healthcare expenditure, improved access to prophylactic treatment, and supportive reimbursement frameworks are further propelling market expansion across the U.S.

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The U.S. hemophilia treatment market is experiencing steady growth, fueled by the increasing prevalence of hemophilia A and B, rising awareness, and improvements in diagnostic accuracy and early screening. The adoption of prophylactic treatment regimens and the shift from plasma-derived to recombinant coagulation factors are reshaping the therapeutic landscape, offering enhanced safety and efficacy. The growing focus on personalized care, combined with advancements in extended half-life factor concentrates and non-factor therapies, is improving patient compliance and clinical outcomes.

In June 2023, the FDA approved Roctavian (valoctocogene roxaparvovec), the first gene therapy for adults with severe hemophilia A, as a one-time infusion. Clinical data from the Phase 3 GENEr8-1 trial demonstrated reductions in annualized bleeding rates and factor VIII usage by 82.9% and 96.8%, respectively, over three years.

Furthermore, market dynamics are positively influenced by favorable reimbursement policies, expanding access to specialty treatment centers, and growing investment in R&D by biopharmaceutical firms. Strategic collaborations between drug manufacturers and advocacy organizations are also helping to address unmet patient needs and improve access to care. As innovation in gene therapy, subcutaneous delivery platforms, and extended-release formulations continues to gain momentum, the U.S. hemophilia treatment market is positioned for sustained expansion through 2032.

The U.S. hemophilia treatment landscape is witnessing a significant shift toward subcutaneous and non-factor therapies, driven by the demand for more convenient and less frequent dosing regimens. These therapies offer an alternative to traditional intravenous factor replacement, improving adherence and quality of life for patients with hemophilia A and B, including those with inhibitors.

In March 2025, Sanofi launched Qfitlia (fitusiran), a bi-monthly subcutaneous siRNA therapy approved for hemophilia A and B patients aged 12 and older. Clinical trials demonstrated a 71–90% reduction in annualized bleeding rates compared to on-demand treatment, establishing Qfitlia as a transformative option for long-term prophylaxis in the U.S. market.

The U.S. hemophilia treatment market is witnessing growing interest in hemostasis-modulating agents that work independently of factor replacement. These novel therapies aim to rebalance coagulation pathways and offer effective bleed control with convenient dosing and broad patient applicability, including those with inhibitors.

In December 2023, Pfizer presented data at the American Society of Hematology, where marstacimab (an anti-TFPI monoclonal antibody) achieved a 35% reduction in annualized bleeding rates vs. standard prophylaxis—and 92% vs. on-demand therapy—in hemophilia A and B patients without inhibitors.

The rise of digital platforms in chronic disease management presents a compelling opportunity for remote monitoring of hemophilia patients. Wearable devices and mobile health apps can help track bleeding episodes, treatment adherence, and infusion logs—reducing emergency visits and enabling data-driven, personalized care.

In January 2025, Pfizer partnered with Huma to roll out an FDA-cleared remote patient monitoring (RPM) platform across U.S. hemophilia centers. The system combines a patient app and clinician portal to log symptoms, vitals, bleeding episodes, and infusions, with tailored nurse navigator support—enhancing adherence, engagement, and timely clinical intervention.

With an increasing number of hemophilia patients shifting toward at-home care, specialty pharmacies and home infusion providers are becoming critical enablers of decentralized treatment. These providers support patient adherence through comprehensive services, including cold-chain delivery, nurse-assisted administration, insurance coordination, and remote education. As demand rises for extended half-life therapies and subcutaneous options, companies with robust home-care logistics and patient engagement platforms are well-positioned to gain market share.

In August 2024, CarePartners Pharmacy completed the acquisition of Evolutionary Pharmacy Solutions (EPSRx), expanding its specialty infusion network across 36 U.S. states. The acquisition bolstered CarePartners’ ability to deliver high-touch, at-home IV infusion services for chronic conditions, including hemophilia, underscoring a strategic push to scale home-based care infrastructure tailored to complex therapies.