Antithrombin Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Usage (Therapeutics, Diagnostics, Research, Others), By Source (Human, Recombinant Goat Milk, Others), By Type (Anticoagulant, Antiplatelet, Thrombolytic Drugs), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 793.11 Million
CAGR (2026-2031)	5.32%
Fastest Growing Segment	Therapeutics
Largest Market	Asia Pacific
Market Size (2031)	USD 1082.43 Million

Market Overview

The Global Antithrombin Market will grow from USD 793.11 Million in 2025 to USD 1082.43 Million by 2031 at a 5.32% CAGR. Antithrombin is a glycoprotein produced by the liver that functions as a critical natural anticoagulant by inactivating serine proteases in the coagulation system, specifically thrombin and Factor Xa. The Global Antithrombin Market is primarily supported by the rising diagnosis rates of hereditary antithrombin deficiency and the increasing necessity for anticoagulation management during complex surgical interventions, such as those requiring cardiopulmonary bypass. This clinical demand is reinforced by the inadequacy of standard treatments for high-risk patients; according to the International Society on Thrombosis and Haemostasis, in 2024, registry data indicated that recurrent thrombosis occurred in 58.6% of patients with hereditary antithrombin deficiency despite standard anticoagulation, underscoring the urgent market requirement for specialized antithrombin replacement therapies.

However, the market faces a substantial challenge regarding the high cost and limited supply of plasma-derived therapeutics, which hinders broad accessibility in cost-sensitive healthcare systems. The production of antithrombin relies heavily on the fractionation of human plasma, a process constrained by donor availability and stringent safety regulations. This reliance on a fluctuating biological raw material creates supply chain vulnerabilities and elevates manufacturing expenses, thereby restricting market penetration in developing regions where healthcare budgets are constrained and alternative, less expensive anticoagulants remain the standard of care.

Key Market Drivers

The Rising Global Prevalence of Venous Thromboembolism (VTE) and Coagulation Disorders serves as a primary catalyst for the expansion of the antithrombin market, necessitating robust therapeutic interventions for high-risk patient populations. As the incidence of thrombotic events escalates globally, particularly among patients with hereditary antithrombin deficiency or those undergoing complex surgeries where standard heparin anticoagulation is insufficient, the clinical demand for specialized replacement therapies has intensified. This surge in therapeutic requirement is directly reflected in the financial performance of major plasma derivative manufacturers who cater to this critical need. According to Grifols, February 2025, in the 'Grifols delivers a strong 2024 exceeding guidance on revenue and free cash flow' report, the Biopharma business unit achieved a revenue growth of 15.1% in the fourth quarter of 2024, a performance explicitly attributed to the strong global underlying demand for plasma proteins.

Simultaneously, the Improved Availability of Plasma-Derived Antithrombin Concentrates is resolving historical supply chain vulnerabilities, allowing for broader market penetration and reliable patient access. The stability of this market relies heavily on the efficient collection and fractionation of human plasma, a process that has seen significant optimization and capacity expansion by key industry stakeholders. According to Kedrion Biopharma, April 2025, in the '2024 in review: achieving +10% growth and unveiling our new identity' report, the company recorded a turnover of 1.578 billion Euro for the fiscal year, representing a 10% increase driven by the strengthened performance of its plasma-derived portfolio. This growth is underpinned by rigorous standards that ensure a sustainable raw material supply; according to the Plasma Protein Therapeutics Association, February 2025, in the 'Science of safe plasma donation' article, recent research demonstrated that adverse events occur in only 0.16% of donations, validating the safety protocols that are essential for maintaining the consistent donor base required for antithrombin production.

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Key Market Challenges

The dependence on human plasma fractionation presents a formidable barrier to the expansion of the Global Antithrombin Market. Unlike synthetic pharmaceuticals, plasma-derived therapies rely on a finite biological resource that cannot be rapidly scaled to meet surging clinical demand. This constraint is compounded by the industry's heavy reliance on specific collection hubs, creating significant supply chain vulnerabilities. According to the Plasma Protein Therapeutics Association, in 2025, North America supplied over 63% of the global plasma used for manufacturing, underscoring the severe geographic concentration of the raw material source. Any disruption in this primary collection region immediately impacts global availability, limiting the market’s ability to ensure consistent product delivery and hampering revenue potential.

Moreover, the complex manufacturing process required to ensure viral safety and purity entails substantial operational costs. These expenses result in high pricing structures that limit accessibility in cost-sensitive healthcare environments. In developing regions where budgets are restricted, healthcare providers often forgo specialized antithrombin treatments in favor of cheaper, non-specific anticoagulants. This economic friction directly impedes market penetration and prevents the widespread adoption of antithrombin therapies in emerging economies, effectively capping the market's global growth trajectory.

Key Market Trends

The Rising Utilization in Extracorporeal Membrane Oxygenation (ECMO) Protocols is reshaping market demand, as clinicians increasingly treat heparin resistance in critically ill patients with antithrombin supplementation. Standard anticoagulation often fails in prolonged extracorporeal circuits due to the rapid consumption of natural antithrombin, necessitating exogenous replacement to ensure circuit patency and prevent catastrophic thrombosis. This integration into high-acuity life support algorithms directly amplifies therapeutic consumption parallel to the global adoption of mechanical circulatory support. According to the Extracorporeal Life Support Organization, April 2025, in the 'ELSO Registry Report for April 2025', the cumulative global registry volume reached 245,291 ECMO runs, evidencing a robust upward trajectory in procedural volume that necessitates reliable, adjunct anticoagulation solutions.

Simultaneously, the Expansion of Clinical Indications into Sepsis and Trauma Care is positioning antithrombin as a dual-action therapeutic, leveraging its anti-inflammatory potential to mitigate coagulopathy in septic shock. Industry players are actively pursuing label expansions to address disseminated intravascular coagulation, aiming to transition the biologic from a niche orphan drug to a frontline critical care intervention. This strategic pivot targets a vast unmet medical need beyond hereditary deficiencies; according to the Global Sepsis Alliance, July 2025, in the 'Get Ready for World Sepsis Day 2025' press release, sepsis is responsible for approximately one in five deaths globally, representing a colossal target population that could exponentially increase the addressable market for plasma-derived therapies.

Segmental Insights

The Therapeutics segment is identified as the fastest-growing category within the Global Antithrombin Market. This expansion is primarily driven by the rising diagnosis of hereditary antithrombin deficiency and the critical necessity for anticoagulation management during high-risk medical procedures, such as childbirth or surgery. Continued approvals by regulatory authorities like the U.S. Food and Drug Administration for specific plasma-derived and recombinant products have broadened clinical access. Consequently, the increasing adoption of these treatments to prevent dangerous blood clots supports the segment's accelerated development.

Regional Insights

Based on recent market research, Asia Pacific holds the leading position in the Global Antithrombin Market, driven by substantial advancements in regional healthcare infrastructure and a rising prevalence of blood coagulation disorders. This dominance is reinforced by strategic government initiatives that facilitate the accessibility of plasma-derived and recombinant therapies across major economies. Additionally, a rapidly aging population has accelerated the clinical demand for effective thrombosis management solutions. Increased investments in domestic biotechnology sectors and improved diagnostic capabilities further consolidate Asia Pacific's standing as the primary hub for market activity and expansion.

Recent Developments

• In November 2025, Grifols announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for its antithrombin III (human) concentrate, Thrombate III. This regulatory milestone allows the therapy to be used for the treatment of pediatric patients with hereditary antithrombin deficiency (hATd), a rare genetic blood clotting disorder. With this approval, the product became the first and only antithrombin concentrate in the United States indicated for both adult and pediatric populations to prevent and treat thromboembolism in clinical situations such as surgery or childbirth.
• In March 2025, Sanofi received approval from the U.S. Food and Drug Administration (FDA) for Qfitlia (fitusiran), a first-in-class antithrombin-lowering therapy. This novel treatment is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and adolescents aged 12 and older with hemophilia A or B, regardless of inhibitor status. The approval was based on data from the ATLAS Phase 3 clinical development program, which demonstrated that the therapy significantly reduced annualized bleeding rates by targeting and lowering antithrombin levels to promote sufficient thrombin generation and rebalance hemostasis.
• In March 2025, Siemens Healthineers obtained clearance from the U.S. Food and Drug Administration (FDA) for its INNOVANCE Antithrombin assay as a companion diagnostic. This chromogenic assay is designed to quantitatively measure antithrombin activity levels in human plasma and was approved for use in conjunction with Sanofi's newly authorized hemophilia therapy, Qfitlia. The diagnostic tool enables healthcare providers to monitor antithrombin levels accurately, ensuring appropriate dosing and management for patients undergoing treatment with the antithrombin-lowering RNA interference therapy.
• In August 2024, Octapharma initiated a pivotal Phase 3 clinical study to evaluate the efficacy and safety of its human plasma-derived antithrombin concentrate, Atenativ. This prospective, double-blind, randomized, placebo-controlled trial, identified as ATN-108, was designed to assess the product's ability to restore heparin responsiveness in patients with acquired antithrombin deficiency who are undergoing cardiac surgery requiring cardiopulmonary bypass. The study aims to enroll approximately 120 patients across multiple centers in the United States and Europe, addressing a critical need for managing heparin resistance in high-risk surgical settings.

Key Market Players

• Grifols, S.A.
• Takeda Pharmaceutical Company Limited
• Octapharma Brasil Ltda.
• LFB USA, Inc.
• Endpoint Health, Inc.
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc
• BioCare, Inc.
• F. Hoffmann-La Roche Ltd
• Kedrion S.p.A

By Usage	By Source	By Type	By Region
Therapeutics Diagnostics Research Others	Human Recombinant Goat Milk Others	Anticoagulant Antiplatelet Thrombolytic Drugs	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Antithrombin Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Antithrombin Market, By Usage:

• Therapeutics
• Diagnostics
• Research
• Others

• Antithrombin Market, By Source:

• Human
• Recombinant Goat Milk
• Others

• Antithrombin Market, By Type:

• Anticoagulant
• Antiplatelet
• Thrombolytic Drugs

• Antithrombin Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE