Factor XII Inhibitors Global Market Report 2025

The factor XII inhibitors market size has grown rapidly in recent years. It will grow from $1.26 billion in 2024 to $1.4 billion in 2025 at a compound annual growth rate (CAGR) of 11.3%. Growth in the historic period can be attributed to the increasing prevalence of thrombosis, a rising need for safer anticoagulants, continued growth in clinical trial activity, greater awareness of contact pathway-based therapies, and expanding recognition of the therapeutic potential of Factor XII inhibition.

The factor XII inhibitors market size is expected to see rapid growth in the next few years. It will grow to $2.12 billion in 2029 at a compound annual growth rate (CAGR) of 10.9%. Growth in the forecast period can be linked to rising cases of thrombotic and cardiovascular diseases, increasing demand for safer anticoagulant medications, growing awareness of hereditary angioedema treatment options, an uptick in clinical trials evaluating FXII inhibitors, and the expanding use of biologics and monoclonal antibodies. Major trends expected in the forecast period include technological progress in anticoagulant drug design, the use of artificial intelligence for target identification, a shift toward safer anticoagulant mechanisms, strategic partnerships between biotechnology companies and pharmaceutical firms, and advancements in surgical techniques.

The rising incidence of thrombotic disorders is expected to drive the growth of the Factor XII inhibitors market. Thrombotic disorders, including venous and arterial blood clots, can block circulation and lead to serious health complications. Their incidence is increasing due to sedentary lifestyles, which contribute to poor blood flow and higher clotting risk. Factor XII inhibitors help prevent abnormal clot formation by selectively blocking the contact activation pathway without interfering with normal hemostasis. This targeted approach allows effective thrombosis management while lowering bleeding risk. For example, in January 2025, the Centers for Disease Control and Prevention (CDC) reported that approximately 900,000 Americans are affected by venous thromboembolism annually, with an estimated 60,000-100,000 deaths and numerous long-term complications. Therefore, the rising prevalence of thrombotic disorders is driving demand for Factor XII inhibitors.

The increasing focus on targeted therapies is further propelling the Factor XII inhibitors market. Targeted therapies precisely inhibit molecular abnormalities in diseases, reducing harm to healthy tissues and improving treatment outcomes. Advances in precision medicine, which tailor treatments to patients’ genetic profiles, have accelerated the adoption of such therapies. Factor XII inhibitors complement targeted therapies by selectively modulating the intrinsic coagulation pathway, minimizing bleeding risks compared to conventional anticoagulants and enhancing treatment safety. For instance, in December 2024, the American Society of Gene & Cell Therapy (ASGCT) reported that the FDA approved six gene therapy products in 2023, up from five in 2022, reflecting the growing emphasis on precision medicine.

Key companies in the Factor XII inhibitors market are developing innovative therapies, such as anti-FXIIa monoclonal antibodies, to improve treatment efficacy and patient outcomes. Anti-FXIIa monoclonal antibodies specifically inhibit activated Factor XII to prevent abnormal clot formation while preserving normal hemostasis. For example, in February 2025, CSL Behring GmbH, a Germany-based biopharmaceutical company, received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for ANDEMBRY (garadacimab) 200 mg subcutaneous injection pens. ANDEMBRY is a human anti-activated Factor XII monoclonal antibody approved for preventing acute attacks of hereditary angioedema (HAE), acting on Factor XIIa, a key trigger of HAE episodes, and is conveniently administered via subcutaneous injection.

Major companies operating in the factor xii inhibitors market are Taylor & Francis Group, Santa Cruz Biotechnology Inc., CSL Limited, Bridge Medicines Inc., KalVista Pharmaceuticals Inc., Ovid Technologies Inc., Affinity Biologicals Inc., Lunac Therapeutics Ltd., Grantome LLC

North America was the largest region in the factor XII inhibitors market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in factor XII inhibitors report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the factor XII inhibitors market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

The factor XII inhibitors market research report is one of a series of new reports that provides factor XII inhibitors market statistics, including factor XII inhibitors industry global market size, regional shares, competitors with a factor XII inhibitors market share, detailed factor XII inhibitors market segments, market trends and opportunities, and any further data you may need to thrive in the factor XII inhibitors industry. This factor XII inhibitors market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Factor XII inhibitors are therapeutic agents that block the activity of coagulation Factor XII, a protein responsible for initiating the intrinsic blood-clotting pathway. They inhibit downstream clotting processes without significantly disrupting normal hemostasis. Their primary purpose is to reduce abnormal thrombosis and other clot-related conditions while offering a lower bleeding risk than traditional anticoagulants.

The key drug types of Factor XII inhibitors include monoclonal antibodies, small-molecule inhibitors, and others. Monoclonal antibodies are laboratory-produced antibodies that specifically target and inhibit Factor XII to prevent abnormal clot formation with minimal bleeding risk. These therapies are delivered through oral, injectable, or other administration routes. They are used for conditions such as hereditary angioedema, thrombosis, inflammatory disorders, and more, serving end users including hospitals, specialty clinics, research institutes, and others.

The factor XII inhibitors market consists of revenues earned by entities by providing services such as formulation development, drug delivery optimization, laboratory testing, diagnostic support, regulatory consulting, pharmacovigilance, and contract manufacturing services. The market value includes the value of related goods sold by the service provider or included within the service offering. The factor XII inhibitors market also includes sales of anticoagulant formulations, combination therapies, diagnostic kits, research reagents, laboratory consumables, and supportive medical devices. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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