Coagulation Testing Market Forecast 2034: Increasing Incidence of Bleeding Disorders and Demand for Accurate Diagnostics Propel Market Growth | Transparency Market Research, Inc

The global coagulation testing market was valued at US$ 3.4 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 6.0% from 2024 to 2034, reaching an estimated US$ 6.5 billion by the end of the forecast period. The rising prevalence of liver diseases, advancements in point-of-care (POC) coagulation testing, and ongoing research and development (R&D) in innovative diagnostic solutions are key factors driving market expansion.

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The increasing burden of liver diseases is a major factor boosting the demand for coagulation testing worldwide. Liver disorders often lead to abnormalities in blood clotting mechanisms, making coagulation tests an essential diagnostic tool for assessing unexplained bleeding in affected patients. Additionally, coagulation testing plays a critical role in pre- and perioperative screening and monitoring of anticoagulant therapies, further strengthening its adoption in clinical settings. The market is witnessing a shift toward rapid and efficient point-of-care coagulation tests, which offer real-time monitoring of coagulation status in patients using anticoagulants, including direct oral anticoagulants. Market players are continuously investing in the development of advanced POC devices to improve patient outcomes and streamline diagnostic processes.

Market Introduction

Coagulation, or blood clotting, is a crucial physiological process wherein blood transforms into a thickened, viscous mass to prevent excessive bleeding. The coagulation process depends on a delicate balance between procoagulant and anticoagulant factors, and any disturbance in this equilibrium can lead to severe complications, such as thrombosis or bleeding disorders. Several clotting factors, including fibrinogen, prothrombin, thromboplastin, calcium, and antihemophilic factor, play a fundamental role in the coagulation cascade. Prothrombin, a plasma protein synthesized by the liver, is particularly important as it converts into thrombin, an enzyme that catalyzes the formation of fibrin monomers, which then polymerize to create fibrin fibers and form a blood clot.

Coagulation testing is widely used to assess hemostatic function and diagnose clotting abnormalities. It is employed in diverse clinical scenarios, including the diagnosis of unexplained bleeding, preoperative evaluations, anticoagulant therapy monitoring, and biomedical research. Key coagulation tests include Prothrombin Time (PT), Activated Partial Thromboplastin Clotting Time (APTT), Thrombin Time (TT), and Activated Clotting Time (ACT). PT measures the clotting time of plasma when exposed to tissue factor, reflecting the extrinsic and common coagulation pathways. APTT evaluates clotting time upon activation of contact factors, while ACT assesses whole blood clotting following intrinsic pathway activation.

Market Drivers

Rise in Prevalence of Liver Diseases

The growing incidence of liver diseases is significantly contributing to the increasing demand for coagulation testing. The liver plays a crucial role in the synthesis of clotting factors, and liver dysfunction often results in coagulation abnormalities. Patients suffering from chronic liver diseases frequently develop complex hemostatic disorders, necessitating routine laboratory tests such as PT and platelet count for accurate diagnosis and management. According to the Global Burden of Liver Disease 2023 Update, liver diseases account for approximately two million deaths annually, constituting 4% of all global fatalities. The rising burden of liver-related conditions highlights the critical need for precise coagulation diagnostic tools.

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R&D of New Tests Fueling Market Progress

Research and development initiatives are propelling advancements in coagulation testing. In February 2024, F. Hoffmann-La Roche Ltd. introduced three new coagulation tests for oral Factor Xa inhibitors-apixaban, edoxaban, and rivaroxaban-across European countries adhering to the CE mark. Factor Xa inhibitors are widely prescribed for various cardiovascular conditions, including non-valvular atrial fibrillation, coronary artery disease (CAD), peripheral arterial disease (PAD), and venous thromboembolism (VTE). With CAD emerging as the leading cause of heart disease, responsible for 375,476 deaths in 2021, according to the Centers for Disease Control and Prevention (CDC), the demand for coagulation testing is anticipated to surge in the coming years. Furthermore, the development of point-of-care (POC) coagulometers is transforming the market landscape by enabling immediate insights into patients' coagulation status, particularly in emergency settings. These innovations are crucial in addressing urgent medical scenarios, such as excessive bleeding or the need for rapid anticoagulant reversal treatment.

Regional Outlook

North America Leading the Market

North America dominated the global coagulation testing market in 2023, driven by the high prevalence of lifestyle-related disorders, increasing healthcare expenditure, and advancements in diagnostic technologies. According to recent trends, approximately 4.5 million adults in the United States are diagnosed with liver disease, further amplifying the demand for coagulation testing solutions. Additionally, significant funding initiatives aimed at supporting diagnostic innovation are bolstering market growth in Europe. In November 2022, Enzyre, a Netherlands-based biotechnology firm, secured €12 million (US$ 11.9 million) in Series A financing to develop its EnzyPad diagnostic technology platform, designed to facilitate real-time home-based monitoring of coagulation status in hemophilia patients.

Competitive Landscape

Key industry players are focusing on introducing portable, hand-held coagulation analyzers that provide rapid and reliable Prothrombin Time (PT) measurements for point-of-care monitoring and management of oral anticoagulant therapy. Leading companies in the global coagulation testing market include F. Hoffmann-La Roche Ltd., Abbott, Siemens Healthineers, Sysmex Corporation, Universal Biosensors, Inc., HemoSonics, LLC, Thermo Fisher Scientific Inc., Randox Laboratories Ltd., Horiba, Ltd., Agappe Diagnostics Ltd., Medtronic, and Helena Laboratories, Inc. These companies have been profiled in the coagulation testing market report based on parameters such as company overview, business strategies, financial performance, product portfolios, and recent developments.

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Key Developments in the Coagulation Testing Market

In 2021, Siemens Healthineers launched Sysmex's CN-3000 and CN-6000 hemostasis systems to cater to mid- and high-volume coagulation testing laboratories. These systems support multiple routine and specialty coagulation assays, enabling comprehensive detection of clotting disorders, including abnormal blood coagulation and excessive bleeding.

The coagulation testing market is set for robust growth driven by rising disease prevalence, increasing adoption of POC diagnostics, and continuous R&D in innovative testing solutions. Market players are capitalizing on technological advancements to introduce novel diagnostic tools, ensuring better patient outcomes and more efficient healthcare delivery worldwide.

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