Coagulation Testing Market Outlook to Reach USD 6.5 Billion by 2034 at 6.0% CAGR | Analysis by TMR

The global coagulation testing market is poised for significant growth as increased liver disease prevalence and rapid advancements in point-of-care (POC) diagnostic solutions drive market expansion across diverse healthcare settings. The global coagulation testing market was valued at US$ 3.4 billion in 2023 and is projected to expand at a CAGR of 6.0% from 2024 to 2034, reaching an estimated US$ 6.5 billion by the end of the forecast period.

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Analyst Viewpoint: Advancing Diagnostics for Enhanced Patient Outcomes

The coagulation testing market is witnessing transformative growth, primarily driven by the surge in liver disease prevalence. Prolonged clotting times may indicate liver dysfunction or deficiencies in critical clotting factors, making coagulation tests essential for diagnosing unexplained bleeding. In parallel, point-of-care (POC) coagulation tests are rapidly gaining traction as they enable clinicians to accurately measure anticoagulant effects, thereby detecting bleeding disorders and monitoring patients on anticoagulant therapy.

Vendors in this space are actively developing rapid POC solutions capable of determining the coagulation status of patients-whether they are on traditional or direct oral anticoagulants-thus ensuring timely and effective clinical decision-making.

Market Introduction: Understanding Coagulation and Its Testing
Coagulation, or clotting, is the process by which blood transforms from a liquid into a gel, forming a clot. This process hinges on a delicate balance between procoagulants and anticoagulants. Disruptions in this balance can result in thrombosis or excessive bleeding. Key clotting factors include fibrinogen, prothrombin, thromboplastin, calcium, and antihemophilic factors. Notably, prothrombin-a plasma protein synthesized by the liver-is converted into thrombin, which then catalyzes the formation of fibrin fibers and stimulates platelet activation through the release of adenosine diphosphate (ADP).

Coagulation testing, which encompasses tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Clotting Time (APTT), Thrombin Time (TT), and Activated Clotting Time (ACT), is instrumental in preoperative assessments, monitoring anticoagulant therapy, and conducting vital research.

Market Drivers
Rise in Prevalence of Liver Diseases:
Liver disease adversely affects prothrombin production, leading to coagulation imbalances. With liver disease accounting for significant global morbidity and mortality-responsible for 4% of all deaths worldwide-demand for coagulation testing continues to grow.

R&D of New Tests Fueling Market Progress:
In February 2024, F. Hoffmann-La Roche Ltd. launched three new coagulation tests in European markets for oral Factor Xa inhibitors (apixaban, edoxaban, and rivaroxaban). These innovations support the growing need to manage cardiovascular conditions such as coronary artery disease (CAD), which remains a leading cause of death globally.

Advancements in POC Coagulometers:
The development of handheld, rapid POC coagulation analyzers is transforming emergency care. These devices provide real-time, comprehensive insights into a patient's clotting status, enabling faster clinical interventions during critical situations.

Regional Outlook: Leading the Way in Diagnostic Innovation
Leading Region: North America
North America held the largest market share in 2023, driven by a high prevalence of lifestyle disorders and liver diseases-with approximately 4.5 million adults in the U.S. diagnosed with liver conditions. Concurrently, Europe is emerging as a significant market thanks to robust funding for advanced diagnostic technologies. In November 2022, Enzyre-a Netherlands-based developer-secured €12 million (US$ 11.9 million) in Series A financing to advance its innovative EnzyPad platform, designed for real-time, at-home coagulation monitoring.

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Competitive Landscape: Key Players Shaping the Future
Leading companies are intensifying their focus on developing state-of-the-art, portable coagulation analyzers for point-of-care applications. Prominent players 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

Helena Laboratories, Inc.

These companies are profiled based on their strategic initiatives, comprehensive product portfolios, and innovative technological advancements.

Key Developments in the Coagulation Testing Market
2021: Siemens Healthineers introduced Sysmex's CN-3000 and CN-6000 hemostasis systems, enabling mid- and high-volume coagulation testing with a range of assays to detect abnormal clotting and bleeding disorders.

2024: The launch of novel coagulation tests by F. Hoffmann-La Roche Ltd. in Europe marked a pivotal advancement in the monitoring of oral anticoagulant therapies.

Market Segmentation
By Product Type:
Instruments, Consumables

By Test Type:

Prothrombin Time (PT), Activated Partial Thromboplastin Clotting Time (APTT), Thrombin Time (TT), Activated Clotting Time (ACT), Others

By End-user:

Hospitals and Clinics, Diagnostic Laboratories, Home Care Settings, Others

By Region:

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Countries Covered:

U.S., Canada, Germany, U.K., France, Italy, Spain, China, India, Japan, Australia & New Zealand, Brazil, Mexico, South Africa, GCC

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Frequently Asked Questions

How big was the global coagulation testing market in 2023?

The market was valued at US$ 3.4 billion in 2023.

What is the expected growth rate for the coagulation testing market?

The market is forecasted to grow at a CAGR of 6.0% from 2024 to 2034.

What factors are driving the demand for coagulation testing?

Key drivers include the rising prevalence of liver diseases and significant R&D advancements in both traditional and POC coagulation testing methods.

Which region held the largest market share in 2023?

North America, driven by high incidences of liver disease and lifestyle disorders, held the largest share.

Who are the major players in the coagulation testing market?

Major players include F. Hoffmann-La Roche Ltd., Abbott, Siemens Healthineers, Sysmex Corporation, and others.

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