Point-of-Care Coagulation (POCC) Testing Devices Market Size, Share & Industry Analysis, By Device Type (Anticoagulation Monitoring Devices {Prothrombin Time/International Normalized Ratio (PT/INR) Testing Devices, Activated Clotting Time (ACT), and Activated Partial Thromboplastin Time (aPPT)}, Platelet Function Monitoring Devices, Viscoelastic Coagulation Monitoring Devices {Thromboelastography (TEG) and Rotational Thromboelastometry (ROTEM)}, and Others), By End User (Hospitals & Clinics, Homecare, and Others), and Regional Forecast, 2024-2032

The global point-of-care coagulation (POCC) testing devices market size was USD 1.76 billion in 2023. The market is projected to grow from USD 1.88 billion in 2024 to USD 3.23 billion by 2032, exhibiting a CAGR of 7.0% during the forecast period. North America dominated the global point-of-care coagulation testing devices market with a market share of 42.05% in 2023.

Regular monitoring of anticoagulation therapy among patients has been plagued with a relatively high incidence of adverse reactions, including hemorrhage or thrombosis. These conditions can occur due to the complexity of anticoagulants or adverse reactions to any drug. Across several healthcare settings, point-of-care coagulation diagnostics are used over conventional analyzers to determine the phase of blood coagulation among patients with bleeding disorders. These diagnostic devices provide rapid and accurate hemostatic function results in patients with coagulopathies or preoperative and post-operative conditions.

Severe bleeding, such as after trauma or during surgery, requires adequate coagulation management. For this purpose, point-of-care (POC) tests allow a fast assessment of the hemostasis and provide important guidance when using a coagulation algorithm. This is surging the demand for diagnostic devices, and the growing focus of market players in optimizing or upgrading existing products through integrating novel technologies is contributing to market growth. Moreover, growing awareness related to bleeding disorders is expected to increase the diagnosis rate, which will likely drive the demand for these products and drive market growth.

The outbreak of COVID-19 had a negative impact on the growth of the point-of-care coagulation (POCC) testing devices market. Key players operating in the market reported a decline in their revenues due to the pandemic. In addition, the lockdown imposed during the COVID-19 pandemic resulted in a huge decline in non-emergency surgical procedures globally, which further limited the usage of coagulation testing devices during preoperative or post-operative conditions

Point-of-Care Coagulation (POCC) Testing Devices Market Trends

Gradual Shift Toward Home Healthcare Devices        

The increasing cost burden of healthcare services and hospital stays has resulted in a gradual shift of patients toward homecare settings for the treatment of diseases such as hemophilia, von Willebrand disease, and others. In addition, companies are constantly investing in the development of advanced and easy-to-operate point-of-care devices for monitoring coagulation disorders at home.

Their efforts have resulted in introduction of portable and advanced devices that can be easily used by patients without the need of professional support.

• For instance, in November 2021, CoaguSense Inc. incorporated a novel direct micromechanical clot-detection technology supported by the MedM remote care platform into its Coag-Sense PT/INR Monitoring System home testing system. The device displays the prothrombin time results in less than 1 minute without the need for lookup tables or curve-fitting algorithms.

Hence, the introduction of such advanced devices by market players is expected to boost the adoption of home-use point-of-care coagulation testing devices during the forecast period.

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Point-of-Care Coagulation (POCC) Testing Devices Market Growth Factors

Increasing Patient Pool with Bleeding Disorders to Boost the Demand for These Devices, Propelling the Market Growth

The increasing patient population with bleeding disorders, including hemophilia, Von Willebrand, venous thromboembolism, and others, is propelling the demand for point-of-care coagulation testing devices. For instance, as per the World Federation of Hemophilia (WFH) 2020 Report, during the study period from 1999-2020, a total of 241,535 people were diagnosed with hemophilia A or B type unknown globally. Furthermore, 87,729 people were diagnosed with von Willebrand disease and 64,394 with some other bleeding disorders in the same study period.

In addition, a significant increase has been observed in the number of geriatric patients suffering from bleeding disorders due to changing hemostatic balance among people with the growing age, further generating the demand for portable and easy-to-use testing devices. The above factors, along with the launch of advanced point-of-care diagnostic devices by market players, are further boosting the adoption of these testing devices globally. As a result, it is poised to accelerate the point-of-care coagulation (POCC) testing devices market growth during the forecast period.

RESTRAINING FACTORS

High Cost of Point-of-Care Coagulation (POCC) Testing Devices May Restrict their Adoption in Emerging Countries

Despite the distinct benefits offered by point-of-care coagulation (POCC) testing devices as compared to conventional coagulation analyzers, certain factors are limiting the growth of the global market. Among them is the high cost associated with such devices in comparison to affordable laboratory assay tests.

• For instance, as per the estimations of the Canadian Agency for Drugs and Technologies in Health (CADTH), the average cost of Roche’s CoaguChek ranges from USD 500 to USD 2,000, as compared to the cost of a PT-INR assay test that ranges from USD 4 to USD 31.

The above costs, combined with additional costs of battery and maintenance, increase the overall annual costs of point-of-care coagulation (POCC) testing devices. Thus, the high cost of these testing devices and the lack of favorable reimbursement policies are a few of the major factors restricting their adoption and demand in emerging countries.

Point-of-Care Coagulation (POCC) Testing Devices Market Segmentation Analysis

By Device Type Analysis

Lower Cost of Anticoagulation Monitoring Devices to Spur the Segment Growth

By device type, the global point-of-care coagulation (POCC) testing devices market is segmented into anticoagulation monitoring devices, platelet function monitoring devices, viscoelastic coagulation monitoring devices, and others.

The anticoagulation monitoring devices segment dominated the global market in 2023 owing to its ability to provide rapid and accurate results. This along with its comparatively lower cost is resulting in higher adoption among healthcare facilities. According to a study published by the Global Journal on Quality and Safety in Healthcare in May 2020, whole blood INR testing for warfarin dose adjustment with validated POCT devices is adequately comparable to the core laboratory results. It also simplifies workflow steps at the thrombosis clinic, enhancing patient experience and convenience via the immediate availability of results, a less invasive procedure, and a marked reduction in waiting time.

The viscoelastic coagulation monitoring devices segment is anticipated to register a higher CAGR during the forecast period. The growth of this segment is due to its clinically proven efficiency in providing information regarding blood clots in all phases of coagulation, which is instrumental for successful hemostasis. Moreover, the expanding presence of these devices through getting regulatory approvals is contributing to the segment’s growth. For instance, in July 2022, Werfen received 510(k) clearance for the ROTEM sigma Thromboelastometry System from the U.S. Food and Drug Administration (FDA). The ROTEM sigma is further commercially available in Europe, Australia, Asia, Latin America, and Africa at the point of care (POC) to guide bleeding management.

On the other hand, the platelet function monitoring devices segment is anticipated to grow at a steady pace during the forecast period. The growth is attributed to the expanding application of these devices in various healthcare settings for conditions such as inherited bleeding disorders, cardiovascular intensive care, trauma coagulopathy, liver transplantation, and obstetric care.

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By End User Analysis

Hospital & Clinics Segment Led Due to Growing Number of Hospitalizations

Based on end user, the market for point-of-care coagulation (POCC) testing devices is divided into hospital & clinics, homecare, and others.

The hospital & clinics segment held a dominating share in the global market in 2023 due to the increasing number of hospitalizations of patients suffering from chronic bleeding disorders and comparatively higher adoption of cutting-edge technology in these settings. The reimbursement offered by these settings reduces treatment costs, influencing patient preference.

On the other hand, the homecare segment is anticipated to register a comparatively higher CAGR during the forecast period owing to rising awareness among the general population regarding monitoring of bleeding disorders and growing demand and usage of in-home point-of-care testing devices.

REGIONAL INSIGHTS

Regionally, the market is divided into the Asia Pacific, Europe, the Middle East & Africa, North America, and Latin America.

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The point-of-care coagulation (POCC) testing devices market size in North America stood at USD 0.74 billion in 2023. The region’s dominance is attributed to the presence of a large patient pool with bleeding disorders, higher implementation of technologically advanced devices, and higher per capita healthcare expenditure. For example, according to the data published by the Centers for Disease Control & Prevention (CDC), the estimated prevalence of hemophilia in the U.S. is 12 cases per 100,000 U.S. males for hemophilia A and 3.7 cases per 100,000 U.S. males for hemophilia B. This large patient pool is anticipated to surge the demand for testing devices across the region, subsequently leading to market growth.

Europe market for point-of-care coagulation (POCC) testing devices held the second-largest share in 2023, owing to the introduction of advanced coagulation testing devices in the market due to technological advancements in point-of-care diagnostics. In July 2021, Sysmex Europe launched two new automated blood coagulation analyzers, CN-3500 and CN-6500, in specific countries of the EMEA region. The company targeted medium- and large-scale hospitals, commercial labs, and other healthcare facilities.

The Asia Pacific market for point-of-care coagulation (POCC) testing devices is anticipated to grow at a higher CAGR during the forecast period due to increasing number of patients with hemophilia, Von Willebrand Disease (VWD), and others. This along with the shifting focus of market players on expanding their direct presence in emerging countries such as China and India is further expected to boost the growth of this region. In August 2023, Universal Biosensors received approval from the Indian Central Drugs Standard Control Organisation (CDSCO) for the sale of Xprecia Prime, with the first order received from UBI’s distributor for the region.

On the other hand, Latin America and the Middle East & Africa are anticipated to register a moderate CAGR during the forecast period. This is due to their developing healthcare infrastructure and lack of reimbursement policies for point-of-care coagulation (POCC) testing devices.

List of Key Companies in Point-of-Care Coagulation (POCC) Testing Devices Market

Leading Players Dominate Due to Robust Product Portfolio

The global market is consolidated in terms of the competitive landscape, with few players such as F. Hoffmann-La Roche Ltd, Abbott, and Siemens Healthcare GmbH accounting for the largest point-of-care coagulation (POCC) testing devices market share in 2023. The dominance of these players is attributed to their strong operating network and robust portfolio for point-of-care coagulation (POCC) devices. These companies are focused on getting regulatory approvals to expand their products’ presence across various regions.

• For instance, in January 2021, Abbott received the U.S. FDA clearance for its rapid i-STAT TBI Plasma test. It is a handheld traumatic brain injury (TBI) blood test that assists clinicians in assessing patients with suspected mild TBIs.

A few other players operating in the market are Haemonetics Corporation, Werfen, CoaguSense, Inc., Helena Laboratories Corporation, Medtronic, and Koninklijke Philips N.V. These players are focused on making strategic alliances to expand their market presence. On the contrary, new entrants such as HemoSonics LLC are currently emphasizing the introduction of advanced testing devices in the market in order to establish their foothold in the global market.

• For instance, in March 2019, HemoSonics LLC announced that its Quantra hemostasis analyzer and QPlus cartridge received de novo marketing authorization by the U.S. FDA, as a result of which these products were launched in the U.S. market.

LIST OF KEY COMPANIES PROFILED:

• Werfen (Spain)


• CoaguSense, Inc. (U.S.)


• Helena Laboratories Corporation (U.S.)


• Medtronic (Ireland)


• Abbott (U.S.)


• F. Hoffmann-La Roche Ltd (Switzerland)


• Siemens Healthcare AG (U.S.)


• Koninklijke Philips N.V. (Netherlands)


• HemoSonics, LLC (U.S.)


• Haemonetics Corporation (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• October 2023 – Universal Biosensors (UBI) received approval to sell Xprecia Prime 4U directly to patients for self-testing in Europe. Xprecia Prime is a portable coagulation testing device designed for fast and reliable blood clotting testing.


• November 2022 – HemoSonics, LLC., received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for the Quantra Hemostasis System with QStat Cartridge. It helped increase Quantra’s overall diagnostic capabilities and offer the broadest range of clinical indications of any point-of-care hemostasis analyzer available in the U.S. market.


• January 2022 - Werfen received 510(k) clearance for GEM Hemochron 100 whole blood hemostasis system from the U.S. Food and Drug Administration (FDA). GEM Hemochron 100 system delivers fast, actionable activated clotting time (ACT) that results in minutes, informs patient-management decisions, and helps improve workflow at the point of care (POC).


• May 2021 – Perosphere Technologies Inc. received CE mark for its Point-of-Care (PoC) Coagulometer System from the European Commission.


• January 2021 – F. Hoffmann-La Roche Ltd announced the renewal of its partnership with Sysmex Corporation. This deal is aimed at providing high-quality hematology solutions to improve the efficacy of testing across the globe.

REPORT COVERAGE

The research report provides a detailed analysis of the point-of-care coagulation (POCC) testing devices market and focuses on key aspects such as company profiles, device types, and end-users. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the growth of the advanced market over recent years.

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Report Scope & Segmentation