Point of Care (POC) Coagulation Testing Devices Market Size, Share & COVID-19 Impact Analysis, By Device Type (Anticoagulation Monitoring Devices (PT-INR, ACT, aPTT), Platelet Function Monitoring Devices, Viscoelastic Coagulation Monitoring Devices (TEG, and ROTEM), and Others), By End-User (Hospitals & Clinics, Homecare, and Others), and Regional Forecast, 2021-2028

The global point of care (POC) coagulation testing devices market size was USD 1.50 billion in 2020. The global impact of COVID-19 has been unprecedented and staggering, with point of care coagulation testing devices witnessing a negative demand shock across all regions amid the pandemic. Based on our analysis, the global market exhibited a decline of -3.8% in 2020. The market is projected to grow from USD 1.53 billion in 2021 to USD 2.44 billion in 2028 at a CAGR of 6.9% in the 2021-2028 period. The sudden rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Regular monitoring of anticoagulation therapy among patients has been plagued with a relatively high incidence of adverse reaction including hemorrhage or thrombosis. These conditions can occur due to the complexity of anticoagulants or adverse reaction of any drug. Across several healthcare settings, POC 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.

Growing Demand for TEG Devices across Healthcare Settings amid Pandemic

The outbreak of COVID-19 has had a negative impact on the growth of this market. Key players operating in the market have reported decline in their revenues due to the pandemic. Also, the government of affected countries laid instructions for the postponement of non-essential surgeries and patient visits.

This 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. However, vital function monitoring viscoelastic devices such as Thromboelastography (TEG) is gaining popularity among healthcare providers to detect venous thromboembolism (VTE) or pulmonary embolism (PE) among critically ill COVID-19 patients.

• For instance, in May 2020, a study published by French researchers in Intensive Care Medicine Journal observed an increase in incidence of prothrombotic conditions in patients with severe symptoms of COVID-19 infection.

As a result, coagulation tests such as D-dimer, prothrombin time (PT), TEG, activated partial thromboplastin time (aPTT) became a crucial indicator in the hospital settings. Additionally, the recent outbreak of new COVID-19 strain in countries such as U.K., India, and others, is further expected to continue the trend of postponement of surgeries and will also increase the burden on the healthcare system of the affected countries.

LATEST TRENDS

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Increasing Demand & Adoption of Home Healthcare Devices to Aid Market Growth

Increasing cost burden of healthcare services and hospital stays has resulted in gradual shift of patients towards homecare settings for treatment of diseases such as hemophilia, VWD, and others. Additionally, companies are constantly investing in development of advanced and easy to operate point of care devices for monitoring of 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 April 2018, F. Hoffmann-La Roche Ltd, launched CoaguChek vantus system in the market. This system was a self-testing device integrated with advanced features such as wireless reporting of INR results.

Hence, 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.

DRIVING FACTORS

Increasing Patient Pool with Bleeding Disorders to Boost Demand for POC Coagulation Diagnostics

Increasing patient population with bleeding disorders including hemophilia, Von Willebrand, venous thromboembolism, and others is propelling the demand for POC coagulation testing. For instance, the World Federation of Hemophilia (WFH) estimated that around 195,263 patients globally were suffering from hemophilia in 2019.

Also, a significant increase has been observed in number of geriatric patients suffering with bleeding disorders due to changing hemostatic balance among people with the growing age. Further generating 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 is further boosting the adoption of these testing devices globally. Hence,  subsequently accelerating the point of care (POC) coagulation testing devices market growth during the forecast period.

RESTRAINING FACTORS

High Cost of POC Coagulation Testing Devices to Restrict Adoption in Emerging Countries

Despite the distinct benefits offered by point of care coagulation testing devices as compared to conventional coagulation analyzers, certain factors are limting 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 CADTH, the average cost of Roche’s CoaguChek ranged from USD 500 to USD 2,000, as compared to the cost of PT-INR assay test that ranged from USD 4 to USD 31.

These above costs combined with additional costs of battery, and maintenance can lead to higher overall annual costs of POC coagulation testing devices. Thus, high cost of these testing devices, and lack of favourable reimbursement policies are few of the major factors restricting its adoption and growth in emerging countries.

SEGMENTATION

By Device Type Analysis

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Viscoelastic Coagulation Monitoring Devices to Register Higher CAGR during 2021-2028

Among device type, the global point of care coagulation 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 2020 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.

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 clinical proven efficiency in providing information regarding blood clots in all phases of coagulation, which is instrumental for successful hemostasis.

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.

By End-User Analysis

Hospital & Clinics to Hold a Significant Share in 2020

Based on end-users, the market includes hospital & clinics, homecare and others.

The hospital & clinics segment held a dominating share of the global market in 2020 due to increasing number of hospitalizations of patients suffering with chronic bleeding disorders and comparatively higher adoption of cutting edge technology in these settings.

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

REGIONAL INSIGHTS

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The POC coagulation testing devices market size in North America held a market size of USD 0.62 billion in 2020. Presence of large patient pool with bleeding disorders, higher implementation of technologically advanced devices, and higher per capita healthcare expenditure are few of the major factors responsible for the dominance of North America. For example, according to the data published by the Centers for Disease Control & Prevention (CDC), it was estimated that around 33,000 male patients in the U.S. were suffering from hemophilia in 2019.

The market in Europe is expected to register a significant CAGR owing to the introduction of advanced coagulation testing devices in the market due to technological advancements in point of care diagnostics.

Asia Pacific is anticipated to grow at a higher CAGR due to increasing number of patients with hemophilia, Von Willebrand Disease (VWD) and others. This along with the shifting focus of market players to expand their direct presence in emerging countries such as China, India is further expected to boost the growth of this region.

However, 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 (POC) coagulation testing devices.

KEY INDUSTRY PLAYERS

Robust Product Offerings by Major Players Led to Market Dominance in 2020

Competitive landscape of the market is consolidated, with few players such as F. Hoffmann-La Roche Ltd, Abbott, and Siemens Healthcare GmbH accounting for the largest share of market in 2020. The dominance of these players is attributed to their strong operating network and robust portfolio for point of care coagulation devices.

On the other hand, new entrants such as HemoSonics LLC are currently focusing towards introducing 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.

Few other players operating in the market are Haemonetics Corporation, Werfen, CoaguSense, Inc., Helena Laboratories Corporation, Medtronic, and Koninklijke Philips N.V.

LIST OF KEY COMPANIES PROFILED:

• Werfen (Barcelona, Spain)


• CoaguSense, Inc. (California, U.S.)


• Helena Laboratories Corporation (Texas, U.S.)


• Medtronic (Dublin, Ireland)


• Abbott (Illinois, U.S.)


• F. Hoffmann-La Roche Ltd (Basel, Switzerland)


• Siemens Healthcare GmbH (Munich, Germany)


• Koninklijke Philips N.V. (Amsterdam, Netherlands)


• HemoSonics, LLC (Virginia, U.S.)


• Haemonetics Corporation (Boston, U.S.)

KEY INDUSTRY DEVELOPMENTS:

• January 2021 – Abbott received the U.S. FDA clearance for its rapid handheld traumatic brain injury (TBI) blood test. This test will be performed on the company’s i-STAT Alinity platform that provides results within 15 minutes after the plasma is placed on the test cartridge.


• January 2021 - F. Hoffmann-La Roche Ltd renewed its partnership with Sysmex Corporation with an aim to offer high quality hematology solutions for improving testing efficacy worldwide.

REPORT COVERAGE

An Infographic Representation of Point-of-Care Coagulation Testing Devices Market

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The point of care (POC) coagulation testing devices market research report provides a detailed analysis of the market and focuses on key aspects such as company profiles, device type, 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.

Report Scope & Segmentation