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Coagulation Instruments and Reagents

Coagulation market looks promising in coming years

The significance of monitoring D-dimer levels, along with the augmented demand for the techniques of advanced coagulation testing, is estimated to pave way for rapid growth of the global coagulation testing market in the near future.

Blood coagulation monitoring has been increasingly important in recent years for detecting hemorrhage sources, creating anticoagulant medications, measuring bleeding risk in major surgery operations and dialysis, and evaluating the efficacy of hemostatic therapy. From measuring the optical density of a clot in a cuvette to detecting clotting components, hemostasis diagnostics have come a long way. Flow cytometry, chromogenic tests, molecular typing, immunologic assays, functional testing of specific coagulation proteins, and platelet function analyzers are examples of these techniques. These technological advancements have resulted in increased capability, productivity, sensitivity, specificity, and, eventually, improved patient clinical care.

Over the past decade, the introduction of new coagulation analyzer tests has led to an increase in the quality and efficiency of hemostasis laboratories.

Some of the modern complex coagulators also possess high throughput, flexibility, and reliability. Other than this, they provide improved accuracy and precision, and easy-to-use advanced software, provided with in-built graphs and calibration curves.

Moreover, there has been a significant rise in the prevalence of cardiac diseases and blood disorders, which has created the need for improved coagulation analyzers across the globe.

Besides this, the sales of coagulation analyzers are positively being influenced by the increasing number of hospitals, diagnostic centers, and research institutes established worldwide.

In addition, there is a huge demand for coagulation-associated parameters like D-dimer. The increase in D-dimer was the most significant change in coagulation parameters in Covid-19 patients, and occurred more frequently than other coagulation parameters, such as prothrombin time (PT) or aPTT.

The recently published IFCC guidelines on Covid-19 strongly suggest D-dimer testing in patients with Covid-19 since studies on SARS-CoV-2 revealed a high correlation between severity and outcome of Covid-19 in patients with increased D-dimer levels. Physicians are preferring D-dimer test as a potential prognostic marker to assess the disease severity of the Covid-19 patients.

Also, serious novel Covid-19 pneumonia patients have thrombosis (blood clot), and this requires continuous monitoring of patients during treatment. This aspect is eventually fueling the demand for coagulation testing procedures, which is expected to accelerate the market growth in the Covid-19 outbreak.

The global D-dimer testing market is estimated to reach USD 2.7 billion by 2027, growing at a CAGR of 3.8 percent. Point-of-care tests (POCT) segment is projected to record a 4-percent CAGR and reach USD 1.1 billion by the end of 2027. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the laboratory tests segment is readjusted to a revised 3.7-percent CAGR for the next seven-year period.

The significance of monitoring D-dimer levels in Covid-19 cases during treatment, along with the augmented demand for the techniques of advanced coagulation testing, is estimated to pave way for rapid growth of the global D-dimer testing market in the near future.

The global market for coagulation testing instruments and reagents is expected to reach a value of USD 3814.3 million by 2026 at a 7.1-percent CAGR from 2020 to 2026. Consumables held the largest global market share in the previous years and are estimated to account for USD 1975.8 million by 2026. Instruments segment is the fastest growing in the market, and it will generate a revenue of USD 1718.8 million in 2026. Clinical laboratories, hospitals, and POCT users were amongst the main target group for this fast-developing market. POCT segment is a rapidly progressing segment in the global market, and it has registered a revenue of USD 310 million in 2021 and is expected to generate a revenue of USD 495.7 million by 2026.

The market for prothrombin time application accounted for the highest coagulation testing market size in 2021, and is projected to generate revenue of USD 2648.1 million till 2026. This growth is attributed to wide usage of coagulation testing procedures for prothrombin time application in hospitals to evaluate the hemostatic system.

Besides prothrombin time, the market for APTT accounted for second-highest market share in the global market, and is expected to register USD 639.2 million in 2026. By end-users, hospital end-use accounted for majority of the coagulation testing market share in 2021, which was about 38 percent, and is projected to continue its growth over the next five years. Increasing number of patients admitting in hospitals due to growing prevalence of chronic disorders requires continuous monitoring; this factor is projected to enhance the market size in coming years.

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 the market in 2021. The dominance of these players is attributed to their strong operating network and robust portfolio for POC coagulation devices.

On the other hand, new entrants, such as HemoSonics LLC, are currently focusing toward introducing advanced testing devices in the market, in order to establish their foothold in the global market.

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

In January 2021, Abbott received the USFDA 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. In the same month, 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.

Research Corner
Researchers have developed a new blood-clotting test that uses only a single drop of blood and a smartphone vibration motor and camera.

Blood clots form naturally as a way to stop bleeding when someone is injured. But blood clots in patients with medical issues, such as mechanical heart valves or other heart conditions, can lead to a stroke or heart attack. That is why millions of Americans take blood-thinning medications, such as warfarin that make it harder for their blood to clot.

Warfarin is not perfect, however, and requires patients to be tested frequently to make sure their blood is in the correct range – blood that clots too easily could still lead to a stroke or a heart attack while blood that does not clot can lead to extended bleeding after an injury. To be tested, patients either have to go to a clinic laboratory or use a costly at-home testing system.

Researchers at the University of Washington have developed a new blood-clotting test that uses only a single drop of blood and a smartphone vibration motor and camera. The system includes a plastic attachment that holds a tiny cup beneath the phone’s camera.

A person adds a drop of blood to the cup, which contains a small copper particle and a chemical that starts the blood-clotting process. Then the phone’s vibration motor shakes the cup while the camera monitors the movement of the particle, which slows down and then stops moving as the clot forms. The researchers showed that this method falls within the accuracy range of the standard instruments of the field.

The team published these findings February 11, 2022, in Nature Communications.

“Back in the day, doctors used to manually rock tubes of blood back and forth to monitor how long it took a clot to form. This, however, requires a lot of blood, making it infeasible to use in home settings,” said senior author Shyam Gollakota, UW professor in the Paul G. Allen School of Computer Science & Engineering. “The creative leap we make here is that we’re showing that by using the vibration motor on a smartphone, our algorithms can do the same thing, except with a single drop of blood. And we get accuracy similar to the best commercially available techniques.”

Doctors can rank blood-clotting ability using two numbers – the time it takes for the clot to form, what’s known as the prothrombin time or PT; and a ratio calculated from the PT that allows doctors to more easily compare results between different tests or laboratories, called the international normalized ratio or INR.

Patients who can monitor their PT/INR levels from home would only need to go to see a clinician if the test suggested they were outside of that desirable range, Michaelsen said.

The researchers wanted an inexpensive device that could work similarly to how at-home blood sugar monitors work for people with diabetes: A person can prick their finger and test a drop of blood. The team added a small copper particle because its motion was so much more reliable to track. To calculate PT and INR, the phone collects two time stamps – first when the user inserts the blood and second when the particle stops moving.

The researchers tested this method on three different types of blood samples. As a proof of concept, the team started with plasma, a component of blood that is transparent and, therefore, easier to test. The researchers tested plasma from 140 anonymized patients at the University of Washington Medical Center. The team also examined plasma from 79 patients with known blood-clotting issues. For both these conditions, the test had results that were similar to commercially available tests.

To mimic what a patient at home would experience, the team then tested whole blood from 80 anonymized patients at both Harborview and the University of Washington medical centers. This test also yielded results that were in the accuracy range of commercial tests.

This device is still in a proof-of-concept stage. The researchers have publicly released the code and are exploring commercialization opportunities as well as further testing. For example, currently all these tests have been done in the lab. The next step is to work with patients to test this system at home. The researchers also want to see how the system fares in more resource-limited areas and countries.

“Almost every smartphone from the past decade has a vibration motor and a camera. This means that almost everyone who has a phone can use this. All you need is a simple plastic attachment, no additional electronics of any kind,” Gollakota said. “This is the best of all worlds – it is basically the holy grail of PT/INR testing. It makes it frugal and accessible to millions of people, even where resources are very limited.”

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