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Coagulation Instruments and Reagents

Evolving Toward Next Generation Of Coagulation Analyzers

The next-generation coagulation analyzers are likely to be more compact and smartly designed with added parameters and specialty tests.

Hemostasis test results can point out major clinical issues, some of which may be life-threatening if not dealt with swiftly and accurately. For instance, cardiovascular disease (CVD) is one of the leading causes of death and disability in the world. And this is not likely to change any time soon, considering the demographics and lifestyle seen today. Like all patients, people with CVD have the best chance of survival when their illness is detected early. Advances in technology, together with the variety of tests offered by new coagulation analyzers allow laboratories to deliver better information. In the recent past, with increase in screening tests and therapeutic monitoring of hemostasis, many new innovative techniques have been introduced for coagulation analyzers. Automation has revolutionized the workflow with modern complex coagulometers having high-throughput, reliability, flexibility, easy-to-use advanced software with in-built LJ graphs and calibration curves, improved accuracy, and precision with minimum human error in measurement. Technological advancements have undeniably resulted in increased quality and efficiency in the hemostasis laboratory.

Nowadays, laboratories need analyzers that can transmit data, directly or indirectly into software, then into their HIS and ultimately into their EMR systems. Advancements in technology has boosted market growth due to efficient detection of blood clots by high precision devices and equipment. Moreover, improving automation and introduction of portable analyzers has further aided in increasing adoption of these systems in ambulatory and emergency care settings. Easy operation of these devices has also reduced the requirement of further skills at healthcare settings, thus increasing its adoption in remote settings and clinics. The global hemostasis/coagulation analyzers market was valued at USD 3650.1 million in 2017 and is expected to reach USD 9548.0 million by 2026, increasing at a CAGR of 9.9 percent, estimates Research and Markets. Swift expansion in the number of hospitals and healthcare centers is a significant driving factor for the growth of the market. Favorable government steps toward improving the healthcare infrastructure will also direct the market growth.

Indian market dynamics
The Indian coagulation instruments and reagents market in 2017 is estimated at Rs 134 crore. The year showed a 9 percent growth over 2016, having received a setback from the lingering impact of demonetization and teething issues with the GST rollout. It is poised to return to its normal 12 percent growth from 2018 onwards.

The installed base in 2017 is estimated at 4215 instruments, with semi-automated instruments at 3650 units, and fully automated ones at 565 units. As a ballpark figure, 5 percent instruments are sold and balance are placed by the vendors in quantity terms, contributing 10 percent to revenues.

In the Rs 118.8 crore reagents market, 80 percent of value is attributed by tests conducted for routine parameter tests (PT and APTT), while the remaining 20 percent is by specialized coagulation parameter tests. This number in volume terms is translated to 95 percent for routine parameter tests and 5 percent to specialized coagulation parameter tests, the market for which is growing rapidly. In routine parameter tests, 70 percent are PT while 30 percent are APTT.

The market is also seeing availability of compact and mid-size fully automated coagulation analyzers with enhanced throughput making them ideal for mid-sized laboratories. This allows small to mid-size laboratories to have fully automated analyzers.

The Indian coagulation market is a significantly growing market in the IVD segment. Majority of the coagulation testing is performed in hospitals or attached laboratories as compared to standalone labs. When compared to the clinical chemistry segment, automation is not popular in the coagulation market in rural areas due to the high cost of the hardware and consumables. The automation segment is controlled mainly by the multinational companies with their fully automated systems which are placed on reagent rental in high workload laboratories. In semi-automated systems, the market is controlled by European and Japanese brands. Low-cost Chinese instruments are finding it difficult to gain market share.

India is undergoing a paradigm shift in terms of modernization of its healthcare facilities. This includes government funding for the installation of such diagnostic instruments into public healthcare facilities. For instance, the Hemophilia Federation of India has proposed to build several Hemophilia Care Centers, which would create an effective mechanism for diagnosis and treatment of the coagulation disorder. Furthermore, with increasing investment in the improvement of healthcare infrastructures and government’s aim to provide quality, affordable healthcare to all, the coagulation analyzers market will witness a huge surge in growth opportunities in the coming few years.

Technological advances
New instruments allow clinicians to drive personalized, clinically, and economically sound treatment while also allowing them to make decisions with confidence.

Flexibility in reagent packaging. Capacity flexibility has become important in the past year or two. Within some of the large hospital systems, one might have a remote clinic that does a few tests, versus a large reference lab in the group that does the great bulk of testing. But both want to work off the same lot number of reagents. So in order to improve the management of the quality control results, and the normal ranges reported within a group’s patient population, manufactures are now offering flexibility in reagent packaging – multiple packaging with the same lot. Manufacturers are also introducing multiple package sizes – 10 mL and 20 mL – for reagents used for PT/INR testing within a laboratory group. This flexibility will affect not only the efficiency of a reagent use but also the QC workflow and management of quality results, as well as the costs to manage those quality results.

Ultrasound technology. These technologies employ a variety of different principles to generate vibration and are detected and related to changes in viscoelastic properties as a function of the coagulation and fibrinolysis properties of the sample. One of the novel devices uses a patented, ultrasound technology called SEER (sonic estimation of elasticity via resonance) sonorheometry that uses high-frequency ultrasound pulses like those used in diagnostic imaging to measure changes over time in shear modulus, a direct physical measure of clot stiffness. The utilization of ultrasound allows the sample to be interrogated without having physical contact with moving parts, thereby reducing the potential interference with the coagulation process as occurs in classic technologies. This result in increased sensitivity to early clot formation and increased sensitivity to soft clots, which are often those associated with clinical bleeding. Furthermore, in contrast to other viscoelasticity technologies, the direct measurement of the sample shear modulus allows accurate estimation of the relative contributions of platelets and FIB to overall clot stiffness.

Electromagnetic induction sensor. With the increasing demand for coagulation PoC testing for patients in the surgery department or the ICU, rapid coagulation testing technologies have drawn widespread attention from physicians and businessmen. The use of electromagnetic induction sensor probes for detection of dynamic processes causing changes in the blood viscosity and density before and after coagulation based on the damped vibration principle may become a new trend in order to evaluate the coagulation status. The electromagnetic induction coagulation testing sensors have a good elasticity and anti-fatigue, which can meet the accuracy requirement of clinical detection.

Advances in coagulation analyzers. The new handheld coagulation analyzers mimic the look of a smartphone and provide results in 60 seconds or under. While the handheld concept is not new to the industry, what is new is that these devices use the same reagents for PT/INR used in the large analyzer portfolio. This feature ties into customers’ desire to standardize instruments and reagents and better correlate results.

People in the industry are also realizing that platelets cause a lot more problems than typical coagulation factors, and they are figuring out ways to add platelet testing technology to their instrumentation. While most coagulation analyzers do a pretty decent menu of coagulation tests, none of them have the ability to do platelet function tests until very recently. Another example of coagulation innovation is preanalytical checks, which have always been a feature of chemistry analyzers. Now coagulation analyzers are starting to respond in kind. Some manufacturers have developed a module that is in the pre-submission stage with the US FDA and may be seen in the market very soon.

Cartridge-based systems have automated the testing process by eliminating the need to openly transfer blood from the collection tube or to manually mix reagents. This reduces the chance for untimely pre-analytical processing errors that can delay the time to obtain results needed to treat patients. Furthermore, it offers the opportunity to use the system by non-laboratory healthcare personnel at the PoC. Improvements in automating steps have been proven to reduce inter-operator and intra-operator variability of results in multiuser settings.

Finally, with a unique and intuitive display offered by many new instruments, the interpretation of test results can be made easier for less experienced clinicians to arrive at the correct conclusions. The new display incorporates dials that are ubiquitous in everyday life. Clinicians can easily detect coagulation characteristics that may clarify the reason for bleeding or thrombosis or portend an increased risk for either condition.

Way forward
Labs offering hemostasis testing can really support clinicians with patient diagnosis. Since confidence in the subsequent clinical decision-making is essential, one need equipment that performs reliably and produces results of consistent, high quality at all times. Labs need to meet TAT demands and help patients as soon as possible, so the tests have to be performed fast – even with complex samples that require precise pre-analytical treatment. And as the industry evolves, the spectrum of test requests is increasing too. It is a challenging situation. The strong technological performance both stabilizes the routine and provides high consistency – the essential basis for reliable, accurate results, and confident interpretation. As new technologies for bleeding management are introduced in the clinical market, their primary goal is to not compromise clinical performance in exchange for testing automation, speed, and space-saving design.

Manufacturers are focusing on developing a compact diagnostic instrument that provides clinicians with rapid, comprehensive, and accurate identification of a patient’s hemostasis condition in a surgical theater, laboratory, or PoC setting. As India is undergoing a paradigm shift in healthcare with quality and timely affordable service to all, this will bring a manifold increase in the usage of coagulometers. The next-generation coagulation analyzers are likely to be more compact and smartly designed with added parameters and more specialty tests according to the need of the hour. Future PoC coagulation devices are likely to be electrochemical microfluidic multiplexed biosensor platforms.

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