Moving out of the Central Laboratory

Moving out of the Central Laboratory

The year 2018 witnessed the increasing trend of diagnostic testing steadily moving out of the central laboratory and into testing sites closer to patients, thus making the technological innovations in hemolysis management patient-centric.

India is going through an exemplar shift as the IVD industry is expanding the span of facilities. 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 high cost of 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.

In the coming years, numerous diagnostic centers will be established in rural areas, propelled by improved diagnostic tools, enhanced treatment monitoring, increased availability of over-the-counter tests, easy availability of coagulation solutions at affordable prices, and high investments from the private sector. High-throughput results, increasing adoption of automation, and development of high sensitivity and specificity of coagulation instruments will drive the market growth in the years to come.

Global market

The global coagulation analyzers market is expected to exceed USD 5 billion by 2024 from USD 3.7 billion in 2018, at a CAGR of 10 from 2019 to 2024. The rising demand for coagulation analyzers is anticipated due to increasing population base suffering from lifestyle associated disease, and chronic blood disorders. Furthermore, increasing awareness about these conditions is expected to improve the diagnostic rate and preventive care management, which is predicted to substantially increase the testing volume.

Analyzers retained dominant share of the total revenue in 2018 and are expected to grow at a lucrative CAGR over the next 5 years. Factors promoting this growth are anticipated to be developing healthcare infrastructure and rising healthcare spending, coupled with increasing incidences of lifestyle-related conditions, such as obesity, diabetes, and cardiovascular disorders. Special emphasis on providing quality and timely care to patients is expected to propel growth of diagnostic market, which in turn is anticipated to cause a hike in demand for hemostasis analyzers.

Clinical laboratory segment held the largest share in 2018. Clinical laboratory analyzers are predominantly used in hospitals for hematological analysis of patients on a daily basis.

Consumables held over 65 percent of the share and are further segmented into reagents and stains. All tests require the presence of reagents; hence large inventory or repeated orders of these products are placed by hospitals, leading to higher demand. Increasing volume of testing and development of new assays is expected to boost sales of these consumables.

In terms of test type, prothrombin segment was estimated to account for the largest share in the region, followed by APTT test based in 2018.

Rapid expansion in hospitals and primary healthcare centers is expected to be a high-impact rendering driver. In addition, favorable government initiatives to improve healthcare delivery are expected to help the future growth. Furthermore, availability of advanced equipment, which has higher accuracy and features to perform multiple tests, is another vital driver for the growth.

Diagnostic centers dominated the end-use segment in 2018, with the prevailing trend of outsourcing the hemostasis tests to diagnostic centers. However, hospitals are expected to witness lucrative growth during 2019 to 2024 due to rapid expansion of hospitals, coupled with availability of analyzers and consumables based on hospital needs.

Some of the key players in this industry include Siemens Healthcare, Roche Diagnostics, and Instrumentation Laboratory. The players are mostly present in the international space, and due to easy global accessibility, they are competing directly to gain a bigger share.

Vendor update

In May 2019, Haemonetics Corporation has received clearance from the USFDA to expand the medical indication of its TEG 6s hemostasis analyzer system for use in adult trauma settings. This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures. The site-of-care TEG 6s system provides actionable test results in as little as 10 minutes.

In April 2019, a de novo clearance was given to Hemosonics’ point-of-care (PoC) diagnostic. Cartridge-based Quantra analyzer uses ultrasound waves to measure the viscosity of a whole-blood sample in a fully closed system designed for busy perioperative settings.

In April 2019, Ortho Clinical Diagnostics in collaboration with Diazyme Laboratories, Inc. has launched its D-Dimer assay. The D-Dimer assay detects the presence of intravascular coagulation and fibrinolysis through the measurement of the fibrin-degradation product D-Dimer.

In March 2019, Arkray, Inc. has launched Spotchem HS HS-7710 blood coagulation analyzer. With this analyzer, it is be possible to perform measurements quickly and easily in the operating room, allowing doctors to comprehensively determine blood coagulability using whole-blood samples.

In December 2018, Sysmex Corporation announced the launch of its next-generation analyzers in the hemostasis field, the automated blood coagulation analyzers CN-6000 and CN-3000. Through these analyzers, the company aims to further enhance levels of productivity, reliability, and operability, in turn responding to diverse customer needs and contributing to even better efficiency and higher quality in the field of hemostasis.

Technology trends

Currently available conventional coagulation tests include the activated partial thromboplastin time (aPTT), prothrombin time (PT), and international normalized ratio (INR). These in-hospital tests are performed on blood plasma, and require a central laboratory with trained personnel. However, access to specialized coagulation testing in a central laboratory is often limited in community hospitals as well as at point-of-injury in remote battlefield or civilian conditions, and the long delay associated with such tests means that results are obtained at time points much later than the onset of hemostatic imbalance.

On the other hand, several handheld, PoC coagulation devices are currently commercially available. 2018 witnessed the increasing trend of diagnostic testing steadily moving out of the central laboratory and into testing sites closer to patients, thus making technological innovations in hemolysis management patient-centric. With the advent of novel strategies, there are high expectations arising amongst the manufacturers. They are increasingly focusing on the devices’ distinct features, including: rapid results, reduced patient discomfort, simplicity, cost-effectiveness, enablement of early diagnosis and accessibility in remote areas, and making these technologies affordable and available to the medical professionals.

Some of the ongoing technologies expected to impact the market in coming years include:

Dielectric spectroscopy (DS) is a fully electrical, label-free, and nondestructive measurement technique that can enable a simple and easy-to-use PoC device for extracting information on the physiologic properties of blood in real time. It is a well-established method to study the molecular and cellular composition of a variety of biomaterials. However, this technique has been restricted to studies using laboratory-based benchtop measurement equipment and >100 µL blood-volume samples.

T2 magnetic resonance (T2MR) is a new technology that is able to detect clot formation based on partitioning of red blood cells and proteins, which occurs during fibrin formation and platelet-mediated clot contraction. This device can be used to measure clotting times, individual coagulation factors, and platelet function. T2MR has also revealed a novel hypercoagulable signature that needs further study to determine if it can be used to predict patients at higher risk of thrombosis. This helps medical professionals determine the diagnosis without compromising with the accuracy of the diagnosis.

Infrared spectroscopy is being utilized to detect clot formation in the Perosphere Technologies’ hand-held PoC coagulometers. This device uses fresh or citrated whole blood with clotting activation initiated by glass contact. The turnaround time is fast, providing a clotting time within 3 to 10 minutes. Although the use of handheld devices is not new, preliminary data shows that this device may be useful in assessing coagulation response to any of the direct oral anticoagulants (doacs) as well as the antithrombin-dependent activated factor X (fxa) inhibiting anticoagulants. This allows medical practitioners to make the diagnosis with precision, and that too in a short time.

Microfabricated sensors have been successfully developed for PoC blood-coagulation monitoring, which utilize blood viscosity by monitoring a frequency shift when the blood sample is in direct contact with a micro-fabricated resonant structure. Nonetheless, the force applied when blood is in direct contact with a mechanical transducer can potentially interfere with the natural coagulation process. Non-contact methods have also been developed; however, they require the use of discrete ultrasonic transducers or laser illumination and optical microscopy, and require a regular blood sample.

The manufacturers are actively pursuing novel analyzers, which more specifically assess the role of platelets in human pathologies, including bleeding and thrombotic disorders, cancer, sickle cell disease, stroke, ischemic heart disease, and others. There are several analyzers like acoustic waves that are already commercially available, with ability to assess platelet contractile forces. These analyzers are utilized in a miniaturized PoC device capable of using only a small amount of citrated whole blood, measuring the time required for fluorescent microspheres to cease motion due to clot formation. The result provided is a clotting time in seconds. Also, this system may be useful for assessing anticoagulant effects. All things considered, the ongoing novel strategies based on microfluidics and nanotechnology may enable potential for self-testing and self-monitoring, but a great reduction in sample volume is needed. There are important mechanical parameters that relate to coagulation but are not measured, and finally they do not evaluate, monitor, or mitigate acute bleeding or thrombosis risk. These drawbacks demand for the development/standardization of novel strategies that can improve the clinical diagnosis process. A continuous quest is ongoing to discover new methods of clot detection, or other novel types of coagulation analyzers are in development or will soon be ready for prime time for use in routine diagnostics of hemostasis disorders. However, these require more standardization and more clinical studies to assess and exploit their potential before they are made available in the market.

Outlook

The future of coagulation analyzers is currently undefined, and no sixth sense can accurately predict it. Manufacturers are looking forward to cost-effective, multi-parameter, portable, novel, and pocket-sized analyzers with a specially trained workforce in clinics and hospitals, backed by less training cost, to handle them. High-throughput results, increasing adoption of automation, and development of high sensitivity and specificity of coagulation instruments will drive the market growth in the years to come.

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