Market Overview The global coagulation monitoring products market size was valued at US$ XX million in 2020 and is estimated to reach US$ XX million by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Coagulation tests assess blood’s ability to clot as well as the time it takes to clot. Testing can assist a doctor in determining the risk of excessive bleeding or the formation of clots (thrombosis) in blood vessels.
Market Dynamics The factors driving the global coagulation monitoring products market are the increasing demand for point of care testing devices. In addition, increasing technological advancements in monitoring devices are also expected to drive market growth over the forecast period.
Increasing point of care testing devices is expected to drive the global coagulation monitoring products market
The rapid, specific examination of bodily fluids at the bedside is known as point-of-care testing (POCT). There is an ever-expanding range of POCT available, the majority of which are beyond the scope of this article, which will focus on those that are routinely used and important to the management of perioperative coagulation. Because typical laboratory tests have a somewhat long turnaround time. There is growing interest in point-of-care coagulation testing (POCCT) to avoid unnecessary transfusion, which can offer results in minutes. Furthermore, the widespread acceptance of the current cell-based coagulation model has resulted in a focus on the critical role of platelets and a particular interest in devices that test whole blood rather than plasma, which is employed in laboratory-based tests. The prothrombin time (PT) and activated partial thromboplastin time (aPTT), which provide information on the first phase of coagulation up to fibrin production, are examples of the latter. Viscoelastic POCCT devices, on the other hand, produce information on all phases of coagulation, offering insight into interactions between the cellular and plasma components of whole blood and the fibrinolytic system's activity which are critical for successful hemostasis.
The most recent POC coagulation analyzers produce real-time results while maintaining the central lab's diagnostic quality controls. POC testing must strike a compromise between the desire for quick findings and the absolute requirement for accuracy and QC that the lab guarantees. Siemens Healthineers' Xprecia Stride Coagulation Analyzer is a recent FDA-cleared POC PT/INR gadget. This device has established performance parity in PT/INR testing with the Roche CoaguChek XS POC system and reference laboratory analysis. Recent point-of-care PT/INR systems include both electronic and internal QC checks on test strips. Convenient device test strip ejects mechanisms allow for the safe disposal of spent strips, reducing odours.
Technological advancements in monitoring devices are expected to drive the market growth during the forecast period
Blood coagulation monitoring has been increasingly important in diagnosing the causes of hemorrhages, creating anticoagulant medications, measuring bleeding risk in prolonged surgery procedures and dialysis, and researching the efficacy of hemostatic therapy in recent years. Microfluidics, fluorescence microscopy, electrochemical sensing, photoacoustic detection, and micro/nanoelectromechanical systems (MEMS/NEMS) have been used to build extremely precise, resilient, and cost-effective points of care (POC) devices. These instruments measure the electrochemical, optical, and mechanical properties of clotting blood.
With advancements in artificial intelligence (AI) and machine learning, algorithms that can track multiple parameters concurrently throughout a treatment/diagnosis and identify patient-specific patterns that can aid in pinpointing proper treatment or underlying causes will be one of the most significant developments in coagulation measurement technologies in the coming years. With the challenges posed by novel anticoagulant technologies for current measurement techniques and the validity and applicability of diagnostic parameters such as INR, simultaneous observation of multiple parameters or complex patterns within them may be required for proper observation of patients with special needs. AI and machine learning-based algorithms may very well find a role in future new POC blood coagulation testing systems for these unique circumstances in the next years.
For instance, on June 14th 2018, Roche launched the CoaguChek Vantus system, the first self-testing coagulation monitoring gadget with Bluetooth technology. Patient self-testing using the Bluetooth-enabled CoaguChek Vantus system opened new possibilities for patient monitoring.
High cost and limitations of testing devices are expected to hamper the market growth
The major reason restricting the use of medical devices such as POC coagulation monitoring devices is the high cost of these devices compared to the laboratory tests for monitoring. Due to limited economic opportunities, low and middle-income countries (LIC/MICs) face significant challenges. In addition to economic difficulties, LICs bear a large burden of infectious diseases, posing serious risks to the population's well-being. Healthcare systems and practitioners in LICs are sometimes ill-equipped to serve patients as effectively as possible, particularly in rural areas. Given the economic and infrastructure challenges in LIC, point-of-care diagnostics, which are often distinguished by being independent of laboratory or medical infrastructure and being highly affordable and holding significant promise to improve the situation, are becoming increasingly popular.
POCT limitations include improper handling and/or maintenance of the analyzers by untrained clinical staff, insufficient or even absent calibrations and/or quality controls, a lack of cost-effectiveness due to an increased number of analyzers and more expensive reagents, insufficient documentation, and difficult comparability of the obtained POCT-results with routine laboratory results.
Market Industry Analysis
COVID-19 Impact Analysis COVID-19 has affected the healthcare industry moderately. To stop its spread, government-imposed lockdown. People are fearful they may experience occupational effects and negative health from the COVID-19 pandemic. Because hypercoagulability has been observed in COVID-19 patients, the FDA recognized the importance and utility of increasing the availability of devices to test for and manage coagulopathies in patients in hospitals and other healthcare facilities experiencing an increase in patient load as a result of the COVID-19 public health emergency. Hence, the US Food and Drug Administration (FDA) authorizes manufacturers to adapt coagulation systems to assess whole blood viscoelastic characteristics, allowing for increased use in hospitals for supportive care of COVID-19 patients. This has boosted the global coagulation monitoring products market.
Global Coagulation Monitoring Products Market - By End-User • Hospitals • Clinics and Diagnostic centers • Home Setting • Ambulatory Settings
Global Coagulation Monitoring Products Market - By Region • North America • Europe • South America • Asia Pacific • Middle East and Africa
The US Food and Drug Administration (FDA) authorised manufacturers to adapt coagulation systems for assessing whole blood viscoelastic characteristics, allowing for increased use in hospitals for supportive care of COVID-19 patients. The enforcement policy, published in January 2021, is only temporary and will be in effect only during the COVID-19 public health emergency.
Competitive Landscape The global coagulation monitoring products market is highly competitive with the increasing demand during COVID-19 and technological advancement in product.
Major key players in the global coagulation monitoring products market are CoaguSense Inc., Helena Laboratories, Hemosonics, Siemens, Thermo Fisher Scientific, HORIBA Medical, Maccura Biotechnology Co., Sclavo Diagnostics International S.r.l, Biosystems S. and Bio Group Medical System.
Siemens Healthineers
Overview: Siemens Healthineers AG is the market leader in diagnostic imaging. The company is in Erlangen, Germany. It is the parent company of various medical technology companies. The company’s diagnostic imaging equipment include computed tomography, magnetic resonance imaging, molecular imaging, X-ray products, ultrasound systems, and imaging IT.
Product Portfolio: Siemens Healthineers hemostasis products include Sysmex CN-3000 and CN-6000 Systems, Atellica COAG 360 System1 is a fully automated high-volume coagulation analyzer and Hemostasis Assays
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