D-dimer tests were the savior of the coagulation market

Once COVID-19 peters out, demand for D-dimer test shall also peter out, yet the market size is expected to have stabilized at double the market from the pre-Covid days.

COVID-19 has created a shift in the market segment, and 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. 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.

The global market for D-dimer testing, estimated at USD 2.1 billion in the year 2020, is projected to reach a revised size of USD 2.7 billion by 2027, growing at a CAGR of 3.8 percent. Point-of-care (POC) tests segment is projected to record 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 coagulation testing instruments and reagents market is expected to reach a value of USD 3.81 billion by 2026 at a 7.1-percent CAGR from 2020 to 2026.

By product type, consumables held the global market share in the previous years, and are estimated to account for USD 1975.8 million by 2026. Consumables contain strains and reagents; all testing procedures require reagents, thereby wide consumption and repeated orders of consumables for coagulation testing. This factor is projected to drive the market size. Instruments segment will grow at a healthy rate of 7.4-percent CAGR, and is estimated to reach up to USD 1838.5 million by 2026. Growing diagnosis centers and developments in diagnostic analyzers, along with enhanced monitoring procedures, are projected to drive demand for instruments.

The market for prothrombin time application accounted for the highest coagulation testing market size in 2020, 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.

The Indian coagulation instruments and reagents market in 2020 is estimated at ₹153.53 crore. The value of the fully automated instruments that were sold is ₹1.93 crore, with 12 units being sold, and semi-automated as 900 units, estimated at value ₹7.6 crore. An additional 120 fully automated and 100 units of semi-automated instruments were placed. The three leading players remain Stago, Werfen, and Sysmex.

The coagulation reagents took a major dip in 2020. The D-dimer tests were the savior of the coagulation market. Once COVID-19 peters out, demand for D-dimer test shall also peter out, yet the market size is expected to have stabilized at double the market from the pre-COVID days. While satellite centers of laboratory chains had D-dimer analyzers placed, the small laboratories used semi-automated instruments to conduct the tests.

As a trend, the three brands reported that while they were not able to sell a large number of fully automated instruments, average unit prices not only declined but there was a huge variation between the final prices. Additionally, the manufacturers’ exposure increased in 2020 as more analyzers compared to 2019 and 2018 were placed, and that is expected to give better return over the next few years. There is a huge expectation that the reagents market in 2021 shall increase, before it settles down at a stable, normal level by 2022.

Over the past decade, rapid advancements in technology, and the introduction of new coagulation analyzer tests, have 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.

Manufacturers are focused on providing systems with high throughput, reliability, and easy-to-use advanced software with LJ graphs and calibration curves for minimum errors. Advances in technology have resulted in greater capability, productivity, sensitivity, specificity, and ultimately improvement in the clinical care of patients.

With increase in screening for coagulation and therapeutic monitoring, the market is witnessing a shift toward nex-gen POCT. The high cost of fully automated analyzers is bringing about this market trend. While large hospitals and lab chains with high workload continue to prefer fully automated systems, compact, cost-effective POCT devices are being preferred by labs with less workload.

Also, with the advancements in artificial intelligence (AI) and machine learning, algorithms that can track multiple parameters simultaneously throughout a treatment/diagnosis and find out patient-specific patterns that can aid in pinpointing proper treatment or underlying causes will become one of the biggest developments in coagulation-measurement technologies in the upcoming years. Especially with the challenges set by the novel anticoagulant technologies for the current measurement techniques and the validity and applicability of diagnostic parameters, such as INR, simultaneous observation of multiple parameters, or complicated patterns within them, may be necessary for proper observation of patients with special needs. For these special cases, AI and machine learning-based algorithms may very likely find place within the future novel POC blood coagulation-measurement technologies in the upcoming years.

Continued growth in POCT is certain as technologies improve and the benefits of POCT are realized in value-based healthcare. As more experience and understanding is gained by using POC devices, the benefits of quick results and ease of testing are likely to come to be seen as significant and desirable as well as routine.

The other upcoming technologies include T2 magnetic resonance, acoustic waves, laser speckle rheology, and infrared spectroscopy. With these technologies, the analyzers will offer advanced testing for Von Willebrand disease, platelet aggregation, heparin-induced thrombocytopenia, and chromogenic factor assays, D-dimer, and antiphospholipid antibodies.

Although recent developments in coagulation analyzers are promising, still there is a high potential for developing novel monitoring and therapeutic technology in the future, based on photoacoustic detection and nanotechnology.