D-dimer Testing Market by Testing Methods (Point-of-Care Tests and Laboratory Tests) Forecast 2022

At present, the in vitro diagnostics market is one of the fastest growing markets globally. This remarkable growth can be attributed to the improved health care awareness, preference of the people for preventive health checkups, accessibility to disease specific tests, and shift from manual to semi-automated and automated instruments. Diagnostic laboratories are facing challenges in delivering high-quality, efficient and timely testing solutions due to rising health care awareness and stringent regulations that put pressure on the health care budgets. This has led to growing adoption of automated solutions and new analyzers that deliver high throughput in lesser time and with enhanced efficiency. Point-of care testing has gained momentum in the past few years to meet the demand for quick turnaround time, thus accelerating reliable results. D-dimer assays and POC kits have been developed to confirm the exclusion of deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC).

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Demand for D-dimer tests has substantially increased due to its accuracy, cost effectiveness, and lack of radiological interventions. Despite its increased demand, D-dimer is not used as a confirmatory test, but mostly used to confirm the exclusion of the mentioned condition i.e., when a patient is suffering from a coagulation disorder, and not illustrating the type of the disorder such as DVT, PE, or DIC. The global market for D-dimer testing is segmented broadly into testing methods and applications. The point-of-care test segment includes rapid diagnostic kits, whereas the laboratory test segment comprises reagents and assays employed for analyzing the presence of D-dimer in blood sample

On the basis of applications, the global D-dimer testing market has been segmented into: deep vein thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation (DIC).  According to the Society of Interventional Radiology (U.S.), about 600,000 new cases of DVT are diagnosed in the U.S. each year, while the National Health Service (NHS) records about 1 person in 1,000 with DVT in the U.K. each year. The number of D-dimer tests for DVT application  were 130.0 million in 2013 and are expected to reach 171.1 million in 2022. Pulmonary embolism is difficult to detect based on clinical symptoms and therefore demanded the use of fully automated coagulation analyzers to run tests based on multiple methods with increased safety, precision, and accuracy compared with manual methods. Diagnosis of DIC is difficult because clinical manifestations are not uniform and there is no consensus regarding appropriate tests for laboratory diagnosis. Despite the drawbacks, most clinicians rely on D-dimer test results to indicate the presence or absence of DIC. In the past few years, rapid D-dimer assays with clinical performance are at par with conventional ELISA that has become widely available for exclusion of DIC.

In terms of accurate quantitative estimation of D-dimer, laboratory-based analysis is a robust technique as compared to point-of-care test. Moreover, laboratory-based test can be paramount in not only identifying individuals who are at a risk of first thrombotic event, but also detecting the chances of having a recurrent VTE. Overall, the drawbacks associated with laboratory test include need for adequate space to set up and high response time (40 minutes to 50 minutes) as compared to POC tests (10 minutes to 15 minutes). The laboratory test segment has been sub-segmented into coagulation analyzers and clinical chemistry analyzers.

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Clinical chemistry analyzers are commonly used to determine D-dimer level in blood serum in a laboratory setup. Compared to coagulation analyzers, demand for clinical chemistry analyzers is high due to low cost of test. Technological advancements have contributed significantly in reducing the unit cost associated with D-dimer tests at laboratories and POCs. Some of the widely used kits and reagents in clinical chemistry analyzers include Tina-quant D-Dimer (Roche Diagnostics), Diazyme D-Dimer Assay (Diazyme Laboratories), and Nordic Red D-dimer (Nordic Biomarker). The advent of sensitive D-dimer assays that are used on automated coagulation analyzers has completely revolutionized the market dynamics in the past few years. Kits used in coagulation analyzers are highly specific to the device/manufacturer and are expensive as compared to clinical chemistry analyzers.

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