Today, medical devices field seeks to provide improved health care by focusing on the use of in vitro diagnostic tools. These tools assist in screening, diagnosis, staging as well as disease management for selection of drugs and dosage. D-dimer test is used as a screening test to diagnose thrombosis and consequently rule out conditions of deep vein thrombosis (DVT), pulmonary embolism (PE) and/or disseminated intravascular coagulation (DIC). D-dimer tests avoid unnecessary imaging procedures and treatment and reduce hospital stays. The test avoids risks associated with invasive procedures. The prominent drivers of D-dimer tests include non-invasiveness, device compactness and elimination of radiological intervention.
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The global D-dimer testing market is segmented broadly into testing methods, applications and geography. The testing methods are further segmented into point-of-care tests and laboratory tests. Laboratory testing is the most commonly used method in market since decades. Laboratory tests are categorized into coagulation analyzers and clinical chemistry analyzers. Point-of-care tests help in meeting the demand of quick turnaround time, thus accelerate reliable results. Hence, these tests are likely to have rapid growth in the near future. The three major disease applications for D-dimer testing include DVT, PE and DIC.
Major growth drivers for the global D-dimer testing market include rise in the number of patients demanding coagulation testing, various technological advancements such as introduction of highly sensitive and specific hemostasis markers for automated instruments, and monitoring of patients on anti-coagulation therapy. However, interpretation of D-dimer levels in the aged population remains a major challenge. This has been attributed to the dramatic increase in rate of thrombosis with age, thus rendering D-dimer test less useful in excluding DVT or PE. Clinical acceptance of point-of-care D-dimer tests by hospitals and clinics is another obstacle in the market growth. Poor bioequivalence compared to laboratory services raises concerns regarding the acceptability of POC device in emergency departments. Since last few years, detection of PE based on clinical symptoms has become complicated demanding the development of fully automated coagulation analyzers capable of running tests based on multiple methods with increased safety, precision, and accuracy compared with manual methods.
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Geographically, North America accounts for the largest market share in terms of revenue in 2013 and is expected to maintain its position by the end of forecast period. North America is followed by Europe in term of number of D-dimer tests performed across the globe. Increasing research activities to improve specificity of D-dimer tests in order to identify the presence of any coagulation diseases such as DVT, PE and DIC are the major drivers of the D-dimer market in Europe. According to the Society of Interventional Radiology (U.S.), about 600,000 new cases of DVT are diagnosed in the U.S. each year. An increase in the number of laboratories and growing demand for D-dimer POC tests, development of public health care systems, rising interest of big pharmaceutical players, and increasing population, are several factors expected to drive the D-dimer testing market in Asia-Pacific, Latin America and MENA regions.
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The key players contributing to the global D-dimer testing market include Abbott Laboratories, Alere, Inc., Beckman Coulter, Inc., Bio/Data Corporation, Becton, Dickinson and Company, Corgenix, F. Hoffman-La Roche Ltd., Helena Biosciences, Siemens Healthcare, Sysmex Corporation, Thermo Fisher Scientific, and Trinity Biotech. The future holds challenges for the market leaders and niche suppliers due to continuous expansion through acquisitions and growing number of customers.
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