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.
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.
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.
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.
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).
The D-dimer testing market has been extensively analyzed on the basis of testing methods, applications, and geography. Testing methods include point-of-care testing (POC) and laboratory testing. Laboratory testing has been further segmented into coagulation analyzers and clinical chemistry analyzers. Applications comprise deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC). Each of the segments has been analyzed in detail for market trends, number of D-dimer tests, recent developments, outlook, and opportunities. The report provides current and future market size for each segment and sub-segment for the period from 2014 to 2022, in terms of revenue in USD million and number of tests in million, considering 2012 and 2013 as the base years. The compound annual growth rate (%CAGR) for each market segment has been provided for the forecast period from 2014 to 2022 along with the estimations of market size.
Geographically, the global D-dimer testing market has been classified into six major geographical regions: North America (U.S., Canada), Europe (Germany, U.K.), Asia-Pacific (Japan, China), Latin America (Brazil, Mexico), MENA (Saudi Arabia, U.A.E.), and Rest of the World (RoW). The regions have been further segmented by major countries. The current and future market sizes in terms of revenue (USD million) and number of tests (million) of these regional markets and their major countries have been provided in the report for the period from 2012 to 2022, with their growth rate (%) for the period from 2014 to 2022. The study also offers a list of recommendations and highlights of the market for new companies willing to enter the market and for existing companies to increase market shares, which is likely to help in the decision-making process. Heat map analysis has also been provided for various hematology and automated analyzer manufacturers designed to perform D-dimer tests.
The market overview section of the report demonstrates the market dynamics and market trends such as drivers, restraints, and opportunities that influence the current and future status of the D-dimer industry. The report also covers market attractiveness analysis, Porter’s Five Forces analysis and key market share analysis in the market overview section, in order to give a thorough analysis of the overall competitive scenario in the global D-dimer testing market.
The report concludes with the company profiles section that includes key information about the major players in the market. Key players profiled in this report 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. Each of these players is profiled in the report considering parameters such as company overview, financial overview, business strategies, product portfolio, and recent developments.
The global D-dimer Testing Market is segmented as follows:
D-dimer Testing Market Revenue (USD Million) and Volume (Number of Tests), by Testing Method
- Point-of-Care Tests
- Coagulation Analyzers
- Clinical Chemistry Analyzers
D-dimer Testing Market Revenue (USD Million) and Volume (Number of Tests), by Applications
- Deep Vein Thrombosis
- Pulmonary Embolism
- Disseminated Intravascular Coagulation
D-dimer Testing Market Revenue (USD Million) and Volume (Number of Tests), by Geography
- Rest of Europe
- Rest of Asia Pacific
Latin America (LATAM)
- Rest of Latin America
Middle East and North Africa (MENA)
- Saudi Arabia
- United Arab Emirates (U.A.E)
- Rest of MENA
- Rest of the World (RoW)