D-dimer Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Analyzers and Reagents & Consumables), By Test Type (Clinical Laboratory Tests and Point-of-Care Tests), By Method (Enzyme-linked Immunosorbent Assay {ELISA}, Latex-enhanced Immunoturbidimetric Assays, Fluorescence Immunoassays, and Others), By Application (Deep Vein Thrombosis, Pulmonary Embolism, Disseminated Intravascular Coagulation, and Others), By End Use (Hospitals, Academic & Research Institutes, Diagnostic Centers, and Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.02 Billion
CAGR (2026-2031)	4.76%
Fastest Growing Segment	Hospitals
Largest Market	North America
Market Size (2031)	USD 2.67 Billion

Market Overview

The Global D-dimer Testing Market will grow from USD 2.02 Billion in 2025 to USD 2.67 Billion by 2031 at a 4.76% CAGR. The D-dimer test involves the quantitative or qualitative detection of fibrin degradation products in the blood, serving as a critical exclusion marker for thrombotic conditions such as deep vein thrombosis, pulmonary embolism, and disseminated intravascular coagulation. The market is primarily supported by the increasing global prevalence of coagulation disorders and an expanding geriatric demographic susceptible to venous thromboembolism. Furthermore, the operational necessity for rapid exclusion diagnostics in emergency departments drives the consistent adoption of these assays to optimize patient throughput and reduce unnecessary hospital admissions.

Despite this growth, the market faces a significant challenge regarding low specificity, as non-thrombotic factors such as inflammation, malignancy, or pregnancy can induce false-positive results, necessitating expensive confirmatory imaging. Illustrating the critical burden of these conditions, according to the International Society on Thrombosis and Haemostasis, in 2024, thrombosis was identified as the underlying cause of one in four deaths worldwide. While this high mortality rate underscores the urgent need for robust screening, specificity limitations continue to impede the efficiency and broader clinical reliance on D-dimer assays alone.

Key Market Drivers

The rising prevalence of Venous Thromboembolism (VTE) and Deep Vein Thrombosis (DVT) acts as the primary catalyst for the global D-dimer testing market. As these conditions present with non-specific symptoms, D-dimer assays are universally mandated as the initial screening tool to rule out thromboembolic events in low-to-moderate risk patients, thereby reducing the dependency on costly imaging procedures. The clinical urgency to manage this disease burden is substantial, given the high volume of affected individuals requiring immediate diagnostic stratification. According to the Centers for Disease Control and Prevention, May 2024, in the 'Impact of Blood Clots on the United States' infographic, venous thromboembolism affects as many as 900,000 Americans each year. This magnitude of disease incidence necessitates a continuous supply of high-sensitivity reagents and automated assay platforms to facilitate rapid decision-making in emergency and critical care settings.

Simultaneously, the increasing incidence of cardiovascular diseases (CVD) significantly amplifies the demand for hemostasis testing. D-dimer levels are increasingly utilized beyond simple exclusion, serving as prognostic markers for risk stratification in patients with heart failure, aortic dissection, and stroke. This expanding patient pool compels healthcare facilities to upgrade their diagnostic infrastructure to handle higher testing throughputs. According to the American Heart Association, January 2024, in the 'Heart Disease and Stroke Statistics—2024 Update', cardiovascular disease accounted for approximately 19.91 million global deaths in 2021. Consequently, manufacturers are witnessing robust growth in the adoption of advanced coagulation instruments required to process these critical tests. Highlighting this commercial trajectory, according to Werfen, in 2024, North American sales revenue grew by 5.2%, reflecting the sustained demand for specialized diagnostics. This confirms that escalating cardiovascular risks directly translate into momentum for testing technologies.

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Key Market Challenges

The primary impediment to the Global D-dimer Testing Market is the assay's inherent low specificity, which frequently results in false-positive readings. Because elevated D-dimer levels can arise from non-thrombotic physiological states such as inflammation, pregnancy, or malignancy, a positive result does not definitively diagnose thrombosis. This limitation compels healthcare providers to proceed with expensive and resource-intensive confirmatory imaging, such as Computed Tomography Pulmonary Angiography, to rule out conditions like pulmonary embolism. Consequently, the operational and financial burden of these secondary diagnostic procedures reduces the standalone cost-effectiveness of D-dimer testing, restricting its adoption to a purely exclusionary role rather than a definitive diagnostic tool.

This inefficiency creates a substantial bottleneck in clinical workflows, particularly given the large volume of patients presenting with symptoms requiring evaluation. According to the American Heart Association, in 2024, the estimated incidence rate of all venous thromboembolism in the USA was 264.6 per 100,000 person-years. With such a significant incidence of thrombotic conditions, the inability of D-dimer assays to accurately distinguish between true cases and false alarms forces healthcare systems to absorb avoidable costs, directly hampering the market's potential for broader clinical reliance.

Key Market Trends

Proliferation of Next-Generation Point-of-Care Testing Devices is fundamentally reshaping the market by shifting diagnostics from central laboratories to decentralized settings. This trend is characterized by the widespread adoption of portable, multi-assay platforms that allow clinicians to perform laboratory-quality D-dimer testing directly at the patient's bedside or in primary care clinics. This capability is crucial for accelerating triage times and facilitating immediate treatment decisions, particularly in remote areas lacking complex infrastructure. Validating this industry-wide transition, according to Roche, July 2024, in the 'Roche closes acquisition of LumiraDx's Point of Care technology' press release, the company completed the acquisition of LumiraDx’s diagnostics platform for approximately $295 million to expand global access to decentralized testing solutions. This strategic consolidation highlights the commercial viability of microfluidic technologies that integrate critical coagulation assays into compact, user-friendly devices.

Integration of Artificial Intelligence and Machine Learning Algorithms is simultaneously revolutionizing the clinical utility of D-dimer assays by addressing their inherent specificity limitations through advanced predictive modeling. Machine learning algorithms are increasingly being deployed to analyze D-dimer values alongside other physiological parameters, creating robust risk stratification tools that significantly reduce false-positive rates and unnecessary imaging referrals. Highlighting the efficacy of this approach, according to the American Society of Hematology, December 2024, in the 'AI Algorithm Using ECG, D-Dimer Provides Impressive Accuracy for PE Diagnosis' report, a new algorithm combining D-dimer results with AI-analyzed electrocardiograms achieved an area under the curve (AUC) of 0.93 for predicting pulmonary embolisms. By enhancing the diagnostic precision of exclusion algorithms, these digital innovations are transforming D-dimer from a simple rule-out test into a central component of high-accuracy, automated clinical decision support systems.

Segmental Insights

The Hospitals segment is identified as the fastest-growing category in the Global D-dimer Testing Market, driven by the increasing volume of emergency admissions for suspected coagulation disorders. Medical professionals in these facilities rely extensively on D-dimer assays for the rapid exclusion of critical conditions such as Deep Vein Thrombosis and Pulmonary Embolism. Additionally, the widespread adoption of high-throughput automated analyzers in hospital laboratories enhances testing capacity and result turnaround times. Continued approvals of diagnostic kits by authorities like the US FDA for hospital use further reinforce this expansion by validating clinical utility.

Regional Insights

North America maintains a leading position in the global D-dimer testing market, driven primarily by the rising prevalence of deep vein thrombosis and pulmonary embolism across the region. The United States contributes significantly to this dominance due to its well-established healthcare infrastructure and high healthcare expenditure. Additionally, the strong presence of major diagnostic manufacturers facilitates widespread product availability and distribution. Market expansion is further supported by the regulatory framework of the U.S. Food and Drug Administration, which ensures the safety and efficacy of diagnostic devices, thereby fostering adoption among medical professionals.

Recent Developments

• In December 2025, Sysmex Corporation announced the launch of the Automated Blood Coagulation Analyzer CN-700 in Japan. This new compact model was developed to inherit the high analytical performance and operability of the company’s established CN-Series while offering a smaller footprint suitable for small and medium-sized medical facilities. The analyzer is capable of performing a wide range of hemostasis tests, including D-dimer, which is essential for diagnosing thrombotic diseases. The release marked a strategic expansion of the company's product lineup to support automation and improved efficiency in diverse testing environments.
• In March 2025, Werfen announced the commercial availability of its ACL TOP Family 70 Series Hemostasis Testing Systems in North America following regulatory clearance. This new flagship product line was developed to deliver standardized and automated performance for routine and specialty coagulation testing, including high-sensitivity D-dimer assays for venous thromboembolism exclusion. The systems feature advanced pre-analytical sample integrity checks and enhanced connectivity to optimize laboratory workflows. The commercial release represented a significant expansion of the company's specialized diagnostics portfolio, aiming to improve operational efficiency and patient care in hospital networks.
• In July 2024, Roche announced the completion of its acquisition of the Point of Care technology from LumiraDx. This transaction, valued at a purchase price of $295 million with an additional payment of up to $55 million for reimbursement, allowed Roche to integrate an innovative multi-assay platform into its diagnostics portfolio. The acquired technology supports a wide range of immunoassay and clinical chemistry tests on a single instrument, including assays for D-dimer, which are critical for excluding venous thromboembolism in community-based healthcare settings. This expansion was designed to enhance global access to decentralized diagnostic testing.
• In April 2024, Siemens Healthineers and Sysmex Corporation commenced the independent distribution of their combined hemostasis testing portfolios in the United States and Europe. This strategic shift followed a global original equipment manufacturer (OEM) agreement established between the two companies to supply each other with hemostasis instruments and reagents. Under this new arrangement, each company began offering a comprehensive range of coagulation solutions, including systems for D-dimer testing, under their respective brands. The initiative aimed to provide laboratories with streamlined access to advanced hemostasis diagnostics while allowing both entities to combine their wider product offerings effectively.

Key Market Players

• Thermo Fisher Scientific Inc.
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers AG
• Abbott Laboratories, Inc.
• bioMérieux S.A.,
• Werfen, S.A.
• HORIBA, Ltd.
• QuidelOrtho Corporation
• Diazyme Laboratories, Inc.
• BioMedica Diagnostics Inc.
• Sekisui Diagnostics, LLC

By Product	By Test Type	By Method	By Application	By End Use	By Region
Analyzers and Reagents & Consumables	Clinical Laboratory Tests and Point-of-Care Tests	Enzyme-linked Immunosorbent Assay {ELISA} Latex-enhanced Immunoturbidimetric Assays Fluorescence Immunoassays and Others	Deep Vein Thrombosis Pulmonary Embolism Disseminated Intravascular Coagulation and Others	Hospitals Academic & Research Institutes Diagnostic Centers and Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global D-dimer Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• D-dimer Testing Market, By Product:

• Analyzers and Reagents & Consumables

• D-dimer Testing Market, By Test Type:

• Clinical Laboratory Tests and Point-of-Care Tests

• D-dimer Testing Market, By Method:

• Enzyme-linked Immunosorbent Assay {ELISA}
• Latex-enhanced Immunoturbidimetric Assays
• Fluorescence Immunoassays
• and Others

• D-dimer Testing Market, By Application:

• Deep Vein Thrombosis
• Pulmonary Embolism
• Disseminated Intravascular Coagulation
• and Others

• D-dimer Testing Market, By End Use:

• Hospitals
• Academic & Research Institutes
• Diagnostic Centers
• and Others

• D-dimer Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE