D-dimer Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global D-dimer Testing Market is projected to expand from a valuation of USD 2.02 Billion in 2025 to reach USD 2.67 Billion by 2031, progressing at a CAGR of 4.76%. These tests function by detecting fibrin degradation products quantitatively or qualitatively in the blood, acting as a crucial exclusion marker for thrombotic events like pulmonary embolism, deep vein thrombosis, and disseminated intravascular coagulation. Market expansion is chiefly driven by the rising global incidence of coagulation disorders and a growing elderly population prone to venous thromboembolism. Additionally, emergency departments increasingly rely on these assays for rapid exclusion diagnostics to streamline patient flow and minimize unwarranted hospital admissions.

However, the market confronts a major obstacle regarding the test's low specificity, as factors unrelated to thrombosis - such as malignancy, inflammation, or pregnancy - can trigger false-positive outcomes, necessitating costly confirmatory imaging. The International Society on Thrombosis and Haemostasis highlighted the severity of these conditions in 2024, noting that thrombosis underlies one in four deaths globally. While this mortality rate emphasizes the critical need for effective screening, the inherent specificity limitations of D-dimer assays continue to hinder their efficiency and restrict their standalone utility in clinical settings.

Market Drivers

The escalating prevalence of Deep Vein Thrombosis (DVT) and Venous Thromboembolism (VTE) serves as the primary engine for the global D-dimer testing market. Since these conditions manifest with non-specific symptoms, D-dimer assays have become the standard initial screening method to exclude thromboembolic events in low-to-moderate risk patients, effectively reducing reliance on expensive imaging techniques. The clinical necessity to manage this burden is underscored by the high volume of patients requiring urgent diagnostic assessment; according to a May 2024 infographic by the Centers for Disease Control and Prevention, venous thromboembolism impacts nearly 900,000 Americans annually. This high incidence rate drives the continuous demand for automated platforms and high-sensitivity reagents to support rapid clinical decision-making.

Concurrently, the rising rates of cardiovascular diseases (CVD) are significantly increasing the demand for hemostasis testing. D-dimer applications have expanded beyond exclusion to serve as prognostic markers for risk stratification in stroke, aortic dissection, and heart failure cases, prompting healthcare facilities to enhance their diagnostic capabilities. The American Heart Association reported in January 2024 that cardiovascular disease was responsible for roughly 19.91 million deaths globally in 2021. Reflecting this trend, Werfen reported a 5.2% growth in North American sales revenue in 2024, confirming that increasing cardiovascular risks are directly fueling the commercial momentum for specialized diagnostic technologies.

Market Challenges

A major constraint facing the Global D-dimer Testing Market is the assay's inherent lack of specificity, which often leads to false-positive results. Since elevated D-dimer levels can be triggered by non-thrombotic physiological conditions like inflammation, malignancy, or pregnancy, a positive reading cannot definitively diagnose thrombosis. This limitation forces medical providers to employ costly and resource-heavy confirmatory imaging, such as Computed Tomography Pulmonary Angiography, to exclude conditions like pulmonary embolism. Consequently, the financial and operational strain of these secondary procedures diminishes the standalone cost-effectiveness of D-dimer testing, confining it to an exclusionary function rather than a definitive diagnostic role.

This inefficiency generates significant bottlenecks in clinical workflows, particularly considering the high volume of patients presenting with symptoms needing evaluation. As reported by the American Heart Association in 2024, the estimated incidence rate for all venous thromboembolism in the United States was 264.6 per 100,000 person-years. Given such a high incidence of thrombotic conditions, the failure of D-dimer assays to accurately differentiate between actual cases and false alarms imposes avoidable costs on healthcare systems, directly impeding the market's potential for more extensive clinical dependence.

Market Trends

The proliferation of Next-Generation Point-of-Care Testing Devices is fundamentally transforming the market by moving diagnostics from centralized laboratories to decentralized environments. This shift is driven by the broad uptake of portable, multi-assay platforms that enable clinicians to conduct laboratory-grade D-dimer testing in primary care clinics or at the patient’s bedside. Such capabilities are essential for speeding up triage and enabling immediate treatment, especially in remote regions with limited infrastructure. This industry-wide transition was validated in July 2024 when Roche acquired LumiraDx’s diagnostics platform for roughly $295 million, a move that underscores the commercial value of microfluidic technologies integrating critical coagulation assays into compact devices.

Simultaneously, the integration of Machine Learning and Artificial Intelligence algorithms is revolutionizing the clinical application of D-dimer assays by mitigating their inherent specificity constraints through advanced predictive modeling. These algorithms analyze D-dimer data alongside other physiological metrics to build robust risk stratification tools that notably lower false-positive rates and reduce unnecessary imaging. The effectiveness of this method was highlighted in a December 2024 report by the American Society of Hematology, which noted that 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 refining exclusion algorithms, these digital advancements are elevating D-dimer tests from simple rule-out tools to integral parts of precise, automated clinical decision support systems.

Key Players Profiled in the D-dimer Testing Market

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

Report Scope

In this report, the Global D-dimer Testing Market has been segmented into the following categories:

D-dimer Testing Market, by Product:

• Analyzers
• Reagents & Consumables

D-dimer Testing Market, by Test Type:

• Clinical Laboratory Tests
• Point-of-Care Tests

D-dimer Testing Market, by Method:

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

D-dimer Testing Market, by Application:

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

D-dimer Testing Market, by End Use:

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

D-dimer Testing Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global D-dimer Testing Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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