Thrombosis and Hemostasis Biomarkers Market

Thrombosis and Hemostasis Biomarkers Market Size

The global thrombosis and hemostasis biomarkers market size was valued at USD 5.2 billion in 2023 and is estimated to grow at a CAGR of over 5.8% from 2024 to 2032. Growth of the market is attributed to the rising incidence of heart diseases and clotting disorders, the development of biomarkers, and increased focus on tailored therapeutic approaches.

For instance, according to the World Health Organization, 17.9 million cases of death are registered due to cardiovascular diseases annually. Such statistics indicate the acquisition of more accurate and timely diagnostic devices, which can only be a step in the right direction when trying to tackle such an enormous problem.

Thrombosis and Hemostasis Biomarkers Market Trends

Innovation in biomarker tests is one of the major drivers of growth in the market of thrombosis and hemostasis biomarkers. The emergence of newer and sophisticated technologies, such as high-sensitivity immunoassays, next-generation sequencing NGS, and digital PCR, greatly increases the understanding of the disease mechanism and patient-specific risk factors by making it possible to accurately pinpoint the thrombo- and hemostatic biomarkers.

Furthermore, new analytical techniques such as multiplex assays, as well as automated coagulation analyzers, increase the level of workflow automation in clinical laboratories, improving the speed and accuracy of diagnostics. In addition, modern Point-of-Care (POC) developments enable the rapid and easy to perform testing of specific biomarkers right at the place of the patients, which is vital in emergency situations such as stroke or pulmonary embolus. More so, increased focus toward noninvasive biomarker testing techniques makes it convenient to monitor virtually all patients continuously without patient discomfort.

Thrombosis and Hemostasis Biomarkers Market Analysis

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Based on product, the market is segmented into analyzers and reagents & consumables. The reagents & consumables segment dominated the market with USD 3.3 billion in 2023.

• The key reagents and consumables segment under the market is used widely for diagnostic and research purposes. This segment includes a range of products such as assay kits, chemicals, buffers, and other reagents which are required for testing and analysis of the hemostatic and thrombotic biomarkers.
  
• Additionally, rapid detection for deep vein thrombosis, pulmonary embolism, and other disorders such as clotting abnormalities have increased the demand.
  
• Furthermore, these products help with the assays-dependent proteolysis in which other biomarkers are detected such as fibrinogen, D-dimer, and prothrombin time, which are very important in monitoring the clotting disorders and anticoagulant therapies.
  

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Based on test location, the thrombosis and hemostasis biomarkers market is divided into clinical laboratory tests and point-of-care tests. The clinical laboratory tests segment accounted for significant market share of 64.1% in 2023.

• Assisting in the diagnosis and treatment of clotting and thrombotic disorders, the segment covering clinical laboratory tests of thrombosis and hemostasis biomarkers has significant importance. Specialized tests such as D-dimer tests, prothrombin time (PT) tests, activated partial thromboplastin time (APTT) tests, and platelet function tests all fall under this category because they are necessary for detecting abnormal conditions within the coagulation mechanisms of the body.
  
• Moreover, these tests evaluate the risks of bleeding and the effectiveness of the measures taken to prevent thrombosis. With the climbing rate of cardiovascular diseases, obesity, and aging populations, the need for effective diagnostic tests has dramatically increased.
  

Based on test type, the thrombosis and hemostasis biomarkers market is segmented into D-dimer, anti-thrombin III, plasminogen, soluble fibrin, factor VIII, post-thrombin (PT), activated partial thromboplastin time (APTT) test, and other test types. The D-dimer segment dominated the market with USD 1.4 billion in 2023.

• In the segment focusing on D-dimer tests, it represents a critical aspect in the diagnosis of thrombo-embolic disorders like deep vein thrombosis (DVT), pulmonary embolism (PE) as well as a crucial segment of the biomarkers for thrombosis and hemostasis market. It assists in evaluating clotting disorders and monitoring people with disseminated intravascular coagulation (DIC) by measuring the blood levels of D-dimer, which is a protein that gets released into the blood when a clot is being dissolved.
  
• Since the D-dimer test is a preliminary test, it is very useful in the elimination of other more invasive tests, as it has the sensitivity to accurately rule out thrombotic events when the results are negative.
  

Based on application, the thrombosis and hemostasis biomarkers market is divided into deep vein thrombosis (DVT), pulmonary embolism (PE), disseminated intravascular coagulation (DIC), and other applications. The deep vein thrombosis (DVT) segment dominated the market with USD 1.9 billion in 2023.

• The deep vein thrombosis (DVT) application segment in the specific biomarker for thrombosis and hemostasis market seeks to develop and provide timely and reliable tools for the diagnosis of DVT, as it also remains one of the dangerous health conditions where the clot is formed in the deep veins of the leg and can travel to the lungs, causing pulmonary embolism (PE), which is often fatal.
  
• DVT biomarker testing can include D-dimer, fibrinogen, and other anticoagulant factors measuring assays where results can be obtained within a short time.
  
• Therefore, the development of the segment can be attributed to rising factors like lifestyle changes, increased obesity, and aged populations causing an increase in DVT.
  

Based on end use, the thrombosis and hemostasis biomarkers market is segmented into hospitals and clinics, diagnostic laboratories, and other end users. The hospitals and clinics segment dominated the market with USD 2.7 billion in 2023 and expected to reach 4.4 billion within the forecast period.

• The segment for hospitals and clinics constitutes an essential part of the market for thrombosis and hemostasis biomarkers owing to the increased need for quality diagnostic tests in acute care situations.
  
• These institutions utilize various biomarker tests such as D-dimer, fibrinogen, and clotting factor tests to facilitate the rapid diagnosis and treatment of clot-related illnesses including deep vein thrombosis (DVT) and pulmonary embolism (PE).
  
• Hospitals deploy high sensitivity and specificity throughput testing, often relying on automated coagulation analyzers and point-of-care testing (POCT) methods due to the sensitive nature of these conditions.
  

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The U.S. thrombosis and hemostasis biomarkers market are expected to grow at 5.8% CAGR, to reach USD 3 billion by the end of 2032.

• The U.S. market for hemostasis and thrombosis biomarkers is expected to expand on account of the growing prevalence of cardiac diseases. For instance, the American Heart Association reports that cardiovascular diseases (CVD) were responsible for 928,741 deaths in America during the year 2020.
  
• Due to increased investment in research and development as well as adoption of precision medicine, the newer biomarkers related to thrombosis and hemorrhage have better prospects. Expansion of business activities by leading biotechnology and pharmaceutical companies accelerates the process of biomarker research and development and marketing with emphasis on prognosis and personalized medicine.
  
• Additionally, there is rapid adoption of innovative technologies because of higher spending on healthcare and more permissive policies on regulations. The growing adoption of point-of-care testing and noninvasive techniques simplifies the healthcare process and promotes market growth.
  

The Germany thrombosis and hemostasis biomarkers market is experiencing robust growth in Europe.  

• The market in Germany is enlarging owing to its well-established medical system, high prevalence of cardiovascular diseases, and state-funded research programs. The concern for health and well-being within the German population invites the healthcare system to adopt precision medicine and new methods of diagnosis, thus creating a need for new sophisticated methods for determining the biomarkers.
  
• Additionally, the development is facilitated by partnerships between academic research and biotechnology companies, whereas the public's interest in genetic testing and proteomics is a driver for the use of such techniques.
  

The Asia Pacific thrombosis and hemostasis biomarkers market is witnessing substantial growth of 6.1% during the analysis period.

• The market in China is growing rapidly because of the growing occurrence of diseases associated with lifestyle and emphasis on investment in modernizing healthcare. The expansion of the healthcare systems in China, especially in the cities, allows advanced diagnostics to be used more widely.
  
• Together with growing popularity and preference, noninvasive biomarker testing and point-of-care measures are on the rise. As a result, diagnostic services are being made more accessible and a well-defined market path is being established.
  

Brazil is experiencing robust growth in Latin America thrombosis and hemostasis biomarkers market.

• In Brazil, the market for thrombosis and hemostasis biomarkers is developing at a steady rate, largely due to higher incidences of cardiovascular disease, an increase in private healthcare, and higher spending by the government on healthcare. However, there are specific factors such as regional healthcare imbalances and inadequate rural access that may limit this market's expansion.
  
• Investment aimed at the urban population is being made in hospitals and diagnostic centers and improving accessibility to biomarker-based tests. In addition, partnerships with foreign healthcare companies are introducing new diagnostic equipment to the market.
  

The Saudi Arabia thrombosis and hemostasis biomarkers industry is witnessing substantial growth during the analysis period.

• The cardiovascular disease, diabetes, and government-initiated healthcare reforms in the KSA contribute to a growing market. Investment is being made to build infrastructure and increase diagnostics as part of the Saudi Vision 2030 plan.
  
• Finding early diagnostic solutions that include biomarkers for thrombosis and hemostasis is increasingly in demand as the population ages and healthcare prevention becomes a priority.
  

Thrombosis and Hemostasis Biomarkers Market Share

The hemophilia and thrombosis biomarkers industry is primarily controlled by major pharmaceutical and biopharmaceutical companies. The demand for precision medicine and diagnostics in cardiovascular healthcare significantly supports the development of the industry. Leading market players utilize diverse portfolios of biomarkers, efficient diagnostic testing, and advanced treatment methods to consume substantial portions of the market.

F. Hoffmann-La Roche utilizes its comprehensive set of diagnostic tools and assays including the Elecsys D-Dimer immunoassay, which is designed to be as sensitive and specific as possible for disorders related to thrombosis and hemostasis. Their innovation in implementing high-level automation enables the achievement of accurate and repeatable results, so they can be relied on by clinical laboratories around the world.

Siemens Healthineers leads in the provision of advanced coagulation analyzers and assays like the Sysmex CS-Series. This combines high-throughput and high-performance for simplified management of thrombosis and hemostasis testing. Their focus on the improvement of lab diagnostics and streamlining the workflow processes clearly define their leadership within the industry.

Thrombosis and Hemostasis Biomarkers Market Companies

Major players operating in the thrombosis and hemostasis biomarkers industry are:

• Abbott Laboratories
• ARUP Laboratories
• Biomedica Diagnostics
• BioMerieux
• Cincinnati Children's Hospital Medical Center
• Cleveland Clinic Laboratories
• Diazyme Laboratories
• F. Hoffmann-La Roche
• HORIBA
• Mayo Clinic Laboratories
• QuidelOrtho
• Siemens Healthineers
• Thermo Fisher Scientific
• Werfen
  

Thrombosis and Hemostasis Biomarkers Industry News

• In June 2024, HORIBA announced the launch of its new Yumizen H550 compact hematology analyzers featuring integration ESR and CBC/Diff features. The new range targeted small to mid-throughput laboratories by providing cost-effective, adaptable hematology solutions in the thrombosis and hemostasis biomarkers industry.
  
• In June 2024, HORIBA announced the FDA 510(k) clearance of its high-throughput Yumizen H2500 hematology analyzer, which permitted its distribution and use within the U.S., enhancing the capabilities for diagnosing diseases in the thrombosis and hemostasis biomarkers sector.
  

The thrombosis and hemostasis biomarkers market research report include an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Product

• Analyzers
• Reagents & consumables

Market, By Test Location

• Clinical laboratory tests
• Point-of-care tests

Market, By Test Type

• D-dimer
• Anti-thrombin III
• Plasminogen
• Soluble fibrin
• Factor VIII
• Post-thrombin (PT)
• Activated partial thromboplastin time (APTT) test
• Other test types

Market, By Application

• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Disseminated intravascular coagulation (DIC)
• Other test applications

Market, By End Use

• Hospitals and clinics
• Diagnostic laboratories
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea 
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE