Coagulation Market Analysis Report | Global Size & Share 2030

The coagulation market is expected to grow from US$ 6,295.28 million in 2022 to US$ 10,853.28 million by 2030; it is anticipated to record a CAGR of 7.0% from 2022 to 2030.

Market Insights and Analyst View:

The coagulation market size is expanding with the increasing cases of blood clotting and other blood-related disorders that lead to blood clots. The Medsafe New Zealand Medicines and Medical Device Safety Authority estimates that 2–6 per 10,000 women taking oral contraceptives face blood clotting conditions annually. Anticoagulant medications, also known as blood thinners, are primarily used in the prevention and treatment of blood clots. Taking blood thinners while in the hospital is common, especially in the first 5–10 days after diagnosis, when the condition is thought to be the most severe or acute. However, those with suitable risk profiles may initially be prescribed blood thinners for use at home. Also, an increase in the cases of cardiovascular diseases, which may be caused due to blood clotting in heart arteries, is fueling the growth of the coagulation market.    

Growth Drivers and Challenges:

Hemophilia A is one of the common X-linked recessive disorders and the second most common inherited clotting factor deficiency after von Willebrand disease, according to the National Organization of Rare Disorders. Also, ~1 in 5,000 male infants suffers from hemophilia A in the US. According to the Global Hemophilia Care 2020 study, 393,658 bleeding disorder cases have been detected and documented worldwide over time—including 241,535 hemophilia cases, 87,729 von Willebrand disease cases, and 64,394 other bleeding disorder cases. According to the National Library of Medicine (NLM), ~30,000–33,000 men were affected by hemophilia in the US in 2020.

As per the reports from the American Cancer Society (CLL), the US recorded ~21,250 new cases of chronic lymphocytic leukemia in 2021. A February 2020 update from the Centers for Disease Control and Prevention (CDC) states that the number of people in the US affected by deep vein thrombosis could reach 900,000 (1–2 per 1,000). The same source estimates that in the US 60,000–100,000 Americans die yearly from venous thromboembolism. According to the US Department of Health & Human Services, ~100,000 Americans were diagnosed with sickle cell disease (SCD) in 2020, which is one of the most commonly inherited blood disorders. In addition, the number of people suffering from SCD is expected to grow by ~30% by 2050.

According to the National Library of Medicine, in 2020, 80 million people were suffering from blood disorders in the European Union. The National Organization for Rare Disorders stated that immune thrombocytopenia (ITP), an autoimmune bleeding disorder, affected ~66 adults per 1 million in the US each year in 2022. Therefore, the rising prevalence of blood disorders drives the coagulation market growth.  

Point-of-care (POC) coagulation analyzers offer significant advantages compared to traditional coagulation analyzers. However, the costs of POC analyzers are higher than affordable laboratory tests. As per the Canadian Agency for Drugs and Technologies in Health (CADTH), the average cost of Roche's CoaguChek ranged from US$ 500 to US$ 2,000, compared to the cost of the PT-INR assay test ranging from US$ 4 to US$ 31. The costs can be combined with the additional costs of battery and maintenance, resulting in higher total annual costs for POC coagulation analyzers. Therefore, the high cost of these testing analyzers limits their adoption and growth in emerging markets.

Deploying coagulation analyzers into clinical settings and offering them to patients leads to a significant financial impact on services offered by healthcare providers. Siemens Healthineers offers a floor-standing coagulation analyzer that costs US$ 250,000. The annual service maintenance cost of a coagulation analyzer ranges from ~US$ 2,000 to US$ 3,000. Further, companies manufacturing coagulation analyzers need to comply with a few stringent rules and regulations set by government organizations to gain approval for their commercial launch, which further adds to the overall price of these devices. Thus, the high costs associated with coagulation analyzers restrain the coagulation market growth.

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Coagulation Market: Strategic Insights

Market Size Value in	US$ 6,295.28 million in 2022
Market Size Value by	US$ 10,853.28 million by 2030
Growth rate	CAGR of 7.0% from 2022 to 2030
Forecast Period	2022-2030
Base Year	2022

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Report Segmentation and Scope:

The coagulation market is divided on the basis of disease indication, type, offering, technology, end user, and geography. Based on disease indications, the coagulation market is segmented into vitamin K deficiency, liver disease, disseminated intravascular coagulation & pulmonary embolism, development of circulating anticoagulants, hemophilia, von Willebrand’s disease, and others. Based on type, the coagulation market is bifurcated into clinical laboratory analyzers and point-of-care testing analyzers. Clinical laboratory analyzers are further categorized as controls and calibrators, assays and reagents, instruments/systems, coagulation factors, and others. Based on offering, the coagulation market is bifurcated into diagnosis and treatment. The diagnosis segment is further classified into prothrombin time testing, fibrinogen testing, activated clotting time testing, activated partial thromboplastin time testing, D-dimmer testing, platelets function testing, and others. The treatment segment is further classified into anti-fibrinolytic drugs, birth control pills, desmopressin and immunosuppressive medicines, vitamin K supplements, blood thinners, thrombin inhibitors or thrombolytics, replacement therapies, catheter-assisted thrombus removal, and others. Based on technology, the coagulation market is segmented into optical technology, mechanical technology, electrochemical technology, and others. The coagulation market, by end user, is segregated into clinical laboratories, hospitals, and others. Based on geography, the coagulation market is segmented into North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Italy, Spain, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), the Middle East & Africa (the UAE, Saudi Arabia, South Africa, and Rest of the Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).

Segmental Analysis:

Based on offering, the coagulation market is bifurcated into diagnosis and treatment. The diagnosis segment is further classified into prothrombin time testing, fibrinogen testing, activated clotting time testing, activated partial thromboplastin time testing, D-dimmer testing, platelets function testing, and others. The treatment segment is further classified into anti-fibrinolytic drugs, birth control pills, desmopressin and immunosuppressive medicines, vitamin K supplements, blood thinners, thrombin inhibitors or thrombolytics, replacement therapies, catheter-assisted thrombus removal, and others. In 2022, the diagnosis segment held a larger share of the coagulation market. The treatment segment is anticipated to register a higher CAGR during 2022–2030. Coagulation plays an important role in the diagnosis of clotting disorders and in monitoring patients who take drugs that impact the clotting process. Fibrinogen testing assesses the levels of fibrinogen protein, a clotting factor. When the body's tissues or blood vessels are damaged, clotting factors combine to form blood clots and stop bleeding. Fibrinogen tests are used to keep track of individuals who exhibit symptoms such as excessive bleeding or unusual blockages in veins or arteries.

The activated clotting time (ACT) test is primarily used to keep track of high doses of unfractionated heparin therapy. ACT is commonly used to monitor high-dose heparin treatment before, during, and for a short time after medical or surgical procedures that require blood clotting prevention, such as heart bypass surgery, coronary angioplasty, and dialysis. It is a quick test that can be conducted at patient's bedside before surgery or other medical procedures. It can also be performed in or near operating rooms at regular intervals during and immediately following surgeries.

Platelets’ ability to aggregate and promote clotting is measured by a variety of assays known as platelet function tests using specialized equipment. Platelet function tests may be used for other purposes besides assessing people for excessive bleeding. These tests are performed to reduce platelets' aggregation ability, especially in people who are more likely to experience heart attacks or harmful blood clots. These patients might be given drugs that lessen platelet activation or their aggregation capacity. Platelet function tests may be performed on patients taking these anti-platelet drugs, such as low-dose aspirin or clopidogrel, to track the effectiveness of their treatment.

A thrombus can be ruled out using the D-dimmer test. The D-dimmer test is used in the diagnosis of deep vein thrombosis (DVT), stroke, and pulmonary embolism (PE). The D-dimer test is recommended as an additional test. As D-dimer is a sensitive but poor specificity test, it should only be used to rule out DVT and not to confirm a diagnosis.

Coagulation Market, by Offering – 2022 and 2030

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Regional Analysis:

Based on geography, the coagulation market is divided into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. North America is the largest contributor to the growth of the coagulation market. Asia Pacific is expected to register the highest CAGR in the coagulation market during 2022–2030. North America accounts for a significant coagulation market share owing to the growing incidences of blood disorders, increasing occurrence of cardiovascular diseases such as atrial fibrillation (AFib), and the presence of major market players engaged in new and existing product developments. Moreover, government support for preventing blood disorders is anticipated to boost the North America coagulation market growth during the forecast period. The US holds the largest share of the coagulation market in North America. According to the Centers for Disease Control and Prevention (CDC), AFib was mentioned as a cause of death on ~183,321 death certificates in the US in 2019, and it was the primary cause of death in nearly 26,535 of these cases. Moreover, 12.1 million people in the US are anticipated to suffer from AFib by 2030. CDC data also mentions that hemophilia A affects 1 in 5,000 male births in the US; moreover, ~400 babies are born with Hemophilia A each year. It also mentioned that ~33,000 males in the US were diagnosed with hemophilia during 2012–2018. Further, nearly 3 million people in the country suffer from anemia. Millions of people in the US carry genes that can cause blood disorders such as sickle cell anemia and hemophilia. According to the US Department of Health and Human Services, sickle cell disease (a blood disorder) affects more than 100,000 people in the country. The source also mentions that Von Willebrand disease (VWD) is among the most common inherited blood disorders in women in the US. Thus, the increasing incidences of cardiovascular diseases and blood disorders are likely to bolster the coagulation market growth in the US.

Industry Developments and Future Opportunities:

Various initiatives by key players operating in the Coagulation Market are listed below:

1. In August 2021, Siemens Healthineers Launched Sysmex CN-3000 and CN-6000 Hemostasis Systems. These fully automated systems enable diagnostics personnel to effectively perform both mid- and high-volume coagulation tests in laboratories.
2. In July 2020, Sysmex Launched CN-6500 and CN-3500 automated blood coagulation analyzers in Japan and EMEA. These integrated analyzers incorporate features of their predecessors the CN-6000/CN-3000, such as high levels of productivity, reliability, operability, and serviceability. They consist of a measuring unit using chemiluminescence enzyme immunoassay methodology (CLEIA), a measuring principle developed with Automated Immunoassay Systems. The CN-6500 and CN-3500 analyzers allow for flexible measurements in response to a broad range of test orders in the fields of thrombosis and hemostasis,  including molecular markers for blood coagulation with a single device..  

Competitive Landscape and Key Companies:

A few of the prominent players operating in the coagulation market are NORDIC BIOMARKER; ImproGen Diagnostik Kimya San. & Tic. Ltd.; Diagnostica Stago, Inc.; Siemens Healthcare Private Limited, Sysmex; Helena Biosciences; F. Hoffmann-La Roche Ltd; Genrui Biotech Co., Ltd.; Transasia Bio-Medicals; and HORIBA Medical. These companies focus on new product launches and geographic expansions to meet the growing consumer demand worldwide and increase their product range in specialty portfolios. Their global presence allows them to serve a large base of customers, subsequently facilitating market expansion.