Hematology and Coagulation Markets, 2023

Hematology and Coagulation Markets, 2023

Nearly $10 billion-dollar market for hematology and coagulation IVD testing

There is a nearly $10 billion-dollar market for hematology and coagulation IVD testing. Increasingly growth is driven by new technologies, the aging population, and the demand for decentralized testing. This report provides:

• Market sizing for Hematology IVD and Coagulation IVD
• Markets for Decentralized and Lab-based Segments.
• Forecasts to 2027
• Market Share
• Country Markets for Hematology (Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Spain, Turkey, United Kingdom, United States)
• Country Markets for Coagulation (Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Spain, Turkey, United Kingdom, United States)
• Company Profiles

Hematology

Hematology is the study of peripheral blood and bone marrow cells in order to diagnose various diseases of the blood including leukemias, anemia and autoimmune diseases. The basis of hematology testing is the complete blood count (CBC) that provides information on blood components: hemoglobin, hematocrit, red blood cells, white blood cells, reticulocytes, platelets. The CBC is run as part of the normal work up in an annual health exam and for every inpatient. Samples that have abnormal levels of any of these components have a microscopic examination of the cell contents performed, called a blood cell differential. A drop of blood is placed on a microscope slide and stained. The slide is then examined under a microscope and the cells are analyzed.

The menu of hematology tests includes:

• CBC + 5-part differential (or 3-part differential)
• manual differential/review
• hematocrit
• hemoglobin (automated, manual)
• sedimentation rate
• reticulocyte count
• white blood cell (WBC) count
• platelet count and analysis
• red blood cell count (RBC).

In the past few years, hematology has joined the march to more automation and management IT solutions, especially for the differential count. Facilitating digital hematology is automated consistent slide staining that optimizes quality and enables standardization to help ensure accurate identification of white blood cells, red blood cell morphology and platelet assessment. Standardized stained slides are immediately available for digitization and viewing upon completion of staining.

Coagulation

Hemostasis (coagulation) is a complex process in which multiple enzymes and proteins regulate blood flow and clot formation. Coagulation (clot formation), fibrinolysis and platelet aggregation are a part of this process. Fibrinolysis refers to the breakup of blood clots. It is a normal body process that keeps naturally occurring blood clots from growing and causing problems.

Anticoagulant drugs help prevent blood platelets from sticking or clumping together, reducing the likelihood that arteries will be blocked by a clot, leading to a stroke or heart attack.

Hemostasis testing needs vary from laboratory to laboratory, with some facilities only performing routine pre-operative testing (PT/INR and PTT), while others also conduct specialty testing (coagulation factors). In either scenario, steadily increasing patient testing volumes, coupled with growing demand to produce reliable results quickly, have required laboratories to seek hemostasis testing solutions that enhance efficiency by providing consistent results and streamline workflow.

All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the markets are presented in U.S. dollar market size for categories of tests, namely laboratory-based and decentralized. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The information presented in this report is derived on publicly available information sources such as company, government, and medical: organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the IVD industry.

Hematology and Coagulation Markets, 2nd Edition examines the current state of two important testing markets. The report provides market size and forecasts for hematology tests and coagulation tests, including lab-based and point of care. Geographic market sizing is provided.

Hematology is the study of peripheral blood and bone marrow cells in order to diagnose various diseases of the blood including leukemias, anemia and autoimmune diseases. The menu of hematology tests includes: CBC + 5-part differential (or 3-part differential), manual differential/review, hematocrit, hemoglobin (automated, manual), sedimentation rate, reticulocyte count, white blood cell (WBC) count, platelet count and analysis, and red blood cell count (RBC).

The report covers:

• Global Hematology Testing Market by Product Segment (Lab-based Hematology and Decentralized [POC] Hematology), 2022-2027 ($ million) (% of market)
• Global Hematology Testing Market by Product Segment (Lab-based Hematology and POC Hematology), 2022-2027 ($ million)
• Lab-Based and Decentralized Hematology Market Summary
• Hematology Analyzer/Instrument FDA CLIA Amendments by Year, 2000-2022
• Hematology Analyzer/Instrument Market Share, by Top Vendor (Abbott, Beckman Coulter, Becton Dickinson, EKF, Horiba, Mindray, Roche, Siemens, Sysmex, Others), 2022 (%)
• And more

Hemostasis (coagulation)

Hemostasis (coagulation) is a complex process in which multiple enzymes and proteins regulate blood flow and clot formation. Coagulation (clot formation), fibrinolysis and platelet aggregation are a part of this process. Hemostasis testing needs vary from laboratory to laboratory, with some facilities only performing routine pre-operative testing (PT/INR and PTT), while others also conduct specialty testing (coagulation factors). In either scenario, steadily increasing patient testing volumes, coupled with growing demand to produce reliable results quickly, have required laboratories to seek hemostasis testing solutions that enhance efficiency by providing consistent results and streamline workflow. Kalorama’s evaluation of the global market for coagulation tests (lab-based and all POC) includes d-dimer as a segment in the market.

Market data points presented include:

• Coagulation Diagnostic Sales by Test Category, 2022 (D-dimer, PT/INR, Thrombophilia SNP, POC) ($ millions)
• Coagulation Diagnostic Sales by Test Category, 2022 (D-dimer, PT/INR, Thrombophilia SNP, POC) ($ millions)
• Coagulation Diagnostic Sales by Broad Test Category, 2017-2022 ($ millions)
• POC Coagulation Testing Market Distribution (Professional, Home/Patient), 2022 (%)
• Coagulation Testing Market by End Use Setting (Laboratory, Point-of-Care), 2017-2027

Regional analysis in the report covers the following countries:

• Australia
• Brazil
• Canada
• China
• France
• Germany
• India
• Italy
• Japan
• Spain
• Turkey
• United Kingdom
• United States

In addition, several international organizations are involved in the hematology and coagulation markets, including select companies profiled in the report: