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, and 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 the 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.
Table of Contents
Chapter 1: Executive Summary
- Hematology Market Overview
- Hematology Market Sales
- Figure 1-1: Global Hematology Testing Market by Product Segment (Lab-based Hematology and Decentralized [POC] Hematology), 2022-2027 ($ million)
- Figure 1-2: Global Hematology Testing Market by Product Segment (Lab-based Hematology and Decentralized [POC] Hematology), 2022-2027 (% market)
- Coagulation Market Overview
- Coagulation Market Sales
- Figure 1-3: Coagulation Diagnostic Sales by Test Category, 2022 (D-dimer, PT/INR, Thrombophilia SNP, POC) ($ millions)
- Figure 1-4: Coagulation Diagnostic Sales by Test Category, 2022 (D-dimer, PT/INR, Thrombophilia SNP, POC) (%)
- Recent Developments in Hematology and Coagulation
- Developments
- Scope and Methodology
Chapter 2: Focus on Hematology
- Overview of Hematology
- Market Outlook
- Figure 2-1: Global Hematology Testing Market by Product Segment (Lab-based Hematology and POC Hematology), 2022-2027 ($ million)
- Table 2-2: Lab-Based and Decentralized Hematology Market Summary
- Figure 2-2: Hematology Analyzer/Instrument FDA CLIA Amendments by Year, 2000-2022
- Figure 2-3: Hematology Analyzer/Instrument Market Share, by Top Vendor (Abbott, Beckman Coulter, Becton Dickinson, EKF, Horiba, Mindray, Roche, Siemens, Sysmex, Others), 2022 (%)
Chapter 3: Focus on Coagulation
- Overview of Diagnostics in Coagulation
- Market Outlook
- Table 3-1: Coagulation Diagnostic Sales by Test Category, 2022 (D-dimer, PT/INR, Thrombophilia SNP, POC) ($ millions)
- Figure 3-1: Coagulation Diagnostic Sales by Broad Test Category, 2017-2022 ($ millions)
- Major Product Activity
- PT/INR
- Thrombophilia SNP
- D-dimer
- POC Coagulation
- Figure 3-2: POC Coagulation Testing Market Distribution (Professional, Home/Patient), 2022 (%)
- Laboratory vs. Point-of-Care Markets
- Figure 3-3: Coagulation Testing Market by End Use Setting (Laboratory, Point-of-Care), 2017-2027
Chapter 4: International Regional Trends
- Regional Hematology Market
- Table 4-1: Hematology Analyzer/Reagent Market by Region (North America, Europe, Asia Pacific, ROW), 2022-2027 ($ millions)
- Figure 4-1: Hematology Analyzer/Reagent Market by Setting and Region (Asia Pacific, Europe, North America, ROW), 2022-2027 ($ millions)
- Regional Coagulation Market
- Table 4-2: Coagulation Diagnostic Test Sales Distribution by Global Region, 2022 (Asia Pacific, Europe, North America, ROW) (%)
- Country-Level Hematology and Coagulation Market
- Figure 4-2: Global Market for Hematology, by Select Country (Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Spain, Turkey, United Kingdom, United States), 2022-2027 ($ millions)
- Figure 4-3: Global Market for Coagulation PT/INR, by Select Country (Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Spain, Turkey, United Kingdom, United States), 2022-2027 ($ millions)
- Australia
- Table 4-3: Australia Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Brazil
- Table 4-4: Brazil Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Canada
- Table 4-5: Canada Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- China
- Table 4-6: China Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- France
- Table 4-7: France Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Germany
- Table 4-8: Germany Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- India
- Table 4-9: India Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Italy
- Table 4-10: Italy Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Japan
- Table 4-11: Japan Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Spain
- Table 4-12: Spain Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- Turkey
- Table 4-13: Turkey Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- United Kingdom
- Table 4-14: United Kingdom Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
- United States
- Table 4-15: US Market for Hematology and Coagulation (Hematology, Coagulation PT/INR), 2022-2027 ($ millions) (%)
Chapter 5: Corporate Profiles
- Top Hematology and Coagulation Company Briefs
- Abbott Diagnostics
- Hematology
- Abingdon Health Ltd.
- Beckman Coulter, Inc./Danaher
- Hematology
- Hematology IT
- Biotype Diagnostic GmbH
- BioView Ltd.
- CellaVision AB
- Danaher
- Diagnostica Stago S.A.S.
- EKF Diagnostics Holdings Plc
- ELITech Group S.A.S.
- Grifols S.A.
- Coagulation
- Horiba Medical
- Instrumentation Laboratory (IL)/Werfen
- Coagulation
- Mast Group
- Menarini Diagnostics
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
- Nihon Kohden
- Nova Biomedical
- Roche Diagnostics
- Hematology
- Coagulation
- Sekisui Diagnostics LLC
- Siemens Healthineers (Siemens)
- Hematology
- Streck Inc.
- Sysmex Corporation
- Hematology
- Coagulation
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Companies Mentioned
- Abbott Diagnostics
- Abingdon Health Ltd.
- Beckman Coulter, Inc./Danaher
- Biotype Diagnostic GmbH
- BioView Ltd.
- CellaVision AB
- Danaher
- Diagnostica Stago S.A.S.
- EKF Diagnostics Holdings Plc
- ELITech Group S.A.S.
- Grifols S.A.
- Horiba Medical
- Instrumentation Laboratory (IL)/Werfen
- Mast Group
- Menarini Diagnostics
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
- Nihon Kohden
- Nova Biomedical
- Roche Diagnostics
- Sekisui Diagnostics LLC
- Siemens Healthineers (Siemens)
- Streck Inc.
- Sysmex Corporation
