Description
Kalorama Information’s Hematology and Coagulation Markets (Lab-based and Decentralized Markets) examines the current state of two growing testing markets.
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).
Kalorama’s examination of the global market for hematology testing includes analyzers/instruments and reagents: all commercial laboratory and hospital-based products, some research use products used in clinical laboratories, and OTC product sales (not test services). Market data points presented include:
- Global Hematology Testing Market by Product Segment, 2019-2024 ($ million) (Laboratory-based Hematology, Decentralized [POC] Hematology, Hematology Testing Market)
- Global Laboratory-based Hematology Test and Instrument Market, 2019 and 2024 ($ millions)
- Global Laboratory-based Hematology Test and Instrument Market, by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Top Tier Hematology, Company Revenues (Laboratory and POC), 2019 ($ millions)
- Decentralized Hematology Test and Instrument Market, 2019 and 2024 ($ millions)
- Global Decentralized Hematology Test and Instrument Market, by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Hematology Analyzer Distribution of Sales by Menu Capability, 2019 estimated (%) (5-part diff analyzer sales, 3-part diff analyzer sales, Other analyzers)
- Lab-based Hematology Sales by Analyte, 2019 estimated (%) (CBC, Hemoglobin, Other specialized)
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:
- Global Coagulation Diagnostic Markets by Segment, 2019-2024 ($ millions) (PT/INR – Lab, D-dimer – Lab, Molecular – Lab, Professional POC, Self POC)
- Global D-dimer Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Global Coagulation Test and Instrument Market by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Top Coagulation (Laboratory-based and POC) Company Revenues, 2019 ($ millions)
The report contains some discussion of COVID-19 as it relates to the hematology and coagulation markets. Several global health organizations and health professionals have reported negative effects of COVID-19 in patients with hematological diseases, including rare diseases such as sickle cell disease and thalassemia. Coagulation testing, including d-dimer, is considered to be a growing indicator of the impact and clinical outcomes of patients with COVID-19. Several international organizations are leading the charge in identifying and publishing recommendations and guidances for coagulopathy management in COVID-19 patients.
Hematology and Coagulation Markets (Lab-based and Decentralized Markets) concludes with company profiles and review:
- Abbott Diagnostics
- Beckman Coulter, Inc. / Danaher
- CellaVision AB
- Diagnostica Stago, S.A.S.
- DIAGON Kft. Hungary
- HemoCue / Radiometer / Danaher
- Horiba Medical
- Medica Corporation
- Microvisk Technologies
- Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.
- Roche Diagnostics
- Siemens Healthineers
- Sysmex Corporation
- Werfen (Instrumentation Laboratory, Accriva Diagnostics)
- West Medica
Table of Contents
Chapter 1: Executive Summary
Hematology Overview
Hematology Market Overview
- Table 1-1: Global Hematology Testing Market by Product Segment, 2019-2024 ($ million) (Laboratory-based Hematology, Decentralized [POC] Hematology, Hematology Testing Market)
Coagulation Overview
Coagulation Market Overview
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- Table 1-2: Global Coagulation Diagnostic Markets by Segment (PT/INR – Lab, D-dimer – Lab, Molecular – Lab, Professional POC, Self POC), 2019-2024 ($ millions)
Scope and Methodology
COVID-19 and Hematology / Coagulation
Chapter 2: Overview of Hematology and Trends
Introduction
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- Figure 2-1: Hematology Analyzer Distribution of Sales by Menu Capability, 2019 estimated (%) (5-part diff analyzer sales, 3-part diff analyzer sales, Other analyzers)
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- Figure 2-2: Lab-based Hematology Sales by Analyte, 2019 estimated (%) (CBC, Hemoglobin, Other specialized)
Digital Image Analysis
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- Table 2-1: CellaVision Market Share Data by Hematology Vendor 2019 (%)
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- Table 2-2: Selected Hematology Image Analysis Innovations, 2014-2019
- Lab Automation ñ The Digital Evolution
Quality Control Measurement Programs
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- Table 2-3: Quality Control Hematology FDA Registrations, 2020
Chapter 3: Laboratory-based Hematology Testing
Overview
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- Figure 3-1: Laboratory-based Hematology Analyzer/Instrument FDA Approvals by Year, through 2019
Product Overview
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- Table 3-1: Selected Hematology Innovations, 2014-2019
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- Figure 3-2: FDA Registration Distribution by Company for Hematology Analyzers/Instruments (%)
Market Summary
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- Table 3-2: Global Laboratory-based Hematology Test and Instrument Market, 2019 and 2024 ($ millions)
- Regional Laboratory-based Hematology Test and Instrument Market
- Table 3-3: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Figure 3-3: Laboratory-based Hematology Test and Instrument Market, Regional Analysis, 2019 (%) (North America, Europe, Asia Pacific, RoW)
Chapter 4: Decentralized Hematology Testing
Overview
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- Figure 4-1: POC-based Hematology Analyzer/Instrument FDA Approvals by Year, through 2020
Hemoglobin/Hematocrit at the POC
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- Table 4-1: POC Hematology Distribution by Specialty (hematocrit/hemoglobin vs. other routine hematology (WBC, erythrocyte, platelet)
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- Table 4-2: Selected POC Hemoglobin and Hematocrit Systems
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- Table 4-3: Selected POC Hematology Analyzer Systems, 2019
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- Figure 4-2: FDA Registration Distribution for CLIA Waived Hematology Device Approvals by Company (%)
Market Summary
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- Table 4-4: Decentralized Hematology Test and Instrument Market, 2019 and 2024 ($ millions) (Instruments, lab-style; Handheld devices; Total)
- Regional Decentralized Hematology Test and Instrument Market
- Table 4-5: Global Decentralized Hematology Test and Instrument Market, by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Figure 4-3: Decentralized Hematology Test and Instrument Market, Regional Analysis, 2019 (%) (North America, Europe, Asia Pacific, RoW)
Chapter 5: Hematology Market Analysis — Leading Suppliers
Summary
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- Table 5-1: Distribution of Revenue for Vendors of Hematology Instruments, Reagents and Services, 2019 (%) (Analyzers, Instruments; Reagents; Services)
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- Table 5-2: Top Tier Hematology, Company Revenues (Laboratory and POC), 2019 ($ millions)
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- Table 5-3: Hematology Vendors (Laboratory, POC), 2019 (Top Tier, Second Tier)
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- Figure 5-1: Global Hematology (Laboratory-based and POC) Market Value by Segment, 2019 (Decentralized [POC] Hematology, Lab-based Hematology)
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- Table 5-4: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
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- Figure 5-2: Global Hematology Market by Testing Platform (Laboratory-based, POC) and Region (North America, Europe, Asia Pacific, RoW), 2019
The Commercial Outlook for Hematology Tests
Chapter 6: Coagulation Market
Special Topics
- COVID-19
- Direct Oral Anticoagulants (DOACs)
- Table 6-1: Major Anticoagulants (Drug; 2019 Sales, estimated [$ billion])
- D-dimer
- Table 6-2: Global D-dimer Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Industry Acquisitions Related to Coagulation Testing
- Table 6-3: Significant Industry Acquisitions for Hematology and Coagulation Diagnostics, 2016-2020
Market Analysis
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- Table 6-4: Global Coagulation Diagnostic Markets by Segment (PT/INR – Lab, D-dimer – Lab, Molecular – Lab, Professional POC, Self POC), 2019-2024 ($ millions)
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- Table 6-5: Global Coagulation Test and Instrument Market by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
Lab-based Testing
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- Table 6-6: Selected Lab-based Coagulation Innovations
- Genetic Markers of Hypercoagulopathies
- Table 6-7: Related CMS Codes for Reimbursement National Limits, Molecular, 2020
- Table 6-8: Global Molecular – Thrombophilia SNP Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
- Table 6-9: Selected Molecular Coagulation Test Innovations
Decentralized Coagulation Testing ñ Professional Use
- Decentralized Coagulation Testing ñ OTC
- Table 6-10: Selected POC Coagulation Test Innovations
- Platelet Testing
- Table 6-11: Selected Platelet Activity Test Innovations
Leading Suppliers
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- Table 6-12: Top Coagulation (Laboratory-based and POC) Company Revenues, 2019 ($ millions)
The Commercial Market for Coagulation Tests
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- Table 6-13: Major Anticoagulants Uses and Tests
Chapter 7: Company Profiles and Review
Abbott Diagnostics
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- Table 7-1: Abbott Diagnosticsí Recent Revenue History ($ million)
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- Table 7-2: Kaloramaís Estimated Breakdown of Abbott’s Revenue in Selected Test Segments, 2015-2019 (Histology [Vysis], Chem/Immuno, Hematology, Molecular, Point of Care, Diabetes, Rapid & Alere) ($ million, estimated)
- Hematology Activity
- Coagulation Activity
- i-STAT Business
Beckman Coulter, Inc. / Danaher
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- Table 7-3: Beckman Coulterís Recent Revenue History, 2015-2019 ($ million, estimated)
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- Table 7-4: Kalorama Information’s Estimate of Beckman Coulter’s Revenue in Selected Test Segments (Routine Chemistry, Immunoassays, Hematology, Microbiology) 2016-2019 ($ million, estimated)
- Hematology Activity
- Coagulation Activity
CellaVision AB
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- Table 7-5: CellaVisionís Recent Revenue History, 2015-2019 ($ million)
- Hematology Activity
Diagnostica Stago, S.A.S.
DIAGON Kft. Hungary
HemoCue / Radiometer / Danaher
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- Table 7-6: HemoCueís Recent Revenue History, 2015-2019 ($ million, estimated)
- Hematology Activity
Horiba Medical
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- Table 7-7: Horiba Medicalís Recent Revenue History, 2015-2019 ($ million)
- Hematology Activity
- Coagulation Activity
Medica Corporation
Microvisk Technologies
Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.
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- Table 7-8: Mindray’s Recent Revenue History, 2015-2019 ($ million)
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- Table 7-9: Kalorama Information’s Estimate of Mindray’s Revenue for IVD sales, 2015-2019 (all, $ million, estimated)
- Hematology Activity
Roche Diagnostics
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- Table 7-10: Rocheís Recent Revenue History, 2015-2019 ($ million)
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- Table 7-11: Kalorama Information Estimates of Roche’s Revenue in Selected Test Segments (Core/POC, Diabetes, Molecular, Tissue), 2015-2019 (in $ millions, estimated)
- Hematology Activity
- Coagulation Activity
Siemens Healthineers
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- Table 7-12: Siemens Healthineersí Recent Revenue History, 2015-2019 ($ million, estimated)
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- Table 7-13: Kalorama Informationís Estimated Breakdown of Siemensí IVD Product Sales in Selected Test Segments (Immunoassays, Coagulation, Hematology, Molecular, Urinalysis, Blood Gases), 2019 ($ million, estimated)
- Hematology Activity
- Coagulation Activity
Sysmex Corporation
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- Table 7-14: Sysmexís Recent Revenue History, 2015-2019 ($ million)
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- Table 7-15: Kalorama Informationís Estimated Breakdown of Sysmex’s Product Sales in Selected Test Segments (Hematology, Coagulation, Urinalysis), 2015-2019 ($ million)
- Hematology Activity
- Coagulation Activity
Werfen (Instrumentation Laboratory, Accriva Diagnostics)
West Medica
