Hematology and Coagulation Markets (Lab-based and Decentralized Markets)


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Hematology and Coagulation Markets (Lab-based and Decentralized Markets)

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

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    • Executive Summary
      • Hematology Overview
      • Hematology Market Overview
        • Table Global Hematology Testing Market by Product Segment, 2019-2024 ($ million) (Laboratorybased Hematology, Decentralized [POC] Hematology, Hematology Testing Market)
      • Coagulation Overview
      • Coagulation Market Overview
        • Table 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
        • Hematology
        • Coagulation
    • Overview of Hematology and Trends
      • Introduction
        • Table Hematology Analyzer Distribution of Sales by Menu Capability, 2019 estimated (%) (5-part diff analyzer sales, 3-part diff analyzer sales, Other analyzers)
        • Table Lab-based Hematology Sales by Analyte, 2019 estimated (%) (CBC, Hemoglobin, Other specialized)
      • Digital Image Analysis
        • Table CellaVision Market Share Data by Hematology Vendor 2019 (%)
        • Table Selected Hematology Image Analysis Innovations, 2014-2019
        • Lab Automation – The Digital Evolution
      • Quality Control Measurement Programs
        • Table Quality Control Hematology FDA Registrations, 2020
    • Laboratory-based Hematology Testing
      • Overview
        • Table Laboratory-based Hematology Analyzer/Instrument FDA Approvals by Year, through 2019
      • Product Overview
        • Table Selected Hematology Innovations, 2014-2019
        • Table FDA Registration Distribution by Company for Hematology Analyzers/Instruments (%)
      • Market Summary
        • Table Global Laboratory-based Hematology Test and Instrument Market, 2019 and 2024 ($ millions)
        • Regional Laboratory-based Hematology Test and Instrument Market
          • Table Global Laboratory-based Hematology Test and Instrument Market, by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
          • Table Laboratory-based Hematology Test and Instrument Market, Regional Analysis, 2019 (%) (North America, Europe, Asia Pacific, RoW)
    • Decentralized Hematology Testing
      • Overview
        • Table POC-based Hematology Analyzer/Instrument FDA Approvals by Year, through 2020
      • Hemoglobin/Hematocrit at the POC
        • Table POC Hematology Distribution by Specialty (hematocrit/hemoglobin vs. other routine hematology (WBC, erythrocyte, platelet)
        • Table Selected POC Hemoglobin and Hematocrit Systems
        • Table Selected POC Hematology Analyzer Systems, 2019
        • Table FDA Registration Distribution for CLIA Waived Hematology Device Approvals by Company (%)
      • Market Summary
        • Table Decentralized Hematology Test and Instrument Market, 2019 and 2024 ($ millions) (Instruments, lab-style; Handheld devices; Total)
        • Regional Decentralized Hematology Test and Instrument Market
          • Table Global Decentralized Hematology Test and Instrument Market, by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
          • Table Decentralized Hematology Test and Instrument Market, Regional Analysis, 2019 (%) (North America, Europe, Asia Pacific, RoW)
    • Hematology Market Analysis Leading Suppliers
      • Summary
        • Table Distribution of Revenue for Vendors of Hematology Instruments, Reagents and Services, 2019 (%) (Analyzers, Instruments; Reagents; Services)
        • Table Top Tier Hematology, Company Revenues (Laboratory and POC), 2019 ($ millions)
        • Table Hematology Vendors (Laboratory, POC), 2019 (Top Tier, Second Tier)
        • Table Global Hematology (Laboratory-based and POC) Market Value by Segment, 2019 (Decentralized [POC] Hematology, Lab-based Hematology)
        • Table Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
        • Table Global Hematology Market by Testing Platform (Laboratory-based, POC) and Region (North America, Europe, Asia Pacific, RoW), 2019
      • The Commercial Outlook for Hematology Tests
    • Coagulation Market
      • Special Topics
        • COVID-19
        • Direct Oral Anticoagulants (DOACs)
          • Table Major Anticoagulants (Drug; 2019 Sales, estimated [$ billion])
        • D-dimer
          • Table Global D-dimer Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
        • Industry Acquisitions Related to Coagulation Testing
          • Table Significant Industry Acquisitions for Hematology and Coagulation Diagnostics, 2016-2020
      • Market Analysis
        • Table Global Coagulation Diagnostic Markets by Segment (PT/INR - Lab, D-dimer - Lab, Molecular - Lab, Professional POC, Self POC), 2019-2024 ($ millions)
        • Table Global Coagulation Test and Instrument Market by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
      • Lab-based Testing
        • Table Selected Lab-based Coagulation Innovations
        • Genetic Markers of Hypercoagulopathies
          • Table Related CMS Codes for Reimbursement National Limits, Molecular, 2020
          • Table Global Molecular - Thrombophilia SNP Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
          • Table Selected Molecular Coagulation Test Innovations
      • Decentralized Coagulation Testing – Professional Use
        • Decentralized Coagulation Testing – OTC
          • Table Selected POC Coagulation Test Innovations
        • Platelet Testing
          • Table Selected Platelet Activity Test Innovations
      • Leading Suppliers
        • Table Top Coagulation (Laboratory-based and POC) Company Revenues, 2019 ($ millions)
      • The Commercial Market for Coagulation Tests
        • Table Major Anticoagulants Uses and Tests
    • Company Profiles and Review
      • Abbott Diagnostics
        • Table Abbott Diagnostics' Recent Revenue History ($ million)
        • Table Kalorama's 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
        • Table Beckman Coulter's Recent Revenue History, 2015-2019 ($ million, estimated)
        • Table 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
        • Table CellaVision's Recent Revenue History, 2015-2019 ($ million)
        • Hematology Activity
      • Diagnostica Stago, S.A.S.
      • DIAGON Kft. Hungary
      • HemoCue / Radiometer / Danaher
        • Table HemoCue's Recent Revenue History, 2015-2019 ($ million, estimated)
        • Hematology Activity
      • Horiba Medical
        • Table Horiba Medical's Recent Revenue History, 2015-2019 ($ million)
        • Hematology Activity
        • Coagulation Activity
      • Medica Corporation
      • Microvisk Technologies
      • Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
        • Table Mindray's Recent Revenue History, 2015-2019 ($ million)
        • Table Kalorama Information's Estimate of Mindray's Revenue for IVD sales, 2015-2019 (all, $ million, estimated)
        • Hematology Activity
      • Roche Diagnostics
        • Table Roche's Recent Revenue History, 2015-2019 ($ million)
        • Table 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
        • Table Siemens Healthineers' Recent Revenue History, 2015-2019 ($ million, estimated)
        • Table Kalorama Information's Estimated Breakdown of Siemens' IVD Product Sales in Selected Test Segments (Immunoassays, Coagulation, Hematology, Molecular, Urinalysis, Blood Gases), 2019 ($ million, estimated)
        • Hematology Activity
        • Coagulation Activity
      • Sysmex Corporation
        • Table Sysmex's Recent Revenue History, 2015-2019 ($ million)
        • Table Kalorama Information's 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

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