Table of Content

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

    • 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

  • Hematology
  • Coagulation

Chapter 2: Overview of Hematology and Trends
Introduction

    • 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)
    • Figure 2-2: Lab-based Hematology Sales by Analyte, 2019 estimated (%) (CBC, Hemoglobin, Other specialized)

Digital Image Analysis

    • Table 2-1: CellaVision Market Share Data by Hematology Vendor 2019 (%)
    • Table 2-2: Selected Hematology Image Analysis Innovations, 2014-2019
  • Lab Automation ñ The Digital Evolution

Quality Control Measurement Programs

    • Table 2-3: Quality Control Hematology FDA Registrations, 2020

Chapter 3: Laboratory-based Hematology Testing
Overview

    • Figure 3-1: Laboratory-based Hematology Analyzer/Instrument FDA Approvals by Year, through 2019

Product Overview

    • Table 3-1: Selected Hematology Innovations, 2014-2019
    • Figure 3-2: FDA Registration Distribution by Company for Hematology Analyzers/Instruments (%)

Market Summary

    • 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

    • Figure 4-1: POC-based Hematology Analyzer/Instrument FDA Approvals by Year, through 2020

Hemoglobin/Hematocrit at the POC

    • Table 4-1: POC Hematology Distribution by Specialty (hematocrit/hemoglobin vs. other routine hematology (WBC, erythrocyte, platelet)
    • Table 4-2: Selected POC Hemoglobin and Hematocrit Systems
    • Table 4-3: Selected POC Hematology Analyzer Systems, 2019
    • Figure 4-2: FDA Registration Distribution for CLIA Waived Hematology Device Approvals by Company (%)

Market Summary

    • 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

    • Table 5-1: Distribution of Revenue for Vendors of Hematology Instruments, Reagents and Services, 2019 (%) (Analyzers, Instruments; Reagents; Services)
    • Table 5-2: Top Tier Hematology, Company Revenues (Laboratory and POC), 2019 ($ millions)
    • Table 5-3: Hematology Vendors (Laboratory, POC), 2019 (Top Tier, Second Tier)
    • Figure 5-1: Global Hematology (Laboratory-based and POC) Market Value by Segment, 2019 (Decentralized [POC] Hematology, Lab-based Hematology)
    • Table 5-4: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)
    • 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

    • Table 6-4: Global Coagulation Diagnostic Markets by Segment (PT/INR – Lab, D-dimer – Lab, Molecular – Lab, Professional POC, Self POC), 2019-2024 ($ millions)
    • Table 6-5: Global Coagulation Test and Instrument Market by Region, 2019 (%) (North America, Europe, Asia Pacific, RoW)

Lab-based Testing

    • 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

    • Table 6-12: Top Coagulation (Laboratory-based and POC) Company Revenues, 2019 ($ millions)

The Commercial Market for Coagulation Tests

    • Table 6-13: Major Anticoagulants Uses and Tests

Chapter 7: Company Profiles and Review
Abbott Diagnostics

    • Table 7-1: Abbott Diagnosticsí Recent Revenue History ($ million)
    • 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

    • Table 7-3: Beckman Coulterís Recent Revenue History, 2015-2019 ($ million, estimated)
    • 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

    • Table 7-5: CellaVisionís Recent Revenue History, 2015-2019 ($ million)
  • Hematology Activity

Diagnostica Stago, S.A.S.
DIAGON Kft. Hungary
HemoCue / Radiometer / Danaher

    • Table 7-6: HemoCueís Recent Revenue History, 2015-2019 ($ million, estimated)
  • Hematology Activity

Horiba Medical

    • 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.

    • Table 7-8: Mindray’s Recent Revenue History, 2015-2019 ($ million)
    • Table 7-9: Kalorama Information’s Estimate of Mindray’s Revenue for IVD sales, 2015-2019 (all, $ million, estimated)
  • Hematology Activity

Roche Diagnostics

    • Table 7-10: Rocheís Recent Revenue History, 2015-2019 ($ million)
    • 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

    • Table 7-12: Siemens Healthineersí Recent Revenue History, 2015-2019 ($ million, estimated)
    • 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

    • Table 7-14: Sysmexís Recent Revenue History, 2015-2019 ($ million)
    • 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