Cardiac Marker Diagnostic Testing Markets

Cardiac Marker Diagnostic Testing Markets

The purpose of this TriMark Publications report is to describe the specific market segment of the in vitro diagnostics (IVD) market devoted to cardiac marker testing. This study examines clinical measurement devices and their reagents and supplies as used in hospitals, clinics and doctor’s offices. This examination is arranged to provide the reader with an overview of the outstanding diagnostic test market segments of cardiac care, with evidence that these segments are poised for high future growth. An overview of the diagnostic testing cardiac marker market is presented with the latest information regarding emerging new products and industry trends. It will not only quantify but also qualify the cardiac marker market segments as an area of research, product development and investment. Forecasts of the cardiac marker market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and future possibilities within this diagnostic category.  
 

1. Overview

1.1 Objectives of the Report

1.2 Methodology

1.3 Scope of the Report

1.4 Executive Summary

2 IVD Clinical Hematology Analyzer Market

2.1 Introduction

2.2 Key Product Segments

2.2.1 Hematology and Associates Instruments

2.2.1.1 Hematology Analyzers

2.2.1.2 Hematology Instruments Offerings by Major Players

2.2.1.2.1 Hematology Reagents and Controls

2.2.1.2.2 Hematology Point of Care Instruments

2.2.1.3 Flow Cytometers

2.2.1.3.1 Flow Cytometry Technology Platforms

2.2.1.3.2 Clinical Applications of Flow Cytometry

2.2.1.3.2.1 Leukocyte Analysis

2.2.1.3.2.2 Immunophenotyping of Leukemias and Lymphomas

2.2.1.3.2.3 Neutropenia

2.2.1.3.2.4 Platelet Analysis

2.2.1.3.2.5 T Cell Subsets

2.2.1.3.2.6 Reticulocyte Count

2.2.1.3.3 Flow Cytometry Market Growth

2.2.1.3.3.1 Applications

2.2.1.3.3.2 Market Size

2.2.1.3.3.3 Instrumentation Preferences

2.2.1.3.3.4 Reagent Selection and Use

2.2.1.3.3.5 Instrument Manufacturers

2.2.1.3.3.6 Future Directions of Flow Cytometry

2.2.1.4 Coagulation Analyzers

2.2.1.4.1 Coagulation Market Size

2.2.1.4.2 Prothrombin Time Test

2.2.1.4.3 Activated Partial Thromboplastin Time (APTT)

2.2.1.4.4 Clinical Advantages of Coagulation Testing

2.2.1.4.5 Coagulation Instruments

2.2.1.4.5.1 Roche Diagnostics

2.2.1.4.5.2 Avocet Medical

2.2.1.4.5.3 International Technidyne Corporation

2.2.1.4.5.4 Cardiovascular Diagnostics

2.2.1.4.5.5 Diagnostica Stago’s STA-R Evolution

2.2.1.4.5.6 Other Companies

2.2.1.4.5.7 Coagulation Reagents

2.2.1.5 Hemoglobinometers

2.2.1.6 Slide Stainers

2.2.1.7 Differential Counters

2.2.1.8 Hematology Stains

2.3 Blood Components

2.3.1 Complete Blood Count (CBC)

2.3.2 Red Blood Cells (RBCs)

2.3.3 White Blood Cells (WBCs)

2.3.4 Platelets

2.3.5 Hematocrit (HCT)

2.4 Hematology Tests

2.5 The Coulter Principle

2.6 Blood Collection

3. IVD Clinical Hematology Analyzer Market

3.1 Markets

3.1.1 Global Markets

3.1.2 Global Drivers of Clinical Hematology Analyzer Testing

3.1.3 Global Outlook

3.1.4 U.S. Market

3.1.5 European Market

3.1.5.1 German Clinical Hematology Analyzer and Reagent Diagnostic Markets

3.1.5.2 U.K. Clinical Hematology Market

3.1.5.3 French Clinical Hematology Market

3.1.5.4 Italian Clinical Hematology Market

3.1.5.5 Spanish Clinical Hematology Market

3.1.5.6 Belgian Clinical Hematology Market

3.1.5.7 Swiss Clinical Hematology Market

3.1.5.8 Dutch Clinical Hematology Market

3.1.5.9 Portuguese Clinical Hematology Market

3.1.5.10 Austrian Clinical Hematology Market

3.1.5.11 Greek Clinical Hematology Market

3.1.5.12 Polish Clinical Hematology Market

3.1.5.13 Czech Clinical Hematology Market

3.1.5.14 Finnish Clinical Hematology Market

3.1.5.15 Scandinavian Clinical Hematology Market

3.1.6 Asian Market

3.1.6.1 Indian Clinical Hematology Market

3.1.6.1.1 India’s in vitro Diagnostic Testing Industry

3.1.6.1.2 Major Indian IVD Companies

3.1.6.2 Japanese Clinical Hematology Market

3.1.6.3 Chinese Clinical Hematology Market

3.1.7 Country Clinical Hematology Smaller Markets

3.1.7.1 Canada Clinical Hematology Market

3.1.7.2 Brazil Clinical Hematology Market

3.1.7.3 Turkey Clinical Hematology Market

3.1.7.4 Australia Clinical Hematology Market

3.1.8 Remaining World Clinical Hematology Market

3.1.9 Overview of Asian Healthcare Market

3.1.9.1 Singapore

3.1.9.2 Malaysia

3.1.9.3 Thailand

3.1.9.4 Indonesia

3.1.9.5 Philippines

3.1.9.6 South Korea

3.1.9.7 Hong Kong

3.1.9.8 Taiwan

3.1.10 Overview of the Latin American Diagnostics Market

3.2 Clinical Hematology Analyzer and Reagents Sector

3.2.1 Industry-Served Markets

3.2.2 Industry Players

3.2.2.1 Manufacturing Companies

3.2.3 Market Specialization

3.2.4 Hematology Sector Companies

3.3 Outlook for Clinical Hematology Analyzer Testing

3.3.1 Long-Term Changes

3.3.2 Market Drivers

3.3.3 The Limits to Growth

3.3.4 Hot Sectors in the IVD Market

3.3.5 Key Technologies

3.3.6 Conclusion

4. Clinical Hematology Instrument Market by Type and Competitor

4.1 Abbott Diagnostics

4.2 Bayer Diagnostics

4.3 Beckman Coulter

4.4 Drew Scientific

4.5 Horiba ABX Inc.

4.6 Sysmex

4.7 Boule Medical

4.8 Beijing Shining Sun

4.9 Hematology Analyzers for Point of Care

5. Important Technology Trends

5.1 Technology Platform Innovations in Hematology Testing

5.2 The New Paradigm

5.3 Consolidated Workstations

5.4 Automation in the Laboratory

5.5 Laboratory Information Systems

5.6 New User-friendly Interfaces

5.7 Data-Management Issues

5.7.1 Wireless LANs

5.7.2 Data and Workflow Management Systems

5.7.3 Beckman Central Command

5.7.4 Middleware

5.8 Robotics - Total Laboratory Automation Robotic Sample Handling

5.9 Image Analysis

5.10 Flow Cytometry

5.11 Laser Technology

5.12 Automating Preanalytics

5.13 Telepathology

6. Business Trends in the Clinical Hematology Analyzer Sector

6.1 Key Developments

6.2 Industrial Sector Consolidation

6.3 Hospital and Commercial Laboratory Consolidation

6.4 Changing Ordering Patterns

6.5 New Products

6.6 Acquisition, License Agreements, Internal Development and Partnerships

6.7 Breadth of Product Offerings

6.8 Government Regulation

6.8.1 U.S. Regulation

6.8.1.1 Importing Medical Devices into the U.S.

6.8.1.2 Exporting Medical Devices from the U.S.

6.8.2 U.K. Regulation

6.8.3 E.U. Regulation

6.8.4 Japanese Regulation

6.8.5 Korean Regulation

6.9 Costs of Doing Business in Europe

6.10 Drivers of European Diagnostics Testing

6.11 European Reimbursement Practices

6.12 Cost Containment in Europe

6.13 Revenue and Reimbursement

7. Product Launches

7.1 Horiba ABX Unveils Pentra DF 120

7.2 Sysmex America Launches Software for Sysmex XE-2100 Hematology Analyzers

7.3 SurroScan™ Develops Laser Scan Cytometry System

7.4 Abbott Receives Clearance for Hematology Instrument

7.5 Clinical Data Receives FDA Clearance for Excyte

7.6 Becton Introduces FACSCanto™

7.7 Abbott’s International Launch of CELL-DYN Sapphire™ Hematology Instrument

7.8 Beckman Coulter Launches LH 1500 Series

7.9 Beckman Launches High-Performance Hematology Analyzer Ac•T

7.10 Abbott Laboratories Released its Cell-Dyn 1800 Automated Hematology Analyzer.

7.11 Becton Dickinson Biosciences’ Imagn System

7.12 Sysmex Network Communications System

7.13 Sysmex XS-1000i Automated Hematology Analyzer

7.14 The Melet Schloesing MS4-5

7.15 Roche CoaguChek XS Plus System

7.16 Sysmex Corp Launches KX-21

7.17 Streck nRBC-Chex

7.18 HORIBA ABX Introduces Micros CRP 200

7.19 Heska Corporation Introduces Advanced Hematology Analyzer

7.20 Specialized Master Software Programs for the Sysmex XE-2100 Hematology Analyzers

7.21 HORIBA ABX e-Sat module

7.22 Medonic M series Hematology Analyzer

7.23 Streck’s ESR-AutoPlus

7.24 Streck Quality Control Reagents

8. Clinical Hematology Testing Sector Trends and Forecasts

8.1 Home Care Analysis

8.2 Non-Traditional Collection for Hematology Analyzer Testing

8.3 New Systems for Critical-Care and Near-Patient Testing

8.4 Utility of Near-Patient Testing in Critical-Care Settings

8.5 Mergers of Diagnostic Companies

8.6 Information Management Advances

8.7 Test Ordering Patterns

8.8 Patient Satisfaction

8.9 Move Away From Central Laboratory

8.10 Healthcare Cost Controls

8.11 Competition for Services

8.12 Drivers of Clinical Hematology analyzer Testing

8.13 Confluence of New Technology

8.14 New Trends in Clinical Laboratory Testing

8.14.1 Trends in Reimbursement Practices

8.14.2 Managed Care

8.14.3 Changes in Patient Management

8.14.4 Focused Testing

8.14.5 Satellite Facilities

8.15 Demographic Trends

9. Corporate Profiles

9.1 Abbott Diagnostics

9.2 A.Menarini Diagnostics

9.3 Bayer Diagnostics

9.4 Beckman Coulter

9.5 Becton Dickenson Biosciences

9.6 Bio-Rad Laboratories Inc.

9.7 Boule Medical AB

9.8 Careside Inc.

9.9 Cholestech

9.10 Dade Behring

9.11 HemoCue

9.12 Heska Corporation

9.13 Horiba Group

9.14 Melet Schloesing

9.15 Micronics

9.16 Nihon Kohden

9.17 PPD

9.18 Roche Diagnostics

9.19 Shenzhen Mindray Bio-Medical Electronics Co. Ltd.

9.20 Streck

9.21 Sysmex

LIST OF TABLES

Table 2.1: Clinical Hematology Tests Submitted to Medicare, 2005-2012

Table 2.2: Clinical Hematology Tests Performed in the U.S., 2005-2012

Table 2.3: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2005

Table 2.4: Competitive Landscape: Companies Participating in the Hematology IVD Sector

Table 2.5: Key Product Segments

Table 2.6: Worldwide Market for Flow Cytometry Instruments and Reagents, 2000-2010

Table 2.7: Worldwide Market for Rapid Coagulation Testing Dollar Volume, 2000-2008

Table 2.8: U.S. Market for Rapid Coagulation Testing Dollar Volume, 2000-2008

Table 2.9: U.S. Market for Rapid Coagulation POC Testing Dollar Volume, 1996-2007

Table 2.10: Slide Stainer Instruments and Manufacturers

Table 2.11: Hematology Stains

Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide in 2005

Table 3.2: Worldwide Distribution of IVD Testing in 2005

Table 3.3: Global Clinical Hematology Analyzer and Reagent Revenues, 2005-2012

Table 3.4: Worldwide Distribution of Clinical Hematology Testing Analyzer and Reagent Revenues, 2005

Table 3.5: Top 15 IVD Manufacturers’ Worldwide Revenue ($ Millions)

Table 3.6 Key Players in Worldwide Hematology Analyzers and Reagent Market

Table 3.7: Leading Players in Worldwide Coagulation Analyzer and Reagent Market

Table 3.8: U.S. Clinical Hematology Analyzer Testing Market, 2000-2011

Table 3.9: U.S. Clinical Hematology Diagnostic Test Market Segments, 2005

Table 3.10: Leading Players in the U.S. Hematology Analyzers Market

Table 3.11: Leading Players in the U.S. Coagulation Analyzers Market

Table 3.12: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012

Table 3.13: European Clinical Laboratory Diagnostic Testing Markets by Analyte, 2003

Table 3.14: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2004

Table 3.15: European Clinical Hematology Instrument and Reagent Testing Market, 2000-2008

Table 3.16: German Hematology Reagent Market Sales, 2003-2012

Table 3.17: UK Hematology Reagent Market Sales, 2003-2012

Table 3.18: French Hematology Reagent Market Sales, 2003-2012

Table 3.19: Italian Hematology Reagent Market Sales, 2003-2012

Table 3.20: Spanish Hematology Reagent Market Sales, 2003-2012

Table 3.21: Belgian Hematology Reagent Market Sales, 2003-2012

Table 3.22: Swiss Hematology Reagent Market Sales, 2003-2012

Table 3.23: Dutch Hematology Reagent Market Sales, 2003-2012

Table 3.24: Portuguese Hematology Reagent Market Sales, 2003-2012

Table 3.25: Austrian Hematology Reagent Market Sales, 2003-2012

Table 3.26: Greek Hematology Reagent Market Sales, 2003-2012

Table 3.27: Polish Hematology Reagent Market Sales, 2003-2012

Table 3.28: Czech Hematology Reagent Market Sales, 2003-2012

Table 3.29: Finnish Hematology Reagent Market Sales, 2003-2012

Table 3.30: Scandinavian Clinical Hematology Diagnostics Products Market Sales, 2002-2008

Table 3.31: Indian IVD Market, 2006-2012

Table 3.32: Indian Hematology Reagent Market Sales, 2006-2012

Table 3.33: Number of Automated Clinical Labs in India, 2004-2012

Table 3.34: Indian IVD Market, 2006

Table 3.35: Market Sales of IVD Equipment and Reagents by Company in India

Table 3.36: Japanese Clinical Hematology Testing Market, 2000-2008

Table 3.37: Chinese Clinical Hematology Reagent Market Sales, 2000-2008

Table 3.38: Canadian Clinical Hematology Testing Market, 2000-2008

Table 3.39: Brazilian Clinical Hematology Analyzer Testing Market, 2000-2008

Table 3.40: Turkish Clinical Hematology Reagents Testing Market, 2000-2008

Table 3.41: Australian Clinical Hematology Reagents Testing Market, 2000-2008

Table 3.42: The ROW Clinical Hematology Reagents Testing Market, 2000-2008

Table 3.43: Estimated Number of Clinical Laboratories in Latin America

Table 3.44: Principal Marketers of Automated Clinical Hematology Analyzer Instruments

Table 4.1: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers

Table 4.2: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers

Table 4.3: Linearity and Precision of Bayer Hematology Analyzers

Table 4.4: Accuracy of the Automated Differential of Bayer Hematology Analyzers

Table 4.5: Linearity and Precision of Beckman Coulter Hematology Instruments

Table 4.6: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers

Table 4.7: Linearity and Precision of Horiba ABX Hematology Analyzers

Table 4.8: Accuracy of the Horiba ABX Hematology Analyzers

Table 4.9: Linearity and Precision of Sysmex Hematology Analyzers

Table 4.10: Accuracy of the Sysmex Hematology Analyzers

Table 4.11: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers

Table 4.12: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers

Table 4.13: Hematology Analyzers with a 5-Part WBC Differential

Table 4.14: Hematology Analyzers with a Three-Part WBC Differential

Table 5.1: Applications for Wireless LAN Technology

Table 8.1: Medicare Billing Guidelines for Multi-channel Hematology Analyzer Tests