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Clinical Laboratory Testing Volume 1: IVD Reagents and Instruments Markets - Product Image

Clinical Laboratory Testing Volume 1: IVD Reagents and Instruments Markets

  • Published: July 2012
  • Region: Global
  • 279 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Abaxis
  • Beckman Coulter, Inc.
  • Hitachi
  • JEOL Ltd.
  • Nova Biomedical
  • Sysmex Corporation
  • MORE

Clinical laboratory analysis for in vitro diagnostic (IVD) testing is one of the most important sectors of medical care. By all accounts, it is very mature, large market employing over 100,000 laboratory workers, and spawning an industry for reagents and instruments comprised of thousands of companies worldwide. The term clinical laboratory analysis usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily collected body fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations.

The purpose of this TriMark Publications report is to describe the specific segments of the global clinical laboratory instrumentation and reagent market. Within this area, the report covers those segments that are highly active in terms of innovation and growth. Specifically, this global clinical laboratory markets report examines the markets for small lab equipment all the way up to highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers' original equipment manufacturer (OEM) additional equipment. The emphasis READ MORE >

1. Overview
1.1 Objectives of the Report
1.2 Methodology
1.3 Scope of the Report
1.4 Executive Summary

2. IVD Industry
2.1 Industry Overview
2.2 IVD Industry Leading Players Comparison and Review
2.2.1 Roche Diagnostics
2.2.2 Abbott Laboratories
2.2.3 Siemens Healthcare Diagnostics
2.2.4 Becton, Dickinson & Co.
2.2.5 Beckman Coulter, Inc.
2.2.6 Ortho-Clinical Diagnostics
2.2.7 bioMérieux
2.2.8 Sysmex
2.2.9 Bio-Rad Laboratories, Inc.
2.2.10 ARKRAY, Inc.
2.2.11 Cytyc Corporation (A Hologic Company)
2.2.12 Gen-Probe, Inc.
2.3 Biotechnology Reagents and Supplies
2.3.1 Vendor Quality Assurance
2.3.2 Partnership Support
2.3.3 Protecting Supply of Raw Materials
2.3.4 Selecting a Second Source for Chemicals
2.3.5 Cost Analysis for Reagent Manufacture
2.3.6 Outsourcing Production of Reagents
2.4 The Fastest Growing IVD Reagent Markets
2.5 High Growth Applications Spur Industry Growth
2.6 Automated Instrument Platforms Evolution
2.7 Reagents and Supplies Market for Clinical Lab Instruments
2.8 Spending for Clinical Laboratory Testing
2.8.1 Reimbursement Pressure
2.8.2 Medicare Part B Spending Trends
2.8.3 Strategies for Revenue Growth
2.8.4 Electronic Health Records

3. IVD Clinical Laboratory Instrument and Reagent Market
3.1 Markets
3.1.1 Global Markets
3.1.2 Global Drivers of Clinical Laboratory Testing
3.1.3 Global Outlook
3.1.4 U.S. Market
3.1.5 European IVD Instruments and Reagents Market
3.1.5.1 German Clinical Laboratory Diagnostic Markets
3.1.5.2 U.K. Clinical Laboratory Testing Diagnostic Product Market
3.1.5.2.1 U.K. Competitive Analysis
3.1.5.2.2 U.K. Market Access
3.1.5.3 French Clinical Laboratory Diagnostic Testing Products Market
3.1.5.4 Italian Clinical Laboratory Diagnostic Products Market
3.1.5.5 Spanish Clinical Laboratory Diagnostic Market
3.1.5.6 Finnish Clinical Laboratory Products Market
3.1.5.7 Turkish Clinical Laboratory Products Market
3.1.5.8 Belgium Clinical Laboratory Diagnostic Products Market
3.1.5.9 Swiss Clinical Laboratory Diagnostic Products Market
3.1.5.10 Dutch Clinical Laboratory Diagnostic Products Market
3.1.5.11 Portuguese Clinical Laboratory Diagnostic Products Market
3.1.5.12 Austrian Clinical Laboratory Diagnostic Products Market
3.1.5.13 Greek Clinical Laboratory Diagnostic Products Market
3.1.5.14 Polish Clinical Laboratory Diagnostic Products Market
3.1.5.15 Romanian Clinical Laboratory Diagnostic Products Market
3.1.5.16 Czech Republic Clinical Laboratory Diagnostic Products Market
3.1.5.17 Swedish Clinical Laboratory Diagnostic Products Market
3.1.5.18 Norwegian Clinical Laboratory Diagnostic Products Market
3.1.5.19 Irish Clinical Laboratory Diagnostic Products Market
3.1.5.20 Hungarian Clinical Laboratory Diagnostic Products Market
3.1.5.21 Bulgarian Clinical Laboratory Diagnostic Products Market
3.1.5.22 Slovakian Clinical Laboratory Diagnostic Products Market
3.1.5.23 Lithuanian Clinical Laboratory Diagnostic Products Market
3.1.5.24 Latvian Clinical Laboratory Diagnostic Products Market
3.1.5.25 Estonian Clinical Laboratory Diagnostic Products Market
3.1.5.26 Slovenian Clinical Laboratory Products Diagnostic Market
3.1.5.27 Russian Clinical Laboratory Diagnostic Products Market
3.1.6 Asian Markets
3.1.6.1 Indian Clinical Laboratory Diagnostic Products Market
3.1.6.1.1 Indian IVD Testing Instrument and Reagents Industry
3.1.6.2 Japanese Clinical Laboratory Testing Products Market
3.1.6.3 Chinese Clinical Laboratory Instrument and Reagent Market
3.1.7 Clinical Laboratory Smaller Country Markets
3.1.7.1 Canadian Clinical Laboratory Market
3.1.7.2 Brazilian Clinical Laboratory Instrument and Reagent Market
3.1.7.3 Australian Clinical Laboratory Instrument and Reagent Market
3.1.8 ROW Clinical Laboratory Testing Instrument and Reagent Market
3.1.9 Overview of Asian Clinical Laboratory Instrument and Reagent 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 India
3.1.9.8 Hong Kong
3.1.9.9 Taiwan
3.1.10 Overview of the Latin American Diagnostics Market
3.2 Clinical Laboratory Sector
3.2.1 Key Industry Players
3.2.2 Market Specialization
3.2.3 Revenue and Reimbursement
3.2.4 Companies
3.3 Outlook for Clinical Laboratory 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 Laboratory Instrument Market by Sector
4.1 Chemistry Analyzers
4.1.1 Ultra-Large Throughput Laboratory Analyzers
4.1.2 Large-Throughput Analyzers
4.1.3 Mid-size Clinical Laboratory Analyzers
4.1.4 Laboratory Analyzers for the Small Volume Market
4.2 Immunochemistry Analyzers
4.2.1 Large Immunochemistry Analyzers
4.2.2 Small Immunoassay Analyzers
4.3 Hematology Analyzers
4.4 Point of Care Testing
4.5 Microbiology Testing
4.6 Serology Testing
4.7 Esoteric Testing
4.8 Anatomic Pathology
4.8.1 Histology
4.8.2 IHC Staining
4.8.3 ISH Staining
4.8.4 Special Stains Staining
4.8.5 Tissue Staining Market
4.8.6 Cancer Diagnostics; Anatomic Pathology
4.9 Drug Testing

5. Important Technology Trends in IVD Instrumentation and Reagents
5.1 Technology Innovations in Instrument and Reagent Development
5.2 Sensor Systems for Diagnostic Applications
5.3 Glucose Measurements
5.4 Glucose Test Methods
5.5 Cholesterol Measurements
5.6 The New Paradigm
5.7 Consolidated Workstations
5.8 Automation in the Laboratory
5.9 Laboratory Information Systems
5.10 New User-friendly Interfaces
5.11 Biosensor Technology
5.12 Data-Management Issues
5.12.1 Wireless LANs
5.12.2 Cepheid?s POC GBS and BCR/ABL Tests
5.12.3 Data and Workflow Management Systems
5.12.4 Beckman Central Command

6. Business Trends in the Clinical Laboratory Analyzer and Reagents Market
6.1 Key Market Developments
6.1.1 Decreasing Revenue from Traditional IVD Markets
6.1.2 High Growth in POCT and Molecular Diagnostics Arena
6.1.3 Move Away from Traditional Kit Testing Methods
6.1.4 Integrated Analytical Systems
6.1.5 Regulatory Changes
6.1.6 Development of a Two-Tier Industry Structure
6.1.7 Labor Costs
6.1.8 Increasing Value of Companies with High-Margin Technology Platforms
6.1.9 The Joining of IVD Testing and Computer Technology
6.1.10 User-friendly User Interfaces
6.2 Sector Consolidation
6.2.1 IVD Company Consolidation
6.2.2 Lab Company Consolidation
6.2.2.1 Acquisition Pricing
6.3 Diagnostic Testing Growth Trends
6.4 Reagent and Hardware Business in Japan
6.5 New Products
6.6 Acquisition, License Agreements, Internal Development and Partnerships
6.7 Product Testing Depth in Clinical Laboratory Testing
6.8 Government Regulation of IVD Devices
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 E.U. Regulation
6.8.3 Japanese Regulation
6.8.4 Korean Regulation
6.8.5 Chinese Regulation
6.8.6 Post Filing Regulations for Medical Devices
6.8.7 Exporting Unapproved POCTs
6.8.8 Analyte Specific Reagents (Home Brew Tests)
6.8.9 Medical Device Registration
6.8.10 Product Labeling
6.8.11 Punitive FDA Actions
6.8.12 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws
6.8.13 Impact of Regulations on the Industry
6.8.14 Minimizing Regulatory Barriers
6.9 Increased Market Penetration
6.10 Costs of Doing Business in Europe
6.11 Drivers of European Diagnostics Testing
6.12 European Reimbursement Practices
6.13 Cost Containment in Europe
6.14 Hospital Outreach Programs
6.15 Electronic Procurement: New Challenges
6.16 Competition for Supply Chain Management Solutions
6.17 E-Commerce in the Hospital Supply Chain
6.17.1 Drivers of E-Commerce Solutions
6.17.2 Barriers to E-Commerce Solutions
6.18 Top Trends in IVD Instrument and Reagent Business Practices
6.19 The Value of the New Diagnostics
6.20 Converging Technologies?Drugs and Diagnostic Tests Combine for Improved Healthcare
6.21 Emerging Technologies in the Downstream Manufacture of Bio-Materials
6.22 GMP Readiness
6.23 Harnessing Human Resource Capabilities and IT Prowess: Biotechnology in the Future
6.24 Partnering with Patient-based Organizations to Achieve Patient Health Goals
6.25 Rumors of the Platform Company?s Demise are Greatly Exaggerated
6.26 Who's Going to Pay for It?
6.27 Clinical Trials Testing.
6.28 Life Insurer Services.
6.29 Employer Services
6.30 Waived Testing

7. Company Profiles
7.1 Abaxis
7.2 Abbott
7.3 Adaltis, Inc.
7.4 Alfa Wasserman, Inc. (Formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)
7.5 Becton, Dickinson & Co.
7.6 Beckman Coulter, Inc.
7.7 bioMérieux
7.8 Hitachi
7.9 Horiba Ltd.
7.10 JEOL Ltd.
7.11 MEDTOX Scientific, Inc.
7.12 Myriad Genetics, Inc.
7.13 Nova Biomedical
7.14 Hologic, Inc.
7.15 Ortho-Clinical Diagnostics, a J&J Company
7.16 Roche Diagnostics Corp.
7.17 Shimadzu
7.18 Sysmex Corporation
7.19 Thermo Fisher Scientific, Inc.
7.20 Vital Scientific, NV
7.21 Tosoh Corporation

INDEX OF FIGURES

Figure 1.1: Worldwide Market Share Distribution of IVD Reagent and Instrument Testing
Figure 1.2: Top 13 Country Market Share Distribution of IVD Reagent and Instrument Testing
Figure 2.1: Market Share of Top Twelve Largest Diagnostic Companies Worldwide
Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-2005
Figure 3.1: IVD Product Demand
Figure 3.2: Global Market for Molecular Diagnostics, 2002-2016
Figure 3.3: European IVD Market by Clinical Specialty
Figure 3.4: Chinese IVD Market, 2006-2016
Figure 3.5: Principal Marketers in the IVD Industry
Figure 4.1: Global Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015
Figure 4.2: U.S. Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015
Figure 4.3: E.U. Revenue of Drugs of Abuse Testing Market Forecast, 2007-2015
Figure 6.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category
Figure 6.2: Hospital Market Share for Outreach Programs

INDEX OF TABLES

Table 1.1: Worldwide Distribution of IVD Reagent and Instrument Testing Revenue, 2011
Table 1.2: Top 13 Country IVD Reagent and Instrument Testing Markets Revenues, 2011
Table 2.1: Top Twelve Largest Diagnostic Companies Worldwide
Table 2.2: Products Marketed by Abbott in the Diagnostic Market
Table 2.3: Beckman Coulter Market Share in Major Diagnostic Sectors
Table 2.4: Prodesse?s ASRs
Table 2.5: CMS Reimbursement for Top 25 Clinical Laboratory Procedures
Table 3.1: Worldwide IVD Testing Instrument and Reagent Market, 2011
Table 3.2: Worldwide Geographic Distribution of IVD Instrument and Reagent Markets, 2011
Table 3.3: Global Clinical Laboratory Instrument and Reagent Testing Market Sales, 1998-2016
Table 3.4: U.S. Clinical Laboratory Instrument and Reagent Testing Market, 2003-2016
Table 3.5: U.S. Clinical Laboratory Diagnostic Instrument and Reagent Test Market Segments, 2011
Table 3.6: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 2011
Table 3.7: U.S. Market for Molecular Diagnostics Testing, 2000-2016
Table 3.8: U.S. Market for Molecular Diagnostics Testing Instruments and Reagents, 2004-2016
Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2016
Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 2011
Table 3.11: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-2016
Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 2011
Table 3.13: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2016
Table 3.14: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.15: Major U.K. IVD Manufacturers
Table 3.16: U.S. IVD Manufacturers Doing Business in the U.K.
Table 3.17: Other European Companies that Manufacture IVD Products in the U.K.
Table 3.18: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2016
Table 3.19: Italian Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.20: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.21: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.22: Turkish Clinical Laboratory Testing Market, 2000-2016
Table 3.23: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.24: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.25: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.26: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.27: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.28: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.29: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.30: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.31: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2004-2016
Table 3.32: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.33: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.34: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.35: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.36: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.37: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.38: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.39: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.40: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.41: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.42: Russian Clinical Laboratory Diagnostics Products Market Sales, 2007-2016
Table 3.43: Asian Geographic Distribution of IVD Testing, 2011
Table 3.44: Summary of Key Business Points of the Asian Healthcare Market
Table 3.45: Outlook for the Asian Healthcare Market, 2010-2012
Table 3.46: Asian IVD Market Drivers
Table 3.47: Asian IVD Market Restraints
Table 3.48: Top Asian IVD Growth Opportunities
Table 3.49: Indian IVD Market for Instruments and Reagents, 2004-2016
Table 3.50: Number of Automated Clinical Labs in India, 2004-2016
Table 3.51: Indian IVD Market, 2011
Table 3.52: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2016
Table 3.53: Drivers of the Japanese IVD Market
Table 3.54: Barriers to the Japanese IVD Market
Table 3.55: Japanese Population and Aging Demographics Forecast, 2000-2050
Table 3.56: Drivers of Growth in the Chinese Clinical Laboratory Market
Table 3.57: Number of Chinese Medical Institutions
Table 3.58: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2016
Table 3.59: Chinese IVD Instrument and Reagent Market, 2011
Table 3.60: Proportion of Medical Expenses Paid Privately
Table 3.61: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin
Table 3.62: Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin
Table 3.63: Chinese International IVD Manufacturers
Table 3.64: Chinese Domestic IVD Manufacturers
Table 3.65: Chinese IVD Distributors
Table 3.66: Canadian Clinical Laboratory Testing Instrument and Reagent Market, 2000-2011
Table 3.67: Brazilian Clinical Laboratory Instrument and Reagent Testing Market, 2000-2011
Table 3.68: Australian Clinical Laboratory Testing Instrument and Reagent Market, 2000-2011
Table 3.69: ROW Clinical Laboratory Testing Instrument and Reagent Market, 2000-2011
Table 3.70: Latin American Geographic Distribution of IVD Testing Reagents and Instruments Markets, 2011
Table 3.71: Number of Clinical Laboratories in Latin America
Table 3.72: Key Market Drivers of Automated Clinical Laboratory Instruments
Table 3.73: Key Market Limits of Automated Clinical Laboratory Instruments
Table 4.1: Ultra-Large Clinical Laboratory Analyzers
Table 4.2: JEOL Analyzer Comparison
Table 4.3: Large Clinical Laboratory Analyzers
Table 4.4: Mid-size Clinical Laboratory Analyzers
Table 4.5: Small Clinical Laboratory Analyzers
Table 4.6: Large Immunochemistry Analyzers
Table 4.7: Small Immunoassay Analyzers
Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers
Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers
Table 4.10: Linearity and Precision of Siemens Hematology Analyzers
Table 4.11: Accuracy of the Automated Differential of Siemens Hematology Analyzers
Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments
Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers
Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers
Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers
Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers
Table 4.17: Accuracy of the Sysmex Hematology Analyzers
Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers
Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers
Table 4.20: Hematology Analyzers with a Five-Part WBC Differential
Table 4.21: Hematology Analyzers with a Three-Part WBC Differential
Table 4.22: Point of Care Testing
Table 4.23: Number of ER Visits in U.S. Hospitals, 2000-2011
Table 4.24: Global Revenue from Drugs of Abuse Testing, 2007-2015
Table 4.25: U.S. Revenue from Drugs of Abuse Testing, 2007-2015
Table 4.26: E.U. Revenue from Drugs of Abuse Testing, 2007-2015
Table 4.27: Worldwide Distribution of Drug Abuse Testing, 2011
Table 5.1: Normal Glucose Values?Fasting State
Table 5.2: Applications for Wireless LAN Technology
Table 6:1: Products Marketed by Abbott in the Diagnostics Market
Table 7.1: Abaxis Blood Analysis Diagnostic Tests
Table 7.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers
Table 7.3: The VITROS ECiQ Immunodiagnostic System

- Abaxis
- Abbott
- Adaltis, Inc.
- Alfa Wasserman, Inc. (Formerly Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.)
- Becton, Dickinson & Co.
- Beckman Coulter, Inc.
- bioMérieux
- Hitachi
- Horiba Ltd.
- JEOL Ltd.
- MEDTOX Scientific, Inc.
- Myriad Genetics, Inc.
- Nova Biomedical
- Hologic, Inc.
- Ortho-Clinical Diagnostics, a J&J Company
- Roche Diagnostics Corp.
- Shimadzu
- Sysmex Corporation
- Thermo Fisher Scientific, Inc.
- Vital Scientific, NV
- Tosoh Corporation

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