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Clinical chemistry analysis is one of the most important areas within clinical laboratory analysis. The term clinical chemistry usually refers to determining the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecule in easily-collected bodily fluids such as blood, serum, plasma or urine. However, it is not necessarily limited to these determinations. The analysis of virtually any biologically-active substance—any place in the body—can loosely be defined as clinical chemistry. In fact, traditional specialization barriers such as microbiology, hematology, blood banking, immunology and even anatomical pathology are rapidly fading, both operationally and instrumentally. But for the sake of defining the subject to a reasonable size, the more traditional scope of clinical chemistry will be the subject of this study. The purpose of this report is to describe the specific segments of the global clinical chemistry instrumentation market. Specifically, this study examines the markets for small lab and highly-automated, large lab platforms, as well as accessory equipment such as reagents, supplies and manufacturers’ original equipment manufacturer (OEM) additional equipment. The emphasis is on those companies and products that are actively developing and marketing chemistry analyzer products for the clinical setting, including hospitals, independent labs, physician’s offices and clinics. Concentration is on the clinical chemistry instrumentation industry market segment in the U.S. and around the world. Particular attention is paid to those areas of the clinical chemistry instrumentation sector that are showing the greatest growth or the most innovation.

TABLE OF CONTENTS



1. Overview 6

1.1 Objectives of the Report 6

1.2 Methodology 6

1.3 Scope of the Report 8

1.4 Executive Summary 9



2. IVD Clinical Chemistry Market 11

2.1 Introduction 11



3. IVD Clinical Chemistry Market 13

3.1 Markets 13

3.1.1 Global Markets 13

3.1.2 Global Drivers of Clinical Chemistry Testing 15

3.1.3 Global Outlook 15

3.1.4 U.S. Market 16

3.1.5 European Market 17

3.1.5.1 German Clinical Chemistry Diagnostic Markets 21

3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 23

3.1.5.2.1 U.K. Market Statistics 23

3.1.5.2.2 U.K. Competitive Analysis 24

3.1.5.2.3 U.K. Market Access 25

3.1.5.3 French Clinical Chemistry Diagnostic Market 25

3.1.5.4 Italian Clinical Chemistry Diagnostic Market 25

3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 26

3.1.5.6 Indian Clinical Chemistry Diagnostic Market 26

3.1.5.6.1 India’s In Vitro Diagnostic Testing Industry 26

3.1.5.7 Scandinavian Clinical Chemistry Market 28

3.1.5.8 Japanese Clinical Chemistry Testing Market 29

3.1.5.9 Country Clinical Chemistry Smaller Markets 29

3.1.5.9.1 Chinese Clinical Chemistry Market 29

3.1.5.9.2 Canada Clinical Chemistry Market 33

3.1.5.9.3 Brazil Clinical Chemistry Market 33

3.1.5.9.4 Turkey Clinical Chemistry Market 34

3.1.5.9.5 Australia Clinical Chemistry Market 34

3.1.5.9.6 Mexico IVD Market 34

3.1.5.10 Remaining World Clinical Chemistry Testing Market 35

3.1.5.11 Overview of Asian Healthcare Market 35

3.1.5.11.1 Singapore 36

3.1.5.11.2 Malaysia 36

3.1.5.11.3 Thailand 36

3.1.5.11.4 Indonesia 37

3.1.5.11.5 Philippines 37

3.1.5.11.6 South Korea 37

3.1.5.11.7 India 38

3.1.5.11.8 Hong Kong 38

3.1.5.11.9 Taiwan 38

3.1.5.12 Overview of the Latin American Diagnostics Market 39

3.2 Clinical Chemistry Sector 39

3.2.1 Industry-Served Markets 39

3.2.2 Industry Players 41

3.2.2.1 Manufacturing Companies 41

3.2.3 Market Specialization 41

3.2.4 Revenue and Reimbursement 43

3.2.5 Companies 44

3.3 Outlook for Clinical Chemistry Testing 45

3.3.1 Long-Term Changes 45

3.3.2 Market Drivers 47

3.3.3 The Limits to Growth 47

3.3.4 Hot Sectors in the IVD Market 47

3.3.5 Key Technologies 48

3.3.6 Conclusion 48



4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 50

4.1 Ultra-Large Throughput Chemistry Analyzers 50

4.2 Large-Throughput Analyzers 57

4.3 Mid-Size Clinical Chemistry Analyzers 68

4.4 Chemistry Analyzers for the Small-Volume Market 72



5. Important Technology Trends 79

5.1 Technology Platform Innovations in Point-of-Care Testing 79

5.2 Sensor Systems for Diagnostic Applications 79

5.3 Glucose Measurements 81

5.4 Glucose Test Methods 84

5.5 Cholesterol Measurements 84

5.6 The New Paradigm 85

5.7 Consolidated Workstations 85

5.8 Automation in the Laboratory in Response to Labor Shortages 87

5.9 Laboratory Information Systems 88

5.10 Biosensor Technology 89

5.11 Data-Management Issues 90

5.11.1 Wireless LANs 91

5.11.2 Data and Workflow Management Systems 91

5.11.3 Beckman Central Command 91

5.12 Connectivity Platforms 92

5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 92

5.12.2 AbbottLink Analyzer Connections 93

5.12.3 Beckman Coulter DL2000 Data Manager v6.5 93

5.12.4 bioMérieux Inc. ENQ 93

5.12.5 Ortho-Clinical Diagnostics Inc. Software Version 1.02 94



6. Business Trends in the Clinical Chemistry Analyzer Sector 95

6.1 Key Developments 95

6.2 Sector Consolidation 95

6.3 Diagnostic Testing Growth Trends 96

6.4 Reagent and Hardware Business in Japan 97

6.5 New Products 97

6.6 Acquisition, License Agreements, Internal Development and Partnerships 97

6.7 Product Testing Depth in Clinical Chemistry Testing 98

6.8 Government Regulation 98

6.8.1 U.S. Regulation 98

6.8.1.1 Importing Medical Devices to the U.S. 99

6.8.1.2 Exporting Medical Devices from the U.S. 100

6.8.2 U.K. Regulation 100

6.8.3 E.U. Regulation 102

6.8.4 Japanese Regulation 103

6.8.5 Korean Regulation 103

6.9 Increased Market Penetration 104

6.10 Costs of Doing Business in Europe 105

6.11 Drivers of European Diagnostics Testing 106

6.12 European Reimbursement Practices 106

6.13 Cost Containment in Europe 106

6.14 Medicare Reimbursement Trends 106



7. Company Profiles 109

7.1 Abaxis 109

7.1.1 Point-of-Care Blood Chemistry Analyzers 109

7.1.2 Hematology 109

7.1.3 Reagent Discs 109

7.1.4 Orbos Process 109

7.1.5 VetScan Canine Heartworm Antigen Test 110

7.2 Abbott Diagnostics 110

7.2.1 Diagnostic Products 110

7.2.2 Business Analysis 111

7.2.3 TriMark Commentary 113

7.3 Adaltis, Inc. 114

7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 115

7.4.1 Background 115

7.4.2 Products 115

7.5 Awareness Technology 115

7.6 Bayer Diagnostics 116

7.6.1 Background 116

7.6.2 General Automated Clinical Chemistry Instruments 116

7.6.2.1 ADVIA® 2400, 1800, 1650 and 1200 Chemistry Systems 116

7.6.3 Business Analysis 118

7.6.4 TriMark Commentary 118

7.7 Beckman Coulter, Inc. 118

7.7.1 Overview 118

7.7.2 Company History 119

7.7.3 Products 119

7.7.3.1 Clinical Diagnostics Products 119

7.7.3.1.1 Overview 119

7.7.3.2 Clinical Chemistry Systems 120

7.7.3.3 Clinical Laboratory Automation 120

7.7.3.4 Hemostasis Systems 121

7.7.3.5 Immunodiagnostic Systems 121

7.7.3.6 Primary Care Diagnostics 122

7.7.3.7 Hematology Systems 122

7.7.4 TriMark Commentary 123

7.8 Dade Behring, Inc. 123

7.8.1 Products 124

7.8.2 Other Served Markets 128

7.9 Hitachi 130

7.9.1 Products 131

7.10 Horiba, Ltd. 131

7.11 JEOL, Ltd. 131

7.12 Olympus America, Inc. Clinical Instruments Division 133

7.12.1 Background 133

7.12.2 Automated General Chemistry Instruments 133

7.12.3 TriMark Commentary 134

7.13 Ortho-Clinical Diagnostics, a Johnson & Johnson Company 134

7.13.1 Background 134

7.13.2 Markets 135

7.13.3 Automated General Chemistry Instruments 135

7.13.4 TriMark Commentary 136

7.14 Roche Diagnostics Corp 136

7.14.1 Background 136

7.14.2 Automated General Chemistry Instruments 137

7.14.3 Business Analysis 137

7.15 Shimadzu 138

7.15.1 Products 138

7.16 Sysmex Corporation 138

7.17 Thermo Electron Corp. 139

7.18 Vital Scientific, NV 140

7.18.1 Background 140

7.18.2 Products 141



8. Clinical Chemistry Testing Sector Trends and Forecasts 142

8.1 Home Care Analysis 142

8.2 Non-traditional Collection for Chemistry Testing 142

8.3 New Systems for Critical-Care and Near-Patient Testing 142

8.4 Utility of Near-Patient Testing in Critical-Care Settings 142

8.5 Mergers of Diagnostic Companies 142

8.6 Information Management Advances 142

8.7 Test Ordering Patterns 142

8.8 Patient Satisfaction 142

8.9 Move Away From Central Laboratory 143

8.10 Healthcare Cost Controls 143

8.11 Competition for Services 143

8.12 Drivers of Clinical Chemistry Testing 143

8.13 Confluence of New Technology 143

8.14 New Trends in Clinical Laboratory Testing 144

8.14.1 Trends in Reimbursement Practices 144

8.14.2 Managed Care 146

8.14.3 Changes in Patient Management 147

8.14.4 Focused Testing 147

8.14.5 Satellite Facilities 147

8.14.6 Point-of-Care Testing 147

8.14.7 Regionalization of Laboratory Care 148

8.15 New Chemistry Analyzers 149

8.16 Multiplexing Technology 149



9. Clinical Chemistry Product Introductions 151

9.1 Clinical Chemistry Analyzer Product Launches 151

9.2 Clinical Chemistry Reagent Product Launches 151



10. Corporate Directory 152





INDEX OF FIGURES



Figure 3.1: European Diagnostic Reagents and Instruments Markets 19

Figure 6.1: Part B Spending on Clinical Laboratory Services: 1991 to 2005 107





LIST OF TABLES



Table 3.1: The Overall In Vitro Diagnostic Testing Market Worldwide: 2006 13

Table 3.2: Worldwide Distribution of IVD Testing: 2006 13

Table 3.3: Global Clinical Chemistry Revenues: 1998 to 2012 14

Table 3.4: Worldwide Distribution of Clinical Chemistry Testing: 2006 14

Table 3.5: Ten Largest Diagnostic Companies Worldwide: 2005 14

Table 3.6: U.S. Clinical Chemistry Testing Market: 2000 to 2012 17

Table 3.7: U.S. Clinical Chemistry Diagnostic Test Market Segments: 2006 17

Table 3.8: U.S. Individual Clinical Chemistry Diagnostic Test Markets: 2006 17

Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market: 2000 to 2012 18

Table 3.10: European Clinical Laboratory Testing IVD Reagents and Instruments Market: 2000 to 2012 18

Table 3.11: European Clinical Laboratory Diagnostic Reagents and Instruments Markets by Analyte: 2006 18

Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market Estimates: 2006 19

Table 3.13: European Clinical Chemistry Testing Market: 2000 to 2008 20

Table 3.14: European Clinical Chemistry Reagents and Instruments Markets by Country: 2006 20

Table 3.15: German Clinical Chemistry Testing Diagnostics Products Market Sales: 2000 to 2007 21

Table 3.16: The German Patient Care Lab Test Market: 2000 to 2008 21

Table 3.17: The German Alternate Site Testing Market (POL): 2000 to 2008 22

Table 3.18: The German Hospital Clinical Chemistry Market: 2000 to 2008 22

Table 3.19: German Clinical Diagnostic Chemistry Test Market Segments by Analyte: 2002 and 2005 22

Table 3.20: U.K. Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008 23

Table 3.21: Major U.K. IVD Manufacturers 24

Table 3.22: U.S. IVD Manufacturers Doing Business in the U.K. 24

Table 3.23: Other European Companies That Manufacture IVD Products in the U.K. 25

Table 3.24: French Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008 25

Table 3.25: Italian Chemistry Diagnostics Products Market Sales: 1998 to 2008 26

Table 3.26: Spanish Clinical Chemistry Diagnostics Products Market Sales: 1998 to 2008 26

Table 3.27: Indian IVD Market: 2006 to 2012 26

Table 3.28: Number of Automated Clinical Labs in India: 2004 to 2012 27

Table 3.29: Indian IVD Market: 2006 27

Table 3.30: Market Sales of IVD Equipment and Reagents by Company in India: 2004 and 2005 28

Table 3.31: Scandinavian Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008 28

Table 3.32: Japan Clinical Chemistry Testing Market: 2000 to 2008 29

Table 3.33: Chinese Clinical Chemistry Diagnostics Products Market Sales: 2000 to 2008 29

Table 3.34: Canadian Clinical Chemistry Testing Market: 2000 to 2008 33

Table 3.35: Brazilian IVD Testing Market: 2000 to 2008 33

Table 3.36: Brazilian Clinical Chemistry Testing Market: 2000 to 2008 33

Table 3.37: Turkish Clinical Chemistry Testing Market: 2000 to 2008 34

Table 3.38: Australian Clinical Chemistry Testing Market: 2000 to 2008 34

Table 3.39: Mexican IVD Testing Market: 2000 to 2008 35

Table 3.40: Mexican Clinical Chemistry Testing Market: 2000 to 2008 35

Table 3.41: The ROW Clinical Chemistry Testing Market: 2000 to 2008 35

Table 3.42: Estimated Number of Clinical Laboratories in Latin America 39

Table 3.43: Principal Marketers of Automated Clinical Chemistry Instruments 41

Table 4.1: Ultra-Large Clinical Chemistry Analyzers 56

Table 4.2: JEOL Analyzer Comparison 64

Table 4.3: Large Clinical Chemistry Analyzers 68

Table 4.4: Mid-size Clinical Chemistry Analyzers 72

Table 4.5: Small Clinical Chemistry Analyzers 78

Table 5.1: Normal Glucose Values—Fasting State 83

Table 5.2: Applications for Wireless LAN Technology 91

Table 6.1: Hospital Laboratory Share of Part B Medicare Spending: 1996 to 2005 107

Table 6.2: Medicare Part B Spending Per Medicare Enrollee: 1998 to 2005 108

Table 6.3: Allowed Charges for Top 25 Clinical Laboratory Procedures: 2005 108

Table 7.1: Products Marketed by Abbott in the Diagnostic Market 113

Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market 125

Table 7.3: Clinically-Significant Tests Available From Dade 129

Table 7.4: Comparison of JEOL Analyzers 132

Table 7.5: VITROS ECiQ Immunodiagnostic System 135

Table 7.6: Sysmex Marketing Summary for China 139

Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests 145