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 TriMark Publications 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 7
1.3 Scope of the Report 8
1.4 Executive Summary 8
2. IVD Clinical Chemistry Market 13
2.1 Introduction 13
3. IVD Clinical Chemistry Market 15
3.1 Markets 15
3.1.1 Global Markets 15
3.1.2 Global Drivers of Clinical Chemistry Testing 20
3.1.3 Global Outlook 20
3.1.4 U.S. Market 21
3.1.5 European Market 23
3.1.5.1 German Clinical Chemistry Diagnostic Markets 32
3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 34
3.1.5.2.1 U.K. Market Statistics 35
3.1.5.2.2 U.K. Competitive Analysis 36
3.1.5.2.3 U.K. Market Access 37
3.1.5.3 French Clinical Chemistry Diagnostic Market 37
3.1.5.4 Italian Clinical Chemistry Diagnostic Market 38
3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 38
3.1.5.6 Scandinavian Clinical Chemistry Market 39
3.1.5.7 Country Clinical Chemistry Smaller Markets 40
3.1.5.7.1 Canadian Clinical Chemistry Market 40
3.1.5.7.2 Brazilian Clinical Chemistry Market 40
3.1.5.7.3 Turkish Clinical Chemistry Market 42
3.1.5.7.4 Australian Clinical Chemistry Market 42
3.1.5.7.5 Mexican IVD Market 43
3.1.5.8 Remaining World Clinical Chemistry Testing Market 45
3.1.5.9 Overview of Asian Healthcare Market 45
3.1.5.10 Japanese Clinical Chemistry Testing Market 45
3.1.5.11 Chinese Clinical Analyzer Market 46
3.1.5.12 Indian Clinical Chemistry Diagnostic Market 58
3.1.5.12.1 India's In Vitro Diagnostic Testing Industry 58
3.1.5.13 Overview of the Latin American Diagnostics Market 63
3.2 Clinical Chemistry Sector 64
3.2.1 Industry-served Markets (Retail Sales) 64
3.2.2 Industry Players 67
3.2.2.1 Manufacturing Companies 67
3.2.3 Market Specialization 68
3.2.4 Revenue and Reimbursement 70
3.2.5 Companies 70
3.3 Outlook for Clinical Chemistry Testing 72
3.3.1 Long-term Changes 72
3.3.2 Market Drivers 73
3.3.3 The Limits to Growth 73
3.3.4 Hot Sectors in the IVD Market 74
3.3.5 Key Technologies 74
3.3.6 Conclusion 74
4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 76
4.1 Ultra-Large Throughput Chemistry Analyzers 76
4.2 Large-Throughput Analyzers 86
4.3 Mid-Size Clinical Chemistry Analyzers 100
4.4 Chemistry Analyzers for the Small-Volume Market 110
4.5 Laboratory Analyzers for the Small-Volume Market 112
5. Important Technology Trends 120
5.1 Technology Platform Innovations in Clinical Chemistry Testing 120
5.2 Sensor Systems for Diagnostic Applications 120
5.3 Broad and Expanded Test Menus 122
5.4 Consolidation of Analyzer Functions 122
5.5 The New Paradigm 123
5.6 Consolidated Workstations 123
5.7 Automation in the Laboratory 125
5.8 Laboratory Information Systems 126
5.9 New User-friendly Interfaces 127
5.10 Biosensor Technology 127
5.11 Data-Management Issues 129
5.11.1 Wireless LANs 130
5.11.2 Cepheid's POC GBS and BCR/ABL Tests 130
5.11.3 Data and Workflow Management Systems 131
5.11.4 Beckman Central Command 131
5.12 Connectivity Platforms 132
5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 133
5.12.2 AbbottLink Analyzer Connections 134
5.12.3 Beckman Coulter DL2000 Data Manager v6.5 135
5.12.4 bioMérieux, Inc. ENQ 136
5.12.5 Siemens Easy Link Data Management System 136
6. Business Trends in the Clinical Chemistry Analyzer Sector 137
6.1 Key Developments 137
6.2 Sector Consolidation 137
6.3 Diagnostic Testing Growth Trends 142
6.4 Reagent and Hardware Business in Japan, China and Asia 143
6.5 New Products 144
6.6 Acquisition, License Agreements, Internal Development and Partnerships 145
6.7 Product Testing Depth in Clinical Chemistry Testing 147
6.8 Government Regulation 147
6.8.1 U.S. Regulation 147
6.8.1.1 Importing Medical Devices to the U.S. 149
6.8.1.2 Exporting Medical Devices from the U.S. 149
6.8.2 E.U. Regulation 150
6.8.3 Japanese Regulation 153
6.8.4 Korean Regulation 154
6.8.5 Chinese Regulation 155
6.8.6 Regulatory Trends for IVD Devices 155
7. Company Profiles 158
7.1 Abaxis, Inc. 158
7.2 Abbott Diagnostics 162
7.3 Adaltis 168
7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 169
7.5 Awareness Technology, Inc. 169
7.6 Siemens 169
7.7 Beckman Coulter, Inc. 173
7.8 bioMérieux 177
7.9 Dade Behring, Inc. 178
7.10 Hitachi Ltd. 178
7.11 Horiba Ltd. 179
7.12 JEOL Ltd. 179
7.13 Medica Corporation 180
7.14 Nova Biomedical Corporation 181
7.15 Ortho-Clinical Diagnostics, Inc. 181
7.16 Roche 183
7.17 Shimadzu Corporation 185
7.18 Sysmex Corporation 185
7.19 Thermo Fisher Scientific, Inc. 186
7.20 Vital Scientific B.V. 188
7.21 Tosoh Corporation 188
8. Clinical Chemistry Testing Sector Trends and Forecasts 189
8.1 Home Care Analysis 189
8.2 Non-traditional Collection for Chemistry Testing 189
8.3 New Systems for Critical-Care and Near-Patient Testing 189
8.4 Utility of Near-Patient Testing in Critical-Care Settings 189
8.5 Mergers of Diagnostic Companies 189
8.6 Information Management Advances 190
8.7 Test Ordering Patterns 190
8.8 Patient Satisfaction 190
8.9 Move Away from Central Laboratory 190
8.10 Healthcare Cost Controls 190
8.11 Competition for Services 190
8.12 Drivers of Clinical Chemistry Testing 191
8.13 Confluence of New Technology 191
8.14 New Trends in Clinical Laboratory Testing 191
8.14.1 Trends in Reimbursement Practices 191
8.14.2 Managed Care 194
8.14.3 Changes in Patient Management 194
8.14.4 Focused Testing 194
8.14.5 Satellite Facilities 195
8.14.6 Point of Care Testing 195
8.14.7 Regionalization of Laboratory Care 195
8.15 New Chemistry Analyzers 197
8.16 Multiplexing Technology 198
9. Clinical Chemistry Product Introductions 200
9.1 Clinical Chemistry Analyzer Product Launches 200
9.2 Clinical Chemistry Reagent Product Launches 200

List of Figures

Figure 3.1: Worldwide IVD Testing Instrument and Reagent Market, 2011 15
Figure 3.2: Worldwide Geographic Distribution of IVD Testing Instrument and Reagent Market, 2011 16
Figure 3.3: Global Clinical Chemistry Revenues, 2000-2017 17
Figure 3.4: Worldwide Geographical Distribution of Clinical Chemistry Testing, 2011 18
Figure 3.5: Worldwide IVD Testing Instrument and Reagent Market, 2011 19
Figure 3.6: U.S. Clinical Chemistry Testing Market, 2011-2017 22
Figure 3.7: U.S. Clinical Laboratory Diagnostic Test Retail Billing Value Market Segments, 2011 23
Figure 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2017 24
Figure 3.9: Chinese IVD Market, 2011 50
Figure 3.10: Growth of Chinese IVD Market, 2006-2012 50
Figure 3.11: Growth of Indian IVD Market, 2009-2017 59
Figure 3.12: Sectors of Indian IVD Market, 2011 60
Figure 3.13: Top Ten Companies of Indian IVD Market 62
Figure 3.14: Lab Retail Revenue by Lab Type 65
Figure 3.15: Lab Retail Revenue by Test Type 65
Figure 4.1: U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 85
Figure 4.2: Non-U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 86
Figure 6.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device
Category 151

List of Tables

Table 3.1: Worldwide IVD Testing Instrument and Reagent Market, 2011 15
Table 3.2: Worldwide Geographic Distribution of IVD Instrument and Reagent Market, 2011 16
Table 3.3: Global Clinical Chemistry Revenues, 2000-2017 17
Table 3.4: Worldwide Distribution of Clinical Chemistry Testing, 2011 18
Table 3.5: Thirteen Largest Diagnostic Companies Worldwide, 2011 19
Table 3.6: U.S. Clinical Chemistry Testing Market, 2011-2017 22
Table 3.7: U.S. Clinical Laboratory Diagnostic Test Retail Billing Value Market Segments, 2011 23
Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2017 24
Table 3.9: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2011 25
Table 3.10: European Clinical Chemistry Testing Market, 2000-2017 32
Table 3.11: German Clinical Chemistry Testing Diagnostics Products Market Sales, 2003-2017 33
Table 3.12: German Hospital Clinical Chemistry Market, 2000-2017 33
Table 3.13: U.K. Clinical Chemistry Diagnostics Products Market Sales, 2000-2017 35
Table 3.14: Major U.K. IVD Manufacturers 36
Table 3.15: U.S. IVD Manufacturers Doing Business in the U.K. 36
Table 3.16: Other European Companies that Manufacture IVD Products in the U.K. 37
Table 3.17: French Clinical Chemistry Diagnostics Products Market Sales, 2000-2017 37
Table 3.18: Italian Chemistry Diagnostics Products Market Sales, 2000-2017 38
Table 3.19: Spanish Clinical Chemistry Diagnostics Products Market Sales, 2000-2017 38
Table 3.20: Scandinavian Clinical Chemistry Diagnostics Products Market Sales, 2000-2017 39
Table 3.21: Canadian Clinical Chemistry Testing Market, 2000-2017 40
Table 3.22: Brazilian IVD Testing Market, 2000-2017 41
Table 3.23: Brazilian Clinical Chemistry Testing Market, 2000-2017 41
Table 3.24: Turkish Clinical Chemistry Testing Market, 2000-2017 42
Table 3.25: Australian Clinical Chemistry Testing Market, 2000-2017 43
Table 3.26: Mexican IVD Testing Market, 2000-2017 43
Table 3.27: Mexican Clinical Chemistry Testing Market, 2000-2017 44
Table 3.28: Mexican Clinical Laboratory Placements by Purchase 44
Table 3.29: The ROW Clinical Chemistry Testing Market, 2000-2017 45
Table 3.30: Japanese Clinical Chemistry Testing Market, 2000-2017 46
Table 3.31: Drivers of Growth in the Chinese Clinical Laboratory Market 46
Table 3.32: Number of Chinese Medical Institutions 47
Table 3.33: Chinese Clinical Diagnostic Products Market, 2000-2017 48
Table 3.34: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2017 49
Table 3.35: Chinese IVD Market, 2011 49
Table 3.36: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin 54
Table 3.37: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin 54
Table 3.38: Chinese International IVD Manufacturers 54
Table 3.39: Chinese Domestic IVD Manufacturers 55
Table 3.40: Chinese IVD Distributors 57
Table 3.41: Indian IVD Market, 2009-2017 59
Table 3.42: Number of Automated Clinical Labs in India, 2004-2017 60
Table 3.43: Indian IVD Market, 2011 60
Table 3.44: Indian IVD Market Top Ten Companies in India 62
Table 3.45: Estimated Number of Clinical Laboratories in Latin America 63
Table 3.46: U.S. Clinical Laboratory Retail Testing Sector Revenue for All Types of IVD Testing,
2005-2017 64
Table 3.47: U.S. Clinical Laboratory Retail Billing for All Types of IVD Testing Segments, 2011 65
Table 3.48: Esoteric Tests Performed in the Clinical Laboratory 66
Table 3.49: Growth Rates of Test Types 66
Table 3.50: Drivers of Clinical Lab Testing Volume 67
Table 3.51: Leading Marketers of Automated Clinical Chemistry Instruments 67
Table 4.1: Ultra-Large Clinical Chemistry Analyzers 85
Table 4.2: JEOL Analyzer Comparison 95
Table 4.3: Large Clinical Chemistry Analyzers 99
Table 4.4: Mid-Size Clinical Chemistry Analyzers 109
Table 4.5: Small Clinical Laboratory Analyzers 118
Table 5.1: Applications for Wireless LAN Technology 130
Table 5.2: Key Benefits of Laboratory Connectivity Platforms 132
Table 5.3: Connectivity Interface Platforms for Clinical Chemistry Analyzers 132
Table 6:1: Products Marketed by Abbott in the Diagnostics Market 141
Table 6.2: Drivers of European Diagnostics Testing 157
Table 6.3: Drivers of European Reimbursement Practice 157
Table 7.1: Abaxis Blood Analysis Diagnostic Tests 159
Table 7.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 160
Table 7.3: Products Marketed by Siemens in the Diagnostics Market 170
Table 7.4: Clinically-Significant Tests Available from Siemens 171
Table 7.5: The VITROS ECiQ Immunodiagnostic System 182
Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests 192