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.
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 8
2. IVD Clinical Chemistry Market 12
2.1 Introduction 12
3. IVD Clinical Chemistry Market 14
3.1 Markets 14
3.1.1 Global Markets 14
3.1.2 Global Drivers of Clinical Chemistry Testing 16
3.1.3 Global Outlook 17
3.1.4 U.S. Market 18
3.1.5 European Market 19
3.1.5.1 German Clinical Chemistry Diagnostic Markets 22
3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 23
3.1.5.2.1 U.K. Market Statistics 24
3.1.5.2.2 U.K. Competitive Analysis 25
3.1.5.2.3 U.K. Market Access 26
3.1.5.3 French Clinical Chemistry Diagnostic Market 26
3.1.5.4 Italian Clinical Chemistry Diagnostic Market 27
3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 27
3.1.5.6 Scandinavian Clinical Chemistry Market 28
3.1.5.7 Country Clinical Chemistry Smaller Markets 28
3.1.5.7.1 Canadian Clinical Chemistry Market 28
3.1.5.7.2 Brazilian Clinical Chemistry Market 29
3.1.5.7.3 Turkish Clinical Chemistry Market 30
3.1.5.7.4 Australian Clinical Chemistry Market 30
3.1.5.7.5 Mexican IVD Market 31
3.1.5.8 Remaining World Clinical Chemistry Testing Market 31
3.1.5.9 Overview of Asian Healthcare Market 32
3.1.5.10 Japanese Clinical Chemistry Testing Market 32
3.1.5.11 Chinese Clinical Analyzer Market 33
3.1.5.12 Indian Clinical Chemistry Diagnostic Market 44
3.1.5.12.1 India’s In Vitro Diagnostic Testing Industry 44
3.1.5.13 Overview of the Latin American Diagnostics Market 47
3.2 Clinical Chemistry Sector 48
3.2.1 Industry-served Markets 48
3.2.2 Industry Players 51
3.2.2.1 Manufacturing Companies 51
3.2.3 Market Specialization 51
3.2.4 Revenue and Reimbursement 53
3.2.5 Companies 54
3.3 Outlook for Clinical Chemistry Testing 55
3.3.1 Long-term Changes 55
3.3.2 Market Drivers 56
3.3.3 The Limits to Growth 56
3.3.4 Hot Sectors in the IVD Market 57
3.3.5 Key Technologies 57
3.3.6 Conclusion 58
4. Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 59
4.1 Ultra-Large Throughput Chemistry Analyzers 59
4.2 Large-Throughput Analyzers 69
4.3 Mid-Size Clinical Chemistry Analyzers 83
4.4 Chemistry Analyzers for the Small-Volume Market 92
4.5 Laboratory Analyzers for the Small-Volume Market 94
5. Important Technology Trends 101
5.1 Technology Platform Innovations in Clinical Chemistry Testing 101
5.2 Sensor Systems for Diagnostic Applications 101
5.3 Broad and Expanded Test Menus 103
5.4 Consolidation of Analyzer Functions 103
5.5 The New Paradigm 103
5.6 Consolidated Workstations 104
5.7 Automation in the Laboratory in Response to Labor Shortages 105
5.8 Laboratory Information Systems 106
5.9 Biosensor Technology 107
5.10 Data-Management Issues 109
5.10.1 Wireless LANs 109
5.10.2 Data and Workflow Management Systems 110
5.10.3 Beckman Command Central Version 2.0 110
5.11 Connectivity Platforms 111
5.11.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 112
5.11.2 AbbottLink Analyzer Connections 113
5.11.3 Beckman Coulter DL2000 Data Manager v6.5 115
5.11.4 bioMerieux, Inc. ENQ 115
5.11.5 Siemens Easy Link Data Management System 115
6. Business Trends in the Clinical Chemistry Analyzer Sector 117
6.1 Key Developments 117
6.2 Sector Consolidation 117
6.3 Diagnostic Testing Growth Trends 118
6.4 Reagent and Hardware Business in Japan, China and Asia 119
6.5 New Products 119
6.6 Acquisition, License Agreements, Internal Development and Partnerships 120
6.7 Product Testing Depth in Clinical Chemistry Testing 120
6.8 Government Regulation 121
6.8.1 U.S. Regulation 121
6.8.1.1 Importing Medical Devices to the U.S. 122
6.8.1.2 Exporting Medical Devices from the U.S. 123
6.8.2 U.K. Regulation 123
6.8.3 E.U. Regulation 124
6.8.4 Japanese Regulation 126
6.8.5 Korean Regulation 126
6.8.6 Regulatory Trends for IVD Devices 126
6.9 Medicare Reimbursement Trends 128
7. Company Profiles 131
7.1 Abaxis, Inc. 131
7.2 Abbott Diagnostics 133
7.3 Adaltis 139
7.4 Alfa Wasserman, Inc. (f/k/a Electro-Nucleonics, Inc. and Schiapparelli Biosystems, Inc.) 139
7.5 Awareness Technology, Inc. 140
7.6 Siemens 140
7.7 Beckman Coulter, Inc. 143
7.8 Dade Behring, Inc. 148
7.9 Hitachi Ltd. 148
7.10 Horiba Ltd. 149
7.11 JEOL Ltd. 150
7.12 Nova Biomedical Corporation 150
7.13 Ortho-Clinical Diagnostics, Inc. 150
7.14 Roche 152
7.15 Shimadzu Corporation 153
7.16 Sysmex Corporation 154
7.17 Thermo Fisher Scientific, Inc. 155
7.18 Vital Scientific B.V. 156
7.19 Tosoh Corporation 157
8. Clinical Chemistry Testing Sector Trends and Forecasts 158
8.1 Home Care Analysis 158
8.2 Non-traditional Collection for Chemistry Testing 158
8.3 New Systems for Critical-Care and Near-Patient Testing 158
8.4 Utility of Near-Patient Testing in Critical-Care Settings 158
8.5 Mergers of Diagnostic Companies 158
8.6 Information Management Advances 159
8.7 Test Ordering Patterns 159
8.8 Patient Satisfaction 159
8.9 Move Away from Central Laboratory 159
8.10 Healthcare Cost Controls 159
8.11 Competition for Services 159
8.12 Drivers of Clinical Chemistry Testing 160
8.13 Confluence of New Technology 160
8.14 New Trends in Clinical Laboratory Testing 160
8.14.1 Trends in Reimbursement Practices 160
8.14.2 Managed Care 163
8.14.3 Changes in Patient Management 163
8.14.4 Focused Testing 163
8.14.5 Satellite Facilities 163
8.14.6 Point-of-Care Testing 164
8.14.7 Regionalization of Laboratory Care 164
8.15 New Chemistry Analyzers 165
8.16 Multiplexing Technology 166
9. Clinical Chemistry Product Introductions 168
9.1 Clinical Chemistry Analyzer Product Launches 168
9.2 Clinical Chemistry Reagent Product Launches 168
10. Corporate Directory 170
INDEX OF FIGURES
Figure 3.1: IVD Market by Clinical Specialty 21
Figure 3.2: Chinese IVD Market, 2006-2012 36
Figure 3.3: Lab Revenue by Lab Type 49
Figure 3.4: Lab Revenue by Test Type 49
Figure 4.1: U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 68
Figure 4.2: Non-U.S. Market Share for Ultra-Large Clinical Chemistry Analyzers 69
Figure 6.1: Part B Spending on Clinical Laboratory Services, 1991-2007 128
INDEX OF TABLES
Table 3.1: Worldwide IVD Testing Market, 2009 14
Table 3.2: Worldwide Geographic Distribution of IVD Testing, 2009 14
Table 3.3: Global Clinical Chemistry Revenues, 2000-2012 15
Table 3.4: Worldwide Distribution of Clinical Chemistry Testing, 2009 15
Table 3.5: Thirteen Largest Diagnostic Companies Worldwide, 2009 16
Table 3.6: U.S. Clinical Chemistry Testing Market, 2009-2015 19
Table 3.7: U.S. Clinical Laboratory Diagnostic Test Retail Value Market Segments, 2008 19
Table 3.8: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-2012 19
Table 3.9: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2007 20
Table 3.10: European Clinical Chemistry Testing Market, 2000-2009 22
Table 3.11: German Clinical Chemistry Testing Diagnostics Products Market Sales, 2003-2012 22
Table 3.12: German Hospital Clinical Chemistry Market, 2000-2009 23
Table 3.13: U.K. Clinical Chemistry Diagnostics Products Market Sales, 2000-2009 24
Table 3.14: Major U.K. IVD Manufacturers 25
Table 3.15: U.S. IVD Manufacturers Doing Business in the U.K. 25
Table 3.16: Other European Companies that Manufacture IVD Products in the U.K. 26
Table 3.17: French Clinical Chemistry Diagnostics Products Market Sales, 2000-2009 26
Table 3.18: Italian Chemistry Diagnostics Products Market Sales, 2000-2009 27
Table 3.19: Spanish Clinical Chemistry Diagnostics Products Market Sales, 2000-2009 27
Table 3.20: Scandinavian Clinical Chemistry Diagnostics Products Market Sales, 2000-2009 28
Table 3.21: Canadian Clinical Chemistry Testing Market, 2000-2009 28
Table 3.22: Brazilian IVD Testing Market, 2000-2009 29
Table 3.23: Brazilian Clinical Chemistry Testing Market, 2000-2009 29
Table 3.24: Turkish Clinical Chemistry Testing Market, 2000-2009 30
Table 3.25: Australian Clinical Chemistry Testing Market, 2000-2009 30
Table 3.26: Mexican IVD Testing Market, 2000-2009 31
Table 3.27: Mexican Clinical Chemistry Testing Market, 2000-2009 31
Table 3.28: The ROW Clinical Chemistry Testing Market, 2000-2009 32
Table 3.29: Japanese Clinical Chemistry Testing Market, 2000-2009 32
Table 3.30: Drivers of Growth in the Chinese Clinical Laboratory Market 33
Table 3.31: Number of Chinese Medical Institutions 34
Table 3.32: Chinese Clinical Diagnostic Products Market, 2000-2008 34
Table 3.33: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 35
Table 3.34: Chinese IVD Market, 2008 35
Table 3.35: Market Share of Reagent Imports into the Chinese Clinical Lab Market by Country of Origin 39
Table 3.36: Market Share of Analytical Instrument Imports into the Chinese Clinical Lab Market by Country of Origin 39
Table 3.37: Chinese International IVD Manufacturers 40
Table 3.38: Chinese Domestic IVD Manufacturers 40
Table 3.39: Chinese IVD Distributors 42
Table 3.40: Indian IVD Market, 2006-2012 44
Table 3.41: Number of Automated Clinical Labs in India, 2004-2012 44
Table 3.42: Indian IVD Market, 2009 45
Table 3.43: Indian IVD Market for Instruments and Reagents, 2004-2012 46
Table 3.44: Estimated Number of Clinical Laboratories in Latin America 47
Table 3.45: U.S. Clinical Laboratory Testing Sector Revenue, 2005-2015 48
Table 3.46: U.S. Clinical Laboratory Testing Sector Segments, 2009 48
Table 3.47: Esoteric Tests Performed in the Clinical Laboratory 50
Table 3.48: Growth Rates of Test Types 50
Table 3.49: Drivers of Clinical Lab Testing Volume 50
Table 3.50: Principal Marketers of Automated Clinical Chemistry Instruments 51
Table 4.1: Ultra-Large Clinical Chemistry Analyzers 68
Table 4.2: JEOL Analyzer Comparison 78
Table 4.3: Large Clinical Chemistry Analyzers 82
Table 4.4: Mid-Size Clinical Chemistry Analyzers 91
Table 4.5: Small Clinical Laboratory Analyzers 99
Table 5.1: Drivers of the Laboratory Information Systems Market Growth 107
Table 5.2: Restraints of the Laboratory Information Systems Market Growth 107
Table 5.3: Applications for Wireless LAN Technology 110
Table 5.4: Key Benefits of Laboratory Connectivity Platforms 111
Table 5.5: Connectivity Interface Platforms for Clinical Chemistry Analyzers 111
Table 6.1: Drivers of European Diagnostics Testing 128
Table 6.2: Drivers of European Reimbursement Practice 128
Table 6.3: Medicare Spending on Clinical Lab Services, 1991-2007 129
Table 6.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2009 130
Table 6.5: Allowed Charges for Top 25 Clinical Laboratory Procedures, 2009 130
Table 7.1: Products Marketed by Abbott in the Diagnostic Market 138
Table 7.2: Products Marketed by Siemens in the Diagnostics Market 141
Table 7.3: Clinically-Significant Tests Available from Siemens 141
Table 7.4: VITROS ECiQ Immunodiagnostic System 151
Table 8.1: Medicare Billing Guidelines for Multi-channel Chemistry Tests 161
Other selected research from the 'Chemicals' category:
Agrochemicals Market Global Forecast (2010 - 2015).
Global Specialty Chemicals (2009-2014)
Other selected research from the 'Hospital' category:
EMR 2010 (Market Analysis, ARRA Incentives, Key Players, and Important Trends)
Clinical Chemistry Analyzers