Table of Contents :

1. Overview 5
1.1 Objectives of the Report 5
1.2 Methodology 5
1.3 Scope of the Report 7
1.4 Executive Summary 7

2. IVD Clinical Chemistry Market 9
2.1 Introduction 9

3. IVD Clinical Chemistry Market 11
3.1 Markets 11
3.1.1 Global Markets 11
3.1.2 Global Drivers of Clinical Chemistry Testing 13
3.1.3 Global Outlook 14
3.1.4 U.S. Market 14
3.1.5 European Market 16
3.1.5.1 German Clinical Chemistry Diagnostic Markets 19
3.1.5.2 U.K. Clinical Chemistry Testing Diagnostic Market 21
3.1.5.2.1 U.K. Market Statistics 21
3.1.5.2.2 U.K. Competitive Analysis 22
3.1.5.2.3 U.K. Market Access 23
3.1.5.3 French Clinical Chemistry Diagnostic Market 23
3.1.5.4 Italian Clinical Chemistry Diagnostic Market 24
3.1.5.5 Spanish Clinical Chemistry Diagnostic Market 24
3.1.5.6 Indian Clinical Chemistry Diagnostic Market 25
3.1.5.6.1 Indiaâeuro™s In Vitro Diagnostic Testing Industry 25
3.1.5.7 Scandinavian Clinical Chemistry Market 27
3.1.5.8 Japanese Clinical Chemistry Testing Market 27
3.1.5.9 Country Clinical Chemistry Smaller Markets 28
3.1.5.9.1 Chinese Clinical Chemistry Market 28
3.1.5.9.2 Canada Clinical Chemistry Market 31
3.1.5.9.3 Brazil Clinical Chemistry Market 32
3.1.5.9.4 Turkey Clinical Chemistry Market 33
3.1.5.9.5 Australia Clinical Chemistry Market 33
3.1.5.9.6 Mexico IVD Market 33
3.1.5.10 Remaining World Clinical Chemistry Testing Market 34
3.1.5.11 Overview of Asian Healthcare Market 35
3.1.5.11.1 Singapore 35
3.1.5.11.2 Malaysia 35
3.1.5.11.3 Thailand 35
3.1.5.11.4 Indonesia 36
3.1.5.11.5 Philippines 36
3.1.5.11.6 South Korea 36
3.1.5.11.7 India 37
3.1.5.11.8 Hong Kong 37
3.1.5.11.9 Taiwan 37
3.1.5.12 Overview of the Latin American Diagnostics Market 37
3.2 Clinical Chemistry Sector 38
3.2.1 Industry-Served Markets 38
3.2.2 Industry Players 38
3.2.2.1 Manufacturing Companies 38
3.2.3 Market Specialization 39
3.2.4 Revenue and Reimbursement 41
3.2.5 Companies 41
3.3 Outlook for Clinical Chemistry Testing 42
3.3.1 Long-Term Changes 42
3.3.2 Market Drivers 44
3.3.3 The Limits to Growth 44
3.3.4 Hot Sectors in the IVD Market 44
3.3.5 Key Technologies 45
3.3.6 Conclusion 45

4.

Clinical Chemistry Instrument Market by Sector: Size, Growth, Share and Competitors 46
4.1 Ultra-Large Throughput Chemistry Analyzers 46
4.2 Large-Throughput Analyzers 61
4.3 Mid-Size Clinical Chemistry Analyzers 73
4.4 Chemistry Analyzers for the Small-Volume Market 78

5. Important Technology Trends 81
5.1 Technology Platform Innovations in Point-of-Care Testing 81
5.2 Sensor Systems for Diagnostic Applications 81
5.3 Glucose Measurements 83
5.4 Glucose Test Methods 86
5.5 Cholesterol Measurements 86
5.6 The New Paradigm 87
5.7 Consolidated Workstations 87
5.8 Automation in the Laboratory in Response to Labor Shortages 89
5.9 Laboratory Information Systems 90
5.10 Biosensor Technology 91
5.11 Data-Management Issues 92
5.11.1 Wireless LANs 93
5.11.2 Data and Workflow Management Systems 93
5.11.3 Beckman Command Central Version 2.0 94
5.12 Connectivity Platforms 94
5.12.1 Laboratory Data Linking Software and Interface to the Laboratory Information System 94
5.12.2 AbbottLink Analyzer Connections 95
5.12.3 Beckman Coulter DL2000 Data Manager v6.5 95
5.12.4 bioMérieux Inc. ENQ 95

6. Business Trends in the Clinical Chemistry Analyzer Sector 97
6.1 Key Developments 97
6.2 Sector Consolidation 97
6.3 Diagnostic Testing Growth Trends 98
6.4 Reagent and Hardware Business in Japan 99
6.5 New Products 99
6.6 Acquisition, License Agreements, Internal Development and Partnerships 99
6.7 Product Testing Depth in Clinical Chemistry Testing 100
6.8 Government Regulation 100
6.8.1 U.S. Regulation 100
6.8.1.1 Importing Medical Devices to the U.S. 102
6.8.1.2 Exporting Medical Devices from the U.S. 102
6.8.2 U.K. Regulation 103
6.8.3 E.U. Regulation 104
6.8.4 Japanese Regulation 105
6.8.5 Korean Regulation 106
6.9 Increased Market Penetration 106
6.10 Costs of Doing Business in Europe 108
6.11 Drivers of European Diagnostics Testing 108
6.12 European Reimbursement Practices 108
6.13 Cost Containment in Europe 108
6.14 Medicare Reimbursement Trends 108

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