Clinical Laboratory Testing Volume 1: Reagents and Instruments

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Publication Date: 2009-04-02

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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 and diverse--crossing the $39 billion mark in 2008--and 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 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 in this analysis is on those companies and products that are actively developing and marketing laboratory analyzer products for the clinical setting, including hospitals, independent labs, physician\'s offices and miscellaneous clinics.

This study concentrates on the clinical laboratory instrumentation industry market segment and the companion reagents sector in the U.S. and around the world. The regional markets and their differences are examined, including Europe, Asia (Japan, China and India) and the rest of the world (ROW). Particular attention is paid to those areas of the clinical laboratory instrumentation and reagents sector that are showing the greatest growth or the most innovation.

This report attempts to answer the following questions:

This analysis reviews the market for clinical laboratory instrumentation used in clinical practice. It defines the dollar volume of sales in each major regional market, as well as 25 individual European country markets, and it analyzes the factors that influence the size and the growth of the individual market segments.

The report details market sizes and growth rates for the U.S. and world markets.

The study surveys some of the leading companies known to be marketing, manufacturing or developing products for the clinical laboratory instrumentation and reagent market for those sectors covered here. Each company is discussed in depth with a section on the history of the company, product lines, business and marketing analysis, and a subjective commentary of the position of the company in its market. The unique benefits of this report are:

Table of Contents

 

  • LIST OF FIGURES

  • Figure 2.1: Clinical Laboratory Testing Sector Providers17
  • Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-200757
  • Figure 3.1: IVD Product Demand63
  • Figure 3.2: European IVD Market by Clinical Specialty70
  • Figure 3.3: Chinese IVD Market, 2006-2012104
  • Figure 3.4: Annual Worldwide IVD Market Growth, 2003-2012119
  • Figure 3.5: POL Revenue, 2000-2006121
  • Figure 3.6: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006121
  • Figure 3.7: Total Number of Non-Waived POLs, 2000-2006122
  • Figure 3.8: Number of New Tests Granted CLIA-Waived Status, 2000-2006123
  • Figure 3.9: High-Volume Waived Tests124
  • Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006226
  • Figure 6.2: Hospital Market Share for Outreach Programs240


  • LIST OF TABLES

  • Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-201217
  • Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 200718
  • Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-201218
  • Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-201218
  • Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 200819
  • Table 2.6: Revenue Growth at Quest Diagnostics, 2000-200824
  • Table 2.7: Revenue Growth at LabCorp, 2000-200825
  • Table 2.8: Quest\'s Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 200725
  • Table 2.9: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-200827
  • Table 2.10: European Cardiovascular Disease Management Expenditures, 2003-201031
  • Table 2.11: U.S. Doctor\'s Office Lab Test Dollar Volume and Growth Rates, 200632
  • Table 2.12: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-201233
  • Table 2.13: Thirteen Largest Diagnostic Companies Worldwide, 200734
  • Table 2.14: Products Marketed by Abbott in the Diagnostic Market39
  • Table 2.15: Prodesse\'s ASRs49
  • Table 2.16: Allowed Charges for Top 25 Clinical Laboratory Procedures, 200958
  • Table 3.1: Worldwide IVD Testing Market, 200859
  • Table 3.2: Worldwide Distribution of IVD Testing, 200859
  • Table 3.3: Global Clinical Laboratory Market Sales, 1998-201260
  • Table 3.4: Thirteen Largest Diagnostic Companies Worldwide, 200761
  • Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-201264
  • Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 200764
  • Table 3.7: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 200765
  • Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 200765
  • Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-201266
  • Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 200666
  • Table 3.11: European Clinical Chemistry Testing IVD Reagents and Instruments Market, 2000-201267
  • Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 200868
  • Table 3.13: European Rapid POCT by Country Market, 200869
  • Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 200669
  • Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-201276
  • Table 3.16: German Clinical Diagnostic Rapid Test Market Segments, 200876
  • Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-201277
  • Table 3.18: U.K. Clinical Diagnostic Rapid Test Market Segments, 200878
  • Table 3.19: Major U.K. IVD Manufacturers79
  • Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K.79
  • Table 3.21: Other European Companies that Manufacture IVD Products in the U.K.79
  • Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-201280
  • Table 3.23: French Clinical Diagnostic Rapid Test Market Segments, 200880
  • Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-201281
  • Table 3.25: Italian Clinical Diagnostic Rapid Test Market Segments, 200882
  • Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-201282
  • Table 3.27: Spanish Clinical Diagnostic Rapid Test Market Segments, 200883
  • Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-201283
  • Table 3.29: Turkish Clinical Laboratory Testing Market, 2000-201284
  • Table 3.30: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-201284
  • Table 3.31: Belgium Clinical Reagents and Instruments Market, 200685
  • Table 3.32: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-201285
  • Table 3.33: Swiss Clinical Reagents and Instruments Market, 200686
  • Table 3.34: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-201286
  • Table 3.35: Dutch Clinical Reagents and Instruments Market, 200687
  • Table 3.36: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-201287
  • Table 3.37: Portuguese Clinical Reagents and Instruments Market, 200688
  • Table 3.38: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-201288
  • Table 3.39: Austrian Clinical Reagents and Instruments Market, 200689
  • Table 3.40: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-201289
  • Table 3.41: Greek Clinical Reagents and Instruments Market, 200690
  • Table 3.42: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-201290
  • Table 3.43: Polish Clinical Reagents and Instruments Market, 200691
  • Table 3.44: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-201291
  • Table 3.45: Romanian Clinical Reagents and Instruments Market, 200692
  • Table 3.46: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-201292
  • Table 3.47: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-201293
  • Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-201293
  • Table 3.49: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-201294
  • Table 3.50: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-201294
  • Table 3.51: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-201295
  • Table 3.52: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-201295
  • Table 3.53: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-201296
  • Table 3.54: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-201296
  • Table 3.55: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-201297
  • Table 3.56: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-201297
  • Table 3.57: Indian IVD Market for Instruments and Reagents, 2004-201298
  • Table 3.58: Number of Automated Clinical Labs in India, 2004-201298
  • Table 3.59: Indian IVD Market, 200899
  • Table 3.60: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012103
  • Table 3.61: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012104
  • Table 3.62: Chinese IVD Market, 2008104
  • Table 3.63: Proportion of Medical Expenses Paid Privately106
  • Table 3.64: Chinese International IVD Manufacturers107
  • Table 3.65: Chinese Domestic IVD Manufacturers108
  • Table 3.66: Chinese IVD Distributors110
  • Table 3.67: Canadian Clinical Laboratory Testing Market, 2000-2008111
  • Table 3.68: Brazilian Clinical Laboratory Testing Market, 2000-2008112
  • Table 3.69: Australian Clinical Laboratory Testing Market, 2000-2008112
  • Table 3.70: ROW Clinical Laboratory Testing Market, 2000-2008113
  • Table 3.71: Number of Clinical Laboratories in Latin America118
  • Table 3.72: Twenty Most Common Laboratory Tests Offered at Family Physician Offices125
  • Table 3.73: Important New Waived Tests125
  • Table 3.74: Principal Marketers of Automated Clinical Laboratory Instruments126
  • Table 3.75: Key Market Drivers of Automated Clinical Laboratory Instruments131
  • Table 3.76: Key Market Limits of Automated Clinical Laboratory Instruments133
  • Table 4.1: Ultra-Large Clinical Laboratory Analyzers143
  • Table 4.2: JEOL Analyzer Comparison151
  • Table 4.3: Large Clinical Laboratory Analyzers154
  • Table 4.4: Mid-size Clinical Laboratory Analyzers158
  • Table 4.5: Small Clinical Laboratory Analyzers164
  • Table 4.6: Large Immunochemistry Analyzers173
  • Table 4.7: Small Immunoassay Analyzers176
  • Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers178
  • Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers179
  • Table 4.10: Linearity and Precision of Siemens Hematology Analyzers180
  • Table 4.11: Accuracy of the Automated Differential of Siemens Hematology Analyzers181
  • Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments183
  • Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers183
  • Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers185
  • Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers186
  • Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers189
  • Table 4.17: Accuracy of the Sysmex Hematology Analyzers189
  • Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers190
  • Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers190
  • Table 4.20: Hematology Analyzers with a Five-Part WBC Differential191
  • Table 4.21: Hematology Analyzers with a Three-Part WBC Differential191
  • Table 4.22: Point of Care Testing193
  • Table 4.23: Number of ER Visits in U.S. Hospitals, 1997-2007195
  • Table 4.24: Number of POCT in U.S., 2000-2012195
  • Table 4.25: PAP Tests in Top European Markets197
  • Table 4.26: PAP Tests in Top Asian Markets197
  • Table 5.1: Normal Glucose Values-Fasting State207
  • Table 5.2: Applications for Wireless LAN Technology216
  • Table 7.1: Products Marketed by Abbott in the Diagnostics Market253
  • Table 7.2: Comparison of JEOL Analyzers267
  • Table 7.3: The VITROS ECiQ Immunodiagnostic System273
  • Table 7.4: Sysmex Marketing Summary for China279
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