Clinical Laboratory Testing Volume 1: Reagents and Instruments

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Publication Date: 2007-03-01

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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 $33 billion mark in 2006--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 TriMark Publications 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. 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 Providers18
  • Figure 2.2: Part B Spending on Clinical Laboratory Services, 1991-200563
  • Figure 3.1: European IVD Market by Clinical Specialty76
  • Figure 3.2: Chinese IVD Market, 1995-2004112
  • Figure 3.3: Annual Worldwide IVD Market Growth, 2003-2005126
  • Figure 3.4: POL Revenue, 2000-2006128
  • Figure 3.5: Unweighted Average Medicare Reimbursement for Ten Most Common POL Tests, 2002 vs. 2006128
  • Figure 3.6: Total Number of Non-Waived POLs, 2000-2006129
  • Figure 3.7: Number of New Tests Granted CLIA-Waived Status, 2000-2006129
  • Figure 3.8: High-Volume Waived Tests130
  • Figure 3.9: U.S. Revenue for Six Largest IVD Vendors, 2005132
  • Figure 3.10: U.S. Revenue Change for Six Largest IVD Vendors, 2005133
  • Figure 6.1: Average Revenue-Multiple Paid to Acquire Labs, 2000-2006244
  • Figure 6.2: Hospital Market Share for Outreach Programs261


  • LIST OF TABLES

  • Table 2.1: Total U.S. Clinical Laboratory Revenue from Third Party and Direct Payment, 2005-201218
  • Table 2.2: U.S. Clinical Laboratory Diagnostic Test Market Segments, 200519
  • Table 2.3: Independent Commercial Laboratory Testing Market Value, 2005-201219
  • Table 2.4: Independent Commercial Laboratory Testing Test Volume, 2005-201219
  • Table 2.5: Leading U.S. Reference Laboratories Grouped by Market Capitalization, 200620
  • Table 2.6: Revenue Growth at Quest Diagnostics, 2000-200625
  • Table 2.7: Revenue Growth at LabCorp, 2000-200625
  • Table 2.8: Quest Diagnostics Revenue from Managed Care Contracts, 2004-200626
  • Table 2.9: LabCorp Revenue from Managed Care Contracts, 2004-200626
  • Table 2.10: Quest's Total Volume of Requisitions and Net Revenues from Clinical Laboratory Testing, 200526
  • Table 2.11: Number of Hospital Based Clinical Laboratory Tests in the U.S., 2002-200828
  • Table 2.12: European Cardiovascular Disease Management Expenditures, 2003-201032
  • Table 2.13: U.S. Doctor's Office Lab Test Dollar Volume and Growth Rates, 200634
  • Table 2.14: Worldwide Alternate Site Clinical Lab Instrument and Reagents Sales, 2005-201234
  • Table 2.15: Top IVD Manufacturers, 200536
  • Table 2.16: Products Marketed by Abbott in the Diagnostic Market41
  • Table 2.17: Prodesse's ASRs57
  • Table 2.18: Hospital Laboratory Share of Part B Medicare Spending, 1996-200564
  • Table 2.19: Medicare Spending on Clinical Lab Services, 1991-200564
  • Table 2.20: Medicare Part B Spending Per Medicare Enrollee, 1998-200565
  • Table 2.21: Allowed Charges for Top 25 Clinical Laboratory Procedures, 200565
  • Table 3.1: Worldwide IVD Testing Market, 200667
  • Table 3.2: Worldwide Distribution of IVD Testing, 200667
  • Table 3.3: Global Clinical Laboratory Market Sales, 1998-201068
  • Table 3.4: Top 15 IVD Manufacturers' Worldwide Revenue69
  • Table 3.5: U.S. Clinical Laboratory Testing Market, 2003-201271
  • Table 3.6: U.S. Clinical Laboratory Diagnostic Test Market Segments, 200672
  • Table 3.7: U.S. Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 200672
  • Table 3.8: U.S. Individual Clinical Chemistry Laboratory Diagnostic Test Markets, 200672
  • Table 3.9: European Clinical Laboratory Testing IVD Reagents and Instruments Market, 2000-201273
  • Table 3.10: European Clinical Laboratory Diagnostic Testing Reagents and Instruments Market by Analyte, 200673
  • Table 3.11: European Clinical Chemistry Testing Reagents and Instruments Market, 200674
  • Table 3.12: European Clinical Laboratory Testing Diagnostics by Country Market, 200674
  • Table 3.13: European Rapid POCT by Country Market, 200675
  • Table 3.14: European Patient Self Testing OTC Diagnostics by Country Market, 200675
  • Table 3.15: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-201282
  • Table 3.16: German Clinical Reagents and Instruments Market, 200382
  • Table 3.17: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-201284
  • Table 3.18: U.K. Clinical Reagents and Instruments Market, 200684
  • Table 3.19: Major U.K. IVD Manufacturers85
  • Table 3.20: U.S. IVD Manufacturers Doing Business in the U.K.85
  • Table 3.21: Other European Companies that Manufacture IVD Products in the U.K.86
  • Table 3.22: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-201287
  • Table 3.23: French Clinical Reagents and Instruments Market, 200687
  • Table 3.24: Italian Laboratory Diagnostics Products Market Sales, 2003-201288
  • Table 3.25: Italian Clinical Reagents and Instruments Market, 200688
  • Table 3.26: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-201289
  • Table 3.27: Spanish Clinical Reagents and Instruments Market, 200689
  • Table 3.28: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-201290
  • Table 3.29: Finnish Clinical Reagents and Instruments Market, 200690
  • Table 3.30: Turkish Clinical Laboratory Testing Market, 2003-201291
  • Table 3.31: Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-201291
  • Table 3.32: Belgium Clinical Reagents and Instruments Market, 200692
  • Table 3.33: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-201292
  • Table 3.34: Swiss Clinical Reagents and Instruments Market, 200693
  • Table 3.35: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-201293
  • Table 3.36: Dutch Clinical Reagents and Instruments Market, 200693
  • Table 3.37: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-201294
  • Table 3.38: Portuguese Clinical Reagents and Instruments Market, 200694
  • Table 3.39: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-201295
  • Table 3.40: Austrian Clinical Reagents and Instruments Market, 200695
  • Table 3.41: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-201296
  • Table 3.42: Greek Clinical Reagents and Instruments Market, 200696
  • Table 3.43: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-201297
  • Table 3.44: Polish Clinical Reagents and Instruments Market, 200697
  • Table 3.45: Romanian Clinical Laboratory Diagnostics Products Market Sales, 2003-201298
  • Table 3.46: Romanian Clinical Reagents and Instruments Market, 200698
  • Table 3.47: Czech Republic Clinical Laboratory Diagnostics Products Market Sales, 2003-201299
  • Table 3.48: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-201299
  • Table 3.49: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012100
  • Table 3.50: Irish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012100
  • Table 3.51: Hungarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012101
  • Table 3.52: Bulgarian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012101
  • Table 3.53: Slovakian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012102
  • Table 3.54: Lithuanian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012102
  • Table 3.55: Latvian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012103
  • Table 3.56: Estonian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012103
  • Table 3.57: Slovenian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012104
  • Table 3.58: Indian IVD Market for Instruments and Reagents, 2004-2012104
  • Table 3.59: Number of Automated Clinical Labs in India, 2004-2012105
  • Table 3.60: Indian IVD Market, 2006105
  • Table 3.61: Market Sales of IVD Equipment and Reagents by Company in India, 2004 and 2005108
  • Table 3.62: Japanese Clinical Laboratory Testing Instrument and Reagents Market, 2003-2012111
  • Table 3.63: Chinese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012112
  • Table 3.64: Chinese IVD Market112
  • Table 3.65: Proportion of Medical Expenses Paid Privately114
  • Table 3.66: Chinese International IVD Manufacturers115
  • Table 3.67: Chinese Domestic IVD Manufacturers116
  • Table 3.68: Chinese IVD Distributors118
  • Table 3.69: Canadian Clinical Laboratory Testing Market, 2000-2008119
  • Table 3.70: Brazilian Clinical Laboratory Testing Market, 2000-2008120
  • Table 3.71: Australian Clinical Laboratory Testing Market, 2000-2008120
  • Table 3.72: ROW Clinical Laboratory Testing Market, 2000-2008121
  • Table 3.73: Number of Clinical Laboratories in Latin America125
  • Table 3.74: Twenty Most Common Laboratory Tests Offered at Family Physician Offices131
  • Table 3.75: Important New Waived Tests132
  • Table 3.76: Principal Marketers of Automated Clinical Laboratory Instruments133
  • Table 4.1: Ultra-Large Clinical Laboratory Analyzers149
  • Table 4.2: JEOL Analyzer Comparison157
  • Table 4.3: Large Clinical Laboratory Analyzers160
  • Table 4.4: Mid-size Clinical Laboratory Analyzers163
  • Table 4.5: Small Clinical Laboratory Analyzers168
  • Table 4.6: Large Immunochemistry Analyzers177
  • Table 4.7: Small Immunoassay Analyzers180
  • Table 4.8: Linearity and Precision of Abbott CELL-DYN Hematology Analyzers182
  • Table 4.9: Accuracy of the Automated Differential of Abbott CELL-DYN Analyzers183
  • Table 4.10: Linearity and Precision of Bayer Hematology Analyzers184
  • Table 4.11: Accuracy of the Automated Differential of Bayer Hematology Analyzers184
  • Table 4.12: Linearity and Precision of Beckman Coulter Hematology Instruments186
  • Table 4.13: Accuracy of the Automated Differential of Beckman Coulter Hematology Analyzers186
  • Table 4.14: Linearity and Precision of Horiba ABX Hematology Analyzers188
  • Table 4.15: Accuracy of the Horiba ABX Hematology Analyzers189
  • Table 4.16: Linearity and Precision of Sysmex Hematology Analyzers191
  • Table 4.17: Accuracy of the Sysmex Hematology Analyzers192
  • Table 4.18: Comparison of Linearity and Precision of Top-of-the-Line Hematology Analyzers192
  • Table 4.19: Comparison of Accuracy of the Top-of-the-Line Hematology Analyzers193
  • Table 4.20: Hematology Analyzers with a Five-Part WBC Differential193
  • Table 4.21: Hematology Analyzers with a Three-Part WBC Differential194
  • Table 4.22: POCT195
  • Table 4.23: Number of ER Visits in U.S. Hospitals, 1996-2005197
  • Table 4.24: Number of POCT in U.S., 2000-2011198
  • Table 4.25: Global POC Revenues, 1998-2008199
  • Table 4.26: Worldwide Distribution of POCT, 2005199
  • Table 4.27: U.S. POCT Market, 2000-2011200
  • Table 4.28: U.S. Clinical Diagnostic Test Market Segments, Revenue from Clinical Laboratory Testing, 2005200
  • Table 4.29: U.S. POCT by Distribution Location, 2005200
  • Table 4.30: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2005201
  • Table 4.31: Drivers of European Diagnostics Testing202
  • Table 4.32: Regional Comparison of Healthcare and IVD for Eastern Europe203
  • Table 4.33: European IVD Reagent Testing Market, 2000-2012203
  • Table 4.34: European Testing Diagnostics Market, 2004203
  • Table 4.35: Top Dozen Country IVD Testing Markets and POC Share, 2004204
  • Table 4.36: German POCT Diagnostics Products Market Sales, 2002-2007204
  • Table 4.37: German Patient Care Central Lab Test Market, 2000-2008205
  • Table 4.38: German Alternate Site Testing Market (POL), 2000-2008205
  • Table 4.39: German Hospital POC Market, 2000-2008205
  • Table 4.40: German Clinical Diagnostic Test Market Segments; Sales from Clinical Laboratory Testing, 2004206
  • Table 4.41: German Clinical Diagnostic Rapid Test Market Segments206
  • Table 4.42: U.K. POC Diagnostics Products Market Sales, 1998-2007207
  • Table 4.43: Major U.K. IVD Manufacturers208
  • Table 4.44: U.S. IVD Manufacturers Doing Business in the U.K.208
  • Table 4.45: Other European Companies that Manufacture IVD Products in the U.K.209
  • Table 4.46: French POC Diagnostics Products Market Sales, 1998-2007210
  • Table 4.47: Italian POC Diagnostics Products Market Sales, 1998-2007210
  • Table 4.48: Spanish POC Diagnostics Products Market Sales, 1998-2007211
  • Table 4.49: Scandinavian POC Diagnostics Products Market Sales, 2000-2008211
  • Table 4.50: Japanese POCT Market, 2000-2008212
  • Table 4.51: Chinese POC Diagnostics Products Market Sales, 2000-2008212
  • Table 4.52: Canadian POCT Market, 2000-2008214
  • Table 4.53: Brazilian POCT Market, 2000-2008215
  • Table 4.54: Turkish POCT Market, 2000-2008215
  • Table 4.55: Australian POCT Market, 2000-2008216
  • Table 4.56: ROW POCT Market, 2000-2007216
  • Table 4.57: PAP Tests in Top European Markets218
  • Table 4.58: PAP Tests in Top Asian Markets218
  • Table 5.1: Normal Glucose Values-Fasting State225
  • Table 5.2: Applications for Wireless LAN Technology234
  • Table 7.1: Products Marketed by Abbott in the Diagnostics Market277
  • Table 7.2: Products Marketed by Dade Behring in the Diagnostics Market288
  • Table 7.3: Clinically Significant Tests Available From Dade292
  • Table 7.4: Comparison of JEOL Analyzers297
  • Table 7.5: The VITROS ECiQ Immunodiagnostic System302
  • Table 7.6: Sysmex Marketing Summary for China308

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