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 Pricing and Ordering Information

U.S. Markets for
Clinical Laboratory Products
March 2001, 451 pages
Report #RP-891357

In conjunction with the on-going evolution of healthcare delivery in the U.S., the clinical laboratory products market has also undergone broad restructuring.  Suppliers are facing an increasingly challenging environment due to changing customer requirements.  Although cost containment is the overriding determinant driving change in the industry, other considerations that are playing important roles include the need to maintain the quality of healthcare in the face of reduced resources; the impact of government regulations designed to improve the quality of laboratory results; the pressure to shorten test result turnaround times, which enables the physician to provide the patient with more rapid and effective treatment; and increasing demands for laboratory automation as a result of reductions in laboratory staffing.

Sales of clinical laboratory products in the U.S. reached $8.6 billion in 1999 and are expected to continue to grow throughout the forecast period covered by this report from Medtech Insight.  Major topics in this report include analysis of test volumes, technologies, products, current and forecast markets, competitors, and opportunities in:  clinical chemistry; coagulation; conventional microbiology; flow cytometry; hematology & cell analysis; histology & cytology; immunodiagnostics; immunohematology; molecular microbiology; point-of-care testing; therapeutic drug monitoring & drugs-of-abuse detection; and urinalysis.

Methodology

Reports are produced exclusively by Medtech Insight, through extensive primary and secondary research among the clinicians, researchers, and competitors in the marketplace, and draw upon the industry expertise of a network of industry insiders. Medtech Insight exhaustively corroborates the data as a baseline for completing forward-looking analysis and providing insight into product, technology and market evolution.

 

TABLE OF CONTENTS

 

EXECUTIVE SUMMARY

 i.   The Clinical Chemistry Market Segment

 ii.   The Hematology, Flow Cytometry, Coagulation, and Urinalysis

      Market Segment

 iii.  The Microbiology Market Segment

 iv.  The Immunodiagnostics Market Segment

 v.  Other Market Segments

 vi.  Factors Affecting the Overall Market

 vii. Competitors in the Overall Market

 

1. CLINICAL AND HOSPITAL LABORATORY MARKET OVERVIEW

     1.1 Hospital Laboratories

     1.2 Independent Commercial Laboratories

     1.3 Physician’s Office Laboratories

     1.4 Point-of-Care Testing

          1.4.1 Training Programs

          1.4.2 Quality Assurance/Quality Control Procedures

     1.5 Blood Banks and Plasma Centers

     1.6 Laboratory Automation

     1.7 Trends in Clinical Laboratory Testing

     1.8 Trends in Healthcare Delivery and Managed Care

          1.8.1 Impact of Cost-Reduction Efforts

          1.8.2 Impact on Medical Device Manufacturers

     1.9 Clinical Laboratory Improvement Amendments of 1988

          1.9.1 Test Classification

          1.9.2 Impact on Operations

 

2. THE CLINICAL CHEMISTRY TESTING PRODUCTS MARKET

     2.1 Test Volumes

     2.2 Equipment

          2.2.1 Existing Products

                  2.2.1.1 General Chemistry Analyzers

                  2.2.1.2 Whole-Blood Glucose Analyzers

                  2.2.1.3 Blood Gas/Electrolyte Analyzers

          2.2.2 Technologies and Products Under Development

          2.2.3 Market Forecast

                  2.2.3.1 Capital Equipment

                  2.2.3.2 Consumables

          2.2.4 Competitor Analysis

          2.2.5 Industry Trends

 

3. THE HEMATOLOGY, FLOW CYTOMETRY, COAGULATION, AND

     URINALYSIS PRODUCTS MARKET

     3.1 Hematology

          3.1.1 Test Volumes

          3.1.2 Equipment

                  3.1.2.1 Existing Products

                  3.1.2.2 Technologies and Products Under Development

                  3.1.2.3 Market Forecast

                             3.1.2.3.1 Capital Equipment

                             3.1.2.3.2 Consumables

                  3.1.2.4 Competitor Analysis

                  3.1.2.5 Industry Trends

     3.2 Flow Cytometry

          3.2.1 Test Volumes

          3.2.2 Equipment

                  3.2.2.1 Existing Products

                  3.2.2.2 Technologies and Products Under Development

                  3.2.2.3 Market Forecast

                             3.2.2.3.1 Capital Equipment

                             3.2.2.3.2 Consumables

                  3.2.2.4 Competitor Analysis

                  3.2.2.5 Industry Trends

     3.3 Coagulation

          3.3.1 Test Volumes

          3.3.2 Equipment

                  3.3.2.1 Existing Products

                  3.3.2.2 Technologies and Products Under Development

                  3.3.2.3 Market Forecast

                             3.3.2.3.1 Capital Equipment

                             3.3.2.3.2 Consumables

                  3.3.2.4 Competitor Analysis

                  3.3.2.5 Industry Trends

     3.4 Urinalysis

          3.4.1 Test Volumes

          3.4.2 Equipment

                  3.4.2.1 Existing Products

                  3.4.2.2 Technologies and Products Under Development

                  3.4.2.3 Market Forecast

                             3.4.2.3.1 Capital Equipment

                             3.4.2.3.2 Consumables

                  3.4.2.4 Competitor Analysis

                  3.4.2.5 Industry Trends

 

4. THE MICROBIOLOGY TESTING PRODUCTS MARKET

     4.1 Conventional Microbiology Testing

          4.1.1 Test Volumes

          4.1.2 Equipment

                  4.1.2.1 Existing Products

                  4.1.2.2 Technologies and Products Under Development

                  4.1.2.3 Market Forecast

                             4.1.2.3.1 Capital Equipment

                             4.1.2.3.2 Consumables

                  4.1.2.4 Competitor Analysis

                  4.1.2.5 Industry Trends

     4.2 Infectious Diseases Nucleic Acid Testing

          4.2.1 Test Volumes

          4.2.2 Equipment

                  4.2.2.1 Existing Products

                  4.2.2.2 Technologies and Products Under Development

                  4.2.2.3 Market Forecast

                             4.2.2.3.1 Capital Equipment

                             4.2.2.3.2 Consumables

                  4.2.2.4 Competitor Analysis

                  4.2.2.5 Industry Trends

 

5. THE IMMUNODIAGNOSTICS PRODUCTS MARKET

     5.1 Test Volumes

     5.2 Equipment

          5.2.1 Existing Products

          5.2.2 Technologies and Products Under Development

          5.2.3 Market Forecast

                  5.2.3.1 Capital Equipment

                  5.2.3.2 Consumables

          5.2.4 Competitor Analysis

          5.2.5 Industry Trends

 

6. THE THERAPEUTIC DRUG MONITORING AND DRUGS-OF-ABUSE DETECTION PRODUCTS MARKET

     6.1 Test Volumes

     6.2 Equipment

          6.2.1 Existing Products

          6.2.2 Technologies and Products Under Development

          6.2.3 Market Forecast

                  6.2.3.1 Capital Equipment

                  6.2.3.2 Consumables

          6.2.4 Competitor Analysis

          6.2.5 Industry Trends

 

7. THE IMMUNOHEMATOLOGY TESTING PRODUCTS MARKET

     7.1 Test Volumes

     7.2 Equipment

          7.2.1 Existing Products

          7.2.2 Technologies and Products Under Development

          7.2.3 Market Forecast

                  7.2.3.1 Capital Equipment

                  7.2.3.2 Consumables

          7.2.4 Competitor Analysis

          7.2.5 Industry Trends

 

8. THE PATHOLOGY, CYTOLOGY, AND CYTOGENETICS PRODUCTS

     MARKET

     8.1 Pathology

          8.1.1 Test Volumes

          8.1.2 Equipment

                  8.1.2.1 Existing Products

                  8.1.2.2 Technologies and Products Under Development

          8.1.3 Market Forecast

                  8.1.3.1 Capital Equipment

                  8.1.3.2 Consumables

          8.1.4 Competitor Analysis

          8.1.5 Industry Trends

     8.2 Cytology—Papanicolaou Smear Preparation and Analysis

          8.2.1 Test Volumes

          8.2.2 Equipment

                  8.2.2.1 Existing Products

                  8.2.2.2 Technologies and Products Under Development

          8.2.3 Market Forecast

                  8.2.3.1 Capital Equipment

                  8.2.3.2 Consumables

          8.2.4 Competitor Analysis

          8.2.5 Industry Trends

     8.3 Cytogenetics

          8.3.1 Test Volumes

          8.3.2 Equipment

                  8.3.2.1 Existing Products

                  8.3.2.2 Technologies and Products Under Development

          8.3.3 Market Forecast

                  8.3.3.1 Capital Equipment

                  8.3.3.2 Consumables

          8.3.4 Competitor Analysis

          8.3.5 Industry Trends

 

9. COMPANY PROFILES

9.1   Abbott Laboratories, Inc.

9.2   Alexon-Trend, Inc./Apogent Technologies, Inc.

9.3   Alfa Wassermann, Inc./Alfa Wassermann SpA

9.4   Bayer Diagnostics/Bayer Corporation/Bayer AG

9.5   Beckman Coulter, Inc.

9.6   Becton Dickinson and Company

9.7   bioMérieux, Inc./bioMérieux SA

9.8   Bio-Rad Laboratories, Inc.

9.9   Biosite Diagnostics, Inc.

9.10 Careside, Inc.

9.11 Dade Behring, Inc.

9.12 Diagnostic Products Corporation

9.13 Diametrics Medical, Inc.

9.14 Digene Corporation

9.15 Gen-Probe, Inc./Chugai Pharmaceutical Company LTD

9.16 Instrumentation Laboratory

9.17 International Remote Imaging Systems, Inc.

9.18 International Technidyne Corporation/Thoratec Corporation

9.19 i-STAT Corporation

9.20 Olympus America, Inc./Olympus Group

9.21 Organon, Inc./Akzo Nobel NV

9.22 Roche Diagnostics, Inc./F. Hoffmann-La Roche LTD

9.23 Sanofi-Synthélabo, Inc.

9.24 Sysmex Corporation of America/Sysmex Corporation LTD

9.25 Tosoh Corporation

 

COMPANY LISTING

LIST OF EXHIBITS

 

Exhibit ES-1:  Healthcare Issues and Trends Impacting the Clinical Diagnostic Products Market 

Exhibit ES-2:  Clinical Diagnostic Testing Products, Market Forecast, by Segment, 1999-2005 

Exhibit ES-3:  Clinical Chemistry Testing Products, Market Forecast, by Segment, 1999-2005 

Exhibit ES-4:  Hematology Testing Products, Market Forecast, 1999-2005 

Exhibit ES-5:  Microbiology Testing Products, Market Forecast, 1999-2005 

Exhibit ES-6:  Immunodiagnostics Testing Products, Market Forecast, 1999-2005 

Exhibit ES-7:  Pathology, Papanicolaou Smear Preparation and Analysis, and Cytogenetic Testing Products, Market Forecast, 1999-2005 

Exhibit ES-8:  Traditional Serology and Controls Products, Market Forecast, 1999-2005 

Exhibit ES-9:  Technological Issues and Trends Impacting the Clinical Diagnostic Products Market 

 

Exhibit 1-1:    Registered Clinical Laboratories, by Type, 1996-1999 

Exhibit 1-2:    2000, Key Trends in the Clinical Laboratory Products Market 

Exhibit 1-3:    2000, Point-of-Care Testing Practices in Clinical Laboratories, Survey Results 

Exhibit 1-4:    2000, Clinical Diagnostic Tests Performed at Point-of-Care, Survey Results 

Exhibit 1-5:    2000, Advantages and Disadvantages of Point-of-Care Testing 

Exhibit 1-6:    2000, Point-of-Care Testing Issues in the Hospital Setting 

Exhibit 1-7:    Automation Alternatives for Clinical Laboratories 

Exhibit 1-8:    2000, Current Trends in Healthcare Delivery 

Exhibit 1-9:    2000, Staying Competitive Within the Managed Care Environment 

Exhibit 1-10:  Exempted In Vitro Diagnostic Testing Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) 

Exhibit 1-11:  2000, Analytes Currently on the Waived List Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) 

Exhibit 1-12:  Required Characteristics for Waived Tests Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) 

Exhibit 1-13:  The Impact of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) on In Vitro Diagnostics Device Manufacturers 

 

Exhibit 2-1:    2000, Most Commonly Performed General Chemistry Tests 

Exhibit 2-2:    General Chemistries, Blood Gases/Electrolytes, and Whole-Blood Glucose Analyses, Test Volumes Forecast, 1999-2005 

Exhibit 2-3:    2000, Selected General Chemistry Testing Products 

Exhibit 2-4:    2000, Selected Whole-Blood Glucose Testing Products 

Exhibit 2-5:    2000, Selected Blood Gas/Electrolyte Testing Products 

Exhibit 2-6:    General Chemistry Testing Products, Market Forecast, 1999-2005 

Exhibit 2-7:    Whole-Blood Glucose Testing Products, Market Forecast, 1999-2005 

Exhibit 2-8:    Blood Gas/Electrolyte Testing Products, Market Forecast, 1999-2005 

Exhibit 2-9:    General Chemistry Testing Equipment, Market Forecast, 1999-2005 

Exhibit 2-10:  Blood Gas/Electrolyte Testing Equipment, Market Forecast, 1999-2005 

Exhibit 2-11:  General Chemistry Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 2-12:  Blood Gas/Electrolyte Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 2-13:  1999, General Chemistry Testing Products Market, Share by Supplier 

Exhibit 2-14:  1999, Whole-Blood Glucose Testing Products Market, Share by Supplier 

Exhibit 2-15:  1999, Blood Gas/Electrolyte Testing Products Market, Share by Supplier 

 

Exhibit 3-1:    Hematology, Test Volumes Forecast, 1999-2005 

Exhibit 3-2:    2000, Selected Hematology Testing Products 

Exhibit 3-3:    Hematology/Flow Cytometry Testing Products, Market Forecast, 1999-2005 

Exhibit 3-4:    Hematology/Flow Cytometry Testing Equipment, Market Forecast, 1999-2005 

Exhibit 3-5:    Hematology Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 3-6:    1999, Hematology/Flow Cytometry Testing Products Market, Share by Supplier 

Exhibit 3-7:    Flow Cytometry, Test Volumes Forecast, 1999-2005 

Exhibit 3-8:    2000, Selected Flow Cytometry Testing Products 

Exhibit 3-9:    Flow Cytometry Testing Products, Market Forecast, 1999-2005 

Exhibit 3-10:  Flow Cytometry Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 3-11:  1999, Flow Cytometry Testing Products Market, Share by Supplier 

Exhibit 3-12:  Coagulation, Test Volumes Forecast, 1999-2005 

Exhibit 3-13:  2000, Selected Coagulation Testing Products 

Exhibit 3-14:  Coagulation Testing Products, Market Forecast, 1999-2005 

Exhibit 3-15:  Coagulation Testing Equipment, Market Forecast, 1999-2005 

Exhibit 3-16:  Coagulation Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 3-17:  1999, Coagulation Testing Products Market, Share by Supplier 

Exhibit 3-18:  Urinalysis, Test Volumes Forecast, 1999-2005 

Exhibit 3-19:  2000, Selected Urinalysis Testing Products 

Exhibit 3-20:  Urinalysis Testing Products, Market Forecast, 1999-2005 

Exhibit 3-21:  Urinalysis Testing Equipment, Market Forecast, 1999-2005 

Exhibit 3-22:  Urinalysis Testing, Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 3-23:  1999, Urinalysis Testing Products Market, Share by Supplier 

 

Exhibit 4-1:    Conventional Microbiology, Test Volumes Forecast, 1999-2005 

Exhibit 4-2:    2000, Selected Conventional Microbiology Products 

Exhibit 4-3:    Conventional Microbiology Products, Market Forecast, 1999-2005 

Exhibit 4-4:    Microbial Identification and Antimicrobial Susceptibility Testing Equipment, Market Forecast, 1999-2005 

Exhibit 4-5:    Blood Culture Testing Equipment, Market Forecast, 1999-2005 

Exhibit 4-6:    Microbial Identification and Antimicrobial Susceptibility Testing, Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 4-7:    Blood Culture Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 4-8:    1999, Microbial Identification and Antibiotic Susceptibility Testing Products Market, Share by Supplier 

Exhibit 4-9:    1999, Blood Culture Testing Products Market, Share by Supplier 

Exhibit 4-10:  Infectious Diseases Nucleic Acid Testing, Test Volumes Forecast, 1999-2005 

Exhibit 4-11:  2000, Selected Infectious Diseases Nucleic Acid Testing Products 

Exhibit 4-12:  Infectious Diseases Nucleic Acid Testing Products, Market Forecast, 1999-2005 

Exhibit 4-13:  Infectious Diseases Nucleic Acid Testing Equipment, Market Forecast, 1999-2005 

Exhibit 4-14:  Infectious Diseases Nucleic Acid Testing Products, Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 4-15:  1999, Infectious Diseases Nucleic Acid Testing Products Markets, Share by Supplier 

 

Exhibit 5-1:    Immunodiagnostics, Test Volumes Forecast, 1999-2005 

Exhibit 5-2:    2000, Selected Immunodiagnostics Products 

Exhibit 5-3:    Immunodiagnostics Testing Products, Market Forecast, 1999-2005 

Exhibit 5-4:    Immunodiagnostics Testing Equipment, Market Forecast, 1999-2005 

Exhibit 5-5:    Immunodiagnostics Testing Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 5-6:    1999, Immunodiagnostics Testing Reagents and Supplies Market, by Segment 

Exhibit 5-7:    1999, Immunodiagnostics Testing Products Market, Share by Supplier 

 

Exhibit 6-1:    Therapeutic Drug Monitoring and Drugs-of-Abuse Detection, Test Volumes Forecast, 1999-2005 

Exhibit 6-2:    2000, Selected Therapeutic Drug Monitoring and Drugs-of-Abuse Detection Products 

Exhibit 6-3:    Therapeutic Drug Monitoring and Drugs-of-Abuse Detection Products, Market Forecast, 1999-2005 

Exhibit 6-4:    Therapeutic Drug Monitoring and Drugs-of-Abuse Detection, Dedicated Testing Equipment, Market Forecast, 1999-2005 

Exhibit 6-5:    Therapeutic Drug Monitoring and Drugs-of-Abuse Detection, Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 6-6:    Therapeutic Drug Monitoring, Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 6-7:    Drugs-of-Abuse Detection, Reagents and Supplies, Market Forecast, 1999-2005 

Exhibit 6-8:    1999, Therapeutic Drug Monitoring and Drugs-of-Abuse Detection Products Market, Share by Supplier 

 

Exhibit 7-1:    Immunohematology, Test Volumes Forecast, 1999-2005 

Exhibit 7-2:    2000, Selected Immunohematology Testing Products 

Exhibit 7-3:    Immunohematology Testing Products, Market Forecast, 1999-2005 

Exhibit 7-4:    Immunohematology Testing Products, Consumables, Market Forecast, 1999-2005 

Exhibit 7-5:    1999, Immunohematology Testing Products Market, Share by Supplier 

 

Exhibit 8-1:    2000, Selected Pathology Products 

Exhibit 8-2:    Pathology Products, Market Forecast, 1999-2005 

Exhibit 8-3:    1999, Pathology Products Market, Share by Supplier 

Exhibit 8-4:    2000, Selected Papanicolaou Smear Analysis Products 

Exhibit 8-5:    Papanicolaou Smear Preparation and Analysis Products, Market Forecast, 1999-2005 

Exhibit 8-6:    1999, Papanicolaou Smear Preparation and Analysis Products Market, Share by Supplier 

Exhibit 8-7:    2000, Selected Cytogenetics Testing Products 

Exhibit 8-8:    Cytogenetics Testing Products, Market Forecast, 1999-2005 

Exhibit 8-9:    1999, Cytogenetics Testing Products Market, Share by Supplier

 

Copyright 2001, Medtech Insight, LLC


Ordering Information

Title

 Report# Publication
Date		 List Price

U.S. Markets for
Clinical Laboratory Products

RP-891357

 March
2001

$2,900*

 

*The pdf version of each report costs an additional $500 when purchased in addition to the hardcopy.

To order reports or obtain information about special pre-publication offers from within the U.S., contact reports@medtechinsight.com. From outside the U.S., contact internationalsales@medtechinsight.com. You can also call 1.949.219.0150 (or toll-free within the U.S. at 1.888.290.2225) or fax 1.949.219.0037.

 

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