U.S. MARKETS FOR CLINICAL LABORATORY PRODUCTS

451 Pages | 96 Exhibits | 2001 Analysis | Forecasts Through 2005

OVERVIEW:
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.

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     bioMerieux, Inc./bioMerieux 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-Synthelabo, 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  

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

Exhibit 1-12:   Required Characteristics for Waived Tests Under the Clinical Laboratory Improvement Amendments of 1988  

Exhibit 1-13:   The Impact of the Clinical Laboratory Improvement Amendments of 1988 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

 



COMPANIES COVERED:

  1. Abbott Laboratories, Inc.
  2. Alexon-Trend, Inc./Apogent Technologies, Inc.
  3. Alfa-Wassermann, Inc.
  4. Bayer Group
  5. Beckman Coulter, Inc.
  6. Becton Dickinson and Company
  7. BioChem ImmunoSystems/ABX Diagnostics/Horiba Group
  8. bioMerieux SA
  9. Bio-Rad Laboratories, Inc.
  10. Biosite Diagnostics, Inc.
  11. Careside, Inc.
  12. Dade Behring, Inc.
  13. Diagnostic Products Corporation
  14. Diametrics Medical, Inc.
  15. Digene Corporation
  16. Gen-Probe, Inc./Chugai Pharmaceutical Company LTD
  17. Innogenetics NV
  18. Instrumentation Laboratory
  19. International Remote Imaging Systems, Inc.
  20. International Technidyne Corporation
  21. I-STAT Corporation
  22. Olympus Group
  23. Organon, Inc./Akzo Nobel NV
  24. Roche Diagnostics, Inc./F. Hoffmann-La Roche LTD
  25. Sysmex Corporation LTD
  26. Tosoh Corporation
Contact Us

Need help finding medtech research? Let us help you!