The U.S. Clinical Diagnostic Equipment Market

SUMMARY

INTRODUCTION

STUDY GOALS AND OBJECTIVES

The United States is the world's largest single market for diagnostic equipment, with a value of $13.5 billion in 2002. The emergence and growth ofmanaged health care in recent years have led to cost reductions and an increase in demand for efficiency among clinical laboratories. This hasresulted in consolidation of both laboratories and manufacturers, altering the structure of the clinical laboratory market. The most significant areaof this industry is the clinical laboratory instrumentation segment. Coupled to this segment are the emerging point-of-care instrument market and themedical diagnostic kit (MDK) market that we also address in this study.

This study provides the reader with an intensive examination of this changing medical diagnostics segment. It specifically will address the changesthat have occurred as the result of technological advances, cost reduction efforts and regulatory implementations.

Beyond focusing on these changes it will define the entire in vitro diagnostic industry, including its structure and dynamics. Also discussed arethe major players, relative market shares, the impact of external forces and current and emerging technologies.

REASONS FOR DOING THIS STUDY

Changes have occurred in the clinical diagnostics equipment market since Business Communications Co. last examined it in 1999. The market has seenchanges at both ends of the testing spectrum. The introduction of total laboratory automation (TLA) using robotics has evolved in the largerlaboratories, and the development of inexpensive automated testing devices, known as point-of-care (POC) instruments, has allowed diagnostic testingat the patient's bedside, as well as in smaller laboratories and physicians' offices.

It is BCC's goal to identify and examine these trends and to forecast future market changes through 2007.

SCOPE AND FORMAT

This study will describe the market for clinical diagnostics in the U.S. It focuses on key market segments and important industry players withinthese segments. Specifically, the report: describes the clinical diagnostic industry profiles end-user segments and their changing demands analyzesmarket influences in the industry and predicts the changes that will shape the future clinical diagnostics market discusses trends within the marketsegments and provides a future outlook for each segment reviews business activities of market leaders in each segment highlights emerging and leadingtechnologies that are likely to have an impact in the future

CONTRIBUTIONS OF THE STUDY AND AUDIENCE

This study will prove particularly beneficial to diagnostic industry participants that hold marketing, management and technical developmentpositions. It also will benefit readers who are suppliers to this industry as well as investors, venture capitalists, reimbursers and those interestedin diagnostic medical testing.

METHODOLOGY AND INFORMATION SOURCES

The primary data collection methodology for this report involved interviews with industry and government agency personnel, industry observers,scientists and industry professional organizations. In addition to these primary data sources, secondary data research techniques were used in aliterature search of BCC's extensive library, as well as medical and business libraries.

All data collected were analyzed by BCC personnel to determine specific findings and make forecasts. Once these forecasts were obtained, they werevalidated by consultation with industry experts. Consequently, all estimates provided in this report represent a consensus opinion of BCC personnel,industry participants and industry observers.

Growth forecasts are made in constant dollars based on the U.S. manufacturers' (wholesale) price level unless otherwise noted.

TABLE OF CONTENTS

TABLE OF CONTENTS

INTRODUCTION

• STUDY GOALS AND OBJECTIVES
• REASONS FOR DOING THIS STUDY
• SCOPE AND FORMAT
• CONTRIBUTIONS OF THE STUDY AND AUDIENCE
• METHODOLOGY AND INFORMATION SOURCES
• AUTHOR'S CREDENTIALS
• RELATED BCC WORK CREDENTIALS
• BCC ON-LINE SERVICES

EXECUTIVE SUMMARY

• MAJOR FINDINGS
• Summary Table: U.S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)
• Summary Figure: U. S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, 2002 AND 2007 ($ BILLIONS)

OVERVIEW OF THE CLINICAL DIAGNOSTICS MARKET

• CLINICAL DIAGNOSTICS
• DIAGNOSIS
• MONITORING
• SCREENING
• RESEARCH
• CLINICAL DIAGNOSTICS INDUSTRY STRUCTURE
• INTERNATIONAL MARKET
• Table 1 WORLDWIDE CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)
• Figure 1 WORLDWIDE CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, 2002 (%)
• INTERNATIONAL MARKET COMPOSITION
• MARKET FORCES
• AGING POPULATION
• Table 2 U.S. POPULATION PROJECTIONS OF THOSE 55+, 2000-2007 (MILLIONS)
• CHANGES IN INCIDENCE OF DISEASES
• Table 3 PREVALENCE OF SELECTED DISEASES IN THE U.S. POPULATION*, 1987 AND 1997 (MILLIONS OF CASES)
• DRIVING FORCES OF THE DIAGNOSTICS MARKET
• TECHNOLOGICAL ADVANCEMENT
• Total Laboratory Automation (TLA)
• Modular Discreet Laboratory Automation
• Point-of-Care Automation
• TRADE PRACTICES
• Pricing
• Industry Distribution Channels
• Figure 2 DISTRIBUTION CHANNELS: IN VITRO DIAGNOSTIC DEVICES
• PROMOTION
• STRATEGIC ALLIANCES
• DIAGNOSTIC TESTING TYPES
• CLINICAL CHEMISTRY
• Table 4 SELECTED LISTING OF COMMON CHEMISTRY DIAGNOSTIC TESTS
• IMMUNOASSAY
• Table 5 SELECTED LISTING OF COMMON IMMUNOASSAY TESTS
• HEMATOLOGY AND HEMOSTASIS
• Table 6 SELECTED LISTING OF HEMOTOLOGY AND HEMOSTASIS TESTS
• MICROBIOLOGY
• Table 7 SELECTED LISTING OF BACTERIA FOUND IN CLINICAL SPECIMENS AND DISEASES THEY CAUSE
• Table 8 MAJOR VIRAL INFECTIOUS AGENTS
• URINALYSIS
• Table 9 DIAGNOSTIC INDICATIONS FROM URINALYSIS TESTS
• BLOOD BANKING (TYPING AND CROSS-MATCHING)
• Table 10 BLOOD BANK TESTS
• MARKET SIZE
• Table 11 U.S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)
• Figure 3 U.S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, 2002 AND 2007 ($ BILLIONS)
• LABORATORY INSTRUMENT SEGMENT
• POINT-OF-CARE (POC) TESTING
• Table 12 SELECTED LISTING OF TYPICAL POC DIAGNOSTIC TESTS
• MEDICAL DIAGNOSTIC KITS (MDKs)
• EXTERNAL MARKET FORCES
• Figure 4 EXTERNAL MARKET FACTORS AFFECTING THE IN VITRO DIAGNOSTICS INDUSTRY
• REGULATORY IMPACT
• FDA (Food and Drug Administration)
• Clinical Laboratory Improvement Amendments (CLIA)
• Table 13 CLIA WAIVED TESTS
• Table 13 (CONTINUED)
• Good Manufacturing Practice (GMP)
• Table 14 PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING IN VITRO DIAGNOSTICS
• Medicare Reimbursement Changes
• MARKET SEGMENTATION
• CLINICAL LABORATORIES
• Table 15 U.S. LABORATORIES BY TYPE, 2002
• CLIA Certified Laboratories
• Non-CLIA Laboratories/Facilities
• Table 16 U.S. LABORATORIES BY TESTING AND SALES VOLUMES, 2002
• RESEARCH LABORATORIES
• HOME-USE MARKET
• CLINICAL LABORATORY STAFFING
• PATHOLOGISTS
• Anatomical Pathologists
• Clinical Pathologists
• TECHNOLOGISTS AND TECHNICIANS
• Working Conditions
• Educational Requirements
• MARKET INFLUENCES ON THE DIAGNOSTICS INDUSTRY
• COST CONTAINMENT
• Diagnosis Related Groups (DRGs)
• Medicare
• Third-party Payers
• Physician Ownership/Referral Clinical Laboratory Services
• LABORATORY CONSOLIDATION
• EMERGING ALTERNATE TESTING LOCATIONS

TECHNOLOGY

• ROBOTICS - TOTAL LABORATORY AUTOMATION
• ROBOTIC SAMPLE HANDLING
• MODULAR AUTOMATION-WORKCELLS
• ENHANCED DATA MANAGEMENT
• INTERNET-BASED COMMUNICATIONS
• DATA AND IMAGE TRANSMISSION
• Digital Radio Technology
• MEDICAL INFORMATICS
• MINIATURIZATION AND BIOSENSORS
• MOLECULAR DIAGNOSTIC TESTS
• IMAGE ANALYSIS
• FLOW CYTOMETRY
• MICRO-TOTAL ANALYSIS SYSTEMS
• LASER TECHNOLOGY

CLINICAL LABORATORY INSTRUMENT MARKET

• KEY INDUSTRY PLAYERS
• MARKET COMPONENTS
• MARKET VALUE
• REAGENTS AND CONSUMABLES
• Table 17 U.S. CLINICAL LABORATORY INSTRUMENTS INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)
• Figure 5 U.S. CLINICAL LABORATORY INSTRUMENTS INCLUDING REAGENTS AND CONSUMABLES, 2002 AND 2007 ($ BILLIONS)
• CLINICAL CHEMISTRY
• MARKET SIZE AND GROWTH
• Table 18 U.S. CLINICAL CHEMISTRY INSTRUMENT MARKET SIZE INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)
• MARKET LEADERS
• Table 19 U.S. CLINICAL CHEMISTRY* MARKET SHARE, 2002 (%)
• MAJOR CLINICAL CHEMISTRY INSTRUMENTS
• Abbott Diagnostics
• Bayer Diagnostics
• ADVIAa1650 Chemistry SystemTechnicon Systems
• EXPRESSaPlus SystemBeckman Coulter
• Table 20 BECKMAN COULTER SYNCHRON SERIES OF CHEMISTRY INSTRUMENTS
• Table 20 (CONTINUED)
• Dade Behring
• Table 21 DADE BEHRING CHEMISTRY ANALYZERS
• Table 21 (CONTINUED)
• Ortho-Clinical Diagnostics
• Table 22 ORTHO-CLINICAL DIAGNOSTICS CHEMISTRY ANALYZERS
• Roche Diagnostics
• Table 23 ROCHE DIAGNOSTICS CHEMISTRY ANALYZERS
• IMMUNOANALYSIS
• MARKET SIZE AND GROWTH
• Table 24 U.S. IMMUNOANALYSIS MARKET: INSTRUMENTS, REAGENTS, AND CONSUMABLES THROUGH 2007 ($ BILLIONS)
• IMMUNOASSAY ANALYTICAL METHODS
• Enzyme Immunoassay (EIA)
• Basic EIA
• Figure 6 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS
• Alternate EIA Methods
• Second-antibody Precipitation Method
• Double-antibody Sandwich Method
• Reverse-sandwich Method
• Reverse-sandwich Inhibition Method
• IMMUNOANALYSIS INSTRUMENTS
• Table 25 SELECTED LISTING OF IMMUNOANALYSIS TESTS AVAILABLE ON VARIOUS INSTRUMENTS
• IMMUNOANALYSIS AS PART OF WORKCELL SYSTEMS
• MARKET LEADERS
• Table 26 U.S. *IMMUNOANALYSIS MARKET SHARE BY DOLLAR VOLUME, 2002 ($ MILLION, %)
• Figure 7 U.S. *IMMUNOANALYSIS MARKET SHARE BY DOLLAR VOLUME, 2002 (%)
• MAJOR PRODUCTS
• Table 27 MAJOR IMMUNOASSAY PRODUCTS
• Table 27 (CONTINUED)
• Table 27 (CONTINUED)
• HEMATOLOGY/HEMOSTASIS
• MARKET SIZE AND GROWTH
• Table 28 U.S. HEMATOLOGY/HEMOSTASIS INSTRUMENT, REAGENT AND CONSUMABLE MARKET THROUGH 2007 ($ BILLIONS)
• MARKET PARTICIPANTS BY SEGMENT
• Table 29 SELECTED LISTING OF PARTICIPANTS IN THE HEMOTOLOGY/HEMOSTASIS INSTRUMENT U.S. MARKET BY SEGMENT
• HEMATOLOGY MARKET DYNAMICS
• Market Share
• Table 30 U.S. HEMATOLOGY INSTRUMENT MANUFACTURER MARKET SHARE, 2002
• Figure 8 U.S. HEMATOLOGY INSTRUMENT MANUFACTURER MARKET SHARE, 2002 (%)
• Hematology Market Participants and Product Lines
• Abbott Laboratories
• CELL-DYN 1200
• CELL-DYN 1700
• CELL-DYN 3200
• CELL-DYN 3700
• CELL-DYN 4000
• CELL-DYN SMS
• Cell-DYN WorkCell
• Table 31 ABBOTT LABORATORIES PRODUCT LINE
• Table 31 (CONTINUED)
• Bayer Corporation
• ADVIAa60 Hematology SystemADVIAa70ADVIAa120ADVIAaS60Beckman Coulter
• AC?TO 8AC?TO 10AC?TO diffAC?TO 5 diffAC?TO 5 diff CP (Cap Pierce)Coulter GenSO System 2Coulter HmX
• Coulter LHR700 SeriesCoulter MAXMO SeriesCoulteraSTKSORoche Diagnostics/SysmexTable 32 ROCHE DIAGNOSTICS/SYSMEX PRODUCT LINES
• HEMOSTASIS MARKET DYNAMICS
• Market Share
• Table 33 U.S. HEMOSTASIS INSTRUMENT MANUFACTURER MARKET SHARE, 2002
• Figure 9 U.S. HEMOSTASIS INSTRUMENT MANUFACTURER MARKET SHARE, 2002 (%)
• Hemostasis Automated Instrument Market Participants and Product Lines
• Beckman Coulter (Instrumentation Laboratory)
• ACLa100ACLa1000ACLa7000ACLa9000ACLaAdvanceElectraa1400CElectraa1800CDade Behring/Sysmex
• SysmexaCA-500RSysmexaCA 1500SysmexaCA 6000The SysmexaCA 7000PFA-100RDiagnostica Stago, Inc.Helena Laboratories
• Trinity Biotech (Sigma Diagnostics)
• Hemostasis Electromechanical Clot Timing Instrument Market Participants and Product Lines
• Becton Dickinson (BD)
• Chrono-log Corp.
• International Technidyne Corp.
• ProTimeaMicrocoagulation SystemMICROBIOLOGY
• MARKET SIZE
• Table 34 U.S. MICROBIOLOGY INSTRUMENTS AND RELATED REAGENT AND CONSUMABLE MARKET, THROUGH 2007 ($ BILLIONS)
• MARKET STRUCTURE
• MARKET SHARE
• Table 35 U.S. MICROBIOLOGY INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002
• Figure 10 U.S. MICROBIOLOGY INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002 (%)
• MARKET PARTICIPANTS AND PRODUCT LINES
• Becton Dickinson (BD)
• BACTEC 9000 System
• BACTECO 460TB System and BACTECO MGITO 960 SystemPhoenixO SystembioMerieux
• VITEK
• VITEK 2 and VITEK 2 XL
• URINALYSIS
• MARKET STRUCTURE
• MARKET SIZE
• Table 36 U.S. URINALYSIS INSTRUMENTS AND RELATED REAGENT AND CONSUMABLE MARKET, THROUGH 2007 ($ BILLIONS)
• MARKET SHARE
• Table 37 U.S. URINALYSIS INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002
• Figure 11 U.S. URINALYSIS INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002 (%)
• MARKET PARTICIPANTS
• IRIS Diagnostics
• Model 500 Urine/Fluids Workstation and 939UDxO Urine Pathology SystemARKRAY AUTION MAXO AX-4280Sysmex
• Bayer (Ames)
• ClinitekRAtlas SystemRoche
• Urisys 2400
• Criterion II and CUA
• BLOOD BANKING
• MARKET SIZE
• Table 38 U.S. MARKET SIZE FOR BLOOD BANKING INSTRUMENTS, THROUGH 2007 ($ BILLIONS)
• MARKET STRUCTURE
• Blood Banking
• Immucor
• ABS2000
• Rosys Plato
• Ortho-Clinical Diagnostics TECAN MEGAFlex ID Microtyping System
• Emerging Blood Bank Instruments
• Abbot PRISM
• Olympus Tango
• MOLECULAR DIAGNOSTICS
• Market Size.
• Table 39 U.S. MARKET FOR MOLECULAR DIAGNOSTIC INSTRUMENTS, REAGENTS AND SUPPLIES (NOT INCLUDING MDKs), THROUGH 2007 ($ BILLIONS)
• Molecular Diagnostic Instruments and Tests
• Roche Diagnostics
• Tecan
• Gentra
• Third Wave Technologies Inc.

POINT-OF-CARE TESTING

• MARKET SIZE
• Table 40 U.S. POINT-OF-CARE INSTRUMENT TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)
• MARKET PARTICIPANTS
• Table 41 SELECTED LISTING OF CURRENTLY MARKETED POC DEVICES
• Table 41 (CONTINUED)
• CRITICAL CARE
• Careside
• Abbott I-STAT
• Instrumentation Laboratory (IL)
• Abaxis
• URINALYSIS
• COAGULATION TESTING
• Pharmanetics
• International Technidyne Corp.
• CONNECTIVITY
• CONNECTIVITY INDUSTRY CONSORTIUM (CIC)

MEDICAL DIAGNOSTIC KITS (MDKs)

• WHAT ARE MDKs?
• ADVANTAGES OF MDKs
• MARKET SIZE
• Table 42 U.S. MDK MARKET SIZE, THROUGH 2007 ($ BILLIONS)
• RELATION TO TOTAL TESTING MARKET
• RELATIVE SIZE
• Table 43 RELATIVE SHARE OF U.S. TESTING MARKET, THROUGH 2007 ($ BILLIONS AT MANUFACTURERS' SALES LEVEL)
• Figure 12 RELATIVE SHARE OF U.S. TESTING MARKET, 2002 AND 2007 ($ BILLIONS AT MANUFACTURERS' SALES LEVEL)
• Table 44 DIAGNOSTIC MARKETPLACE BY TYPE OF TEST METHOD, 2002 (PERCENT SHARE)
• INDUSTRY LEADERS
• INDUSTRY STRUCTURE
• REAGENTS
• DEVICE/CARRIER
• PACKAGING
• COMPONENT SUPPLIERS
• Figure 13 MDK COMPONENTS
• Table 45 SELECTED LISTING OF MDK COMPONENT SUPPLIERS BY AREA OF PARTICIPATION
• Table 45 (CONTINUED)
• END MARKETS
• Table 46 MDK USE BY END USE FACILITY
• Table 46 (CONTINUED)
• TECHNOLOGY TYPES USED IN MDKS
• Table 47 ESTIMATED SHARE OF MDK BY TECHNOLOGY TYPE, 2002
• Figure 14 ESTIMATED SHARE OF MDK BY TECHNOLOGY TYPE, 2002 (%)
• MDK APPLICATIONS
• Table 48 SELECTED MDK APPLICATIONS
• SEGMENTS
• Table 49 U.S. MDK APPLICATIONS MARKET, THROUGH 2007 ($ BILLIONS)
• CLINICAL LABORATORY APPLICATIONS
• Types of MDKs for Infectious Disease Testing
• Immunodiagnostic Kits
• Dipsticks
• Microbial and Rapid Test Kits
• Table 50 SELECTED LISTING OF FDA APPROVED INFECTIOUS DISEASE TESTING MDKS BY ASSAY TYPE
• Table 50 (CONTINUED)
• Gene Probe Kits
• Market Size
• Table 51 U.S. MDK MARKET SIZE FOR INFECTIOUS DISEASE TESTING, THROUGH 2007 ($ MILLIONS)
• Market Dynamics
• Blood/Urine Chemistry Testing
• Market Size and Structure
• Table 52 ESTIMATED MARKET FOR BLOOD/URINE CHEMISTRY MDKS, THROUGH 2007 ($ MILLIONS)
• MDK Types
• Table 53 CLIA APPROVED MDKs FOR BLOOD/URINE CHEMISTRY TESTING
• Table 53 (CONTINUED)
• Table 53 (CONTINUED)
• Table 53 (CONTINUED)
• Table 53 (CONTINUED)
• Dipsticks
• Drug Testing
• Drug Types
• Market Size
• Table 54 U.S. MARKET SIZE OF MDKs FOR DRUG TESTING, THROUGH 2007 ($ MILLIONS)
• MDK Applications in Drug Testing
• Therapeutic Monitoring
• Diagnosing Overdoses
• Differential Diagnosis
• Detecting Drug Abuse
• Table 55 SELECTED LIST OF DRUG TESTING MDKs CURRENTLY BEING MARKETED
• Home Detection Methods
• Types of Drug Testing MDKS
• Hormones
• Diagnostic Benefits of Hormone Analysis
• Types of Hormone MDK Tests
• Table 56 SELECTED LISTING OF MDK HORMONE TESTS
• Hormone Tests Marketed
• Table 57 SELECTED LISTING OF HORMONE MDKs
• Market Size
• Table 58 U.S. MARKET SIZE OF MDKs FOR HORMONE TESTING, THROUGH 2007 ($ MILLIONS)
• Cancer Testing
• Cancer Detection
• MDKs for Cancer Testing
• Table 59 SELECTED LISTING OF CANCER DIAGNOSTIC AND THERAPEUTIC MANAGEMENT MDK TESTS*
• Market Size and Structure
• Table 60 U.S. MDK MARKET SIZE FOR CANCER DIAGNOSTIC NONRESEARCH TESTING APPLICATIONS, THROUGH 2007 ($ MILLIONS)
• HOME USE TESTING
• MARKET SIZE AND STRUCTURE
• Table 61 ESTIMATED HOME USE MDK MARKET SIZE, THROUGH 2007 ($ MILLIONS)
• HOME USE MDK MARKET PARTICIPANTS

PROFILES OF MAJOR MARKET PARTICIPANTS

• ABBOTT LABORATORIES
• BAYER CORP.
• BECKMAN COULTER
• BECTON DICKINSON (BD)
• bioMERIEUXDADE BEHRING, INC.
• DIASORIN
• INSTRUMENTATION LABORATORIES (IL)
• INTERNATIONAL REMOTE IMAGING SYSTEMS, INC. (IRIS)
• INTERNATIONAL TECHNIDYNE CORP.
• ORTHO-CLINICAL DIAGNOSTICS
• ROCHE DIAGNOSTICS SYSTEMS
• TRINITY BIOTECH (SIGMA-ALDRICH CORP.)
• SYSMEX CORP., LTD.

APPENDIX I

• COMPANY DIRECTORY
• ABBOTT LABORATORIES
• ACON LABORATORIES, INC.
• AMDL, INC.
• APPLIED BIOTECH
• AVOX SYSTEMS
• BAYER CORP.
• BAYER DIAGNOSTICS
• BECKMAN COULTER, INC.
• BECTON DICKINSON (BD)
• BINAX
• BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
• BIOMERIEUXBIO-RAD
• BIOSCAN
• BIOSITE DIAGNOSTICS
• CENOGENICS
• CHEMATICS, INC.
• CHEMTRAK
• CHOLESTECH CORP.
• CHRONO-LOG CORP.
• DADE BEHRING, INC.
• DIAGNOSTIC PRODUCTS CORP.
• DIAGNOSTICA STAGO INC
• DIAMEDIX CORP.
• DIASORIN, INC.
• DNA TECHNOLOGIES
• FISHER HEALTHCARE
• GELMAN SCIENCES
• GEN-PROBE INC.
• GENZYME
• HELENA LABORATORIES
• HYCOR BIOMEDICAL, INC.
• IMMUNOSTICS, INC.
• INSTRUMENTATION LABORATORIES (IL)
• INTERNATIONAL REMOTE IMAGING SYSTEMS, INC. (IRIS)
• INTERNATIONAL TECHNIDYNE CORP.
• LIFESTREAM TECHNOLOGIES, INC.
• OLYMPUS AMERICA, INC.
• ORTHO-CLINICAL DIAGNOSTICS
• PHARMANETICS, INC
• QIAGEN, INC.
• QUANTUM BIOTECHNOLOGIES, INC.
• QUIDEL
• REMEL, INC.
• ROCHE DIAGNOSTICS SYSTEMS
• SERADYN CLINICAL DIAGNOSTICS
• SYNTRON BIORESEARCH
• SYSMEX CORP., LTD.
• THE BINDING SITE, INC.
• THERASENSE, INC.
• TOSOH MEDICS, INC.
• TREK DIAGNOSTIC SYSTEMS, INC.
• TRINITY BIOTECH (SIGMA DIAGNOSTICS)
• WAKO CHEMICALS INC.
• ZAXIS INTERNATIONAL, INC.
• ZEUS SCIENTIFIC, INC.

APPENDIX II

• PARTICIPATING COMPANIES
• Table 62 COMPANIES BY AREA OF PARTICIPATION
• Table 62 (CONTINUED)

APPENDIX III

• KEY INDUSTRY CONTACTS
• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• FOOD AND DRUG ADMINISTRATION
• U.S. CUSTOMS SERVICE
• GOVERNMENT PRINTING OFFICE
• AMERICAN SOCIETY FOR TESTING OF MATERIALS (ASTM)
• FEDERAL COMMUNICATIONS COMMISSION (FCC)
• ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)
• ASSOCIATION OF MEDICAL DIAGNOSTICS MANUFACTURERS (AMDM)
• HEALTH INDUSTRY DISTRIBUTORS ASSOCIATION (HIDA)
• HEALTH INDUSTRY MANUFACTURERS ASSOCIATION (HIMA)
• HEALTH INDUSTRY REPRESENTATIVES ASSOCIATION (HIRA)
• INDEPENDENT MEDICAL DISTRIBUTORS ASSOCIATION (IMDA)
• NATIONAL ASSOCIATION OF MEDICAL EQUIPMENT SUPPLIERS (NAMES)
• HEALTH INDUSTRY BUSINESS COMMUNICATIONS COUNCIL
• HEALTH INDUSTRY MANUFACTURERS ASSOCIATION
• INDEPENDENT MEDICAL DISTRIBUTORS ASSOCIATION
• IN-VITRO DIAGNOSTICS MANUFACTURERS COALITION
• INTERNATIONAL REMOTE IMAGING SYSTEMS, INC.
• MEDICAL ALLEY ASSOCIATION
• MEDICAL DEVICE MANUFACTURERS ASSOCIATION (MDMA)
• NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA)
• UNDERWRITER LABORATORIES (UL)

LIST OF TABLES

• Summary Table:
• U.S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)

Table 1 WORLDWIDE CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)

Table 2 U.S. POPULATION PROJECTIONS OF THOSE 55+, 2000-2007 (MILLIONS)

Table 3 PREVALENCE OF SELECTED DISEASES IN THE U.S. POPULATION, 1987 AND 1997 (MILLIONS OF CASES)

Table 4 SELECTED LISTING OF COMMON CHEMISTRY DIAGNOSTIC TESTS

Table 5 SELECTED LISTING OF COMMON IMMUNOASSAY TESTS

Table 6 SELECTED LISTING OF HEMOTOLOGY AND HEMOSTASIS TESTS

Table 7 SELECTED LISTING OF BACTERIA FOUND IN CLINICAL SPECIMENS AND DISEASES THEY CAUSE

Table 8 MAJOR VIRAL INFECTIOUS AGENTS

Table 9 DIAGNOSTIC INDICATIONS FROM URINALYSIS TESTS

Table 10 BLOOD BANK TESTS

Table 11 U.S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)

Table 12 SELECTED LISTING OF TYPICAL POC DIAGNOSTIC TESTS

Table 13 CLIA WAIVED TESTS

Table 14 PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING IN VITRO DIAGNOSTICS

Table 15 U.S. LABORATORIES BY TYPE, 2002

Table 16 U.S. LABORATORIES BY TESTING AND SALES VOLUMES, 2002

Table 17 U.S. CLINICAL LABORATORY INSTRUMENTS INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)

Table 18 U.S. CLINICAL CHEMISTRY INSTRUMENT MARKET SIZE INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)

Table 19 U.S. CLINICAL CHEMISTRY* MARKET SHARE, 2002 (%)

Table 20 BECKMAN COULTER SYNCHRON SERIES OF CHEMISTRY INSTRUMENTS

Table 21 DADE BEHRING CHEMISTRY ANALYZERS

Table 22 ORTHO-CLINICAL DIAGNOSTICS CHEMISTRY ANALYZERS

Table 23 ROCHE DIAGNOSTICS CHEMISTRY ANALYZERS

Table 24 U.S. IMMUNOANALYSIS MARKET: INSTRUMENTS, REAGENTS, AND CONSUMABLES THROUGH 2007 ($ BILLIONS)

Table 25 SELECTED LISTING OF IMMUNOANALYSIS TESTS AVAILABLE ON VARIOUS INSTRUMENTS

Table 26 U.S. IMMUNOANALYSIS MARKET SHARE BY DOLLAR VOLUME, 2002 ($ MILLION, %)

Table 27 MAJOR IMMUNOASSAY PRODUCTS

Table 28 U.S. HEMATOLOGY/HEMOSTASIS INSTRUMENT, REAGENT AND CONSUMABLE MARKET THROUGH 2007 ($ BILLIONS)

Table 29 SELECTED LISTING OF PARTICIPANTS IN THE HEMOTOLOGY/HEMOSTASIS INSTRUMENT U.S. MARKET BY SEGMENT

Table 30 U.S. HEMATOLOGY INSTRUMENT MANUFACTURER MARKET SHARE, 2002

Table 31 ABBOTT LABORATORIES PRODUCT LINE

Table 32 ROCHE DIAGNOSTICS/SYSMEX PRODUCT LINES

Table 33 U.S. HEMOSTASIS INSTRUMENT MANUFACTURER MARKET SHARE, 2002

Table 34 U.S. MICROBIOLOGY INSTRUMENTS AND RELATED REAGENT AND CONSUMABLE MARKET, THROUGH 2007 ($ BILLIONS)

Table 35 U.S. MICROBIOLOGY INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002

Table 36 U.S. URINALYSIS INSTRUMENTS AND RELATED REAGENT AND CONSUMABLE MARKET, THROUGH 2007 ($ BILLIONS)

Table 37 U.S. URINALYSIS INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002

Table 38 U.S. MARKET SIZE FOR BLOOD BANKING INSTRUMENTS, THROUGH 2007 ($ BILLIONS)

Table 39 U.S. MARKET FOR MOLECULAR DIAGNOSTIC INSTRUMENTS, REAGENTS AND SUPPLIES (NOT INCLUDING MDKs), THROUGH 2007 ($ BILLIONS)

Table 40 U.S. POINT-OF-CARE INSTRUMENT TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, THROUGH 2007 ($ BILLIONS)

Table 41 SELECTED LISTING OF CURRENTLY MARKETED POC DEVICES

Table 42 U.S. MDK MARKET SIZE, THROUGH 2007 ($ BILLIONS)

Table 43 RELATIVE SHARE OF U.S. TESTING MARKET, THROUGH 2007 ($ BILLIONS AT MANUFACTURERS' SALES LEVEL)

Table 44 DIAGNOSTIC MARKETPLACE BY TYPE OF TEST METHOD, 2002 (PERCENT SHARE)

Table 45 SELECTED LISTING OF MDK COMPONENT SUPPLIERS BY AREA OF PARTICIPATION

Table 46 MDK USE BY END USE FACILITY

Table 47 ESTIMATED SHARE OF MDK BY TECHNOLOGY TYPE, 2002

Table 48 SELECTED MDK APPLICATIONS

Table 49 U.S. MDK APPLICATIONS MARKET, THROUGH 2007 ($ BILLIONS)

Table 50 SELECTED LISTING OF FDA APPROVED INFECTIOUS DISEASE TESTING MDKS BY ASSAY TYPE

Table 51 U.S. MDK MARKET SIZE FOR INFECTIOUS DISEASE TESTING, THROUGH 2007 ($ MILLIONS)

Table 52 ESTIMATED MARKET FOR BLOOD/URINE CHEMISTRY MDKS, THROUGH 2007 ($ MILLIONS)

Table 53 CLIA APPROVED MDKs FOR BLOOD/URINE CHEMISTRY TESTING

Table 54 U.S. MARKET SIZE OF MDKs FOR DRUG TESTING, THROUGH 2007 ($ MILLIONS)

Table 55 SELECTED LIST OF DRUG TESTING MDKs CURRENTLY BEING MARKETED

Table 56 SELECTED LISTING OF MDK HORMONE TESTS

Table 57 SELECTED LISTING OF HORMONE MDKs

Table 58 U.S. MARKET SIZE OF MDKs FOR HORMONE TESTING, THROUGH 2007 ($ MILLIONS)

Table 59 SELECTED LISTING OF CANCER DIAGNOSTIC AND THERAPEUTIC MANAGEMENT MDK TESTS

Table 60 U.S. MDK MARKET SIZE FOR CANCER DIAGNOSTIC NONRESEARCH TESTING APPLICATIONS, THROUGH 2007 ($ MILLIONS)

Table 61 ESTIMATED HOME USE MDK MARKET SIZE, THROUGH 2007 ($ MILLIONS)

Table 62 COMPANIES BY AREA OF PARTICIPATION

LIST OF FIGURES

Summary Figure:

U. S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, 2002 AND 2007 ($ BILLIONS)

Figure 1 WORLDWIDE CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, 2002 (%)

Figure 2 DISTRIBUTION CHANNELS: IN VITRO DIAGNOSTIC DEVICES

Figure 3 U.S. CLINICAL DIAGNOSTIC TESTING MARKET INCLUDING REAGENTS AND CONSUMABLES, 2002 AND 2007 ($ BILLIONS)

Figure 4 EXTERNAL MARKET FACTORS AFFECTING THE IN VITRO DIAGNOSTICS INDUSTRY

Figure 5 U.S. CLINICAL LABORATORY INSTRUMENTS INCLUDING REAGENTS AND CONSUMABLES, 2002 AND 2007 ($ BILLIONS)

Figure 6 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS

Figure 7 U.S. IMMUNOANALYSIS MARKET SHARE BY DOLLAR VOLUME, 2002 (%)

Figure 8 U.S. HEMATOLOGY INSTRUMENT MANUFACTURER MARKET SHARE, 2002 (%)

Figure 9 U.S. HEMOSTASIS INSTRUMENT MANUFACTURER MARKET SHARE, 2002 (%)

Figure 10 U.S. MICROBIOLOGY INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002 (%)

Figure 11 U.S. URINALYSIS INSTRUMENT MANUFACTURER MARKET SHARE INCLUDING REAGENTS AND CONSUMABLES, 2002 (%)

Figure 12 RELATIVE SHARE OF U.S. TESTING MARKET, 2002 AND 2007 ($ BILLIONS AT MANUFACTURERS' SALES LEVEL)

Figure 13 MDK COMPONENTS

Figure 14 ESTIMATED SHARE OF MDK BY TECHNOLOGY TYPE, 2002 (%)