MEDICAL DIAGNOSTIC REAGENTS, CARRIERS AND OTHER CONSUMABLES

SUMMARY

MEDICAL DIAGNOSTIC REAGENTS, CHEMICALS, AND OTHER CONSUMABLES

Clinical and research laboratories, health-care providers, andmanufacturers of single-use medical diagnostic kits (MDKs) in the United States consume $6.8 billion per year of in-vitro reagents, chemicals, andother consumables in order to evaluate individuals' overall health and diagnose, treat, and monitor disease. This study focuses on the resultingmarket for:

• Reagents and other active substances that are used to interact with sample substances to produce a reaction that can be measured and/or seen.
• Nonactive ingredients that are added to or used in conjunction with the reagents to enhance their manufacturability, performance, and/orpreservation (e.g., surfactants, polymers, functional materials, biocides, and preservatives).
• Consumable or single-use devices and containers, such as vials, cards, slides, films, filters, membranes, and trays-integrals parts of the testscarried out using the reagents.

The study does not cover:

• Reagents and other substances used in in-vivo testing.
• Laboratory or analytical devices, such as centrifuges and spectrometers.
• Reusable laboratory ware, such as glass beakers and test tubes.
• Packaging materials.

STUDY BACKGROUND

In recent years, there have been dramatic changes in the diagnostic market. The range of conditions thatcan be tested for has greatly expanded as well as the variety of analytical techniques employed. Other major trends in the diagnostic industry havebeen the rapid growth of the at-home testing market (including both greater use of established types of tests and the addition of new tests, such ascholesterol measurements) at the expense of the laboratory testing market, and the expansion of the medical research market segment. An additionaltrend that has influenced the diagnostic market has been the development of inexpensive, automated testing devices known as point-of-care (POC)instruments, which have replaced single-use diagnostic kits in smaller laboratories and physicians' offices. Recognizing the changes that haveoccurred in the diagnostic market, Business Communications Co. (BCC) published an in-depth analysis of the medical diagnostic kit (MDK) industry andmarket in 2002, C-045X, Medical Diagnostic Kits.

STUDY GOALS AND OBJECTIVES

This study is intended to complement C-045X, MedicalDiagnostic Kits by analyzing the implications of the changing medical diagnostic market for diagnostic reagents, chemicals, and other consumables inMDKs, as well as in traditional laboratory, clinic, and physicians' office settings. It analyzes U.S. and global markets for these products in thelight of the most recent available information. In addition to looking at current and future markets for reagents, chemicals, and other consumables,the study analyzes technological, economic, and regulatory developments that may have a long-term impact on the size and structure of the market

Thisreport provides an analysis of the market for diagnostic reagents, chemicals, and other consumables by application (e.g., infectious diseases,cancer), product type (e.g., type of reagent) and target market (e.g., consumer market or research laboratories). Future market trends are analyzedwith consumption forecasts for specific market segments.

More specific objectives are to:

• Identify and segment the main types of reagents, chemicals, and other consumables that have been commercialized to date.
• Analyze the historical and current value of shipments of each of these product segments in specified applications and end-user markets.
• Identify and evaluate the impact of demographic, technological, regulatory, and other factors that will drive future demand in each of thesesegments.
• Forecast the value of future shipments in each segment.
• Identify promising new diagnostic technologies and products still in the development and testing stage, and assess the probability that theywill be commercialized successfully in the next 5 years.
• Identify leading suppliers of reagents, chemicals, and other consumables, and analyze industry structure (e.g., market shares, concentration,recent M&A activity).
• Assess the long-term outlook for diagnostic reagents, chemicals, and other consumables, taking into account market opportunities as well astechnological, financial, and economic factors.

INTENDED AUDIENCE

The report has been written for the entire medical and health-care interest community, but is tailoredespecially for readers with an interest in the marketing and management dimensions of reagents, chemicals, and other consumables used in diagnostictesting procedures, such as:

• manufacturers and distributors of pharmaceuticals and biochemicals
• manufacturers and distributors of disposable and single-use laboratoryware
• investors
• the financial and analyst community

SCOPE AND FORMAT

This report is an analytical business tool whose primary purpose is to describe and analyze the dynamicsof the market for in-vitro diagnostic reagents, other chemical components, and other consumables used in performing diagnostic tests, such as devicecarriers. It does not include:

• laboratory and analytical devices and equipment
• multiple-use diagnostic devices and equipment, such as laboratory devices and reusable glassware
• shipping containers, packaging, or instructional materials

The study includes reagents, chemicals, carriers, and other consumables sold at arm's length, as well as components produced by integratedmanufacturers for incorporation into diagnostic kits and systems. In such cases, the market reflects only the estimated value of the chemicals andother components, and not the additional value added by producing and selling the kit or system.

The study focuses primarily on the U.S. market,with a section discussing international markets for diagnostic chemicals and other consumables on a more general level of detail. Other sections ofthe report cover the following topics:

• major product types and applications, both commercial and developmental
• U.S. market size and segmentation, including historical data on sales by application, product type, and end-user group
• market drivers and constraints
• detailed U.S. market projections through 2008
• industry structure, competition, and market shares
• factors that may influence the long-term market for diagnostic reagents, chemicals, and consumables

METHODOLOGY AND INFORMATION SOURCES

The findings and conclusions of this report are based on information gathered frommanufacturers and distributors of diagnostic reagents, chemicals, and other consumables, as well as manufacturers of related devices (e.g., medicaldiagnostic kits), laboratories, and other end users. Interview data were combined with information gathered through an extensive review of secondarysources, such as trade publications, trade associations, company literature, and online databases to produce the baseline market estimates containedin this report.

The base year for analyses and projections is 2002. At the time this report was prepared, year-end data for 2002 were not yetuniversally available. Where necessary, market estimates for 2002 were developed using interim (partial) data for 2002 combined with historical datafor the years 1999 to 2001.

With 2002 as a baseline, market projections were developed for 2003 to 2008. These projections are based on a consensusamong the primary contacts combined with our understanding of the key market drivers and their impact from a historical and analytical perspective.The analytical methodologies used to generate the market estimates are described in detail in Detailed Market Projections. All dollar projectionspresented in this report are in 2002 constant dollars.

TABLE OF CONTENTS

• MEDICAL DIAGNOSTIC REAGENTS, CHEMICALS, AND OTHER CONSUMABLES
• STUDY BACKGROUND
• STUDY GOALS AND OBJECTIVES
• INTENDED AUDIENCE
• SCOPE AND FORMAT
• METHODOLOGY AND INFORMATION SOURCES
• ANALYST CREDENTIALS
• RELATED BCC RESEARCH
• REPORTS
• MONTHLY NEWSLETTER
• BCC ON-LINE SERVICES

• SUMMARY TABLE TOTAL U.S. AND GLOBAL MARKET FOR IN-VITRO DIAGNOSTIC CHEMICALS, CARRIERS, AND CONSUMABLES, THROUGH 2008 ($ BILLIONS)
• SUMMARY FIGURE TOTAL U.S. AND GLOBAL MARKET FOR IN-VITRO DIAGNOSTIC CHEMICALS, CARRIERS, AND CONSUMABLES, 2002-2008 ($ BILLIONS)

• TYPES OF TESTS
• MICROBIOLOGICAL ANALYSIS
• CHEMICAL ANALYSIS
• IMMUNOLOGICAL ANALYSIS
• NUCLEIC ACID ANALYSIS
• TYPES OF PRODUCTS
• REAGENTS
  • Microbiological Reagents
• TABLE 1 MAJOR MICROBIOLOGICAL REAGENTS
  • Chemical Reagents
• TABLE 2 MAJOR DIAGNOSTIC CHEMICAL REAGENTS
  • Immunological Reagents
• TABLE 3 MAJOR DIAGNOSTIC IMMUNOLOGICAL REAGENTS
• TABLE 3 (CONTINUED)
  • Nucleic Acid Reagents

• OTHER CHEMICALS
  • Functional Chemicals
  • Nonfunctional Chemicals
• DISPOSABLE DEVICE CARRIERS AND OTHER CONSUMABLES
  • Disposable Device Carriers and Other Consumables (Continued)

• DIAGNOSTIC TESTING APPLICATIONS
• INFECTIOUS DISEASE TESTING
• FIGURE 1 U.S. MARKET FOR INFECTIOUS DISEASE REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
  • Current Market
• FIGURE 2 PERCENT MARKET SHARE FOR DIAGNOSTIC TESTS FOR INFECTIOUS DISEASES BY TYPE OF TEST, 2002 (%)
• TABLE 5 U.S. INFECTIOUS DISEASE TESTING MARKET BY PRODUCT TYPE, 2002
  • Market Drivers
  • Epidemiological Trends
• TABLE 6 U.S. TRENDS IN MAJOR INFECTIOUS DISEASES, 1990 THROUGH 2002 (NUMBER OF NEW CASES ANNUALLY)
• TABLE 7 IMPACT OF EPIDEMIOLOGICAL TRENDS ON THE MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN INFECTIOUS DISEASETESTING, 2002-2008 ($ MILLIONS)
  • Development and Commercialization of New Diagnostic Techniques
  • Threat of Bioterrorism
  • Projected Market
• TABLE 8 PROJECTED DEMAND FOR INFECTIOUS DISEASE DIAGNOSTIC PRODUCTS, THROUGH 2008 ($ MILLIONS)
  • CANCER TESTING
• FIGURE 3 MARKET FOR CANCER TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
  • Current Market
• FIGURE 4 DIAGNOSTIC TESTS FOR CANCER BY TYPE OF TEST, 2002 (PERCENT OF ALL TESTS BY VALUE)
• TABLE 9 U.S. CANCER TESTING MARKET BY PRODUCT TYPE, 2002 ($ BILLIONS)
  • Market Drivers
  • Demographic and Epidemiological Trends, 2002-2008
• TABLE 10 IMPACT OF DEMOGRAPHIC AND EPIDEMIOLOGICAL TRENDS ON THE MARKET FOR CANCER DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES,2002-2008 ($ MILLIONS)
  • Development and Commercialization of New Diagnostic Techniques
  • Replacement Tests
  • New Applications
  • HPV Screening for Cervical Cancer
  • Mammastatin Serum Assays for Breast Cancer Screening
• TABLE 11 IMPACT OF NEW TECHNOLOGIES ON MARKET FOR CANCER DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
  • Projected Market
• TABLE 12 PROJECTED DEMAND FOR CANCER DIAGNOSTIC PRODUCTS, THROUGH 2008 ($ MILLIONS)
  • HORMONE ANALYSIS
• FIGURE 5 MARKET FOR HORMONE TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
  • Current Market
• FIGURE 6 HORMONE TESTS BY TYPE OF TEST, 2002 (PERCENT OF ALL TESTS BY VALUE)
• TABLE 13 U.S. HORMONE TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)
  • Market Drivers
  • Childbearing Trends
• TABLE 14 U.S. TRENDS IN FERTILITY AND CHILDBEARING, THROUGH 2002
  • Increase in Older Age Groups
• TABLE 15 TRENDS IN OLDER AGE GROUPS OF U.S. POPULATION, THROUGH 2002
  • Projected Market
• TABLE 16 IMPACT OF EPIDEMIOLOGICAL TRENDS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN HORMONE TESTING, 2002-2008($ MILLIONS)
  • DRUG TESTING
• FIGURE 7 MARKET FOR DRUG TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
  • Current Market
• FIGURE 8 DRUG TESTS BY TYPE OF TEST, 2002 (PERCENT OF ALL TESTS BY VALUE)
• TABLE 17 U.S. DRUG TESTING MARKET BY PRODUCT TYPE, 2002
  • Market Drivers
  • Legislation
  • Drug Abuse Rates
  • New Products and Testing Technologies
  • Growing Use of Prescription Drugs
  • Projected Market
• TABLE 18 IMPACT OF DEMAND DRIVERS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN DRUG TESTING, 2002-2008
  • BLOOD/URINE TESTING
• TABLE 19 KEY BLOOD AND URINE CHEMISTRY PARAMETERS
• TABLE 19 (CONTINUED)
• FIGURE 9 MARKET FOR BLOOD AND URINE TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
  • Current Market
• TABLE 20 U.S. BLOOD/URINE TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)
  • Market Drivers
  • At-Risk Populations
• TABLE 21 INCIDENCE OF DIABETES AMONG DIFFERENT AGE GROUPS
  • Incidence of Diabetes
  • New Products and Testing Technologies
  • Projected Market
• TABLE 22 IMPACT OF DEMAND DRIVERS ON THE MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN BLOOD/URINE CHEMISTRY TESTING,2002-2008 ($ MILLIONS)
  • MEDICAL RESEARCH
• FIGURE 10 MARKET DIAGNOSTIC REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN MEDICAL RESEARCH, THROUGH 2008 ($ MILLIONS)
  • Current Market
• TABLE 23 U.S. MEDICAL RESEARCH TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)
  • Market Drivers and the National Institutes of Health
  • Projected Market
• TABLE 24 IMPACT OF DEMAND DRIVERS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN MEDICAL RESEARCH, 2002-2008 ($MILLIONS)
  • VETERINARY MEDICINE
• FIGURE 11 MARKET FOR VETERINARY TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)
• FIGURE 11 (CONTINUED)
  • Current Market
• TABLE 25 U.S. VETERINARY TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)
  • Market Drivers
  • Commercial Livestock Trends
• TABLE 26 TRENDS IN U.S. MEAT PRODUCTION, THROUGH 2002 (BILLION POUNDS)
  • Trends in Consumer Spending on Companion Animal Care
• TABLE 27 TRENDS IN U.S. CONSUMER SPENDING ON PET CARE, INCLUDING VETERINARY SERVICES, THROUGH 2002 ($ BILLIONS)
  • Projected Market
• TABLE 28 IMPACT OF DEMAND DRIVERS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN VETERINARY DIAGNOSTIC TESTING,2002-2008 ($ MILLIONS)
  • END-USE MARKETS
  • CLINICAL LABORATORIES
• FIGURE 12 NUMBER OF CLIA-REGISTERED CLINICAL LABORATORIES, 1993-2002
• FIGURE 13 TOTAL CLIA-REGISTERED LABORATORIES, BY TYPE, 2002 (PERCENT OF LABORATORIES REPORTING)
• FIGURE 14 DIAGNOSTIC AND OTHER CLINICAL TESTS CARRIED OUT BY TYPE OF LABORATORY, 2002 (PERCENT OF ALL TESTS, BY VALUE)
  • MEDICAL RESEARCH LABORATORIES
• TABLE 29 ENTITIES ENGAGED IN MEDICAL RESEARCH
  • VETERINARY LABORATORIES
• TABLE 30 ENTITIES ENGAGED IN VETERINARY DIAGNOSTIC ACTIVITIES
  • INDIVIDUAL CONSUMERS FOR HOME-USE MARKET
    • Individual Consumers for Home-Use Market (Continued)

• FOOD AND DRUG ADMINISTRATION
  • Premarket Clearance
  • Premarket Clearance (Continued)
  • Good Manufacturing Practices
  • Responsible Agencies
  • Center for Devices and Radiological Health
  • Center for Biologics Evaluation and Research
  • Centers for Medicare and Medicaid Services
  • State Governments
  • Not-for-Profit Organizations
  • College of American Pathologists
  • American Medical Association
  • U.S. Department of Agriculture

• SUMMARY
• FIGURE 15 TOTAL U.S. MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND CONSUMABLES, 2000-2008 ($ MILLIONS)
  • DETAILED MARKET ESTIMATES AND PROJECTIONS, 2000 – 2008
  • MARKET PROJECTION METHODOLOGY AND DATA SOURCES
  • MARKET BY APPLICATION
• TABLE 31 U.S. MARKET FOR DIAGNOSTIC CHEMICALS AND OTHER CONSUMABLES BY APPLICATION SEGMENT, THROUGH 2008 ($ MILLIONS)
• FIGURE 16 MARKET SHARES BY APPLICATION SEGMENT, 2003 AND 2008 (PERCENT OF TOTAL SALES)
  • MARKET BY PRODUCT TYPE
    • Summary
• TABLE 32 TRENDS IN OVERALL CONSUMPTION OF DIAGNOSTIC COMPONENTS BY TYPE OF PRODUCT, THROUGH 2008 ($ MILLIONS)
  • Detailed Analysis
  • Reagents
• TABLE 33 TRENDS IN OVERALL CONSUMPTION OF REAGENTS, BY TYPE OF REAGENT, THROUGH 2008 ($ MILLIONS)
• TABLE 34 LARGEST-SELLING REAGENTS, 2002-2008 ($ MILLIONS)
  • Microbiological Reagents
• TABLE 35 U.S. MARKET FOR PAP STAINS AND OTHER MICROBIOLOGICAL REAGENTS, THROUGH 2008 ($ MILLIONS)
  • Chemical Reagents
• TABLE 36 TRENDS IN U.S. MARKET FOR CHEMICAL REAGENTS, THROUGH 2008 ($ MILLIONS)
  • Immunological Reagents
• TABLE 37 TRENDS IN THE U.S. MARKET FOR IMMUNOLOGICAL REAGENTS, THROUGH 2008 ($ MILLIONS)
  • Nucleic Acid Reagents
• TABLE 38 TRENDS IN THE U.S. MARKET FOR NUCLEIC ACID REAGENTS, THROUGH 2008 ($ MILLIONS)
  • Other Chemicals
• TABLE 39 TRENDS IN THE U.S. MARKET FOR OTHER CHEMICALS, THROUGH 2008 ($ MILLIONS)
  • Device Carriers and Other Consumables
• TABLE 40 TRENDS IN THE U.S. MARKET FOR DEVICE CARRIERS AND OTHER CONSUMABLES, THROUGH 2008 ($ MILLIONS)
  • MARKET BY END-USE
• FIGURE 17 TRENDS IN DIAGNOSTIC COMPONENT END-USER SEGMENTS, 2003 AND 2008
• TABLE 41 DIAGNOSTIC COMPONENT SALES BY END-USER SEGMENT, THROUGH 2008 ($ MILLIONS)
  • LONG-TERM OUTLOOK FOR THE U.S. MARKET
  • DEVELOPMENTS THAT WILL INFLUENCE THE LONG-TERM MARKET
    • Demographic and Epidemiological Trends
    • Technology Trends
    • Economic Trends
    • Governmental/Regulatory Trends
    • Trends in the Structure of the Health-Care Industry
  • LONG-TERM MARKET PROSPECTS

• INDUSTRY STRUCTURE
• SUMMARY
• FIGURE 18 TOTAL U.S. SHIPMENTS OF DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002 (%)
  • DIAGNOSTIC REAGENTS AND CHEMICALS
    • Domestic Production
    • Industry Structure
• TABLE 42 U.S. IN-VITRO DIAGNOSTIC SUBSTANCE MANUFACTURERS CLASSIFIED BY SIZE OF ESTABLISHMENT
• FIGURE 19 IN-VITRO DIAGNOSTIC PRODUCT SHIPMENTS BY SIZE OF ESTABLISHMENT (PERCENT OF TOTAL MANUFACTURERS\' SHIPMENTS)
• TABLE 43 U.S. IN-VITRO DIAGNOSTIC REAGENT MANUFACTURERS, CLASSIFIED BY PRINCIPAL PRODUCT
  • Foreign Trade
• TABLE 44 NET U.S. IMPORTS OF PHARMACEUTICALS AND MEDICINES, 1997-2000 ($ BILLIONS)
• TABLE 45 DOMESTIC PRODUCTION AND NET IMPORTS OF IN-VITRO DIAGNOSTIC PRODUCTS, 2000-2003 ($ BILLIONS)
  • DEVICE CARRIERS AND CONSUMABLES
    • Domestic Production
    • Industry Structure
• FIGURE 20 U.S. IN-VITRO DIAGNOSTIC ASSAY SYSTEM COMPONENTS SUPPLIERS (TOTAL NUMBER OF COMPANIES IN EACH CATEGORY)
  • PERFORMANCE
  • SALES
• TABLE 46 SELECTED DIAGNOSTIC PRODUCT COMPANIES\' SALES PERFORMANCE, THROUGH 2002 ($ MILLIONS)
• TABLE 47 COMPANY SIZE VS. SALES PERFORMANCE, THROUGH 2002
  • PROFITABILITY
• TABLE 48 COMPANY SIZE VS. PROFITABILITY, 2000-2002
  • COMPETITION AND MARKET SHARES
  • CLINICAL AND RESEARCH MARKET
• FIGURE 21 U.S. CLINICAL AND RESEARCH DIAGNOSTIC COMPONENT MARKET LEADERS, 2002 (PERCENT OF TOTAL SALES)
• TABLE 49 CLINICAL AND RESEARCH DIAGNOSTIC COMPONENT VENDORS\' U.S. SALES, 2002
  • VETERINARY MARKET
• FIGURE 22 U.S. VETERINARY DIAGNOSTIC COMPONENT MARKET LEADERS, 2002 (PERCENT OF TOTAL SALES)
• TABLE 50 VETERINARY DIAGNOSTIC COMPONENT VENDORS\' U.S. SALES, 2002
  • SALES AND DISTRIBUTION
• FIGURE 23 U.S. DISTRIBUTION CHANNELS FOR DIAGNOSTIC COMPONENTS (PERCENT OF TOTAL SALES THROUGH EACH CHANNEL)
  • TRENDS IN OWNERSHIP AND INDUSTRY STRUCTURE
    • Trends in Ownership and Industry Structure (Continued)

• GLOBAL MARKET ESTIMATES AND PROJECTIONS, 2002 TO 2008
• FIGURE 24 TRENDS IN THE GLOBAL MARKET FOR DIAGNOSTIC REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ BILLIONS)
  • LONG-TERM TRENDS IN GLOBAL MARKETS

• DIAGNOSTIC REAGENTS, CHEMICALS, AND KITS
• ABAXIS, INC.
• TABLE 51 ABAXIS, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • ABBOTT LABORATORIES, INC.
• TABLE 52 ABBOTT LABORATORIES, INC. SALES OF DIAGNOSTIC PRODUCTS, THROUGH 2002 ($ MILLIONS)
  • ACON LABORATORIES, INC.
  • AFFYMETRIX, INC.
  • BAYER DIAGNOSTICS
  • BECKMAN COULTER, INC.
• TABLE 53 BECKMAN COULTER, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
• TABLE 54 BECKMAN COULTER, INC. SALES BY GEOGRAPHICAL REGION, 2002
  • BECTON DICKINSON & CO.
• TABLE 55 BECTON DICKINSON & CO. CLINICAL LABORATORY SOLUTIONS SEGMENT REVENUES, THROUGH 2002 ($ MILLIONS)
  • BIOCHECK, INC.
  • BIOMEDICAL DIAGNOSTICS, LLC
  • CYTYC CORP.
• TABLE 56 CYTYC CORP. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • DADE BEHRING
• TABLE 57 DADE BEHRING SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • DIADEXUS
  • GENZYME DIAGNOSTICS
  • HEMAGEN DIAGNOSTICS, INC.
  • HESKA CORP.
• TABLE 58 HESKA CORP. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • IDEXX LABORATORIES, INC.
• TABLE 59 IDEXX LABORATORIES, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • INFECTIO DIAGNOSTICS, INC.
  • INOVA DIAGNOSTICS, INC.
  • IVAX DIAGNOSTICS, INC.
• TABLE 60 IVAX DIAGNOSTICS, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • MERIDIAN BIOSCIENCE, INC.
• TABLE 61 MERIDIAN BIOSCIENCE, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • MICROMEDX
  • MYRIAD GENETIC LABORATORIES, INC.
  • NEW HORIZONS DIAGNOSTICS CORP.
  • ORASURE TECHNOLOGIES, INC.
  • ORTHO-CLINICAL DIAGNOSTICS
  • PHARMACIA
  • QUEST DIAGNOSTICS, INC.
  • QIAGEN N.V.
  • ROCHE DIAGNOSTICS
• TABLE 62 ROCHE DIAGNOSTICS SALES BY BUSINESS SEGMENT, 2002
  • SYNBIOTICS CORP.
• TABLE 63 SYNBIOTICS CORP. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)
  • VYSIS, INC.
  • WORLDWIDE MEDICAL CORP.
  • DEVICE CARRIERS
  • DIAGNOSTIC LAMINATIONS ENGINEERING
  • EVERGREEN SCIENTIFIC, INC.
  • EXCEL SCIENTIFIC, INC.
  • GLOBE SCIENTIFIC, INC.
  • INTEGRATED BIOMEDICAL TECHNOLOGY
  • MILLENIUM DIAGNOSTICS, LTD.
  • NORTH AMERICAN BIOMEDICAL
  • SCHLEICHER & SCHUELL BIOSCIENCE
  • VIROTEK, LLC
  • WHATMAN, PLC

• MAJOR DIAGNOSTIC TESTS
• INFECTIOUS DISEASE TESTS
  • Bacterial Tests
• TABLE 64 COMMON TYPES OF BACTERIAL INFECTIOUS DISEASES AND ASSOCIATED DIAGNOSTIC TESTS
  • Staphylococcus
  • Helicobacter Pylori
  • Chlamydia
  • Streptococcus
  • Treponema
  • Neisseria Gonorrhea
  • Borrelia
  • Escherichia
  • Shigella
  • Legionella
  • Fungal Tests
• TABLE 65 COMMON TYPES OF FUNGAL INFECTIOUS DISEASES AND ASSOCIATED DIAGNOSTIC TESTS
• TABLE 65 (CONTINUED)
  • Aspergillus
  • Blastomyces
  • Candida
  • Coccidomycosis
  • Cryptococcosis
  • Histoplasmosis
  • Sporotrichosis
  • Viral Tests
• TABLE 66 COMMON TYPES OF VIRAL DISEASES AND ASSOCIATED DIAGNOSTIC TESTS
  • Cytomegalovirus
  • Epstein-Barr Virus
  • Hepatitis
  • Human Immunodeficiency Virus (HIV)
  • Influenza
  • Paramyxovirus
  • Rubella
  • Varicella Zoster
  • Protozoan Tests
• TABLE 67 COMMON TYPES OF PROTOZOAL INFECTIOUS DISEASES AND ASSOCIATED DIAGNOSTIC TESTS
  • Cryptosporidiosis
  • Giardiasis
  • Amoebic Dysentery
  • Toxoplasmosis
  • Malaria
  • Trichomoniasis
  • CANCER TESTING
    • FDA-Approved Tests
• TABLE 68 COMMON TYPES OF CANCER AND ASSOCIATED DIAGNOSTIC TESTS
• TABLE 68 (CONTINUED)
  • Cervical Cancer Tests
  • Pap Smear
  • Human Papilloma Virus Test
  • Colorectal Cancer Tests
  • Fecal Occult Blood Test
  • Bladder Cancer Tests
  • Bladder Tumor Antigen Test
  • Nuclear Matrix Protein Test for Bladder Cancer
  • Genetic Markers for Bladder Cancer Test
  • Breast Cancer Tests
  • CA (Cancer Antigen) 15-3 Test
  • CA 27-29 (Truquant) Test
  • Estrogen and Progesterone Receptor Tests
  • HER-2/Neu Test
  • Central Nervous System
  • Neuron-Specific Enolase Test
  • Colorectal Cancer
  • Carcinoembryonic Antigen Test
  • Gastric/Pancreatic/Stomach Cancer
  • Ca 19-9 Test
  • Liver Cancer
  • Alpha-Fetoprotein Test
  • Metastatic Melanoma
  • S-100 Test
  • Multiple Myeloma
  • Nasophryngeal Cancer and Epstein-Barr Virus Antibodies Test
  • Ovarian Cancer
  • CA-125 Test
  • CA 72-4 Test
  • Prostate Cancer
  • Prostatic-Specific Antigen Test
  • Testicular Cancer
  • Human Chronic Gonadotropin Test
  • Thyroid Medullary Carcinoma
  • Calcitonin Test
  • New Tests
  • Genetic Test for HPV
  • Genetic Test for Potential Recurrence of Breast Cancer
  • Genetic Test for Colon Cancer
  • Genetic Test for Lung Cancer

SUMMARY TABLE:

TOTAL U.S. AND GLOBAL MARKET FOR IN-VITRO DIAGNOSTIC CHEMICALS, CARRIERS, AND CONSUMABLES, THROUGH 2008 ($ BILLIONS)

TABLE 1 MAJOR MICROBIOLOGICAL REAGENTS

TABLE 2 MAJOR DIAGNOSTIC CHEMICAL REAGENTS

TABLE 3 MAJOR DIAGNOSTIC IMMUNOLOGICAL REAGENTS

TABLE 4 DIAGNOSTIC NUCLEIC ACID REAGENTS

TABLE 5 U.S. INFECTIOUS DISEASE TESTING MARKET BY PRODUCT TYPE, 2002

TABLE 6 U.S. TRENDS IN MAJOR INFECTIOUS DISEASES, 1990 THROUGH 2002 (NUMBER OF NEW CASES ANNUALLY)

TABLE 7 IMPACT OF EPIDEMIOLOGICAL TRENDS ON THE MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN INFECTIOUS DISEASETESTING, 2002-2008 ($ MILLIONS)

TABLE 8 PROJECTED DEMAND FOR INFECTIOUS DISEASE DIAGNOSTIC PRODUCTS, THROUGH 2008 ($ MILLIONS)

TABLE 9 U.S. CANCER TESTING MARKET BY PRODUCT TYPE, 2002 ($ BILLIONS)

TABLE 10 IMPACT OF DEMOGRAPHIC AND EPIDEMIOLOGICAL TRENDS ON THE MARKET FOR CANCER DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES,2002-2008 ($ MILLIONS)

TABLE 11 IMPACT OF NEW TECHNOLOGIES ON MARKET FOR CANCER DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

TABLE 12 PROJECTED DEMAND FOR CANCER DIAGNOSTIC PRODUCTS, THROUGH 2008 ($ MILLIONS)

TABLE 13 U.S. HORMONE TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)

TABLE 14 U.S. TRENDS IN FERTILITY AND CHILDBEARING, THROUGH 2002

TABLE 15 TRENDS IN OLDER AGE GROUPS OF U.S. POPULATION, THROUGH 2002

TABLE 16 IMPACT OF EPIDEMIOLOGICAL TRENDS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN HORMONE TESTING, 2002-2008($ MILLIONS)

TABLE 17 U.S. DRUG TESTING MARKET BY PRODUCT TYPE, 2002

TABLE 18 IMPACT OF DEMAND DRIVERS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN DRUG TESTING, 2002-2008

TABLE 19 KEY BLOOD AND URINE CHEMISTRY PARAMETERS

TABLE 20 U.S. BLOOD/URINE TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)

TABLE 21 INCIDENCE OF DIABETES AMONG DIFFERENT AGE GROUPS

TABLE 22 IMPACT OF DEMAND DRIVERS ON THE MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN BLOOD/URINE CHEMISTRY TESTING,2002-2008 ($ MILLIONS)

TABLE 23 U.S. MEDICAL RESEARCH TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)

TABLE 24 IMPACT OF DEMAND DRIVERS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN MEDICAL RESEARCH, 2002-2008 ($MILLIONS)

TABLE 25 U.S. VETERINARY TESTING MARKET BY PRODUCT TYPE, 2002 ($ MILLIONS)

TABLE 26 TRENDS IN U.S. MEAT PRODUCTION, THROUGH 2002 (BILLION POUNDS)

TABLE 27 TRENDS IN U.S. CONSUMER SPENDING ON PET CARE, INCLUDING VETERINARY SERVICES, THROUGH 2002 ($ BILLIONS)

TABLE 28 IMPACT OF DEMAND DRIVERS ON MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN VETERINARY DIAGNOSTIC TESTING,2002-2008 ($ MILLIONS)

TABLE 29 ENTITIES ENGAGED IN MEDICAL RESEARCH

TABLE 30 ENTITIES ENGAGED IN VETERINARY DIAGNOSTIC ACTIVITIES

TABLE 31 U.S. MARKET FOR DIAGNOSTIC CHEMICALS AND OTHER CONSUMABLES BY APPLICATION SEGMENT, THROUGH 2008 ($ MILLIONS)

TABLE 32 TRENDS IN OVERALL CONSUMPTION OF DIAGNOSTIC COMPONENTS BY TYPE OF PRODUCT, THROUGH 2008 ($ MILLIONS)

TABLE 33 TRENDS IN OVERALL CONSUMPTION OF REAGENTS, BY TYPE OF REAGENT, THROUGH 2008 ($ MILLIONS)

TABLE 34 LARGEST-SELLING REAGENTS, 2002-2008 ($ MILLIONS)

TABLE 35 U.S. MARKET FOR PAP STAINS AND OTHER MICROBIOLOGICAL REAGENTS, THROUGH 2008 ($ MILLIONS)

TABLE 36 TRENDS IN U.S. MARKET FOR CHEMICAL REAGENTS, THROUGH 2008 ($ MILLIONS)

TABLE 37 TRENDS IN THE U.S. MARKET FOR IMMUNOLOGICAL REAGENTS, THROUGH 2008 ($ MILLIONS)

TABLE 38 TRENDS IN THE U.S. MARKET FOR NUCLEIC ACID REAGENTS, THROUGH 2008 ($ MILLIONS)

TABLE 39 TRENDS IN THE U.S. MARKET FOR OTHER CHEMICALS, THROUGH 2008 ($ MILLIONS)

TABLE 40 TRENDS IN THE U.S. MARKET FOR DEVICE CARRIERS AND OTHER CONSUMABLES, THROUGH 2008 ($ MILLIONS)

TABLE 41 DIAGNOSTIC COMPONENT SALES BY END-USER SEGMENT, THROUGH 2008 ($ MILLIONS)

TABLE 42 U.S. IN-VITRO DIAGNOSTIC SUBSTANCE MANUFACTURERS CLASSIFIED BY SIZE OF ESTABLISHMENT

TABLE 43 U.S. IN-VITRO DIAGNOSTIC REAGENT MANUFACTURERS, CLASSIFIED BY PRINCIPAL PRODUCT

TABLE 44 NET U.S. IMPORTS OF PHARMACEUTICALS AND MEDICINES, 1997-2000 ($ BILLIONS)

TABLE 45 DOMESTIC PRODUCTION AND NET IMPORTS OF IN-VITRO DIAGNOSTIC PRODUCTS, 2000-2003 ($ BILLIONS)

TABLE 46 SELECTED DIAGNOSTIC PRODUCT COMPANIES\' SALES PERFORMANCE, THROUGH 2002 ($ MILLIONS)

TABLE 47 COMPANY SIZE VS. SALES PERFORMANCE, THROUGH 2002

TABLE 48 COMPANY SIZE VS. PROFITABILITY, 2000-2002

TABLE 49 CLINICAL AND RESEARCH DIAGNOSTIC COMPONENT VENDORS\' U.S. SALES, 2002

TABLE 50 VETERINARY DIAGNOSTIC COMPONENT VENDORS\' U.S. SALES, 2002

TABLE 51 ABAXIS, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 52 ABBOTT LABORATORIES, INC. SALES OF DIAGNOSTIC PRODUCTS, THROUGH 2002 ($ MILLIONS)

TABLE 53 BECKMAN COULTER, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 54 BECKMAN COULTER, INC. SALES BY GEOGRAPHICAL REGION, 2002

TABLE 55 BECTON DICKINSON & CO. CLINICAL LABORATORY SOLUTIONS SEGMENT REVENUES, THROUGH 2002 ($ MILLIONS)

TABLE 56 CYTYC CORP. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 57 DADE BEHRING SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 58 HESKA CORP. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 59 IDEXX LABORATORIES, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 60 IVAX DIAGNOSTICS, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 61 MERIDIAN BIOSCIENCE, INC. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 62 ROCHE DIAGNOSTICS SALES BY BUSINESS SEGMENT, 2002

TABLE 63 SYNBIOTICS CORP. SELECTED FINANCIAL DATA, THROUGH 2002 ($ MILLIONS)

TABLE 64 COMMON TYPES OF BACTERIAL INFECTIOUS DISEASES AND ASSOCIATED DIAGNOSTIC TESTS

TABLE 65 COMMON TYPES OF FUNGAL INFECTIOUS DISEASES AND ASSOCIATED DIAGNOSTIC TESTS

TABLE 66 COMMON TYPES OF VIRAL DISEASES AND ASSOCIATED DIAGNOSTIC TESTS

TABLE 67 COMMON TYPES OF PROTOZOAL INFECTIOUS DISEASES AND ASSOCIATED DIAGNOSTIC TESTS

TABLE 68 COMMON TYPES OF CANCER AND ASSOCIATED DIAGNOSTIC TESTS

LIST OF FIGURES

SUMMARY FIGURE:

TOTAL U.S. AND GLOBAL MARKET FOR IN-VITRO DIAGNOSTIC CHEMICALS, CARRIERS, AND CONSUMABLES, 2002-2008 ($ BILLIONS)

FIGURE 1 U.S. MARKET FOR INFECTIOUS DISEASE REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

FIGURE 2 PERCENT MARKET SHARE FOR DIAGNOSTIC TESTS FOR INFECTIOUS DISEASES BY TYPE OF TEST, 2002 (%)

FIGURE 3 MARKET FOR CANCER TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

FIGURE 4 DIAGNOSTIC TESTS FOR CANCER BY TYPE OF TEST, 2002 (PERCENT OF ALL TESTS BY VALUE)

FIGURE 5 MARKET FOR HORMONE TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

FIGURE 6 HORMONE TESTS BY TYPE OF TEST, 2002 (PERCENT OF ALL TESTS BY VALUE)

FIGURE 7 MARKET FOR DRUG TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

FIGURE 8 DRUG TESTS BY TYPE OF TEST, 2002 (PERCENT OF ALL TESTS BY VALUE)

FIGURE 9 MARKET FOR BLOOD AND URINE TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

FIGURE 10 MARKET DIAGNOSTIC REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES USED IN MEDICAL RESEARCH, THROUGH 2008 ($ MILLIONS)

FIGURE 11 MARKET FOR VETERINARY TESTING REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ MILLIONS)

FIGURE 12 NUMBER OF CLIA-REGISTERED CLINICAL LABORATORIES, 1993-2002

FIGURE 13 TOTAL CLIA-REGISTERED LABORATORIES, BY TYPE, 2002 (PERCENT OF LABORATORIES REPORTING)

FIGURE 14 DIAGNOSTIC AND OTHER CLINICAL TESTS CARRIED OUT BY TYPE OF LABORATORY, 2002 (PERCENT OF ALL TESTS, BY VALUE)

FIGURE 15 TOTAL U.S. MARKET FOR DIAGNOSTIC CHEMICALS, CARRIERS, AND CONSUMABLES, 2000-2008 ($ MILLIONS)

FIGURE 16 MARKET SHARES BY APPLICATION SEGMENT, 2003 AND 2008 (PERCENT OF TOTAL SALES)

FIGURE 17 TRENDS IN DIAGNOSTIC COMPONENT END-USER SEGMENTS, 2003 AND 2008

FIGURE 18 TOTAL U.S. SHIPMENTS OF DIAGNOSTIC CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002 (%)

FIGURE 19 IN-VITRO DIAGNOSTIC PRODUCT SHIPMENTS BY SIZE OF ESTABLISHMENT (PERCENT OF TOTAL MANUFACTURERS\' SHIPMENTS)

FIGURE 20 U.S. IN-VITRO DIAGNOSTIC ASSAY SYSTEM COMPONENTS SUPPLIERS (TOTAL NUMBER OF COMPANIES IN EACH CATEGORY)

FIGURE 21 U.S. CLINICAL AND RESEARCH DIAGNOSTIC COMPONENT MARKET LEADERS, 2002 (PERCENT OF TOTAL SALES)

FIGURE 22 U.S. VETERINARY DIAGNOSTIC COMPONENT MARKET LEADERS, 2002 (PERCENT OF TOTAL SALES)

FIGURE 23 U.S. DISTRIBUTION CHANNELS FOR DIAGNOSTIC COMPONENTS (PERCENT OF TOTAL SALES THROUGH EACH CHANNEL)

FIGURE 24 TRENDS IN THE GLOBAL MARKET FOR DIAGNOSTIC REAGENTS, CHEMICALS, CARRIERS, AND OTHER CONSUMABLES, 2002-2008 ($ BILLIONS)