Medical Diagnostic Kits

Medical Diagnostic Kits

Describes the products that comprise the Medical Diagnostic Kits (MDK) industry Details emerging and current MDK technologies Analyzes these technologies and their impact on future products and market growth Evaluates market structure and current market size with forecasts through 2013 with specific emphasis on each segment Addresses the effects of external market forces, such as insurance, regulatory and economic issues and increased incidence of disease.  
 

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

INTENDED AUDIENCE

SCOPE OF REPORT

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED REPORTS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

REPORT HIGHLIGHTS

SUMMARY TABLE PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, THROUGH 2013 ($ MILLIONS)

SUMMARY FIGURE PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, 2007- 2013 ($ MILLIONS)

THE MDK INDUSTRY

WHAT ARE MDKS?

ADVANTAGES OF MDKS

USES FOR MDKS

CLINICAL TESTING

Clinical Diagnostic Testing

Monitoring

Screening

Confirmatory Testing

RESEARCH

HOME USE

VETERINARY DIAGNOSIS

MARKET SIZE

TABLE 1 PROJECTED U.S. MDK MARKET COMPARED WITH THE TOTAL DIAGNOSTIC TESTING INDUSTRY, THROUGH 2013 ($ BILLIONS)

RELATION TO TOTAL TESTING MARKET

FIGURE 1 MDK’S RELATIVE SHARE OF U.S. TESTING MARKET PROJECTED, THROUGH 2013 ($ BILLIONS)

ALTERNATIVE METHODS

TABLE 2 ALTERNATIVE METHODS TO MDKS AND AREA OF PRIMARY USE

Chemical Assay

Culture

Microscopy

Biological Assay

Chromatographic Separation

MDK APPLICATIONS

TABLE 3 SELECTED MDK APPLICATIONS

INDUSTRY STRUCTURE

REAGENTS

DEVICE/CARRIER

PACKAGING

COMPONENT SUPPLIERS

FIGURE 2 COMPONENTS OF AN MDK

TABLE 4 SELECTED LISTING OF MDK COMPONENT SUPPLIERS BY AREA OF PARTICIPATION

END MARKETS

TABLE 5 MDK APPLICATIONS BY END-USE FACILITY

CLINICAL TESTING FACILITIES

TABLE 6 U.S. CLINICAL TESTING FACILITIES WITH POTENTIAL FOR USING MDKS: CLIA VS. NON-CLIA

CLIA-Certified Laboratories

Non-CLIA Laboratories/Facilities

RESEARCH LABORATORIES

HOME-USE MARKET

VETERINARY APPLICATIONS

TABLE 7 SELECTED LISTING OF ANIMAL TESTING MDKS

INTERNAL MARKET FORCES, EXTERNAL MARKET FORCES

TRADE PRACTICES

Promotion

Pricing

Sales Tie-ins

INDUSTRY CHANNELS OF DISTRIBUTION

FIGURE 3 CHANNELS OF DISTRIBUTION FOR MDKS

STRATEGIC ALLIANCES

ACQUISITIONS

TABLE 8 SELECTED COMPANY ACQUISITIONS, 1995-2008

TABLE 8 (CONTINUED)

STRATEGIES IN CONSUMER ADVERTISING

EXTERNAL MARKET FORCES

FIGURE 4 EXTERNAL MARKET FACTORS AFFECTING THE MDK INDUSTRY

REGULATORY

Food and Drug Administration (FDA)

Clinical Laboratory Improvement Amendments

Clinical Laboratory Improvement …(Continued)

Clinical Laboratory Improvement …(Continued)

TABLE 9 CLIA WAIVED TESTS

TABLE 9 (CONTINUED)

Good Manufacturing Practice

TABLE 10 PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING MDKS

COST CONTAINMENT EFFORTS

Diagnosis Related Groups (DRGs)

Medicare

Third-Party Payers

Physician Ownership/Referral Clinical Laboratory Services

CHANGES IN THE INCIDENCE OF DISEASE

TABLE 11 PREVALENCE OF SELECTED DISEASES IN THE U.S. POPULATION* (THOUSANDS OF CASES)

FIGURE 5 U.S. POPULATION BY AGE BRACKET, 2005 AND 2010

TRENDS IN POINT-OF-CARE TESTING

TABLE 12 SELECTED LISTING OF CURRENTLY MARKETED POC DEVICES

TABLE 13 PROJECTED U.S POINT-OF-CARE DEVICE MARKET, THROUGH 2013 ($ BILLIONS)

I-STAT SYSTEM

ABAXIS PICCOLO SYSTEM

INTERNATIONAL ASPECTS OF MDK MARKET

PRESENCE OF U.S. MANUFACTURERS IN THE WORLDWIDE MARKET

TECHNOLOGICAL ASPECTS OF MDK INDUSTRY

TESTING METHODS

TABLE 14 MAJOR MDK APPLICATIONS BY TYPE OF TECHNOLOGY

TABLE 14 (CONTINUED)

CHEMICAL ANALYSIS

ENZYMATIC ANALYSIS

IMMUNOLOGICAL ANALYSIS

ENZYME IMMUNOASSAY

Basic EIA

FIGURE 6 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS

Alternative EIA Methods

SECOND-ANTIBODY PRECIPITATION METHOD

DOUBLE-ANTIBODY SANDWICH METHOD

REVERSE-SANDWICH METHOD

REVERSE-SANDWICH INHIBITION METHOD

FLUORESCENCE IMMUNOASSAY

Direct FA

Indirect FA

LATEX AGGLUTINATION

RADIOIMMUNOASSAY

Limitations to RIA Testing

Types of RIA Methods

IMMUNOPRECIPITATION/AGGLUTINATION

GENE PROBE ANALYSIS

Gene Probes

Gene Probe Glossary

TYPES OF HYBRIDIZATION COMMONLY USED

Gel Electrophoresis/Southern Blot Method

HYBRIDIZATION IN SOLUTIONS

Solid Support Methods

DNA ARRAY TECHNOLOGY

AMPLIFICATION

Importance of Amplification in the Development of Probes

TARGET AMPLIFICATION TECHNIQUES

Polymerase Chain Reaction Amplification

Nucleic Acid Sequence-Based Amplification (NASBA)

Strand-Displacement Amplification

Transcription-Mediated Amplification

PROBE AMPLIFICATION

Q-Beta Replicase

Ligase Chain Reaction

Cycling Probe Technology

SIGNAL AMPLIFICATION

Branched DNA Assay

MDK FEATURES AFFECTING MARKETABILITY

RELIABILITY AND ACCURACY

RANGE OF MEASUREMENT AND SENSITIVITY

STORAGE STABILITY

EASE OF USE

CLINICAL MDK APPLICATIONS

SEGMENTS

TABLE 15 PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, THROUGH 2013 ($ MILLIONS)

CLINICAL LABORATORY APPLICATIONS

INFECTIOUS DISEASE TESTING

TABLE 16 SELECTED LISTING OF BACTERIA FOUND IN CLINICAL SPECIMENS AND THE DISEASES THEY CAUSE

TABLE 17 MAJOR VIRAL INFECTIOUS AGENTS

Importance of Testing

Clinical Testing Methods

TYPES OF MDKS FOR INFECTIOUS DISEASE TESTING

Immunodiagnostic Kits

DipSticks

Microbial and Rapid-Test Kits

TABLE 18 SELECTED LISTING OF FDA APPROVED INFECTIOUS DISEASE TESTING MDKS BY TYPE OF ASSAY

TABLE 18 (CONTINUED)

TABLE 18 (CONTINUED)

TABLE 18 (CONTINUED)

Gene Probe Kits

MARKET SIZE

TABLE 19 PROJECTED MDKS MARKET FOR INFECTIOUS DISEASE TESTING BY APPLICATION, THROUGH 2013 ($ MILLIONS)

MARKET DYNAMICS

HIV/AIDS Testing

Leading Market Participants

Tuberculosis and Other Mycobacterium Infections

MTD-Direct Detection of Mycobacterium Tuberculosis

Confirmatory Gene Probe Kit Tests for Mycobacteria Species

SEXUALLY TRANSMITTED DISEASES (STDS)

Syphilis

Gonorrhea

TABLE 20 ANNUAL INCIDENCE OF SEXUALLY TRANSMITTED DISEASES IN THE U.S., 2006*

Chlamydia

Human Papillomavirus

Genital Herpes

STREPTOCOCCI

HEPATITIS

DRUG TESTING

TYPES OF DRUGS

MARKET SIZE

TABLE 21 PROJECTED U.S. MDK DRUG TESTING MARKET, THROUGH 2013 ($ MILLIONS)

MDK APPLICATIONS IN DRUG TESTING

Therapeutic Monitoring

Diagnosing Overdoses

Differential Diagnosis

Detecting Drug Abuse

TABLE 22 SELECTED LISTING OF DRUG TESTING MDKS CURRENTLY MARKETED BY COMPANY

ALTERNATIVES TO MDKS

HOME-DETECTION METHODS

TYPES OF DRUG TESTING MDKS

HORMONES

Diagnostic Benefits of Hormone Analysis

Types of Hormone MDK Tests

Hypothalamus

Pituitary

Thyroid

Parathyroid

Adrenal Glands

Pancreas

Brain Peptides

HORMONE TESTS MARKETED

TABLE 23 SELECTED LISTING OF HORMONE MDKS BY COMPANY

Market Size

TABLE 24 PROJECTED U.S. MDK HORMONE TESTING MARKET, THROUGH 2013 ($ MILLIONS)

ALTERNATIVES TO MDKS

CANCER TESTING

Incidence of New Cancer Cases Annually

TABLE 25 INCIDENCE OF NEW CANCER CASES IN THE U.S., 2006 AND 2007 (PER ANNUM)

Detection of Cancer

MDKs for Cancer Testing

TABLE 26 SELECTED LISTING OF CANCER DIAGNOSTICS AND THERAPEUTIC MANAGEMENT MDK TESTS*

Market Size and Structure

TABLE 27 PROJECTED U.S. MARKET FOR CANCER DIAGNOSTIC MDKS: NON-RESEARCH TESTING APPLICATIONS, THROUGH 20013 ($ MILLIONS)

BLOOD/URINE CHEMISTRY TESTING

Market Size and Structure

TABLE 28 PROJECTED U.S. BLOOD/URINE CHEMISTRY MDK MARKET, THROUGH 2013 ($ MILLIONS)

AUTOMATION VERSUS MDKS

POINT-OF-CARE (POC) ANALYTICAL SYSTEMS USING MDKS

TYPES OF MDKS

TABLE 29 CLIA APPROVED MDKS FOR BLOOD/URINE CHEMISTRY TESTING BY COMPANY, 2002-2007

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

TABLE 29 (CONTINUED)

Dipsticks

EMERGING MDKS FOR CLINICAL TESTING

Biochips

Reporter Genes

Automatic Sequencing

HOME-USE TESTING MARKET

MARKET SIZE AND STRUCTURE

TABLE 30 PROJECTED U.S. HOME-USE MDK MARKET BY TYPE OF TEST, THROUGH 2013 ($ MILLIONS)

HOME-USE MDK MARKET PARTICIPANTS

TABLE 31 SELECTED COMPANIES MARKETING HOME-USE MDK TESTS

BY TEST TYPE

TABLE 31 (CONTINUED)

MAJOR HOME-USE MDK SEGMENTS

HOME PREGNANCY AND OVULATION TESTING

Market Size

TABLE 32 PROJECTED U.S. HOME-USE PREGNANCY AND OVULATION TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

Market Participants

GLUCOSE MONITORING

Market Size

TABLE 33 PROJECTED U.S. HOME-USE GLUCOSE TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

CHOLESTEROL TESTING

Market Size

TABLE 34 PROJECTED U.S. HOME-USE CHOLESTEROL TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

HIV/HEPATITIS TESTING

FECAL OCCULT BLOOD TESTING

Market Size

URINARY OCCULT BLOOD/URINARY INFECTION TESTING

Urinary Infection Testing

DRUG TESTING

Market Size

Regulatory Environment

U.S. RESEARCH APPLICATIONS

MARKET STRUCTURE

MARKET SIZE

TABLE 35 PROJECTED U.S. RESEARCH MDK MARKET, THROUGH 2013 ($ MILLIONS)

RESEARCH AREAS

EPIGENETICS

PCR-BASED ASSAYS

GENE MAPPING

Gene Probes

Molecular Biology

TABLE 36 SELECTED TYPES OF MDKS MARKETED FOR MOLECULAR BIOLOGY RESEARCH

TABLE 37 PROJECTED U.S. MOLECULAR DIAGNOSTIC MDK MARKET, THROUGH 2013 ($ MILLIONS)

VETERINARY APPLICATIONS

VETERINARY MEDICINE

CHANGES IN THE PRACTICE OF DOMESTIC VETERINARY MEDICINE

MARKET SIZE AND STRUCTURE

TABLE 38 PROJECTED U.S. VETERINARY TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 39 DEMAND FOR VETERINARY CARE FOR DOMESTIC PETS, THROUGH 2013 (VISITS PER YR/PETS IN MILLIONS)

IMPACT OF AUTOMATED VETERINARY SYSTEMS

MARKET PARTICIPANTS

VETERINARY MDKS

FELINE LEUKEMIA VIRUS

TABLE 40 SELECTED LISTING OF VETERINARY MDKS AND SUPPLIERS FOR COMPANION ANIMALS—CANINE, FELINE, AVIAN, EQUINE

TABLE 41 SELECTED LISTING OF VETERINARY MDKS AND SUPPLIERS FOR LIVESTOCK ANIMALS (AVIAN, BOVINE, SWINE, EQUINE)

CANINE HEARTWORM

FELINE HEARTWORM

FELINE IMMUNODEFICIENCY VIRUS (FIV)

CANINE PARVOVIRUS

PROGESTERONE

JOHNE’S DISEASE

CHEMISTRY TESTS

APPENDIX I CLIA WAIVED TESTS: 2002-2007

TABLE 42 CLIA WAIVED TESTS: 2002-2007

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

TABLE 42 (CONTINUED)

APPENDIX II COMPANY PROFILES

ABBOTT LABORATORIES

ALFA SCIENTIFIC DESIGNS

BAYER AG (MILES-BAYER)

BECKMAN COULTER

BECTON DICKINSON

BIOMERIEUX

BIO-RAD LABORATORIES

GEN-PROBE

GENZYME

HESKA CORP

HOME ACCESS HEALTH

IDEXX LABORATORIES

INBIOS INTERNATIONAL

INNOVACON (FORMERLY ACON LABORATORIES)

INVERNESS MEDICAL INNOVATIONS

INVITROGEN

JOHNSON & JOHNSON

LIFESIGN, LLC

PHAMATECH

QIAGEN

QUIDEL

REMEL

ROCHE DIAGNOSTICS

THERMOFISHER SCIENTIFIC

APPENDIX III COMPANIES BY PRODUCT TYPE

TABLE 43 COMPANIES BY PRODUCT TYPE

TABLE 43 (CONTINUED)

TABLE 43 (CONTINUED)

APPENDIX IV DIRECTORY OF MDK COMPANIES

AMDL, INC.

ABBOTT LABORATORIES

ACCUTECH, LLC

ACON INTERNATIONAL

AERSCHER DIAGNOSTICS

ALFA SCIENTIFIC DESIGNS, INC

AMERICAN MICROSCAN

AMNISURE INTERNATIONAL, LLC

ANALYTAB PRODUCTS (BIOMERIEUX)

APEX BIOTECHNOLOGY CORP

APPLIED BIOSYSTEMS

ARMKEL, LLC

BAYER AG

BECKMAN COULTER

BECTON DICKINSON

BETHAM CORP

BINAX

BIOMERICA, INC

BIOMERIEUX, INC

BIO-RAD LABORATORIES, INC.

BIOSAFE MEDICAL TECHNOLOGIES, INC

BIOSITE

BIOTECX

BIOWHITTAKER, INC.

BOEHRINGER MANNHEIM

CEPHEID

CENOGENICS CORP

CHEMATICS, INC

CHIRON CORP

CHOLESTECH CORP

CLONTECH LABORATORIES, INC

CHROMOGENIC MEDIA

CHRONIMED

CUNO, INC.

DNA TECHNOLOGIES

DADE BEHRING, INC

DIAGNOSTIC PRODUCTS

ENZO LIFE SCIENCES, INC.

EPICENTRE TECHNOLOGIES

FILTERTEK, INC

FIRST CHECK DIAGNOSTICS

FORT DODGE ANIMAL HEALTH

GDS TECHNOLOGY, INC.

GEN-PROBE

GENZYME DIAGNOSTICS

GERMAINE LABORATORIES

GI SUPPLY

GLAXO SMITHKLINE

GLUCO PLUS

W.L. GORE AND ASSOCIATES, INC

HARLAN BIOPRODUCTS FOR SCIENCE, INC.

HELENA LABORATORIES

HENRY SCHEIN, INC.

HESKA CORP

HOME ACCESS HEALTH

HOME DIAGNOSTICS, INC

ID BIOMEDICAL

IDEXX LABORATORIES

IMMUNOSTICS, INC

INBIOS INTERNATIONAL, INC.

INCYTE

INOVA DIAGNOSTICS

INNOVACON

INTERFLOW TECHNOLOGIES

INTERNATIONAL TECHNIDYNE CORP. (ITC)

INVERNESS MEDICAL INNOVATIONS

INVITROGEN

J&S MEDICAL ASSOCIATES, INC

JANT PHARMACAL

JOHNSON & JOHNSON

KIMBERLY CLARK/BALLARD

LIFESIGN, LLC

LITMUS CONCEPTS

LXN CORP.

MATRITECH, INC

MEDICAL ANALYSIS SYSTEMS, INC.

MEDISENSE, INC

MEDITEST, INC

MERIDIAN BIOSCIENCE

MILLIPORE CORP

MYRIAD GENETICS, INC

NOVAGEN

NOVEX

ORASURE TECHNOLOGIES

PALL CORP.

PHAMATECH

PHARMANETICS, INC

POLYMEDCO, INC.

POLYMER TECHNOLOGY SYSTEMS, INC

PORETICS CORP.

PRINCETON BIOMEDITECH CORP.

PSYCHEMEDICS CORP

QIAGEN, INC.

QUANTUM BIOTECHNOLOGIES, INC.

QUIDEL

REDWOOD TOXICOLOGY LABORATORY, INC.

REMEL, INC.

ROCHE DIAGNOSTIC CORP

SA SCIENTIFIC, INC

STC TECHNOLOGIES, INC

SANOFI DIAGNOSTICS PASTEUR, INC.

SERADYN

SERIM RESEARCH CORP.

SIEMENS HEALTHCARE DIAGNOSTICS, INC

SIGMA-ALDRICH

SPECTRAL DIAGNOSTICS

STANBIO LABORATORY

STRATAGENE

STRECK

SYNBIOTICS

SYNTRON BIORESEARCH

SYVA/BEHRING DIAGNOSTICS

TAIDOC TECHNOLOGY

TECO DIAGNOSTICS

TETKO, INC

THERASENSE

THERMO BIOSTAR, INC.

THERMOFISHER SCIENTIFIC

UNIPATH

WAKO CHEMICALS USA

ZEUS SCIENTIFIC, INC

LIST OF TABLES

SUMMARY TABLE PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, THROUGH 2013 ($ MILLIONS)

TABLE 1 PROJECTED U.S. MDK MARKET COMPARED WITH THE TOTAL DIAGNOSTIC TESTING INDUSTRY, THROUGH 2013 ($ BILLIONS)

TABLE 2 ALTERNATIVE METHODS TO MDKS AND AREA OF PRIMARY USE

TABLE 3 SELECTED MDK APPLICATIONS

TABLE 4 SELECTED LISTING OF MDK COMPONENT SUPPLIERS BY AREA OF PARTICIPATION

TABLE 5 MDK APPLICATIONS BY END-USE FACILITY

TABLE 6 U.S. CLINICAL TESTING FACILITIES WITH POTENTIAL FOR USING MDKS: CLIA VS. NON-CLIA

TABLE 7 SELECTED LISTING OF ANIMAL TESTING MDKS

TABLE 8 SELECTED COMPANY ACQUISITIONS, 1995-2008

TABLE 9 CLIA WAIVED TESTS

TABLE 10 PERTINENT PARAMETERS OF GMP REGULATIONS AFFECTING MDKS

TABLE 11 PREVALENCE OF SELECTED DISEASES IN THE U.S. POPULATION* (THOUSANDS OF CASES)

TABLE 12 SELECTED LISTING OF CURRENTLY MARKETED POC DEVICES

TABLE 13 PROJECTED U.S POINT-OF-CARE DEVICE MARKET, THROUGH 2013 ($ BILLIONS)

TABLE 14 MAJOR MDK APPLICATIONS BY TYPE OF TECHNOLOGY

TABLE 15 PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, THROUGH 2013 ($ MILLIONS)

TABLE 16 SELECTED LISTING OF BACTERIA FOUND IN CLINICAL SPECIMENS AND THE DISEASES THEY CAUSE

TABLE 17 MAJOR VIRAL INFECTIOUS AGENTS

TABLE 18 SELECTED LISTING OF FDA APPROVED INFECTIOUS DISEASE TESTING MDKS BY TYPE OF ASSAY

TABLE 19 PROJECTED MDKS MARKET FOR INFECTIOUS DISEASE TESTING BY APPLICATION, THROUGH 2013 ($ MILLIONS)

TABLE 20 ANNUAL INCIDENCE OF SEXUALLY TRANSMITTED DISEASES IN THE U.S., 2006*

TABLE 21 PROJECTED U.S. MDK DRUG TESTING MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 22 SELECTED LISTING OF DRUG TESTING MDKS CURRENTLY MARKETED BY COMPANY

TABLE 23 SELECTED LISTING OF HORMONE MDKS BY COMPANY

TABLE 24 PROJECTED U.S. MDK HORMONE TESTING MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 25 INCIDENCE OF NEW CANCER CASES IN THE U.S., 2006 AND 2007 (PER ANNUM)

TABLE 26 SELECTED LISTING OF CANCER DIAGNOSTICS AND THERAPEUTIC MANAGEMENT MDK TESTS*

TABLE 27 PROJECTED U.S. MARKET FOR CANCER DIAGNOSTIC MDKS: NON-RESEARCH TESTING APPLICATIONS, THROUGH 20013 ($ MILLIONS)

TABLE 28 PROJECTED U.S. BLOOD/URINE CHEMISTRY MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 29 CLIA APPROVED MDKS FOR BLOOD/URINE CHEMISTRY TESTING BY COMPANY, 2002-2007

TABLE 30 PROJECTED U.S. HOME-USE MDK MARKET BY TYPE OF TEST, THROUGH 2013 ($ MILLIONS)

TABLE 31 SELECTED COMPANIES MARKETING HOME-USE MDK TESTS BY TEST TYPE

TABLE 32 PROJECTED U.S. HOME-USE PREGNANCY AND OVULATION TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 33 PROJECTED U.S. HOME-USE GLUCOSE TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 34 PROJECTED U.S. HOME-USE CHOLESTEROL TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 35 PROJECTED U.S. RESEARCH MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 36 SELECTED TYPES OF MDKS MARKETED FOR MOLECULAR BIOLOGY RESEARCH

TABLE 37 PROJECTED U.S. MOLECULAR DIAGNOSTIC MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 38 PROJECTED U.S. VETERINARY TESTING MDK MARKET, THROUGH 2013 ($ MILLIONS)

TABLE 39 DEMAND FOR VETERINARY CARE FOR DOMESTIC PETS, THROUGH 2013 (VISITS PER YR/PETS IN MILLIONS)

TABLE 40 SELECTED LISTING OF VETERINARY MDKS AND SUPPLIERS FOR COMPANION ANIMALS—CANINE, FELINE, AVIAN, EQUINE

TABLE 41 SELECTED LISTING OF VETERINARY MDKS AND SUPPLIERS FOR LIVESTOCK ANIMALS (AVIAN, BOVINE, SWINE, EQUINE)

TABLE 42 CLIA WAIVED TESTS: 2002-2007

TABLE 43 COMPANIES BY PRODUCT TYPE

LIST OF FIGURES

SUMMARY FIGURE PROJECTED U.S. MDK MARKET BY END-USE SEGMENT, 2007- 2013 ($ MILLIONS)

FIGURE 1 MDK’S RELATIVE SHARE OF U.S. TESTING MARKET PROJECTED, THROUGH 2013 ($ BILLIONS)

FIGURE 2 COMPONENTS OF AN MDK

FIGURE 3 CHANNELS OF DISTRIBUTION FOR MDKS

FIGURE 4 EXTERNAL MARKET FACTORS AFFECTING THE MDK INDUSTRY

FIGURE 5 U.S. POPULATION BY AGE BRACKET, 2005 AND 2010

FIGURE 6 THE BASIC ENZYME IMMUNOASSAY (EIA) PROCESS