Medical Diagnostic Kits

Table of Contents

• Medical Diagnostic Kits

Chapter- 1: 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)

Chapter- 2: 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

Chapter- 3: 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

Chapter- 4: 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

Chapter- 5: 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

Chapter- 6: 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)

Chapter- 7: 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

Chapter- 8: APPENDIX I CLIA WAIVED TESTS: 2002・ 007

• 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)

Chapter- 9: 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

Chapter- 10: APPENDIX III COMPANIES BY PRODUCT TYPE

• TABLE 43 COMPANIES BY PRODUCT TYPE
• TABLE 43 (CONTINUED)
• TABLE 43 (CONTINUED)

Chapter- 11: 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.