Medical Diagnostic Kits

Summary

Study Goals And Objectives

This Study, Medical Diagnostic Kits (Mdks), Provides The Reader With An Intensive Examination Of The In Vitro Medical Diagnostic Kit Segment Of The Medical Device Market. It Will Specifically Address The Changes That Have Occurred As The Result Of Technological Advances And Regulatory Implementations From 22 To 27, And The Impact These Changes Will Have On The Overall Market And Key Market Segments.

Beyond Focusing On These Changes, This Report Will Define The Entire Mdk Industry, Including Its Structure And Dynamics. The Report Will Also Discuss The Major Players, Their Relative Market Shares, The Impact Of External Market Forces, And Implications For Current And Emerging Technologies.

Reasons For Doing The Study

Significant Changes Have Occurred In The Mdk Market Since Bcc Research Last Examined The Market In 22. The Market For Analytical Test Kits Packaged For Use On A Single-Test Basis To Test For A Wide Variety Of Substances Has Been Affected By Dramatic Changes In The Global Environment, As Well As Changes In Demographics And National Security Issues Within The United States. Significant Changes Include The Following:

• An Extremely Large Aging Population Of 78 Million So-Called "baby Boomers"
• Increasing Rates Of Various Types Of Cancer
• Continued Threat Of Bioterrorism Through Chemical/Biological Methods
• An Ever-Increasing At-Risk Population Of Individuals With Diabetes, Hepatitis, And Human Papillomavirus
• A Slow Down In Hiv/Aids Diagnosed Cases
• A Virtual Epidemic Of Substance Abuse
• Introduction Of Infectious Diseases From Global Migrations Of People
• Re-Introduction Of Infectious Diseases Such As Syphilis, Tuberculosis, And Measles, Thought To Be Vanquished.

This Report Will Identify And Examine These Marketplace Trends And Forecast Future Market Changes From 27 Through 213.

The Current Marketplace Is Highly Competitive Among Established Companies And New Entrants Expanding The Variety Of Tests Available As Mdks. To Differentiate Their Products From Competitors, New Technologies And Innovative Marketing Strategies Are Being Used.

In Addition To The Expansion Of The Market Through New Tests, The Mdk Market Is Also Affected By The Development Of Inexpensive, Automated Testing Devices, Known As Point-Of-Care (Poc) Instruments, Which Have Replaced Mdks In Smaller Laboratories And Physicians' Offices. This Trend Is Definitely Present In The Clinical Testing And Veterinary Markets. Additionally, Clinical Testing Is Being Affected By The Introduction Of Automated Suites Of Instruments Designed To Increase The Processing Of Diagnostic Assay Kits. All Of The Major Manufacturers Of Mdks Now Have Automated Suites Of Instrumentation For The Clinical, Research, And Veterinary Markets.

Intended Audience

This Study Of The Competitive And Evolving Mdk Industry Will Be Beneficial To Diagnostic Industry Participants Holding Marketing, Management, And Technical Development Positions. It Will Also Benefit Readers Who Are Suppliers To This Industry. Additionally, Investors, Venture Capitalists, Insurance Companies, And Those Interested In Diagnostic Medical Testing Will Find This Report Valuable.

Scope Of Report

All Products Classified As Mdks Are Found In This Report. These Include Products Prepackaged For In Vitro Manual Testing (Whether The End Point Is Detected By The Naked Eye Or By Using A Reading Device). The Report Specifically Excludes Tests That Involve Automated Testing Or Tests That Require Processing Devices And Semi-Automated Batch Testing Devices.

The Mdk Market Encapsulates Current And Potential Products, Related Technologies, Components And Component Suppliers, End Markets, Governmental And Regulatory Agencies, Major Companies Competing In This Market, Relative Market Shares, And The Impact Of The Worldwide Market Status.

This Study Defines The Mdk Market And Provides Detailed Information On The Following:

• Products That Comprise The Mdk Industry
• Emerging And Current Mdk Technologies
• Analysis Of These Technologies And Their Effect On Future Products And Market Growth
• Market Structure And Current Market Size, With Forecasts Through 213, By Each Segment
• Current Market Dynamics And Trends
• Emerging Marketing Practices, Such As Strategic Alliances And Acquisitions
• The Effect Of External Market Forces, Such As Insurance, Regulatory And Economic Issues, And Increased Incidence Of Disease
• Internal Aspects Of The Industry
• Specific Opportunities For Industry Participants And Industry Suppliers

Information Sources

Information Sources For This Report Include Company Websites And Product Literature, Financial Analyst Reports, Industry Association Members, And Industry Sources.

The Primary Data Collection Methodology For This Report Focuses On Information Provided By Industry Personnel, Through Web-Based Sources Or Interviews, Government Agencies, Industry Observers, And Industry Professional Organizations. In Addition To These Primary Data Sources, Secondary Data Research Techniques Include A Literature Search Of Medical, Government, And Business Libraries.

All Data Collected Were Analyzed By Bcc Personnel To Determine Specific Findings And To Make Forecasts. Once These Forecasts Were Obtained, They Were Validated 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 27 Dollars Based On The U.S. Manufacturers' (Wholesale) Price Levels, Unless Otherwise Noted.

Analyst Credentials

Vicki Mcconnell And Peggy Lehr Were Bcc Research Co-Project Directors Of This Report. Collectively, They Have More Than 4 Years Of Medical Industry Experience. Ms. Mcconnell Has Written Numerous Reports And Textbook Entries On Medical Equipment Components, Materials, And Manufacturing Methods. Ms. Lehr Specializes In Marketing Reports For A Variety Of Industries.

Contents

• Dawn Petershlc7g
• 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 213 ($ Millions)
• Summary Figure Projected U.S. Mdk Market By End-Use Segment, 27- 213 ($ 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 Projected U.S. Mdk Market Compared With The Total Diagnostic Testing Industry, Through 213 ($ Billions)
• Relation To Total Testing Market
• Figure Mdks Relative Share Of U.S. Testing Market Projected, Through 213 ($ Billions)
• Alternative Methods
• Table Alternative Methods To Mdks And Area Of Primary Use
• Chemical Assay
• Culture7
• Microscopy
• Biological Assay
• Chromatographic Separation
• Mdk Applications
• Table Selected Mdk Applications
• Industry Structure
• Reagents
• Device/Carrier
• Packaging
• Component Suppliers
• Figure Components Of An Mdk
• Table Selected Listing Of Mdk Component Suppliers By Area Of Participation
• End Markets
• Table Mdk Applications By End-Use Facility
• Clinical Testing Facilities
• Table 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 Selected Listing Of Animal Testing Mdks
• Internal Market Forces, External Market Forces
• Trade Practices
• Promotion
• Pricing
• Sales Tie-Ins
• Industry Channels Of Distribution
• Figure Channels Of Distribution For Mdks
• Strategic Alliances
• Acquisitions
• Table Selected Company Acquisitions, 199528
• Strategies In Consumer Advertising
• External Market Forces
• Figure 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 Clia Waived Tests
• Good Manufacturing Practice
• Table 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 Prevalence Of Selected Diseases In The U.S. Population* (Thousands Of Cases)
• Figure U.S. Population By Age Bracket, 25 And 21
• Trends In Point-Of-Care Testing
• Table Selected Listing Of Currently Marketed Poc Devices
• Table Projected U.S Point-Of-Care Device Market, Through 213 ($ Billions)
• -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 Major Mdk Applications By Type Of Technology
• Chemical Analysis
• Enzymatic Analysis
• Immunological Analysis
• Enzyme Immunoassay
• Basic Eia
• Figure 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 Projected U.S. Mdk Market By End-Use Segment, Through 213 ($ Millions)
• Clinical Laboratory Applications
• Infectious Disease Testing
• Table Selected Listing Of Bacteria Found In Clinical Specimens And The Diseases They Cause
• Table 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 Selected Listing Of Fda Approved Infectious Disease Testing Mdks By Type Of Assay
• Gene Probe Kits
• Market Size
• Table Projected Mdks Market For Infectious Disease Testing By Application, Through 213 ($ 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 Annual Incidence Of Sexually Transmitted Diseases In The U.S., 26*
• Chlamydia
• Human Papillomavirus
• Genital Herpes
• Streptococci
• Hepatitis
• Drug Testing
• Types Of Drugs
• Market Size
• Table Projected U.S. Mdk Drug Testing Market, Through 213 ($ Millions)
• Mdk Applications In Drug Testing
• Therapeutic Monitoring
• Diagnosing Overdoses
• Differential Diagnosis
• Detecting Drug Abuse72
• Table 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 Selected Listing Of Hormone Mdks By Company
• Market Size
• Table Projected U.S. Mdk Hormone Testing Market, Through 213 ($ Millions)
• Alternatives To Mdks
• Cancer Testing
• Incidence Of New Cancer Cases Annually
• Table Incidence Of New Cancer Cases In The U.S., 26 And 27 (Per Annum)
• Detection Of Cancer
• Mdks For Cancer Testing
• Table Selected Listing Of Cancer Diagnostics And Therapeutic Management Mdk Tests*
• Market Size And Structure
• Table Projected U.S. Market For Cancer Diagnostic Mdks: Non-Research Testing Applications, Through 213 ($ Millions)
• Blood/Urine Chemistry Testing
• Market Size And Structure
• Table Projected U.S. Blood/Urine Chemistry Mdk Market, Through 213 ($ Millions)
• Automation Versus Mdks
• Point-Of-Care (Poc) Analytical Systems Using Mdks
• Types Of Mdks
• Table Clia Approved Mdks For Blood/Urine Chemistry Testing By Company, 2227
• Dipsticks
• Emerging Mdks For Clinical Testing
• Biochips
• Reporter Genes
• Automatic Sequencing
• Home-Use Testing Market
• Market Size And Structure
• Table Projected U.S. Home-Use Mdk Market By Type Of Test, Through 213 ($ Millions)
• Home-Use Mdk Market Participants
• Table Selected Companies Marketing Home-Use Mdk Tests
• By Test Type
• Major Home-Use Mdk Segments
• Home Pregnancy And Ovulation Testing
• Market Size
• Table Projected U.S. Home-Use Pregnancy And Ovulation Testing Mdk Market, Through 213 ($ Millions)
• Market Participants
• Glucose Monitoring
• Market Size
• Table Projected U.S. Home-Use Glucose Testing Mdk Market, Through 213 ($ Millions)
• Cholesterol Testing
• Market Size
• Table Projected U.S. Home-Use Cholesterol Testing Mdk Market, Through 213 ($ 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 Projected U.S. Research Mdk Market, Through 213 ($ Millions)
• Research Areas
• Epigenetics
• Pcr-Based Assays
• Gene Mapping
• Gene Probes
• Molecular Biology
• Table Selected Types Of Mdks Marketed For Molecular Biology Research
• Table Projected U.S. Molecular Diagnostic Mdk Market, Through 213 ($ Millions)
• Veterinary Applications
• Veterinary Medicine
• Changes In The Practice Of Domestic Veterinary Medicine
• Market Size And Structure
• Table Projected U.S. Veterinary Testing Mdk Market, Through 213 ($ Millions)
• Table Demand For Veterinary Care For Domestic Pets, Through 213 (Visits Per Yr/Pets In Millions)
• Impact Of Automated Veterinary Systems
• Market Participants
• Veterinary Mdks
• Feline Leukemia Virus
• Table Selected Listing Of Veterinary Mdks And Suppliers For Companion Animalscanine, Feline, Avian, Equine
• Table 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
• Johnes Disease
• Chemistry Tests
• Appendix Clia Waived Tests: 2227
• Table Clia Waived Tests: 2227
• Appendix 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
• Ide 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 Companies By Product Type
• 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
• Ide 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.
• Summary Table Projected U.S. Mdk Market By End-Use Segment, Through 213 ($ Millions)
• Table Projected U.S. Mdk Market Compared With The Total Diagnostic Testing Industry, Through 213 ($ Billions)
• Table Alternative Methods To Mdks And Area Of Primary Use
• Table Selected Mdk Applications
• Table Selected Listing Of Mdk Component Suppliers By Area Of Participation
• Table Mdk Applications By End-Use Facility
• Table U.S. Clinical Testing Facilities With Potential For Using Mdks: Clia Vs. Non-Clia
• Table Selected Listing Of Animal Testing Mdks
• Table Selected Company Acquisitions, 199528
• Table Clia Waived Tests
• Table Pertinent Parameters Of Gmp Regulations Affecting Mdks
• Table Prevalence Of Selected Diseases In The U.S. Population* (Thousands Of Cases)
• Table Selected Listing Of Currently Marketed Poc Devices
• Table Projected U.S Point-Of-Care Device Market, Through 213 ($ Billions)
• Table Major Mdk Applications By Type Of Technology
• Table Projected U.S. Mdk Market By End-Use Segment, Through 213 ($ Millions)
• Table Selected Listing Of Bacteria Found In Clinical Specimens And The Diseases They Cause
• Table Major Viral Infectious Agents
• Table Selected Listing Of Fda Approved Infectious Disease Testing Mdks By Type Of Assay
• Table Projected Mdks Market For Infectious Disease Testing By Application, Through 213 ($ Millions)
• Table Annual Incidence Of Sexually Transmitted Diseases In The U.S., 26*
• Table Projected U.S. Mdk Drug Testing Market, Through 213 ($ Millions)
• Table Selected Listing Of Drug Testing Mdks Currently Marketed By Company
• Table Selected Listing Of Hormone Mdks By Company
• Table Projected U.S. Mdk Hormone Testing Market, Through 213 ($ Millions)
• Table Incidence Of New Cancer Cases In The U.S., 26 And 27 (Per Annum)
• Table Selected Listing Of Cancer Diagnostics And Therapeutic Management Mdk Tests*
• Table Projected U.S. Market For Cancer Diagnostic Mdks: Non-Research Testing Applications, Through 213 ($ Millions)
• Table Projected U.S. Blood/Urine Chemistry Mdk Market, Through 213 ($ Millions)
• Table Clia Approved Mdks For Blood/Urine Chemistry Testing By Company, 2227
• Table Projected U.S. Home-Use Mdk Market By Type Of Test, Through 213 ($ Millions)
• Table Selected Companies Marketing Home-Use Mdk Tests By Test Type
• Table Projected U.S. Home-Use Pregnancy And Ovulation Testing Mdk Market, Through 213 ($ Millions)
• Table Projected U.S. Home-Use Glucose Testing Mdk Market, Through 213 ($ Millions)
• Table Projected U.S. Home-Use Cholesterol Testing Mdk Market, Through 213 ($ Millions)
• Table Projected U.S. Research Mdk Market, Through 213 ($ Millions)
• Table Selected Types Of Mdks Marketed For Molecular Biology Research
• Table Projected U.S. Molecular Diagnostic Mdk Market, Through 213 ($ Millions)
• Table Projected U.S. Veterinary Testing Mdk Market, Through 213 ($ Millions)
• Table Demand For Veterinary Care For Domestic Pets, Through 213 (Visits Per Yr/Pets In Millions)
• Table Selected Listing Of Veterinary Mdks And Suppliers For Companion Animalscanine, Feline, Avian, Equine
• Table Selected Listing Of Veterinary Mdks And Suppliers For Livestock Animals (Avian, Bovine, Swine, Equine)
• Table Clia Waived Tests: 2227
• Table Companies By Product Type
• Summary Figure Projected U.S. Mdk Market By End-Use Segment, 27- 213 ($ Millions)
• Figure Mdks Relative Share Of U.S. Testing Market Projected, Through 213 ($ Billions)
• Figure Components Of An Mdk
• Figure Channels Of Distribution For Mdks
• Figure External Market Factors Affecting The Mdk Industry
• Figure U.S. Population By Age Bracket, 25 And 21
• Figure The Basic Enzyme Immunoassay (Eia) Process