World Automated and Rapid Microbiological Tests Market

World Automated and Rapid Microbiological Tests Market

This report analyzes the worldwide markets for Automated and Rapid Microbiological Tests in Millions of US$. The Major End-Use Segments Analyzed are Clinical Applications (Automated Identification & Susceptibility Systems, Automated Blood Culture Systems, Automated Tuberculosis Systems, Streptococcal Infection Rapid Tests, GC/Chlamydia Rapid Tests, & Other Automated & Rapid Microbiological Tests), and Non-Clinical Applications. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2000 through 2015. The report profiles 128 companies including many key and niche players worldwide such as Abbott Laboratories, Abbott Diagnostics, Becton Dickinson and Company, bioMerieux, bioMerieux, Inc., Bio-Rad Laboratories, Cellabs Pty Ltd, Celsis International Plc., Coris BioConcept, F. Hoffmann-La Roche Ltd., Gen-Probe Incorporated, Genzyme Diagnostics, Inverness Medical Innovations, Inc., Unipath Limited, MedMira Inc., Meridian Biosciences, Inc., Orasure Technologies, Inc., Orion Diagnostica Oy, Quidel Corporation, Siemens Medical Solutions Diagnostics, Thermo Fisher Scientific, Inc., Remel, Inc., and Oxoid Limited. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

AUTOMATED AND RAPID MICROBIOLOGICAL TESTS MCP-1093
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Automated and Rapid Microbiological Tests: A Definition I-3
Clinical Applications I-4
Automated Identification and Susceptibility Systems I-4
Automated Blood Culture Systems I-4
Automated Tuberculosis Systems I-4
Streptococcal Infection Rapid Tests I-4
GC/Chlamydia Rapid Tests I-4
Other Automated & Rapid Microbiological Tests I-5
Non-Clinical Applications I-5


II. EXECUTIVE SUMMARY

1. Industry Overview II-1
Outlook II-1
Evolutionary Battle Against the Bugs Drives the Future of the
Market II-1
Automated Microbiological Tests: A Pesky Gray Area in the
Clinical Diagnostics Market II-1
Traditional Rapid Microbiological Tests Destined to Go Out
With the Old II-2
A Current & Future Analysis II-2
Segmental Perspective II-3
Clinical Applications II-3
Non-Clinical Applications II-3
Macro: The Big Picture II-3
Deciding the Market’s Future II-4
A Holistic Peek into a Few Noteworthy Trends II-4
Biotechnology & Rapid Microbial Tests II-5
Automated & Rapid Microbiological Tests: “Current Market Stance” II-5
A Business Case for Automated & Rapid Microbiological Testing II-6
Near Patient Testing: An Offshoot of Rapid Microbiological Tests II-6
Pros & Cons of Near Patient Testing II-7
Role of Near Patient Testing in Reducing Antibiotic
Resistance in Humans II-7
The Pre/Post Microbial Rapid Testing Era: A Review II-8
Market Structure II-8
Competitive Setup of the Diverse Automated & Rapid
Microbiology Products Market II-8
Historic Data II-9
Table 1: Leading Players in World Market for IVD Automated
Microbiology Systems (2000) - Percentage Breakdown of Value
Sales by Company forbioMerieux, Dade Behring, Becton
Dickinson,Organon Teknika, and Others
(includescorresponding Graph/Chart) II-9

2. Trends & Issues II-10
Advancements in Molecular Diagnostics - A Boon or a Threat II-10
Antibiotic Resistant Bacteria Throws the Spotlight On
Microbial Testing II-10
Instant Detection of Pathogens - A New Epoch in the Fight for
Survival II-11
Lower Cost Rapid Tests Built on Multiple Sampling Modalities -
Gaining Momentum II-11
“Time Constraints?” - Rapid Tests to the Rescue II-11
Rapid HIV Tests: A New Age Diagnostic Weapon Against the
Killer Disease II-12
Accuracy/Reliability of Home HIV Testing: A Bone of Contention II-12
Development of Near Patient Test Kits: A Market Driven Phenomenon II-13
Near Patient Test Kits: A Rumination of Possibilities II-13
Automated Blood Culture Systems: A Winning Edge in the Fight
Against Bacteremia II-13
Leading Food Processors Resort to Rapid Microbiological Testing II-14
Impact of Food Scares on Rapid Microbiological Tests Market II-15
Demand for Microbiological Tests & Level of QC in the Food
Industry II-15
Rapid Tests Creating Brighter Avenues in Food Microbiology
Testing Market II-16
Dire Need to Nip Operating Costs Throws the Spotlight on Rapid
Tests II-16
Key Advantages/Benefits of Rapid Microbiological Tests on Food II-17
Food Packages of the Future Ingrained with Microbial Alert
Systems II-17
Technology Innovations in Rapid Food Microbial Testing II-17
Obtaining Regulatory Approval - A Major Non-Technical Hindrance II-18

3. Factors Influencing the Market II-19
Continuing Biological Warfare with Pathogens Sparks Market Growth II-19
Innovative Products - A Key Growth Strategy II-19
Other Market Drivers in a Capsule II-19
Low Turnaround Times Skyrocket Demand II-19
Greater Patient Awareness II-19
Rising Incidence of STDs Kindles Universal Market Acceptance II-20
Ultra-Rapid HIV-Screening Tests- A Strong Fight against HIV-
Epidemic II-20
Validation of Rapid Microbiological Tests: An Imperative
Prerequisite II-20
Non-Conformance to Testing Requirements: A Weighty Concern II-21
Influenza - Boosting Rapid Test Prospects II-21

4. Product/Technology Overview II-23
Automated & Rapid Microbiological Tests: A Definition II-23
Benefits of Automated & Rapid Microbiological Tests II-23
Classification of Rapid Microbiological Test Methods II-24
How Does a Rapid Test Work? II-24
Sample Preparation - A Key Procedure II-25
Automated Identification and Susceptibility Systems II-25
Automated Blood Culture Systems II-25
Automated Tuberculosis Systems II-26
Microminiaturization of Diagnostic Tests: How Is It Effected? II-26
Advantages of Microminiaturisation: II-26
Acid-Fast Microscopy - The Forerunner of Rapid Tests II-27
Gram's Stain: A Time-Honored & Rapid Method to Detect
Pathogens in Blood II-27
Enabling Technologies of Automated & Rapid Microbiological Tests II-28
Growth-based Technologies II-28
Viability-based Technologies II-28
Cellular-Component or Artifact-based Technologies II-28
Genomics/ Proteomics II-28
Microarrays/ Microfluidics II-29
DNA Microchips/Probes II-29
Polymerase Chain Reaction (PCR) II-30
Immunoassay II-30
Immunoassay Escalates into Diverse Fields of Diagnostic Testing II-30
Nucleic Acid Testing (NAT) II-31
Nucleic Acid Probes II-31
Signal-Amplified Tests II-31
Nucleic Acid Amplification Tests II-31
Traditional Methods with Computer-Aided Imaging II-32
Combination Methods II-32

5. End-Use Application Analysis II-33
Applications in Clinical Investigations II-33
STD Rapid Tests II-33
GC/Chlamydia Rapid Tests II-33
HIV Rapid Tests II-34
HIV Facts & Figures II-34
Advantages of Rapid HIV Testing II-35
Disadvantages of Rapid HIV Testing II-35
Syphilis Rapid Tests II-36
Respiratory Rapid Tests II-36
RSV/ Influenza Rapid Tests II-36
Tuberculosis Rapid Tests II-37
Group A beta Hemolytic Streptococcus Rapid Tests II-37
Mononucleosis Rapid Tests II-37
Streptococcus Rapid Tests II-37
Streptococcus A Rapid Tests II-38
Streptococcus B Rapid Tests II-38
Gastrointestinal Rapid Tests II-39
Giardia Lamblia Rapid Tests II-39
H. Pylori Rapid Tests II-39
Cryptosporidium Rapid Tests II-39
C. Difficile Rapid Tests II-40
Applications in Non-Clinical Investigations II-40
Food/Water Safety Tests II-40
Food Safety Testing: A Lucrative Application Area II-41
Rapid Microbiological Methods in Pharmaceutical Sector II-41
Limitations of RMMs II-42
Advantages of RMMs II-42
Applications in Pharmaceutical Sector II-42
Environmental Tests II-43
Other Miscellaneous Applications II-43

6. Product Innovations/Introductions II-44
Meridian Bioscience Rolls Out Two New Rapid Tests for
Detecting Epstein-Barr Virus II-44
Oxoid Introduces Staph Plus System for Identifying
Staphylococcal Species II-44
Siemens Healthcare Diagnostics Launches MicroScan® WalkAway®
plus Diagnostic Microbiology Systems II-44
Bio-Rad Launches a Rapid test for Screening MRSA, MRSASelect™
test, in US II-44
bioMérieux Introduces VIDAS®, an automated Clostridium
difficile A & B Toxins Detection Test II-45
Oxoid Launches Remel Wellcolex® Colour Tests for Testing
Shigella, E. coli O157 and Salmonella II-45
Siemens Healthcare Diagnostics Obtains Health Canada Approval
for its VERSANT 440 Molecular System II-45
Oxoid Unveils Remel Xpect™ Clostridium Difficile Toxin A/B Test II-46
Neogen Introduces Soleris System II-46
ATCC Introduces Authenticult™ Quality Control Microbiological
Testing Tool II-46
Bio-Rad Introduces New EBV Kits II-46
Roche Seeks FDA Marketing Approval for Hepatitis C Virus Test II-46
Roche Seeks US FDA Approval for its Cobas TaqScreen MPX Test II-47
FDA Clears Usage of TIGRIS® System for Testing WNV in Donated
Blood II-47
FDA Approves ImmunoCard STAT!® EHEC for Detecting E. coli
Infection II-47
bioMérieux Introduces TEMPO® Quality Indicator Testing System II-47
Biotrace Introduces Tecra Unique Campylobacter Rapid Test II-48
bioMérieux Introduces TEMPO® EB test for Enterobacteriaceae II-48
Roche Unveils Elecsys TORCH Assays II-48
Roche Diagnostics Introduces Cobas TaqMan MTB Test in Japan II-48
bioMérieux Develops Advanced Colorimetry™ NH Card II-48
Roche Introduces Rapid LightCycler SeptiFast Sepsis Test
across EU II-49
Oxoid Launches New Rapid Test for Salmonella Detection in Food
Products II-49
Oxoid Unveils New Contact Plate Design II-49
FDA Approves Fluconazole Susceptibility Tests from BioMérieux II-49
Polysciences Unveils New Microbiological & Bacterial Detection
Applications II-50
Researchers Develop New Rapid MODS Test for TB Detection II-50
Dade Behring Unveils Automated Quadriga BeFree System II-50
FDA Approves Abbott PRISM® HBsAg Assay II-50
Bayer’s EHIV Test Receives FDA Clearance II-51
Gen-Probe Obtains FDA Approval to Use Aptima Test on
Additional Specimens II-51
Roche Diagnostics’ cobas TaqScreen MPX Test Receives CE Mark
Approval II-51
Cepheid Introduces Rapid Xpert® MRSA Test in Europe II-51
Bio-Rad Widens Culture Media with Addition of RAPID'Salmonella II-51
Chemogen Develops New Tuberculosis Rapid Test II-52
bioMerieux Rolls Out VIDAS® LDUO Test II-52
Zonda Develops New Rapid Test for Chlamydia II-52
MedMira Launches MiraCare Rapid HIV Test II-52
STMicroelectronics and Mobidiag Unveil Lab-On-Chip II-52
Vermicon Launches ScanVIT-Legionella Rapid Test Kit II-53
New Line of Rapid Microbial Detection Systems from Centrus II-53
OraSure Rolls Out OraQuick ADVANCE II-53
Abbott Unveils Automated HCV Test II-53
ViroMed Rolls Out Rapid PCR Tests for Detecting Influenza and
Respiratory Pathogens II-53
Biophage Pharma Offers Service for Microbiological Testing II-53
bioMerieux Releases New Rapid Test for Nosocomial Infections II-54
bioMerieux Widens Product Portfolio with Addition of TEMPO®
System II-54
Celsis Introduces CellScan Innovate Rapid Screening System II-54
Millipore Rolls Out Rapid Microbiology Detection System II-54
Calypte Biomedical Develops Oral Fluid Rapid Test for HIV- 1/2 II-54
BioMerieux Unveils VITEK® 2 Compact II-55
Bio-Rad Unveils New Test Kits and Comprehensive Automated Systems II-55

7. Recent Industry Activity II-56
Becton, Dickinson Establishes New Rapid Diagnostic Products
Manufacturing Facility in China II-56
Quidel Corporation Obtains CLIA Waiver from US FDA for its
QuickVue(R) RSV Test II-56
Siemens Obtains US FDA Approval for its VERSANT™ 440
Molecular System II-56
bioMérieux to Market Wescor’s Customized Slide Stainer
Instruments under bioMérieux Brand II-56
Schering-Plough and OraSure Ink Collaboration Agreement for
Developing Rapid Oral HCV Test II-57
Abbott Obtains US FDA Approval for its Automated HTLV-I/HTLV
-II Blood Screening Test II-57
Quidel and bioMérieux Form a Long-term Alliance in Rapid
Diagnostic Tests II-57
BD Diagnostics Obtains US FDA Approval BD GeneOhm™ StaphSR assay II-57
Meridian Bioscience Obtains US FDA Approval for Two New Rapid
Tests II-58
Siemens AG Acquires Dade Behring II-58
Thermo Fisher Scientific Teams Up with KBA for Expanding its
Microbiology Business Division in Lenexa II-58
OraSure and SCMS Enter into an Agreement for Supplying
OraQuick(R) HIV Test to PEPFAR Countries II-58
Abbott Obtains US FDA Approval for its Fully Automated PRISM®
HCV Test II-59
Gen-Probe Obtains US FDA Approval for its PROCLEIX® TIGRIS®
System for Testing Donated Blood II-59
AdvanDx Ropes In bioMérieux for Distributing its Rapid
Diagnostic Tests in US II-59
3M and Gen-Probe Join Hands to Develop Rapid Molecular Tests
For Detecting HAIs II-59
Gen-Probe’s PROCLEIX® TIGRIS® System Obtains US FDA Approval
for Screening Donated Blood for West Nile Virus II-60
3M Acquires Acolyte Biomedica II-60
Formation of Siemens Medical Solutions Diagnostics II-61
bioMérieux Bags Contract to Provide VITEK® 2 System for
Scottish NHS Labs II-61
bioMérieux Licenses NorChip’s HPV Test Technology for Cervical
Cancer II-61
bioMérieux in Strategic Agreement with Cepheid for Sepsis Assays II-62
3M Health Care Creates New Medical Diagnostics Unit II-62
Schering-Plough & OraSure to Develop Rapid Oral HCV Test II-62
3M Acquires Biotrace International II-62
Siemens Acquires DPC II-63
Oxoid Acquires Microbiology Business Activities of Dako II-63
Inverness Acquires IDT and Thermo BioStar II-63
BMD in Agreement with MND for Research on Diagnostic Tests II-64
Cepheid Wins CDC Contract to Develop Rapid Bird Flu Virus
Detection Test II-64
Dutch Government Grants €7.9 Million to FIND II-64
FIND and Hain to Develop Rapid Test for MDR and XDR TB II-65
3M & Gen-Probe Ally for Developing Rapid Molecular Tests for
Food Safety II-65
Bio View Inks Three-Year Distribution Agreement with Abbott
Molecular II-65
Bodycote Acquires Foodscan Laboratories II-66
Cepheid Bags STTR Funding for Development of Rapid TB Test II-66
Abbott and Verax in Distribution Agreement for Verax Platelet
PGD® Test II-66
BSL Supplies ABBOTT PRISM® System to Blood Donor Testing Centers II-66
Abbott & ARC in Agreement for Automated Blood Screening Tests II-67
BD to Set Up Production Facility for Rapid Diagnostic Products
in China II-67
BD Diagnostics Delivers STI Testing Products to BioReference II-67
Meridian Licenses LAMP Diagnostic Test Technology from Eiken II-67
OraSure Inks Multi-Year Purchase Contract with New York City II-68
Abbott Inks Single-Source Agreement with Novation for HIV Test II-68
Neogen Takes Over Centrus International II-68
Becton, Dickinson and Company Acquires GeneOhm Sciences II-68
Inverness Medical Innovations Makes a Synergetic Purchase of
ACON Laboratories II-69
Quest Diagnostics Strikes Deal with BD Diagnostics II-69
Novation Inks Pact with Abbott for Rapid HIV-1/2 Antibody Test II-69
TREK Diagnostic and Novation Inks Agreement II-69
Clinton Foundation Inks Agreement with Four Companies to Cut
Prices II-69
Chembio Obtains FDA Approval for HIV 1/2 Stat-Pak and Sure
Check HIV 1/2 Rapid Test PMAs II-69
Roche’s LightCycler SeptiFast Test Attains CE Mark II-70
Zonda Expands Distribution of Products in Europe II-70
OraSure Wins Rapid HIV Tests Order II-70
MedMira Secures Orders for Rapid HIV Tests II-70
Cepheid Collaborates with Foundation for Innovative Diagnostics II-70
Chembio Obtains Clearance for Rapid HIV Tests in Kenya II-71
Genesis Bioventures Bags US Patent for Rapid Prion- Detection
Assay II-71
MedMira Obtains CE Mark for MiraCare II-71
Setema to Distribute Chembio’s Rapid HIV Tests in Ethiopia II-71
Clinton Foundation HIV/AIDS Initiative Selects Chembio to
Provide Rapid HIV Tests II-71
Quidel Acquires immunochemical Fecal Occult Blood Test II-71
Xact Aid Snaps Up STD Alert II-71
Grant Life Sciences Acquires Rapid Tests from AccuDx II-72
Millipore Ties Up with Gen-Probe II-72
Foundation for Innovative New Diagnostics forms Collaboration
with Eiken Chemical II-72
WayPoint and Global Rapid Diagnostic Leader Enter into an
Agreement II-72
Akers Biosciences Enters into a Distribution Agreement with
Alco Industries II-72
Celsis and BioVentures Enter into Licensing Agreement II-72
Thermo Electron Inks Pact with Genomic Profiling Systems II-73
Abbott and OraSure Enters into Agreement for OraQuick ADVANCE
Rapid HIV-1/2 Test II-73
bioMérieux Signs Agreement with Novel Diagnostics II-73
Dade Behring Bags FDA Approval for Antimicrobial
Susceptibility Test Panels II-73
OraSure Bags HCV Patent License from Chiron and Ortho-
Clinical Diagnostics II-73
BD Diagnostics Receives FDA Approval for BD Directigen™ EZ Flu
A+B Test II-74
BD Diagnostics Bags FDA Clearance for BBL™ CHROMagar™ MRSA
Product II-74
MedMira Obtains Rights to Market Rapid HIV Tests in Guizhou
Province, China II-74
Gen-Probe Obtains FDA Clearance for PROCLEIX® West Nile Virus
Assay II-74
Medical Services International Secures Clearance for Rapid
Test Kits II-74
Medical Services International Receives Exclusive Marketing
Rights for TB Test Kit II-74
Adaltis Receives Orders for HIV Rapid Tests from China II-74
MedCap Bags Exclusive Distribution Rights for Syphilis Rapid Test II-74
Genomic Profiling Systems Obtains NIAID Funds to Develop
Testing Platform II-75
Gen-Probe Obtains US Patent for Automated Process for Nucleic
Acid Testing II-75
Bio-Rad Receives Approval for HIV-1/HIV-2 Rapid Test II-75
Cambrex Makes a Synergetic Purchase of Genolife II-75
Cambrex Bioproducts Acquires Worldwide License from Epoch
Biosciences II-75
Cambrex Forges Licensing Agreement with John Hopkins University II-76
Calypte Biomedical and Adaltis Enters into an Agreement II-76
Calypte Biomedical Signs MoU with Pacific Biotech II-76
GlaxoSmithKline Process Employing Pall Rapid Test Receives FDA
Approval II-76
Binax Receives FDA Approval for NOW Influenza A & B Rapid Test II-76
Spectral Diagnostics and IDx Inc. Announce US$12 Million R&D
Project II-76
Genome Therapeutics Transfers Streptococcus Pneumoniae Patent
to Aventis II-77
Abbott Inks an Agreement with BioGenex Laboratories II-77
Bio-Rad and Enzon Announce Marketing Agreement II-77
bioMérieux and Omnimed Join Forces to Fight Against AIDS II-77

8. Focus on Select Global Players II-78
Abbott Laboratories (USA) II-78
Abbott Diagnostics (USA) II-78
Becton Dickinson and Company (USA) II-78
bioMerieux (France) II-79
bioMerieux, Inc. (USA) II-79
Bio-Rad Laboratories (USA) II-79
Cellabs Pty Ltd (Australia) II-80
Celsis International Plc (UK) II-80
Coris BioConcept (Belgium) II-80
F. Hoffmann-La Roche Ltd. (Switzerland) II-81
Gen-Probe Incorporated (USA) II-81
Genzyme Diagnostics (USA) II-81
Inverness Medical Innovations, Inc. (USA) II-82
Unipath Limited (UK) II-82
MedMira Inc. (Canada) II-82
Meridian Biosciences, Inc. (USA) II-83
Orasure Technologies, Inc. (USA) II-83
Orion Diagnostica Oy (Finland) II-83
Quidel Corporation (USA) II-84
Siemens Medical Solutions Diagnostics (USA) II-84
Thermo Fisher Scientific, Inc. (USA) II-85
Remel, Inc. (USA) II-85
Oxoid Limited (UK) II-85

9. Global Market Perspective II-86
Table 2: World Recent Past, Current & Future Market Analysis
for Automated and Rapid Microbiological Tests by Geographic
Region - US, Europe, and Rest of World Independently Analyzed
with Annual Revenues in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-86

Table 3: World Long-term Projections for Automated and Rapid
Microbiological Tests by Geographic Region - US, Europe, and
Rest of World Independently Analyzed with Annual Revenues in
US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-87

Table 4: World 10-Year Perspective for Automated and Rapid
Microbiological Tests by Geographic Region - Percentage
Breakdown of Revenues for US, Europe, and Rest of World for
Years 2003, 2008 & 2012 (includes corresponding Graph/Chart) II-88

Table 5: World Recent Past, Current & Future Market Analysis
for Automated and Rapid Microbiological Tests in Clinical
Applications by Geographic Region - US, Europe, and Rest of
World Independently Analyzed with Annual Revenues in US$
Million for Years 2000 through 2010 (includescorresponding
Graph/Chart) II-89

Table 6: World Long-term Projections for Automated and Rapid
Microbiological Tests in Clinical Applications by Geographic
Region - US, Europe, and Rest of World Independently Analyzed
with Annual Revenues in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) II-90

Table 7: World Recent Past, Current & Future Market Analysis
for Automated and Rapid Microbiological Tests in Clinical
Applications by Equipment Used - Automated Identification &
Susceptibility Systems, Automated Blood Culture Systems,
Automated Tuberculosis Systems,Streptococcal Infection Rapid
Tests, GC/Chlamydia RapidTests and Other Automated & Rapid
Microbiological Tests Independently Analyzed with Annual
Revenues in US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-91

Table 8: World Long-term Projections for Automated and Rapid
Microbiological Tests in Clinical Applications by Equipment
Used - Automated Identification & Susceptibility Systems,
Automated Blood Culture Systems, Automated Tuberculosis
Systems, Streptococcal Infection Rapid Tests, GC/Chlamydia
RapidTests and Other Automated & Rapid Microbiological Tests
IndependentlyAnalyzed with Annual Revenues in US$ Million for
Years 2011 through 2015 (includes corresponding Graph/Chart) II-92

Table 9: World 10-Year Perspective for Automated and Rapid
Microbiological Tests in Clinical Applicationsby Geographic
Region - Percentage Breakdown of Revenues for US, Europe, and
Rest of World forYears 2003, 2008 & 2012 (includes
corresponding Graph/Chart) II-93

Table 10: World 10-Year Perspective for Automated and Rapid
Microbiological Tests in Clinical Applications by Equipment
Used - Percentage Breakdown of Revenues for Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems, Streptococcal
Infection Rapid Tests, GC/Chlamydia RapidTests and Other
Automated & Rapid Microbiological Tests for Years 2003, 2008 &
2012 (includes corresponding Graph/Chart) II-94

Table 11: World Recent Past, Current & Future Market Analysis
for Automated Identification & Susceptibility Systems in
Clinical Applications by Geographic Region - US, Europe, and
Rest of World Independently Analyzed with Annual Revenues in
US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-95

Table 12: World Long-term Projections for Automated and Rapid
Microbiological Tests in Clinical Applications by Equipment
Used - Automated Identification & Susceptibility Systems,
Automated Blood Culture Systems, Automated Tuberculosis
Systems, Streptococcal Infection Rapid Tests, GC/Chlamydia
RapidTests and Other Automated & Rapid Microbiological Tests
IndependentlyAnalyzed with Annual Revenues in US$ Million for
Years 2011 through 2015 (includes corresponding Graph/Chart) II-96

Table 13: World 10-Year Perspective for Automated
Identification & Susceptibility Systems in Clinical
Applications by Geographic Region - Percentage Breakdown of
Revenues for US, Europe, and Rest of World for Years 2003,
2008 & 2012 (includes corresponding Graph/Chart) II-97

Table 14: World Recent Past, Current & Future Market Analysis
for Automated Blood Culture Systems in Clinical Applications
by Geographic Region - US, Europe, and Rest of World
Independently Analyzed with Annual Revenues in US$ Million for
Years 2000 through 2010 (includes corresponding Graph/Chart) II-98

Table 15: World Long-term Projections for Automated Blood
Culture Systems in Clinical Applications by Geographic Region
- US, Europe, and Rest of World Independently Analyzed with
Annual Revenues in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-99

Table 16: World 10-Year Perspective for Automated Blood
Culture Systems in Clinical Applications by Geographic Region
- Percentage Breakdown of Revenues for US, Europe, and Rest of
World for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) II-100

Table 17: World Recent Past, Current & Future Market Analysis
for Automated Tuberculosis Systems in Clinical Applications by
Geographic Region - US, Europe, and Rest of World
Independently Analyzed with Annual Revenues in US$ Million for
Years 2000 through 2010 (includes corresponding Graph/Chart) II-101

Table 18: World Long-term Projections for Automated
Tuberculosis Systems in Clinical Applications by Geographic
Region - US, Europe, and Rest of World Independently Analyzed
with Annual Revenues in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) II-102

Table 19: World 10-Year Perspective for Automated Tuberculosis
Systems in Clinical Applications by Geographic Region -
Percentage Breakdown of Revenues for US, Europe, and Rest of
World for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) II-103

Table 20: World Recent Past, Current & Future Market Analysis
for Streptococcal Infection Rapid Tests in Clinical
Applications by Geographic Region - US, Europe, and Rest of
World Independently Analyzed with Annual Revenues in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) II-104

Table 21: World Long-term Projections for Streptococcal
Infection Rapid Tests in Clinical Applications by Geographic
Region - US, Europe, and Rest of World Independently Analyzed
with Annual Revenues in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) II-105

Table 22: World 10-Year Perspective for Streptococcal
Infection Rapid Tests in Clinical Applications by Geographic
Region - Percentage Breakdown of Revenues for US, Europe, and
Rest of World for Years 2003, 2008 & 2012 (includes
corresponding Graph/Chart) II-106

Table 23: World Recent Past, Current & Future Market Analysis
for GC/Chlamydia Rapid Tests in Clinical Applications by
Geographic Region - US, Europe, and Rest of World
Independently Analyzed with Annual Revenues in US$ Million for
Years 2000 through 2010 (includes corresponding Graph/Chart) II-107

Table 24: World Long-term Projections for GC/Chlamydia
RapidTests (*) in Clinical Applications by Geographic Region -
US, Europe, and Rest of World Independently Analyzed with
Annual Revenues in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-108

Table 25: World 10-Year Perspective for GC/Chlamydia Rapid
Tests in Clinical Applications by Geographic Region -
Percentage Breakdown of Revenues for US, Europe, and Rest of
World for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) II-109

Table 26: World Recent Past, Current & Future Market Analysis
for Other Automated & Rapid Microbiological Tests in Clinical
Applications by Geographic Region - US, Europe, and Rest of
World Independently Analyzed with Annual Revenues in US$
Million for Years 2000 through 2010(includes corresponding
Graph/Chart) II-110

Table 27: World Long-term Projections for Other Automated &
Rapid Microbiological Tests in Clinical Applications by
Geographic Region - US, Europe, and Rest of World
Independently Analyzed with Annual Revenues in US$ Million for
Years 2011 through 2015 (includes corresponding Graph/Chart) II-111

Table 28: World 10-Year Perspective for Other Automated &
Rapid Microbiological Tests in Clinical Applications by
Geographic Region - Percentage Breakdown of Revenues for US,
Europe, and Rest of World for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-112

Table 29: World Recent Past, Current & Future Market Analysis
for Automated and Rapid Microbiological Tests in Non-Clinical
Applications by Geographic Region - US,Europe, and Rest of
World Independently Analyzed with Annual Revenues in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) II-113

Table 30: World Long-term Projections for Automated and Rapid
Microbiological Tests in Non-Clinical Applications by
Geographic Region - US, Europe, and Rest of World
Independently Analyzed with Annual Revenues in US$ Million for
Years 2011 through 2015 (includes corresponding Graph/Chart) II-114

Table 31: World 10-Year Perspective for Automated and Rapid
Microbiological Tests in Non-Clinical Applications by
Geographic Region - Percentage Breakdown of Revenues for US,
Europe, and Rest of World for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-115


III. MARKET

1. The United States III-1
A.Market Analysis III-1
A Current & Future Analysis III-1
Rapid Microbiology Tests - A Competitive Profile III-1
Consolidation in the Automated and Rapid Microbiological
Tests Market III-1
Bioterrorism Tests - Gaining Prominence III-1
Tracking Trends Across Product Segments III-2
STD Rapid Tests III-2
Market Share Trends of Leading Players: III-2
Table 32: Leading Players in the US Market for
GC/Chlamydia Rapid Tests (2004 & 2005) - Percentage
Breakdown of Value Sales by Company for Gen-Probe,
Abbott, Becton Dickinson and Roche (includes
corresponding Graph/Chart) III-2

Table 33: Leading Players in the US Market for Chlamydia
Rapid Tests (2004 & 2005) - Percentage Breakdown of Value
Sales by Company for Thermo Electron, Wampole / Inverness
Medical Innovations, and Quidel (includes corresponding
Graph/Chart) III-3

Table 34: Leading Players in the US Market for Syphilis
Rapid Tests (2004 & 2005) - Percentage Breakdown of Value
Sales by Company for Becton Dickinson, Wampole/Inverness
Medical Innovations, and Others (includes corresponding
Graph/Chart) III-3
Leading Players in HIV Rapid Testing Market III-4
Gastrointestinal Rapid Tests III-4
Market Share Trends of Leading Players III-4
Table 35: Leading Players in the US Market for C.
Difficile Rapid Tests (2004 & 2005) -Percentage Breakdown
of Value Sales by Company for Wampole/Inverness Medical
Innovations, Meridian Biosciences, BioSite, Becton
Dickinson, Thermo Electron, and Others (includes
corresponding Graph/Chart) III-4

Table 36: Leading Players in the US Market for
Cryptosporidium Rapid Tests (2004 & 2005) - Percentage
Breakdown of Value Sales by Company for Remel, Meridian
Biosciences, and Becton Dickinson (includes
correspondingGraph/Chart) III-5

Table 37: Leading Players in the US Market for Rotavirus
Rapid Tests (2004 & 2005) - Percentage Breakdown of Value
Sales by Company for Meridian Biosciences,
FisherScientific, and Others (includes corresponding
Graph/Chart) III-5

Table 38: Leading Players in the US Market for Giardia
Rapid Tests (2004 & 2005) - Percentage Breakdown of
Value Sales by Company for Remel, Meridian Biosciences,
and Becton Dickinson (includes corresponding Graph/Chart) III-6
Respiratory Rapid Tests III-6
Competition: III-6
Table 39: Leading Players in the US Market for Influenza
Rapid Tests (2004 & 2005) - Percentage Breakdown of Value
Sales by Company for Quidel, Becton Dickinson, Thermo
Electron, Binax and Others (includes corresponding
Graph/Chart) III-7

Table 40: Leading Players in the US Market for RSV Rapid
Tests (2004 & 2005) - Percentage Breakdown of Value Sales
by Company for Becton Dickinson, Binax, Thermo Electron
and Others (includes corresponding Graph/Chart) III-7

Table 41: Leading Players in the US Market for
Tuberculosis Rapid Tests (2004 & 2005) - Percentage
Breakdown of Value Sales by Company for Gen-Probe, and
Becton Dickinson III-8

Table 42: Leading Players in the US Market for M.
Pneumoniae Rapid Tests (2004 & 2005) - Percentage
Breakdown of Value Sales by Company for Meridian
Biosciences, and Remel, Inc. III-8

Table 43: Leading Players in the US Market for
Mononucleosis Rapid Tests (2004 & 2005) - Percentage
Breakdown of Value Sales by Company for Wampole, Remel,
Quidel, Thermo Electronand Others (includes
corresponding Graph/Chart) III-8
Streptococcus Infection Rapid Tests III-9
Table 44: Leading Players in the US Market for
Streptococcus A Rapid Tests (2004 & 2005) -Percentage
Breakdown of Value Sales by Company for Quidel, Thermo
Electron, Becton Dickinson, Genzyme and Others (includes
corresponding Graph/Chart) III-9
Average Prices III-10
Table 45: Average Costs for Rapid Tests in the US (includes
corresponding Graph/Chart) III-10
A Peek into the Testing Practices of the US Food Industry III-10
Table 46: Microbiology Tests in the US Food Industry by
Sector: 2001 (includes corresponding Graph/Chart) III-11
Product Innovations/Introductions III-11
Strategic Corporate Developments III-18
Focus on Key Players III-31
Abbott Laboratories III-31
Abbott Diagnostics III-31
Arlington Scientific, Inc. III-32
Becton Dickinson And Company III-32
bioMerieux, Inc. III-32
Bio-Rad Laboratories III-32
Gen-Probe Incorporated III-33
Genzyme Diagnostics III-33
Inverness Medical Innovations, Inc III-33
Meridian Biosciences, Inc. III-34
Orasure Technologies, Inc. III-34
Quidel Corporation III-35
Remel Inc. III-35
Siemens Healthcare Diagnostics III-35
B.Market Analytics III-36
Table 47: US Recent Past, Current & Future Market Analysis
for Automated & Rapid Microbiological Tests by End-Use
Segment - Clinical Applications (Automated Identification &
Susceptibility Systems, Automated Blood Culture Systems,
Automated Tuberculosis Systems, Streptococcal Infection
Rapid Tests, GC/Chlamydia Rapid Tests, and Other Automated &
Rapid Microbiological Tests) and Non-Clinical Applications
Independently Analyzed with Annual Revenues in US$ Million
for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-36

Table 48: US Long-term Projections for Automated & Rapid
Microbiological Tests by End-Use Segment - Clinical
Applications (Automated Identification & Susceptibility
Systems, Automated Blood Culture Systems, Automated
Tuberculosis Systems, Streptococcal Infection Rapid Tests,
GC/Chlamydia Rapid Tests, and Other Automated & Rapid
Microbiological Tests) and Non-Clinical Applications
Independently Analyzed with Annual Revenues in US$ Million
for Years 2011 through 2015 (includes corresponding
Graph/Chart) III-37

Table 49: US 10-Year Perspective for Automated & Rapid
Microbiological Tests by End-Use Segment - Percentage
Breakdown of Revenues for Clinical Applications (Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems,
Streptococcal Infection Rapid Tests, C/Chlamydia Rapid
Tests, and Other Automated & Rapid MicrobiologicalTests) and
Non-Clinical Applications for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-38

Table 50: US Recent Past, Current & Future Market Analysis
for Rapid Microbiological Tests by End-Use Segment -
Clinical Applications (Streptococcus Infection Rapid Tests
{Streptococcus A, and Streptococcus B}, STD Rapid Tests
{GC/Chlamydia, HIV, and Syphilis}, Respiratory Rapid Tests
{RSV, Mononucleosis, Tuberculosis, Mycoplasma Pneumoniae,
Legionella, and Influenza} and Gastrointestinal Rapid Tests
{Cryptosporidium, Giardia, Rotavirus, C. Difficile, and H.
Pylori}) and Non-Clinical Applications Independently
Analyzed with Annual Revenues in US$Million for Years 2000
through 2010 (includes corresponding Graph/Chart) III-39

Table 51: US Long-term Projections for Rapid Microbiological
Tests by End-Use Segment - Clinical Applications
(Streptococcus Infection Rapid Tests {Streptococcus A, and
Streptococcus B}, STD Rapid Tests {GC/Chlamydia, HIV, and
Syphilis}, Respiratory Rapid Tests {RSV, Mononucleosis,
Tuberculosis, Mycoplasma Pneumoniae, Legionella, and
Influenza} and Gastrointestinal Rapid Tests
{Cryptosporidium, Giardia, Rotavirus, C. Difficile, and H.
Pylori}) and Non-Clinical Applications IndependentlyAnalyzed
with Annual Revenues in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-40

Table 52: US 10-Year Perspective for Rapid Microbiological
Tests by End-Use Segment - Percentage Breakdown of Revenues
for Clinical Applications (Streptococcus Infection Rapid
Tests {Streptococcus A, and Streptococcus B}, STD Rapid
Tests {GC/Chlamydia, HIV, and Syphilis}, Respiratory Rapid
Tests {RSV, Mononucleosis, Tuberculosis, Mycoplasma
Pneumoniae, Legionella, and Influenza} and Gastrointestinal
Rapid Tests {Cryptosporidium, Giardia, Rotavirus, C.
Difficile, and H. Pylori}) and Non-Clinical Applications
for2003, 2008 & 2012 (includes corresponding Graph/Chart) III-41

2. Europe III-42
A.Market Analysis III-42
A Current & Future Analysis III-42
European Market Primer III-42
What Drives the Requirement Patterns of End-Users? III-42
Competitive Profile III-42
Table 53: Leading Players in European Market for Automated
& Rapid Microbiological Tests (2000) - Percentage
Breakdown of Value Sales by Company for bioMerieux, Becton
Dickinson, Organon Teknika, Merlin, Abbott, Dade, Unipath,
and Others(includes corresponding Graph/Chart) III-43
Trends & Issues III-43
Proliferation of Automated, and Rapid Tests in Europe III-43
European Automated Market III-44
Probe Tests: “A Crack in the Future of Rapid Tests” III-44
Trends Across Product Segments III-44
GC/Chlamydia Rapid Tests III-44
Streptococcal Infection (Strep A) Rapid Tests III-44
Automated Tuberculosis Systems Market III-45
Historic Competitive Profile III-45
Table 54: Leading Players in European Market for Chlamydia
Rapid Tests (2000) - Percentage Breakdown of Value Sales by
Company for Abbott, Oxoid, Unipath, Quidel, and Others
(includes corresponding Graph/Chart) III-45

Table 55: Leading Players in European Market for
Streptococcal Infection (Strep A) Rapid Tests (2000) -
Percentage Breakdown of Value Sales by Company for Abbott,
Unipath, Quidel, Orion Diagnostics, Oxoid, and Becton
Dickinson (includes corresponding Graph/Chart) III-45

Table 56: Leading Players in European Market for Automated
Blood Culture Systems (2000) - Percentage Breakdown of
Value Sales by Company for Becton Dickinson, Organon
Teknika, and bioMerieux (includes corresponding
Graph/Chart) III-45
Product Innovations/Introductions III-46
B.Market Analytics III-47
Table 57: European Recent Past, Current & Future Market
Analysis for Automated & Rapid Microbiological Tests by
Geographic Region - France, Germany, The United Kingdom,
Italy, Spain, Russia, & Rest of Europe Independently
Analyzed with Annual Revenuesin US$ Million for Years 2000
through 2010(includes corresponding Graph/Chart) III-47

Table 58: European Long-term Projections for Automated
&Rapid Microbiological Tests by Geographic Region - France,
Germany, The United Kingdom, Italy, Spain, Russia, & Rest of
Europe Independently Analyzed withAnnual Revenues in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) III-48

Table 59: European Recent Past, Current & Future Market
Analysis for Automated & Rapid Microbiological Tests by
End-Use Segment - Clinical Applications (Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems,
Streptococcal Infection Rapid Tests, GC/Chlamydia Rapid
Tests, and Other Automated & Rapid Microbiological Tests)
and Non-Clinical Applications Independently Analyzed with
Annual Revenues in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-49

Table 60: European Recent Past, Current & Future Market
Analysis for Automated & Rapid Microbiological Tests by
End-Use Segment - Clinical Applications (Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems,
Streptococcal Infection Rapid Tests, GC/Chlamydia Rapid
Tests,and Other Automated & Rapid Microbiological Tests) and
Non-Clinical Applications Independently Analyzed with Annual
Revenues in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) III-50

Table 61: European 10-Year Perspective for Automated & Rapid
Microbiological Tests by Geographic Region - Percentage
Breakdown of Revenues for France, Germany, The United
Kingdom, Italy, Spain, Russia, & Rest of Europe for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) III-51

Table 62: European 10-Year Perspective for Automated & Rapid
Microbiological Tests by End-Use Segment - Percentage
Breakdown of Revenues for Clinical Applications (Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems,
Streptococcal InfectionRapid Tests, GC/Chlamydia Rapid
Tests, and Other Automated & Rapid Microbiological Tests)
and Non-Clinical Applications for 2003, 2008 & 2012
(includes corresponding Graph/Chart) III-52

2a. France III-53
A.Market Analysis III-53
A Current & Future Analysis III-53
Leading Players in Select Segments -Historic Data III-53
Table 63: Leading Players in French Market for Automated &
Rapid Microbiological Tests (2000) - Percentage Breakdown
of Value Sales by Company for bioMerieux, Becton Dickinson,
Merlin, Organon Teknika, Dade, Pasteur Sanofi Diagnostic,
Oxoid and Abbott (includes corresponding Graph/Chart) III-53
Chlamydia Rapid Tests III-53
Table 64: Leading Players in French Market for Chlamydia
Rapid Tests (2000) - Percentage Breakdown of Value Salesby
Company for Oxoid and Others III-53
Automated Tuberculosis Systems III-54
Table 65: Leading Players in French Market for Automated
Tuberculosis Systems (2000) - Percentage Breakdown of
Value Sales by Company for Becton Dickinson and Others III-54
Automated Blood Culture Systems III-54
Table 66: Leading Players in French Market for Automated
Blood Culture Systems (2000) - Percentage Breakdown of
Value Sales by Company for Becton Dickinson, Organon
Teknika, bioMerieux, and Pasteur Sanofi Diagnostic
(includes corresponding Graph/Chart) III-54
Automated Identification and Susceptibility Systems III-54
Table 67: Leading Players in French Market for Automated
Identification and Susceptibility Systems (2000) -
Percentage Breakdown of Value Sales by Company for
bioMerieux, Merlin, Dade, and Becton Dickinson (includes
corresponding Graph/Chart) III-54
bioMerieux: A Key Player III-54
Product Innovations/Introductions III-55
Strategic Corporate Developments III-56
B.Market Analytics III-58
Table 68: French Recent Past, Current & Future Market
Analysis for Automated & Rapid Microbiological Tests by
End-Use Segment - Clinical Applications (Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems,
Streptococcal Infection Rapid Tests, GC/Chlamydia Rapid
Tests, and Other Automated & Rapid Microbiological Tests)
and Non-Clinical Applications Independently Analyzed with
Annual Revenues in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-58

Table 69: French Long-term Projections for Automated & Rapid
Microbiological Tests by End-Use Segment - Clinical
Applications (Automated Identification & Susceptibility
Systems, Automated Blood Culture Systems, Automated
Tuberculosis Systems, Streptococcal Infection Rapid Tests,
GC/Chlamydia Rapid Tests, and Other Automated & Rapid
Microbiological Tests) and Non-Clinical Applications
Independently Analyzed with Annual Revenues in US$ Million
for Years 2011 through 2015 (includes corresponding
Graph/Chart) III-59

Table 70: French 10-Year Perspective for Automated & Rapid
Microbiological Tests by End-Use Segment - Percentage
Breakdown of Revenues for Clinical Applications (Automated
Identification & Susceptibility Systems, Automated Blood
Culture Systems, Automated Tuberculosis Systems,
Streptococcal Infection Rapid Tests, GC/Chlamydia Rapid