Global Automated and Rapid Microbiological Tests Industry

• Publication date: October 2011

This report analyzes the worldwide markets for Automated and Rapid Microbiological Tests in US$ Million by the following End-Use Segments: 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. The report provides separa...

This report analyzes the worldwide markets for Automated and Rapid Microbiological Tests in US$ Million by the following End-Use Segments: 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. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. A six-year historic analysis is also provided for these markets.The report profiles 93 companies including many key and niche players such as Abbott Laboratories, Abbott Diagnostics, Alere Inc., Becton Dickinson and Company, bioMerieux SA, bioMerieux, Inc., Bio-Rad Laboratories, Inc., Cellabs Pty Ltd, Celsis International Plc., Coris BioConcept, F. Hoffmann-La Roche Ltd., Gen-Probe Inc., MedMira Inc., Meridian Biosciences, Inc., Orasure Technologies, Inc., Orion Diagnostica Oy, Quidel Corporation, Sekisui Diagnostics, Siemens Healthcare Diagnostics, Inc., 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.

Global In Vitro Diagnostic Industry

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

2. INDUSTRY OVERVIEW 6
Outlook 6
Evolutionary Battle Against Bugs Drives Market Future 6
Automated Microbiological Tests: A Pesky Gray Area in the
Clinical Diagnostics Market 6
Traditional Rapid Microbiological Tests Destined to Go Out
With the Old 7
A Current & Future Analysis 7
Segmental Perspective 8
Clinical Applications 8
Non-Clinical Applications 8
Macro: The Big Picture 8
Deciding the Market’s Future 9
A Holistic Peek into a Few Noteworthy Trends 9
Biotechnology & Rapid Microbial Tests 10
Automated & Rapid Microbiological Tests: “Current Market Stance” 11
A Business Case for Automated & Rapid Microbiological Testing 11
Near Patient Testing: An Offshoot of Rapid Microbiological Tests 12
Pros & Cons of Near Patient Testing 12
Role of Near Patient Testing in Reducing Antibiotic
Resistance in Humans 13
The Pre/Post Microbial Rapid Testing Era: A Review 13
Market Structure 14
Competitive Setup of the Diverse Automated & Rapid
Microbiology Products Market 14
Competitive Landscape 15
Table 1: World Market for Microorganism Identification and
Resistance Tests by Leading Players (2010): Market Share
Breakdown of Value Share for BioMérieux; Becton, Dickinson
and Co; and Others (includes corresponding Graph/Chart) 15

Table 2: World In-Vitro Diagnostics (IVD) Market by Leading
Players (2010): Market Share Breakdown for Roche, Siemens,
Abbott Diagnostics, Becton Dickinson, Beckman Coulter and
Others (includes corresponding Graph/Chart) 15

Table 3: World Blood Screening Market by Leading Players
(2010): Market Share Breakdown for Gen-Probe/Novartis,
Roche, and Others (includes corresponding Graph/Chart) 15

3. MARKET TRENDS & ISSUES 16
Advancements in Molecular Diagnostics - A Boon or a Threat 16
Leading Companies in Molecular Diagnostics Market 16
Antibiotic Resistant Bacteria Throws the Spotlight On
Microbial Testing 16
Instant Detection of Pathogens - A New Epoch in the Fight for
Survival 17
Lower Cost Rapid Tests Built on Multiple Sampling Modalities -
Gaining Momentum 17
“Time Constraints?” - Rapid Tests to the Rescue 17
Rapid HIV Tests: A New Age Diagnostic Weapon Against the
Killer Disease 18
Accuracy/Reliability of Home HIV Testing: A Bone of Contention 18
Development of Near Patient Test Kits: A Market Driven Phenomenon 19
Near Patient Test Kits: A Rumination of Possibilities 19
Automated Blood Culture Systems: A Winning Edge in the Fight
Against Bacteremia 20
Leading Food Processors Resort to Rapid Microbiological Testing 20
Impact of Food Scares on Rapid Microbiological Tests Market 21
Demand for Microbiological Tests & Level of QC in the Food
Industry 22
Rapid Tests Creating Brighter Avenues in Food Microbiology
Testing Market 23
Dire Need to Nip Operating Costs Throws the Spotlight on Rapid
Tests 23
Key Advantages/Benefits of Rapid Microbiological Tests on Food 24
Food Packages of the Future Ingrained with Microbial Alert
Systems 24
Technology Innovations in Rapid Food Microbial Testing: A
Historic Brief 24
Obtaining Regulatory Approval - A Major Non-Technical Hindrance 25

4. FACTORS INFLUENCING THE MARKET 26
Continuing Biological Warfare with Pathogens Sparks Market Growth 26
Innovative Products - A Key Growth Strategy 26
Other Market Drivers in a Capsule 26
Low Turnaround Times Skyrocket Demand 26
Greater Patient Awareness 26
Rising Incidence of STDs Kindles Universal Market Acceptance 27
Ultra-Rapid HIV-Screening Tests- A Strong Fight against HIV-
Epidemic 27
Validation of Rapid Microbiological Tests: An Imperative
Prerequisite 27
Non-Conformance to Testing Requirements: A Weighty Concern 28
Influenza - Boosting Rapid Test Prospects 29

5. PRODUCT/TECHNOLOGY OVERVIEW 30
Automated & Rapid Microbiological Tests: A Definition 30
Benefits of Automated & Rapid Microbiological Tests 30
Classification of Rapid Microbiological Test Methods 31
How Does a Rapid Test Work? 31
Sample Preparation - A Key Procedure 32
Automated Identification and Susceptibility Systems 32
Automated Blood Culture Systems 33
Automated Tuberculosis Systems 33
Microminiaturization of Diagnostic Tests: How Is It Effected? 33
Advantages of Microminiaturisation: 34
Acid-Fast Microscopy - The Forerunner of Rapid Tests 34
Gram's Stain: A Time-Honored & Rapid Method to Detect
Pathogens in Blood 34
Enabling Technologies of Automated & Rapid Microbiological Tests 35
Growth-based Technologies 35
Viability-based Technologies 35
Cellular-Component or Artifact-based Technologies 36
Genomics/ Proteomics 36
Microarrays/Microfluidics 36
DNA Microchips/Probes 37
Polymerase Chain Reaction (PCR) 37
Immunoassay 38
Immunoassay Escalates into Diverse Fields of Diagnostic Testing 38
Nucleic Acid Testing (NAT) 38
Nucleic Acid Probes 39
Signal-Amplified Tests 39
Nucleic Acid Amplification Tests 39
Traditional Methods with Computer-Aided Imaging 40
Combination Methods 40

6. END-USE APPLICATION ANALYSIS 41
Applications in Clinical Investigations 41
STD Rapid Tests 41
GC/Chlamydia Rapid Tests 41
HIV Rapid Tests 42
HIV Facts & Figures 43
Table 4: Global Prevalence of HIV Infection by Region:
2007 & 2008 (includes corresponding Graph/Chart) 43

Table 5: Global HIV Related Deaths by Region: 2007 & 2008
(includes corresponding Graph/Chart) 44

Table 6: Global Distribution of HIV Prevalence, Incidence
and Mortality: 2008 (includes corresponding Graph/Chart) 45
Advantages of Rapid HIV Testing 45
Disadvantages of Rapid HIV Testing 45
Syphilis Rapid Tests 46
Respiratory Rapid Tests 46
RSV/ Influenza Rapid Tests 46
Tuberculosis Rapid Tests 47
Group A beta Hemolytic Streptococcus Rapid Tests 47
Mononucleosis Rapid Tests 47
Streptococcus Rapid Tests 48
Streptococcus A Rapid Tests 48
Streptococcus B Rapid Tests 48
Gastrointestinal Rapid Tests 49
Giardia Lamblia Rapid Tests 49
H. Pylori Rapid Tests 49
Cryptosporidium Rapid Tests 50
C. Difficile Rapid Tests 50
Applications in Non-Clinical Investigations 50
Food/Water Safety Tests 51
Food Safety Testing: A Lucrative Application Area 51
Rapid Microbiological Methods in Pharmaceutical Sector 52
Limitations of RMMs 52
Advantages of RMMs 53
Applications in Pharmaceutical Sector 53
Environmental Tests 53
Other Miscellaneous Applications 54

7. PRODUCT INNOVATIONS/INTRODUCTIONS 55
BioControl Systems Develops PCR for Detecting Non-O157
Serotypes of STEC 55
InDevR Introduces New Virus Counter 55
MicroPhage Receives Approval from FDA for KeyPath™ MRSA/MSSA
Blood Culture Test - BT 55
Health Canada Approves DuPont’s BAX® System Real-Time Assay 56
Neogen Receives Approval from AOAC for Reveal 2.0 Test 56
Life Technologies and University of Pennsylvania School of
Veterinary Medicine Introduce TaqMan® Salmonella enteritidis
Detection Kit 56
AdvanDX Obtains 510(k) Clearance from US FDA for GNR Traffic
Light™ PNA FISH® 56
Pall Introduces GeneDisc Rapid Microbiology System 56
Abbott Laboratories Introduces PLEX-ID™ Biothreat Assay 57
bioMerieux Receives FDA Clearance for NucliSENS EasyQ MRSA 57
BD Launches BD Max™ Open System 57
Luxcel Biosciences and Mocon Develop GreenLight™900 Series 58
Bruker Launches pTD™ for Homeland Security 58
Hygiena International Launches EnSURE 58
Researchers at University of Georgia Develop Pneumonia
Diagnostic Test 59
BD Diagnostics Obtains Approval from FDA for BD MAX™ GBS Assay 59
bioMérieux Receives Approval for TEMPO® STA from AOAC and AFNOR 59
Bruker Introduces MALDI Sepsityper™ Kit 59
AdvanDx Introduces GNR Traffic Light™ PNA FISH® 59
ZyGEM Launches Microbial Fingerprinting Diagnostic Technology 60
BD Diagnostics Launches BD BACTEC™ MGIT™ 320 Mycobacteria
Culture System 60
Particle Measuring Systems Launches BioLaz™ Real-Time
Microbial Monitor 60
NanoLogix Launches Quick-Test Product Line 61
MOCON Introduces GreenLight™ Screening System 61
Life Technologies Unveils MicroSEQ® Rapid Microbial
Identification System 61
IDEXX Laboratories Launch Enterolert®-DW in Europe 61
Alere Rolls Out three Cardiac Testing Solutions 62
Millipore Introduces New Milliflex Quantum Rapid
Microbiological Test Method 62
BD Diagnostics Adds Automated Microbiology Specimen Processor
to its Diagnostic Portfolio 62
Roche Introduces New Automatic Clinical Laboratory System,
Cobas®4800 63
Thermo Fisher Scientific Launches an Automated Photometric Method 63
Thermo Fisher Scientific Introduces Salmonella Rapid Culture
Method 63
BD Receives FDA Clearance for BD ProbeTec Amplified DNA Assays
on BD Viper System 64
Oxoid Introduces Xpect® Flu A&B 64
Oxoid Extends ProSpecT Range 64
Oxoid Launches ELISA Systems Test Kits Range 65
Oxoid Introduces Brilliance VRE Agar and Brilliance ESBL Agar 65
Oxoid Launches RapID Kits 66
Inverness Medical Innovations Introduces C. DIFF QUIK CHEK
COMPLETETM Rapid Test 66
Celsis International Launches Celsis ReACTTM 67
Roche Diagnostics Introduces LightCycler® Mycobacterium
Detection Kit 67
bioMérieux Introduces NucliSENS EasyQ® HIV-1 v2.0 68
Celsis International Unveils RapiScreenTM Beverage 69
Siemens Launches MicroScan Synergies plus® gram-positive ID/
MIC and MIC Combination Panels 69
Oxoid Introduces IDEIATM Norovirus 69
Oxoid Introduces Salmonella PrecisTM Process 70
Remel Offers FDA Approved RPMI 1640 Agar w/MOPS and 2% Glucose 70
Oxoid Launches Rapid MDG Broth 70
Lonza Introduces microCompass TYMC (Total Yeast and Mould
Count) Detection Kit 71
Inverness Medical Introduces Determine HIV-1/2 Ag/Ab Combo 71
Meridian Bioscience Rolls Out Two New Rapid Tests for
Detecting Epstein-Barr Virus 72
Oxoid Introduces Staph Plus System for Identifying
Staphylococcal Species 72

8. PRODUCT INNOVATIONS/INTRODUCTIONS IN RECENT PAST - A
PERSPECTIVE BUILDER 73
Siemens Healthcare Diagnostics Launches MicroScan® WalkAway®
plus Diagnostic Microbiology Systems 73
Bio-Rad Launches a Rapid test for Screening MRSA, MRSASelect™
test, in US 73
bioMérieux Introduces VIDAS®, an automated Clostridium
difficile A & B Toxins Detection Test 73
Oxoid Launches Remel Wellcolex® Colour Tests for Testing
Shigella, E. coli O157 and Salmonella 74
Siemens Healthcare Diagnostics Obtains Health Canada Approval
for its VERSANT 440 Molecular System 74
Oxoid Unveils Remel Xpect™ Clostridium Difficile Toxin A/B Test 74
Neogen Introduces Soleris System 74
ATCC Introduces Authenticult™ Quality Control Microbiological
Testing Tool 75
Bio-Rad Introduces New EBV Kits 75
Roche Seeks FDA Marketing Approval for Hepatitis C Virus Test 75
Roche Seeks US FDA Approval for its Cobas TaqScreen MPX Test 75
FDA Clears Usage of TIGRIS® System for Testing WNV in Donated
Blood 76
FDA Approves ImmunoCard STAT!® EHEC for Detecting E. coli
Infection 76
bioMérieux Introduces TEMPO® Quality Indicator Testing System 76
Biotrace Introduces Tecra Unique Campylobacter Rapid Test 76
bioMérieux Introduces TEMPO® EB test for Enterobacteriaceae 77
Roche Unveils Elecsys TORCH Assays 77
Roche Diagnostics Introduces Cobas TaqMan MTB Test in Japan 77
bioMérieux Develops Advanced Colorimetry™ NH Card 77
Roche Introduces Rapid LightCycler SeptiFast Sepsis Test
across EU 78
Oxoid Launches New Rapid Test for Salmonella Detection in Food
Products 78
Oxoid Unveils New Contact Plate Design 78
FDA Approves Fluconazole Susceptibility Tests from BioMérieux 78
Polysciences Unveils New Microbiological & Bacterial Detection
Applications 79
Researchers Develop New Rapid MODS Test for TB Detection 79
Dade Behring Unveils Automated Quadriga BeFree System 79
FDA Approves Abbott PRISM® HBsAg Assay 79
Bayer’s EHIV Test Receives FDA Clearance 80
Gen-Probe Obtains FDA Approval to Use Aptima Test on
Additional Specimens 80
Roche Diagnostics’ cobas TaqScreen MPX Test Receives CE Mark
Approval 80
Cepheid Introduces Rapid Xpert® MRSA Test in Europe 80
Bio-Rad Widens Culture Media with Addition of RAPID'Salmonella 81
Chemogen Develops New Tuberculosis Rapid Test 81
bioMerieux Rolls Out VIDAS® LDUO Test 81
Zonda Develops New Rapid Test for Chlamydia 81
MedMira Launches MiraCare Rapid HIV Test 81
STMicroelectronics and Mobidiag Unveil Lab-On-Chip 82
Vermicon Launches ScanVIT-Legionella Rapid Test Kit 82
New Line of Rapid Microbial Detection Systems from Centrus 82
OraSure Rolls Out OraQuick ADVANCE 82
Abbott Unveils Automated HCV Test 82
ViroMed Rolls Out Rapid PCR Tests for Detecting Influenza and
Respiratory Pathogens 83
Biophage Pharma Offers Service for Microbiological Testing 83
bioMerieux Releases New Rapid Test for Nosocomial Infections 83
bioMerieux Widens Product Portfolio with Addition of TEMPO®
System 83

9. RECENT INDUSTRY ACTIVITY 84
Sekisui Chemical Acquires Diagnostic Products Business of Genzyme 84
Dynacare Laboratories Acquires Bruker MALDI Biotyper System 84
Magellan Biosciences Enters into Partnership with miacom
Diagnostics 84
Lonza Signs Distribution Agreement with Roche 84
BD Enters into Collaboration with Bruker Daltonics 85
Seegene Enters into Partnership with Molzym 85
bioMérieux Enters into Partnership with Shanghai Institutes
for Biological Sciences 85
Becton, Dickinson and Company Acquires Global Rights to Market
Micro PRO 85
Rapid Micro Biosystems Enters Into Partnership with Life
Technologies 86
DuPont and U.S. Department of Agriculture to Collaborate for
New Microbiological Test 86
bioMérieux and Biocartis Enter into Partnership 86
BD Diagnostics Collaborates with Lonza Group 86
Rapid Micro Biosystems Signs Contract with BARDA 87
Shimadzu and bioMérieux Enter into Partnership 87
Micro Identification Technologies and OSI Optoelectronics Sign
Agreement 87
Inverness Medical Adopts New Corporate Identity 87
Thermo Fisher Acquires Ahura Scientific 87
Don Whitley Signs Distribution Agreement with Zisys 88
Charm Sciences Acquires MLX Microplate Luminometer Product
Line from Dynex Technologies 88
Alpha Analytical Acquires Boston Analytical Inc. 89
Roche Group Acquires Genentech 89
Roche Acquires Innovatis AG 89
3M Takes Over Biotrace International 89
Lab21 Buys Majority Stake in Biotec Laboratories 90
Vacci-Test Acquires Maxivet 90
bioMerieux Acquires PML Microbiologicals 90
3M Acquires Food Diagnostics AS 91
Becton, Dickinson and Company Receives License for its
GeneOhmTM from Health Canada 91
BD Diagnostics Receives CE Marking for BD GeneOhmTM VanR Test 91
bioMérieux Bags AOAC Research Institute's Performance- Tested
Methods SM Approval 92
MedMira Receives Sales Approval of Multiplo HBV/HIV/HCV Rapid
Tests Market 92
Schering-Plough Inks International Collaboration Agreement
with OraSure Technologies 92
Roche Selects Quidel's Influenza Test 93
Quidel Enters into Global Alliance with bioMerieux 93
Premier's QUEST Selects Remel SpectraTM MRSA 93
Thermo Fisher Scientific and MedAssets Supply Chain Systems
Enter into a Supply Agreement 93
Thermo Fisher Scientific Bags FDA Approval for SpectraTM MRSA 94
Advantest to Take Over Credence Systems 94
DSM Food Specialties to Acquire CMT Srl 94
Sysmex Signs Agreement with bioMerieux 94
Nanogen Enters into Definitive Agreement with Elitech Group 95
Silliker Acquires Majority Stake in EGI Laboratory 95
BD Establishes New Rapid Diagnostic Products Manufacturing
Facility in China 95
Quidel Corporation Obtains CLIA Waiver from US FDA for its
QuickVue(R) RSV Test 96
Siemens Obtains US FDA Approval for its VERSANT™ 440 Molecular
System 96
bioMérieux to Market Wescor’s Customized Slide Stainer
Instruments under bioMérieux Brand 96
Schering-Plough and OraSure Ink Collaboration Agreement for
Developing Rapid Oral HCV Test 96
Abbott Obtains US FDA Approval for its Automated HTLV-I/HTLV-
II Blood Screening Test 97
Quidel and bioMérieux Form a Long-term Alliance in Rapid
Diagnostic Tests 97
BD Diagnostics Obtains US FDA Approval for BD GeneOhm™ StaphSR
Assay 97

10. CORPORATE ACTIVITY IN RECENT PAST - A PERSPECTIVE BUILDER 98
Siemens Acquires Dade Behring 98
Concateno Acquires Euromed 98
Meridian Bioscience Obtains US FDA Approval for Two New Rapid
Tests 98
Thermo Fisher Scientific Teams Up with KBA for Expanding its
Microbiology Business Division in Lenexa 98
OraSure and SCMS Enter into an Agreement for Supplying
OraQuick(R) HIV Test to PEPFAR Countries 99
Abbott Obtains US FDA Approval for its Fully Automated PRISM®
HCV Test 99
Gen-Probe Obtains US FDA Approval for its PROCLEIX® TIGRIS®
System for Testing Donated Blood 99
AdvanDx Ropes In bioMérieux for Distributing its Rapid
Diagnostic Tests in US 99
3M and Gen-Probe Join Hands to Develop Rapid Molecular Tests
For Detecting HAIs 100
Gen-Probe’s PROCLEIX® TIGRIS® System Obtains US FDA Approval
for Screening Donated Blood for West Nile Virus 100
3M Acquires Acolyte Biomedica 100
Formation of Siemens Medical Solutions Diagnostics 101
bioMérieux Bags Contract to Provide VITEK® 2 System for
Scottish NHS Labs 101
bioMérieux Licenses NorChip’s HPV Test Technology for Cervical
Cancer 102
bioMérieux in Strategic Agreement with Cepheid for Sepsis Assays 102
3M Health Care Creates New Medical Diagnostics Unit 102
Schering-Plough & OraSure to Develop Rapid Oral HCV Test 103
3M Acquires Biotrace International 103
Siemens Acquires DPC 103
Oxoid Acquires Microbiology Business Activities of Dako 104
Inverness Acquires IDT and Thermo BioStar 104
BMD in Agreement with MND for Research on Diagnostic Tests 104
Cepheid Wins CDC Contract to Develop Rapid Bird Flu Virus
Detection Test 104
Dutch Government Grants €7.9 Million to FIND 105
FIND and Hain to Develop Rapid Test for MDR and XDR TB 105
3M & Gen-Probe Ally for Developing Rapid Molecular Tests for
Food Safety 105
Bio View Inks Three-Year Distribution Agreement with Abbott
Molecular 106
Bodycote Acquires Foodscan Laboratories 106
Cepheid Bags STTR Funding for Development of Rapid TB Test 106
Abbott and Verax in Distribution Agreement for Verax Platelet
PGD® Test 107
BSL Supplies ABBOTT PRISM® System to Blood Donor Testing Centers 107
Abbott & ARC in Agreement for Automated Blood Screening Tests 107
BD to Set Up Production Facility for Rapid Diagnostic Products
in China 108
BD Diagnostics Delivers STI Testing Products to BioReference 108
Meridian Licenses LAMP Diagnostic Test Technology from Eiken 108
OraSure Inks Multi-Year Purchase Contract with New York City 108
Abbott Inks Single-Source Agreement with Novation for HIV Test 109
Neogen Takes Over Centrus International 109
Becton, Dickinson and Company Acquires GeneOhm Sciences 109
Inverness Medical Innovations Makes a Synergetic Purchase of
ACON Laboratories 109
Quest Diagnostics Strikes Deal with BD Diagnostics 110
Novation Inks Pact with Abbott for Rapid HIV-1/2 Antibody Test 110
TREK Diagnostic and Novation Inks Agreement 110
Clinton Foundation Inks Agreement with Four Companies to Cut
Prices 110
Chembio Obtains FDA Approval for HIV 1/2 Stat-Pak and Sure
Check HIV 1/2 Rapid Test PMAs 110
Roche’s LightCycler SeptiFast Test Attains CE Mark 111
Zonda Expands Distribution of Products in Europe 111
OraSure Wins Rapid HIV Tests Order 111
MedMira Secures Orders for Rapid HIV Tests 111
Cepheid Collaborates with Foundation for Innovative Diagnostics 111
Chembio Obtains Clearance for Rapid HIV Tests in Kenya 112
Genesis Bioventures Bags US Patent for Rapid Prion- Detection
Assay 112
MedMira Obtains CE Mark for MiraCare 112
Setema to Distribute Chembio’s Rapid HIV Tests in Ethiopia 112
Clinton Foundation HIV/AIDS Initiative Selects Chembio to
Provide Rapid HIV Tests 112
Quidel Acquires immunochemical Fecal Occult Blood Test 112
Xact Aid Snaps Up STD Alert 112
Grant Life Sciences Acquires Rapid Tests from AccuDx 113
Millipore Ties Up with Gen-Probe 113
Foundation for Innovative New Diagnostics forms Collaboration
with Eiken Chemical 113
WayPoint and Global Rapid Diagnostic Leader Enter into an
Agreement 113
Akers Biosciences Enters into a Distribution Agreement with
Alco Industries 113
Celsis and BioVentures Enter into Licensing Agreement 114
Thermo Electron Inks Pact with Genomic Profiling Systems 114
Abbott and OraSure Enters into Agreement for OraQuick ADVANCE
Rapid HIV-1/2 Test 114
bioMérieux Signs Agreement with Novel Diagnostics 114
Dade Behring Bags FDA Approval for Antimicrobial
Susceptibility Test Panels 114
OraSure Bags HCV Patent License from Chiron and Ortho-
Clinical Diagnostics 115
BD Diagnostics Receives FDA Approval for BD Directigen™ EZ Flu
A+B Test 115
BD Diagnostics Bags FDA Clearance for BBL™ CHROMagar™ MRSA
Product 115
MedMira Obtains Rights to Market Rapid HIV Tests in Guizhou
Province, China 115
Gen-Probe Obtains FDA Clearance for PROCLEIX® West Nile Virus
Assay 115
Medical Services International Secures Clearance for Rapid
Test Kits 115
Medical Services International Receives Exclusive Marketing
Rights for TB Test Kit 115
Adaltis Receives Orders for HIV Rapid Tests from China 116
MedCap Bags Exclusive Distribution Rights for Syphilis Rapid Test 116
Genomic Profiling Systems Obtains NIAID Funds to Develop
Testing Platform 116
Gen-Probe Obtains US Patent for Automated Process for Nucleic
Acid Testing 116
Bio-Rad Receives Approval for HIV-1/HIV-2 Rapid Test 116

11. FOCUS ON SELECT GLOBAL PLAYERS 117
Abbott Laboratories (USA) 117
Abbott Diagnostics (USA) 117
Alere Inc. (US) 117
Becton Dickinson and Company (USA) 118
bioMerieux SA (France) 118
bioMerieux, Inc. (USA) 119
Bio-Rad Laboratories, Inc (USA) 119
Cellabs Pty Ltd (Australia) 119
Celsis International Plc (UK) 120
Coris BioConcept (Belgium) 120
F. Hoffmann-La Roche Ltd. (Switzerland) 120
Gen-Probe Inc. (USA) 121
MedMira, Inc. (Canada) 121
Meridian Biosciences, Inc. (USA) 122
Orasure Technologies, Inc. (USA) 122
Orion Diagnostica Oy (Finland) 122
Quidel Corp. (USA) 123
Sekisui Diagnostics (Japan) 123
Siemens Healthcare Diagnostics, Inc. (USA) 124
Thermo Fisher Scientific, Inc. (USA) 124
Remel, Inc. (USA) 124
Oxoid Limited (UK) 125

12. GLOBAL MARKET PERSPECTIVE 126
Table 7: World Recent Past, Current & Future 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 2009 through
2017(includes corresponding Graph/Chart) 126

Table 8: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) 127

Table 9: World 15-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, 2010 & 2017 (includes corresponding Graph/Chart) 128

Table 10: World Recent Past, Current & Future 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 2009 through 2017 (includes corresponding
Graph/Chart) 129

Table 11: World Historic Review 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 2003 through
2008 (includes corresponding Graph/Chart) 130

Table 12: World 15-Year Perspective for Automated and Rapid
Microbiological Tests in Clinical Applications by Geographic
Region - Percentage Breakdown of Revenues for US, Europe, and
Rest of World for Years 2003, 2010 & 2017 (includes
corresponding Graph/Chart) 131

Table 13: World Recent Past, Current & Future 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 Rapid Tests and Other Automated & Rapid
Microbiological Tests Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) 132

Table 14: World Historic Review 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
Rapid Tests and Other Automated & Rapid Microbiological Tests
Independently Analyzed with Annual Revenues in US$ Million for
Years 2003 through 2008 (includes corresponding Graph/Chart) 133

Table 15: World 15-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 Rapid Tests and Other
Automated & Rapid Microbiological Tests for Years 2003, 2010 &
2017 (includes corresponding Graph/Chart) 134

Table 16: World Recent Past, Current & Future 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 2009 through 2017 (includes corresponding
Graph/Chart) 135

Table 17: World Historic Review 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 2003 through
2008 (includes corresponding Graph/Chart) 136

Table 18: World 15-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 2005,
2010 & 2015 (includes corresponding Graph/Chart) 137

Table 19: World Recent Past, Current & Future 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 2009 through 2017(includes corresponding Graph/Chart) 138

Table 20: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) 139

Table 21: World 15-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, 2010 & 2017 (includes corresponding
Graph/Chart) 140

Table 22: World Recent Past, Current & Future 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 2009 through 2017(includes corresponding Graph/Chart) 141

Table 23: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) 142

Table 24: World 15-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, 2010 & 2017 (includes corresponding
Graph/Chart) 143

Table 25: World Recent Past, Current & Future 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 2009 through 2017(includes corresponding Graph/Chart) 144

Table 26: World Historic Review 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 2003 through 2008
(includes corresponding Graph/Chart) 145

Table 27: World 15-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, 2010 & 2017 (includes
corresponding Graph/Chart) 146

Table 28: World Recent Past, Current & Future 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 2009 through 2017(includes corresponding Graph/Chart) 147

Table 29: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) 148

Table 30: World 15-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, 2010 & 2017 (includes corresponding
Graph/Chart) 149

Table 31: World Recent Past, Current & Future 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 2009 through 2017 (includes corresponding
Graph/Chart) 150

Table 32: World Historic Review 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 2003 through
2008 (includes corresponding Graph/Chart) 151

Table 33: World 15-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, 2010 & 2017
(includes corresponding Graph/Chart) 152

Table 34: World Recent Past, Current & Future 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 2009 through 2017(includes corresponding
Graph/Chart) 153

Table 35: World Historic Review 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 2003 through 2008 (includes corresponding Graph/Chart) 154

Table 36: World 15-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, 2010 & 2017
(includes corresponding Graph/Chart) 155

13. THE UNITED STATES 156
A.Market Analysis 156
A Current & Future Analysis 156
Rapid Microbiology Tests - A Competitive Profile 156
Consolidation in the Automated and Rapid Microbiological
Tests Market 156
Bioterrorism Tests - Gaining Prominence 157
Tracking Trends Across Product Segments 157
STD Rapid Tests 157
Market Share Trends of Leading Players 157
Table 37: Leading Players in the US Market for
GC/Chlamydia Rapid Tests (2010) - Percentage Breakdown of
Value Sales by Company for Gen-Probe, Abbott, Becton
Dickinson and Roche (includes corresponding Graph/Chart) 158

Table 38: Leading Players in the US Market for Chlamydia
Rapid Tests (2010) - Percentage Breakdown of Value Sales
by Company for Thermo Fischer Scientific, Alere ,and
Quidel (includes corresponding Graph/Chart) 158

Table 39: Leading Players in the US Market for Syphilis
Rapid Tests (2010) - Percentage Breakdown of Value Sales
by Company for Becton Dickinson, Alere, and Others
(includes corresponding Graph/Chart) 158
Leading Players in HIV Rapid Testing Market 158
Gastrointestinal Rapid Tests 159
Market Share Data of Leading Players 159
Table 40: Leading Players in the US Market for C.
Difficile Rapid Tests (2010) -Percentage Breakdown of
Value Sales by Company for Alere, Meridian Biosciences,
BioSite, Becton Dickinson, Thermo Fischer Scientific, and
Others (includes corresponding Graph/Chart) 159

Table 41: Leading Players in the US Market for
Cryptosporidium Rapid Tests (2010) - Percentage Breakdown
of Value Sales by Company for Remel, Meridian Biosciences,
and Becton Dickinson (includes correspondingGraph/Chart) 159

Table 42: Leading Players in the US Market for Rotavirus
Rapid Tests (2010) - Percentage Breakdown of Value Sales
by Company for Meridian Biosciences, Thermo Fisher
Scientific, and Others (includes corresponding
Graph/Chart) 160

Table 43: Leading Players in the US Market for Giardia
Rapid Tests (2010) - Percentage Breakdown of Value Sales
by Company for Remel, Meridian Biosciences, and Becton
Dickinson (includes corresponding Graph/Chart) 160
Respiratory Rapid Tests 160
Competition 160
Market Share Data of Leading Players 161
Table 44: Leading Players in the US Market for Influenza
Rapid Tests (2010) - Percentage Breakdown of Value Sales
by Company for Quidel, Becton Dickinson, Thermo Fischer
Scientific and Others (includes corresponding
Graph/Chart) 161

Table 45: Leading Players in the US Market for RSV Rapid
Tests (2010) - Percentage Breakdown of Value Sales by
Company for Becton Dickinson, Binax,,Thermo Fischer
Scientific and Others (includes corresponding
Graph/Chart) 161

Table 46: Leading Players in the US Market for
Tuberculosis Rapid Tests (2010) - Percentage Breakdown of
Value Sales by Company for Gen-Probe and Becton Dickinson
(includes corresponding Graph/Chart) 161

Table 47: Leading Players in the US Market for M.
Pneumoniae Rapid Tests (2010) - Percentage Breakdown of
Value Sales by Company for Meridian Biosciences, and
Remel, Inc. (includes corresponding Graph/Chart) 162

Table 48: Leading Players in the US Market for
Mononucleosis Rapid Tests (2010) - Percentage Breakdown
of Value Sales by Company for Alere, Remel, Quidel, and
Others (includes corresponding Graph/Chart) 162
Streptococcus Infection Rapid Tests 162
Market Share Data of Leading Players 163
Table 49: Leading Players in the US Market for
Streptococcus A Rapid Tests (2010) -Percentage Breakdown
of Value Sales by Company for Quidel, Thermo Fischer
Scientific, Becton Dickinson, and Others (includes
corresponding Graph/Chart) 163
A Peek into the Testing Practices of the US Food Industry 163
B.Market Analytics 164
Table 50: US Recent Past, Current & Future 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 2009 through 2017(includes corresponding
Graph/Chart) 164

Table 51: US Historic Review 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 2003 through 2008 (includes corresponding
Graph/Chart) 165

Table 52: US 15-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
Tests, and Other Automated & Rapid Microbiological Tests)
and Non-Clinical Applications for 2003, 2010 & 2017
(includes corresponding Graph/Chart) 166

Table 53: US Recent Past, Current & Future 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 2009
through 2017(includes corresponding Graph/Chart) 167

Table 54: US Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) 168

Table 55: US 15-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 for
2003, 2010 & 2017 (includes corresponding Graph/Chart) 169

14. EUROPE 170
A.Market Analysis 170
A Current & Future Analysis 170
European Market Primer 170
What Drives the Requirement Patterns of End-Users? 170
Competitive Profile 171
Trends & Issues 171
Proliferation of Automated, and Rapid Tests in Europe 171
European Automated Market 172
Probe Tests: “A Crack in the Future of Rapid Tests” 172
Trends Across Product Segments 172
GC/Chlamydia Rapid Tests 172
Streptococcal Infection (Strep A) Rapid Tests 172
Automated Tuberculosis Systems Market 172
B.Market Analytics 173
Table 56: European Recent Past, Current & Future Analysis
for Automated & Rapid Microbiological Tests by Geographic
Region - France, Germany, The United Kingdom, Italy, Spain,
Russia, & Rest of Europe Independently Analyzed with Annual
Revenues in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) 173

Table 57: European Historic Review for Automated & Rapid
Microbiological Tests by Geographic Region - France,
Germany, The United Kingdom, Italy, Spain, Russia, & Rest of
Europe Independently Analyzed with Annual Revenues in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) 174

Table 58: European 15-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, 2010 & 2017 (includes corresponding Graph/Chart) 175

Table 59: European Recent Past, Current & Future 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 2009 through 2017 (includes corresponding
Graph/Chart) 176

Table 60: European Historic Review 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 2003 through 2008 (includes corresponding
Graph/Chart) 177

Table 61: European 15-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
Tests, and Other Automated & Rapid Microbiological Tests)
and Non-Clinical Applications for 2003, 2010 & 2017
(includes corresponding Graph/Chart) 178