Automated and Rapid Microbiological Tests - A Worldwide Market Review

Automated and Rapid Microbiological Tests - A Worldwide Market Review

High prevalence of infectious diseases and sexually transmitted diseases (STDs) continue to drive the automated and rapid tests market, as need for quicker, higher volume and more accurate methods of testing gains importance. With humans and bacteria locked in a perennial biological warfare, there exists a perpetual need for new and advanced rapid microbial testing methods and instruments. Hitherto growth in the automated microbiological test systems market stemmed from laboratories worldwide embarking on the transition from manual to automated forms of testing.

Technology developments and changes have initiated sweeping changes in the market for automated and rapid microbiological tests. With probe tests threatening the survival of immunoassay based rapid tests and with advances in automated microbiological testing systems promising potential opportunities, the landscape is fraught with a unique mixture of opportunities and related threats. The new methods offer greater speed, accuracy, specificity and sensitivity than can be achieved with conventional culturing or immunoassay methods. Molecular diagnostics is the new enabling technology of numerous next generation rapid microbiology test kits.

These and other market data and trends are presented in “Automated and Rapid Microbiological Tests: A Worldwide Market Review” by BizAcumen, Inc. Our reports are designed to be most comprehensive in geographic coverage and vertical market analyses.

AUTOMATED AND RAPID MICROBIOLOGICAL TESTS BMR-1008


CONTENTS


1. METHODOLOGY 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Quantitative Techniques & Reporting Level 3

2. GLOBAL MARKET OVERVIEW AND OUTLOOK 4
Outlook 4
Evolutionary Battle Against Bugs Drives Future of the Market 4
Automated Microbiological Tests: A Pesky Gray Area in the
Clinical Diagnostics Market 4
Traditional Rapid Microbiological Tests Destined to Go Out
With the Old 5
A Current & Future Analysis 6
Macro: The Big Picture 6
Deciding the Market’s Future 6
A Holistic Peek into a Few Noteworthy Trends 7
Biotechnology & Rapid Microbial Tests 8
Automated & Rapid Microbiological Tests: “Current Market Stance” 8
A Business Case for Automated & Rapid Microbiological Testing 9
Near Patient Testing: An Offshoot of Rapid Microbiological Tests 10
Pros & Cons of Near Patient Testing 10
Role of Near Patient Testing in Reducing Antibiotic
Resistance in Humans 11
The Pre/Post Microbial Rapid Testing Era: A Review 11
Market Structure 12
Competitive Setup of the Diverse Automated & Rapid
Microbiology Products Market 12
Historic Data 13

3. TRENDS & ISSUES 13
Advancements in Molecular Diagnostics - A Boon or a Threat 13
Antibiotic Resistant Bacteria Throws the Spotlight On
Microbial Testing 14
Instant Detection of Pathogens - A New Epoch in the Fight for
Survival 15
Lower Cost Rapid Tests Built on Multiple Sampling Modalities -
Gaining Momentum 15
“Time Constraints?” - Rapid Tests to the Rescue 15
Rapid HIV Tests: A New Age Diagnostic Weapon Against the
Killer Disease 16
Accuracy/Reliability of Home HIV Testing: A Bone of Contention 17
Development of Near Patient Test Kits: A Market Driven Phenomenon 17
Near Patient Test Kits: A Rumination of Possibilities 18
Automated Blood Culture Systems: A Winning Edge in the Fight
Against Bacteremia 18
Leading Food Processors Resort to Rapid Microbiological Testing 19
Impact of Food Scares on Rapid Microbiological Tests Market 20
Demand for Microbiological Tests & Level of QC in the Food
Industry 21
Rapid Tests Creating Brighter Avenues in Food Microbiology
Testing Market 22
Dire Need to Nip Operating Costs Throws the Spotlight on Rapid
Tests 22
Key Advantages/Benefits of Rapid Microbiological Tests on Food 23
Food Packages of the Future Ingrained with Microbial Alert
Systems 23
Technology Innovations in Rapid Food Microbial Testing 24
Obtaining Regulatory Approval - A Major Non-Technical Hindrance 24

4. FACTORS INFLUENCING THE MARKET 25
Continuing Biological Warfare with Pathogens Sparks Market Growth 25
Innovative Products - A Key Growth Strategy 25
Other Market Drivers in a Capsule 25
Low Turnaround Times Skyrocket Demand 25
Greater Patient Awareness 26
Rising Incidence of STDs Kindles Universal Market Acceptance 26
Ultra-Rapid HIV-Screening Tests- A Strong Fight against HIV-
Epidemic 26
Validation of Rapid Microbiological Tests: An Imperative
Prerequisite 27
Non-Conformance to Testing Requirements: A Weighty Concern 28
Influenza - Boosting Rapid Test Prospects 28

5. PRODUCT FACTS 29
1. Clinical Applications 29
Automated Identification and Susceptibility Systems 29
Automated Blood Culture Systems 30
Automated Tuberculosis Systems 30
Streptococcal Infection Rapid Tests 30
GC/Chlamydia Rapid Tests 30
Other Automated & Rapid Microbiological Tests 30
2. Non-Clinical Applications 31

6. CORPORATE DEVELOPMENTS 31
BD Establishes New Rapid Diagnostic Products Manufacturing
Facility in China 31
Quidel Corporation Obtains CLIA Waiver from FDA for its
QuickVue(R) RSV Test 31
Siemens Obtains US FDA Approval for its VERSANT™ 440 Molecular
System (USA) 31
bioMérieux to Market Wescor’s Customized Slide Stainer
Instruments under bioMérieux Brand 32
Schering-Plough and OraSure Ink Collaboration Agreement for
Developing Rapid Oral HCV Test 32
Abbott Obtains US FDA Approval for its Automated HTLV-I/HTLV-
II Blood Screening Test (USA) 33
Quidel and bioMérieux Form a Long-term Alliance in Rapid
Diagnostic Tests 33
BD Diagnostics Obtains US FDA Approval for BD GeneOhm™ StaphSR
Assay 33
Meridian Bioscience Rolls Out Two New Rapid Tests for
Detecting Epstein- Barr Virus 33
Oxoid Introduces Staph Plus System for Identifying
Staphylococcal Species 34
Meridian Bioscience Obtains US FDA Approval for Two New Rapid
Tests 34
Siemens AG Acquires Dade Behring 34
Thermo Fisher Scientific Teams Up with KBA for Expanding its
Microbiology Business Division in Lenexa 35
OraSure and SCMS Enter into an Agreement for Supplying
OraQuick(R) HIV Test to PEPFAR Countries 35
Abbott Obtains US FDA Approval for its Fully Automated PRISM®
HCV Test 35
Gen-Probe Obtains US FDA Approval for its PROCLEIX® TIGRIS®
System for Testing Donated Blood 35
AdvanDx Ropes in bioMérieux for Distributing its Rapid
Diagnostic Tests in US 36
3M and Gen-Probe Join Hands to Develop Rapid Molecular Tests
For Detecting HAIs (USA) 36
Gen-Probe’s PROCLEIX® TIGRIS® System Obtains US FDA Approval
for Screening Donated Blood for West Nile Virus 37
3M Acquires Acolyte Biomedica 37
Formation of Siemens Medical Solutions Diagnostics 38
bioMérieux Bags Contract to Provide VITEK® 2 System for
Scottish NHS Labs 38
bioMérieux Licenses NorChip’s HPV Test Technology for Cervical
Cancer 38
bioMérieux in Strategic Agreement with Cepheid for Sepsis Assays 39
3M Health Care Creates New Medical Diagnostics Unit 39
Schering-Plough & OraSure to Develop Rapid Oral HCV Test 40
Siemens Healthcare Diagnostics Launches MicroScan® WalkAway®
plus Diagnostic Microbiology Systems 40
Bio-Rad Launches a Rapid test for Screening MRSA, MRSASelect™
test, in US 40
bioMérieux Introduces VIDAS®, an automated Clostridium
difficile A & B Toxins Detection Test 41
Oxoid Launches Remel Wellcolex® Colour Tests for Testing
Shigella, E. coli O157 and Salmonella 41
Siemens Healthcare Diagnostics Obtains Health Canada Approval
for its VERSANT 440 Molecular System 41
Oxoid Unveils Remel Xpect™ Clostridium Difficile Toxin A/B Test 42
Neogen Introduces Soleris System 42
ATCC Introduces Authenticult™ Quality Control Microbiological
Testing Tool 42
Bio-Rad Introduces New EBV Kits 43
Roche Seeks FDA Marketing Approval for Hepatitis C Virus Test 43
Roche Seeks US FDA Approval for its Cobas TaqScreen MPX Test 43
FDA Clears Usage of TIGRIS® System for Testing WNV in Donated
Blood 43
FDA Approves ImmunoCard STAT!® EHEC for Detecting E. coli
Infection 44

7. MAJOR PLAYERS 44
Abbott Laboratories (USA) 44
Abbott Diagnostics (USA) 44
Becton Dickinson and Company (USA) 44
bioMerieux (France) 45
bioMerieux, Inc. (USA) 45
Bio-Rad Laboratories (USA) 45
Cellabs Pty Ltd (Australia) 45
Celsis International Plc (UK) 45
Coris BioConcept (Belgium) 46
F. Hoffmann-La Roche Ltd. (Switzerland) 46
Gen-Probe Incorporated (USA) 46
Genzyme Diagnostics (USA) 46
Inverness Medical Innovations, Inc. (USA) 47
MedMira, Inc. (Canada) 47
Meridian Biosciences, Inc. (USA) 47
Orasure Technologies, Inc. (USA) 47
Orion Diagnostica Oy (Finland) 47
Quidel Corporation (USA) 47
Siemens Healthcare Diagnostics (USA) 48
Thermo Fisher Scientific, Inc. (USA) 48
Remel, Inc. (USA) 48
Oxoid Limited (UK) 48

8. GLOBAL MARKET ANALYTICS 49

9. THE UNITED STATES 59
Rapid Microbiology Tests - A Competitive Profile 59
Consolidation in the Automated and Rapid Microbiological
Tests Market 59
Bioterrorism Tests - Gaining Prominence 59
Tracking Trends Across Product Segments 60
STD Rapid Tests 60
Market Share Trends of Leading Players: 60
Leading Players in HIV Rapid Testing Market 61
Gastrointestinal Rapid Tests 62
Market Share Trends of Leading Players 62
Respiratory Rapid Tests 63
Competition 64
Streptococcus Infection Rapid Tests 65
Average Prices 66
A Peek into the Testing Practices of the US Food Industry 68

10. EUROPE 71

a. France 78

b. Germany 81

c. The United Kingdom 84

d. Italy 87

e. Spain 89

f. Russia 91

g. Rest of Europe 92

11. REST OF WORLD 94
Latin American Market 94
Asia-Pacific - The Next Epicenter for the AIDS Epidemic 94
Table 1: Percentage Breakdown of Leading Players in World
Market for IVD Automated Microbiology Systems - 2000

Table 2: Global Automated and Rapid Microbiological Tests
Market by Region for the Period 2007-2015 (Sales in US$
Million)

Table 3: Percentage Breakdown of Global Automated and Rapid
Microbiological Tests Market by Region for the Years 2008 &
2012

Table 4: Global Market for Automated and Rapid
Microbiological Tests in Clinical Applications by Region for
the Period 2007-2015 (Sales in US$ Million)

Table 5: Percentage Breakdown of Global Market for Automated
and Rapid Microbiological Tests in Clinical Applications by
Region for the Years 2008 & 2012

Table 6: Global Market for Automated and Rapid Microbiological
Tests in Clinical Applications by Equipment Used for the
Period 2007-2015 (Sales in US$ Million)

Table 7: Percentage Breakdown of Global Market for Automated
and Rapid Microbiological Tests in Clinical Applications by
Equipment Used for the Years 2008 & 2012

Table 8: Global Market for Automated Identification &
Susceptibility Systems in Clinical Applications by Region for
the Period 2007-2015 (Sales in US$ Million)

Table 9: Percentage Breakdown of Global Market for Automated
Identification & Susceptibility Systems in Clinical
Applications by Region for the Years 2008 & 2012

Table 10: Global Market for Automated Blood Culture Systems in
Clinical Applications by Region for the Period 2007-2015
(Sales in US$ Million)

Table 11: Percentage Breakdown of Global Market for Automated
Blood Culture Systems in Clinical Applications by Region for
the Years 2008 & 2012

Table 12: Global Market for Automated Tuberculosis Systems in
Clinical Applications by Region for the Period 2007-2015
(Sales in US$ Million)

Table 13: Percentage Breakdown of Global Market for Automated
Tuberculosis Systems in Clinical Applications by Region for
the Years 2008 & 2012

Table 14: Global Market for Streptococcal Infection Rapid
Tests in Clinical Applications by Region for the Period
2007-2015 (Sales in US$ Million)

Table 15: Percentage Breakdown of Global Market for
Streptococcal Infection Rapid Tests in Clinical Applications
by Region for the Years 2008 & 2012

Table 16: Global Market for GC/Chlamydia Rapid Tests in
Clinical Applications by Region for the Period 2007-2015
(Sales in US$ Million)

Table 17: Percentage Breakdown of Global Market for
GC/Chlamydia Rapid Tests in Clinical Applications by Region
for the Years 2008 & 2012

Table 18: Global Market for Other Automated & Rapid
Microbiological Tests in Clinical Applications by Region for
the Period 2007-2015 (Sales in US$ Million)

Table 19: Percentage Breakdown of Global Market for Other
Automated & Rapid Microbiological Tests in Clinical
Applications by Region for the Years 2008 & 2012

Table 20: Global Market for Automated and Rapid
Microbiological Tests in Non-Clinical Applications by Region
for the Period 2007-2015 (Sales in US$ Million)

Table 21: Percentage Breakdown of Global Market for Automated
and Rapid Microbiological Tests in Non-Clinical Applications
by Region for the Years 2008 & 2012

Table 22: Percentage Breakdown of Leading Players in the US
Market for GC/Chlamydia Rapid Tests - 2005

Table 23: Percentage Breakdown of Leading Players in the US
Market for Chlamydia Rapid Tests - 2005

Table 24: Percentage Breakdown of Leading Players in the US
Market for Syphilis Rapid Tests - 2005

Table 25: Percentage Breakdown of Leading Players in the US
Market for C. Difficile Rapid Tests - 2005

Table 26: Percentage Breakdown of Leading Players in the US
Market for Cryptosporidium Rapid Tests - 2005

Table 27: Percentage Breakdown of Leading Players in the US
Market for Rotavirus Rapid Tests - 2005

Table 28: Percentage Breakdown of Leading Players in the US
Market for Giardia Rapid Tests - 2005

Table 29: Percentage Breakdown of Leading Players in the US
Market for Influenza Rapid Tests - 2005

Table 30: Percentage Breakdown of Leading Players in the US
Market for RSV Rapid Tests - 2005

Table 31: Percentage Breakdown of Leading Players in the US
Marketfor Tuberculosis Rapid Tests - 2005

Table 32: Percentage Breakdown of Leading Players in the US
Market for M. Pneumoniae Rapid Tests - 2005

Table 33: Percentage Breakdown of Leading Players in the US
Market for Mononucleosis Rapid Tests - 2005

Table 34: Percentage Breakdown of Leading Players in the
USMarket for Streptococcus A Rapid Tests - 2005

Table 35: Average Costs for Rapid Tests in the US

Table 36: Automated and Rapid Microbiological Tests Market by
End-Use Segment in the US: 2007-2015 (Sales in US$ Million)

Table 37: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in the US for
the Years 2008 & 2012

Table 38: Rapid Microbiological Tests Market by End-Use
Segment in the US: 2007-2015 (Sales in US$ Million)

Table 39: Percentage Breakdown of Rapid Microbiological Tests
Market by End-Use Segment in the US for the Years 2008 & 2012

Table 40: Percentage Breakdown of Leading Players in European
Market for Automated & Rapid Microbiological Tests - 2000

Table 41: Percentage Breakdown of Leading Players in European
Market for Chlamydia Rapid Tests - 2000

Table 42: Percentage Breakdown of Leading Players in European
Market for Streptococcal Infection (Strep A) Rapid Tests -
2000

Table 43: Percentage Breakdown of Leading Players in European
Market for Automated Blood Culture Systems - 2000

Table 44: Automated and Rapid Microbiological Tests Market by
Region in Europe: 2007-2015 (Sales in US$ Million)

Table 45: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by Region in Europe for the Years
2008 & 2012

Table 46: Automated and Rapid Microbiological Tests Market by
End-Use Segment in Europe: 2007-2015 (Sales in US$ Million)

Table 47: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Europe for
the Years 2008 & 2012

Table 48: Percentage Breakdown of Leading Players in French
Market for Automated & Rapid Microbiological Tests - 2000

Table 49: Percentage Breakdown of Leading Players in French
Market for Chlamydia Rapid Tests - 2000

Table 50: Percentage Breakdown of Leading Players in French
Market for Automated Tuberculosis Systems - 2000

Table 51: Percentage Breakdown of Leading Players in French
Market for Automated Blood Culture Systems - 2000

Table 52: Percentage Breakdown of Leading Players in French
Market for Automated Identification and Susceptibility Systems
- 2000

Table 53: Automated and Rapid Microbiological Tests Market by
End- Use Segment in France: 2007-2015 (Sales in US$ Million)

Table 54: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in France for
the Years 2008 & 2012

Table 55: Percentage Breakdown of Leading Players in German
Market for Automated & Rapid Microbiological Tests - 2000

Table 56: Percentage Breakdown of Leading Players in German
Market for Streptococcal Infection Rapid Tests - 2000

Table 57: Percentage Breakdown of Leading Players in German
Market for Automated Tuberculosis Systems - 2000

Table 58: Percentage Breakdown of Leading Players in German
Market for Automated Blood Culture Systems - 2000

Table 59: Percentage Breakdown of Leading Players in German
Market for Chlamydia Rapid Tests - 2000

Table 60: Percentage Breakdown of Leading Players in German
Market for Automated Identification and Susceptibility
Systems - 2000

Table 61: Automated and Rapid Microbiological Tests Market by
End-Use Segment in Germany: 2007-2015 (Sales in US$ Million)

Table 62: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Germany for
the Years 2008 & 2012

Table 63: Percentage Breakdown of Leading Players in the UK
Market for Automated & Rapid Microbiological Tests - 2000

Table 64: Percentage Breakdown of Leading Players in the UK
Market for Chlamydia Rapid Tests - 2000

Table 65: Percentage Breakdown of Leading Players in the UK
Market for Automated Tuberculosis Systems - 2000

Table 66: Percentage Breakdown of Leading Players in the UK
Market for Automated Identification and Susceptibility Systems
- 2000

Table 67: Percentage Breakdown of Leading Players in the UK
Market for Streptococcal Infection Rapid Tests - 2000

Table 68: Percentage Breakdown of Leading Players in the UK
Market for Automated Blood Culture Systems - 2000

Table 69: Automated and Rapid Microbiological Tests Market by
End-Use Segment in the UK: 2007-2015 (Sales in US$ Million)

Table 70: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in the UK for
the Years 2008 & 2012

Table 71: Percentage Breakdown of Leading Players in Italian
Market for Automated & Rapid Microbiological Tests - 2000

Table 72: Percentage Breakdown of Leading Players in Italian
Market for Streptococcal Infection Rapid Tests - 2000

Table 73: Percentage Breakdown of Leading Players in Italian
Market for Automated Tuberculosis Systems - 2000

Table 74: Percentage Breakdown of Leading Players in Italian
Market for Chlamydia Rapid Tests - 2000

Table 75: Automated and Rapid Microbiological Tests Market by
End- Use Segment in Italy: 2007-2015 (Sales in US$ Million)

Table 76: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Italy for
the Years 2008 & 2012

Table 77: Percentage Breakdown of Leading Players in Spanish
Market for Automated Tuberculosis Systems - 2000

Table 78: Automated and Rapid Microbiological Tests Market by
End-Use Segment in Spain: 2007-2015 (Sales in US$ Million)

Table 79: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Spain for
the Years 2008 & 2012

Table 80: Automated and Rapid Microbiological Tests Market by
End- Use Segment in Russia: 2007-2015 (Sales in US$ Million)

Table 81: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Russia for
the Years 2008 & 2012

Table 82: Percentage Breakdown of Leading Players in
Streptococcal Infection Rapid Tests Market in Rest of Europe -
2000

Table 83: Percentage Breakdown of Leading Players in Automated
Identification and Susceptibility Systems Market in Rest of
Europe - 2000

Table 84: Automated and Rapid Microbiological Tests Market by
End-Use Segment in Rest of Europe: 2007-2015 (Sales in US$
Million)

Table 85: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Rest of
Europe for the Years 2008 & 2012

Table 86: Automated and Rapid Microbiological Tests Market by
End-Use Segment in Rest of World: 2007-2015 (Sales in US$
Million)

Table 87: Percentage Breakdown of Automated and Rapid
Microbiological Tests Market by End-Use Segment in Rest of
World for the Years 2008 & 2012


COMPANIES PROFILED