Automated Microbial Testing Markets

Microorganisms are ubiquitous and may be found in almost every environment on earth. As such, they are a diverse group with an assortment of genotypic and phenotypic features and varying growth and reproduction requirements. There is continual interaction between humans and microbes, ranging from disease-causing pathogenic organisms invading the human body to microorganisms harnessed by humans to aid in the fermentation of food products. The detection and characterization of these organisms enables us to better understand how to manipulate and exert some control over their impact on our lives and welfare.

This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as the diagnostic microbiology and focuses primarily on the automated microbial testing systems. Within medical diagnostics, automated microbial testing for infectious disease-causing organisms offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics--as well as the development of microarray devices--have led the microbiology market to accept the power of advanced analytical techniques for the diagnosis and treatment of infectious disease.

For this analysis, the automated microbial testing market has been divided into the following segments for this examination:
1) microbial detection,
2) microbial enumeration,
3) microbial identification and
4) detection of antibiotic resistance.

This report analyzes the size and growth of the automated microbial testing market in its applications for infectious disease detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the U.S. and worldwide.

Report Highlights

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1. Overview 4
1.1 Statement of Report 4
1.2 About this Report 4
1.3 Scope of the Report 5
1.4 Objectives 5
1.5 Methodology 6
1.6 Executive Summary 7

2. Introduction to Automated Microbial Testing 8
2.1 Limitations of Standard Culturing Techniques 8
2.2 Advantages of Automated Microbial Testing 9
2.3 Objectives of Automated Microbial Testing Systems 10
2.3.1 Microbial Detection 10
2.3.2 Microbial Quantitation 11
2.3.3 Microbial Identification 11
2.3.4 Detection of Antibiotic Resistance 12
2.4 Specimen Processing/Preparation 13

3. Automated Microbial Testing Market 15
3.1 Market Overview-A Business Case for Automated Microbial Testing 15
3.2 Clinical Diagnostics Market 18
3.2.1 Major Market Segments 21
3.2.1.1 Hospital Market 22
3.2.1.2 Independent Clinical Laboratory Market 24
3.2.1.3 Public Health Laboratory Market 24
3.2.1.4 Blood Banks 25
3.2.2 Overview of Clinical Specimen Types 28
3.2.2.1 Importance of Specimen Collection and Transport 29
3.2.3 Sales Projections of Major Clinical Applications 30
3.2.3.1 Blood Culture 30
3.2.3.2 Urine Screening 31
3.2.3.3 Microbial Identification and Antibiotic Susceptibility 32
3.3 Industrial Microbiology Market 33
3.3.1 Food Testing Market 35
3.3.2 Pharmaceutical Testing Market 39
3.3.3 Biodefense and Water Monitoring Market 42
3.4 Competitive Landscape and Market Share Analysis of Automated Microbiology Products 44
3.5 Global Market Analysis 45

4. Technology Platforms and Industry Players 48
4.1 Instrumentation Review 48
4.1.1 Automated Cell Culturing 48
4.1.2 Automated Biochemical Assays 52
4.1.3 Automated Genetic-based Assays 57
4.1.4 Automated Immunological Assays 63

5. Important Trends Affecting Automated Microbial Detection 66
5.1 Increase in Antibiotic Resistance 66
5.2 Influenza and Other Infectious Diseases 70
5.3 Concerns about Food and Drug Safety 74
5.4 Security against Bioterrorism 75
5.5 Regulatory Landscape 75
5.6 Business Landscape 77
5.6.1 Technology and Market Trends 77
5.6.1.1 Technology Trends 77
5.6.1.2 Specific New Instrument Opportunities 80
5.6.2 Potential Market Entry Barriers and Risks 81
5.6.3 Alternative Market Penetration Strategies 81
5.6.4 Business Planning Issues and Concerns 82
5.6.4.1 M&A Activity 82
5.6.5 Partnering 83
5.6.6 Competitive Situation 83
5.6.6.1 Primary Competitors 83
5.6.6.2 Industry Challenges and Strategic Recommendations 85
5.6.6.3 Commercialization of Automated Microbial Testing Products 85
5.6.7 Intellectual Property Rights 86
5.7 New Opportunities and Strategic Recommendations 87
5.7.1 Specific Opportunities for Automated Instrumentation Systems with Significant Market Appeal During the Next Five Years 87
5.7.2 Developments for Microbial Sensitivity Instrumentation Products 87
5.7.3 Market Penetration Strategies for Microbial Susceptibility Testing 88
5.7.4 Automated Microbial Testing Sector Commercial Developments 88

6. Company Profiles 89
6.1 Abbott Laboratories 89
6.2 AES Chemunex 92
6.3 Advanced Analytical Technologies, Inc. 92
6.4 Applied Biosystems (Part of Life Technologies Corporation) 92
6.5 Becton Dickinson and Company 94
6.6 bioMerieux 94
6.7 Celsis International plc 95
6.8 Cepheid 95
6.9 Dupont Qualicon 96
6.10 Eiken Chemical Co., Ltd. 96
6.11 Gen-Probe, Inc. 96
6.12 Giles Scientific 97
6.13 Lonza Group Ltd. 97
6.14 3M 98
6.15 Merlin Diagnostika GmbH 98
6.16 MIDI, Inc. 99
6.17 Millipore Corp. 99
6.18 Pall Corporation 100
6.19 PDS 101
6.20 Roche Ltd. 101
6.21 Siemens Healthcare Diagnostics 102
6.22 TREK Diagnostic Systems (Part of Magellan Biosciences, Inc.) 103
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Table 3.1: Global Microbiology Market Size, 2003-2015 15
Table 3.2: Automated Microbial Testing Market Segments Overview 16
Table 3.3: Global Microbiology Market by Operational Sector, 2003-2013 17
Table 3.4: Medical Instrument Automation Technologies Market: Diagnostic Applications, 2003-2015 17
Table 3.5: Key Drivers in the Automated Microbial Testing Market 18
Table 3.6: Key Barriers to the Automated Microbial Testing Market 18
Table 3.7: Global Clinical In Vitro Diagnostics Markets by Assay Type 19
Table 3.8: Clinical Bacteriology Market Size by Testing Method 19
Table 3.9: Global Market for Detection of Infectious Diseases Using Molecular Diagnostic Methods, 2006-2015 20
Table 3.10: Share of Molecular Diagnostics Market Size Testing by Type 20
Table 3.11: Global Market for Blood-Screening Diagnostic Testing, 2000-2009 26
Table 3.12: U.S. Market for Blood-Screening Diagnostic Testing, 2000-2009 26
Table 3.13: Overview of Specimens for Culture 28
Table 3.14: Global Urinalysis Market 31
Table 3.15: Global Microbiology ID/AST Market, 2002-2009 32
Table 3.16: Global Market Segments Performing Microbiology Tests by Test Volume 33
Table 3.17: Global Food Microbiology Market, 2005-2013 35
Table 3.18: Traditional and Rapid Microbiology Testing in the Food Industry, 2005-2013 38
Table 3.19: RMM in Pharmaceutical Testing Market by Type 40
Table 3.20: U.S. Market for Biological Threat Detection Testing, 2000-2010 43
Table 3.21: Microbiology Market Share Profile, 2009 44
Table 3.22: ID/AST Market Share Profile, 2009 44
Table 3.23: Global IVD Growth Rates, 2009-2014 45
Table 4.1: Automated Cell Culturing 48
Table 4.2: Automated Biochemical Assays 53
Table 4.3: Automated Genetic-based Assays 57
Table 4.4: Automated Immunological Assays 63
Table 5.1: Major Pathogens Identified in the Last 30 Years 70
Table 5.2: Global Market Potential for TB Diagnostic Testing, 2000-2010 74
Table 5.3 Key Regulatory Requirements for Microbial Testing Instruments and Reagents 76
Table 5.4 Drivers of the Microbial Testing Market 77
Table 5.5: Technology Trends in Microbial Susceptibility Testing 79
Table 5.6: Market Trends in Microbial Susceptibility Testing 80
Table 5.7 Microbial Testing Markets: Market Drivers Ranked in Order of Impact 80
Table 5.8 Microbial Testing Markets: Market Restraints Ranked in Order of Impact 80
Table 5.9: Companies that Offer Products for Automated Microbial Testing 84
Table 5.10: Competitive Factors in the Automated Microbial Testing Diagnostics Infectious Disease Market 84
Table 5.11: Infectious Disease Testing Market: Strategic Recommendations on Sector Business Functions 85
Table 5.12: Automated Microbial Testing Market: Impact of Top Industry Challenges (U.S.) 85
Table 6.1: Products Marketed by Abbott in the Diagnostic Market 91
Figure 3.1: World Market for Treatments of Infectious Diseases, 2008-2014 15
Figure 3.2: Global Microbiology Market by Region, 2009 16
Figure 3.3: Microbiology Market by Sector, 2003-2013 17
Figure 3.4: Molecular Diagnostics Market Segmentation 20
Figure 3.5: U.S. Lab Market Share by Test Volume, 2009 22
Figure 3.6: Percentage of Clinical Samples Containing Pathogens by Specimen Type 29
Figure 3.7: Total Micro Testing Process Flow Chart 29
Figure 3.8: Rapid and Traditional Industrial Microbiology Testing Volume, 2003-2013 34
Figure 3.9: Rapid and Traditional Industrial Microbiology Testing as Percentage of Total, 2003-2013 35
Figure 3.10: Food Microbiology Testing Sample Collection Points 37
Figure 3.11: Microbiology Test Volume in the Food Industry, 2005-2013 38
Figure 3.12: Percentage of Pharmaceutical Manufacturers Using Rapid Microbiological Methods 40
Figure 3.13: Flowchart of Steps for Implementation of Rapid Microbial Methods 41
Figure 3.14: Clinical Bacteriology Market Size by Region 46
Figure 3.15: Industrial Applications Market by Region 47
Figure 5.1: Incidence Rates of Infectious MRSA Infections by Age 67
Figure 5.2: Global Frequency of Vancomycin-resistant Enterococcus, 2006 69
Figure 5.3: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009 71
Figure 5.4: Status of H5N1 Avian Influenza, 2009 72
Figure 5.5: Global Trend of HIV Infection, 1991-2007 73
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