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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.

1. 1. Overview 4
2. 1.1 Statement of Report 4
3. 1.2 About this Report 4
4. 1.3 Scope of the Report 5
5. 1.4 Objectives 5
6. 1.5 Methodology 6
7. 1.6 Executive Summary 7
9. 2. Introduction to Automated Microbial Testing 8
10. 2.1 Limitations of Standard Culturing Techniques 8
11. 2.2 Advantages of Automated Microbial Testing 9
12. 2.3 Objectives of Automated Microbial Testing Systems 10
13. 2.3.1 Microbial Detection 10
14. 2.3.2 Microbial Quantitation 11
15. 2.3.3 Microbial Identification 11
16. 2.3.4 Detection of Antibiotic Resistance 12
17. 2.4 Specimen Processing/Preparation 13
19. 3. Automated Microbial Testing Market 15
20. 3.1 Market Overview-A Business Case for Automated Microbial Testing 15
21. 3.2 Clinical Diagnostics Market 18
22. 3.2.1 Major Market Segments 21
23. 3.2.1.1 Hospital Market 22
24. 3.2.1.2 Independent Clinical Laboratory Market 24
25. 3.2.1.3 Public Health Laboratory Market 24
26. 3.2.1.4 Blood Banks 25
27. 3.2.2 Overview of Clinical Specimen Types 28
28. 3.2.2.1 Importance of Specimen Collection and Transport 29
29. 3.2.3 Sales Projections of Major Clinical Applications 30
30. 3.2.3.1 Blood Culture 30
31. 3.2.3.2 Urine Screening 31
32. 3.2.3.3 Microbial Identification and Antibiotic Susceptibility 32
33. 3.3 Industrial Microbiology Market 33
34. 3.3.1 Food Testing Market 35
35. 3.3.2 Pharmaceutical Testing Market 39
36. 3.3.3 Biodefense and Water Monitoring Market 42
37. 3.4 Competitive Landscape and Market Share Analysis of Automated Microbiology Products 44
38. 3.5 Global Market Analysis 45
40. 4. Technology Platforms and Industry Players 48
41. 4.1 Instrumentation Review 48
42. 4.1.1 Automated Cell Culturing 48
43. 4.1.2 Automated Biochemical Assays 52
44. 4.1.3 Automated Genetic-based Assays 57
45. 4.1.4 Automated Immunological Assays 63
47. 5. Important Trends Affecting Automated Microbial Detection 66
48. 5.1 Increase in Antibiotic Resistance 66
49. 5.2 Influenza and Other Infectious Diseases 70
50. 5.3 Concerns about Food and Drug Safety 74
51. 5.4 Security against Bioterrorism 75
52. 5.5 Regulatory Landscape 75
53. 5.6 Business Landscape 77
54. 5.6.1 Technology and Market Trends 77
55. 5.6.1.1 Technology Trends 77
56. 5.6.1.2 Specific New Instrument Opportunities 80
57. 5.6.2 Potential Market Entry Barriers and Risks 81
58. 5.6.3 Alternative Market Penetration Strategies 81
59. 5.6.4 Business Planning Issues and Concerns 82
60. 5.6.4.1 M&A Activity 82
61. 5.6.5 Partnering 83
62. 5.6.6 Competitive Situation 83
63. 5.6.6.1 Primary Competitors 83
64. 5.6.6.2 Industry Challenges and Strategic Recommendations 85
65. 5.6.6.3 Commercialization of Automated Microbial Testing Products 85
66. 5.6.7 Intellectual Property Rights 86
67. 5.7 New Opportunities and Strategic Recommendations 87
68. 5.7.1 Specific Opportunities for Automated Instrumentation Systems with Significant Market Appeal During the Next Five Years 87
69. 5.7.2 Developments for Microbial Sensitivity Instrumentation Products 87
70. 5.7.3 Market Penetration Strategies for Microbial Susceptibility Testing 88
71. 5.7.4 Automated Microbial Testing Sector Commercial Developments 88
73. 6. Company Profiles 89
74. 6.1 Abbott Laboratories 89
75. 6.2 AES Chemunex 92
76. 6.3 Advanced Analytical Technologies, Inc. 92
77. 6.4 Applied Biosystems (Part of Life Technologies Corporation) 92
78. 6.5 Becton Dickinson and Company 94
79. 6.6 bioMérieux 94
80. 6.7 Celsis International plc 95
81. 6.8 Cepheid 95
82. 6.9 Dupont Qualicon 96
83. 6.10 Eiken Chemical Co., Ltd. 96
84. 6.11 Gen-Probe, Inc. 96
85. 6.12 Giles Scientific 97
86. 6.13 Lonza Group Ltd. 97
87. 6.14 3M 98
88. 6.15 Merlin Diagnostika GmbH 98
89. 6.16 MIDI, Inc. 99
90. 6.17 Millipore Corp. 99
91. 6.18 Pall Corporation 100
92. 6.19 PDS 101
93. 6.20 Roche Ltd. 101
94. 6.21 Siemens Healthcare Diagnostics 102
95. 6.22 TREK Diagnostic Systems (Part of Magellan Biosciences, Inc.) 103
98. INDEX OF FIGURES
100. Figure 3.1: World Market for Treatments of Infectious Diseases, 2008-2014 15
101. Figure 3.2: Global Microbiology Market by Region, 2009 16
102. Figure 3.3: Microbiology Market by Sector, 2003-2013 17
103. Figure 3.4: Molecular Diagnostics Market Segmentation 20
104. Figure 3.5: U.S. Lab Market Share by Test Volume, 2009 22
105. Figure 3.6: Percentage of Clinical Samples Containing Pathogens by Specimen Type 29
106. Figure 3.7: Total Micro Testing Process Flow Chart 29
107. Figure 3.8: Rapid and Traditional Industrial Microbiology Testing Volume, 2003-2013 34
108. Figure 3.9: Rapid and Traditional Industrial Microbiology Testing as Percentage of Total, 2003-2013 35
109. Figure 3.10: Food Microbiology Testing Sample Collection Points 37
110. Figure 3.11: Microbiology Test Volume in the Food Industry, 2005-2013 38
111. Figure 3.12: Percentage of Pharmaceutical Manufacturers Using Rapid Microbiological Methods 40
112. Figure 3.13: Flowchart of Steps for Implementation of Rapid Microbial Methods 41
113. Figure 3.14: Clinical Bacteriology Market Size by Region 46
114. Figure 3.15: Industrial Applications Market by Region 47
115. Figure 5.1: Incidence Rates of Infectious MRSA Infections by Age 67
116. Figure 5.2: Global Frequency of Vancomycin-resistant Enterococcus, 2006 69
117. Figure 5.3: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009 71
118. Figure 5.4: Status of H5N1 Avian Influenza, 2009 72
119. Figure 5.5: Global Trend of HIV Infection, 1991-2007 73
122. INDEX OF TABLES
124. Table 3.1: Global Microbiology Market Size, 2003-2015 15
125. Table 3.2: Automated Microbial Testing Market Segments Overview 16
126. Table 3.3: Global Microbiology Market by Operational Sector, 2003-2013 17
127. Table 3.4: Medical Instrument Automation Technologies Market: Diagnostic Applications, 2003-2015 17
128. Table 3.5: Key Drivers in the Automated Microbial Testing Market 18
129. Table 3.6: Key Barriers to the Automated Microbial Testing Market 18
130. Table 3.7: Global Clinical In Vitro Diagnostics Markets by Assay Type 19
131. Table 3.8: Clinical Bacteriology Market Size by Testing Method 19
132. Table 3.9: Global Market for Detection of Infectious Diseases Using Molecular Diagnostic Methods, 2006-2015 20
133. Table 3.10: Share of Molecular Diagnostics Market Size Testing by Type 20
134. Table 3.11: Global Market for Blood-Screening Diagnostic Testing, 2000-2009 26
135. Table 3.12: U.S. Market for Blood-Screening Diagnostic Testing, 2000-2009 26
136. Table 3.13: Overview of Specimens for Culture 28
137. Table 3.14: Global Urinalysis Market 31
138. Table 3.15: Global Microbiology ID/AST Market, 2002-2009 32
139. Table 3.16: Global Market Segments Performing Microbiology Tests by Test Volume 33
140. Table 3.17: Global Food Microbiology Market, 2005-2013 35
141. Table 3.18: Traditional and Rapid Microbiology Testing in the Food Industry, 2005-2013 38
142. Table 3.19: RMM in Pharmaceutical Testing Market by Type 40
143. Table 3.20: U.S. Market for Biological Threat Detection Testing, 2000-2010 43
144. Table 3.21: Microbiology Market Share Profile, 2009 44
145. Table 3.22: ID/AST Market Share Profile, 2009 44
146. Table 3.23: Global IVD Growth Rates, 2009-2014 45
147. Table 4.1: Automated Cell Culturing 48
148. Table 4.2: Automated Biochemical Assays 53
149. Table 4.3: Automated Genetic-based Assays 57
150. Table 4.4: Automated Immunological Assays 63
151. Table 5.1: Major Pathogens Identified in the Last 30 Years 70
152. Table 5.2: Global Market Potential for TB Diagnostic Testing, 2000-2010 74
153. Table 5.3 Key Regulatory Requirements for Microbial Testing Instruments and Reagents 76
154. Table 5.4 Drivers of the Microbial Testing Market 77
155. Table 5.5: Technology Trends in Microbial Susceptibility Testing 79
156. Table 5.6: Market Trends in Microbial Susceptibility Testing 80
157. Table 5.7 Microbial Testing Markets: Market Drivers Ranked in Order of Impact 80
158. Table 5.8 Microbial Testing Markets: Market Restraints Ranked in Order of Impact 80
159. Table 5.9: Companies that Offer Products for Automated Microbial Testing 84
160. Table 5.10: Competitive Factors in the Automated Microbial Testing Diagnostics Infectious Disease Market 84
161. Table 5.11: Infectious Disease Testing Market: Strategic Recommendations on Sector Business Functions 85
162. Table 5.12: Automated Microbial Testing Market: Impact of Top Industry Challenges (U.S.) 85
163. Table 6.1: Products Marketed by Abbott in the Diagnostic Market 91