DNA Sequencing and PCR Markets - Biotechnology, Healthcare and Life Sciences Publishing

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DNA Sequencing and PCR Markets
Publication Date: 12-NOV-04
Pages: 252
Study: TMRPCR
Format/Price: PDF document / $999.00

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The focus of this TriMark Publications report is to describe the specific segment of the life sciences market called DNA sequencing. This analysis includes all of the generally-accepted DNA-oriented analytical activities that are currently used today, such as enabling technologies like polymerase chain reaction (PCR). It examines these measurement technology platforms and their reagents and supplies as utilized in biotechnology research, pharmacology and healthcare. Generally, diagnostic tests which are marketed primarily as over-the-counter products directly to patients are not included in this study, although there is inevitably some overlap. This examination will: 1) identify viable technology drivers through a comprehensive look at various platform technologies for molecular sequencing, including immunoassays electrophoretic methods, probe-based nucleic acid assays, microarrays and non-PCR sequencing; 2) obtain a complete understanding of the chief molecular sequencing tests for predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic applications; 3) discover feasible market opportunities via an identification of high-growth applications in different therapeutic areas, with a focus on the biggest and expanding markets-communicable diseases, cardiology and oncology; and 4) focus on global industry development through an in-depth analysis of the major world markets for molecular sequencing, including forecasts for growth.

Table of Contents:

1. Overview 7
1.1 Statement of Report 7
1.2 About This Report 7
1.3 Scope of the Report 7
1.4 Objectives 8
1.5 Methodology 8
1.6 Executive Summary 9
2. Introduction to DNA Sequencing and Amplification and PCR Technology 11
2.1 Science Overview: Introduction to DNA 11
2.1.1 Types of Genetics Investigations 13
2.1.2 Proteomics 13
2.1.3 Products for the Genomics Market 13
2.2 The Impact of the Human Genome Project on Molecular Biology 13
2.3 Impact of DNA Sequencing Techniques on Biotechnology, Pharmaceutical and Healthcare Industries 14
2.4 Molecular Diagnosis in the Postgenomic Era-The Role of SNPs 17
2.5 Advances in Molecular Diagnostic Technologies 18
2.6 The Use of PCR Technology 20
2.7 Genetic Variability and Disease 21
3. Market Analysis of PCR and DNA Amplification Product 23
3.1 Overview of the Sequencing and Amplification Market 23
3.1.1 Research Laboratories 27
3.1.1.1 Market Share 27
3.1.2 Biotechnology 28
3.1.2.1 Competitive Situation 28
3.1.3 Pharmaceutical 29
3.1.3.1 Paradigm Shift in Drug Discovery and Development 29
3.1.3.2 Systems Biology and the Need for More Effective Tools 29
3.1.3.3 Molecular Medicine and the New Therapeutics 29
3.1.3.4 Pharmacogenomics Using Genotyping and Phenotyping Clinical Biomarkers 29
3.1.3.5 Competitive Situation 30
3.1.4 Nucleic Acid Test (NAT) Applications for Blood Testing and Infectious Diseases 30
3.1.4.1 The Market 31
3.1.4.2 Market Share Research Segment 37
3.1.4.3 Growth Rate 37
3.1.4.4 Competitive Situation 38
3.1.4.5 DNA Kit Companies 39
3.1.4.6 Estimate of Units Sold 40
3.1.4.7 Pricing 41
3.2 Diagnostic Testing Using DNA 41
3.2.1 HIV 43
3.2.2 Hepatitis Serological Markers and Nucleic Acid Testing 45
3.2.3 SARS Virus 47
3.2.3.1 Microarray or DNA Chip-Based Tests 49
3.2.4 Cancer Detection 50
3.2.5 Microbiology Testing 50
3.2.6 Blood Screening 53
3.3 SNPs in Clinical Diagnostics 55
3.3.1 The Forensics Market 60
3.4 Target Selection 61
3.5 Detection of Amplified DNA 61
3.5.1 PCR 61
3.5.2 DNA Reagent Applications Market Share and Key Players 62
3.6 New Developments in PCR 63
3.6.1 Ramification Amplification Method 63
3.6.2 Rolling Circle Amplification 63
3.7 Real-Time Quantitative PCR 64
3.8 Light Cycler PCR 65
3.9 Hot-Start PCR 65
3.10 Ligation-Mediated PCR (Ligase Chain Reaction) 66
3.11 Molecular Beacons 66
3.12 Amplification of Refractory Mutation System (ARMS) 67
3.13 Market Size 1998-2008 and Growth Projections in DNA Amplification Instrumentation 68
3.13.1 U.S. Market 68
3.13.2 Far East and Asian Market 68
3.13.3 European Market 69
3.14 Market Share of Key Players in DNA Amplification 69
3.15 Competitive Situation 70
3.15.1 Key Companies in PCR 70
3.15.2 Product Description 71
3.15.3 Installed Base of PCR Instruments and ThermoCyclers 72
3.15.4 Pricing 72
3.16 Isolation of DNA for PCR Profiling 74
3.16.1 Analysis by PCR-Based DNA Typing 75
3.17 Rapid Isolation of DNA for RFLP and PCR 75
3.17.1 DNA for PCR-STR Typing 75
3.18 Industrial Applications 75
3.18.1 The Market for Industrial Testing and Food Diagnostics 75
3.18.2 Detection of H. pylori by PCR 76
3.18.3 E. coli 0157 76
3.18.4 Enteric Viruses 77
3.19 The Drivers of the Biotech Industry 77
3.20 Biotechnology Instrumentation Outlook 77
3.20.1 Products for the Genomics Market 77
3.20.2 Products for the Proteomics Market 81
3.20.3 Products for the Drug Metabolism and Pharmacokinetics Market 83
3.20.4 Cell Biology and Functional Proteomics Products 84
3.21 PCR/DNA Testing Market Analysis 85
4. Use of PCR and DNA Amplification Products 86
4.1 PCR Components 86
4.1.1 Primers for PCR 86
4.1.2 Thermal Cyclers 86
4.2 Sources of DNA for PCR 88
4.3 PCR Primer Sequence 89
4.4 Thermostable DNA Polymerases 91
4.5 PCR Protocols 91
4.6 Equipment for PCR 92
4.6.1 Microchip PCR Array Instrument 92
4.6.1.1 Overview 92
4.6.1.2 Leading Microarray Companies 93
4.6.2 Automated Programmable Electronic Matrix (APEX) 93
4.6.3 Microchips and DNA Microarrays 93
4.6.3.1 Gene Chip Usage in Molecular Diagnostics: Expression Chip vs. Sequencing Chip 95
4.6.3.2 Designing of a Microarray 100
4.6.3.3 Sequencing Chips 100
4.6.3.4 Gene Chips 101
4.6.3.5 DNA Analysis Arrays 104
4.6.3.6 DNA Chip Sensors 108
4.6.4 Miniaturized Microfluidics Systems 108
4.6.5 Microfluidic Automated DNA Analysis Using PCR 110
4.6.6 Lab-On-A-Chip 113
4.6.7 RNA Chip 117
4.6.8 Protein Chip 118
4.6.9 Applications of Protein Chip Technology 119
4.7 FISH Amplification 120
4.8 Lab Chip Market Size 120
4.8.1 Market Size and Growth Projections 120
4.8.2 Market Share of Key Players 120
4.8.3 Competitive Situation 121
4.8.3.1 Key Companies in Microchip and Microfluidics 121
4.8.3.2 Drivers of Competition 121
4.8.3.3 Funding Sources 121
4.8.3.4 Pricing 121
5. Technical Trends in PCR 122
5.1 Practical Applications of PCR 122
5.1.1 Overview 122
5.1.2 Proteomics 122
5.1.3 Bioinformatics 123
5.1.4 Genomics 123
5.1.5 Biotherapeutics 123
5.2 Quality Control Issues in PCR 124
5.3 Determining Length of cDNA Product 124
5.3.1 Electrochemical Detection of DNA 127
5.3.2 New Technologies for Signal Amplification 128
5.3.2.1 Dendritic Nucleic Acid (3 DNA) Signal Amplification 128
5.3.2.2 Direct Signal Amplification Using the Invader Assay 129
5.3.3 Biosensor Technologies 131
5.3.3.1 DNA Hybridization Biosensor Chips 131
5.3.3.2 PNA-Based Biosensors 132
5.3.3.3 Optical Biosensors 132
5.3.3.4 Surface Plasmon Resonance Biosensors 132
5.4 Quantum Dot Technology 133
5.5 Novel Nucleic Acid Amplification Techniques 134
5.6 Microfluidic Devices 134
5.7 Genotyping Methods 135
5.7.1 Use of DNA Sequencers 135
5.7.1.1 Capillary-Based Sequencers 136
5.7.1.2 Online DNA Sequencers 137
5.7.1.3 Pyrosequencing 137
5.7.2 Use of Microarrays 138
5.8 Evolution of Rapid Point-of-Care Formats 140
5.9 SNP Genotyping on Very-High-Density Arrays 140
5.10 Protein Microarrays 140
5.11 RiboMaker Detection System 141
5.12 RNA Isolation Kits 142
6. New Developments in Molecular Diagnostics 143
6.1 Pharmacogenomics 143
6.1.1 The Market 143
6.1.1.1 Oncology 143
6.1.1.2 Toxicogenomics 143
6.2 DNA Microarrays 144
6.2.1 The Technique 144
6.2.2 The Market 144
6.2.3 Identification of Sequence SNPs 145
6.2.4 Gene Expression Monitoring Arrays 145
6.3 Emerging Markets of DNA Arrays 145
6.4 Business Trends in the Industry 146
6.4.1 Pharmaceutical Industry Trends 146
6.4.2 Acquisitions, License Agreements, Partnerships 146
6.4.3 Legal and Patent Developments 147
6.4.4 Ethical, Legal and Social Issues and the Use of Genetic Information 148
7. New Products Under Development 149
7.1 Gene Expression Profiling 149
7.2 Proteomic Multiplex Assays 149
7.2.1 eTag Chemistries 149
7.2.2 ArrayPlate Microarray-Based Approach 149
7.3 Solution-Phase Multiplexing 151
7.4 RNAi 151
7.4.1 The Role of RNAi in Drug Target Validation 152
7.4.2 Other Companies Involved in the RNAi Market 152
7.5 Alternatives to PCR Amplification 153
7.5.1 Locked Nucleic Acid 153
7.5.2 Multiplexed Nuclease-Protection Assay and ArrayPlate 154
8. Corporate Directory 156
8.1 Abbott Laboratories 156
8.2 Aclara BioSciences 158
8.3 Advalytix 159
8.4 Affymerix 160
8.5 Agilent Techologies 169
8.6 Ambion 170
8.7 GE Healthcare 170
8.8 Applera Applied Biosystems 170
8.9 Bayer Corporation 173
8.10 Beckman Coulter, Inc. 175
8.11 bioMérieux 177
8.12 Bio-Rad Laboratories 179
8.13 BioTrove, Inc. 180
8.14 Caliper LifeSciences 180
8.15 454 Life Sciences 182
8.16 Cellomics 182
8.17 Cepheid 183
8.18 Chiron 184
8.19 Ciphergen Biosystems 185
8.20 Combimatrix Group 186
8.21 CuraGen Corporation 187
8.22 Cytocell 192
8.23 DakoCytomation A/S 192
8.24 diaDexus 192
8.25 Digene Diagnostics Inc 194
8.26 Enzo Biochem 196
8.27 Epicentre 196
8.28 Exiqon 196
8.29 Gene Logic 197
8.30 Genisphere 199
8.31 Gen-Probe 200
8.32 Genset 203
8.33 Genta, Inc 203
8.34 Gentra Systems 203
8.35 Genzyme 204
8.36 Hamilton Thorne Biosciences 207
8.37 High Throughput Genomics 207
8.38 Hycor Biomedical 208
8.39 ID Biomedical 208
8.40 BioVeris 208
8.41 Illumina 209
8.42 Incyte Genomics, Inc. 210
8.43 Invitrogen 212
8.44 Johnson & Johnson Clinical Diagnostics 212
8.45 Kreatech Diagnostics 214
8.46 LI-COR 214
8.47 Lion Bioscience, AG 215
8.48 Luminex Corporation 217
8.49 Matritech 218
8.50 Meridian Biosciences 220
8.51 Millennium Predictive Medicine 221
8.52 Myriad Genetics 221
8.53 Nanogen 222
8.54 Nanosys 225
8.55 NimbleGen, Inc. 226
8.56 Nova Molecular Inc 227
8.57 Nymox 227
8.58 Orchid Cellmark 227
8.59 Organon Teknika 228
8.60 Ostex 228
8.61 PamGene 228
8.62 PE Tropix 228
8.63 Pharmingen 228
8.64 PNA Diagnostics 229
8.65 PPD 229
8.66 PPGx 229
8.67 Professional Genetics Laboratory 230
8.68 Promega 230
8.69 Biotage 230
8.70 Qiagen 231
8.71 Quidel 232
8.72 Roche Molecular Systems 233
8.73 Sequenom 236
8.74 Stratagene 237
8.75 Tepnel Life Sciences 238
8.76 Third Wave Technologies 238
8.77 Tm Bioscience 240
8.78 Visible Genetics 241
8.79 Vysis 241
9. Market Trends and Forecasts 242
9.1 Market Dynamics 242
9.2 Future Considerations for Molecular Diagnosis 242
9.3 How Genomics is Transforming Pharmaceutical R&D 243
9.4 Cancer Markers 243
9.5 Cytology Markers 243
9.6 RNA Detection 244
9.7 Diagnosis of Inherited Disease 244
9.8 Ethical Considerations 244
9.9 NAT and Personalized Medicine 245
9.10 Three Growth Areas of Molecular Diagnostics 245
9.11 PNA Probes 246
9.12 Rolling Circle Amplification 246
9.13 Ramification Amplification Method 247
9.14 Invader Assays/Third Wave Technologies 248
9.15 Molecular Beacons 249
Appendix 250
Glossary 251
LIST OF FIGURES
Figure 1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship 12
Figure 2: Overall Structure of Nucleic Acid Testing Market 32
Figure 3: Formation of Enzyme-DNA Complex Analyte 64
Figure 4: Cepheid's I-CORE Module 111
Figure 5: Diversa's GigaMatrix Well Plate 111
Figure 6: The Topaz™ Crystallizer 112
Figure 7: Illustration of SNP Genotyping 119
Figure 8: The Layered Structure of the 3DNA Dendrimer 128
Figure 9: Example of Protein or Antibody (Ab) Array (Hypomatrix) 141
LIST OF TABLES
Table 1: Global Market for DNA Sequencing 15
Table 2: DNA Sequencing Market Players and Related Revenue 15
Table 3: Reagents and Equipment Sales for Use in DNA Sequencing Worldwide 24
Table 4: The Worldwide Market for Protein Sequencing Instrumentation 25
Table 5: Global Market for Tools and Consumables Used in Drug Discovery and Development, Clinical Diagnostics and Biomedical Research 27
Table 6: Estimated Market Share and Major Competitors in the DNA/PCR Kit Research Market Segment in the U.S., 2002 28
Table 7: Key Bioassay Technologies in the Life Sciences Industry 28
Table 8: Global Market for Molecular Diagnostic Testing 33
Table 9: Global Market for Nucleic Acid Testing 34
Table 10: Summary of Molecular Diagnostic Testing 2003 34
Table 11: Annual U.S. Market for DNA Probe Diagnostics 35
Table 12: Annual Worldwide Market for DNA Probe Diagnostics 35
Table 13: Estimated Market Share and Major Competitors in the DNA/PCR Kit Diagnostics Market Segment in the U.S. 2002 37
Table 14: DNA Probe Market Segments for the U.S. Market 38
Table 15: Companies Marketing Products Using DNA Probes 40
Table 16: Number of Units of DNA Probe Kits Sold World Wide 41
Table 17: Summary of Assays for HIV Viral Load Testing 43
Table 18: Global Market for HIV Diagnostic Testing 44
Table 19: U.S. Market for HIV Diagnostic Testing 44
Table 20: Lower Detection Limits of HBV DNA Assays 45
Table 21: Gen-Probe Clinical Diagnostic Products for the Detection of Viral Microorganisms 47
Table 22: Global Market for SARS Diagnostic Testing 48
Table 23: U.S. Market for SARS Diagnostic Testing 49
Table 24: Global Market for Molecular Diagnostic Cancer Testing 50
Table 25: Annual Test Volume for Infectious Disease NAT Testing 51
Table 26: World Market Dollar Volume of NAT STD Testing 51
Table 27: U.S. Market Dollar Volume of NAT STD Testing 51
Table 28: U.S. Market Share of NAT STD Testing 52
Table 29: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Microorganisms 52
Table 30: Global Market for Blood Screening Diagnostic Testing 54
Table 31: U.S. Market for Blood Screening Diagnostic Testing 54
Table 32: Gen-Probe Blood Screening Products 54
Table 33: Leading Players in SNP Genotyping 57
Table 34: Global Market for SNP Genotyping 57
Table 35: DNA Analysis Market Competitors 59
Table 36: Leading Companies in Medical Utility of SNPs 60
Table 37: U.S. Market for Forensic Diagnostic Testing 60
Table 38: Properties of Various Acid Amplification Techniques 62
Table 39: Frequency Usage of DNA Amplification Applications 63
Table 40: Hot-Start PCR Leaders and U.S. Market Share 2002 65
Table 41: Companies Licensed to Sell Custom Molecular Beacon Probes 67
Table 42: U.S. Market Size 1998-2010 and Growth Projections in DNA Amplification Instrumentation 68
Table 43: Far East and Europe Market Size 2000-2008 and Growth Projections in DNA Amplification Instrumentation 69
Table 44: Market Share of Key Players in DNA Clinical Amplification 70
Table 45: Market Share of Key Players in DNA Amplification Thermostable Enzymes 70
Table 46: Real Time PCR Type of DNA Amplification Market Share 70
Table 47: Nucleic Acid Amplification Methods 71
Table 48: Amplification Reagent Product Description 71
Table 49: Installed Base of Real Time PCR Instruments and Thermo Cyclers 72
Table 50: Leading Manufacturers of Thermal Cyclers and Market Share 72
Table 51: Standard Prep Pricing 73
Table 52: Small Target Prep Pricing 73
Table 53: Hybridization Pricing 73
Table 54: Analysis Pricing 73
Table 55: Gene Chip Pricing 74
Table 56: Affymerix Made-To-Order Arrays 74
Table 57: U.S. Market for Food Screening Diagnostic Testing 76
Table 58: Leading Manufacturers of Thermal Cyclers and Market Share 87
Table 59: Thermo Electron Molecular Biology Thermal Cyclers 88
Table 60: Companies Developing or Marketing Potentially Competitive DNA Arrays 95
Table 61: Global Market for DNA Chips 2000-2006 96
Table 62: Worldwide Market for Microfluidic Devices 99
Table 63: Lab Chip Products 114
Table 64: Automated Chip Systems 115
Table 65: Chip Application Development Systems 116
Table 66: The Worldwide Protein Biochip Market 116
Table 67: Global Protein Chip Market 120
Table 68: Ribomaker™ Assays to be Introduced for Cancer and Pathogen Detection 141
Table 69: Products Marketed By Abbott in the Diagnostic Market 157
Table 70: Summary of Selected Affymerix Expression Profiling Customers 162
Table 71: Summary of Affymerix-Selected Collaborators and Licensees 165
Table 72: Gene Expression Monitoring 168
Table 73: Gen-Probe PACE Product Sales as a Percentage of Total Company Revenue 201
Table 74: Past Developments of HTG 207
Table 75: Qiagen Sales by Country 2002 and 2003 232
Table 76: Roche Diagnostics' Key Products 234
Table 77: Third Wave Technologies Invader Product Portfolio 240

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