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Molecular Diagnostics: Immediate Opportunities and Future Implications

DateJan, 2001
Pages313
Price / format€15997 / Hard Copy

€10 000 

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Abstract:
 This new Genesis Group business report analyzes the current and potential business opportunities in molecular diagnostics.

This report provides and analysis of current and future clinical research and product development projects in leading worldwide markets.

Extensive primary and secondary resources were used in the analysis and assessment of this market and in preparation of this study.





The objectives of this report are to provide:

-An overview of molecular diagnostics and the impact these technologies will have on the evolution of diagnostics.

-A review of medical/clinical needs, focusing on those health-care indications identified as prime targets for diagnostic testing.

-An assessment of the impact of molecular diagnostics on future diagnostics development in clinical chemistry / biochemistry, hematology / coagulation, immunochemistry, microbiology, and other emerging diagnostic technologies.

-A view of the competitive environment in a manner useful for business planning and analysis.

-Insight as to which companies appear to be best positioned to succeed in commercializing the coming significant advances in molecular diagnostics technologies.





Table of contents:
 MOLECULAR DIAGNOSTICS…IMMEDIATE OPPORTUNITIES AND FUTURE IMPLICATIONS

TABLE OF CONTENTS

EXECUTIVE SUMMARY.........................................................................................................................................I
SECTION 1 INTRODUCTION................................................................................................................................ 1
1.1 SCOPE AND OBJECTIVES OF THIS REPORT...................................................................................... 1
1.2 METHODOLOGY OF INVESTIGATION................................................................................................ 1
1.3 LIMITATIONS OF INVESTIGATIONS................................................................................................... 2
SECTION 2 ROLE OF GENOMICS AND PROTEOMICS IN IDENTIFYING NEW DIAGNOSTIC
TARGETS...................................................................................................................................... 5
2.1 ROLE OF THE HUMAN GENOME PROJECT........................................................................................ 5
2.1.1 Mission, Structure, and History Behind the Human Genome Project .............................................. 5
2.1.2 Human Genome Project Goals ......................................................................................................... 8
2.1.3 The Race to Complete the Human Genome Early.......................................................................... 10
2.1.4 Enabling Technology for the Human Genome Project................................................................... 11
2.1.5 Improvements in DNA Sequencing Technology............................................................................ 14
2.1.6 Bioinformatics ............................................................................................................................... 22
2.2 GENOMICS: BEYOND THE HUMAN GENOME PROJECT............................................................... 25
2.2.1 Structural Genomics ....................................................................................................................... 25
2.2.2 Functional Genomics...................................................................................................................... 26
2.2.3 Pharmacogenomics........................................................................................................................ 27
2.2.4 Diagnostic Utility Of Genomic Targets.......................................................................................... 28
2.3 THE GENETIC BASIS FOR DIAGNOSTICS ........................................................................................ 33
2.3.1 Genetic Basis Of Cancer ................................................................................................................ 34
2.3.2 Genetic Basis of Disease Traditionally Known as Genetic Diseases ............................................. 38
2.3.3 Genetic Basis of Cardiovascular Disease ....................................................................................... 46
2.3.4 Genetic Basis of CNS Disease ....................................................................................................... 47
2.3.5 Genetic Basis of Respiratory Disease............................................................................................. 50
2.3.6 Genetic Basis of Metabolic Diseases.............................................................................................. 51
2.3.7 Genetic Basis of Autoimmune, Inflammatory Disease, and Other Immune Diseases.................... 52
2.3.8 Genetic Basis of Infectious Disease ............................................................................................... 53
2.4 THE NEXT STEP: CATALOGUING GENETIC DIVERSITY............................................................. 56
2.4.1 The Need for Genetic Diversity Studies......................................................................................... 56
2.4.2 Sequel to Sequencing the Human Genome: The SNP Consortium ................................................ 57
2.5 DRUG DISCOVERY AND DIAGNOSTIC TARGETS IN SYNERGY................................................. 58
2.5.1 Introduction ................................................................................................................................... 58
2.5.2 Current Drug Development Situation............................................................................................. 59
2.5.3 Modern Drug Discovery................................................................................................................. 60
2.5.4 Gene Discovery .............................................................................................................................. 63
2.5.5 Gene Target Validation .................................................................................................................. 63
2.5.6 Drug Discovery and Drug Screening.............................................................................................. 64
2.5.7 Potential for Diagnostic Opportunity ............................................................................................. 64
2.5.8 New Technologies Emerging ......................................................................................................... 65
2.5.9 Conclusion..................................................................................................................................... 65
SECTION 3 TRENDS IN MOLECULAR DIAGNOSTICS TECHNOLOGIES................................................ 67
3.1 INTRODUCTION ................................................................................................................................... 67
3.1.1 Single/Limited Combination Probes .............................................................................................. 67
3.1.2 Arrays ............................................................................................................................................ 67
3.1.3 Biochip Arrays ............................................................................................................................... 68
3.1.4 Gene Sequencing........................................................................................................................... 69
3.1.5 Single Nucleotide Polymorphisms ................................................................................................. 77
3.2 DIRECT DETECTION TECHNOLOGIES.............................................................................................. 81
3.2.1 Mutation Detection........................................................................................................................ 81
3.2.2 Single-Stranded Conformational Polymorphism (SSCP)............................................................... 81
3.2.3 Denaturing HPLC DHPLC............................................................................................................. 82
3.2.4 SCS................................................................................................................................................ 83
3.2.5 Southern Blot................................................................................................................................. 83
3.2.6 RFLP ............................................................................................................................................. 84
3.3 SIGNAL AMPLIFICATION METHODS................................................................................................ 84
3.3.1 PCR ............................................................................................................................................... 84
3.3.2 Ligase Chain Rreaction (LCR)....................................................................................................... 85
3.3.3 Transcription-mediated Amplification (TMA)............................................................................... 85
3.3.4 Strand Displacement...................................................................................................................... 86
3.3.5 Branched DNA Hybridization Assay, or bDNA ............................................................................ 87
3.3.6 Signal Mediated Amplification of RNA Technology - SMART.................................................... 87
3.3.7 Split Promoter Amplification Reaction - SPAR............................................................................. 87
3.3.8 Direct Detection Methods............................................................................................................... 88
3.3.9 PACE 2 Direct Probes.................................................................................................................... 88
3.3.10 Hybrid Capture ............................................................................................................................... 89
3.3.11 Dot Blot......................................................................................................................................... 89
3.3.12 FISH/In Situ Hybridization ............................................................................................................ 89
3.3.13 Polymer-Electrodes for Detecting Nucleic Acid Hybridization ..................................................... 90
3.3.14 Tessera Array Technology ............................................................................................................. 90
3.3.15 Automation Improves Speed & Reliability .................................................................................... 91
3.4 AUTOMATED MANUFACTURE .......................................................................................................... 91
3.4.1 Automated Processing.................................................................................................................... 91
3.4.2 Progress in Sample Preparation...................................................................................................... 92
3.4.3 Microfluidics ................................................................................................................................. 92
3.4.4 Chaotropes..................................................................................................................................... 92
3.4.5 Adsorption..................................................................................................................................... 93
3.4.6 Integration ..................................................................................................................................... 93
3.5 TECHNOLOGY EVOLVES WITH INCREASING COMPLEXITY OF MULTIPLE DIAGNOSTIC
TARGETS................................................................................................................................................ 93
3.5.1 Array Design ................................................................................................................................. 94
3.5.2 Design Engineering ........................................................................................................................ 94
3.5.3 Instrumentation Advances .............................................................................................................. 94
3.5.4 Software ........................................................................................................................................ 95
3.5.5 Databases....................................................................................................................................... 95
3.5.6 Information Management ............................................................................................................... 95
3.6 INNOVATIONS IN MINIATURIZATION, MICROMACHINERY & NANOTECHNOLOGY .......... 96
3.6.1 Planar Arrays................................................................................................................................. 96
3.6.2 Bead Arrays................................................................................................................................... 97
3.6.3 Fiber Arrays................................................................................................................................... 97
3.7 LABELING/SIGNAL DETECTION........................................................................................................ 98
3.7.1 Isotopic .......................................................................................................................................... 98
3.7.2 Fluorescence.................................................................................................................................. 98
3.7.3 Chemiluminescence....................................................................................................................... 98
3.7.4 Electrochemiluminescence ............................................................................................................. 99
3.7.5 Gold............................................................................................................................................... 99
3.7.6 Molecular Beacons ......................................................................................................................... 99
3.7.7 Other............................................................................................................................................ 100
3.8 APPLICATIONS OF MOLECULAR DIAGNOSTIC TECHNOLOGY............................................... 101
3.8.1 Genomics..................................................................................................................................... 102
3.8.2 Gene Target Validation ................................................................................................................ 103
3.8.3 Drug Discovery ............................................................................................................................ 104
3.8.4 Pharmacogenomics...................................................................................................................... 106
3.8.5 Clinical Diagnostics ..................................................................................................................... 108
3.8.6 Sequences .................................................................................................................................... 108
3.8.7 Automated Sequencing................................................................................................................. 111
3.8.8 Haplotyping for HLA................................................................................................................... 113
3.9 CONCLUSION...................................................................................................................................... 113
3.9.1 Current State of the Art ................................................................................................................ 114
3.9.2 Technology Forecast .................................................................................................................... 114
SECTION 4 MARKETPLACE ANALYSIS AND FORECAST BY OPPORTUNITY SEGMENT .............. 117
4.1 MOLECULAR DIAGNOSTIC MARKETPLACE OVERVIEW.......................................................... 117
4.1.1 Market Segment Overview........................................................................................................... 117
4.1.2 Market Overview by Manufacturer .............................................................................................. 121
4.2 MOLECULAR DIAGNOSTICS – GETTING TO THE ROOT OF THE PROBLEM.......................... 122
4.2.1 Molecular Probes......................................................................................................................... 123
4.2.2 Genotypic and Phenotypic Testing............................................................................................... 124
4.2.3 Gene Sequencing......................................................................................................................... 124
4.2.4 Chip Technology .......................................................................................................................... 125
4.3 INFECTIOUS DISEASE DIAGNOSTIC MARKETS........................................................................... 126
4.3.1 Overview of the Infectious Disease Market ................................................................................. 126
4.3.2 Chlamydia and Gonorrhea Diagnostics ........................................................................................ 129
4.3.3 HIV Diagnostics ........................................................................................................................... 130
4.3.4 Hepatitis B and C Diagnostics...................................................................................................... 130
4.3.5 Human Papilloma Virus (HPV) Diagnostics................................................................................ 133
4.3.6 Mycobacteria Diagnostics ............................................................................................................ 135
4.3.7 Other Infectious Disease Diagnostics........................................................................................... 135
4.3.8 A More Detailed Look at The HIV Diagnostic Market................................................................ 137
4.3.9 Detection (Diagnosis, Blood Bank).............................................................................................. 139
4.3.10 Viral Load Testing........................................................................................................................ 140
4.3.11 Genotyping / Virtual Phenotyping................................................................................................ 140
4.4 CANCER DIAGNOSTIC MARKET ..................................................................................................... 143
4.5 OTHER DIAGNOSTIC MARKETS...................................................................................................... 149
4.5.1 Genetic Testing............................................................................................................................ 149
4.5.2 Transplant/Tissue Typing............................................................................................................. 151
SECTION 5 ANALYSIS OF THE EVOLVING COMPETITIVE ENVIRONMENT OF MOLECULAR
DIAGNOSTICS......................................................................................................................... 153
5.1 INTRODUCTION ................................................................................................................................. 153
5.2 DETERMINANTS OF MARKETPLACE SUCCESS ........................................................................... 153
5.3 COMPETITIVE ANALYSIS OF PARTICIPATING MANUFACTURERS ........................................ 158
5.3.1 Marketing Expertise Determines Success .................................................................................... 158
5.3.2 Technological/Trial Expertise and Innovation ............................................................................. 160
5.3.3 Emotional and Portfolio Commitment to Marketplace................................................................. 162
5.3.4 Summary Analysis of Determinants of Success........................................................................... 163
SECTION 6 PROFILES OF CURRENT MARKET SHAREHOLDERS, LEADING DIAGNOSTIC
MANUFACTURERS, AND OTHER LARGE CORPORATE STAKEHOLDERS IN
MOLECULAR DIAGNOSTICS............................................................................................... 165
6.1 ABBOTT LABORATORIES ................................................................................................................. 165
6.2 AGILENT TECHNOLOGIES (Previously HEWLETT-PACKARD) ................................................... 167
6.3 AMERSHAM PHARMACIA BIOTECH............................................................................................... 169
6.4 APPLIED BIOSYSTEMS (PREVIOUSLY PE BIOSYSTEMS)........................................................... 171
6.5 BAYER DIAGNOSTICS....................................................................................................................... 173
6.6 BECKMAN COULTER ......................................................................................................................... 176
6.7 BECTON DICKINSON......................................................................................................................... 178
6.8 BIOMERIEUX-PIERRE FABRE........................................................................................................... 179
6.9 BIO-RAD LABORATORIES................................................................................................................. 181
6.10 DIGENE................................................................................................................................................. 182
6.11 GEN-PROBE ......................................................................................................................................... 183
6.12 HITACHI / MIRABIO ( PREVIOUSLY HITACHI GENETIC SYSTEMS) ........................................ 185
6.13 MOTOROLA......................................................................................................................................... 187
6.14 ORGANON TEKNIKA......................................................................................................................... 188
6.15 PACKARD BIOSCIENCE ..................................................................................................................... 190
6.16 PERKIN ELMER................................................................................................................................... 191
6.17 QIAGEN ................................................................................................................................................ 193
6.18 ROCHE DIAGNOSTICS....................................................................................................................... 195
6.19 TECAN .................................................................................................................................................. 197
6.20 VISIBLE GENETICS ............................................................................................................................. 199
6.21 VYSIS.................................................................................................................................................... 200
SECTION 7 PROFILES OF LEADING BIOTECHNOLOGY / RESEARCH INSTITUTIONS WITH
STRATEGIC INTEREST IN THE MOLECULAR DIAGNOSTICS MARKET................ 205
7.1 ACACIA RESEARCH / COMBIMATRIX............................................................................................ 205
7.2 ACLARA BIOSCIENCES..................................................................................................................... 206
7.3 ADVANCED ARRAY TECHNOLOGY S.A. ....................................................................................... 208
7.4 AFFYMETRIX ...................................................................................................................................... 209
7.5 ALPHAGENE........................................................................................................................................ 213
7.6 ANDCARE ............................................................................................................................................ 214
7.7 APPLIED GENE TECHNOLOGIES ..................................................................................................... 215
7.8 ARRADIAL........................................................................................................................................... 217
7.9 ASPER BIOTECH................................................................................................................................. 217
7.10 AURORA BIOSCIENCES ..................................................................................................................... 218
7.11 AUTOGEN ............................................................................................................................................ 219
7.12 AVIVA BIOSCIENCES ......................................................................................................................... 220
7.13 AXON INSTRUMENTS ........................................................................................................................ 221
7.14 AXYS..................................................................................................................................................... 222
7.15 BIOARRAY SOLUTIONS..................................................................................................................... 223
7.16 BIOFORCE LABORATORY................................................................................................................. 225
7.17 BIOGENEX LABORATORIES............................................................................................................. 226
7.18 BIOMICRO SYSTEMS......................................................................................................................... 227
7.19 BOSTON BIOMEDICA / BBI BIOSEQ ................................................................................................ 227
7.20 BOSTON PROBES................................................................................................................................ 229
7.21 CALIPER TECHNOLOGIES................................................................................................................. 230
7.22 CEPHEID............................................................................................................................................... 232
7.23 CLONDIAG CHIP TECHNOLOGIES................................................................................................... 234
7.24 CORNING LIFE SCIENCES ................................................................................................................. 235
7.25 CYTOCELL........................................................................................................................................... 236
7.26 DIADEXUS ........................................................................................................................................... 237
7.27 DIAGNOSWISS .................................................................................................................................... 239
7.28 DISCOVERY PARTNERS .................................................................................................................... 239
7.29 DISPLAY SYSTEMS BIOTECH........................................................................................................... 240
7.30 DNAMICROARRAY.COM................................................................................................................... 241
7.31 ELCATECH........................................................................................................................................... 241
7.32 EPIGENOMICS..................................................................................................................................... 242
7.33 EUROGENTEC..................................................................................................................................... 242
7.34 EXACT SCIENCES............................................................................................................................... 243
7.35 EXIQON AS .......................................................................................................................................... 244
7.36 FEBIT GMBH........................................................................................................................................ 244
7.37 GAMIDAGEN LTD ............................................................................................................................... 245
7.38 GENE CHECK ...................................................................................................................................... 246
7.39 GENE LOGIC........................................................................................................................................ 246
7.40 GENEMACHINES ................................................................................................................................ 248
7.41 GENESCAN EUROPE AG .................................................................................................................... 250
7.42 GENETIC VECTORS ............................................................................................................................ 251
7.43 GENETRACE SYSTEMS...................................................................................................................... 252
7.44 GENICON SCIENCES.......................................................................................................................... 254
7.45 GENISPHERE ....................................................................................................................................... 255
7.46 GENOMETRIX ..................................................................................................................................... 256
7.47 GENOMIC SOLUTIONS...................................................................................................................... 257
7.48 GENORX............................................................................................................................................... 258
7.49 GENSET ................................................................................................................................................ 259
7.50 GERON.................................................................................................................................................. 260
7.51 HYSEQ .................................................................................................................................................. 261
7.52 ID BIOMEDICAL ................................................................................................................................. 263
7.53 ILLUMINA............................................................................................................................................ 265
7.54 INFECTIO DIAGNOSTIC..................................................................................................................... 266
7.55 INNOGENETICS .................................................................................................................................. 267
7.56 INTERACTIVA BIOTECH.................................................................................................................... 268
7.57 INTERLEUKIN GENETICS.................................................................................................................. 269
7.58 INVITROGEN / LIFE TECHNOLOGIES ............................................................................................. 269
7.59 IXION BIOTECHNOLOGIES ............................................................................................................... 271
7.60 LIFECODES.......................................................................................................................................... 271
7.61 LUMINEX ............................................................................................................................................. 272
7.62 LYNX .................................................................................................................................................... 273
7.63 MERGEN LTD...................................................................................................................................... 274
7.64 MICROBIONICS................................................................................................................................... 275
7.65 MICRONICS ......................................................................................................................................... 276
7.66 MILLENNIUM PREDICTIVE MEDICINE .......................................................................................... 277
7.67 MITSUBISHI RAYON.......................................................................................................................... 278
7.68 MJ RESEARCH..................................................................................................................................... 279
7.69 MOLECULAR STAGING ..................................................................................................................... 279
7.70 MOSAIC TECHNOLOGIES.................................................................................................................. 280
7.71 MWG-BIOTECH AG............................................................................................................................. 282
7.72 NANOGEN............................................................................................................................................ 283
7.73 NANOSPHERE ..................................................................................................................................... 285
7.74 NIMBLEGEN SYSTEMS ...................................................................................................................... 285
7.75 ONE LAMBDA..................................................................................................................................... 285
7.76 OPERON TECHNOLOGIES ................................................................................................................. 286
7.77 ORCHID BIOSCIENCES...................................................................................................................... 287
7.78 ORIGENE TECHNOLOGIES................................................................................................................ 289
7.79 OXFORD GENE TECHNOLOGY LTD................................................................................................ 289
7.80 PAMGENE ............................................................................................................................................ 290
7.81 PHARMASEQ....................................................................................................................................... 290
7.82 PHASE-1 MOLECULAR TOXICOLOGY............................................................................................ 292
7.83 POLYGENYX ....................................................................................................................................... 293
7.84 PROLIGO .............................................................................................................................................. 294
7.85 PROLINX .............................................................................................................................................. 294
7.86 PROMEGA............................................................................................................................................ 295
7.87 PROTOGENE........................................................................................................................................ 296
7.88 PYROSEQUENCING............................................................................................................................ 297
7.89 QBIOGENE ........................................................................................................................................... 297
7.90 RADIUS BIOSCIENCES ....................................................................................................................... 298
7.91 SANGAMO BIOSCIENCES.................................................................................................................. 298
7.92 SEQUENOM ......................................................................................................................................... 299
7.93 SIGMA-GENOSYS ............................................................................................................................... 301
7.94 STRATAGENE ..................................................................................................................................... 302
7.95 TAKARA BIOMEDICAL GROUP........................................................................................................ 302
7.96 TECHNE / R&D SYSTEMS .................................................................................................................. 303
7.97 TELECHEM INTERNATIONAL .......................................................................................................... 304
7.98 TM BIOSCIENCE ................................................................................................................................. 304
7.99 TORSANA BIOSENSOR A/S................................................................................................................ 305
7.100 TREVIGEN............................................................................................................................................ 306
7.101 TRINITY BIOTECH .............................................................................................................................. 306
7.102 US GENOMICS..................................................................................................................................... 307
7.103 VISIBLE GENETICS ............................................................................................................................. 307
7.104 VYSIS .................................................................................................................................................... 309
7.105 XEOTRON............................................................................................................................................. 311
7.106 XTRANA............................................................................................................................................... 311
7.107 ZEPTOSENS ......................................................................................................................................... 312

LIST OF FIGURES

Figure ES-1 WW Forecast for HIV Diagnostics by Technology Platform ............................... vii
Figure ES-2 WW Forecast for HCV Diagnostics by Technology Platform.............................viii

LIST OF TABLES

TableES-1 Historic WW Sales ($MM) – Molecular Diagnostics............................................ ix
Table ES-2 Historic US Sales ($MM) – Molecular Diagnostics .............................................. ix
Table ES-3 Historic & Forecast WW Sales – Molecular Diagnostics in
Microbiology/Infectious Disease ......................................................................... xiv
Table ES-4 Historic & Forecast US Sales – Molecular Diagnostics in
Microbiology/Infectious Disease ......................................................................... xiv
Table ES-5 Leading Companies’ Molecular Diagnostics Focus Existing Product Lines &
Product Development...........................................................................................xix
Table ES-6 Leading Companies’ Strategic Alliances in Molecular Diagnostics Product
Development ......................................................................................................... xx
Table ES-7 Leading Companies Rating Scale .......................................................................xxii
Table 2.1 Oncogene Families and Genes .............................................................................. 36
Table 2.2 Cancers Associated with the Loss of a Tumor Suppressor Gene.......................... 37
Table 4.1 Historic WW Sales ($MM) – Molecular Diagnostics......................................... 118
Table 4.2 Historic US Sales ($MM) – Molecular Diagnostics ........................................... 118
Table 4.3 Forecast WW Sales – Molecular Diagnostics (IVDP)........................................ 120
Table 4.4 Forecast US Sales – Molecular Diagnostics (IVDP) .......................................... 120
Table 4.5 Summary of WW Sales in 2000 – Molecular Diagnosis Market by
Manufacturer ....................................................................................................... 121
Table 4.6 Historic WW Sales ($MM) – Infectious Disease Testing by Molecular
Diagnostics .......................................................................................................... 127
Table 4.7 Historic US Sales ($MM) – Infectious Disease Testing by Molecular
Diagnostics .......................................................................................................... 127
Table 4.8 Historic & Forecast WW Sales – Molecular Diagnostics in
Microbiology/Infectious Disease ........................................................................ 128
Table 4.9 Historic & Forecast US Sales – Molecular Diagnostics in
Microbiology/Infectious Disease ........................................................................ 129
Table 4.10 Historic WW Sales ($MM) – HIV Molecular Diagnostics................................. 137
Table 4.11 Historic US Sales ($MM) – HIV Molecular Diagnostics ................................... 138
Table 4.12 Historic and Forecast WW Sales – HIV Molecular Diagnostics ........................ 138
Table 4.13 Historic and Forecast US Sales – HIV Molecular Diagnostics........................... 139
Table 5.1 Leading Companies’ Molecular Diagnostics Focus Existing Product Lines &
Product Development.......................................................................................... 155
Table 5.2 Leading Companies’ Strategic Alliances in Molecular Diagnostics Product
Development ....................................................................................................... 156
Table 5.3 Leading Companies’ Market Strength in Molecular Diagnostics Market .......... 160
Table 5.4 Leading Companies’ Technology Innovation in Molecular Diagnostics
Markets................................................................................................................ 161
Table 5.5 Leading Companies’ Emotional Commitment to Molecular Diagnostics
Markets................................................................................................................ 163
Table 5.6 Leading Companies Rating Scale ....................................................................... 164




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