プロテオミクス：テクノロジーと商品化可能性

Proteomics: An Assessment of the Technologies and Commercial Potential Proteomics is an emerging field that has developed in the wake of genomics. Its goal is to understand protein expression at the cellular level, and apply this information to scientific and medical problems. For example, compared to healthy cells, how does influenza virus infection affect the total protein output? Are any of the proteins expressed only in the infected cells suitable targets for new antiviral drugs? This approach also applies to cancerous cells, and cells from patients with degenerative diseases and many other conditions. New technologies like protein chips and capillary electrophoresis are emerging to serve proteomic studies, and more mature technologies like 2-D electrophoresis, mass spectroscopy, and nuclear magnetic resonance spectroscopy are being adapted for protein studies, and in some cases, for high throughput uses. Bioinformatics applications are constantly being developed to analyze the data produced by all of these technologies. This BCC study examines how proteomics technologies have affected basic research and pharmaceutical research, and how they are likely to affect research in the near future. It also analyzes how proteomics technologies are developing, and examines new companies that are likely to make substantial contributions to the field. An important part of the report analyzes instruments that are vital to proteomics studies. Sales and spending projections through 2006 are included.

TABLE OF CONTENTS

INTRODUCTION ..................VIII

• STUDY GOALS AND OBJECTIVES ..................VIII
• REASONS FOR DOING THE STUDY ..................VIII
• AUDIENCE FOR THE REPORT ..................IX
• SCOPE AND FORMAT ..................IX
• METHODOLOGY AND INFORMATION SOURCES .................. X
• BCC INFORMATION AND RELATED BCC STUDIES .................. X
• DISCLAIMER ..................XI

EXECUTIVE SUMMARY ..................XII

• OVERVIEW: PROTEOMICS AND THE CURRENT PROTEOMICS MARKET STRUCTURE .................. 1
  • WHAT IS PROTEOMICS? .................. 1
  • TOOLS OF PROTEOMICS .................. 2
    • 2-D ELECTROPHORESIS .................. 2
    • MASS SPECTROSCOPY .................. 3
    • BIOINFORMATICS .................. 4
    OTHER IMPORTANT PROTEOMICS TOOLS .................. 5
    • PROTEIN CHIPS .................. 5
    • CAPILLARY HPLC .................. 6
    USES OF PROTEOMICS TECHNOLOGIES .................. 7
    • IN ACADEMIA .................. 7
    • USES IN DRUG DISCOVERY .................. 7
    • USES IN DIAGNOSTICS .................. 8
    INDUSTRY PERCEPTIONS OF PROTEOMICS AND ITS POTENTIAL .................. 9
  • AN IMPORTANT NOTE ..................10
  GOVERNMENT REGULATIONS ..................12
  • INTRODUCTION ..................12
  • DRUG DISCOVERY ..................13
  • PRECLINICAL TESTING AND SUBMISSION OF AN IND ..................14
  • SUBMISSION OF AN NDA ..................15
  • POST-FDA APPROVAL ..................15
  • CONCLUSIONS ..................16
  • OTHER FINANCIAL ISSUES RELATED TO PHARMACEUTICALS ..................19
  • NEW DRUG APPROVALS ..................20
  MASS SPECTROSCOPY ..................22
  • BASIC THEORY ..................22
  • LIQUID CHROMATOGRAPHY AND MASS SPECTROSCOPY COMBINED ..................22
  • MASS SPECTROSCOPY MARKETS: 2000 TO 2006 ..................23
  • TIME-OF-FLIGHT MASS SPECTROSCOPY ..................27
    • MALDI-TOF ..................28
    • Q-TOF ..................30
    LC-MS: QUADRUPOLE MASS SPECTROSCOPY ..................31
  • LC-ION TRAP MASS SPECTROSCOPY ..................33
  • OTHER DEVELOPMENTS IN THE MASS SPECTROSCOPY BUSINESS ..................33
• PROTEOMICS MARKETS ..................35
  • TWO-DIMENSIONAL ELECTROPHORESIS ..................35
    • OTHER TECHNIQUES FOR SEPARATING PROTEIN MIXTURES ..................38
    MARKET OUTLOOK ..................39
    • SUPPLIERS ..................40
    • Market Leaders in 2-D Electrophoresis ..................43
    CAPILLARY ELECTROPHORESIS (CE) ..................43
    • BACKGROUND ..................44
    • OTHER CE TECHNIQUES FOR ANALYZING PROTEINS ..................47
  • PROTEIN CHIPS ..................50
    • RECENT ADVANCES AND FUTURE OUTLOOK ..................51
  • BIOINFORMATICS ..................54
    • STRUCTURE OF THE BIOINFORMATICS INDUSTRY ..................56
    • BIOINFORMATICS AND PROTEOMICS: DATABASES ..................57
    • BIOINFORMATICS AND PROTEOMICS: SOFTWARE FOR ANALYSIS ..................60
    • CONCLUDING REMARKS ..................61
• PATENT TRENDS ..................63
  • MASS SPECTROSCOPY ..................63
    • PATENTS BY YEAR OF ISSUANCE AND BY TYPE ..................63
    • PATENT ASSIGNEES ..................66
  • CAPILLARY ELECTROPHORESIS PATENT TRENDS ..................70
    • PATENTS BY YEAR OF ISSUANCE AND BY TYPE ..................70
    • PATENT ASSIGNEES ..................76
  • TWO-DIMENSIONAL ELECTROPHORESIS PATENT TRENDS ..................78
    • PATENTS BY YEAR OF ISSUANCE AND BY TYPE ..................78
    • PATENT ASSIGNEES ..................82
• COMPANY PROFILES ..................84
  • MASS SPECTROSCOPY INSTRUMENT SUPPLIERS ..................84
    • AGILENT TECHNOLOGIES, INC. ..................84
    • APPLERA CORPORATION ..................84
    • APPLIED BIOSYSTEMS ..................85
    • BEAR INSTRUMENTS, INC. ..................86
    • GBC SCIENTIFIC EQUIPMENT, PTY. LTD. ..................86
    • HITACHI INSTRUMENTS, INC. ..................87
    • KRATOS ANALYTICAL ..................87
    • MICROMASS ..................87
    • PERKINELMER, INC. ..................88
    • PHENOMENEX ..................89
    • RICHARD SCIENTIFIC, INC. ..................89
    • SHIMADZU SCIENTIFIC INSTRUMENTS ..................90
    • SPARK HOLLAND ..................91
    • THERMO ELECTRON ..................91
    • THERMO SEPARATION PRODUCTS (THERMOQUEST) ..................92
    • VARIAN, INC. ..................92
    • WATERS CORPORATION ..................92
  • 2-D ELECTROPHORESIS OR CAPILLARY ELECTROPHORESIS SUPPLIERS ..................93
    • AMERSHAM PHARMACIA BIOTECH ..................93
    • BIO-RAD LABORATORIES ..................94
    • COMPUGEN ..................95
    • DECODON, GMBH ..................95
    • DIONEX CORPORATION ..................96
    • GENE LOGIC ..................96
    • GENEVA PROTEOMICS ..................97
    • GENOMIC SOLUTIONS, INC. ..................98
    • INVITROGEN ..................98
    • LARGE SCALE BIOLOGY CORPORATION ..................99
    • MICRO-TECH SCIENTIFIC ..................100
    • NONLINEAR DYNAMICS ..................100
    • PROTEOME SYSTEMS LTD. ..................101
    • SCIMAGIX ..................102
    • ZAXIS, INC. ..................102
  • PROTEIN CHIP COMPANIES ..................102
    • APPLERA CORPORATION ..................102
    • BIOSITE, INC. ..................103
    • CELERA GENOMICS ..................104
    • CIPHERGEN BIOSYSTEMS, INC. ..................104
    • GENOMIC SOLUTIONS, INC. ..................105
    • GLAUCUS PROTEOMICS ..................105
    • HTS BIOSYTEMS ..................106
    • HYBRIGENICS SA ..................106
    • ILLUMINA, INC. ..................107
    • LARGE SCALE BIOLOGY CORPORATION ..................108
    • LUMICYTE, INC. ..................108
    • PHYLOS, INC. ..................109
    • PROTIVERIS ..................110
    • SOMALOGIC, INC. ..................110
    • ZYOMYX, INC. ..................111
  • BIOINFORMATICS COMPANIES ..................111
    • AXCELL BIOSCIENCES CORPORATION ..................111
    • CELERA GENOMICS GROUP ..................112
    • GENEVA BIOINFORMATICS ..................112
    • GENEPROT (GENEVA PROTEOMICS) ..................113
    • GENOMIC SOLUTIONS, INC. ..................114
    • HYBRIGENICS SA ..................114
    • INCYTE GENOMICS ..................115
    • INPHARMATICA LTD ..................116
    • INTEGRATIVE PROTEOMICS ..................116
    • MDS PROTEOMICS ..................117
    • MYRIAD GENETICS, INC. ..................117
    • PROTEOME SYSTEMS LTD. ..................118
    • STRUCTURAL BIOINFORMATICS ..................119

LIST OF TABLES

• SUMMARY TABLE: REVENUES FOR SELECTED PROTEOMICS-RELATED PRODUCTS,* WORLDWIDE FORECAST, THROUGH 2006 ..................XII
• 1 PUBLICATIONS CONERNING PROTEOMICS .................. 2
• 2 A SAMPLE OF 2-D ELECTROPHORESIS SUPPLIERS .................. 3
• 3 A SAMPLE OF MASS SPECTROSCOPY SUPPLIERS .................. 4
• 4 A SAMPLE OF COMPANIES INVOLVED IN PROTEOMICS-BIOINFORMATICS .................. 4
• 5 A SAMPLE OF PROTEIN CHIP COMPANIES .................. 6
• 6 IMPORTANT CAPILLARY HPLC COMPANIES .................. 7
• 7 R&D SPENDING IN THE PHARMACEUTICAL INDUSTRY, 1980 TO 2001 ..................17
• 8 DISTRIBUTION OF DRUG RESEARCH COSTS ..................18
• 9 DRUGS APPROVED BY THE FDA, 1993 TO 2000 ..................20
• 10 MASS SPECTROSCOPY EXPENDITURES, THROUGH 2006 ..................23
• 11 MARKET-SPECIFIC MASS SPECTROSCOPY EXPENDITURES, THROUGH 2006 ..................24
• 12 OVERALL MARKET SHARES FOR MASS SPECTROSCOPY, 2000 ..................25
• 13 SELECTED MALDI-TOF MODELS ..................29
• 14 Q-TOF MODELS ..................30
• 15 SELECTED QUADRUPOLE MASS SPECTROMETERS ..................32
• 16 SELECTED ION TRAP MASS SPECTROMETER MODELS ..................33
• 17 2-D GEL ELECTROPHORESIS EXPENDITURES, THROUGH 2006 ..................38
• 18 SELECTED UNITS FOR 2-D ELECTROPHORESIS UNITS* ..................41
• 19 SELECTED SOFTWARE PACKAGES FOR ANALYZING 2-D ELECTROPHORESIS EXPERIMENTS ..................41
• 20 THE CAPILLARY HPLC MARKET, THROUGH 2006 ..................44
• 21 SELECTED MODELS OF AUTOMATED CAPILLARY HPLC EQUIPMENT ..................46
• 22 SELECTED MODELS OF AUTOMATED CAPILLARY ELECTROPHORESIS EQUIPMENT ..................49
• 23 PROJECTIONS FOR PROTEIN CHIP REVENUES, THROUGH 2006 ..................50
• 24 SUPPLIERS OF PROTEIN CHIPS ..................53
• 25 PROJECTIONS FOR BIOINFORMATICS EXPENDITURES, THROUGH 2006 ..................55
• 26 SELECTED COMMERICAL PROTEOMICS DATABASES ..................58
• 27 SELECTED SOFTWARE PACKAGES FOR ANALYZING 2-D ELECTROPHORESIS EXPERIMENTS ..................60
• 28 MASS SPECTROSCOPY PATENTS BY YEAR OF ISSUANCE: 1996 TO JULY 2001 ..................63
• 29 PATENTS BY TECHNOLOGY TYPE, 1996 TO JULY 2001 ..................64
• 30 PATENTS RELATING TO PROTEIN SEQUENCING BY MASS SPECTROSCOPY, 1996 TO JULY 2001 ..................66
• 31 PATENTS BY ASSIGNEE CLASSIFICATION ..................66
• 32 PATENTS BY INSTITUTION, 1996 TO JULY 2001* ..................67
• 33 CAPILLARY ELECTROPHORESIS/MASS SPECTROSCOPY PATENTS ..................68
• 34 MALDI-TOF PATENTS ..................69
• 35 PROTEOMICS-RELATED METHODS/MASS SPECTROSCOPY PATENTS ..................70
• 36 CAPILLARY ELECTROPHORESIS PATENTS BY YEAR OF ISSUANCE, 1996 TO JULY 2001 ..................71
• 37 CAPILLARY ELECTROPHORESIS: APPARATUS AND REAGENTS PATENTS, 1996 TO JULY 2001 ..................72
• 38 CAPILLARY ELECTROPHORESIS: METHODS PATENTS, 1996 TO JULY 2001 ..................74
• 39 CAPILLARY ELECTROPHORESIS PATENTS BY TECHNOLOGY TYPE, 1996 TO JULY 2001 ..................76
• 40 CAPILLARY ELECTROPHORESIS PATENTS BY ASSIGNEE CLASSIFICATION ..................77
• 41 ALL ELECTROPHORESIS PATENTS BY INSTITUTION, 1996 TO JULY 2001* ..................77
• 42 TWO DIMENSIONAL ELECTROPHORESIS PATENTS BY YEAR OF ISSUANCE, 1986 TO JULY 2001 ..................78
• 43 TWO DIMENSIONAL ELECTROPHORESIS: APPARATUS AND REAGENTS PATENTS, 1986 TO JULY 2001 ..................79
• 44 TWO DIMENSIONAL ELECTROPHORESIS: METHODS PATENTS, 1989 TO JULY 2001 ..................81
• 45 PATENTS BY TECHNOLOGY TYPE, 1996 TO JULY 2001 ..................82
• 46 ALL ELECTROPHORESIS PATENTS BY INSTITUTION, 1996 TO JULY 2001* ..................83

LIST OF FIGURES

• SUMMARY FIGURE: REVENUES FOR SELECTED PROTEOMICS-RELATED PRODUCTS,* WORLDWIDE FORECAST, 2000, 2001 AND 2006 ..................XIII
• 1 DRUGS APPROVED BY THE FDA, 1993 TO 2000 ..................21
• 2 MASS SPECTROSCOPY EXPENDITURES, 2000, 2001 AND 2006 ..................24
• 3 OVERALL MARKET SHARES FOR MASS SPECTROSCOPY, 2000 ..................26
• 4 PROTEIN SEPARATION USING 2-D ELECTROPHORESIS ..................36