市場調査報告書：遺伝子検査の世界市場

FACTS AT A GLANCE

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. Overview II-1

Progressing from Service Driven to Product-Driven Market II-1
Genetic Testing Outlook Brightens II-1
Genetic Testing - Accurate and Cost Saving II-2
Issues & Trends Affecting the Market II-2
Genetic Testing and its Effect on the Insurance sector II-2
Challenges Faced II-3
Online Approach Gaining Momentum II-3
Recommendations of ACOG and ACGM Augments Demand for CF Testing II-3
Ethical Issues & Need for Appropriate Regulating Policies II-4
Routine Clinical Testing Vs. Predictive Genetic Testing II-4
Issues Related to Genetic Tests for Obesity II-5
Competitive Scenario II-5
Table 1: Leading Players in the Worldwide Genetic Testing Market (2004 & 2005E): Percentage Breakdown by Value Sales for Roche Diagnostics / Affymetrix, Abbott Laboratories, Bio-Rad Laboratories, and Others (includes corresponding Graph/Chart) II-6

2. Product Overview II-7

Preface to Genetic Testing II-7
Genetic Testing and its Applications II-7
Gene Candidate and Genome Screen II-8
'DNA Chip' to Chip into Genetic Field II-8
Techniques Used to Identify Changes in Genes II-9
Types of Genetic Testing II-9
Steps in Genetic Testing Process II-11
Benefits II-11
Limitations II-11
Risks and Other Limitations of Genetic Testing II-12
Medical Institutions to Reap the Benefits of Genetic Testing II-12
Pharmacogenetics/Pharmacogenomics II-12
Review of Select Genetic Tests II-12
Cystic Fibrosis II-12
Breast and Ovarian Cancer II-13
Alzheimer's Disease II-13
Colorectal Cancer II-13
Haemochromatosis (HH) II-13
Cowden Syndrome II-13
Huntington's Disease II-13

3. Advances in the Field of Research II-14

Epigenomics Designs New Test for Prostate Cancer II-14
Tm Bioscience Corporation and TPC to Develop a Range of Genetic Tests II-14
SLAMDUNK, a New Way to Identify Down Syndrome II-14
New Test to Analyze Behavior of Brain Tumor Patients to Chemotherapy II-14
CD's provide Researchers Economical access to Molecular Screening II-15
Gail Method to Identify Women Prone to Breast Cancer II-15

4. Technological Developments II-16

New Molecular Diagnostic device to Improve Genetic Tests for Alzheimer disease II-16
Deakin Clinic Offers PGD, a Sophisticated Testing for Genetic Disorders II-16
New Gene Mapping Method to Enhance Identification of Haplotype Block II-16
New Non-Invasive test a Better Indicator of Malignancy than the PSA Test II-16

5. Update on the Regulatory Front II-17

Singapore Sets Guidelines for Genetic Research and Testing II-17
Sweden Bans Disclosure of Individuals Genetic Information II-17
US FDA Bars Roche from selling its New Genetic Test, AmpliChip CYP450 II-17
US Senate Bars Discrimination on the basis of Genetic Testing II-17
UK's HGC Bans Direct Sale of Genetic Information to Public II-18
FDA Approves DNA Based Tests to Detect Factor V Leiden II-18

6. Product Launches II-19

Orchid BioSciences Introduces New Testing Kit II-19
Focus Diagnostics Introduces GenomEx(TM) Service II-19
Relative Genetics Introduces Y-chromosome haplogroup Service on Web Site II-19
Genzyme Unveils Upgraded CFplus Cystic Fibrosis (CF)Mutation Analysis II-19
TMC Introduces AJP II-19
Genaissance Rolls Out FAMILION Test II-20
Tm Bioscience Rolls Out Tag-It Mutation Detection Kits II-20
Quest Diagnostics Launches CF Complete Test II-20
Tm Bioscience Corporation Launches Tag-It Mutation Detection Kit II-20
Roche Diagnostics and Innogenetics Roll Out their First Ever Test Kits II-20
INFINITI・System, AutoGenomics' New Genetic Testing for Medical Institutions II-20

7. Recent Industry Activity II-21

Orchid BioSceinces Enters into an Agreementwith Prion Diagnostica II-21
DNAPrint・genomics to Purchase Ellipsis II-21
Tm Bioscience Inks a Pact with Maxxam Analytics II-21
DNAPrint genomics Takes Over Trace Genetics II-21
Roche Diagnostics Inks a Licensing Agreement with Innogenetics II-21
Clinical Data Purchases Genaissance Pharmaceuticals II-22
Illumina Pockets CyVera Corporation II-22
Orchid Cellmark Inks Contract with Merial II-22
Sequenom Gains Noninvasive Prenatal Diagnostic IP Rights from Isis II-22
TMC Inks a Pact with ARUP Laboratories II-22
Specialty Laboratories Accords with Roche II-22
TMC Ceases Licensing Agreement with Abbott II-23
Correlagen Diagnostics Collaborates with Children's Hospital Boston II-23
Edith Cowan University Strikes Deal with Solbec II-23
InterGenetics Join Hands with i.d.e.a.s. II-23
Clinical Data Acquires Icoria II-23
SomaLogic Strikes a Deal with Quest Diagnostics II-23
DNAPrint Bags Grant from the Federal Government II-23
Tepnel Acquires Orchid's Diagnostic Unit II-24
Lark Tech. Merges with Genaissance II-24
PRF in Alliance with Sydney Biotech II-24
Osmetech and LGC Sign Licensing Pact II-24
TMC Signs a Pact with LabOne II-24
Abbott in Agreement with Atria II-24
Third Wave Grants Marketing and Distribution Rights to Innogenetics II-25
Genetic Technologies Bags Contract from GreyhoundsAustralasia II-25
Orchid Bags Deal to Provide Testing Services to Immigrants to New Zealand II-25
Tm Bioscience Contracts with Pharmacogenetics II-25
FDA Grants PerkinElmer License to Develop and Ship II-26
Genetic Technologies Grants License to Genzyme II-26
New Genetic Testing Identifies Gene Responsible for Alzheimer Disease II-26
Roche Licenses GeneChipｮ Technology from Affymetrix II-26
Genaissance Acquires DNA Sciences II-26
GTG Joins GENDIA Diagnostic Genetic Testing Network II-26
Arch Collaborates with GeneLink to Market Formulations II-27
Roche Diagnostics and GIS to Develop SARSDetection Kit II-27
Roche Diagnostics in Agreement with Innogenetics II-27
Cenetron in Alliance with Roche Diagnostics II-27
Gribbles Establishes Gribbles Molecular Science, a New Genetic Testing Firm II-27
Roche the First to Receive Clearance for Thrombophilia Genetic Disorder Tests II-28
Roche and DeCode Develop DNA-based Tests to Foretell Behavior II-28
Roche and deCODE Discover Changes in Gene Responsible for Osteoporosis II-28
Roche and deCODE Announce Discovery of New Gene Structures II-28
Mayo Contracts with Tm Bioscience II-28
Abbott forms Alliance with Celera II-29
GTG Forms a Joint Venture with Agriculture Victoria Services II-29
GTG in Alliance with Myriad Genetics Inc II-29
Pyrosequencing AB Expands Agreement with University of Geneva II-29
Genzyme Genetics Expands Cancer Testing Services to Monitor CML Patients II-29
deCODE Joins Hands with Pharmacia II-30
Bio-Rad Acquires Quantase II-30
Abbott Takes Over Vysis II-30
Abbott Strikes Deal with Vysis II-30
Roche and DeCode Join Hands to DevelopGenetic Tests II-30
Myriad Introduces BRACAnalysis, a Predictive Medicine Test II-30
deCODE Joins Hands with Affymetrix to Develop Chip-Based Genotyping Tools II-31
deCODE Contracts with Genmab II-31
Pyrosequencing Collaborates with CHoP II-31
Myriad Grants License to Falco to Provide Genetic Testing in Japan II-31

8. Focus on Select Global Players II-32

Abbott Laboratories (USA) II-32
Vysis (USA) II-32
AutoGenomics, Inc. (USA) II-32
BioRad Laboratories (USA) II-32
Bioscientia (Germany) II-33
Celera Diagnostics (USA) II-33
Genzyme Genetics (USA) II-33
Orchid Cellmark, Inc (USA) II-34
PerkinElmer Inc., (USA) II-34
Quest Diagnostics, Inc. (USA) II-34
Roche Diagnostics, Corp. (Switzerland) II-35
Sciona, Limited. (USA) II-35

9. Global Market Perspective II-36

Table 2: World Recent Past, Current & Future Market Analysis for Genetic Testing by Geographic Region - US, Canada, Japan, Europe and Rest of World Independently Analyzedwith Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) II-36
Table 3: World 10-Year Perspective for Genetic Testing by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe and Rest of World Markets for Years 2000, 2005 & 2010 (includes corresponding Graph/Chart) II-36

III. MARKET

1. The United States III-1

A. Market Analysis III-1
Current and Future Analysis III-1
Hybridization Technology III-1
Florida Broadens Genetic Disease Trials in Infants III-1
Prenatal Genetic Testing: The Big Brother III-1
Table 4: US Prenatal Genetic Testing Market (2000-2005): Annual Sales in US$ Million (includes corresponding Graph/Chart) III-2
Genetic Tests Gain Ground III-2
US Regulatory Environment III-2
Impact of Genetic Testing on Workplace and Insurance Industry - A Growing Concern III-3
US Senate Bars Discrimination on the Basis of Genetic Testing III-3
Key and Emerging Players in US III-3
Abbott Laboratories III-3
Vysis III-4
AutoGenomics, Inc. III-4
BioRad Laboratories III-4
Celera Diagnostics III-5
Genaissance Pharmaceuticals, Inc. III-5
Genova Diagnostics III-5
Genzyme Genetics III-6
InterGenetics III-6
Myriad Genetic Laboratories, Inc. III-6
Nanogen, Inc. III-6
Orchid Cellmark, Inc III-6
PerkinElmer, Inc III-7
Quest Diagnostics, Inc. III-7
Third Wave Technologies III-7
Product Launches III-8
Strategic Developments III-9
B. Market Analytics III-15
Table 5: US Recent Past, Current & Future Analysis for Genetic Testing - Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart) III-15

2. Canada III-16

A. Market Analysis III-16
Canada, the Market to be Watched Out For III-16
Low Funding Dampens Genetic Testing Market III-16
Tm Bioscience Corp - A Key Canadian Player III-16
Product Launches III-16
Strategic Developments III-17
B. Market Analytics III-18
Table 6: Canadian Recent Past, Current & FutureAnalysis for Genetic Testing - Annual Sales Figuresin US$ Million for Years 2000 through 2010(includes corresponding Graph/Chart) III-18

3. Japan III-19

A. Market Analysis III-19
Overview III-19
Genetic Testing Catching Up in Japan III-19
New Regulations in Japan III-19
B. Market Analytics III-20
Table 7: Japanese Recent Past, Current & Future Analysis for Genetic Testing - Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart). III-20

4. Europe III-21

A. Market Analysis III-21
Europe: Fastest Growing Market for Genetic Testing Worldwide III-21
A Brief Overview of Legislations/Regulatory Policies in Select European Countries III-21
Government Encourages Genetic Testing in UK III-22
Key and Emerging Players in Europe III-22
Bioscientia (Germany) III-22
Biotage AB (Sweden) III-22
IMGM Laboratories (Germany) III-22
Sciona, Limited. (UK) III-23
Roche Diagnostics, Corp. (Switzerland) III-23
Product Launch III-23
Strategic Developments III-24
B. Market Analytics III-27
Table 8: European Recent Past, Current & Future Analysis for Genetic Testing - Annual Sales Figures in US$ Million for Years 2000 through 2010(includes corresponding Graph/Chart). III-27

5. Rest of World III-28

A. Market Analysis III-28
Asia & Latin America: The Future Markets for Genetic Testing III-28
Approval of Experiments on Human Embryos in New Zealand III-28
Gribbles Group, Limited. - A Major Australian Player III-28
Strategic Developments III-29
B. Market Analytics III-30
Table 9: Rest of World market for Genetic Testing - Recent Past, Current & Future Analysis with Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes correspondingGraph/Chart) III-30

IV. COMPETITION

1. Abbott Laboratories (USA) IV-1
Table 10: Nine Months Sales Analysis: 2004-2005 (Nine Months Ended, September) (In US$ billion) IV-3
Table 11: Annual Sales Analysis: 2003-2004 (In US$ billion) IV-3
Table 12: Quarterly Sales Analysis: 2003-2004 (In US$ billion) IV-3
Table 13: Annual Sales Analysis by Segment: 2003-2004 (In US$ billion) IV-4
Table 14: Annual Sales Analysis by Geographical Region: 2003-2004 (In US$ billion) IV-4
Abbott Diagnostics (USA) IV-8
Vysis, Inc. (USA) IV-11
2. Affiliated Genetics, Inc. (USA) IV-16
3. Affymetrix, Inc. (USA) IV-17
Table 15: Nine Months Sales Analysis: 2004-2005 (Nine Month Ended, September) (In US$ million) IV-18
Table 16: Annual Sales Analysis: 2002-2004 (In US$ million) IV-18
Table 17: Annual Sales Analysis by Business Segment: 2003-2004 (In US$ million) IV-18
Table 18: Annual Sales Analysis by Geographic Segment: 2003-2004 (In US$ million) IV-18
4. American Genetics, Inc. (USA) IV-22
5. Applied Biosystems Group (USA) IV-24
6. Autogenomics, Inc. (USA) IV-31
7. Autoimmune Technologies LLC (USA) IV-33
8. Becton, Dickinson & Company (USA) IV-36
Table 19: Half-Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-38
Table 20: Half-Yearly Sales Analysis by Segment: 2004-2005 (H1) (In US$ million) IV-38
Table 21: Annual Sales Analysis: 2003-2004 (In US$ million) IV-38
9. Biogenetic Services, Inc. (USA) IV-51
10. Bio-Rad Laboratories, Inc. (USA) IV-53
Table 22: First Quarter Sales Analysis: 2004-2005 (Q1) (In US$ million) IV-54
Table 23: Annual Sales Analysis: 2003-2004 (In US$ million) IV-54
Table 24: Quarterly Sales Analysis: 2003-2004 (In US$ million) IV-55
11. Bioscientia (Germany) IV-59
12. Biotage AB (Sweden) IV-60
Table 25: Annual Sales Analysis: 2003-2004 (In SEK million) IV-61
Table 26: Annual Sales Analysis by Segment: 2003-2004 (In SEK million) IV-61
Table 27: Annual Sales Analysis by Region: 2003-2004 (In SEK million) IV-61
13. BRT Laboratories, Inc. (USA) IV-65
14. Celera Diagnostics (USA) IV-68
Table 28: Annual Sales Analysis: 2004-2005 (In US$ million) IV-68
15. Columbia Laboratory Services (USA) IV-72
16. Digene Corporation (USA) IV-75
Table 29: Annual Sales Analysis: 2003-2005 (In US$ million) IV-75
Table 30: Annual Sales Analysis by Geographical Region: 2003-2004 (In US$ million) IV-76
Table 31: Quarterly Sales Analysis: 2004-2005 (In US$ million) IV-76
Digene Germany GmbH (USA) IV-78
17. DNA Diagnostics Center (USA) IV-79
18. DNAPrint Genomics, Inc. (USA) IV-80
19. Elan Corporation PLC (Ireland) IV-83
Table 32: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-84
Table 33: Annual Sales Analysis: 2003-2004 (In US$ million) IV-84
Table 34: Annual Sales Analysis by Business Segment: 2003-2004 (In US$ million) IV-84
Table 35: Annual Sales Analysis by Geographic Region: 2003-2004 In US$ million) IV-84
20. Fujirebio Diagnostics, Inc. (USA) IV-86
21. Genaissance Pharmaceuticals, Inc. (USA) IV-88
Table 36: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-88
Table 37: Half Yearly Sales Analysis by Business Segment: 2004-2005 (H1) (In US$ million) IV-89
Table 38: Annual Sales Analysis: 2002-2004 (In US$ million) IV-89
Table 39: Annual Sales Analysis by Business Segment: 2003-2004 (In US$ million) IV-89
22. Genecare Medical Genetics Center (USA) IV-94
23. Genedx, Inc. (USA) IV-95
24. Genelex Corporation (USA) IV-103
25. Genetest Corporation (USA) IV-105
26. Genetic Profiles Laboratory (USA) IV-108
27. Genetic Technologies, Inc. (USA) IV-109
28. Genetica DNA Laboratories, Inc. (USA) IV-110
29. Genetics & IVF Institute (USA) IV-111
30. Genetree DNA Testing Center (USA) IV-112
31. Genex Diagnostics Swabtest (USA) IV-114
32. Genomic Health, Inc. (USA) IV-115
33. Genova Diagnostics (USA) IV-116
34. Gentra Systems, Inc. (USA) IV-117
35. Genzyme Genetics (USA) IV-119
36. Great Lakes Genetics, SC (USA) IV-123
37. Gribbles Group Ltd. (Australia) IV-127
Table 40: Annual Sales Analysis: 2003-2004 (In A$ million) IV-127
38. Healthcheck USA (USA) IV-129
39. ID Labs Biotechnology (Canada) IV-136
40. Identigene (USA) IV-141
41. Identity Genetics, Inc. (USA) IV-141
42. IMGM Laboratories (Germany) IV-142
43. Independent Forensics (USA) IV-143
44. Innogenetics NV (Belgium) IV-144
Table 41: Half Yearly Sales Analysis: 2004-2005 (H1) (In € million) IV-145
Table 42: Half Yearly Sales Analysis by Business Segment: 2004-2005 (H1) (In € million) IV-145
Table 43: Annual Sales Analysis: 2002-2004 (In € million) IV-146
Table 44: Annual Sales Analysis by Business Segment: 2003-2004 (In € million) IV-146
45. Intergenetics, Inc. (USA) IV-154
46. Interleukin Genetics, Inc. (USA) IV-155
47. Investigen, Inc. (USA) IV-157
48. Invitrogen Corporation (USA) IV-158
Table 45: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-159
Table 46: Annual Sales Analysis: 2003-2004 (In US$ million) IV-159
Table 47: Annual Sales Analysis by Segment: 2003-2004 (In US$ million) IV-159
49. Kimball Genetics, Inc. (USA) IV-164
50. Laboratory Corporation Of America Holdings (USA) IV-166
51. Lark Technologies, Inc. (USA) IV-172
52. London Biosciences Corporation (UK) IV-173
53. MDS Diagnostic Services (Canada) IV-174
54. Myriad Genetics, Inc (USA). IV-176
Table 48: Annual Sales Analysis: 2003-2005 (In US$ million) IV-177
Table 49: Quarterly Sales Analysis: 2004-2005 (In US$ million) IV-177
55. Nanogen, Inc. (USA) IV-180
Table 50: Half-Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-181
Table 51: Annual Sales Analysis: 2003-2004 (In US$ million) IV-181
56. Orchid Cellmark (USA) IV-183
Orchid Cellmark Europe (UK) IV-186
Genescreen, Inc. (USA) IV-187
57. Osmetech, Inc. - Critical Care Division (USA) IV-188
Table 52: Annual Sales analysis: 2003-2004 (In ｣ million) IV-189
58. Panomics, Inc. (USA) IV-191
59. Paragon Genetics・(USA) IV-194
60. Pediatrix Screening (USA) IV-195
61. PerkinElmer, Inc. (USA) IV-196
Table 53: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-198
Table 54: Annual Sales Analysis: 2003-2004 (In US$ million) IV-198
Table 55: Quarterly Sales Analysis: 2003-2004 (In US$ million) IV-198
Table 56: Annual Sales Analysis by Division: 2003-2004 (In US$ million) IV-198
Table 57: Annual Sales Analysis by Region: 2003-2004 (In US$ million) IV-198
62. Proactive Genetics, Inc. (USA) IV-206
63. PRO-DNA Diagnostic (Canada) IV-207
64. Qiagen NV (The Netherlands) IV-209
Table 58: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-209
Table 59: Annual Sales Analysis: 2003-2004 (In US$ million) IV-210
Table 60: Annual Sales Analysis by Geographic Region: 2003-2004 (In US$ million) IV-210
65. Quest Diagnostics, Inc. (USA) IV-218
Table 61: Nine Months Sales Analysis: 2004-2005 (Nine Months Ended, September) (In US$ million) IV-219
Table 62: Annual Sales Analysis: 2003-2004 (In US$ million) IV-219
66. Reliagene Technologies, Inc. (USA) IV-224
67. Roche Diagnostics (Switzerland) IV-226
Table 63: Annual Sales Analysis: 2003-2004 (In SWF billion) IV-227
Roche Diagnostics Corporation (USA) IV-230
68. Sciona, Inc. (USA) IV-233
Sciona Ltd. (UK) IV-234
69. Sequenom, Inc. (USA) IV-235
Table 64: Half Yearly Sales Analysis:004-2005 (H1) (In US$ million) IV-235
Table 65: Half yearly Sales Analysis By Segment: 2004-2005 (H1) (In US$ thousands) IV-235
Table 66: Annual Sales Analysis: 2003-2004 (In US$ million) IV-236
Table 67: Annual Sales Analysis By Segment: 2003-2004 (In US$ million) IV-236
70. St. Joseph's DNA Diagnostic Laboratories (USA) IV-238
71. Tepnel Life Sciences PLC (UK) IV-239
Table 68: Half Yearly Sales Analysis: 2004-2005 (H1) (In ｣ million) IV-239
72. Third Wave Technologies, Inc. (USA) IV-242
Table 69: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million) IV-243
Table 70: Annual Sales Analysis: 2003-2004 (In US$ million) IV-243
Table 71: Quarterly Sales Analysis: 2003-2004 (In US$ million) IV-243
73. TM Bioscience Corporation (Canada) IV-246
Table 72: Half Yearly Sales Analysis:
004-2005 (H1) (In US $ million) IV-246
Table 73: Annual Sales Analysis: 2003-2004 (In US$ million) IV-246
74. Xtrana, Inc. (USA) IV-248

遺伝子検査の世界市場

GENETIC TESTING

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. Overview II-1

2. Product Overview II-7

3. Advances in the Field of Research II-14

4. Technological Developments II-16

5. Update on the Regulatory Front II-17

6. Product Launches II-19

7. Recent Industry Activity II-21

8. Focus on Select Global Players II-32

9. Global Market Perspective II-36

III. MARKET

1. The United States III-1

2. Canada III-16

3. Japan III-19

4. Europe III-21

5. Rest of World III-28

IV. COMPETITION