Genetic Testing

Published by: Global Industry Analysts

Published: Feb. 1, 2006 - 325 Pages

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. Overview

Progressing from Service Driven to Product-Driven Market

Genetic Testing Outlook Brightens

Genetic Testing - Accurate and Cost Saving

Issues & Trends Affecting the Market

Genetic Testing and its Effect on the Insurance sector

Challenges Faced

Online Approach Gaining Momentum

Recommendations of ACOG and ACGM Augments Demand for CF Testing

Ethical Issues & Need for Appropriate Regulating Policies

Routine Clinical Testing Vs. Predictive Genetic Testing

Issues Related to Genetic Tests for Obesity

Competitive Scenario

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)

2. Product Overview

Preface to Genetic Testing

Genetic Testing and its Applications

Gene Candidate and Genome Screen

‘DNA Chip’ to Chip into Genetic Field

Techniques Used to Identify Changes in Genes

Types of Genetic Testing

Steps in Genetic Testing Process

Benefits

Limitations

Risks and Other Limitations of Genetic Testing

Medical Institutions to Reap the Benefits of Genetic Testing

Pharmacogenetics/Pharmacogenomics

Review of Select Genetic Tests

Cystic Fibrosis

Breast and Ovarian Cancer

Alzheimer's Disease

Colorectal Cancer

Haemochromatosis (HH)

Cowden Syndrome

Huntington's Disease

3. Advances in the Field of Research

Epigenomics Designs New Test for Prostate Cancer

Tm Bioscience Corporation and TPC to Develop a Range of Genetic Tests

SLAMDUNK, a New Way to Identify Down Syndrome

New Test to Analyze Behavior of Brain Tumor Patients to Chemotherapy

CD’s provide Researchers Economical access to Molecular Screening

Gail Method to Identify Women Prone to Breast Cancer

4. Technological Developments

New Molecular Diagnostic device to Improve Genetic Tests for Alzheimer disease

Deakin Clinic Offers PGD, a Sophisticated Testing for Genetic Disorders

New Gene Mapping Method to Enhance Identification of Haplotype Block

New Non-Invasive test a Better Indicator of Malignancy than the PSA Test

5. Update on the Regulatory Front

Singapore Sets Guidelines for Genetic Research and Testing

Sweden Bans Disclosure of Individuals Genetic Information

US FDA Bars Roche from selling its New Genetic Test, AmpliChip CYP450

US Senate Bars Discrimination on the basis of Genetic Testing

UK’s HGC Bans Direct Sale of Genetic Information to Public

FDA Approves DNA Based Tests to Detect Factor V Leiden

6. Product Launches

Orchid BioSciences Introduces New Testing Kit

Focus Diagnostics Introduces GenomEx(TM) Service

Relative Genetics Introduces Y-chromosome haplogroup Service on Web Site

Genzyme Unveils Upgraded CFplus Cystic Fibrosis (CF) Mutation Analysis

TMC Introduces AJP

Genaissance Rolls Out FAMILION Test

Tm Bioscience Rolls Out Tag-It Mutation Detection Kits

Quest Diagnostics Launches CF Complete Test

Tm Bioscience Corporation Launches Tag-It Mutation Detection Kit

Roche Diagnostics and Innogenetics Roll Out their First Ever Test Kits

INFINITI™ System, AutoGenomics’ New Genetic Testing for Medical Institutions

7. Recent Industry Activity

Orchid BioSceinces Enters into an Agreement with Prion Diagnostica

DNAPrint™ genomics to Purchase Ellipsis

Tm Bioscience Inks a Pact with Maxxam Analytics

DNAPrint genomics Takes Over Trace Genetics

Roche Diagnostics Inks a Licensing Agreement with Innogenetics

Clinical Data Purchases Genaissance Pharmaceuticals

Illumina Pockets CyVera Corporation

Orchid Cellmark Inks Contract with Merial

Sequenom Gains Noninvasive Prenatal Diagnostic IP Rights from Isis

TMC Inks a Pact with ARUP Laboratories

Specialty Laboratories Accords with Roche

TMC Ceases Licensing Agreement with Abbott

Correlagen Diagnostics Collaborates with Children's Hospital Boston

Edith Cowan University Strikes Deal with Solbec

InterGenetics Join Hands with i.d.e.a.s.

Clinical Data Acquires Icoria

SomaLogic Strikes a Deal with Quest Diagnostics

DNAPrint Bags Grant from the Federal Government

Tepnel Acquires Orchid’s Diagnostic Unit

Lark Tech. Merges with Genaissance

PRF in Alliance with Sydney Biotech

Osmetech and LGC Sign Licensing Pact

TMC Signs a Pact with LabOne

Abbott in Agreement with Atria

Third Wave Grants Marketing and Distribution Rights to Innogenetics

Genetic Technologies Bags Contract from Greyhounds Australasia

Orchid Bags Deal to Provide Testing Services to Immigrants to New Zealand

Tm Bioscience Contracts with Pharmacogenetics

FDA Grants PerkinElmer License to Develop and Ship

Genetic Technologies Grants License to Genzyme

New Genetic Testing Identifies Gene Responsible for Alzheimer Disease

Roche Licenses GeneChip® Technology from Affymetrix

Genaissance Acquires DNA Sciences

GTG Joins GENDIA Diagnostic Genetic Testing Network

Arch Collaborates with GeneLink to Market Formulations

Roche Diagnostics and GIS to Develop SARS Detection Kit

Roche Diagnostics in Agreement with Innogenetics

Cenetron in Alliance with Roche Diagnostics

Gribbles Establishes Gribbles Molecular Science, a New Genetic Testing Firm

Roche the First to Receive Clearance for Thrombophilia Genetic Disorder Tests

Roche and DeCode Develop DNA-based Tests to Foretell Behavior

Roche and deCODE Discover Changes in Gene Responsible for Osteoporosis

Roche and deCODE Announce Discovery of New Gene Structures

Mayo Contracts with Tm Bioscience

Abbott forms Alliance with Celera

GTG Forms a Joint Venture with Agriculture Victoria Services

GTG in Alliance with Myriad Genetics Inc

Pyrosequencing AB Expands Agreement with University of Geneva

Genzyme Genetics Expands Cancer Testing Services to Monitor CML Patients

deCODE Joins Hands with Pharmacia

Bio-Rad Acquires Quantase

Abbott Takes Over Vysis

Abbott Strikes Deal with Vysis

Roche and DeCode Join Hands to Develop Genetic Tests

Myriad Introduces BRACAnalysis, a Predictive Medicine Test

deCODE Joins Hands with Affymetrix to Develop Chip-Based Genotyping Tools

deCODE Contracts with Genmab

Pyrosequencing Collaborates with CHoP

Myriad Grants License to Falco to Provide Genetic Testing in Japan

8. Focus on Select Global Players

Abbott Laboratories (USA)

Vysis (USA)

AutoGenomics, Inc. (USA)

BioRad Laboratories (USA)

Bioscientia (Germany)

Celera Diagnostics (USA)

Genzyme Genetics (USA)

Orchid Cellmark, Inc (USA)

PerkinElmer Inc., (USA)

Quest Diagnostics, Inc. (USA)

Roche Diagnostics, Corp. (Switzerland)

Sciona, Limited. (USA)

9. Global Market Perspective

Table 2: World Recent Past, Current & Future Market Analysis for Genetic Testing by Geographic Region - US, Canada, Japan, Europe and Rest of World Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010(includes corresponding Graph/Chart)

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)

III. MARKET

1. The United States

A.Market Analysis

Current and Future Analysis

Hybridization Technology

Florida Broadens Genetic Disease Trials in Infants

Prenatal Genetic Testing: The Big Brother

Table 4: US Prenatal Genetic Testing Market(2000-2005): Annual Sales in US$ Million (includes corresponding Graph/Chart)

Genetic Tests Gain Ground

US Regulatory Environment

Impact of Genetic Testing on Workplace and InsuranceIndustry - A Growing Concern

US Senate Bars Discrimination on the Basis of Genetic Testing

Key and Emerging Players in US

Abbott Laboratories

Vysis

AutoGenomics, Inc.

BioRad Laboratories

Celera Diagnostics

Genaissance Pharmaceuticals, Inc.

Genova Diagnostics

Genzyme Genetics

InterGenetics

Myriad Genetic Laboratories, Inc.

Nanogen, Inc.

Orchid Cellmark, Inc

PerkinElmer, Inc

Quest Diagnostics, Inc.

Third Wave Technologies

Product Launches

Strategic Developments

B.Market Analytics

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)

2. Canada

A.Market Analysis

Canada, the Market to be Watched Out For

Low Funding Dampens Genetic Testing Market

Tm Bioscience Corp - A Key Canadian Player

Product Launches

Strategic Developments

B.Market Analytics

Table 6: Canadian Recent Past, Current & Future Analysis for Genetic Testing - Annual Sales Figures in US$ Million for Years 2000 through 2010 (includes corresponding Graph/Chart)

3. Japan

A.Market Analysis

Overview

Genetic Testing Catching Up in Japan

New Regulations in Japan

B.Market Analytics

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).

4. Europe

A.Market Analysis

Europe: Fastest Growing Market for Genetic Testing Worldwide

A Brief Overview of Legislations/Regulatory Policies in Select European Countries

Government Encourages Genetic Testing in UK

Key and Emerging Players in Europe

Bioscientia (Germany)

Biotage AB (Sweden)

IMGM Laboratories (Germany)

Sciona, Limited. (UK)

Roche Diagnostics, Corp. (Switzerland)

Product Launch

Strategic Developments

B.Market Analytics

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).

5. Rest of World

A. Market Analysis

Asia & Latin America: The Future Markets for Genetic Testing

Approval of Experiments on Human Embryos in New Zealand

Gribbles Group, Limited. - A Major Australian Player

Strategic Developments

B.Market Analytics

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 corresponding Graph/Chart)

IV. COMPETITION

1. Abbott Laboratories (USA)

Table 10: Nine Months Sales Analysis: 2004-2005 (Nine Months Ended, September) (In US$ billion)

Table 11: Annual Sales Analysis: 2003-2004 (In US$ billion)

Table 12: Quarterly Sales Analysis: 2003-2004 (In US$ billion)

Table 13: Annual Sales Analysis by Segment: 2003-2004 (In US$ billion)

Table 14: Annual Sales Analysis by Geographical Region:2003-2004 (In US$ billion)

Abbott Diagnostics (USA)

Vysis, Inc. (USA)

2. Affiliated Genetics, Inc. (USA)

3. Affymetrix, Inc. (USA)

Table 15: Nine Months Sales Analysis: 2004-2005 (Nine Month Ended, September) (In US$ million)

Table 16: Annual Sales Analysis: 2002-2004 (In US$ million)

Table 17: Annual Sales Analysis by Business Segment:2003-2004 (In US$ million)

Table 18: Annual Sales Analysis by Geographic Segment:2003-2004 (In US$ million)

4. American Genetics, Inc. (USA)

5. Applied Biosystems Group (USA)

6. Autogenomics, Inc. (USA)

7. Autoimmune Technologies LLC (USA)

8. Becton, Dickinson & Company (USA)

Table 19: Half-Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 20: Half-Yearly Sales Analysis by Segment: 2004-2005 (H1) (In US$ million)

Table 21: Annual Sales Analysis: 2003-2004 (In US$ million)

9. Biogenetic Services, Inc. (USA)

10. Bio-Rad Laboratories, Inc. (USA)

Table 22: First Quarter Sales Analysis: 2004-2005 (Q1)(In US$ million)

Table 23: Annual Sales Analysis: 2003-2004 (In US$ million)

Table 24: Quarterly Sales Analysis: 2003-2004 (In US$ million)

11. Bioscientia (Germany)

12. Biotage AB (Sweden)

Table 25: Annual Sales Analysis: 2003-2004 (In SEK million)

Table 26: Annual Sales Analysis by Segment: 2003-2004 (In SEK million)

Table 27: Annual Sales Analysis by Region: 2003-2004 (In SEK million)

13. BRT Laboratories, Inc.(USA)

14. Celera Diagnostics (USA)

Table 28: Annual Sales Analysis: 2004-2005 (In US$ million)

15. Columbia Laboratory Services (USA)

16. Digene Corporation (USA)

Table 29: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 30: Annual Sales Analysis by Geographical Region: 2003-2004 (In US$ million)

Table 31: Quarterly Sales Analysis: 2004-2005 (In US$ million)

Digene Germany GmbH (USA)

17. DNA Diagnostics Center (USA)

18. DNAPrint Genomics, Inc. (USA)

19. Elan Corporation PLC (Ireland)

Table 32: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million)

Table 33: Annual Sales Analysis: 2003-2004 (In US$ million)

Table 34: Annual Sales Analysis by Business Segment: 2003-2004 (In US$ million)

Table 35: Annual Sales Analysis by Geographic Region:2003-2004 In US$ million)

20. Fujirebio Diagnostics, Inc. (USA)

21. Genaissance Pharmaceuticals, Inc. (USA)

Table 36: Half Yearly Sales Analysis: 2004-2005 (H1) (In US$ million)

Table 37: Half Yearly Sales Analysis by Busines Segment: 2004-2005 (H1) (In US$ million)

Table 38: Annual Sales Analysis: 2002-2004 (In US$ million)

Table 39: Annual Sales Analysis by Business Segment: 2003-2004 (In US$ million)

22. Genecare Medical Genetics Center (USA)

23. Genedx, Inc. (USA)

24. Genelex Corporation (USA)

25. Genetest Corporation (USA)

26. Genetic Profiles Laboratory (USA)

27. Genetic Technologies, Inc. (USA)

28. Genetica DNA Laboratories, Inc. (USA)

29. Genetics & IVF Institute (USA)

30. Genetree DNA Testing Center (USA)

31. Genex Diagnostics Swabtest (USA)

32. Genomic Health, Inc. (USA)

33. Genova Diagnostics (USA)

34. Gentra Systems, Inc. (USA)

35. Genzyme Genetics (USA)

36. Great Lakes Genetics, SC (USA)

37. Gribbles Group Ltd. (Australia)

Table 40: Annual Sales Analysis: 2003-2004 (In A$ million)

38. Healthcheck USA (USA)

39. ID Labs Biotechnology (Canada)

40. Identigene (USA)

41. Identity Genetics, Inc.(USA)

42. IMGM Laboratories (Germany)

43. Independent Forensics (USA)

44. Innogenetics NV (Belgium)

Table 41: Half Yearly Sales Analysis: 2004-2005 (H1)(In € million)

Table 42: Half Yearly Sales Analysis by Business Segment: 2004-2005 (H1) (In € million)

Table 43: Annual Sales Analysis: 2002-2004 (In € million)

Table 44: Annual Sales Analysis by Business Segment:2003-2004 (In € million)

45. Intergenetics, Inc. (USA)

46. Interleukin Genetics, Inc. (USA)

47. Investigen, Inc. (USA)

48. Invitrogen Corporation (USA)

Table 45: Half Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 46: Annual Sales Analysis: 2003-2004 (In US$ million)

Table 47: Annual Sales Analysis by Segment:2003-2004 (In US$ million)

49. Kimball Genetics, Inc. (USA)

50. Laboratory Corporation Of America Holdings(USA)

51. Lark Technologies, Inc. (USA)

52. London Biosciences Corporation (UK)

53. MDS Diagnostic Services (Canada)

54. Myriad Genetics, Inc (USA).

Table 48: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 49: Quarterly Sales Analysis: 2004-2005 (In US$ million)

55. Nanogen, Inc. (USA)

Table 50: Half-Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 51: Annual Sales Analysis: 2003-2004 (In US$ million)

56. Orchid Cellmark (USA)

Orchid Cellmark Europe (UK)

Genescreen, Inc. (USA)

57. Osmetech, Inc. - Critical Care Division (USA)

Table 52: Annual Sales analysis: 2003-2004 (In £ million)

58. Panomics, Inc. (USA)

59. Paragon Genetics™ (USA)

60. Pediatrix Screening (USA)

61. PerkinElmer, Inc. (USA)

Table 53: Half Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 54: Annual Sales Analysis: 2003-2004 (In US$ million)

Table 55: Quarterly Sales Analysis: 2003-2004 (In US$ million)

Table 56: Annual Sales Analysis by Division: 2003-2004(In US$ million)

Table 57: Annual Sales Analysis by Region: 2003-2004 (In US$ million)

62. Proactive Genetics, Inc. (USA)

63. PRO-DNA Diagnostic (Canada)

64. Qiagen NV (The Netherlands)

Table 58: Half Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 59: Annual Sales Analysis: 2003-2004 (In US million)

Table 60: Annual Sales Analysis by Geographic Region:2003-2004 (In US$ million)

65. Quest Diagnostics, Inc. (USA)

Table 61: Nine Months Sales Analysis: 2004-2005 (Nine Months Ended, September) (In US$ million)

Table 62: Annual Sales Analysis: 2003-2004 (In US$million)

66. Reliagene Technologies, Inc. (USA)

67. Roche Diagnostics (Switzerland)

Table 63: Annual Sales Analysis: 2003-2004 (In SWF billion)

Roche Diagnostics Corporation (USA)

68. Sciona, Inc. (USA)

Sciona Ltd. (UK)

69. Sequenom, Inc. (USA)

Table 64: Half Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 65: Half yearly Sales Analysis By Segment: 2004- 2005 (H1) (In US$ thousands)

Table 66: Annual Sales Analysis: 2003-2004 (In US$ million)

Table 67: Annual Sales Analysis By Segment: 2003-2004 (In US$ million)

70. St. Joseph's DNA Diagnostic Laboratories (USA)

71. Tepnel Life Sciences PLC (UK)

Table 68: Half Yearly Sales Analysis: 2004-2005 (H1) (In £ million)

72. Third Wave Technologies, Inc. (USA)

Table 69: Half Yearly Sales Analysis: 2004-2005 (H1)(In US$ million)

Table 70: Annual Sales Analysis: 2003-2004 (In US$million)

Table 71: Quarterly Sales Analysis: 2003-2004 (In US$ million)

73. TM Bioscience Corporation (Canada)

Table 72: Half Yearly Sales Analysis: 2004-2005 (H1) (In US $ million)

Table 73: Annual Sales Analysis: 2003-2004 (In US$million)

74. Xtrana, Inc. (USA)

Abstract

This report analyzes the worldwide markets for Genetic Testing in Millions of US$. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2000 through 2010. The report profiles 74 companies including many key and niche players worldwide such as Abbott Laboratories, Vysis, AutoGenomics, Inc., BioRad Laboratories, Bioscientia, Celera Diagnostics, Genzyme Genetics, Orchid Cellmark, Inc., PerkinElmer, Inc., Quest Diagnostics, Inc., Roche Diagnostics, Corp., and Sciona Ltd.

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