Global Direct-to-Consumer Genetic Testing Industry

  • August 2012
  • -
  • Global Industry Analysts
  • -
  • 238 pages

This report analyzes the worldwide markets for Direct-to-Consumer Genetic Testing in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2018. The report profiles 39 companies including many key and niche players such as 23andMe, Inc., Atlas Sports Genetics, LLC, deCODE genetics, DNA Direct, Inc., DNA Plus, Eastern Biotech & Life Sciences, Genelex Corporation, GeneLink Biosciences, Inc., Interleukin Genetics, Inc., Lumigenix Pty Ltd., MediChecks.com Ltd., Navigenics, Inc., and SeqWright, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Table Of Contents




I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Direct-to-Consumer Genetic Testing - A Prelude II-1
Current and Future Analysis II-1
Growth Driving Factors II-2
Ageing Population II-2
Decreasing Costs II-2
Privacy and Anonymity II-2
Market Dynamics II-2
Genetic Testing: Heralding a New Era II-2
Creating A Platform for Genetic Testing Companies II-3
Business Models for DTC Genetic Testing Firms II-4
Waxing Prominence of DTC GT: A Boon or a Curse? II-4
Challenges to Reckon with II-5
Better Regulatory Safeguards Required for Global DTC Genetic
Testing Industry II-5

2. DIRECT-TO-CONSUMER GENETIC TESTING: AN OVERVIEW II-7
DTC Genetic Testing: An Introduction II-7
Process of DTC Genetic Testing II-7
Preface to Genetic Testing II-7
Genetic Testing and its Applications II-7
Select DTC Genetic Testing Companies and Tests Offered II-9
Types of DTC Genetic Tests II-10
Advantages of DTC Genetic Testing II-10
Risks Involved in DTC Genetic Testing II-10
Interpretation of Results II-10
Positive-Tested Result II-10
Negative-Tested Result II-11

3. RECENT INDUSTRY ACTIVITY II-12
Capsalus to Acquire Marketing Rights and Assets of GeneWize
Life Sciences II-12
OraSure Technologies Acquires DNA Genotek II-12
easyDNA Inks Joint Venture Agreement with Philippines-based
Harris DNA Testing Center II-12
Sequenom Enters into European Licensing Agreement with LifeCodexx II-13
Laboratory Corporation of America Holdings Acquires Orchid
Cellmark II-13
Medco Health Solutions Acquires DNA Direct II-13
Bar Harbor BioTechnology Establishes New Division II-14
Laboratory Corporation of America Holdings to Take Over
Genzyme Genetic Counseling II-14
Signal Genetics Enters into Partnership with Array BioPharma II-14
Interleukin Genetics Inks Partnership Agreement with Amway Global II-15
Navigenics Takes Over Affymetrix Clinical Services Laboratory II-15
Pathway Genomicsâ„¢ Enters into Partnership with OptumHealth Allies II-15
Knome Collaborates with SeqWright II-16
Progenika and ARUP Laboratories Enter into Agreement II-16
Sequenom Acquires SensiGen II-17

4. PRODUCT LAUNCHES/TECHNOLOGY DEVELOPMENTS II-18
Interleukin Genetics Launches Better Online Weight Loss Services II-18
DNA Direct Launches Novel Health Plan Clients to Manage
Molecular Diagnostic and Genetic Tests II-18
Knome Launches kGAPâ„¢ 2.0 II-19
Akonni Biosystems Launches TruTip Kit II-19
Lineagen Launches FirstStepDx II-19
InoLife Technologies Rolls Out DNA Predisposition Testing Product II-20
LabCorp Launches Novel Paternity Test Using Promega Kits II-20
GeneWize Life Sciences Introduces New LifeMap Meâ„¢ DNA
Customized Skin Serum II-20
CyGene Laboratories Launches DTC Predictive Genetic Products II-20
Pathway Genomics Introduces Public DNA Testing Service II-21
Illumina to Introduce Personal Genome Service II-21

5. FOCUS ON SELECT GLOBAL PLAYERS II-22
23andMe, Inc. (US) II-22
Atlas Sports Genetics, LLC (US) II-22
deCODE genetics (Iceland) II-22
DNA Direct, Inc. (US) II-22
DNA Plus (US) II-23
Eastern Biotech and Life Sciences (Dubai) II-23
Genelex Corporation (US) II-23
GeneLink Biosciences, Inc. (US) II-24
Interleukin Genetics, Inc. (US) II-24
Lumigenix Pty Ltd. (Australia) II-24
MediChecks.com Ltd. (UK) II-25
Navigenics, Inc. (US) II-25
SeqWright, Inc. (US) II-25

6. GLOBAL MARKET PERSPECTIVE II-26
Table 1: World Recent Past, Current and Future Analysis for
Direct-to-Consumer Genetic Testing by Geographic
Region/Country - US, Canada, Japan, Europe, and Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2009 through 2018 (includes
corresponding Graph/Chart) II-26

Table 2: World 10-Year Perspective for Direct-to- Consumer
Genetic Testing by Geographic Region/ Country - Percentage
Breakdown of Dollar Sales for US, Canada, Japan, Europe, and
Rest of World Markets for Years 2009, 2012 and 2018 (includes
corresponding Graph/Chart) II-27


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
Overview of DTC Genetic Testing Market in the US III-1
Absence of Rigid Regulations, DTC Genetic Testing Faces
Uncertainty III-1
GAO Issues Report on Ambiguity in Results of DTC Genetic
Testing III-2
EGAPP Launched to Assess Effectiveness of Specific Genetic
Tests III-3
NIH Launches Public Database III-3
AMA Demands Strict Regulation for DTC Genetic Testing III-3
FDA to Closely Monitor DTC Genetic Testing Companies III-3
FDA Increased Scrutiny over Announcement of Retail
Availability of Pathway Genomics’ DTC Genetic Test III-4
GINA to Safeguard Americans from Genetic Discrimination III-4
ASHG Issues Guidelines on Ancestral DTC Genetic Testing III-4
Product Launches III-5
Recent Industry Activity III-8
Key Players III-13
B.Market Analytics III-17
Table 3: US Recent Past, Current and Future Analysis for
Direct-to-Consumer Genetic Testing Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2018 (includes corresponding Graph/Chart) III-17

2. CANADA III-18
A.Market Analysis III-18
Current and Future Analysis III-18
Regulatory Scenario in Canada III-18
Recent Industry Activity III-18
B.Market Analytics III-19
Table 4: Canadian Recent Past, Current and Future Analysis
for Direct-to-Consumer Genetic Testing Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2009 through 2018 (includes corresponding Graph/Chart) III-19

3. JAPAN III-20
A.Market Analysis III-20
DTC Genetic Testing Market in Japan III-20
Regulatory Scenario: Outline III-20
B.Market Analytics III-21
Table 5: Japanese Recent Past, Current and Future Analysis
for Direct-to-Consumer Genetic Testing Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2009 through 2018 (includes corresponding Graph/Chart) III-21

4. EUROPE III-22
A.Market Analysis III-22
Current and Future Analysis III-22
Analysis by Country III-22
Regulatory Environment in the EU: A Quick Primer III-22
ESHG Advocates Regulation of Predictive DTC Gene Testing III-23
B.Market Analytics III-24
Table 6: European Recent Past, Current and Future Analysis
for Direct-to-Consumer Genetic Testing by Geographic
Region/Country - France, Italy, the UK, and Rest of Europe
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-24

Table 7: European 10-Year Perspective for Direct-to-Consumer
Genetic Testing by Geographic Region/ Country - Percentage
Breakdown of Dollar Sales for France, Italy, the UK, and
Rest of Europe for Years 2009, 2012 and 2018 (includes
corresponding Graph/Chart) III-25

4a. FRANCE III-26
A.Market Analysis III-26
Current and Future Analysis III-26
Regulatory Environment in France III-26
B.Market Analytics III-27
Table 8: French Recent Past, Current and Future Analysis for
Direct-to-Consumer Genetic Testing Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2018 (includes corresponding Graph/Chart) III-27

4b. ITALY III-28
Market Analysis III-28
Table 9: Italian Recent Past, Current and Future Analysis
for Direct-to-Consumer Genetic Testing Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2009 through 2018 (includes corresponding Graph/Chart) III-28

4c. THE UNITED KINGDOM III-29
A.Market Analysis III-29
Current and Future Analysis III-29
Regulatory Scenario in the UK III-29
Non-consensual Analysis of DNA Made Illegal III-29
Principles for DTC Genetic Testing Laid out by HGC III-29
MediChecks.com Ltd. - A Key Player from the UK III-29
B.Market Analytics III-30
Table 10: UK Recent Past, Current and Future Analysis for
Direct-to-Consumer Genetic Testing Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2018 (includes corresponding Graph/Chart) III-30

4d. REST OF EUROPE III-31
A.Market Analysis III-31
Current and Future Analysis III-31
Product Launch III-31
Key Player III-31
B.Market Analytics III-32
Table 11: Rest of Europe Recent Past, Current and Future
Analysis for Direct-to-Consumer Genetic Testing
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-32

5. REST OF WORLD III-33
A.Market Analysis III-33
Current and Future Analysis III-33
Recent Industry Activity III-33
Focus on Select Players III-33
B.Market Analytics III-34
Table 12: Rest of World Recent Past, Current and Future
Analysis for Direct-to-Consumer Genetic Testing
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2018 (includes corresponding
Graph/Chart) III-34


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 39 (including Divisions/Subsidiaries - 44)

The United States (35)
canada (1)
Europe (5)
- The United Kingdom (3)
- Rest of Europe (2)
Asia-Pacific (Excluding Japan) (2)
Middle-East (1)

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