Global Predictive Diagnostics Industry

  • September 2013
  • -
  • Global Industry Analysts
  • -
  • 148 pages

This report analyzes the worldwide markets for Predictive Diagnostics 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 2010 through 2018. Also, a six-year historic analysis is provided for these markets.

The report profiles 58 companies including many key and niche players such as Abbott Molecular, Almac Group Ltd., BioGenex, Covance, Inc., Dako Denmark A/S, Epistem Plc, F. Hoffmann-La Roche Ltd., Genomic Health, Inc., MDxHEALTH, Inc., Myriad Genetics, Inc., Precision Therapeutics, Inc., Prometheus Laboratories, and QIAGEN N.V. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

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
Curtain Raiser II-1
Outlook for Predictive Diagnostics Market II-2

2. MAJOR MARKET TRENDS, DRIVERS and ISSUES II-3
Prospects for Predictive Genetic Diagnostics and Testing Grow
Brighter II-3
Increasing Incidence and Prevalence of CDDs: A Major Growth
Driver II-3
Diagnosed Cases of Cancer on the Rise II-4
Table 1: Global Cancer Incidence by Region: 2012 (includes
corresponding Graph/Chart) II-4
Table 2: Cancer Incidence in Developed Nations By Site: 2012
(includes corresponding Graph/Chart) II-5
Incidence of Neurodegenerative Diseases Increasing II-6
Alzheimer’s Disease II-6
Huntington’s Disease II-7
Quick Facts on the Global Prevalence of Huntington's Disease II-7
Ballooning Global Population Offers Significant Growth
Opportunities II-8
Table 3: Top 25 Countries Worldwide in Terms of Population:
2007, 2010 and 2013 II-9
Ageing Population Boosts Predictive Diagnostics II-9
Table 4: Elderly Population (65+ Years) as a Percentage of
the Total Population: 2000 and 2025 (includes corresponding
Graph/Chart) II-10

Table 5: Life Expectancy at Birth for Select Countries (2012)
(includes corresponding Graph/Chart) II-11

Table 6: Percentage of Population Aged 65 and Above in EU-27
Countries, the US and Japan (1960-2030) (includes
corresponding Graph/Chart) II-11
Pharmacogenomics Development Augurs Growth of Predictive
Diagnostics II-12
Discovery of Novel Biomarkers Crucial to Predictive Diagnostics II-12
Next-Generation Sequencing - A Giant Leap in Genome Sequencing II-13
Breast Cancer Gene Testing Market to Expansion Strongly II-13
Myriad Genetics - The Unquestioned Leader in Breast Cancer
Testing II-14
Growing Direct-to-Consumer Genetic Testing: Boon or Bane?? II-14
Genomic Research Remains Confined to Fundamental Research II-15
Unresolved Issues Hamper Widespread Implementation of Genetic
Diagnosis and Testing for Monogenetic Disease II-15
Dearth of Genetic Counselors a Major Hurdle for the Predictive
Genetic Testing II-16
Framework for Validation, Regulation and Ethical Issues - The
Need of the Hour II-17

3. PRODUCT OVERVIEW II-19
Introduction II-19
Underlying Principles of Predictive Diagnostics II-19
Predictive Diagnostics vs. Conventional Testing II-19
Characteristics of an Effective Predictive Diagnostic Test II-20
Applications of Predictive Diagnostics II-20
Pre-Symptomatic II-20
Predisposition Testing II-20
Cancer Testing II-20
Carrier Identification II-20
Pharmacogenetics II-21
Pharmacogenomics II-21
Prenatal Diagnosis II-21
Steps in Genetic Testing Process II-21
Limitations II-21
Risks and Other Limitations of Genetic Testing II-22
Select Diseases Identified Using Predictive Diagnostics II-22
Cystic Fibrosis II-22
Breast and Ovarian Cancer (BRCA) II-22
Alzheimer's Disease II-22
Colorectal Cancer II-22
Hemochromatosis (HH) II-23
Huntington's Disease (HD) II-23
Costs of Select Tests II-23
Table 7: Costs of Select Genetic Tests II-23
Medical Ethics Surrounding Predictive Diagnostics II-23

4. RECENT INDUSTRY ACTIVITY II-24
QIAGEN Takes Over Ingenuity Systems II-24
Cenix to Partner with Debiopharm II-24
MolecularMD Corp. Obtains License for LKB1 Gene Technology II-24
MolecularMD Develops and Validates Assay Tests to Determine
LKB1 Expression and Mutation Status II-25
Abbott's Galectin-3 Assay Awarded CE Marking II-25
Asuragen Introduces BRAF and KRAS Mutation Testing Services II-25
Dako to Acquire IP rights from System Dynamic II-26
Agilent Acquires Dako II-26
Celgene Takes Over Avila Therapeutics II-26
Signal Genetics to Acquire ChipDX II-26
Roche and Med Fusion Form Strategic Alliance II-27
Epistem Inks Supply and Distribution Agreement with Becton
Dickinson for Tuberculosis Test II-27
Rosetta Genomics Signs Co-Marketing Agreement with Precision
Therapeutics II-28
Quintiles Establishes Oxford Cancer Biomarkers for
Personalized Medicine Care II-28
Cornell University Licenses microRNA Diagnostic IP to Prolias
Technologies II-28
Signal Genetics Introduces ResultsPXâ„¢ Analysis Tool and
Physician Web Portal for Genetic Test Results II-29
Myriad Genetics Acquires Rules-Based Medicine II-29
Nestle Health Science Acquires Prometheus II-30
NeoGenomics Signs Distribution Agreement with Signal Genetics II-30
MDxHealth Signs Collaboration Agreement with Newcastle
University, Pfizer and CRT II-30
Roche Forms Strategic Partnership with Cedars-Sinai II-31
Quanticel, Celgene, and Versant Sign Strategic Collaboration
Agreement for Cancer Drug Discovery II-31
Epistem Collaborates with NPIA for ADAPT Program II-32
Epistem and Xcelris Sign TB Diagnostic Collaboration II-32
Ventana Medical Systems Obtains FDA Approval for
Commercialization of HER2 Dual ISH Assay II-33
Roche’s Cobas KRAS Mutation Test Receives CE Mark II-33
Prometheus Introduces PROMETHEUS IBD sgi Diagnostic Test II-34
Signal Genetics and UAMS Sign Licensing Deal II-34
Predictive Biosciences Acquires OncoDiagnostic Laboratory II-34
Golden Helix Collaborates with Sirius Genomics II-34
Signal Genetics Partners with Array BioPharma II-35
MDxHealth and Predictive Biosciences Sign Licensing Agreement II-35
Prometheus Signs Collaboration Agreement with Tarrot Laboratories II-35
Roche Secures Associate License for P13K Biomarker from QIAGEN II-35
Myriad Genetics Rolls Out PANEXIA II-36

5. FOCUS ON SELECT PLAYERS II-37
Abbott Molecular (US) II-37
Almac Group Ltd. (Ireland) II-37
BioGenex (US) II-37
Covance, Inc. (US) II-38
Dako Denmark A/S (Denmark) II-38
Epistem Plc (UK) II-38
F. Hoffmann-La Roche Ltd. (Switzerland) II-39
Genomic Health, Inc. (US) II-40
MDxHEALTH, Inc. (US) II-40
Myriad Genetics, Inc. (US) II-41
Precision Therapeutics, Inc. (US) II-41
Prometheus Laboratories (US) II-42
QIAGEN N.V. (Netherlands) II-42

6. GLOBAL MARKET PERSPECTIVE II-43
Table 8: World Recent Past, Current and Future Analysis for
Predictive Diagnostics by Geographic Region - US, Canada,
Japan, Europe, and Rest of World Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for the
Years 2010 through 2018 (includes corresponding Graph/Chart) II-43

Table 9: World Historic Review for Predictive Diagnostics by
Geographic Region - US, Canada, Japan, Europe, and Rest of
World Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for the Years 2004 through 2009
(includes corresponding Graph/Chart) II-44

Table 10: World 15-Year Perspective for Predictive Diagnostics
by Geographic Region - Percentage Breakdown of Dollar Revenues
for US, Canada, Japan, Europe, and Rest of World Markets for
the Years 2004, 2013 and 2018 (includes corresponding
Graph/Chart) II-45


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Outlook III-1
Genetic Information Nondiscrimination Act Boosts Genetic
Testing III-1
Direct-to-Consumer Testing - A Growing Market III-1
Transparency III-2
Provider Education III-2
Test and Laboratory Quality III-2
High Frequency of Predictive CFTR Screening in Expectant
Mothers III-2
Strategic Corporate Developments III-2
Key Players III-12
B.Market Analytics III-17
Table 11: US Recent Past, Current and Future Analysis for
Predictive Diagnostics with Annual Revenue Figures in US$
Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-17

Table 12: US Historic Review for Predictive Diagnostics with
Annual Revenue Figures in US$ Million for the Years 2004
through 2009 (includes corresponding Graph/Chart) III-18

2. CANADA III-19
A.Market Analysis III-19
Current and Future Analysis III-19
B.Market Analytics III-19
Table 13: Canadian Recent Past, Current and Future Analysis
for Predictive Diagnostics with Annual Revenue Figures in
US$ Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-19

Table 14: Canadian Historic Review for Predictive
Diagnostics with Annual Revenue Figures in US$ Million for
the Years 2004 through 2009 (includes corresponding
Graph/Chart) III-20

3. JAPAN III-21
A.Market Analysis III-21
Current and Future Analysis III-21
B.Market Analytics III-21
Table 15: Japanese Recent Past, Current and Future Analysis
for Predictive Diagnostics with Annual Revenue Figures in
US$ Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-21

Table 16: Japanese Historic Review for Predictive
Diagnostics with Annual Revenue Figures in US$ Million for
the Years 2004 through 2009 (includes corresponding
Graph/Chart) III-22

4. EUROPE III-23
A.Market Analysis III-23
Current and Future Analysis III-23
Predictive Testing to Dominate Genetic Testing and Screening
Services in Europe III-23
Hassles Faced by European Genetic Testing Market III-23
Strategic Corporate Developments III-24
B.Market Analytics III-25
Table 17: European Recent Past, Current and Future Analysis
for Predictive Diagnostics by Geographic Region - France,
Germany, Italy, UK, and Rest of Europe Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for the
Years 2010 through 2018 (includes corresponding Graph/Chart) III-25

Table 18: European Historic Review for Predictive
Diagnostics by Geographic Region - France, Germany, Italy,
UK, and Rest of Europe Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for the Years 2004
through 2009 (includes corresponding Graph/Chart) III-26

Table 19: European 15-Year Perspective for Predictive
Diagnostics by Geographic Region - Percentage Breakdown of
Dollar Revenues for France, Germany, Italy, UK, and Rest of
Europe Markets for the Years 2004, 2013 and 2018 (includes
corresponding Graph/Chart) III-27

4a. FRANCE III-28
A.Market Analysis III-28
Current and Future Analysis III-28
B.Market Analytics III-28
Table 20: French Recent Past, Current and Future Analysis for
Predictive Diagnostics with Annual Revenue Figures in US$
Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-28

Table 21: French Historic Review for Predictive Diagnostics
with Annual Revenue Figures in US$ Million for the Years
2004 through 2009 (includes corresponding Graph/Chart) III-29

4b. GERMANY III-30
A.Market Analysis III-30
Current and Future Analysis III-30
German Ethics Council Releases Recommendations for Genetic
Testing III-30
Proposals Mentioned: A Snapshot III-30
Strategic Corporate Development III-31
Imgm Laboratories Gmbh - A Key Player III-31
B.Market Analytics III-32
Table 22: German Recent Past, Current and Future Analysis for
Predictive Diagnostics with Annual Revenue Figures in US$
Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-32

Table 23: German Historic Review for Predictive Diagnostics
with Annual Revenue Figures in US$ Million for the Years
2004 through 2009 (includes corresponding Graph/Chart) III-32

4c. ITALY III-33
A.Market Analysis III-33
Current and Future Analysis III-33
B.Market Analytics III-33
Table 24: Italian Recent Past, Current and Future Analysis for
Predictive Diagnostics with Annual Revenue Figures in US$
Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-33

Table 25: Italian Historic Review for Predictive Diagnostics
with Annual Revenue Figures in US$ Million for the Years
2004 through 2009 (includes corresponding Graph/Chart) III-34

4d. THE UNITED KINGDOM III-35
A.Market Analysis III-35
Current and Future Analysis III-35
UK Government Encourages Genetic Testing III-35
Strategic Corporate Developments III-35
Epistem Plc - A Key Player III-36
B.Market Analytics III-37
Table 26: UK Recent Past, Current and Future Analysis for
Predictive Diagnostics with Annual Revenue Figures in US$
Million for the Years 2010 through 2018 (includes
corresponding Graph/Chart) III-37

Table 27: UK Historic Review for Predictive Diagnostics with
Annual Revenue Figures in US$ Million for the Years 2004
through 2009 (includes corresponding Graph/Chart) III-37

4e. REST OF EUROPE III-38
A.Market Analysis III-38
Current and Future Analysis III-38
Strategic Corporate Development III-38
Key Players III-38
B.Market Analytics III-41
Table 28: Rest of Europe Recent Past, Current and Future
Analysis for Predictive Diagnostics with Annual Revenue
Figures in US$ Million for the Years 2010 through 2018
(includes corresponding Graph/Chart) III-41

Table 29: Rest of Europe Historic Review for Predictive
Diagnostics with Annual Revenue Figures in US$ Million for
the Years 2004 through 2009 (includes corresponding
Graph/Chart) III-42

5. REST OF WORLD III-43
A.Market Analysis III-43
Current and Future Analysis III-43
Strategic Corporate Developments III-43
Emsurg Healthcare (India) Pvt. Limited - A Key Player III-44
B.Market Analytics III-45
Table 30: Rest of World Recent Past, Current and Future
Analysis for Predictive Diagnostics with Annual Revenue
Figures in US$ Million for the Years 2010 through 2018
(includes corresponding Graph/Chart) III-45

Table 31: Rest of World Historic Review for Predictive
Diagnostics with Annual Revenue Figures in US$ Million for
the Years 2004 through 2009 (includes corresponding
Graph/Chart) III-46


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 58 (including Divisions/Subsidiaries - 61)
The United States (31)
Canada (2)
Europe (19)
- Germany (4)
- The United Kingdom (7)
- Spain (1)
- Rest of Europe (7)
Asia-Pacific (Excluding Japan) (7)
Middle East (2)

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