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Personalized Medicine: Companies, Trends and World Market

This broad, high-level report analyzes the expanding Personalized Medicine market. This world market includes important core medical product areas that will continue to have a powerful impact on current and future healthcare delivery. This business report examines key market segments such as targeted drugs and key personalized medicine diagnostics, including companion diagnostic IVDs, LDTs, diagnostic services and related tools or technologies.

Many people already know about DNA, genes and the human genome. The science driving personalized medicine includes pharmacogenetics, pharmacoproteomics and pharmacometabalomix. Personalized medicine uses a targeted drug that depends on the patient information identified by a companion diagnostic (genetic biomarker test). The companion diagnostic identifies which patients would likely benefit from a particular therapy or those who might suffer from a bad side effect. The test information enables doctors to select the drug therapy that would benefit the patient. Drug developers in clinical trials could use a companion diagnostic to select patents that would benefit from a targeted drug.

The report discusses important technologies, including microarray, next-generation sequencing, PCR, bioinformatics, nanotechnology and other platforms. This section highlights key platforms and selected vendors. For example, the field of clinical next generation sequencing is expected to have an impact on personalized medicine.

The report covers subjects including important personalized medicine concepts. The study discusses key biomarkers, commercial diagnostics and therapeutics that drive personalized medicine. The study highlights new personalized diagnostics. This research examines the current targeted therapeutics on the market and drugs in the clinical pipeline.

The report highlights major government regulatory activities that involve personalized medicine in the US and Europe. The US FDA and the European EMA have drafted guidance papers to help drug makers and diagnostic firms develop future targeted therapies guided by companion diagnostics. The recent FDA approvals of Pfizer’s Xalkori for lung cancer and Roche’s Zelboraf for melanoma demonstrate that a surge in new targeted drugs is happening.

Takeda Pacific offers this report in an interactive PDF format. The interactive feature uses hyperlinks that enable the reader to click the mouse to jump from Table of Contents items to sections inside the report. The hyperlinks also allow the reader to click on links to Internet information.

This study discusses important personalized medicine topics and provides the reader with key findings. The report estimates that the world personalized medicine market value will reach multi-billions of dollars in 2012, with a strong double-digit growth rate. This study reviews the activities of 31 companies.

The report uses 71 figures and tables to help the reader scan the details of major trends, market segmentation, forecast, M&As, partnerships, grant funding, patents and so on. This must-have report would benefit people with job titles including CEO, VPs, Director of Business Development, Research Directors, Entrepreneurs, Venture Capitalists, Investment Planners, Research Scientists, Consultants or Industry Analysts.


1. Emerging Personalized Medicine Products
Background
Industry Definition of Personalized Medicine
Personalized Medicine Is Growing
Targeted Medicines
FDA & EMA On Drug-Companion IVD Co-Development
Market Landscape
Drivers and Stakeholders of Personalized Medicine
Government
Diagnostic Industry
Drug Makers
Healthcare Payers
Pharmacy Benefit Managers (PBM)
Drug/ Diagnostic Co-Development
Medical Conditions Targeted by Personalized Medicine
Status of Drug/ Diagnostic Co-Developed Products
Examples of Drug/ Diagnostic Co-Developed Products
Drug/ Diagnostic Co-Development Pipeline
Medical Conditions with Unmet Medical Need
Drug/ Diagnostic Co-Developed Products in Development
2. Healthcare Regulators, Payers and Personalized Medicine
Regulatory Considerations
FDA and EMA on Biomarker Validation
FDA Guidance for IVDMIA Based Tests
Status of Complex Laboratory Developed Tests (LDTs)
Navigating Emerging Rules for Healthcare Reform
Health Insurance (CDx) Reimbursement
Standard Diagnostic Pricing v. Value-based Pricing
Timeline for Getting Payers to Validate and Pay for New Diagnostics
3. Survey of Personalized Medicine R&D Alliances
Summary of Personalized Medicine Alliances By Alliance Type
Summary Personalized Medicine Alliances By Major Diseases
Personalized Medicine Alliances by Major Disease, 2007-2011
Personalized Medicine Alliances by Major Disease, 2011
Personalized Medicine Alliances by Major Disease, 2010
Personalized Medicine R&D Alliances by Major Disease, 2009
Personalized Medicine Alliances by Major Disease, 2008
Personalized Medicine Alliances by Major Disease, 2007
4. Emerging Tools & Technologies for Personalized Medicine
Diagnostic Biochips and Microarrays
PM Dx Biochip & Microarray Market Size Major Makers
Alere (fmr. Inverness Medical)
Agendia BV
Roche Molecular Diagnostics
Next Generation Sequencers for Personalized Medicine
Clinical Next Gen. Sequencing Market Size and Major Makers
Illumina
Roche/ 454
Life Technologies
Oxford Nanopore Technologies
PCR Tests
PM Dx PCR Test Market Size and Major Makers
Roche Molecular
Qiagen NV
Genomic Health
Epigenetic Diagnostic Tests
PM Dx Epigenetic Test Market Size and Major Makers
LabCorp
Quest Diagnostics
Oncomethylome
Bioinformatics for Personalized Medicine
PM Dx Bioinformatic Market Size and Major Makers
Accelrys
Entelos
Microsoft Corporation
Molecular Imaging Agents
PM Dx Molecular Imaging Market Size and Major Makers
GE Healthcare
Celera (acq. by Quest Diagnostics)
Avid Radiopharmaceuticals (Eli Lilly)
Nanobiotech
PM Dx Nanobiotech Market Size and Major Makers
Abbott Molecular
Roche/ Ventana Medical
5. Personalized Medicine Healthcare Market to 2016
WW Total Core Personalized Medicine Market Size, 2011~2016
Total Core Personalized Medicine Diagnostic Product Market Size
Total Core Personalized Medicine Diagnostic Lab Service Market Size
Total Personalized & Targeted Therapeutics Product Market Size
WW Personalized Medicine Therapeutic Market Size by Major Disease
Cancer
Cardiovascular
CNS
Infectious Disease
WW Personalized Medicine Therapeutic Market Size by Region
North America
Europe
Japan
Emerging Market
ROW
WW Personalized Medicine Diagnostic IVD Market Size by Technology, 2011~2016
Genomic Technology
Proteomic Technology
Bioinformatics
Epigenomic Technology
Cytogenetics
Nanobiotech
Laser Capture Microdissection
Next Generation Sequencers
Molecular Imaging
Other Technologies
WW Personalized Medicine Diagnostic IVD Market Size by Major Disease, 2011~2016
Infectious Disease
Blood Screening
Genetic Testing
Cancer (MDx)
Cancer (Adv. TDx)
Companion Diagnostic (CDx) Product and Lab Services Market Size, 2011~2016
Combined Companion Diagnostic IVD Product and LDT Lab Services Market Size, by Major Disease, 2011~2016
Cancer
Cardiovascular
CNS
Others
Personalized Medicine Diagnostic IVD Market Size by WW Regions
Personalized Medicine Diagnostic Lab Service Market Size by Disease, 2011~2016
Infectious Disease
Blood Screening
Genetic Testing
Cancer (MDx)
Cancer (Adv.TDx)
WW Personalized Medicine Diagnostic Lab Service Market Size by Regions
North America
Europe
Asia Pacific/ Japan
ROW
6. Key Findings and Business Opportunities for Personalized Medicine
Key Findings
Definition of Personalized Medicine is Fluid
P4 - Another View of Personalized Medicine
Increasing Government Participation In Personalized Medicine
The FDA Can Regulate Laboratory Developed Tests (LDTs) If It Wants
The Outlook for Drug/ Diagnostic Co-Developed Products for Personalized Medicine
Trend of More Activity in Drug/ Diagnostic Co-Development
FDA’s Draft Guidance for Drug/ Companion IVD Co-development
Multiple Rx/CDx Combinations For the Real World
Trend for Key Indications for Rx/CDx Applications
Drug/ Diagnostic Co-Development Success or Failure
Good Clinical Data and Good Marketing Pay Off
Regulatory Struggles
Payer Challenges
Drug/ Diagnostic Co-Development Commercial Implications For Personalized Medicine
Emerging Markets Provide New Opportunities
7. Selected Companies in Personalized Medicine
Abbott Molecular
Affymetrix, Inc.
Almac Group, Ltd.
Arbor Vita Corporation
Asuragen, Inc.
bioMérieux SA
Celera Corporation (Quest Diagnostics)
Cepheid
CombiMatrix Molecular Diagnostics, Inc.
Comprehensive Biomarker Center GmbH (Febit)
Dako A/S (EQT)
Danaher/Beckman Coulter, Inc.
Epigenomics AG
Gen-Probe, Inc.
Hologic, Inc.
Illumina, Inc.
Ingenuity Systems, Inc.
LabCorp
Life Technologies, Inc.
Luminex Corporation
Medco Health Solutions, Inc.
Myriad RBM, Inc.
Nanosphere, Inc.
NanoString Technologies, Inc.
Orion Genomics LLC
Protagen AG
QIAGEN N.V.
Quest Diagnostics, Inc.
Roche/454 Life Sciences
Sequenom, Inc.
Singulex, Inc.
8. Appendix
Glossary: Drug/ Diagnostic Co-Development Tools for Personalized Medicine
Diagnostics Company Contacts
Drug Company Contacts
Government Contacts
Industry Advocacy Groups
Major Disease Population Sizes
About Takeda Pacific
About the Authors
List of Tables
Table 1. Selected Targeted Medicines
Table 2. Example of Pipeline Targeted Medicines & CDx Tests
Table 3. Examples of Existing Drug/ Diagnostic Companion Products
Table 4. Drug Efficacy Rate by Therapeutic Area
Table 5. Selected Drug-Diagnostic Co-Development Product Pipeline Areas
Table 6. Summary: The FDA Table of Validated Biomarkers
Table 7. FDA Table of Required Biomarker Tests
Table 8. EMA Table of Required Biomarker Tests
Table 9. Typical Reimbursement Fees for Molecular Dx
Table 10. Selected Diagnostic Tests Receiving High Reimbursement Fees
Table 11. Summary of Personalized Medicine Alliances in by Alliance Type and Year
Table 12. Summary of Personalized Medicine Alliances by Major Disease and Year
Table 13. Personalized Medicine R&D Alliances by Major Disease, 2011
Table 14. Personalized Medicine R&D Alliances by Major Disease, 2010
Table 15. Personalized Medicine R&D Alliances by Major Disease, 2009
Table 16. Personalized Medicine R&D Alliances by Major Disease, 2008
Table 17. Personalized Medicine R&D Alliances by Major Disease, 2007
Table 18. Biochip & Microarray Market Size Est., 2011-2016
Table 19. Next Generation Sequencing (Dx) Market Size, 2011-2016
Table 20. PCR Dx Estimated Market Size, 2011-2016
Table 21. Personalized Medicine Epigenetic Test Market Size, 2011-2016
Table 22. Personalized Medicine Bioinformatics Market Size, 2011-2016
Table 23. Est. Pers. Med. Molecular Imaging Market Size, 2011-2016
Table 24. Pers. Med Nanobiotechnology Market Size, 2011-2016
Table 25. WW Total Core Personalized Medicine Market Size ($M), 2011-2016
Table 26. WW Personalized Medicine Therapeutic Product Market Size ($M)
Table 27. WW Personalized Medicine Therapeutic Market Size ($M) by Region
Table 28. Personalized Medicine Diagnostic Product Market Size by Technology
Table 29. WW Personalized Medicine Diagnostic IVD Market By Major Disease
Table 30. WW Companion Diagnostic IVD Test & LDT Service Market
Table 31. WW Companion Diagnostic IVD & LDT Lab Services Market by Major Disease
Table 32. Personalized Medicine Diagnostic IVD Market by WW Regions
Table 33. WW Personalized Medicine Diagnostic Lab Services By Major Disease
Table 34. WW Personalized Medicine Diagnostic Lab Service Market by Regions
Table 35. Elements of P4 Medicine
Table 36. Glossary of Personalized Medicine Terms
Table 37. Diagnostic Companies
Table 38. Drug Companies
Table 39. Government Organizations
Table 40. Industry Groups
Table 41. Estimated Patient Populations by Disease in the Developed World
Table 42. Top Health Risk Factors Leading to Death in the Developed World
List of Figures
Figure 1. FDA’s Ideal Drug- Companion IVD Co-Development Model
Figure 2. Personalized Medicine Market Landscape
Figure 3. Diagnostic Microarrays
Figure 4. Emerging Genome Sequencers and Personalized Medicine
Figure 5. Molecular Imaging Shows Neurological Disease
Figure 6. Biopsy Tissue Diagnostics using Quantum Dot Technology
Figure 7. WW Total Core Personalized Medicine Market Size ($M), 2011-2016
Figure 8. WW Personalized Medicine Therapeutic Product Market Size ($M)
Figure 9. WW Personalized Medicine Therapeutic Market Size by Major Disease
Figure 10. WW Personalized Medicine Therapeutic Market Size by Region
Figure 11. Personalized Medicine Diagnostic Product Market Size by Technology
Figure 12. WW Personalized Medicine Diagnostic IVD Market By Major Disease
Figure 13. WW Companion Diagnostic IVD Test & LDT Service Market
Figure 14. WW Companion Diagnostic IVD & LDT Lab Services Market by Major Disease
Figure 15. Personalized Medicine Diagnostic IVD Market by WW Regions
Figure 16. WW Personalized Medicine Diagnostic Lab Services By Major Disease
Figure 17. WW Personalized Medicine Diagnostic Lab Service Market by Regions

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