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.
This report is 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. SHOW LESS READ MORE >
1.Emerging Personalized Medicine Products
-Industry Definition of Personalized Medicine
-Personalized Medicine Is Growing
-FDA & EMA On Drug-Companion IVD Co-Development
-Drivers and Stakeholders of Personalized Medicine
-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
-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)
-Roche Molecular Diagnostics
-Next Generation Sequencers for Personalized Medicine
-Clinical Next Gen. Sequencing Market Size and Major Makers
-Oxford Nanopore Technologies
-PM Dx PCR Test Market Size and Major Makers
-Epigenetic Diagnostic Tests
-PM Dx Epigenetic Test Market Size and Major Makers
-Bioinformatics for Personalized Medicine
-PM Dx Bioinformatic Market Size and Major Makers
-Molecular Imaging Agents
-PM Dx Molecular Imaging Market Size and Major Makers
-Celera (acq. by Quest Diagnostics)
-Avid Radiopharmaceuticals (Eli Lilly)
-PM Dx Nanobiotech Market Size and Major Makers
-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
-WW Personalized Medicine Therapeutic Market Size by Region
-WW Personalized Medicine Diagnostic IVD Market Size by Technology, 2011-2016
-Laser Capture Microdissection
-Next Generation Sequencers
-WW Personalized Medicine Diagnostic IVD Market Size by Major Disease, 2011-2016
-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
-Personalized Medicine Diagnostic IVD Market Size by WW Regions
-Personalized Medicine Diagnostic Lab Service Market Size by Disease, 2011-2016
-WW Personalized Medicine Diagnostic Lab Service Market Size by Regions
-Asia Pacific/ Japan
6.Key Findings and Business Opportunities for Personalized Medicine
-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
-Drug/ Diagnostic Co-Development Commercial Implications For Personalized Medicine
-Emerging Markets Provide New Opportunities
7.Selected Companies in Personalized Medicine
-Almac Group, Ltd.
-Arbor Vita Corporation
-Celera Corporation (Quest Diagnostics)
-CombiMatrix Molecular Diagnostics, Inc.
-Comprehensive Biomarker Center GmbH (Febit)
-Dako A/S (EQT)
-Danaher/Beckman Coulter, Inc.
-Ingenuity Systems, Inc.
-Life Technologies, Inc.
-Medco Health Solutions, Inc.
-Myriad RBM, Inc.
-NanoString Technologies, Inc.
-Orion Genomics LLC
-Quest Diagnostics, Inc.
-Roche/454 Life Sciences
-Glossary: Drug/ Diagnostic Co-Development Tools for Personalized Medicine
-Diagnostics Company Contacts
-Drug Company 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
- Abbott Molecular
- Affymetrix, Inc.
- Almac Group, Ltd.
- Arbor Vita Corporation
- Asuragen, Inc.
- bioMérieux SA
- Celera Corporation (Quest Diagnostics)
- 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.
- 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.