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Published: April 2012 171 pages; Can be printed; fully searchable PDF format; TOC hyperlinks and Internet hyperlinks
SKU: TPR3186
Price: $2,895.00 (USD) PDF Single User License $4,995.00 (USD) PDF Single Office License (2 to 5 users) $6,995.00 (USD) PDF Global Site License
Description
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.
Table of Contents
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 ----------------------------------------------------------------------------------------- For more information or to order the above publications, |
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