Abstract
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.
About Takeda Pacific
Analysts at Takeda Pacific developed this report. The company provides
business consulting that focuses on facilitating market research and business
development projects. The business projects may involve European, Japanese
and North American Life Science companies. Since it's founding in late 1992,
TP has reviewed or analyzed thousands of life Science and technology firms for
its clients.
Takeda Pacific has produced numerous industry reports about emerging pharma,
biotech, medical devices and technology companies and markets. The company
also offers follow-up consulting or custom research consulting to assist in
your business development or benchmarking, market assessment projects.
Report Statistics
- Publication Date: April 2012
- Authors: Jay K. Myers, Paula Mitchell Myers
- Total Number of Pages: 171(can be printed; fully searchable PDF
format)
- Categories: Personalized Medicine/ Biomarkers/
Pharmacogenomics/Targeted Therapeutics/ Drugs/ Pharmaceuticals/ Pipeline
Molecular Diagnostics, Companion Diagnostics, LDTs, IVD Clinical Laboratory
Services, Clinical Trials, PBM Epigenetics, DNA Methylation/ Histone
modification Biotechnology, Tissue Diagnostics/ Healthcare Payers Life Science
Tools and Technologies, P4 Medicine, Next Generation Sequencing, PCR,
Microarray, Genome
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
- 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
- Personalized Medicine Therapeutic Market Size by Major Disease
- Cancer
- Cardiovascular
- CNS
- Infectious Disease
- Personalized Medicine Therapeutic Market Size by Region
- North America
- Europe
- Japan
- Emerging Market
- ROW
- 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
- 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 Regions
- Personalized Medicine Diagnostic Lab Service Market Size by Disease,
2011~2016
- Infectious Disease
- Blood Screening
- Genetic Testing
- Cancer (MDx)
- Cancer (Adv.TDx)
- 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.
- bioMerieux 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
