Worldwide Personalized Medicine Market
Enabling Equipment, Tools, Technologies, Players,
Drugs, Opportunities & Market Outlook
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Published August 2010 by
MRG, Inc. and Fuji-Keizai |
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Pages: 155 |
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Executive Summary
This report reviews, analyzes and sizes the core personalized medicine diagnostic, clinical lab service and therapeutics market. The study reveals interesting information about key technologies, predictive and companion diagnostic tests, software and services marketed to healthcare centers worldwide.
This report assesses the market landscape with its expanding universe of companies. The financial section sizes the market and discusses the five-year revenue projection to 2014. The market is segmented by major product and service areas by disease, by major technology and by major world regions to see the growth opportunity.
This study reviews and analyzes major company alliances and M&As during the last few years. Large data tables summarize the alliances and M&As. The alliance tables provide a large amount of deal information.
This report reviews the personalized medicine technology and business trends over the next three to five-years. Detailed analytical tables help the reader quickly understand the trend information. For example, this study assessed recent changes in the FDA policy towards laboratory developed tests, or LDTs.
The study methodology uses both primary and secondary information that was gathered from numerous sources including in-person interviews and discussions, telephone interviews, and surveys, attendance at business presentations at healthcare technical and financial conferences.
This research report is designed for people that include marketers, business development, top executives, investors, VCs, consultants, R&D managers, entrepreneurs and the like. More than 62 detailed tables or figures provide key data about items such as strategic alliances, M&As, market size, segments, product details and the like.
This report includes 31 company profiles that provide the reader a snapshot of the companies’ focus or activities. The provided Internet links help readers access companies’ own web sites for further review.
Target Personalized Medicine Market
Personalized Medicine Dx Esoteric IVD Tests |
Molecular Dx IVD Tests, screening, early detection, risk predisposition, profiling, monitoring |
| Companion Dx IVD Tests for drug selection, response prediction, therapy monitoring |
| Adv.Tissue Dx for cancer biopsies (IHC/FISH); drug compatibility testing |
Personalized Medicine Dx Esoteric Lab Services |
IVD/LDT Molecular Dx Services for risk prediction, etc. |
| Companion Dx LDT Tests for drug selection, response prediction, therapy monitoring. |
| Adv. Tissue Dx Testing |
Personalized Therapeutics |
Targeted Cancer Therapeutics- Br. Cancer, Lung cancer, Colorectal cancer, Leukemia, etc. |
| Other therapeutics that use companion Dx to guide dose management or drug interactions. |
Related Diagnostics |
Molecular Imaging – FDG –PET, Alzheimer’s CVD, Cancer – to detect/monitor therapy |
| Others |
Target Technology
Genomic Technology, Proteomic Technology, Bioinformatics, Epigenomic Technology, Cytogenetics, Nanobiotech, Laser Capture Microdissection, Next Generation Sequencers, Molecular Imaging
Target Companies
Protagen AG, Rules-Based Medicine, Inc., febit Holding GmbH, Epigenomics AG, Quest Diagnostics, Inc., LabCorp, Asuragen, Inc., Almac Group, Ltd., 454 Life Sciences (Roche), Affymetrix, Inc., Arbor Vita Corporation, Illumina, Inc., Ingenuity Systems, Inc., Life Technologies, Inc., NanoString Technologies, Inc. Singulex, Inc., Pharmacy Benefit Managers (PBM), Medco Health Solutions, Inc., Molecular Diagnostics, Celera Corporation, Cepheid, Gen-Probe, Inc., QIAGEN N.V., Abbott Molecular, Dako A/S (EQT), Nanosphere, Inc., Beckman Coulter, Inc. , bioMérieux SA, CombiMatrix Molecular Diagnostics, Inc., Orion Genomics LLC, Sequenom, Inc., Luminex Corporation, Hologic, Inc.
Table of Contents
| |
Executive Summary |
| |
|
| 1 |
Era of Personalized Medicine: Emerging Products |
| 1.1 |
Overview of Personalized Medicine |
| 1.1.1 |
Industry Consensus of Definition or Vision of Personalized Medicine |
| 1.1.2 |
Personalized Medicine Is Here Today |
| 1.1.3 |
Targeted Medicines |
| 1.1.4 |
The Need for Drug-Diagnostic Co-Development |
| 1.2 |
Market Landscape |
| 1.3 |
Drivers and Stakeholders of Personalized Medicine |
| 1.3.1 |
Government |
| 1.3.2 |
Diagnostic Industry |
| 1.3.3 |
Drug Makers |
| 1.3.4 |
Healthcare Payers |
| 1.3.5 |
Pharmacy Benefit Managers (PBM) |
| 1.4 |
Drug/Diagnostic Co-Development |
| 1.4.1 |
Medical Conditions Targeted By Personalized Medicine |
| 1.5 |
Status of Drug/Diagnostic Co-Developed Products |
| 1.5.1 |
Examples of Drug/Diagnostic Co-Developed Products |
| 1.6 |
Drug/ Diagnostic Co-Development Pipeline |
| 1.6.1 |
Medical Conditions with Unmet Medical Need |
| 1.6.2 |
Drug/Diagnostic Co-Developed Products in Development |
| 1.7 |
Government Regulatory Considerations |
| 1.7.1 |
FDA Guidance for Biomarker Validation |
| 1.7.2 |
FDA Guidance for IVDMIA Based Tests |
| 1.7.3 |
Status of Complex Laboratory Developed Tests (LDTs) |
| 1.7.4 |
Navigating Emerging Rules for Healthcare Reform |
| 1.8 |
Insurance Reimbursement |
| 1.8.1 |
Standard Diagnostic Pricing v. Value-based Pricing |
| 1.8.2 |
Timeline for Getting Payers to Validate and Pay for New Diagnostics |
| |
|
| 2 |
Key Enabling Tools & Technologies for Personalized Medicine |
| 2.1 |
Diagnostic Biochips and Microarrays |
| 2.1.1 |
PM Dx Biochip & Microarray Market Size and Major Makers |
| 2.1.2 |
Alere (fmr. Inverness Medical) |
| 2.1.3 |
Agendia BV |
| 2.1.4 |
Roche Molecular Diagnostics |
| 2.2 |
Next Generation Sequencers for Personalized Medicine |
| 2.2.1 |
PM Dx Next Gen. Sequencing Market Size and Major Makers |
| 2.2.2 |
Illumina |
| 2.2.3 |
Roche/454 |
| 2.2.4 |
Life Technologies |
| 2.3 |
PCR Tests |
| 2.3.1 |
PM Dx PCR Test Market Size and Major Makers |
| 2.3.2 |
Roche Molecular |
| 2.3.3 |
Qiagen NV |
| 2.3.4 |
Genomic Health |
| 2.4 |
Epigenetic Diagnostic Tests |
| 2.4.1 |
PM Dx Epigenetic Test Market Size and Major Makers |
| 2.4.2 |
LabCorp |
| 2.4.3 |
Quest Diagnostics |
| 2.4.4 |
Oncomethylome |
| 2.5 |
Bioinformatics for Personalized Medicine |
| 2.5.1 |
PM Dx Bioinformatic Market Size and Major Makers |
| 2.5.2 |
Accelrys |
| 2.5.3 |
Entelos |
| 2.5.4 |
Microsoft Corporation |
| 2.6 |
Molecular Imaging Agents |
| 2.6.1 |
PM Dx Molecular Imaging Market Size and Major Makers |
| 2.6.2 |
GE Healthcare |
| 2.6.3 |
Celera |
| 2.6.4 |
Avid Radiopharmaceuticals |
| 2.7 |
Nanobiotech |
| 2.7.1 |
PM Dx Nanobiotech Market Size and Major Makers |
| 2.7.2 |
Roche/Ventana Medical |
| 2.7.3 |
Abbott Molecular |
| |
|
| 3 |
Alliance Trends in Personalized Medicine R&D |
| 3.1 |
Alliances in Personalized Medicine R&D By Alliance Type |
| 3.2 |
Alliances in Personalized Medicine R&D By Major Diseases |
| 3.3 |
Alliances in Personalized Medicine by Major Disease, 2010 |
| 3.4 |
Alliances in Personalized Medicine by Major Disease, 2009 |
| 3.5 |
Alliances in Personalized Medicine by Major Disease, 2008 |
| 3.6 |
Alliances in Personalized Medicine by Major Disease, 2007 |
| 3.7 |
Alliances in Personalized Medicine by Major Disease, 2006 |
| |
|
| 4 |
The Market Outlook for Personalized Medicine Based Healthcare |
| 4.1 |
WW Total of the Core Personalized Medicine Market Size, 2009-2014 |
| 4.1.1 |
Total Personalized Medicine Diagnostic Product Market Size |
| 4.1.2 |
Total Personalized Medicine Diagnostic Lab Service Market Size |
| 4.1.3 |
Total Personalized Medicine Therapeutic Product Market Size |
| 4.2 |
WW Personalized Medicine Diagnostic Product Market Size By Technology, 2009-2014 |
| 4.2.1 |
Genomic Technology |
| 4.2.2 |
Proteomic Technology |
| 4.2.3 |
Bioinformatics |
| 4.2.4 |
Epigenomic Technology |
| 4.2.5 |
Cytogenetics |
| 4.2.6 |
Nanobiotech |
| 4.2.7 |
Laser Capture Microdissection |
| 4.2.8 |
Next Generation Sequencers |
| 4.2.9 |
Molecular Imaging |
| 4.2.10 |
Other Technologies |
| 4.3 |
WW Personalized Medicine Diagnostic IVD Market Size By Major Disease, 2009-2014 |
| 4.3.1 |
Infectious Disease |
| 4.3.2 |
Blood Screening |
| 4.3.3 |
Genetic Testing |
| 4.3.4 |
Cancer (MDx) |
| 4.3.5 |
Cancer (Adv. TDx) |
| 4.4 |
Companion Diagnostic (CDx) Product and Lab Services Market Size, 2009-2014 |
| 4.5 |
Combined Companion Diagnostic IVD Product and LDT Lab Services Market Size, By Major Disease, 2009-2014 |
| 4.5.1 |
Cancer |
| 4.5.2 |
Cardiovascular |
| 4.5.3 |
CNS |
| 4.5.4 |
Others |
| 4.6 |
Personalized Medicine Diagnostic Product Market By WW Regions |
| 4.7 |
Personalized Medicine Diagnostic Lab Service Market Size By Disease, 2009-2014 |
| 4.7.1 |
Infectious Disease |
| 4.7.2 |
Blood Screening |
| 4.7.3 |
Genetic Testing |
| 4.7.4 |
Cancer (MDx) |
| 4.7.5 |
Cancer (Adv.TDx) |
| 4.8 |
WW Personalized Medicine Diagnostic Lab Service Market By Regions |
| 4.8.1 |
North America |
| 4.8.2 |
Europe |
| 4.8.3 |
Asia Pacific/Japan |
| 4.8.4 |
ROW |
| |
|
| 5 |
Selected Company Profiles |
| 5.1 |
Biomarker Discovery |
| 5.1.1-5.1.4 |
(Total 4) |
| 5.2 |
Diagnostic Lab Services |
| 5.2.1-5.2.4 |
(Total 4) |
| 5.3 |
Equipment Platforms & Software |
| 5.3.1-5.3.8 |
(Total 8) |
| 5.4 |
Pharmacy Benefit Managers (PBM) |
| 5.4.1 |
(Total 1) |
| 5.5 |
Molecular Diagnostics |
| 5.5.1-5.5.14 |
(Total 14) |
| |
|
| 6 |
Key Findings and Business Opportunities for Personalized Medicine |
| 6.1 |
Key Findings |
| 6.2 |
The Outlook for Emerging Drug/Diagnostic Co-Developed Products for Personalized Medicine |
| 6.3 |
Likely Drug/Diagnostic Co-Development Success and Failure Factors |
| 6.4 |
Drug/Diagnostic Co-Development Commercial Implications for Personalized Medicine |
| |
|
| 7 |
Appendix |
| 7.1 |
Glossary: Drug/Diagnostic Co-Development for Personalized Medicine 150 |
| 7.2 |
Diagnostics Company Contacts |
| 7.3 |
Drug Company Contacts |
| 7.4 |
Government Contacts |
| 7.5 |
Industry Advocacy Groups |
| 7.6 |
Major Disease Population Sizes |
Table of Illustrations
| Figure 1: |
FDA’s Ideal Drug Diagnostic Co-Development Concept |
| Figure 2: |
Personalized Medicine Market Landscape |
| Figure 3: |
Diagnostic Microarrays |
| Figure 4: |
Next Generation 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, 2009-2014 |
| Figure 8: |
WW Personalized Medicine Therapeutic Product Market Size |
| Figure 9: |
Personalized Medicine Diagnostic Product Market Size by Technology |
| Figure 10: |
WW Personalized Medicine Diagnostic IVD Market By Major Disease |
| Figure 11: |
WW Companion Diagnostic IVD Test & LDT Service Market |
| Figure 12: |
WW Companion Diagnostic IVD & LDT Lab Services Market By Major Disease |
| Figure 13: |
Personalized Medicine Diagnostic IVD Market By WW Regions |
| Figure 14: |
WW Personalized Medicine Diagnostic Lab Services By Major Disease |
| Figure 15: |
WW Personalized Medicine Diagnostic Lab Service Market By Regions |
Table of Tables
| Table 1: |
Selected Targeted Medicines, 2008, 2009 |
| Table 2: |
Example of Pipeline Targeted Medicines & CDx Tests |
| Table 3: |
Examples of Existing Drug Diagnostic Co-Developed 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: |
Biochip & Microarray Market Size Est., 2009-2014 |
| Table 12: |
Major Maker’s Market Share, 2009 |
| Table 13: |
Est Next Gen. Seq. (Dx) Market Size, 2009-2014 |
| Table 14: |
Est Next Gen. Seq. Major Maker’s Dx Market Share, 2009 |
| Table 15: |
PCR Dx Estimated Market Size, 2009-2014 |
| Table 16: |
Major NG Seq. Maker’s Est. Market Share, 2009 |
| Table 17: |
Pers. Med. Epigenomic Test Market Size, 2009-2014 |
| Table 18: |
Major Maker’s Market Share, 2009 |
| Table 19: |
Pers. Med. Bioinformatics Market Size, 2009-2014 |
| Table 20: |
Major Maker’s Market Share, 2009 |
| Table 21: |
Est. Pers. Med. Molecular Imaging Market Size, 2009-2014 |
| Table 22: |
Est. Molecular Imaging Major Maker’s Market Share, 2009 |
| Table 23: |
Pers. Med Nanobiotechnology Market Size, 2009-2014 |
| Table 24: |
Est. Major Maker’s Market share, 2009 |
| Table 25: |
Summary of Alliances in Personalized Medicine R&D by Alliance Type and Year |
| Table 26: |
Alliances in Personalized Medicine by Major Disease (2006-Apr/2010) |
| Table 27: |
Key Alliances for Personalized Medicine R&D by Major Disease and Indication/ Application, to April-2010 |
| Table 28: |
Alliances for Personalized Medicine R&D by Major Disease and Indication/ Application, 2009 |
| Table 29: |
Alliances for Personalized Medicine R&D by Major Disease and Indication/ Application, 2008 |
| Table 30: |
Alliances for Personalized Medicine R&D by Major Disease and Indication/ Application, 2007 |
| Table 31: |
Alliances for Personalized Medicine R&D by Major Disease and Indication/ Application, 2006 |
| Table 32: |
WW Total Core Personalized Medicine Market Size, 2009-2014 |
| Table 33: |
WW Personalized Medicine Therapeutic Product Market Size |
| Table 34: |
Personalized Medicine Diagnostic Product Market Size by Technology |
| Table 35: |
WW Personalized Medicine Diagnostic IVD Market By Major Disease |
| Table 36: |
WW Companion Diagnostic IVD Test & LDT Service Market |
| Table 37: |
WW Companion Diagnostic IVD & LDT Lab Services Market by Major Disease |
| Table 38: |
Personalized Medicine Diagnostic IVD Market by WW Regions |
| Table 39: |
WW Personalized Medicine Diagnostic Lab Services By Major Disease |
| Table 40: |
WW Personalized Medicine Diagnostic Lab Service Market by Regions |
| Table 41: |
Elements of P4 Medicine |
| Table 42: |
WW Combined Companion Diagnostic IVD & LDT Market by Region |
| Table 43: |
Glossary of Personalized Medicine Terms |
| Table 44: |
Diagnostic Companies |
| Table 45: |
Drug Companies |
| Table 46: |
Government Organizations |
| Table 47: |
Industry Groups |
| Table 48: |
Estimated Patient Populations by Disease in the Developed World |
| Table 49: |
Top Health Risk Factors Leading to Death in the Developed World |
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