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This report is a comprehensive analysis of the Personalized Medicines market. We explore the benefits and disadvantages of personal medicines, the role of pharmacogenomics, role of diagnostic tools, emergence of linked diagnostics and therapeutics, the efficacy of treatment with personalized medicines and many other factors.

We also include an analysis of whether the emergence of personalized medicines means an end of the era of blockbuster drugs. We also examine the benefits for businesses and partnership/alliance models in the market, followed by an analysis of the essentials of personalized medicine practice.

Genetics has changed the face of the pharmaceutical industry today. With advances in the field of genetics, it is now possible to customize even your medicines according to your genetic constitution. The emergence of personalized medicines has taken the pharmaceutical industry by storm.

With genetics making it possible to personalize your medicines, it has now become possible to tailor medicines to cure diseases such as cancer, sinusitis and scientists are looking at options for curing AIDS as well with personalized medicines. Often described as the right treatment for the right person at the right time, personalized medicines however face many challenges before they become widely available, the biggest challenge being regulatory hurdles and cost.

The applications of personalized medicines in predictive medicine, treatment optimization, cancer, pharmacogenetics and pharmacometabolomics as well as other met and unmet therapy areas are also examined in this report. An analysis of the regulatory framework that is critical to the success of personalized medicines is included.

The economic impact of personalized medicines and the role of venture capital in this market are also examined. Since technology obviously plays a major role in the development of personalized medicines, we analyze the various technology platforms as well as the technological requirements for the personalized medicines market.

Challenges facing the industry as well as a look at the key markets where personalized medicines are being used is included, followed by an analysis of the personalized medicine applications currently on the market and the major industry players.


Pages: 178
Published: February 2013
Publisher: Red Mountain Insights
ISBN: 978-1-62484-016-6

What is Personalized Medicine? 10
Introduction 10
Advantages & Disadvantages of Personal Medicine 12
Role of Pharmacogenomics 12
Role of Diagnostic Tools 15
Molecular Diagnostics 15
Personal Genomes and Genetic Profiles 17
Emergence of Linked Diagnostics and Therapeutics 18
Clinical Domains 19
Personalized Medicine & Medical Technology Innovation Pathway 20
Increasing Treatment Efficacy with Personalized Medicines 24
Capabilities System of Personalized Medicine (PMx) 24
End of Blockbuster Drugs? 26
Impact of Personalized Medicine on Healthcare 27
Partnership & Alliance Models in Personalized Medicine 28
Benefits for Businesses 33
Essentials of Personalized Medicine Practice 35
Applications of Personalized Medicine 37
Predictive Medicine 37
Treatment Optimization 40
Cancer 43
Overview 43
Ovarian Cancer 45
Cervical Cancer 47
Pharmacogenetics & Pharmacometabolomics 49
Chronic Sinusitis 50
Met & Unmet Therapy Areas 51
Regulatory Framework 54
Federal Agencies Involved in Personalized Medicine 54
Role of the US FDA 58
Role of CMS/CLIA 60
FDA & CLIA Regulation 61
Critical Path Initiative 61
Function & Content of Agencies Involved in Personalized Medicine 63
Economics of Personalized Medicine 64
Economic Impact of Personalized Medicines 64
Role of Venture Capital in Personalized Medicine 64
Technology Platforms 68
Expression Profiling - RNA & Pharmacogenomics 68
Proteins & Pharmacoproteomics 68
DNA Sequence Profiling - Pharmacogenetic & SNP Analysis 69
High-throughput Sequencing 70
Role of Amplification Technologies 70
Technological Requirements 72
Overview 72
Genome Sequencing 73
Single Nucleotide Polymorphisms 75
DNA Structural Variation 76
Expression Microarrays 76
Role of Biospecimen Banks 76
Challenges Facing Personalized Medicine 80
Discrimination Concerns 80
Issues for Insurers 80
Technological Challenges 81
Intellectual Property Protection 83
Public/Private Investment 84
Development of Key Translational Tools 85
Key Market Analysis 88
Europe 88
Canada 89
United States 91
Personalized Medicine Applications Currently on the Market 94
AlloMap® Test 94
AmpliChip® CYP450 Test 94
Antiretroviral Drug Resistance Tests 94
HER2/neu Tests 95
HLA B*5701 Test 95
Invader® UGT1A1 Assay 95
Oncotype DX® 96
TPMT Assays 96
Trofile™ Assay 97
Warfarin Metabolism Tests 97
Major Players 98
20/20 GeneSystems 98
A&G Pharmaceutical, Inc 102
ACGT, Inc. 104
ACM Medical Laboratory, Inc. 105
Advanced Cell Diagnostics, Inc. 106
Ambry Genetics Corporation 106
ApoCell, Inc. 107
Arcxis Biotechnologies, Inc. 108
AssureRx 109
Aushon BiosyStems, Inc. 110
AutoGenomics Inc. 111
BioNanomatrix, Inc. 111
Cellular Dynamics International, Inc. 112
Cira Discovery Sciences, Inc. 113
CombiMatrix Corporation 113
Cypress Bioscience, Inc 115
Gene Express Inc 116
Genetics Squared, Inc. 117
Genomas, Inc. 118
Genomica Corp. 122
Gentris Clinical Genetics, Inc. 122
Golden Helix, Inc. 123
Health Discovery Corp. 124
HistoRx 125
ICON Laboratories, Inc. 128
Illumina Inc 129
Intrinsic LifeSciences LLC 130
Iris Biotechnologies Inc 131
LineaGen Research Corporation 132
Lipomics Technologies, Inc. 133
Medical Diagnostic Laboratories 134
Myriad Genetics Inc. 135
Nanosphere, Inc. 136
NanoString Technologies 137
Proventys, Inc. 138
QuantRX Biomedical Corporation 139
Rheonix, Inc. 140
RxGen PrimaTox, Inc. 141
Sequenom Inc. 141
SeqWright Incorporated 143
Serametrix Corporation 144
Smart Personalized Medicine, LLC 144
Tethys Bioscience 145
Waban Software, Inc. 149
Future of Personalized Medicines 152
Glossary 157

20/20 GeneSystems
A&G Pharmaceutical, Inc
ACGT, Inc.
ACM Medical Laboratory, Inc.
Advanced Cell Diagnostics, Inc.
Ambry Genetics Corporation
ApoCell, Inc.
Arcxis Biotechnologies, Inc.
AssureRx 109
Aushon BiosyStems, Inc.
AutoGenomics Inc.
BioNanomatrix, Inc.
Cellular Dynamics International, Inc.
Cira Discovery Sciences, Inc.
CombiMatrix Corporation
Cypress Bioscience, Inc
Gene Express Inc
Genetics Squared, Inc.
Genomas, Inc.
Genomica Corp.
Gentris Clinical Genetics, Inc.
Golden Helix, Inc.
Health Discovery Corp.
HistoRx
ICON Laboratories, Inc.
Illumina Inc
Intrinsic LifeSciences LLC
Iris Biotechnologies Inc
LineaGen Research Corporation
Lipomics Technologies, Inc.
Medical Diagnostic Laboratories
Myriad Genetics Inc.
Nanosphere, Inc.
NanoString Technologies
Proventys, Inc.
QuantRX Biomedical Corporation
Rheonix, Inc.
RxGen PrimaTox, Inc.
Sequenom Inc.
SeqWright Incorporated
Serametrix Corporation
Smart Personalized Medicine, LLC
Tethys Bioscience
Waban Software, Inc.

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