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Companion Diagnostics and Personalized Medicine Market Report 2012


 This is the latest and most up-to-date Market Report from Select Biosciences addressing the companion
diagnostics (CDx) and personalized medicine marketplace.Personalized medicine is a broad field with several
stakeholders all of which must be aligned in order to capture the immense potential value in targeting
therapeutics to the correct patient population—the field of stratified medicine.
 Companion Diagnostics has been rapidly expanding over the past 3 years and in this market report we
describe the current state of the marketplace from the following perspectives:
  All the Prognostic and Predictive Biomarkers with Potential Clinical Utility are described—a few
have already been developed into CDx and we expect growth in this space Targeted Therapeutics, Associated
Biomarkers, Therapeutic Indications, and Testing Mandates are Described Companion Diagnostics
Partnerships and Collaborations from 2009 to 2012 are Presented—Provides an Up-to-Date State of the
Industry Describing the Disease Areas being Addressed and Types of Biomarkers Being Deployed
Quantitative Market Metrics Quantitative Market Forecast: Market Sizing and Growth Rate Revenue
Breakout: Rx versus Dx Targeted Rx and CDx Pricing Publication Hotspot Analyses of the Various Cancer
Biomarker Classes for Identifying Niches of Market Opportunity in Various Disease Classes This
data-driven characterization of the Companion Diagnostics and Personalized Medicine field is a hands-on
document that can be used for competitive benchmarking, business planning, and strategy
development—all the data that have been collected in this industry analysis are presented and they form
the basis for the conclusions drawn throughout the market report presented in a format enabling
“drag-and-drop” into business presentations/business plans—this Market Report is
written and delivered to customers in PowerPoint format.
 Extensive Market Analyses Presented in this Report
 Personalized Medicine and Companion Diagnostics: Market Segmentation and Quantitative Analysis
  Prognostic Biomarkers in Cancer Listing, Description, and Clinical Significance Predictive Biomarkers in
Cancer Listing, Description, and Clinical Significance Summary of Pathways to Regulatory Approval of
Companion Diagnostics LDTs under CLIA Certification Outcomes with Drugs in Various Disease Classes
Percent of Tumor Classes where Tumors are Associated with Characterized Somatic Mutations Companion
Diagnostics and Personalized Medicine: Quantitative Market Metrics How Much Does it Cost to Develop a
Companion Diagnostic? Precedent for Premium Pricing in Cancer Targeted Therapeutics Pricing of Selected
Personalized Medicine Tests Growth of the Personalized Medicine Marketplace: Market Size/Forecast and
Growth Rate Personalized Medicine Industry Landscape: Selected Indications, Biomarkers and Therapeutics
 Market Trends and Evolution of the CDx Marketplace
  Disparities between Rx and CDx Companies Varying Economic Incentives between Rx and Dx
Development Increasing Targeted Rx in the Oncology Space and Effect on CDx Development Current
Rx/CDx Co-development Programs in Phase III Trials with Listing of Associated Biomarkers Cancer Classes
Addressable by CDx Characterization of Molecular Biomarker Classes: Hotspot Analysis of Publications
Cancer Biomarkers Oncogenes Tumor Suppressor Genes Non-coding RNAs Collaborations and Partnering
in the CDx Space
  2012 2011 2010 2009



Companion Diagnostics and Personalized Medicine Market Report 2012
table Of Content


chapter I. personalized Medicine And Companion Diagnostics: Market Segmentation And Quantitative
Analysis




definition Of Companion Diagnostics
classes Of Biomarkers And Their Utility In Personalized Medicine
prognostic Biomarkers In Cancer Listing, Description, And Clinical Significance
predictive Biomarkers In Cancer Listing, Description, And Clinical Significance
challenges For The Broader Personalized Medicine Field And Its Adoption
summary Of Pathways To Regulatory Approval Of Companion Diagnostics
ldts Under Clia Certification
outcomes With Drugs In Various Disease Classes
percent Of Tumor Classes Where Tumors Are Associated With Characterized Somatic Mutations
somatic Mutation Sequelae In Lung Cancer And Gastrointestinal Cancers
xalkori® Story
zelboraf® Story
companion Diagnostics And Personalized Medicine: Quantitative Market Metrics
how Much Does It Cost To Develop A Companion Diagnostic?
precedent For Premium Pricing In Cancer Targeted Therapeutics
pricing Of Selected Personalized Medicine Tests
growth Of The Personalized Medicine Marketplace: Market Size/forecast And Growth Rate


chapter Ii. personalized Medicine Industry Landscape: Selected Indications, Biomarkers And Therapeutics




therapeutic
biomarker
indication
testing Mandate
this Comprehensive Listing Frames The Various Personalized Medicine Tests That Are Either
“required”, “recommended”, “for Information Use Only”, Or
“with No Pharmacogenomic Information On The Drug Label”


chapter Iii. market Trends And Evolution Of The Cdx Marketplace

Companion Diagnostics and Personalized Medicine Market Report 2012
timeline Of Rx/cdx Co-development Over The Last Two Decades
disparities Between Rx And Cdx Companies
varying Economic Incentives Between Rx And Dx Development
increasing Targeted Rx In The Oncology Space And Effect On Cdx Development
current Rx/cdx Co-development Programs In Phase Iii Trials With Listing Of Associated Biomarkers
cancer Classes Addressable By Cdx
characterization Of Molecular Biomarker Classes: Hotspot Analysis Of Publications
cancer Biomarkers
oncogenes
tumor Suppressor Genes
non-coding Rnas


collaborations And Partnering In The Cdx Space


2012
2011
2010
2009


appendix I.research Methodology


appendix Ii.listing And Description Of Cancer Biomarkers

About Us:
Transparency Market Research is a market intelligence company providing global business information
reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides
forward-looking insight for thousands of decision makers. We are privileged with highly experienced team of
Analysts, Researchers and Consultants, who use proprietary data sources and various tools and techniques to
gather, and analyze information. Our business offerings represent the latest and the most reliable information
indispensable for businesses to sustain a competitive edge.

Contact:
ResearchMoz
90 State Street,
Suite 700,

Companion Diagnostics and Personalized Medicine Market Report 2012
Albany NY - 12207
United States
Tel: +1-518-618-1030
USA - Canada Toll Free 866-997-4948
Email: sales@researchmoz.us
Blog: http://researchmoz.blogspot.com/
Website: http://www.researchmoz.us/



Companion Diagnostics and Personalized Medicine Market Report 2012

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Companion Diagnostics and Personalized Medicine Market

  • 1. Companion Diagnostics and Personalized Medicine Market Report 2012 This is the latest and most up-to-date Market Report from Select Biosciences addressing the companion diagnostics (CDx) and personalized medicine marketplace.Personalized medicine is a broad field with several stakeholders all of which must be aligned in order to capture the immense potential value in targeting therapeutics to the correct patient population—the field of stratified medicine. Companion Diagnostics has been rapidly expanding over the past 3 years and in this market report we describe the current state of the marketplace from the following perspectives: All the Prognostic and Predictive Biomarkers with Potential Clinical Utility are described—a few have already been developed into CDx and we expect growth in this space Targeted Therapeutics, Associated Biomarkers, Therapeutic Indications, and Testing Mandates are Described Companion Diagnostics Partnerships and Collaborations from 2009 to 2012 are Presented—Provides an Up-to-Date State of the Industry Describing the Disease Areas being Addressed and Types of Biomarkers Being Deployed Quantitative Market Metrics Quantitative Market Forecast: Market Sizing and Growth Rate Revenue Breakout: Rx versus Dx Targeted Rx and CDx Pricing Publication Hotspot Analyses of the Various Cancer Biomarker Classes for Identifying Niches of Market Opportunity in Various Disease Classes This data-driven characterization of the Companion Diagnostics and Personalized Medicine field is a hands-on document that can be used for competitive benchmarking, business planning, and strategy development—all the data that have been collected in this industry analysis are presented and they form the basis for the conclusions drawn throughout the market report presented in a format enabling “drag-and-drop” into business presentations/business plans—this Market Report is written and delivered to customers in PowerPoint format. Extensive Market Analyses Presented in this Report Personalized Medicine and Companion Diagnostics: Market Segmentation and Quantitative Analysis Prognostic Biomarkers in Cancer Listing, Description, and Clinical Significance Predictive Biomarkers in Cancer Listing, Description, and Clinical Significance Summary of Pathways to Regulatory Approval of Companion Diagnostics LDTs under CLIA Certification Outcomes with Drugs in Various Disease Classes Percent of Tumor Classes where Tumors are Associated with Characterized Somatic Mutations Companion Diagnostics and Personalized Medicine: Quantitative Market Metrics How Much Does it Cost to Develop a Companion Diagnostic? Precedent for Premium Pricing in Cancer Targeted Therapeutics Pricing of Selected Personalized Medicine Tests Growth of the Personalized Medicine Marketplace: Market Size/Forecast and Growth Rate Personalized Medicine Industry Landscape: Selected Indications, Biomarkers and Therapeutics Market Trends and Evolution of the CDx Marketplace Disparities between Rx and CDx Companies Varying Economic Incentives between Rx and Dx Development Increasing Targeted Rx in the Oncology Space and Effect on CDx Development Current Rx/CDx Co-development Programs in Phase III Trials with Listing of Associated Biomarkers Cancer Classes Addressable by CDx Characterization of Molecular Biomarker Classes: Hotspot Analysis of Publications Cancer Biomarkers Oncogenes Tumor Suppressor Genes Non-coding RNAs Collaborations and Partnering in the CDx Space 2012 2011 2010 2009 Companion Diagnostics and Personalized Medicine Market Report 2012
  • 2. table Of Content chapter I. personalized Medicine And Companion Diagnostics: Market Segmentation And Quantitative Analysis definition Of Companion Diagnostics classes Of Biomarkers And Their Utility In Personalized Medicine prognostic Biomarkers In Cancer Listing, Description, And Clinical Significance predictive Biomarkers In Cancer Listing, Description, And Clinical Significance challenges For The Broader Personalized Medicine Field And Its Adoption summary Of Pathways To Regulatory Approval Of Companion Diagnostics ldts Under Clia Certification outcomes With Drugs In Various Disease Classes percent Of Tumor Classes Where Tumors Are Associated With Characterized Somatic Mutations somatic Mutation Sequelae In Lung Cancer And Gastrointestinal Cancers xalkori® Story zelboraf® Story companion Diagnostics And Personalized Medicine: Quantitative Market Metrics how Much Does It Cost To Develop A Companion Diagnostic? precedent For Premium Pricing In Cancer Targeted Therapeutics pricing Of Selected Personalized Medicine Tests growth Of The Personalized Medicine Marketplace: Market Size/forecast And Growth Rate chapter Ii. personalized Medicine Industry Landscape: Selected Indications, Biomarkers And Therapeutics therapeutic biomarker indication testing Mandate this Comprehensive Listing Frames The Various Personalized Medicine Tests That Are Either “required”, “recommended”, “for Information Use Only”, Or “with No Pharmacogenomic Information On The Drug Label” chapter Iii. market Trends And Evolution Of The Cdx Marketplace Companion Diagnostics and Personalized Medicine Market Report 2012
  • 3. timeline Of Rx/cdx Co-development Over The Last Two Decades disparities Between Rx And Cdx Companies varying Economic Incentives Between Rx And Dx Development increasing Targeted Rx In The Oncology Space And Effect On Cdx Development current Rx/cdx Co-development Programs In Phase Iii Trials With Listing Of Associated Biomarkers cancer Classes Addressable By Cdx characterization Of Molecular Biomarker Classes: Hotspot Analysis Of Publications cancer Biomarkers oncogenes tumor Suppressor Genes non-coding Rnas collaborations And Partnering In The Cdx Space 2012 2011 2010 2009 appendix I.research Methodology appendix Ii.listing And Description Of Cancer Biomarkers About Us: Transparency Market Research is a market intelligence company providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for thousands of decision makers. We are privileged with highly experienced team of Analysts, Researchers and Consultants, who use proprietary data sources and various tools and techniques to gather, and analyze information. Our business offerings represent the latest and the most reliable information indispensable for businesses to sustain a competitive edge. Contact: ResearchMoz 90 State Street, Suite 700, Companion Diagnostics and Personalized Medicine Market Report 2012
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