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Epigenetic and MicroRNA Biomarkers Market Report © 2013 Epigenetic and MicroRNA Biomarkers Market Report © 2013 Page 1

SELECTBIO Epigenetic and MicroRNA Biomarkers2013 Market Report

For More Information, Please Contact:

Kathy GraySELECTBIO

[email protected]

SELECTBIO Market Reports Website:

SelectBiosciences.com/marketreports/

Report Publication Date: July 2013

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Legal Disclaimer and Terms of UseThis Market Report is Copyright Protected by SELECTBIO. All rights reserved. Neither this Market Report nor its contents

(in whole or in part) may be reproduced in any form without the expressed written consent of SELECTBIO by its authorized representative.

For Questions or Technical Information, Please Contact SELECTBIO

Enal Razvi, Ph.D.Biotechnology Analyst, SELECTBIO

Telephone: +1 415-505-8960 E-mail: [email protected]

Terms of Use Governing This Market Report

SELECTBIO has exercised commercially-reasonable efforts in the preparation of this market report (“Report”), which isbased on information available to the public, proprietary technology/market analyses, and information submitted bycompanies and institutions. This Report is intended solely for internal use by the purchaser (“Purchaser”) for specificinformational, research, or other business purposes. The Purchaser shall not reproduce, distribute, or provide to anythird-party this Report (in whole or in part) without the prior written permission of SELECTBIO.

SELECTBIO MAKES NO REPRESENTATIONS OR WARRANTIES AND EXPRESSLY DISCLAIMS ANY FURTHERREPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, REGARDING THE REPORT, INCLUDING BUTNOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. SELECTBIO SHALL NOT BE LIABLE TO THE PURCHASER FOR ANY CLAIM REGARDING THE ACCURACY ORCOMPLETENESS OF THE INFORMATION CONTAINED IN THE REPORT.

Under no circumstances shall SELECTBIO be liable for incidental, special, indirect, direct or consequential damages or lossof profits, interruption of business, or related expenses that may arise from use of this Report, including but not limited tothose resulting from inaccuracy of the data therein. Due to the content nature of this Market Report, no returns or refundsof any kind are issued by SELECTBIO after shipment of this Report to the Purchaser.

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Description of Chapter Page Numbers

Chapter I. Epigenetics Research Market AnalysisPrimary Market Survey to Characterize Marketplace from the Bottom-Up: Qualitative and Quantitative Market DataCurrent Research ParadigmsQuantitative Segmentation of Epigenetics ResearchEpigenetics Research in Cancer: Quantitative SegmentationCommercial Kit and Reagent Offerings in the Epigenetics Research Marketplace

6-27

Chapter II. Epigenetic Signatures as Potential BiomarkersBig Data Analysis of Epigenetics Publication Landscape

Hotspot Analysis of Publications Describes Segments of Opportunity vis-à-vis Research Product Development as well as Potential Assay Development for Disease Associations, Harvesting of Prognostic as well as Diagnostic Biomarkers

Epigenetic Signatures Described in Various Disease ClassesDNA Methylation as Disease BiomarkersHistone Modifications as Disease BiomarkersPotential Epigenetic Biomarkers in Various Cancer Classes

Gastric CancerPancreatic CancerProstate Cancer

28-57

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Description of Chapter Page Numbers

Chapter III. microRNA Research Market AnalysismicroRNA Signatures as Potential Biomarkers

Primary Market Survey to Characterize Marketplace from the Bottom-Up: Qualitative and Quantitative Market DatamicroRNA Research vis-à-vis Content ClassesmicroRNA Research in CancermicroRNA Research Workflow: Quantitative BreakoutmicroRNA Expression Profiling Quantitative Market BreakoutmicroRNA Vendor Market Penetration Space MapNGS to Study microRNAs—Market Breakout by PlatformUnmet Needs in the microRNA Research SpacemicroRNA Signatures Described in Various Disease Classes: Potential for Biomarker Development

Tumor Suppressor microRNA MethylationmicroRNAs in BiofluidsCirculating microRNAs as Potential Tumor Markers

58-91

Chapter IV. Characterization of Molecular Biomarker ClassesTraditional Cancer BiomarkersOncogenesTumor Suppressor Genes

92-113

Appendix I. Epigenetic and MicroRNA Biomarker Summary Attached Excel File

Appendix II. List of Companion Diagnostics (CDx) on the Market, In Progress CDx in Development/Partnerships, Potential Market Size for Epigenetic and microRNA-based CDx

Attached PDF File

Appendix III. Research Methodology 117-118

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This market report presents the current worldwide market landscape of epigenetic and microRNAbiomarkers

Presented herein are the following:

Epigenetics Section Focuses on Characterized Biomarkers to Date, Publication Activity, DNAMethylation Biomarkers, Histone Modifications Characterized to Date, Kits and ReagentsCommercially-Available to Study Epigenetics. Primary Market Survey Data from Industry Participants[Researchers] Focusing on Epigenetics Provides Bottom-Up Insight into Epigenetics-Focused Researchand Practices

MicroRNA Section Focuses on the Documented Associations of Specific microRNA Signatures withDiseases, especially Cancer. Presented herein are Publication Analysis of microRNA-focused Papersfrom the Scientific Literature, MicroRNAs as Circulating Biomarkers, the MicroRNA ResearchMarketplace Characterized via Primary Market Surveys where Data from Industry Participants[Researchers] Focusing on microRNAs Provides Bottom-Up Insight into Current MicroRNA Researchand Practices

Epigenetic and microRNA Potential Biomarkers

List and Description of Cancer Biomarkers as well as Companion Diagnostics (CDx) CurrentlyMarketed as well as those In Development

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SELECTBIO sought to characterize the research marketplace for epigenetics andrecognized that the field is amorphous and fragmented vis-à-vis end-user types andapplication areasFor this reason, characterization of this expanding and emerging marketplace must beperformed from the “bottom-up”—ie., by examining end-user utilization patterns bothqualitatively and quantitativelySELECTBIO performed online market surveys wherein well-curated populations ofresearchers focused on epigenetics research worldwide were e-mailed links to sets ofquestions querying them on their research practices [no confidential information wasrequested]. The data from each of the responding researchers was captured in arelational database and queried in aggregate onlyPresented in this section of the report are the analyses and conclusions on theepigenetics research marketplace based on these dataSELECTBIO frames these data and conclusions in light of the various other marketmetrics collected as part of our industry tracking and presented in this market report

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UK, Western Europe33%

USA41%

Japan3%

Asia-Pacific (China, Taiwan, Singapore, Korea, Australia,

India)13%

Rest-of-the-World (ROW)10%

The Market Survey Respondent Pool Reflects All Geographic Regions

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Academic Research Institution, University

Affiliation, NIH58%

Pharmaceutical Company3%

Biotechnology Company23%

Research Tools/Technologies Vendor

16%

As Predicted, the Market Survey Respondent Pool is Dominated by Researchers from the Academic Community: The Majority of Epigenetics Research Occurs in the Academic

Environment Currently

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Vendor Product Application Additional Information Weblink

Enrichment - Methylated DNA Immunoprecipitation (meDIP)

Use selective enrichment of DNA fragments containing 5-hydroxymethylcytosine (5-hmC) in a high throughput format using DNA isolated from any species.

http://www.epigentek.com/catalog/epiquik-hydroxymethylated-dna-immunoprecipitation-hmedip-kit-p-2854.html


Uses an antibody specific to methyl cytosine is used to immunoprecipitate methylated genomic DNA. http://www.epigentek.com/catalog/epiquik-methylated-dna-immunoprecipitation-kit-p-94.html


In the assay, an antibody specific to methyl cytosine is used to immunoprecipitate methylated genomic DNA.

http://www.epigentek.com/catalog/epiquik-tissue-methylated-dna-immunoprecipitation-kit-p-96.html

DNA AmplificationSuitable for quantitative methylation-specific PCR in a fast format using very minute amounts of DNA. http://www.epigentek.com/catalog/methylamp-ms-qpcr-fast-kit-p-1598.html

DNA Amplification Quantitative analysis of DNA samples http://www.epigentek.com/catalog/epiquik-quantitative-pcr-fast-kit-p-2990.html

Histone Methyltransferase Assays

Measure the activity or inhibition of individual histone methyltransferase that specifically target histone H3 at lysine 4 (H3-K4).

http://www.epigentek.com/catalog/epiquik-histone-methyltransferase-activityinhibition-assay-kit-h3k4-p-100.html








Set of optimized buffers and reagents for measuring the activity or inhibition of total type II PRMT using nuclear extracts or purified enzymes such as PRMT5 and PRMT7 from a broad range of species such as mammals, plants, fungi, and bacteria, in a variety of forms including cultured cells and fresh tissues.

http://www.epigentek.com/catalog/epigenase-prmt-methyltransferase-type-ii-specific-activityinhibition-assay-kit-colorimetric-p-2903.html

Histone Demethylase AssaysMeasure activity/inhibition of H3-K4 specific histone demethylases using cell/ tissue extracts.

http://www.epigentek.com/catalog/epiquik-histone-demethylase-h3k4-specific-activityinhibition-assay-kit-p-1001.html

Histone Demethylase Assays

Antibody-based, immunospecific method directly detects LSD1-converted demethylated products, rather than by-products, in a 96 stripwell microplate format.

http://www.epigentek.com/catalog/epigenase-lsd1-demethylase-activityinhibition-assay-kit-colorimetric-p-2833.html


The antibody-based, immunospecific method directly detects JMJD2-converted demethylated products, rather than by-products, in a 96 stripwell microplate format.

http://www.epigentek.com/catalog/epigenase-jmjd2-demethylase-activityinhibition-assay-kit-colorimetric-p-2830.html


The antibody-based, immunospecific method directly detects JARID-converted demethylated products, rather than by-products, in a 96 stripwell microplate format.

http://www.epigentek.com/catalog/epigenase-jarid-demethylase-activityinhibition-assay-kit-colorimetric-p-2839.html


Designed for measuring activity/inhibition of JMJD3 and UTX using nuclear extracts or purified enzymes from a broad range of species

http://www.epigentek.com/catalog/epigenase-jmjd3utx-demethylase-activityinhibition-assay-kit-colorimetric-p-2912.html

ChIP DNA Preparation http://www.epigentek.com/catalog/epiquik-chromatin-immunoprecipitation-chip-kit-p-59.htmlChIP DNA Preparation http://www.epigentek.com/catalog/epiquik-tissue-chromatin-immunoprecipitation-chip-kit-p-63.htmlChIP DNA Preparation http://www.epigentek.com/catalog/chromaflash-one-step-chip-kit-p-2808.htmlChIP DNA Preparation http://www.epigentek.com/catalog/chromaflash-one-step-magnetic-chip-kit-p-2847.html

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In this section of the report, we present an en bloc analysis of all the publicationsfrom PubMed focusing on EpigeneticsA total of 74,614 publications were analyzed and the data are presented on the nextpages in this sectionFormat of the data is as follows:

Each Row Reflects one Molecular Element [which is found in the title or abstractof the Epigenetics PublicationEach Column is One Keyword that is Interrogated in the Context of the EpigeneticsPublication which has the “Molecular Element” in its title or abstractThe More Publications that “Coalesce” in a Particular Spot on the Matrix, the Darkerthe Particular Spot within the Matrix

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In this section of the chapter, SELECTBIO presents the various epigenetic signaturesdescribed-to-date in different disease classes, primarily oncologyThe data and associated analysis is focused on describing the potential utility ofepigenetic signatures as putative biomarkers for potential LDT/IVD development, asdisease biomarkers [especially in the oncology space], as well as for personalizedmedicine

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There are 28 million CpG located in the human genome in areas called “CpG islands”These CpG islands are normally in the un-methylated state [ie., in an “open chromatin”configuration allowing transcriptional activity to proceed through these regions]In tumors, however, CpG islands gain local methylation, however, there is a global lossof methylation genome-wideEpigenetic instability at the nuclear periphery appears to be pervasive in cancerFurthermore, there is “focal hypermethylation” which often occurs at stem cellpolycomb target loci—stem cell polycomb targets are prone to abnormal DNAmethylation in cancer

Epigenetic Silencing of Tumor Suppressors and Other Loci Appears to beCritical in Cancer and therefore the Identification and Deployment of EpigeneticLesions in Cancer May Have Potential as Biomarkers for Prognostics,Diagnostics, and Personalized Medicine

In this Section, SELECTBIO describes the documented epigenetic lesions and framesthem into the biomarker opportunity

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SELECTBIO sought to characterize the marketplace for microRNA researchThe marketplace is fragmented and evolving as the move takes place towardstranslational applications of microRNAsFor this reason, characterization of this evolving marketplace must be performed fromthe “bottom-up”—ie., by examining end-user utilization patterns both qualitatively andquantitativelySELECTBIO performed online market surveys wherein well-curated populations ofresearchers focused on microRNA research worldwide were e-mailed links to sets ofquestions querying them on their research practices [no confidential information wasrequested]. The data from each of the responding researchers was captured in arelational database and queried in aggregate onlyPresented in this section of the report are the analyses and conclusions on themicroRNA research marketplace based on these dataSELECTBIO frames these data and conclusions in light of the various other marketmetrics collected as part of our industry tracking and presented in this market report

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In this section of the chapter, SELECTBIO presents the various microRNA expressionpatterns/signatures described-to-date in various disease classesThe data and associated analysis is focused on describing the potential utility ofmicroRNA signatures as putative biomarkers for potential LDT/IVD development, asdisease biomarkers [especially in the oncology space], as well as for personalizedmedicine

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See attached Excel File as Part of this Market Report

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See attached PDF File as Part of this Market Report

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Research Methodology

Publicly-Available

◊ Conferences Worldwide

◊ Webinars

◊ Industry Publications

◊ Scientific Literature

◊ SEC Filings

◊ Press Releases

◊ Web sites

Proprietary Select Biosciences

◊ Interviews with Experts

◊ Interviews with Company Representatives

◊ Company Presentations

◊ Algorithm-based parsing and analysis of the scientific literature for research/industry trends

Confidential

◊ Deals

◊ Business Plans

◊ Unpublished data

◊ Personal Communications

Sources for Data in the SELECTBIO Epigenetic and MicroRNA Biomarkers 2013 Market Report

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