Epigenomics: Emerging Opportunities in Biomarkers, Diagnostics and Therapeutics

Published by: BCC Research

Published: Mar. 1, 2007 - 290 Pages

Table of Contents

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

CONTRIBUTION OF THE STUDY AND FOR WHOM

SCOPE AND FORMAT

METHODOLOGY

ANALYST CREDENTIALS

RELATED BCC PUBLICATIONS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

SUMMARY TABLE GLOBAL VALUE OF EPIGENOMICS PRODUCTS

BY MARKET SEGMENT, THROUGH 2012 ($ MILLIONS)

SUMMARY FIGURE GLOBAL VALUE OF EPIGENOMICS PRODUCTS

BY MARKET SEGMENT, 2005-2012 ($ MILLIONS)

OVERVIEW

INTRODUCTION

THE NEW PARADIGM OF EPIGENOMICS

FIGURE 1 EPIGENOMICS: A NEW PARADIGM

HOW EPIGENOMICS FITS WITHIN THE GENOMICS FIELD

TABLE 1 GENOMICS PLATFORMS

ELEMENTS OF THE EPIGENOME COVERED IN THIS REPORT

TABLE 2 ELEMENTS OF THE EPIGENOME COVERED IN THIS REPORT

MARKET POTENTIAL OF EPIGENOMICS

TABLE 3 GLOBAL VALUE OF EPIGENOMICS PRODUCTS BY

MARKET SEGMENT, THROUGH 2012 ($ MILLIONS)

KEY EPIGENOMICS PRODUCTS

RESEARCH TOOLS AND REAGENTS

DIAGNOSTICS

DRUGS

DRIVING FORCES FOR GROWTH IN EPIGENOMICS

IMPORTANCE OF EPIGENETIC TECHNOLOGY

FIGURE 2 EPIGENETIC PROCESSES CAN GENERATE ABNORMAL

CELLS DURING CELL DEVELOPMENT

LIFE CYCLE STATUS OF EPIGENOMICS TECHNOLOGIES

HISTORICAL BACKGROUND

TABLE 4 HISTORICAL OVERVIEW OF EPIGENETICS

THE EPIGENOMICS INDUSTRY

TABLE 5 EPIGENOMICS INDUSTRY

THE EPIGENOMICS INDUSTRY (CONTINUED)

EPIGENETIC TECHNOLOGY

INTRODUCTION

TWO MAIN EPIGENOMIC ANALYSIS TECHNOLOGIES

TABLE 6 TWO TYPES OF EPIGENOMIC ANALYSIS TECHNOLOGIES

STATUS OF DNA AND HISTONE ANALYSIS

TECHNOLOGIES

TABLE 7 STATUS OF DNA AND HISTONE ANALYSIS

TECHNOLOGIES

DNA AND HISTONE ANALYSIS WORKFLOW

FIGURE 3 UPSTREAM AND DOWNSTREAM STEPS IN EPIGENETIC

ANALYSIS

DNA METHYLATION

METHYLATED CYTOSINE—A FIFTH BASE

FIGURE 4 EPIGENETIC CHANGES TO DNA AFFECT GENE

EXPRESSION

BIOLOGICAL ROLE OF DNA METHYLATION

TABLE 8 BIOLOGICAL ROLES OF DNA METHYLATION

TABLE 8 (CONTINUED)

DNA METHYLTRANSFERASE ENZYMES

CPG ISLANDS

TABLE 9 CPG ISLANDS: SUBJECT TO DNA METHYLATION

HISTONE METHYLATION AND ACETYLATION

HISTONES

FIGURE 5 HISTONE TAIL REGIONS MODIFIED BY HAT AND HDAC

HISTONE ACETYLATION AND METHYLATION ENZYMES

FIGURE 6 HISTONE ACETYLATION AND METHYLATION ENZYMES

Histone Acetyl Transferases (HAT Enzymes)

Histone Deacetylases (HDAC Enzymes)

TABLE 10 HDAC ENZYMES CLASSES

Histone Methyltransferases and Demethylases

INAPPROPRIATE METHYLATION AND ACETYLATION

TABLE 11 MECHANISMS FOR INAPPROPRIATE METHYLATION AND ACETYLATION

EPIGENOMIC ANALYSIS TECHNOLOGIES

ROLE OF EPIGENOMIC RESEARCH TOOLS

DNA METHYLATION RESEARCH TOOLS

TABLE 12 DNA METHYLATION ANALYSIS ASSAYS

DNA METHYLATION ANALYSIS WORKFLOW

FIGURE 7 METHYLATED DNA ANALYSIS WORKFLOW

ANALYSIS TYPES BY WORKFLOW

TABLE 13 EXAMPLES OF DNA METHYLATION ASSAYS

DNA METHYLATION ANALYSIS: UPSTREAM TECHNOLOGIES

TABLE 14 COMPARISON OF UPSTREAM EPIGENOMIC

RECOGNITION TECHNOLOGIES

RESTRICTION ENZYME-BASED METHODS

FIGURE 8 ANALYSIS OF DNA METHYLATION BY RESTRICTION

ENZYMES

BISULFITE-BASED METHODS

Bisulfite-Based Methods (Continued)

FIGURE 9 BISULFITE CONVERSION OF DNA

Analysis of Low Complexity DNA—A Unique Challenge

for Bisulfite Methods

ANTIBODY-BASED METHODS

CHALLENGE OF HIGH BACKGROUND METHYLATED DNA

DNA METHYLATION ANALYSIS: DOWNSTREAM

TECHNOLOGIES

GENOME WIDE DNA METHYLATION ANALYSIS

TABLE 15 DNA METHYLATION ANALYSIS TECHNIQUES BY

GENOME RESOLUTION

GENOME WIDE DNA … (CONTINUED)

HIGH THROUGHPUT PLATFORMS

HISTONE EPIGENOMIC ANALYSIS TECHNOLOGIES

CHROMATIN IMMUNOPRECIPITATION

CHIP-ON-CHIP

FIGURE 10 CHIP-ON-CHIP PROCEDURE

TABLE 16 CHIP ASSAYS

TABLE 17 TECHNOLOGIES FOR MAPPING GENOMIC LOCATION OF

CHROMATIN PROTEINS AND ENZYMES

MICROARRAYS

FEATURE DENSITY

FIGURE 11 MICROARRAY FEATURE DENSITY

RESOLUTION

FIGURE 12 MICROARRAY RESOLUTION

GENOME CONTENT

TABLE 18 MICROARRAY GENOME CONTENT

TABLE 19 PLATFORMS FOR HIGH DENSITY OLIGONUCLEOTIDE

EPIGENETICS ARRAYS

SERIAL ANALYSIS OF GENE EXPRESSION

ANTIBODIES

ALTERNATIVES TO ANTIBODIES IN UPSTREAM STEP

DNA ADENINE METHYLTRANSFERASE IDENTIFICATION

(DAM ID)

DNA Adenine Methyltransferase … (Continued)

DNA METHYLATION BIOMARKERS

FROM ANALYSIS TO BIOMARKERS

OPPORTUNITIES FOR BIOTECHNOLOGY COMPANIES IN

DIAGNOSTICS

WHAT IS A BIOMARKER?

DNA METHYLATION AS A CANCER BIOMARKER

DNA METHYLATION IN CANCER ETIOLOGY

TABLE 20 BIOLOGICAL RATIONALE FOR DNA METHYLATION

CANCER BIOMARKERS

TABLE 21 CANCER-RELATED CELL PATHWAYS AND GENES

AFFECTED BY HYPER-METHYLATION

Cell Cycle Control

Cell Invasion and Adhesion

DNA Damage Repair

Growth Factor Response

Regulation of Apoptosis

Hormonal Response

Cytokine Signaling

TABLE 22 CANCER-RELATED EPIGENETIC CHANGES

MOLECULAR BIOMARKER TECHNOLOGY COMPARISON

TABLE 23 COMPARISON OF KEY CANCER BIOMARKER

TECHNOLOGY PLATFORMS

Occurrence within the Genome

Inheritance in Progenitor Cells

DNA Base Mutation

Binary Signal

Presence of Background Signal

Stable Change in Biomarker Status

Stability of Sample Material

Detection of First Hit

Occurrence in Early or Pre-Cancers

Tissue Sample Range

Test Complexity

ASSESSMENT OF DNA METHYLATION BIOMARKER

COMPETITIVE POSITION

EPIGENETIC BIOMARKER CANCER GENES

TABLE 24 PUBLISHED DNA METHYLATION BIOMARKER GENES

FOR CANCERS

EPIGENETIC BIOMARKERS FOR NON-CANCER DISEASES

TABLE 25 DIFFERENTIALLY METHYLATED GENES IN

NEUROLOGIC AND CARDIOVASCULAR DISORDERS

BIOMARKER DISCOVERY PROCESS

METHYLATION BIOMARKER DISCOVERY TECHNOLOGIES

TABLE 26 DNA METHYLATION ANALYSIS TECHNOLOGIES

IN BIOMARKER DISCOVERY

TABLE 26 (CONTINUED)

GENOME-WIDE SCANNING TO HUNT FOR BIOMARKERS

LARGE SCALE REGIONAL EPIGENOMICS PROJECTS

TABLE 27 REGIONAL EPIGENOMICS INITIATIVES

TABLE 27 (CONTINUED)

EUROPE

UNITED STATES

ASIA

HUMAN EPIGENOME PROJECT WILL AID IN THE DISCOVERY

OF NEW METHYLATION MARKERS

TABLE 28 METHYL VARIABLE POSITIONS - MVPS

TABLE 29 HUMAN EPIGENOME PROJECT: METHYL VARIABLE

POSITION ANALYSIS OBJECTIVES

CASE STUDY: FROM RESEARCH TOOLS TO BIOMARKERS

CASE STUDY (CONTINUED)

DEVELOPMENT STAGES FOR AN IN VITRO DIAGNOSTIC

PHASE 1: BIOMARKER DISCOVERY

PHASE 2: BIOMARKER VALIDATION

PHASE 3: FORMAL KIT DEVELOPMENT

PHASE 4: CLINICAL VALIDATION

TYPES OF CANCER METHYLATION MARKERS

FUTURE STATUS OF DNA METHYLATION BIOMARKERS

TABLE 30 TECHNICAL HURDLES FOR DEVELOPMENT OF

METHYLATION EPIGENETIC CANCER BIOMARKERS

EPIGENETIC CANCER THERAPIES

INTRODUCTION

EPIGENETICS IN TUMORIGENESIS

EPIGENETIC DRUG TARGETS

TABLE 31 EPIGENETIC GENES ALTERED IN HUMAN CANCERS

TABLE 31 (CONTINUED)

HISTONE METHYLATION AND ACETYLATION ENZYME DRUG

TARGETS

FIGURE 13 HISTONE DEACETYLASE REACTION

TABLE 32 STATUS OF EPIGENETIC ENZYMES THAT TARGET

HISTONES

HISTONE DEACETYLACE INHIBITORS

HDAC ENZYMES AS DRUG TARGETS

HDAC INHIBITOR DRUG CLASSES

TABLE 33 HDAC INHIBITOR CLASSES AND RELATIVE POTENCY

HYDROXAMATES

FIGURE 14 TRICHOSTATIN A, A HYDROXAMATE CLASS HDAC

INHIBITOR

ALIPHATIC ACIDS

FIGURE 15 PHENYLBUTYRIC ACID, AN ALIPHATIC ACID CLASS

HDAC INHIBITOR

CYCLIC TETRAPEPTIDES

FIGURE 16 APICIDIN A, A CYCLIC TETRAPEPTIDE CLASS HDAC

INHIBITOR

BENZAMIDES

TABLE 34 MS-275, A BENZAMIDE CLASS HDAC INHIBITOR

KEY HDAC INHIBITOR TECHNOLOGY TRENDS

TABLE 35 KEY HDAC INHIBITOR DRUG TRENDS

ENZYME SELECTIVITY

Enzyme Selectivity (Continued)

TABLE 36 HDAC INHIBITOR CLASS I AND II SELECTIVITY (IC50 RATIO)

POTENCY

IMPROVEMENTS IN DRUG-LIKE PROPERTIES

SELECTIVE HDAC COMPOUNDS CAN PROVIDE COMPETITIVE

ADVANTAGE

FIGURE 17 DISEASE HDAC ISOFORM PROFILE

CHEMICAL DESIGN IS THE KEY TO SELECTIVITY

FIGURE 18 STRUCTURAL COMPONENTS MOTIFS OF HDAC

INHIBITORS

HDAC INHIBITORS IN COMBINATION THERAPIES

HDAC INHIBITORS IN … (CONTINUED)

TABLE 37 HDAC INHIBITOR DRUG COMPANIONS

HDAC INHIBITORS IN … (CONTINUED)

HDAC INHIBITORS AS THERAPIES FOR NON-CANCER

DISEASES

CARDIAC DISEASE

DERMATOLOGICAL DISORDERS

PARASITIC DISEASES

NEURODEGENERATIVE DISEASES

DIABETES

INFLAMMATORY DISEASES

DNA METHYLTRANSFERASE INHIBITORS (DNMT)

FIGURE 19 LEAD DNMT INHIBITOR COMPOUNDS

NUCLEOSIDE ANALOGUES

FIGURE 20 DNMT INHIBITORS AND MODE OF ACTION

NON-NUCLEOSIDE ANALOGUES

ANTISENSE OLIGONUCLEOTIDES

FUTURE CHALLENGES FOR EPIGENETIC DRUG

DEVELOPMENT

TABLE 38 FUTURE CHALLENGES FOR EPIGENETIC DRUG

DEVELOPMENT

EPIGENETICS ASSISTED REPRODUCTIVE TECHNOLOGIES

SOMATIC CELL NUCLEAR TRANSFER

FIGURE 21 SOMATIC CELL NUCLEAR TRANSFER

TABLE 39 TECHNOLOGY OPPORTUNITIES IN SOMATIC CELL

NUCLEAR TRANSFER

TABLE 40 EPIGENETIC ALTERATIONS IN ASSISTED

REPRODUCTIVE DISORDERS

APPLICATIONS OF EPIGENOMICS IN CLONING

REPROGRAMMING FACTORS

FIGURE 22 EPIGENETIC PROGRAMMING OF STEM CELLS

CELLULAR IDENTIFICATION AND QUALITY CONTROL

ASSAYS

Cellular Identification … (Continued)

MARKET GROWTH DRIVING FORCES

INTRODUCTION

TABLE 41 GROWTH IN SCIENTIFIC PUBLICATIONS RELATED TO

EPIGENETICS

KEY GROWTH DRIVERS

TABLE 42 PRIMARY FORCES DRIVING EPIGENOMICS PRODUCTS

GROWTH

DEVELOPMENT OF NOVEL EPIGENOMICS RESEARCH

TOOLS

CREATION OF EPIGENETIC MAPS

SCOPE OF EPIGENETIC ANALYSIS

NEED FOR EARLY CANCER DETECTION

NEED FOR BETTER CANCER THERAPIES

GROWTH IN LIFE SCIENCE RESEARCH BUDGETS

PERSONALIZED MEDICINE TRENDS

RESEARCH IN EPIGENETIC PROCESSES

EPIGENOMIC RESEARCH TOOLS MARKETS

PRODUCTS WITHIN RESEARCH TOOLS

EPIGENOMIC KITS

REAGENTS

MICROARRAYS

GLOBAL SALES BY TECHNOLOGY

TABLE 43 GLOBAL MARKET FORECAST FOR EPIGENOMICS

RESEARCH TOOL KITS BY TYPE THROUGH 2012 ($ MILLION)

GLOBAL SALES BY PRODUCT

TABLE 44 GLOBAL MARKET FORECAST FOR EPIGENOMIC

ANALYSIS RESEARCH TOOLS BY TECHNOLOGY THROUGH 2012

($ MILLIONS)

EPIGENOMIC KIT SALES BY TECHNOLOGY

TABLE 45 GLOBAL MARKET FORECAST FOR EPIGENETIC

ANALYSIS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

DNA METHYLATION ANALYSIS KIT MARKET

DNA METHYLATION … (CONTINUED)

TABLE 46 GLOBAL MARKET FORECAST FOR DNA METHYLATION

RESEARCH TOOL KITS BY ANALYSIS OBJECTIVE THROUGH

2012 ($ MILLIONS)

TABLE 47 GLOBAL MARKET FORECAST FOR DNA METHYLATION

RESEARCH TOOLS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 48 GLOBAL MARKET FORECAST FOR DNA METHYLATION

SINGLE LOCI RESEARCH TOOLS KITS BY TECHNOLOGY

THROUGH 2012 ($ MILLIONS)

TABLE 49 GLOBAL MARKET FORECAST FOR DNA METHYLATION

GENOME-WIDE RESEARCH TOOLS KITS BY TECHNOLOGY

THROUGH 2012 ($ MILLIONS)

HISTONE ANALYSIS KIT MARKET

TABLE 50 GLOBAL MARKET FORECAST FOR VALUE OF HISTONE

ANALYSIS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

MICROARRAY MARKET

MICROARRAYS AS DOWNSTREAM ANALYSIS TOOL

Microarray Differentiation

FIGURE 23 MICROARRAYS ENHANCE MULTIPLEX CAPABILITIES OF EPIGENETICS ASSAYS

TABLE 51 MICROARRAY PROBES

Microarray … (Continued)

MICROARRAY ANALYSIS PLATFORMS IN THE CLINIC

TABLE 52 CLINICAL STATUS OF MICROARRAY PLATFORMS

Microarray Analysis … (Continued)

FUTURE MARKET POSITION OF MICROARRAYS

EPIGENOMIC MICROARRAY MARKET

TABLE 53 GLOBAL VALUE OF EPIGENOMIC MICROARRAYS BY

MARKET THROUGH 2012 ($ MILLIONS)

TABLE 54 GLOBAL VALUE OF EPIGENOMIC RESEARCH TOOLS

MICROARRAYS BY ANALYSIS THROUGH 2012 ($ MILLIONS)

TABLE 55 GLOBAL VALUE OF DIAGNOSTIC MICROARRAYS BY

MARKET THROUGH 2012 ($ MILLIONS)

REAGENTS MARKET

TABLE 56 GLOBAL VALUE OF EPIGENOMIC REAGENTS BY

MARKET THROUGH 2012 ($ MILLIONS)

TABLE 57 GLOBAL VALUE OF RESEARCH TOOLS EPIGENOMIC

REAGENTS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

REAGENTS MARKET (CONTINUED)

EPIGENETIC BIOMARKER AND DIAGNOSTICS MARKETS

OVERVIEW OF CANCER DIAGNOSTICS MARKET

TABLE 58 VALUE OF GLOBAL MOLECULAR DIAGNOSTICS

MARKETS BY SEGMENT THROUGH 2012 ($ MILLIONS)

CANCER MOLECULAR DIAGNOSTICS GROWTH DRIVERS

TABLE 59 TARGETED THERAPY CANCER DRUG COMPOUNDS IN

DEVELOPMENT

METHYLATION BIOMARKERS CLINICAL DEVELOPMENT

STATUS

TABLE 60 DEVELOPMENT STATUS OF SELECTED METHYLATION

BIOMARKERS BY CANCER TYPE

CANCER DIAGNOSTIC MARKET SEGMENTS

ATTRACTIVE CANCER INDICATIONS FOR SCREENING

MARKETS

FIGURE 24 CANCER SCREENING OPPORTUNITY MATRIX FOR

EPIGENETIC TESTS IN DEVELOPMENT

FIGURE 25 NEW EPIGENETIC SCREENING PARADIGM

SENSITIVITY AND SPECIFICITY

FIGURE 26 SENSITIVITY AND SPECIFICITY

STATUS OF DIAGNOSTICS TESTS FOR SELECTED CANCER

INDICATIONS

COLORECTAL CANCER

Colorectal Cancer Screening Tests

TABLE 61 CURRENT SCREENING AND DIAGNOSTIC TESTS FOR

COLORECTAL CANCER

DNA-based Colorectal Screening Tests

Epigenetics-based Colorectal Screening Tests

TABLE 62 ACCURACY OF EXISTING COLORECTAL SCREENING

TESTS

Colorectal Cancer Non-screening Tests

BLADDER CANCER

BREAST CANCER

Screening for Breast Cancer

Relapse Risk Prediction

Therapy Prediction

PROSTATE CANCER

LUNG CANCER

OVARIAN CANCER

TABLE 63 OVARIAN CANCER POTENTIAL SCREENING TESTS

CERVICAL CANCER

PANCREATIC CANCER

GASTRIC CANCER

PEDIATRIC CANCERS

PERSONALIZED TREATMENT EPIGENETIC-BASED TESTS

KEY CLINICAL REQUIREMENTS FOR AN EPIGENETIC-BASED

DIAGNOSTICS TEST

TABLE 64 REQUIREMENTS FOR AN EPIGENETICS BISULFITE

DIAGNOSTIC KIT

AVAILABLE MARKET FOR CANCER MOLECULAR DIAGNOSTIC

TESTS

TABLE 65 GLOBAL 2007 POTENTIAL AVAILABLE MARKET FOR

CANCER MOLECULAR DIAGNOSTIC TEST KITS BY MARKET

SEGMENT ($ MILLIONS)

AVAILABLE MARKET FOR … (CONTINUED)

TABLE 66 GLOBAL 2007 POTENTIAL AVAILABLE MARKET FOR

CANCER MOLECULAR DIAGNOSTICS TEST KITS BY

INDICATION ($ MILLIONS)

TABLE 67 CANCER INCIDENCE AND ESTIMATED TREATMENT DECISIONS, 2006

TABLE 67 (CONTINUED)

TABLE 68 BREAST CANCER DIAGNOSTICS PRODUCT SEGMENTS

AGING POPULATIONS CONTRIBUTE TO DIAGNOSTICS MARKET

POTENTIAL

TABLE 69 PROJECTED INCREASE IN AGE 65+ POPULATION BY REGION

DNA METHYLATION DIAGNOSTICS PIPELINE

TABLE 70 PIPELINE FOR DNA METHYLATION DIAGNOSTICS

TESTS

TABLE 70 (CONTINUED)

SCREENING TESTS

Prostate Cancer Screening Tests

Colorectal Cancer Screening Tests

Breast Cancer Screening Tests

Lung Cancer Screening Tests

Bladder Cancer Screening Tests

MONITORING, CLASSIFICATION, AND

PHARMACODIAGNOSTIC TESTS

Breast Cancer Classification Tests

Prostate Cancer Diagnostics Tests

Bladder Cancer Monitoring Tests

Other Non-Screening Tests

EPIGENETICS BASED DIAGNOSTICS KITS MARKET SIZE

TABLE 71 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY

MARKET THROUGH 2012 ($ MILLIONS)

TABLE 72 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY

INDICATION THROUGH 2012 ($ MILLIONS)

TABLE 73 2012 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS

BY INDICATION AND SEGMENT ($ MILLIONS)

EPIGENETIC DIAGNOSTICS KITS MARKET BY TECHNOLOGY

TABLE 74 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY

TECHNOLOGY THROUGH 2012 ($ MILLIONS)

EPIGENETIC DIAGNOSTICS … (CONTINUED)

MARKETS FOR EPIGENETIC DRUGS

OVERVIEW

THE CANCER DRUG MARKET

TABLE 75 GLOBAL MARKET FORECAST FOR SELECTED CANCER

DRUGS BY, THROUGH 2012 ($ MILLIONS)

TARGETED THERAPEUTICS

CANCER DRUG MARKET GROWTH DRIVING FORCES

CANCER DRUG … (CONTINUED)

EPIGENETIC-BASED DRUGS AS CANCER THERAPIES

PROOF OF PRINCIPLE OF EPIGENETIC DRUGS ESTABLISHED

EPIGENETIC THERAPIES BEYOND CANCER

EPIGENETIC DRUG MARKET FORECAST

TABLE 76 GLOBAL MARKET FORECAST FOR EPIGENETIC DRUGS

BY INDICATION, THROUGH 2012 ($ MILLIONS)

TABLE 77 GLOBAL MARKET FORECAST FOR EPIGENETIC DRUGS

BY CLASS, THROUGH 2012 ($ MILLIONS)

INITIAL FOCUS ON HEMATOLOGICAL CANCERS

TABLE 78 OVERVIEW OF MAJOR HEMATOLOGICAL

MALIGNANCIES

MARKET SIZE FOR HEMATOLOGICAL CANCER DRUGS

TABLE 79 GLOBAL MARKET FORECAST OF HEMATOLOGICAL

CANCER DRUGS BY INDICATION THROUGH 2012 ($ MILLIONS)

TABLE 80 COMPARISON OF THREE NEW MDS DRUGS

MARKET SIZE … (CONTINUED)

HDAC INHIBITORS MARKETS

STRATEGIC OPPORTUNITIES IN HDAC INHIBITORS

TABLE 81 SUMMARY OF HDAC INHIBITOR STRATEGIC

OPPORTUNITIES FOR CANCER TREATMENT

HDAC INHIBITORS IN DEVELOPMENT AND CLINICAL

TRIALS

TABLE 82 HDAC INHIBITOR DRUG CANDIDATES IN CLINICAL

TRIALS

Zolinza

PXD-101

TABLE 83 PXD-101 CLINICAL TRIALS STATUS

NVP-LAQ824

Bacacea, Avugane, Savacol

Romidepsin

TABLE 84 ROMIDEPSIN CLINICAL TRIALS STATUS

MS-275

CI 994

MGCD0103

TABLE 85 MBCD0103 INHIBITS SELECTED HDAC ENZYMES

PCI-24781

SRT-501

HDAC INHIBITOR DRUG MARKET SIZE BY INDICATION

TABLE 86 GLOBAL MARKET FORECAST FOR HDAC INHIBITOR

DRUGS BY INDICATION, THROUGH 2012 ($ MILLIONS)

HDAC INHIBITOR MARKET SIZE BY TECHNOLOGY

TABLE 87 GLOBAL VALUE OF HDAC INHIBITOR DRUGS BY

TECHNOLOGY THROUGH 2012 ($ MILLIONS)

DNMT INHIBITORS MARKET

DNMT INHIBITORS IN CLINICAL TRIALS

TABLE 88 DNMT INHIBITORS IN CLINICAL TRIALS AND UNDER

DEVELOPMENT

TABLE 88 (CONTINUED)

Nucleoside Analogues

5-azacytidine (Vidaza)

5-aza-2’-deoxycitidine (Decitabine, Dacogen)

Zebularine

DHAC (Dihydro-5-azacytidine)

Non-Nucleoside Analogues

MG98

Hydralazine

Preclinical Non-Nucleosides

FDA-APPROVED DNMT INHIBITORS

TABLE 89 FDA APPROVED DNMT INHIBITOR DRUGS

MARKET SIZE FOR DNMT INHIBITORS

TABLE 90 GLOBAL VALUE OF DNMT INHIBITOR DRUGS BY

INDICATION THROUGH 2012 ($ MILLIONS)

TABLE 91 GLOBAL VALUE OF DNMT INHIBITOR DRUGS BY

TECHNOLOGY THROUGH 2012 ($ MILLIONS)

ALTERNATIVE DEMETHYLATION THERAPEUTIC

APPROACHES

CLONING AND TISSUE ENGINEERING MARKETS

TABLE 92 GLOBAL VALUE OF CLONING AND TISSUE

ENGINEERING EPIGENETIC KITS THROUGH 2012 ($ MILLIONS)

COMPETITIVE DYNAMICS

RESEARCH TOOLS

TABLE 93 EPIGENOMIC RESEARCH TOOLS SUPPLIERS

DIAGNOSTICS

TABLE 94 STRATEGIC ALLIANCE STATUS FOR BIOTECHNOLOGY

EPIGENETICS DIAGNOSTICS FIRMS

TABLE 94 (CONTINUED)

TABLE 95 COMPETITIVE LANDSCAPE FOR MOLECULAR

DIAGNOSTICS TECHNOLOGIES

EPIGENETIC DRUGS

TABLE 96 COMPETITIVE LANDSCAPE FOR EPIGENETIC DRUG

COMPANIES

PATENTS

RESEARCH TOOLS

TABLE 97 PATENTS AND PATENT APPLICATION STATUS OF

EPIGENOMICS AG RESEARCH TOOLS

BIOMARKERS AND DIAGNOSTICS

TABLE 98 PATENT STATUS FOR BIOTECHNOLOGY DIAGNOSTICS

COMPANIES

PHARMACEUTICALS

TABLE 99 HDAC INHIBITOR PATENT CLAIMS: 2004-2006

TABLE 99 (CONTINUED)

COMPANY PROFILES

ABBOTT LABORATORIES

ABCAM PLC.

ACTIVE MOTIF

AFFYMETRIX

AGILENT TECHNOLOGIES, INC.

APPLIED BIOSYSTEMS

AVIVA SYSTEMS BIOLOGY

BAYER AG

BIOSERVE BIOTECHNOLOGIES, LTD.

BIOVISION

CELLARTIS AB

CELLCENTRIC LTD

CHIPSCREEN BIOSCIENCES LTD.

CHROMA THERAPEUTICS

CURAGEN

TABLE 100 CURAGEN STRATEGIC ALLIANCES

EPIGENOMICS AG

EPIGENOMICS AG (CONTINUED)

EPIGENTEK

EPIONTIS GMBH

ELIXIR PHARMACEUTICALS, INC.

ENTREMED, INC

ENVIVO PHARMACEUTICALS

ES CELL INTERNATIONAL PTE LTD

EXONHIT THERAPEUTICS SA

F. HOFFMANN-LA ROCHE, LTD

GENPATHWAY, INC.

GILEAD SCIENCES (MYOGEN)

GLOUCESTER PHARMACEUTICALS

HUYA BIOSCIENCE INTERNATIONAL

ILLUMINA, INC.

KALYPSYS, INC

KARUS THERAPEUTIC LTD

LEO PHARMA

MERCK & CO. INC.

METHYLGENE

TABLE 101 METHYLGENE EPIGENETIC PRODUCT PIPELINE

MGI PHARMA, INC.

MGI PHARMA, INC. (CONTINUED)

MILLIPORE (CHEMICON/UPSTATE)

NIMBLEGEN SYSTEMS, INC.

NOVARTIS

ONCOMETHYLOME SCIENCES S.A.

Biomarker Identification and Development Partners

Kit Development, Regulatory Review, and Mass Market of

Kits

ORION GENOMICS

ORION GENOMICS (CONTINUED)

PANOMICS, INC.

PHARMACYCLICS

PHARMION CORPORATION

TABLE 102 PHARMION EPIGENETIC DRUG COMBINATION

THERAPIES IN CLINICAL TRIALS

TABLE 103 POTENTIAL PHARMION INTRA-PORTFOLIO DRUG

COMBINATIONS

QUIAGEN GMBH

RUBICON GENOMICS

S*BIO PTE LTD1

SCHERING AG

SCHERING PLOUGH CORPORATION

SEQUENOM

SEQWRIGHT

SIRTRIS PHARMACEUTICALS

TAIHO PHARMACEUTICALS

TAKEDA PHARMACEUTICAL COMPANY LIMITED

TOPOTARGET A/S

TABLE 104 TOPOTARGET’S HDAC INHIBITOR PATENT PORTFOLIO

TABLE104 (CONTINUED)

VERIDEX LLC

ZYMO RESEARCH

LIST OF TABLES

SUMMARY TABLE GLOBAL VALUE OF EPIGENOMICS PRODUCTS BY MARKET SEGMENT, THROUGH 2012 ($ MILLIONS)

TABLE 1 GENOMICS PLATFORMS

TABLE 2 ELEMENTS OF THE EPIGENOME COVERED IN THIS REPORT

TABLE 3 GLOBAL VALUE OF EPIGENOMICS PRODUCTS BY MARKET SEGMENT, THROUGH 2012 ($ MILLIONS)

TABLE 4 HISTORICAL OVERVIEW OF EPIGENETICS

TABLE 5 EPIGENOMICS INDUSTRY

TABLE 6 TWO TYPES OF EPIGENOMIC ANALYSIS TECHNOLOGIES

TABLE 7 STATUS OF DNA AND HISTONE ANALYSIS TECHNOLOGIES

TABLE 8 BIOLOGICAL ROLES OF DNA METHYLATION

TABLE 9 CPG ISLANDS: SUBJECT TO DNA METHYLATION

TABLE 10 HDAC ENZYMES CLASSES

TABLE 11 MECHANISMS FOR INAPPROPRIATE METHYLATION AND ACETYLATION

TABLE 12 DNA METHYLATION ANALYSIS ASSAYS

TABLE 13 EXAMPLES OF DNA METHYLATION ASSAYS

TABLE 14 COMPARISON OF UPSTREAM EPIGENOMIC RECOGNITION TECHNOLOGIES

TABLE 15 DNA METHYLATION ANALYSIS TECHNIQUES BY GENOME RESOLUTION

TABLE 16 CHIP ASSAYS

TABLE 17 TECHNOLOGIES FOR MAPPING GENOMIC LOCATION OF CHROMATIN PROTEINS AND ENZYMES

TABLE 18 MICROARRAY GENOME CONTENT

TABLE 19 PLATFORMS FOR HIGH DENSITY OLIGONUCLEOTIDE EPIGENETICS ARRAYS

TABLE 20 BIOLOGICAL RATIONALE FOR DNA METHYLATION CANCER BIOMARKERS

TABLE 21 CANCER-RELATED CELL PATHWAYS AND GENES AFFECTED BY HYPER-METHYLATION

TABLE 22 CANCER-RELATED EPIGENETIC CHANGES

TABLE 23 COMPARISON OF KEY CANCER BIOMARKER TECHNOLOGY PLATFORMS

TABLE 24 PUBLISHED DNA METHYLATION BIOMARKER GENES FOR CANCERS

TABLE 25 DIFFERENTIALLY METHYLATED GENES IN NEUROLOGIC AND CARDIOVASCULAR DISORDERS

TABLE 26 DNA METHYLATION ANALYSIS TECHNOLOGIES IN BIOMARKER DISCOVERY

TABLE 27 REGIONAL EPIGENOMICS INITIATIVES

TABLE 28 METHYL VARIABLE POSITIONS - MVPS

TABLE 29 HUMAN EPIGENOME PROJECT: METHYL VARIABLE POSITION ANALYSIS OBJECTIVES

TABLE 30 TECHNICAL HURDLES FOR DEVELOPMENT OF METHYLATION EPIGENETIC CANCER BIOMARKERS

TABLE 31 EPIGENETIC GENES ALTERED IN HUMAN CANCERS

TABLE 32 STATUS OF EPIGENETIC ENZYMES THAT TARGET HISTONES

TABLE 33 HDAC INHIBITOR CLASSES AND RELATIVE POTENCY

TABLE 34 MS-275, A BENZAMIDE CLASS HDAC INHIBITOR

TABLE 35 KEY HDAC INHIBITOR DRUG TRENDS

TABLE 36 HDAC INHIBITOR CLASS I AND II SELECTIVITY (IC50 RATIO)

TABLE 37 HDAC INHIBITOR DRUG COMPANIONS

TABLE 38 FUTURE CHALLENGES FOR EPIGENETIC DRUG DEVELOPMENT

TABLE 39 TECHNOLOGY OPPORTUNITIES IN SOMATIC CELL NUCLEAR TRANSFER

TABLE 40 EPIGENETIC ALTERATIONS IN ASSISTED REPRODUCTIVE DISORDERS

TABLE 41 GROWTH IN SCIENTIFIC PUBLICATIONS RELATED TO EPIGENETICS

TABLE 42 PRIMARY FORCES DRIVING EPIGENOMICS PRODUCTS GROWTH

TABLE 43 GLOBAL MARKET FORECAST FOR EPIGENOMICS RESEARCH TOOL KITS BY TYPE THROUGH 2012 ($ MILLION)

TABLE 44 GLOBAL MARKET FORECAST FOR EPIGENOMIC ANALYSIS RESEARCH TOOLS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 45 GLOBAL MARKET FORECAST FOR EPIGENETIC ANALYSIS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 46 GLOBAL MARKET FORECAST FOR DNA METHYLATION RESEARCH TOOL KITS BY ANALYSIS OBJECTIVE THROUGH 2012 ($ MILLIONS)

TABLE 47 GLOBAL MARKET FORECAST FOR DNA METHYLATION RESEARCH TOOLS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 48 GLOBAL MARKET FORECAST FOR DNA METHYLATION SINGLE LOCI RESEARCH TOOLS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 49 GLOBAL MARKET FORECAST FOR DNA METHYLATION GENOME-WIDE RESEARCH TOOLS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 50 GLOBAL MARKET FORECAST FOR VALUE OF HISTONE ANALYSIS KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 51 MICROARRAY PROBES

TABLE 52 CLINICAL STATUS OF MICROARRAY PLATFORMS

TABLE 53 GLOBAL VALUE OF EPIGENOMIC MICROARRAYS BY MARKET THROUGH 2012 ($ MILLIONS)

TABLE 54 GLOBAL VALUE OF EPIGENOMIC RESEARCH TOOLS MICROARRAYS BY ANALYSIS THROUGH 2012 ($ MILLIONS)

TABLE 55 GLOBAL VALUE OF DIAGNOSTIC MICROARRAYS BY MARKET THROUGH 2012 ($ MILLIONS)

TABLE 56 GLOBAL VALUE OF EPIGENOMIC REAGENTS BY MARKET THROUGH 2012 ($ MILLIONS)

TABLE 57 GLOBAL VALUE OF RESEARCH TOOLS EPIGENOMIC REAGENTS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 58 VALUE OF GLOBAL MOLECULAR DIAGNOSTICS MARKETS BY SEGMENT THROUGH 2012 ($ MILLIONS)

TABLE 59 TARGETED THERAPY CANCER DRUG COMPOUNDS IN DEVELOPMENT

TABLE 60 DEVELOPMENT STATUS OF SELECTED METHYLATION BIOMARKERS BY CANCER TYPE

TABLE 61 CURRENT SCREENING AND DIAGNOSTICS TESTS FOR COLORECTAL CANCER

TABLE 62 ACCURACY OF EXISTING COLORECTAL SCREENING TESTS

TABLE 63 OVARIAN CANCER POTENTIAL SCREENING TESTS

TABLE 64 REQUIREMENTS FOR AN EPIGENETICS BISULFITE DIAGNOSTIC KIT

TABLE 65 GLOBAL 2007 POTENTIAL AVAILABLE MARKET FOR CANCER MOLECULAR DIAGNOSTIC TEST KITS BY MARKET SEGMENT ($ MILLIONS)

TABLE 66 GLOBAL 2007 POTENTIAL AVAILABLE MARKET FOR CANCER MOLECULAR DIAGNOSTICS TEST KITS BY INDICATION ($ MILLIONS)

TABLE 67 CANCER INCIDENCE AND ESTIMATED TREATMENT DECISIONS, 2006

TABLE 68 BREAST CANCER DIAGNOSTICS PRODUCT SEGMENTS

TABLE 69 PROJECTED INCREASE IN AGE 65+ POPULATION BY REGION

TABLE 70 PIPELINE FOR DNA METHYLATION DIAGNOSTICS TESTS

TABLE 71 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY MARKET THROUGH 2012 ($ MILLIONS)

TABLE 72 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY INDICATION THROUGH 2012 ($ MILLIONS)

TABLE 73 2012 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY INDICATION AND SEGMENT ($ MILLIONS)

TABLE 74 GLOBAL VALUE OF EPIGENETIC DIAGNOSTIC KITS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 75 GLOBAL MARKET FORECAST FOR SELECTED CANCER DRUGS BY, THROUGH 2012 ($ MILLIONS)

TABLE 76 GLOBAL MARKET FORECAST FOR EPIGENETIC DRUGS BY INDICATION, THROUGH 2012 ($ MILLIONS)

TABLE 77 GLOBAL MARKET FORECAST FOR EPIGENETIC DRUGS BY CLASS, THROUGH 2012 ($ MILLIONS)

TABLE 78 OVERVIEW OF MAJOR HEMATOLOGICAL MALIGNANCIES

TABLE 79 GLOBAL MARKET FORECAST OF HEMATOLOGICAL CANCER DRUGS BY INDICATION THROUGH 2012 ($ MILLIONS)

TABLE 80 COMPARISON OF THREE NEW MDS DRUGS

TABLE 81 SUMMARY OF HDAC INHIBITOR STRATEGIC OPPORTUNITIES FOR CANCER TREATMENT

TABLE 82 HDAC INHIBITOR DRUG CANDIDATES IN CLINICAL TRIALS

TABLE 83 PXD-101 CLINICAL TRIALS STATUS

TABLE 84 ROMIDEPSIN CLINICAL TRIALS STATUS

TABLE 85 MBCD0103 INHIBITS SELECTED HDAC ENZYMES

TABLE 86 GLOBAL MARKET FORECAST FOR HDAC INHIBITOR DRUGS BY INDICATION, THROUGH 2012 ($ MILLIONS)

TABLE 87 GLOBAL VALUE OF HDAC INHIBITOR DRUGS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 88 DNMT INHIBITORS IN CLINICAL TRIALS AND UNDER DEVELOPMENT

TABLE 89 FDA APPROVED DNMT INHIBITOR DRUGS

TABLE 90 GLOBAL VALUE OF DNMT INHIBITOR DRUGS BY INDICATION THROUGH 2012 ($ MILLIONS)

TABLE 91 GLOBAL VALUE OF DNMT INHIBITOR DRUGS BY TECHNOLOGY THROUGH 2012 ($ MILLIONS)

TABLE 92 GLOBAL VALUE OF CLONING AND TISSUE ENGINEERING EPIGENETIC KITS THROUGH 2012 ($ MILLIONS)

TABLE 93 EPIGENOMIC RESEARCH TOOLS SUPPLIERS

TABLE 94 STRATEGIC ALLIANCE STATUS FOR BIOTECHNOLOGY EPIGENETICS DIAGNOSTICS FIRMS

TABLE 95 COMPETITIVE LANDSCAPE FOR MOLECULAR DIAGNOSTICS TECHNOLOGIES

TABLE 96 COMPETITIVE LANDSCAPE FOR EPIGENETIC DRUG COMPANIES

TABLE 97 PATENTS AND PATENT APPLICATION STATUS OF EPIGENOMICS AG RESEARCH TOOLS

TABLE 98 PATENT STATUS FOR BIOTECHNOLOGY DIAGNOSTICS COMPANIES

TABLE 99 HDAC INHIBITOR PATENT CLAIMS: 2004-2006

TABLE 100 CURAGEN STRATEGIC ALLIANCES

TABLE 101 METHYLGENE EPIGENETIC PRODUCT PIPELINE

TABLE 102 PHARMION EPIGENETIC DRUG COMBINATION THERAPIES IN CLINICAL TRIALS

TABLE 103 POTENTIAL PHARMION INTRA-PORTFOLIO DRUG COMBINATIONS

TABLE 104 TOPOTARGET’S HDAC INHIBITOR PATENT PORTFOLIO

LIST OF FIGURES

SUMMARY FIGURE GLOBAL VALUE OF EPIGENOMICS PRODUCTS BY MARKET SEGMENT, 2005-2012 ($ MILLIONS)

FIGURE 1 EPIGENOMICS: A NEW PARADIGM

FIGURE 2 EPIGENETIC PROCESSES CAN GENERATE ABNORMAL CELLS DURING CELL DEVELOPMENT

FIGURE 3 UPSTREAM AND DOWNSTREAM STEPS IN EPIGENETIC ANALYSIS

FIGURE 4 EPIGENETIC CHANGES TO DNA AFFECT GENE EXPRESSION

FIGURE 5 HISTONE TAIL REGIONS MODIFIED BY HAT AND HDAC

FIGURE 6 HISTONE ACETYLATION AND METHYLATION ENZYMES

FIGURE 7 METHYLATED DNA ANALYSIS WORKFLOW

FIGURE 8 ANALYSIS OF DNA METHYLATION BY RESTRICTION ENZYMES

FIGURE 9 BISULFITE CONVERSION OF DNA

FIGURE 10 CHIP-ON-CHIP PROCEDURE

FIGURE 11 MICROARRAY FEATURE DENSITY

FIGURE 12 MICROARRAY RESOLUTION

FIGURE 13 HISTONE DEACETYLASE REACTION

FIGURE 14 TRICHOSTATIN A, A HYDROXAMATE CLASS HDAC INHIBITOR

FIGURE 15 PHENYLBUTYRIC ACID, AN ALIPHATIC ACID CLASS HDAC INHIBITOR

FIGURE 16 APICIDIN A, A CYCLIC TETRAPEPTIDE CLASS HDAC INHIBITOR

FIGURE 17 DISEASE HDAC ISOFORM PROFILE

FIGURE 18 STRUCTURAL COMPONENTS MOTIFS OF HDAC INHIBITORS

FIGURE 19 LEAD DNMT INHIBITOR COMPOUNDS

FIGURE 20 DNMT INHIBITORS AND MODE OF ACTION

FIGURE 21 SOMATIC CELL NUCLEAR TRANSFER

FIGURE 22 EPIGENETIC PROGRAMMING OF STEM CELLS

FIGURE 23 MICROARRAYS ENHANCE MULTIPLEX CAPABILITIES OF EPIGENETICS ASSAYS

FIGURE 24 CANCER SCREENING OPPORTUNITY MATRIX FOR EPIGENETIC TESTS IN DEVELOPMENT

FIGURE 25 NEW EPIGENETIC SCREENING PARADIGM

FIGURE 26 SENSITIVITY AND SPECIFICITY

Abstract

REPORT HIGHLIGHTS
- The global market for epigenomics was $161.8 million in 2005 and $263.2 million in 2006. The market will cross $385 million by 2007 and at a compound annual growth rate (CAGR) of 60.4% will reach nearly $4.1 billion by 2012.

- Drug applications for epigenetics are by far the largest sector of the market. These drugs will hold 61% of the total global market in 2007 and will grow to over a 65% market share by 2012.

- Epigenetic diagnostics has the most potential for growth through the forecast period. In 2006 and 2007 its applications were negligible, but by 2012 this booming sector will be worth over $947 million.

INTRODUCTION

BCC's goal for this study was to determine the current status of emerging commercial epigenomics technologies and products and assess their worldwide growth potential over a 5-year period from 2007 to 2012. We were particularly interested in characterizing the epigenomic research tools market, a key enabling technology for other epigenomics markets. Of particular interest were the larger markets for DNA methylation-based diagnostics and epigenetic drugs for cancer.

Our key objective was to present a comprehensive discussion of where the state-of-the-art is in epigenomics technologies and the current and future commercial potential for the key market segments.

SCOPE OF STUDY

This report contains:
- The major epigenomics technologies and developments that are likely to become commercialized within the next five years
- Provides detailed market information for the global epigenomics market including historical data, current information, and projections to 2012
- Offers a focus on particular applications of epigenomics, including research tools, diagnostics, drugs, and cloning/tissue engineering
- Discusses the market in terms of important medical applications such as biomarkers, cancer therapy, and reproductive technology
- Offers a detailed review of important patents and technologies
- Profiles the most competitive businesses in the industry.

METHODOLOGY

BCC presents an analysis of each of the three key market segments that will be commercially important during the next 5 years: research tools, cancer diagnostics, and cancer therapeutics.

Based on our analysis, we analyze the potential applications of epigenomics in each of the major market segments, and forecast sales revenues for 2007 through 2012.

For research tools, the study presents a forecast from 2007 through 2012 for each of the important products and technologies. For cancer diagnostics, the report forecasts from 2007 through 2012 the demand for epigenetic-based test kits by cancer and disease type. Finally, this study forecasts from 2007 through 2012 the market for epigenetic drugs by cancer type.

INFORMATION SOURCES

BCC surveyed life science companies and research institutions to obtain data for this study. Included were research tools firms, diagnostics firms, drug firms, epigenetic biotechnology companies, and leading epigenomic research institutions. We also spoke with users of in vitro personalized medicine devices. In addition, we compiled data from secondary sources including industry, trade, and government.

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