Companion Diagnostics: Technologies and Markets

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Companion Diagnostics: Technologies and Markets

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STUDY GOALS AND OBJECTIVES

This BCC Research report, Companion Diagnostics: Technologies and Markets, provides an overview of the current state of development in the companion diagnostics field, existing products on the market and detailed analysis of the competitive environments, including new potential markets for current industry trends. The study includes information regarding significant current players in this field of study, trends and challenges, as well as other information affecting assay development in this space of personalized medicine.

REASONS FOR DOING THIS STUDY

When the human genome project was finally completed in 2003, the idea of testing the specific genetic signature for every human individual became a reality. In addition to the fast development of proteomic approaches and array technology, a new trend in personalized medicine started to evolve as part of the healthcare system. Personalized medicine became more embraced by healthcare providers, the pharmaceutical industry and even insurance companies in an attempt to reduce unnecessary expenses and costs for patient treatments. The Personalized Medicine Coalition (PMC), a nonprofit advocacy group, was recently formed to keep close track of all developments and propositions arising in this field.

Companion diagnostics is part of the personalized medicine revolution. The field has evolved as a continuation of biomarker studies and diagnostic testing. This area of industry is still relatively young, but it will become more complicated and developed due to numerous successful U.S. Food and Drug Administration (FDA)-approved products.

Moreover, the companion diagnostics approach in drug development has reduced the cost of bringing new medicines and therapies to the market.

This study will provide knowledge of the current state of the companion diagnostic industry, its main market participants and new technologies in assay development. More importantly, it will describe potential novel commercial venues in this area of the healthcare industry.

SCOPE AND FORMAT

Personalized medicine is relatively new to the market research report format and provides business tools to evaluate new commercial opportunities in diagnostics and biomarker fields. The geographic scope of this study covers U.S. and global companies. The report identifies major commercial sectors in companion diagnostics, including oncology-related products versus cardiovascular diseases. It describes current products in each area, identifies current market participants, and most importantly, notes the trends that are likely to affect further product development in this area. The report also provides information regarding less-developed sectors of this market, along with a list of current companies that have new companion diagnostic products in development.

METHODOLOGY AND INFORMATION SOURCES

Both primary and secondary research methodologies were used to prepare this study. Initially, a comprehensive and exhaustive search of the literature on drug discovery and already marketed products was conducted. These secondary sources included drug discovery and science-related journals, textbooks, press releases, marketing literature, product and promotional literature, annual reports, security analyst reports and other publications. Patent searches and analyses were also conducted.

In a second phase, a series of semi-structured interviews was conducted with company representatives, bench scientists, marketing representatives and other personnel at biotechnology and pharmaceutical companies. Other sources included academic institutions and technology and consulting companies. Subsequent analysis of the documents and interview notes was iterative.

INTENDED AUDIENCE

This report is intended for business development professionals, healthcare professionals, entrepreneurs and other investment groups to help them fully understand and evaluate a new, less-familiar area of the healthcare and diagnostic industry. It provides companies' corporate development departments with new insight into competitors' positions and shows new opportunities otherwise overlooked or unfamiliar to the public.

ANALYST CREDENTIALS

Dr. Marianna Tcherpakov has more than eight years experience as a bench scientist specializing in biochemistry, cell biology and industrial assay development. She has contributed to numerous scientific publications and holds several patents. She has expertise as an assay development scientist, and she is familiar with different research field trends and likely future developments.

REPORT HIGHLIGHTS

The global companion diagnostics market reached $1.1 billion in 2012. The market is expected to grow to $1.2 billion in 2013 and $3.5 billion in 2018 with a compound annual growth rate (CAGR) of 23.9%.

This report provides:
• An overview of the market for companion diagnostics, including existing products on the market and detailed analysis of the competitive environments.
• Analyses of market trends, with data from 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.
• Examination of the current state of the industry, new technologies in assay development, and potential novel commercial venues in this area of the healthcare industry.
• Identification of major commercial sectors in companion diagnostics: oncology related products vs. cardiovascular diseases and other segments.
• Comprehensive company profiles of major players, as well as a list of current companies that have new companion diagnostics products in development.

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
SCOPE AND FORMAT 2
METHODOLOGY AND INFORMATION SOURCES 3
INTENDED AUDIENCE 3
ANALYST CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 3
BCC RESEARCH ONLINE SERVICES 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6

SUMMARY TABLE GLOBAL COMPANION DIAGNOSTICS MARKET, THROUGH 2018 ($
MILLIONS) 7
SUMMARY FIGURE GLOBAL COMPANION DIAGNOSTICS MARKET, 2011-2018 ($
MILLIONS) 7

CHAPTER 3 OVERVIEW, STRUCTURE AND SIGNIFICANCE OF THE COMPANION DIAGNOSTICS INDUSTRY 9

COMPANION DIAGNOSTICS AS A NEW TREND IN PERSONALIZED MEDICINE 9
OVERVIEW 9
PERSONALIZED MEDICINE PRODUCTS OVERVIEW 10
TABLE 1 PERSONALIZED MEDICINE OVERVIEW PRODUCTS 11
PREDISPOSITION TESTS 11
SCREENING TESTS 11
DIAGNOSIS 11
MONITORING TESTS 12
COMPANION DIAGNOSTICS 12
TABLE 2 PERSONALIZED MEDICINE DIAGNOSTIC PRODUCTS BY SEGMENT,
2008-2018 (%) 12
FIGURE 1 PERSONALIZED MEDICINE PRODUCTS BY SEGMENT, 2008-2018 (%) 13
TABLE 3 GLOBAL PERSONALIZED MEDICINE DIAGNOSTICS MARKET, THROUGH
2018 ($ BILLIONS) 13
TABLE 4 COMPANION DIAGNOSTICS INDUSTRY PRODUCTS, 2013 (%) 14
PARTICIPANTS IN THE COMPANION DIAGNOSTICS INDUSTRY 15
In Vitro Diagnostic, Biomarker and Companion Diagnostics
Companies 15
In Vitro Diagnostics Companies 15
Biomarker Research Companies 15
Companion Diagnostics Companies 15
Laboratory Test Services Companies 16
Pharmaceutical Companies 16
Regulatory Entities, Insurance Companies and Healthcare Providers 17
Regulatory Entities 17
Insurance Companies 18
Healthcare Providers 19
Patients, Physicians and Public Opinion as Additional Drivers of the
Companion Diagnostics Industry 19
Organizations Supporting the Personalized Medicine Approach 21
FIGURE 2 COMPANION DIAGNOSTICS INDUSTRY DRIVERS 21
CHALLENGES AND OBSTACLES TO COMPANION DIAGNOSTICS INDUSTRY
DEVELOPMENT 22
FIGURE 3 COMPANION DIAGNOSTICS INDUSTRY CHALLENGES 24

CHAPTER 4 BIOMARKER AND DIAGNOSTICS MARKETS AS THE BASIS FOR THE COMPANION DIAGNOSTICS INDUSTRY 27

BIOMARKER MARKET AS THE BASIS FOR THE COMPANION DIAGNOSTICS
INDUSTRY 27
OVERVIEW 27
TABLE 5 BIOMARKER STATISTICS IN THE DRUG DEVELOPMENT PROCESS, 2013 (%) 27
TABLE 6 GLOBAL BIOMARKER MARKET, THROUGH 2015 ($ BILLIONS) 28
TABLE 7 GLOBAL BIOMARKERS IN VARIOUS RESEARCH AREAS, 2013 ($ BILLIONS) 29
CANCER BIOMARKERS 29
CARDIOVASCULAR DISEASE BIOMARKERS 30
CENTRAL NERVOUS SYSTEM DISORDERS BIOMARKERS 31
IN VITRO DIAGNOSTICS INDUSTRY AS A FOUNDATION AND DRIVER FOR THE
COMPANION DIAGNOSTICS FIELD 31
OVERVIEW 31
TABLE 8 IN VITRO DIAGNOSTICS MARKET BY REGION, 2013 (%) 32
TABLE 9 MAJOR IN VITRO DIAGNOSTICS COMPANIES, 2010 (%) 33

CHAPTER 5 EFFECT OF THE REGULATORY ASPECT, COST AND REIMBURSEMENT POLICIES ON THE COMPANION DIAGNOSTICS INDUSTRY 36

TABLE 10 COMPANION DIAGNOSTICS, ASSOCIATED DRUGS AND REGULATORY
APPROVAL STATES, 2013 38
COMPANION DIAGNOSTICS COST AND REIMBURSEMENT POLICIES AS DRIVERS
FOR INDUSTRY DEVELOPMENT 39
TABLE 11 COMPANION DIAGNOSTICS COST EXAMPLES, 2013 ($) 39
TABLE 12 HEALTHCARE SAVINGS DUE TO COMPANION DIAGNOSTICS TESTS, 2013
($ MILLIONS) 41

CHAPTER 6 EFFECT OF THE PERSONALIZED MEDICINE TREND ON PRODUCT DEVELOPMENT IN OTHER INDUSTRIES 43

OVERVIEW 43
TABLE 13 PERSONALIZED MEDICINE MARKET BY SEGMENT, 2010 AND 2015 ($
BILLIONS) 43
NUTRITION AND WELLNESS MARKET 44
TABLE 14 NUTRITION AND WELLNESS MARKET BY SECTOR, 2013 (%) 44
MEDICAL CARE SERVICES AND HEALTH INFORMATION TECHNOLOGY 44
TABLE 15 HEALTHCARE INFORMATION TECHNOLOGY MARKET BY SECTOR, 2010 (%) 45
DIAGNOSTIC AND THERAPEUTIC SECTOR IN PERSONALIZED MEDICINE 47
TABLE 16 DIAGNOSTIC AND THERAPEUTIC MARKET IN PERSONALIZED MEDICINE
BY SECTOR, 2013 (%) 47
DIRECT-TO-CONSUMER OR AT-HOME GENETIC TESTS 47
PERSONAL GENOME SEQUENCING 50
TABLE 17 PERSONALIZED MEDICINE PRODUCTS ON THE MARKET FOR THE
GENERAL PUBLIC, 2013 (%) 51

CHAPTER 7 PATENT APPLICATIONS FOR COMPANION DIAGNOSTICS AND BIOMARKERS 53

OVERVIEW 53
TABLE 18 GLOBAL PATENT APPLICATIONS IN VARIOUS BIOMARKER RESEARCH
FIELDS, 2012 54
FIGURE 4 GLOBAL PATENT APPLICATIONS IN VARIOUS BIOMARKER RESEARCH
FIELDS, 2012 54
PATENT APPLICATIONS AND GRANTED PATENTS IN THE COMPANION
DIAGNOSTICS INDUSTRY 54
POWER3/STEMTRONIX 54
AVEO PHARMACEUTICALS 55
CLARIENT INC. 55
ENTELOS 55

CHAPTER 8 CURRENT TECHNIQUES AND TECHNOLOGIES FOR COMPANION DIAGNOSTICS 57

OVERVIEW 57
TABLE 19 ADVANTAGES AND DISADVANTAGES OF THE MOST COMMON
TECHNIQUES FOR COMPANION DIAGNOSTICS, 2013 58
NOVEL TRENDS AND TECHNOLOGIES IN COMPANION DIAGNOSTICS ASSAY
DEVELOPMENT 59
DIGITAL PATHOLOGY AND QUANTATIVE IMMUNOSTAINING 59
IMAGING AS A COMPANION DIAGNOSTICS TEST APPROACH 60
COGNITIVE DIAGNOSTICS AS COMPANION DIAGNOSTICS TESTS 61
PROTEOMICS TECHNOLOGIES AS PLATFORMS FOR COMPANION
DIAGNOSTICS DEVELOPMENT 61
METABOLOMIC APPROACH IN COMPANION DIAGNOSTICS ASSAY
DEVELOPMENT 62

CHAPTER 9 GENETIC KNOWLEDGE AND CLINICIAN OPINIONS AS DRIVERS FOR THE COMPANION DIAGNOSTICS MARKET 64

OVERVIEW 64
TABLE 20 U.S. PHYSICIANS ORDERING COMPANION DIAGNOSTICS TESTS AS PART
OF DIAGNOSIS AND TREATMENT, 2012 (%) 64
TABLE 21 U.S. PHYSICIANS' OPINIONS REGARDING THE WAYS NOVEL DRUGS WITH
COMPANION DIAGNOSTICS WILL AFFECT THE USE OF CHEMOTHERAPY TREATMENT,
2012 (%)
65
TABLE 22 U.S. PHYSICIANS' OPINIONS REGARDING VARIOUS ASPECTS OF
PERSONALIZED MEDICINE, 2012 (%) 66

CHAPTER 10 COMPANION DIAGNOSTICS INDUSTRY MARKET EVALUATIONQIAGEN 68

OVERVIEW 68
TABLE 23 PARTICIPANTS IN THE COMPANION DIAGNOSTICS MARKET 68
MAJOR COMPANION DIAGNOSTICS MARKET PARTICIPANTS 73
QIAGEN 73
ROCHE DIAGNOSTICS 74
ABBOTT MOLECULAR 74
DAKO (AGILENT TECHNOLOGIES) 75
NEWCOMERS IN COMPANION DIAGNOSTICS MARKET 76
LIFE TECHNOLOGIES (THERMO FISHER SCIENTIFIC) 76
GENPROBE (HOLOGIC) 77
ACQUISITION BENEFITS 77
TABLE 24 ACQUISITIONS OF COMPANION DIAGNOSTICS COMPANIES, 2008 TO 2013 78
MAJOR PHARMACEUTICAL COMPANIES FORMING PARTNERSHIPS WITH
COMPANION DIAGNOSTICS COMPANIES 78
TABLE 25 PARTNERSHIPS BETWEEN PHARMA AND DIAGNOSTIC COMPANIES, 2009
TO 2013 78
TABLE 26 COMPANION DIAGNOSTICS DEALS BY RESEARCH AREA, 2004-2012 (%) 81
TABLE 27 DEALS IN COMPANION DIAGNOSTICS BY SELECTED PHARMACEUTICAL
PARTNERS, 2009-2012 82
MARKET ESTIMATION FOR COMPANION DIAGNOSTICS DEVELOPMENT 82
TABLE 29 GLOBAL COMPANION DIAGNOSTICS MARKET, THROUGH 2018 ($
MILLIONS) 84

CHAPTER 11 COMPANION DIAGNOSTICS INDUSTRY OVERVIEW IN DIFFERENT RESEARCH AREAS 86

COMPANION DIAGNOSTICS PRODUCTS IN CANCER 86
OVERVIEW 86
TABLE 30 COMMON COMPANION DIAGNOSTICS TESTS IN CANCER APPLICATIONS,
2013 86
MAIN COMPANION DIAGNOSTICS ASSAYS IN ONCOLOGY DRUG MARKET 88
HER2 TEST 88
Manufacturers of the Her2/neu Assay 89
TABLE 31 MAIN HER2 TESTS, 2013 91
KIRSTEN RAS SARCOMA TEST 93
TABLE 32 KRISTEN RAS SARCOMA TEST MANUFACTURERS, 2010 ($) 95
EPIDERMAL GROWTH FACTOR RECEPTOR EXPRESSION TEST 95
ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE TESTING 97
BRAF TESTING 99
UGT1A1 TEST 99
GENETIC ASSAYS FOR BREAST CANCER PROGNOSIS 100
BRCA1/2 100
BREAST CANCER INDEX AND CANCER TYPE IDENTIFICATION 101
MAMMAPRINT 101
ONCOTYPEDX 101
MAMMOSTRAT 102
BREAST CANCER PROGNOSIS TESTING MARKET ANALYSIS 102
TABLE 33 GLOBAL ONCOTYPEDX AND BRAC ANALYSIS MARKET, THROUGH 2018 ($
MILLIONS) 103
FIGURE 5 GLOBAL ONCOTYPEDX AND BRAC ANALYSIS MARKET, 2009-2018 ($
MILLIONS) 103
ADDITIONAL MOLECULAR MARKERS AND PRODUCTS AS COMPANION
DIAGNOSTICS FOR DRUG RESPONSE 104
BCR-ABL ANALYSIS FOR GLEEVEC TREATMENT 104
THIOPURINE S-METHYLTRANSFERASE ACTIVITY FOR PURINETHOL/
THIOGUANINE/AZATHIOPRINE TREATMENTS 105
DEFICIENCY OF DIHYDROPYRIMIDINE DEHYDROGENASE ACTIVITY FOR
5-FLUOROURACIL 105
G6PD DEFICIENCY FOR ELITEK TREATMENT 105
C-KIT FOR GLEEVEC TREATMENT IN STOMACH CANCER 105
CD33 MARKER FOR MYLOTARG TREATMENT 105
CD25 MARKER FOR ONTAK THERAPY 106
INFLUENCE OF CANCER STATISTICS, HEALTHCARE COSTS AND THE DRUG
MARKET ON COMPANION DIAGNOSTICS DEVELOPMENT 106
TABLE 34 U.S. CANCER STATISTICS, 2013 106
BREAST CANCER 106
LUNG CACOLORECTAL CANCERNCER 107
COLORECTAL CANCER 107
LEUKEMIA 107
TABLE 35 U.S. ANNUAL HEALTHCARE COST FOR CANCERS, AND THE AMOUNT
SPENT ON SCIENTIFIC RESEARCH BY TYPE, 2010 AND 2011 ($ BILLIONS/$
MILLIONS)
107
KRISTEN RAS SARCOMA COMPANION DIAGNOSTICS AS AN EXAMPLE FOR NEW
HEALTH ECONOMICS MODEL 108
TABLE 36 COST SAVINGS USING KRISTEN RAS SARCOMA COMPANION DIAGNOSTIC
TEST IN COLORECTAL CANCER PATIENTS 108
DRUG MARKET'S EFFECT ON COMPANION DIAGNOSTICS PRODUCT
DEVELOPMENT 109
TABLE 37 GLOBAL DRUGS ASSOCIATED WITH COMPANION DIAGNOSTIC TESTS,
THROUGH 2018 ($ BILLIONS) 109
HERCEPTIN AND HER2 TEST 109
VECTIBIX AND KRISTEN RAS SARCOMA TEST 110
ERBITUX AND KRISTEN RAS SARCOMA TEST 110
XALKORI AND ANAPLASTIC LYMPHOMA KINASE TEST 110
ZALBORAF AND BRAF TEST 111
PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND THE
PHARMACEUTICAL INDUSTRY IN THE ONCOLOGY SECTOR 112
TABLE 38 PARTNERSHIPS BETWEEN PHARMA AND DIAGNOSTICS COMPANIES IN
ONCOLOGY, 2009 TO 2013 112
QIAGEN/DXS AND PARTNERSHIPS 114
ALMAC DIAGNOSTICS PARTNERSHIPS 115
ABBOTT DIAGNOSTICS PARTNERSHIPS WITH PFIZER AND GSK 115
DAKO (AGILENT TECHNOLOGIES) PARTNERSHIPS 116
COMPANION DIAGNOSTICS PRODUCT DEVELOPMENT IN ONCOLOGY 117
TABLE 39 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, THROUGH 2018
($ MILLIONS) 118
FIGURE 6 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, 2009-2018 ($
MILLIONS) 118
COMPANION DIAGNOSTIC TESTS ON THE MARKET FOR METABOLIC DISORDERS 118
OVERVIEW 118
TABLE 40 COMPANION DIAGNOSTIC TESTS FOR METABOLIC DISEASES, 2013 119
LAB21 119
ENTELOS 120
LIPOMICS TECHNOLOGIES/METABOLON 120
TETHYS BIOSCIENCE 121
BIOCRATES AG 121
GENOMAS 121
PROGNOMIX 122
LIPOPROTEIN RECEPTOR/ATORVASTATIN TESTS 123
PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES,
PHARMACEUTICAL COMPANIES AND ACADMIC INSTITUTIONS IN THE
DEVELOPMENT OF COMPANION ASSAYS FOR METABOLIC DISORDERS
124
TABLE 41 COLLABORATIONS BETWEEN COMPANION DIAGNOSTICS COMPANIES,
PHARMACEUTICAL COMPANIES AND ACADEMIC INSTITUTIONS, 2008 TO 2013 124
LIPOMICS TECHNOLOGIES (METABOLON)/JOSLIN DIABETES CENTER
(HARVARD MEDICAL SCHOOL) 124
GENOMAS/UNIVERSITY OF PUERTO RICO MEDICAL SCIENCE CAMPUS 125
DECODE GENETICS/CELERA (QUEST DIAGNOSTICS) 125
SIEMENS/LABCORP 125
CELGENE CORP (QUEST DIAGNOSTICS)/AGIOS PHARMACEUTICALS 126
MYRIAD GENETICS (RBM)/SANOFI AVENTIS 126
AGAMATRIX/SANOFI-AVENTIS 126
BIOCRATES AG/PFIZER, ALTANA PHARMA 127
MARKET POTENTIAL FOR COMPANION DIAGNOSTICS TESTS IN METABOLIC
DISORDERS 127
TABLE 42 U.S. AND GLOBAL DIABETES, HYPERCHOLESTEROLEMIA AND METABOLIC
SYNDROME MARKET, 2013 (MILLIONS/$ BILLIONS) 127
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS IN CARDIOVASCULAR
DISEASES 128
OVERVIEW 128
TABLE 43 U.S. CARDIOVASCULAR DISEASE AND HEALTHCARE COSTS, 2010 ($
MILLIONS/$ BILLIONS) 129
TABLE 44 COMPANION DIAGNOSTICS FOR CARDIOVASCULAR DISEASES, 2013 129
COMPANION DIAGNOSTIC TEST FOR WARFARIN 130
TABLE 45 U.S. WARFARIN TREATMENT, 2010 ( MILLIONS/NUMBER) 130
Manufacturers of Companion Diagnostic Tests for Warfarin 130
Nanosphere Inc. 131
AutoGenomics 131
Genmark Diagnostics 131
Kimball Genetics 131
Market Analysis for Warfarin Test Competitors 131
TABLE 46 WARFARIN SENSITIVTY TESTS BY MANUFACTURER, 2009 133
Companion Diagnostics for Plavix 133
Protein C Deficiency Test for Warfarin Sensitivity 133
Genotyping for NAT1 and NAT2 for BiDil Treatment 134
DRUG MARKET ASSOCIATED WITH CARDIOVASCULAR COMPANION
DIAGNOSTICS 134
WARFARIN 134
PLAVIX 135
TABLE 47 GLOBAL PLAVIX MARKET, THROUGH 2012 ($ MILLIONS) 135
PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND
PHARMACEUTICAL COMPANIES IN CARDIOVASCULAR DISEASE TREATMENTS 137
TABLE 48 PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES,
PHARMACEUTICAL COMPANIES AND ACADEMIC INSTITUTIONS IN THE
CARDIOVASCULAR DISEASE SECTOR, 2007-2011
137
LABCORP/ARCA BIOPHARMA 137
TABLE 49 U.S. INCIDENCE OF HEART FAILURE AND ANNUAL HEALTHCARE COSTS,
2010 (MILLIONS/$ BILLIONS) 138
AFFOMIX CORP/UNIVERSITY OF MONTREAL PHARMACOGENOMICS CENTRE
AND MONTREAL HEART INSTITUTE 139
CELERA (QUEST DIAGNOSITCS)/DECODE GENETICS 139
ROCHE/CHANTEST CORPORATION 140
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS FOR CENTRAL NERVOUS
SYSTEM DISORDERS 141
OVERVIEW 141
TABLE 50 COMPANION DIAGNOSTIC TESTS FOR CENTRAL NERVOUS SYSTEM
DISORDER DRUG THERAPY, 2013 142
HLA-B*1502 ALLELE TESTING 142
UREA CYCLE DISORDERS TEST 142
PHYZIOTYPE PIMS 143
GENESIGHTRX 144
CURRENT COMPANION DIAGNOSTICS COMPANIES DEVELOPING COMPANION
ASSAYS FOR CENTRAL NERVOUS SYSTEM DISORDERS 144
TABLE 51 COMPANION DIAGNOSTICS COMPANIES DEVELOPING COMPANION
ASSAYS FOR CENTRAL NERVOUS SYSTEM DISORDERS, 2013 144
SALADAX BIOMEDICAL 145
CYTOX 145
DIAXONHIT 146
POPULATION DIAGNOSTICS 146
PROTAGEN 147
NEXTGEN SCIENCES 148
AMARANTUS BIOSCIENCE HOLDINGS 148
CURRENT PARTNERSHIPS BETWEEN DIAGNOSTICS COMPANIES AND THEIR
PHARMACEUTICAL PARTNERS DEVELOPING COMPANION TESTS IN CENTRAL
NERVOUS SYSTEM DISORDERS
149
TABLE 52 PARTNERSHIPS BETWEEN DIAGNOSTICS AND PHARMACEUTICAL
COMPANIES IN COMPANION DIAGNOSTICS FOR CENTRAL NERVOUS SYSTEM
DISORDERS, 2010–2013
149
PSYNOVA NEUROTECH/ROCHE 149
SALADAX BIOMEDICAL/BMS 150
DIAXONHIT/ALLERGEN 150
IMAGINAB/H. LUNDBECK A/S 150
KINEMED/ISIS PHARMACEUTICALS/CHDI FOUNDATION 151
DIAGENIC/MERZ PHARMACEUTICALS 151
DIAGENIC/PFIZER 151
OPKO HEALTH/BRISTOL-MYERS SQUIBB 152
ZINFANDEL PHARMACEUTICALS/TAKEDA 152
MESO SCALE DISCOVERY/BRISTOL-MYERS SQUIBB 153
SIEMENS AG/TOCAGEN 153
LUMINEX/MERCK 153
SUMMARY 154
STATISTICS, HEALTHCARE COSTS AND THE DRUG MARKET FOR CENTRAL
NERVOUS SYSTEM DISORDERS AS AN ESTIMATE FOR COMPANION
DIAGNOSTICS ASSAY DEVELOPMENT
154
TABLE 53 U.S. STATISTICS AND HEALTHCARE COSTS OF SCHIZOPHRENIA,
ALZHEIMER'S DISEASE AND PARKINSON'S DISEASE, 2009 ($ BILLIONS) 154
TABLE 54 U.S. REPRESENTATIVE NEURODEGENERATION DISORDER AND
SCHIZOPHRENIA MARKET, 2013 ($ BILLIONS) 155
SCHIZOPHRENIA AS A MARKET FOR COMPANION DIAGNOSTIC
DEVELOPMENT 155
NEURODEGENERATIVE DISORDERS AS A MARKET FOR COMPANION
DIAGNOSTICS DEVELOPMENT 156
Parkinson's Disease and Current Drug Treatment 156
TABLE 55 REQUIP NET SALES, 2010–2012 ($ MILLIONS) 156
CURRENT PRODUCTS FOR COMPANION DIAGNOSTIC TESTS IN INFECTIOUS
DISEASES 157
OVERVIEW 157
TABLE 57 COMPANION DIAGNOSTIC TESTS ON THE MARKET FOR INFECTIOUS
DISEASES, 2013 157
GENETIC TEST FOR HLA-B 5701 157
GENETIC TEST FOR IL28B 157
TROPISM FOR HUMAN IMMUNODEFICIENCY VIRUS ASSAY 158
TABLE 58 MONOGRAM/LABCORP TROFILE SALES, 2008-2010 (MILLIONS) 159
Competitors of Trofile Assay 159
TABLE 59 ENTRY INHIBITOR DRUG DISCOVERY AS A NEW OPPORTUNITY FOR THE
TROFILE ASSAY 160
HUMAN IMMUNODEFICIENCY VIRUS DRUG-RESISTANCE TESTS 160
Human Immunodeficiency Virus Statistics and Healthcare Cost as a
Factor for Companion Diagnostics Sales Forecast 161
TABLE 60 U.S. HUMAN IMMUNODEFICIENCY VIRUS STATISTICS AND HEALTHCARE
COSTS, 2009 (NUMBER/$ BILLIONS) 162
Human Immunodeficiency Virus Drug Market 162
TABLE 61 GLOBAL HUMAN IMMUNODEFICIENCY VIRUS DRUG MARKET, 2013 AND
2018 ($ BILLIONS) 162
CURRENT PARTNERSHIPS AND COLLABORATIONS FOR COMPANION
DIAGNOSTICS FOR INFECTIOUS DISEASES 163
TABLE 62 PARTNERSHIPS IN THE FIELD OF COMPANION DIAGNOSTICS FOR
INFECTIOUS DISEASES BETWEEN DIAGNOSTICS AND PHARMACEUTICAL
COMPANIES, 2009-2012
163
MITOSCIENCES (ABCAM)/UNIVERSITY OF OREGON 164
LABCORP (MONOGRAM BIOSCIENCE)/PFIZER/SHERING PLOUGH/
PROGENICS/GILEAD SCIENCE 164
ENIGMA DIAGNOSITCS/GLAXOSMITHKLINE 164
LABCORP/MERCK 165
SIEMENS HEALTHCARE DIAGNOSTICS/VIIV HEALTHCARE 165
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS IN OTHER DISEASES 166
OVERVIEW 166
TABLE 63 COMPANION DIAGNOSTICS PRODUCTS IN VARIOUS CLINICAL
APPLICATIONS, 2013 166
ALLOMAP MOLECULAR EXPRESSION TESTING 167
HUMAN LEUKOCYTE ANTIGENTESTING 168
COMPANION DIAGNOSTIC TEST DEVELOPMENT IN DRUG METABOLISM 169
Cytochrome P450 2C9 (CYP2C9) 169
N-acetyltransferase 169
Amplichip CYP2D6/CYP2C19 170
Serology 7 Test for Inflammatory Bowel Disease 170
Cholinesterase Gene Testing 171
G6PD Test 171
ImmuKnow 172
PsoriasisDX 172
FerriScan R2-MRI 173

CHAPTER 12 MARKET SUMMARY 175

TABLE 64 COMPANION DIAGNOSTICS TESTS MENTIONED IN THIS REPORT 175
TABLE 65 COMPANION DIAGNOSTICS INDUSTRY PRODUCTS, 2013 (%) 177
FIGURE 7 COMPANION DIAGNOSTICS INDUSTRY PRODUCTS, 2013 (%) 177
TABLE 66 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, THROUGH 2018
($ MILLIONS) 178
FIGURE 8 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, 2009-2018 ($
MILLIONS) 178
TABLE 67 GLOBAL COMPANION DIAGNOSTICS MARKET, THROUGH 2018 ($
MILLIONS) 179
FIGURE 9 GLOBAL COMPANION DIAGNOSTICS MARKET, 2011-2018 ($ MILLIONS) 179

CHAPTER 13 COMPANY PROFILES 181

ABBOTT LABORATORIES 181
BIOMERIEUX SA 182
CELERA 183
DAKO (AGILENT TECHNOLOGIES) 183
GENOMIC HEALTH INC. 184
LABCORP 185
QIAGEN N.V. 186
QUEST DIAGNOSTICS INC. 187
ROCHE DIAGNOSTICS 188

CHAPTER 14 COMPANIES MENTIONED IN THIS REPORT 190

23ANDME 190
20/20 GENE SYSTEMS 190
ABBOTT LABORATORIES 190
ADVANCED CELL DIAGNOSTICS INC. 190
AFFYMETRIX INC. 190
AGENDIA INC. 190
ALMAC GROUP 191
ALTHEADX 191
AMERITOX 191
AMGEN, INC. 191
APPLIED BIOCODE 191
ARRAYIT CORPORATION 191
ASSURERX HEALTH 192
ASURAGEN INC. 192
AUTOGENOMICS INC. 192
BECKMAN COULTER INC. 192
BG MEDICINE INC. 192
BIOCARTIS SA 192
BIOCRATES LIFE SCIENCES AG 193
BIOMARKER STRATEGIES 193
BIOMERIEUX SA 193
CARDIODX 193
CELERA 193
CEPHEID 193
COMPANIONDX 194
CRESCENDO BIOSCIENCE 194
CYPROTEX 194
DAKO (AGILENT TECHNOLOGIES) 194
DIAGNOCURE INC. 194
DNAVISION 194
EPIGENOMICS AG 195
FOUNDATION MEDICINE INC. 195
GENELEX CORP 195
GENMARK DIAGNOSTICS 195
GENOMAS INC. 195
GENOMIC HEALTH INC. 195
GENPROBE (HOLOGIC) 196
GSK US 196
HORIZON DISCOVERY LTD. 196
IKONISYS 196
ILLUMINA INC. 196
INTERGENETICS INC. 196
LABCORP 197
LIFE TECHNOLOGIES CORP.(THERMO FISHER SCIENTIFIC) 197
MERCK CORPORATE HEADQUARTERS 197
METABOLON INC. 197
MYRIAD GENETICS INC. 197
NANOSPHERE INC. 197
NOVARTIS INTERNATIONAL AG 198
ORION GENOMICS 198
PAMGENE INTERNATIONAL B.V. 198
PANACEA PHARMACEUTICALS 198
PATHWAY GENOMICS CORP 198
PFIZER 198
PHARMIGENE 199
PROGENIKA INC. 199
PROMETHEUS LABORATORIES INC. 199
QIAGEN N.V. 199
QUEST DIAGNOSTICS INC. 199
RESEARCHDX 199
RESPONSE GENETICS INC. 200
ROCHE DIAGNOSTICS 200
SALADAX BIOMEDICAL INC. 200
SEQUENOM INC. 200
TETHYS BIOSCIENCE 200
TRIMGEN CORP 200
UPSTREAM BIOSCIENCES INC 201
XDX 201

LIST OF TABLES

SUMMARY TABLE GLOBAL COMPANION DIAGNOSTICS MARKET, THROUGH 2018 ($
MILLIONS) 7
TABLE 1 PERSONALIZED MEDICINE OVERVIEW PRODUCTS 11
TABLE 2 PERSONALIZED MEDICINE DIAGNOSTIC PRODUCTS BY SEGMENT,
2008-2018 (%) 12
TABLE 3 GLOBAL PERSONALIZED MEDICINE DIAGNOSTICS MARKET, THROUGH 2018
($ BILLIONS) 13
TABLE 4 COMPANION DIAGNOSTICS INDUSTRY PRODUCTS, 2013 (%) 14
TABLE 5 BIOMARKER STATISTICS IN THE DRUG DEVELOPMENT PROCESS, 2013 (%) 27
TABLE 6 GLOBAL BIOMARKER MARKET, THROUGH 2015 ($ BILLIONS) 28
TABLE 7 GLOBAL BIOMARKERS IN VARIOUS RESEARCH AREAS, 2013 ($ BILLIONS) 29
TABLE 8 IN VITRO DIAGNOSTICS MARKET BY REGION, 2013 (%) 32
TABLE 9 MAJOR IN VITRO DIAGNOSTICS COMPANIES, 2010 (%) 33
TABLE 10 COMPANION DIAGNOSTICS, ASSOCIATED DRUGS AND REGULATORY
APPROVAL STATES, 2013 38
TABLE 11 COMPANION DIAGNOSTICS COST EXAMPLES, 2013 ($) 39
TABLE 12 HEALTHCARE SAVINGS DUE TO COMPANION DIAGNOSTICS TESTS, 2013 ($
MILLIONS) 41
TABLE 13 PERSONALIZED MEDICINE MARKET BY SEGMENT, 2010 AND 2015 ($
BILLIONS) 43
TABLE 14 NUTRITION AND WELLNESS MARKET BY SECTOR, 2013 (%) 44
TABLE 15 HEALTHCARE INFORMATION TECHNOLOGY MARKET BY SECTOR, 2010 (%) 45
TABLE 16 DIAGNOSTIC AND THERAPEUTIC MARKET IN PERSONALIZED MEDICINE BY
SECTOR, 2013 (%) 47
TABLE 17 PERSONALIZED MEDICINE PRODUCTS ON THE MARKET FOR THE GENERAL
PUBLIC, 2013 (%) 51
TABLE 18 GLOBAL PATENT APPLICATIONS IN VARIOUS BIOMARKER RESEARCH
FIELDS, 2012 54
TABLE 19 ADVANTAGES AND DISADVANTAGES OF THE MOST COMMON
TECHNIQUES FOR COMPANION DIAGNOSTICS, 2013 58
TABLE 20 U.S. PHYSICIANS ORDERING COMPANION DIAGNOSTICS TESTS AS PART
OF DIAGNOSIS AND TREATMENT, 2012 (%) 64
TABLE 21 U.S. PHYSICIANS' OPINIONS REGARDING THE WAYS NOVEL DRUGS WITH
COMPANION DIAGNOSTICS WILL AFFECT THE USE OF CHEMOTHERAPY TREATMENT,
2012 (%)
65
TABLE 22 U.S. PHYSICIANS' OPINIONS REGARDING VARIOUS ASPECTS OF
PERSONALIZED MEDICINE, 2012 (%) 66
TABLE 23 PARTICIPANTS IN THE COMPANION DIAGNOSTICS MARKET 68
TABLE 24 ACQUISITIONS OF COMPANION DIAGNOSTICS COMPANIES, 2008 TO 2013 78
TABLE 25 PARTNERSHIPS BETWEEN PHARMA AND DIAGNOSTIC COMPANIES, 2009
TO 2013 78
TABLE 26 COMPANION DIAGNOSTICS DEALS BY RESEARCH AREA, 2004-2012 (%) 81
TABLE 27 DEALS IN COMPANION DIAGNOSTICS BY SELECTED PHARMACEUTICAL
PARTNERS, 2009-2012 82
TABLE 29 GLOBAL COMPANION DIAGNOSTICS MARKET, THROUGH 2018 ($ MILLIONS) 84
TABLE 30 COMMON COMPANION DIAGNOSTICS TESTS IN CANCER APPLICATIONS,
2013 86
TABLE 31 MAIN HER2 TESTS, 2013 91
TABLE 32 KRISTEN RAS SARCOMA TEST MANUFACTURERS, 2010 ($) 95
TABLE 33 GLOBAL ONCOTYPEDX AND BRAC ANALYSIS MARKET, THROUGH 2018 ($
MILLIONS) 103
TABLE 34 U.S. CANCER STATISTICS, 2013 106
TABLE 35 U.S. ANNUAL HEALTHCARE COST FOR CANCERS, AND THE AMOUNT
SPENT ON SCIENTIFIC RESEARCH BY TYPE, 2010 AND 2011 ($ BILLIONS/$ MILLIONS) 107
TABLE 36 COST SAVINGS USING KRISTEN RAS SARCOMA COMPANION DIAGNOSTIC
TEST IN COLORECTAL CANCER PATIENTS 108
TABLE 37 GLOBAL DRUGS ASSOCIATED WITH COMPANION DIAGNOSTIC TESTS,
THROUGH 2018 ($ BILLIONS) 109
TABLE 38 PARTNERSHIPS BETWEEN PHARMA AND DIAGNOSTICS COMPANIES IN
ONCOLOGY, 2009 TO 2013 112
TABLE 39 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, THROUGH 2018
($ MILLIONS) 118
TABLE 40 COMPANION DIAGNOSTIC TESTS FOR METABOLIC DISEASES, 2013 119
TABLE 41 COLLABORATIONS BETWEEN COMPANION DIAGNOSTICS COMPANIES,
PHARMACEUTICAL COMPANIES AND ACADEMIC INSTITUTIONS, 2008 TO 2013 124
TABLE 42 U.S. AND GLOBAL DIABETES, HYPERCHOLESTEROLEMIA AND METABOLIC
SYNDROME MARKET, 2013 (MILLIONS/$ BILLIONS) 127
TABLE 43 U.S. CARDIOVASCULAR DISEASE AND HEALTHCARE COSTS, 2010 ($
MILLIONS/$ BILLIONS) 129
TABLE 44 COMPANION DIAGNOSTICS FOR CARDIOVASCULAR DISEASES, 2013 129
TABLE 45 U.S. WARFARIN TREATMENT, 2010 ( MILLIONS/NUMBER) 130
TABLE 46 WARFARIN SENSITIVTY TESTS BY MANUFACTURER, 2009 133
TABLE 47 GLOBAL PLAVIX MARKET, THROUGH 2012 ($ MILLIONS) 135
TABLE 48 PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES,
PHARMACEUTICAL COMPANIES AND ACADEMIC INSTITUTIONS IN THE
CARDIOVASCULAR DISEASE SECTOR, 2007-2011
137
TABLE 49 U.S. INCIDENCE OF HEART FAILURE AND ANNUAL HEALTHCARE COSTS,
2010 (MILLIONS/$ BILLIONS) 138
TABLE 50 COMPANION DIAGNOSTIC TESTS FOR CENTRAL NERVOUS SYSTEM
DISORDER DRUG THERAPY, 2013 142
TABLE 51 COMPANION DIAGNOSTICS COMPANIES DEVELOPING COMPANION ASSAYS
FOR CENTRAL NERVOUS SYSTEM DISORDERS, 2013 144
TABLE 52 PARTNERSHIPS BETWEEN DIAGNOSTICS AND PHARMACEUTICAL
COMPANIES IN COMPANION DIAGNOSTICS FOR CENTRAL NERVOUS SYSTEM
DISORDERS, 2010–2013
149
TABLE 53 U.S. STATISTICS AND HEALTHCARE COSTS OF SCHIZOPHRENIA,
ALZHEIMER'S DISEASE AND PARKINSON'S DISEASE, 2009 ($ BILLIONS) 154
TABLE 54 U.S. REPRESENTATIVE NEURODEGENERATION DISORDER AND
SCHIZOPHRENIA MARKET, 2013 ($ BILLIONS) 155
TABLE 55 REQUIP NET SALES, 2010–2012 ($ MILLIONS) 156
TABLE 57 COMPANION DIAGNOSTIC TESTS ON THE MARKET FOR INFECTIOUS
DISEASES, 2013 157
TABLE 58 MONOGRAM/LABCORP TROFILE SALES, 2008-2010 (MILLIONS) 159
TABLE 59 ENTRY INHIBITOR DRUG DISCOVERY AS A NEW OPPORTUNITY FOR THE
TROFILE ASSAY 160
TABLE 60 U.S. HUMAN IMMUNODEFICIENCY VIRUS STATISTICS AND HEALTHCARE
COSTS, 2009 (NUMBER/$ BILLIONS) 162
TABLE 61 GLOBAL HUMAN IMMUNODEFICIENCY VIRUS DRUG MARKET, 2013 AND
2018 ($ BILLIONS) 162
TABLE 62 PARTNERSHIPS IN THE FIELD OF COMPANION DIAGNOSTICS FOR
INFECTIOUS DISEASES BETWEEN DIAGNOSTICS AND PHARMACEUTICAL COMPANIES,
2009-2012
163
TABLE 63 COMPANION DIAGNOSTICS PRODUCTS IN VARIOUS CLINICAL
APPLICATIONS, 2013 166
TABLE 64 COMPANION DIAGNOSTICS TESTS MENTIONED IN THIS REPORT 175
TABLE 65 COMPANION DIAGNOSTICS INDUSTRY PRODUCTS, 2013 (%) 177
TABLE 66 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, THROUGH 2018
($ MILLIONS) 178
TABLE 67 GLOBAL COMPANION DIAGNOSTICS MARKET, THROUGH 2018 ($ MILLIONS) 179

LIST OF FIGURES

SUMMARY FIGURE GLOBAL COMPANION DIAGNOSTICS MARKET, 2011-2018 ($
MILLIONS) 7
FIGURE 1 PERSONALIZED MEDICINE PRODUCTS BY SEGMENT, 2008-2018 (%) 13
FIGURE 2 COMPANION DIAGNOSTICS INDUSTRY DRIVERS 21
FIGURE 3 COMPANION DIAGNOSTICS INDUSTRY CHALLENGES 24
FIGURE 4 GLOBAL PATENT APPLICATIONS IN VARIOUS BIOMARKER RESEARCH
FIELDS, 2012 54
FIGURE 5 GLOBAL ONCOTYPEDX AND BRAC ANALYSIS MARKET, 2009-2018 ($
MILLIONS) 103
FIGURE 6 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, 2009-2018 ($
MILLIONS) 118
FIGURE 7 COMPANION DIAGNOSTICS INDUSTRY PRODUCTS, 2013 (%) 177
FIGURE 8 COMPANION DIAGNOSTICS IN THE ONCOLOGY MARKET, 2009-2018 ($
MILLIONS) 178
FIGURE 9 GLOBAL COMPANION DIAGNOSTICS MARKET, 2011-2018 ($ MILLIONS) 179

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Companion Diagnostics: Technologies and Markets

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