Reportlinker Adds Companion Diagnostics: Technologies and Global Markets
NEW YORK, Dec. 14, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Companion Diagnostics: Technologies and Global Markets
http://www.reportlinker.com/p0341176/Companion-Diagnostics-Technologies-and-Global-Markets.html
INTRODUCTION
STUDY GOALS AND OBJECTIVES
This BCC Research report, Companion Diagnostics: Technologies and Global 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 about significant current players in this field of study, trends, and challenges, and 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 and more embraced by healthcare providers, the pharmaceutical industry and even insurance companies, in an attempt to reduce unnecessary expenses and costs for patients' treatments. Indeed, a new organization was formed called the Personalized Medicine Coalition (PMC), a nonprofit advocacy group that keeps close track of all the recent developments and propositions in this field.
Companion diagnostics is part of the "personalized medicine revolution." The field evolved as a continuation of biomarker studies and diagnostics testing. And although this area of industry is still young, it becomes more and more complicated and developed, with a number of successful FDA–approved products.
This study will provide knowledge of the current state of the companion diagnostics industry, new technologies in assay development, and more importantly, will describe potential novel commercial venues in this area of the healthcare industry.
SCOPE OF REPORT
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: oncology related products vs. cardiovascular diseases and other segments. This study describes current products in each area, identifies current market participants and, most importantly, notes the trends that are going to affect further product development in this area. The report also provides information about less–developed sectors of this market, and gives a list of current companies that have new companion diagnostics products in development.
METHODOLOGY AND INFORMATION SOURCES
Both primary and secondary research methodologies were used in preparing this study. The methodology employed a triangulating approach, which aids in validity.
Initially, a comprehensive and exhaustive search of the literature on assay development and already–marketed products was conducted. These secondary sources included assay development and science–related journals, textbooks, press releases, marketing literature, other product/promotional literature, annual reports, security analyst reports, and other publications. A patent search and analysis were also conducted.
In a second phase, a series of semistructured interviews were conducted with company representatives, bench scientists, marketing representatives, and other personnel at biotech and pharmaceutical companies. Other resources included academics, technology and consulting companies, which were rich sources of data. Subsequent analysis of the documents and interview notes was performed thoroughly.
INTENDED AUDIENCE
This report is intended for business development professionals, healthcare professionals, entrepreneurs, and other investment groups so that they can 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 less known to the public.
ANALYST CREDENTIALS
Dr. Marianna Tcherpakov has more than 7 years of experience as a bench scientist specializing in the area of biochemistry, cell biology and industrial assay development. She has contributed to a number of scientific publications and holds several patents. She has expertise as an assay development scientist and is familiar with this research field's trends and likely future developments.
Highlights
Oncotype Dx, although not FDS-approved, is still a lead product in the breast cancer diagnosis sector. Oncotype Dx is reimbursed by most insurance companies and therefore enjoys an increase in its sales number every year. Valued at $170 million in 2010, analysts believe that by 2015, Oncotype Dx for breast cancer risk recurrence and drug regimen may reach $300 million, a compound annual growth rate (CAGR) of 12%.
The approval of Selzentry for first time HIV patients is creating new opportunity for the assay Trofile, a companion diagnostic to Selzentry (Celsentri outside U.S.). As a result, Trofile is expected to reach an estimated $34 million by 2015, from $24 million in 2010, a compound annual growth rate (CAGR) of 7.2%.
Chapter- 1: INTRODUCTION -- Complimentary
STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THIS STUDY 1
SCOPE OF REPORT 1
METHODOLOGY AND INFORMATION SOURCES 2
INTENDED AUDIENCE 2
ANALYST CREDENTIALS 2
RELATED REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3
Chapter-2: SUMMARY
SUMMARY 4
SUMMARY TABLE U.S. NET SALES OF ONCOTYPE AND TROFILE THROUGH 2015 ($ MILLIONS) 5
SUMMARY FIGURE U.S. NET SALES OF ONCOTYPE AND TROFILE 2008-2015 ($ MILLIONS) 6
Chapter-3: OVERVIEW, STRUCTURE AND SIGNIFICANCE OF THE COMPANION DIAGNOSTICS INDUSTRY
COMPANION DIAGNOSTICS AS A NEW TREND IN PERSONALIZED MEDICINE 7
HISTORICAL OVERVIEW 7
TABLE 1 PERCENTAGE OF PRODUCTS IN EACH SECTOR OF THE COMPANION DIAGNOSTICS INDUSTRY (%) 8
FIGURE 1 PERCENTAGE OF PRODUCTS IN EACH SECTOR OF THE COMPANION DIAGNOSTICS INDUSTRY 8
PERSONALIZED MEDICINE TREND OVERVIEW 8
TABLE 2 OVERVIEW OF PERSONALIZED MEDICINE PRODUCTS 9
TABLE 3 PERCENTAGE OF EACH PERSONALIZED MEDICINE PRODUCT CATEGORY IN 2008 AND THEIR FORECAST, 2008 AND 2012 (%) 10
FIGURE 2 PERCENTAGE OF EACH PERSONALIZED MEDICINE PRODUCT CATEGORY IN 2008 AND THEIR FORECAST, 2008 AND 2012 (%) 10
FIGURE 2 (CONTINUED) 11
TABLE 4 ESTIMATE FOR COMPANION DIAGNOSTICS TEST MARKET FOR THERAPY SELECTION, THROUGH 2015 ($ MILLIONS) 12
CURRENT PARTICIPANTS IN THE COMPANION DIAGNOSTICS INDUSTRY 12
In Vitro Diagnostics, Biomarker and Companion Diagnostics Companies 12
In Vitro Diagnostics Companies 12
Biomarker Research Companies 12
Companion Diagnostics Companies 13
Laboratory Test Services Companies (CLIA Laboratories) 13
Pharmaceutical Companies 13
Regulatory Entities, Insurance Companies and Healthcare Providers 14
Regulatory Entities 14
Insurance Companies 14
Healthcare Providers 15
Patients, Physicians and Public Opinion as Additional Drivers of the Companion Diagnostic Industry 15
Patients, Physicians and…(Continued) 16
Organizations Supporting the Personalized Medicine Approach 17
FIGURE 3 DRIVERS OF COMPANION DIAGNOSTICS INDUSTRY 18
CHALLENGES AND OBSTACLES TO COMPANION DIAGNOSTICS INDUSTRY DEVELOPMENT 18
Challenges and obstacles of…(Continued) 19
FIGURE 4 CHALLENGES OF COMPANION DIAGNOSTICS INDUSTRY 20
BIOMARKERS MARKET AS BASIS FOR THE COMPANION DIAGNOSTICS INDUSTRY 21
TABLE 5 GLOBAL BIOMARKER MARKET ($ BILLIONS) 21
TABLE 6 WORLDWIDE MARKET FOR BIOMARKERS ACCORDING TO RESEARCH AREAS IN 2008 ($ BILLIONS) 22
CANCER BIOMARKERS 22
CARDIOVASCULAR DISEASE BIOMARKERS 22
CNS DISORDERS BIOMARKERS 23
IN VITRO DIAGNOSTICS (IVD) INDUSTRY AS A DRIVER FOR THE COMPANION DIAGNOSTICS FIELD 23
TABLE 7 ESTIMATE FOR MAJOR PLAYERS OF IVD COMPANIES IN 2010 (%) 24
EFFECT OF THE REGULATORY ASPECT ON COMPANION DIAGNOSTICS INDUSTRY DEVELOPMENT 25
TABLE 8 COMPANION DIAGNOSTICS, ASSOCIATED DRUGS AND REGULATORY APPROVAL STATE 26
COMPANION DIAGNSOTICS COST AND REIMBURSEMENT POLICIES AS DRIVERS FOR INDUSTRY DEVELOPMENT 27
TABLE 9 COMPANION DIAGNOSTICS COST EXAMPLES (DOLLARS) 28
TABLE 10 EXAMPLES OF COMPANION DIAGNOSTICS EFFECT ON HEALTHCARE SAVINGS ($ MILLIONS) 29
GENERAL IMPACT OF PERSONALIZED MEDICINE TREND ON MARKET DEVELOPMENT IN OTHER INDUSTRIES 30
TABLE 11 MARKET SEGMENT ESTIMATES IN PERSONALIZED MEDICINE 2010 AND 2015 ($ BILLIONS) 30
GENERAL IMPACT OF PERSONALIZED…(CONTINUED) 31
GENERAL IMPACT OF PERSONALIZED…(CONTINUED) 32
ADDITIONAL PERSONALIZED MEDICINE PRODUCTS ON THE MARKET 32
TABLE 12 ADDITIONAL PERSONALIZED MEDICINE PRODUCTS ON THE MARKET FOR THE GENERAL PUBLIC ($) 33
Direct to Consumer Genetic Tests or At–Home Genetic Tests 33
Direct to Consumer…(Continued) 34
Personal Genome Sequencing 35
PATENT APPLICATIONS FOR COMPANION DIAGNOSTICS AND BIOMARKERS 35
TABLE 13 PATENT APPLICATIONS WORLDWIDE IN DIFFERENT BIOMARKER RESEARCH FIELDS, 2009-2010 36
FIGURE 5 PATENT APPLICATION WORLDWIDE IN DIFFERENT BIOMARKER RESEARCH FIELDS, 2009-2010 37
EXAMPLES OF RECENT PATENT APPLICATIONS AND GRANTED PATENTS IN THE COMPANION DIAGNOSTICS INDUSTRY 37
Power3/StemTroniX 37
Aveo Pharmaceuticals 37
Clarient Inc. 38
Entelos 38
CURRENT TECHNIQUES AND TECHNOLOGIES FOR COMPANION DIAGNOSTICS 39
TABLE 14 ADVANTAGES AND DISADVANTAGES OF MOST COMMON TECHNIQUES FOR COMPANION DIAGNOSTICS 40
DIGITAL PATHOLOGY AND QUANTITATIVE IMMUNOSTAINING AS A NEW TREND IN COMPANION DIAGNOSTIC ASSAY DEVELOPMENT 41
NEW SCIENTIFIC APPROACHES TO COMPANION TEST DEVELOPMENT 42
MicroRNA (miRNA) Profiling 42
Imaging as a New Approach to Companion Diagnostics Tests 43
Cognitive Diagnostics as Companion Diagnostics Test 44
GENETIC KNOWLEDGE AND CLINICIAN OPINION AS DRIVERS FOR COMPANION DIAGNOSTICS MARKET 44
TABLE 15 STATISTICS IN THE U.S. FOR PHYSICIAN OPINION REGARDING COMPANION DIAGNOSTIC TESTS AS PART OF DIAGNOSIS AND PATIENT TREATMENT (%) 45
TABLE 16 CURRENT STATISTICS ON PHYSICIAN OPINION IN DIFFERENT ASPECTS OF PERSONALIZED MEDICINE IN THE U.S. (%) 45
TABLE 16 (CONTINUED) 46
LIST OF COMPANION DIAGNOSTICS COMPANIES AND EVALUATION OF MARKET PARTICIPANTS 46
TABLE 17 CURRENT MARKET PARTICIPANTS IN COMPANION DIAGNOSTICS 47
TABLE 17 (CONTINUED) 48
TABLE 17 (CONTINUED) 49
TABLE 17 (CONTINUED) 50
TABLE 17 (CONTINUED) 51
CURRENT MARKET ANALYSIS 51
Roche Diagnostics 51
Qiagen 51
DAKO, Quest Diagnostics and LabCorp 52
Other Competitors in the Market 52
"Newcomers" to Companion Diagnostics Field 53
Life Technologies 53
GenProbe 53
GE Healthcare 53
Acquisitions and Partnerships Trend 53
Major Pharmaceutical Companies as Partners for Companion Diagnostics Companies 54
TABLE 18 EXAMPLES OF PARTNERSHIPS BETWEEN PHARMA AND DIAGNOSTIC COMPANIES AND TESTS DEVELOPED BETWEEN 2007 AND 2010 54
TABLE 19 NUMBER AND PERCENTAGE OF DEALS IN COMPANION DIAGNOSTICS ACCORDING TO RESEARCH AREAS 2004-2008 55
Failures and Lessons from Companion Diagnostics Development 55
Nanosphere Inc. 56
Perlegen 56
Sequenom 56
Companion Tests as a Strategy to Improve Drug Sales Performance 57
Companion Diagnostics as a Strategy for "Failing" Drugs 57
Chapter-4: COMPANION DIAGNOSTICS INDUSTRY OVERVIEW IN DIFFERENT RESEARCH AREAS
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS IN CANCER 58
OVERVIEW 58
TABLE 20 COMMON COMPANION DIAGNOSTIC TESTS IN CANCER APPLICATIONS 58
TABLE 20 (CONTINUED) 59
MAIN COMPANION DIAGNOSTICS ASSAY IN ONCOLOGY DRUG MARKET 59
Her2 Test 59
Manufacturers of Her2/neu Assay 60
Manufacturers … (Continued) 61
Manufacturers … (Continued) 62
Kirsten Ras Sarcoma (KRAS) Test 63
KRAS Test Market Participants 63
TABLE 21 PRICE COMPARISON FOR DIFFERENT KRAS TEST MANUFACTURERS (DOLLARS) 64
EGFR Expression Test 65
Manufacturers of EGFR Kits 65
UGT1A1 test 66
Genetic Assays for Breast Cancer Prognosis 67
BRCA1/2 67
Aviara Breast Cancer Index/Cancer Type ID/ Aviara MGI 68
MammaPrint 68
Oncotype Dx 69
Mammostrat 69
Market Analysis for Cancer Prognosis Testing 69
TABLE 22 SALES OF ONCOTYPE DX WORLDWIDE, THROUGH 2015 ($ MILLIONS) 70
FIGURE 6 SALES OF ONCOTYPE DX WORLDWIDE, THROUGH 2015 ($ MILLIONS) 70
Additional Molecular Markers and Products as Companion Diagnostics for Drug Response 71
Target GI Analysis for Erbitux/Vectibix/Fluorouracil/Camptosar Treatments 71
BCR–ABL Analysis for Gleevec Treatment 71
Thiopurine S–methyltransferase (TPMT) Activity for Purinethol/Thioguanine/ Azathioprine Treatments 72
Deficiency of Dihydropyrimidine Dehydrogenase (DPD) Activity for 5–Fluorouracil 72
CupPrint for Chemotherapy Treatments 72
G6PD Deficiency for Elitek Treatment 73
PGx Predict for Rituximab Treatment 73
c–Kit for Gleevec Treatment in Stomach Cancer 73
CD33 Marker for Mylotarg Treatment 73
CD25 Marker for Ontak Therapy 74
SUMMARY OF COMPANION DIAGNOSTICS ONCOLOGY MARKET 74
TABLE 23 MARKET SHARE FOR COMPANION DIAGNOSTICS KIT DEVELOPERS IN THE ONCOLOGY MARKET, 2010 (%) 74
FIGURE 7 MARKET SHARE FOR COMPANION DIAGNOSTICS KIT DEVELOPERS IN ONCOLOGY MARKET, 2010 (%) 75
INFLUENCE OF CANCER STATISTICS, HEALTHCARE COSTS AND DRUG MARKET ON COMPANION DIAGNOSTICS DEVELOPMENT 75
CANCER STATISTICS OVERVIEW 75
TABLE 24 TOTAL U.S. CANCER STATISTICS AS ESTIMATED BY ACS AND NCI, 2010 76
Breast Cancer 76
Lung Cancer 76
Colorectal Cancer 76
Leukemia 77
HEALTHCARE COSTS AS A FACTOR FOR COMPANION DIAGNOSTICS DEVELOPMENT 77
TABLE 25 AVERAGE ANNUAL HEALTHCARE COST FOR DIFFERENT TYPES OF CANCER IN THE U.S. AND AMOUNT SPENT ON SCIENTIFIC RESEARCH IN 2008 77
KRAS Companion Diagnostics as an Example for New Health Economics Model 77
TABLE 26 ESTIMATE FOR COST SAVINGS USING COMPANION DIAGNOSTIC TEST FOR KRAS IN COLORECTAL CANCER PATIENTS 78
EFFECT OF DRUG MARKET ON COMPANION DIAGNOSTICS PRODUCT DEVELOPMENT 78
TABLE 27 EXAMPLES OF DRUGS SALES WORLDWIDE ASSOCIATED WITH COMPANION DIAGNOSTICS TESTS ON THE MARKET ($ BILLIONS) 79
Herceptin and Her2 Test 79
Vectibix and KRAS test 80
PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND THE PHARMACEUTICAL INDUSTRY IN THE ONCOLOGY SECTOR 80
OVERVIEW 80
TABLE 28 EXAMPLES OF PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND THE PHARMACEUTICAL INDUSTRY IN ONCOLOGY, 2004-2009 81
Qiagen/DxS and Partnerships 82
DxS/ Amgen 82
DxS/ Bristol–Myers Squibb/ImClone Systems 82
DxS/ Exosome Diagnostics 83
DxS/ Genzyme Corporation 83
DxS/AstraZeneca 83
DxS/Boehringer 83
Amgen/Lab21 83
Almac Diagnostics Partnerships 84
Almac Diagnostics/Eli Lilly 84
Almac Diagnostics/Merck KGaA and U.K. Medical Research Council 84
Abbott Diagnostics/ Pfizer 84
Ipsogen/ ARUP 84
Epigenomics/Bristol–Meyer Squibb (BMS) and J&J 85
Celera/Merck and Abbott Laboratories 85
DAKO Partnerships 85
DAKO/Genentech (Roche) 85
DAKO/OSI Pharmaceuticals and BMS 85
DAKO/ Genentech, OSI Pharmaceuticals and Roche 86
Roche/ Plexxikon 86
BioMerieux/Ipsen 86
NEW DEALS AND PARTNERSHIPS BETWEEN PHARMACEUTICAL COMPANIES AND COMPANION DIAGNOSTICS IN ONCOLOGY (DURING 2010) 87
OVERVIEW 87
TABLE 29 RECENT PARTNERSHIPS AND COLLABORATIONS BETWEEN PHARMA, ACADEMICS AND COMPANION DIAGNOSTICS COMPANIES DURING 2010 87
Almac Diagnostics/Aeterna Zentaris 88
Althea DX/The Nicholas Conor Institute for Pediatric Cancer Research 88
BioMerieux/GSK 88
Companion Diagnostics Inc./University of Indianapolis 89
DAKO/AstraZeneca 89
DxS (Qiagen)/Pfizer 89
DxS (Qiagen)/ Johns Hopkins University (JHU) 89
Response Genetics/GSK 90
TCLand Expression/Inserm 90
Ventana Medical Systems/Clavis Pharma ASA 90
ANALYSIS OF PARTNERSHIPS TREND 91
CURRENT COMPANION DIAGNOSTICS TESTS ON THE MARKET FOR METABOLIC DISORDERS 91
OVERVIEW 91
TABLE 30 COMPANION DIAGNOSTICS TESTS ON THE MARKET FOR METABOLIC DISEASES 92
Fibromax 92
Entelos 93
Lipomics Technologies/Tethys Bioscience 93
Biocrates –Companion Diagnostics Development 94
Genomas–PhyzioType System 94
LDLR/Atorvastatin 95
PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND PHARMACEUTICALS/ACADEMICS IN DEVELOPMENT OF COMPANION ASSAYS FOR METABOLIC DISORDERS 96
OVERVIEW 96
TABLE 31 PARTNERSHIPS AND COLLABORATION BETWEEN COMPANION DIAGNOSTICS COMPANIES AND PHARMACEUTICALS/ACADEMICS, 2005-2010 96
Lipomics Technologies (Tethys Bioscience)/Joslin Diabetes Center (Harvard Medical School) 96
Genomas/ University of Puerto Rico Medical Science Campus 97
deCODE Genetics/Celera Corp. 97
Siemens/LabCorp 97
Celgene Corp./ Agios Pharmaceuticals Inc. 98
Biocrates/Pfizer, Altana Pharma 98
MARKET POTENTIAL FOR COMPANION DIAGNOSTICS TESTS IN METABOLIC DISORDERS 98
TABLE 32 STATISTICS AND MARKET SIZE FOR DIABETES, HYPERCHOLESTEROLEMIA AND METABOLIC SYNDROME IN THE U.S., 2009 98
Market Potential for Companion … (Continued) 99
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS IN CARDIOVASCULAR DISEASES 100
OVERVIEW 100
TABLE 33 ANNUAL STATISTICS FOR CARDIOVASCULAR DISEASE IN THE U.S. AND RELATED HEALTHCARE COSTS 100
TABLE 34 CURRENT EXAMPLES OF COMPANION DIAGNOSTICS ON THE MARKET FOR CARDIOVASCULAR DISEASES 101
Companion Diagnostics Test for Coumadin (Warfarin) 101
TABLE 35 ANNUAL STATISTICS FOR COUMADIN TREATMENT IN THE U.S., 2010 101
Manufacturers of Companion Diagnostics Test for Warfarin (Coumadin) 102
Nanosphere Inc 102
AutoGenomics 102
Osmotech/Genmark Diagnostics 103
ParagonDx 103
Entrogen 103
Kimball Genetics 103
Additional Companies 103
Market Analysis for Warfarin Test Competitors 104
Market Analysis for … (Continued) 104
TABLE 36 COMPARISON OF FOUR TESTS FOR WARFARIN SENSITIVTY BY FOUR DIFFERENT MANUFACTURERS 105
Companion Diagnostics for Plavix 106
Protein C Deficiency Test for Warfarin Sensitivity 106
Drug Market Associated with Cardiovascular Companion Diagnostics 106
Coumadin 106
Plavix 107
TABLE 37 NET SALES FOR PLAVIX ($ MILLIONS) 108
PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND PHARMACEUTICALS IN CARDIOVASCULAR DISEASES 109
TABLE 38 CURRENT PARTNERSHIPS BETWEEN COMPANION DIAGNOSTICS COMPANIES AND PHARMACEUTICALS OR ACADEMICS IN THE CARDIOVASCULAR DISEASES SECTOR 109
LABCORP/ARCA BIOPHARMA (NUVELO SUBSIDIARY) 109
TABLE 39 U.S. STATISTICS FOR HEART FAILURE AND ANNUAL HEALTHCARE COST 110
AFFOMIX CORP./UNIVERSITY OF MONTREAL PHARMACOGENOMICS CENTRE AND MONTREAL HEART INSTITUTE 111
CELERA CORP./DECODE GENETICS 112
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS IN CNS DISORDERS 113
TABLE 40 CURRENT COMPANION DIAGNOSTICS TESTS ON THE MARKET FOR CNS DISORDERS DRUG THERAPY 113
HLA–B*1502 ALLELE TESTING 113
PHYZIOTYPE PIMS 114
CURRENT COMPANION DIAGNOSTICS COMPANIES DEVELOPING COMPANION ASSAYS IN CNS DISORDERS 114
TABLE 41 CURRENT COMPANION DIAGNOSTICS COMPANIES DEVELOPING COMPANION ASSAYS IN CNS DISORDERS 115
SALADAX BIOMEDICAL 115
CYTOX 115
CURIDIUM MEDICA (AVACTA COMPANY) 116
EXONHIT 116
POPULATION DIAGNOSTICS 116
POWER3 MEDICAL PRODUCTS 117
PROTAGEN 117
CURRENT PARTNERSHIPS BETWEEN DIAGNOSTIC COMPANIES AND THEIR PHARMACEUTICAL PARTNERS DEVELOPING COMPANION TESTS IN CNS DISORDERS 118
TABLE 42 RECENT PARTNERSHIPS IN THE FIELD OF COMPANION DIAGNOSTICS FOR CNS DISORDERS BETWEEN DIAGNOSTICS AND PHARMACEUTICAL COMPANIES 119
PSYNOVA NEUROTECH (RBM)/ROCHE 119
CURIDIUM MEDICA/TAKEDA 120
SALADAX BIOMEDICAL/BRISTOL–MYERS SQUIBB 120
POWER3 MEDICAL PRODUCTS/STEMTRONIX 120
PROTAGEN/ GERMAN FEDERAL MINISTRY OF RESEARCH AND EDUCATION'S BIOPHARMA COMPETITION 121
EXONHIT/ALLERGEN 121
STATISTICS, HEALTHCARE COST AND DRUG MARKET FOR CNS DISRODERS AS AN ESTIMATE FOR COMPANION DIAGNOSTICS ASSAY DEVELOPMENT 122
TABLE 43 STATISTICS AND HEALTHCARE COST OF SCHIZOPHRENIA, ALZHEIMER'S AND PARKINSON'S IN THE U.S. 2009 ($ BILLIONS) 122
TABLE 44 CURRENT MARKET SIZE FOR NEURODEGENERATION DISORDERS AND SCHIZOPHRENIA IN THE U.S. ($ BILLIONS) 123
SCHIZOPHRENIA AS A MARKET FOR COMPANION DIAGNOSTICS DEVELOPMENT 123
NEURODEGENERATIVE DISORDERS AS A MARKET FOR COMPANION DIAGNOSTICS DEVELOPMENT 124
Parkinson's and Current Drug Treatment 124
TABLE 45 NET SALES OF MIRAPEX AND REQUIP 2007-2009 ($ MILLIONS) 125
Alzheimer's and Current Drug Treatment 125
TABLE 46 NET SALES OF NAMENDA AND ARICEPT 2007-2009 ($ MILLIONS) 126
BIOMARKER RESEARCH FOR NEURODEGENERATION AS A DRIVER FOR COMPANION DIAGNOSTICS 126
Alzheimer's Biomarker Trend 126
Alzheimer's Biomarker Trend (Continued) 127
Main CSF Biomarkers in Alzheimer's 128
A?1–42 128
Total tau protein 128
Hyperphosphorylated tau (P–tau) 128
Isoprostanes 128
Cytokines 128
Other Biomarkers 129
Parkinson's Biomarker Trend 129
Future Trends for Development of Companion Diagnostics for CNS Disorders 130
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS TESTS IN INFECTIOUS DISEASES 130
TABLE 47 CURRENT COMPANION DIAGNOSTICS TESTS ON THE MARKET FOR INFECTIOUS DISEASES 131
GENETIC TEST FOR HLA–B 5701 131
TROPISM FOR HIV ASSAY 131
TABLE 48 REVENUES FROM TROFILE SALES BY MONOGRAM/LABCORP ($ MILLIONS) 132
Competitors of Trofile Assay 132
Other New Opportunities for Trofile Use 133
TABLE 49 ENTRY INHIBITORS DRUG DISCOVERY AS NEW OPPORTUNITY FOR TROFILE ASSAY 134
Selzentry as an HIV Trofile Dependent Drug 134
HIV Drug Resistance Tests 135
HIV STATISTICS AND HEALTHCARE COST AS A FACTOR FOR COMPANION DIAGNOSTICS SALES FORECAST 136
TABLE 50 HIV STATISTICS AND HEALTHCARE COST IN THE U.S., 2009 137
HIV DRUG MARKET 137
TABLE 51 MARKET FOR HIV DRUGS WORLDWIDE 2010 AND 2015 ($ BILLIONS) 137
CURRENT PARTNERSHIPS AND COLLABORATIONS FOR COMPANION DIAGNOSTICS FOR INFECTIOUS DISEASES 138
TABLE 52 RECENT PARTNERSHIPS IN THE FIELD OF COMPANION DIAGNOSTICS FOR INFECTIOUS DISEASES BETWEEN DIAGNOSTICS AND PHARMACEUTICAL COMPANIES 139
MitoSciences/University of Oregon 139
LabCorp (Monogram Bioscience)/Pfizer /Shering Plough/Progenics/Gilead Science/Avexa 139
Lab21/Innogenetics 140
CURRENT PRODUCTS FOR COMPANION DIAGNOSTICS IN OTHER DISEASES 141
TABLE 53 CURRENT COMPANION DIAGNOSTICS PRODUCTS IN DIFFERENT CLINICAL APPLICATIONS 141
ALLOMAP GENE PROFILE 141
HLA TESTING 142
COMPANION DIAGNOSTICS TESTS DEVELOPMENT IN DRUG METABOLISM 143
Cytochrome P450 2C9 (CYP2C9) 144
NAT (N–acetyltransferase) 144
Amplichip CYP2D6/CYP2C19 145
SEROLOGY 7 TEST FOR IBD 145
Serology 7 Test for IBD (Continued) 146
Chapter-5: MARKET SUMMARY
TABLE 54 LIST OF COMPANION DIAGNOSTICS PRODUCTS ON THE MARKET MENTIONED IN THE REPORT 147
TABLE 54 (CONTINUED) 148
TABLE 55 PRODUCTS IN EACH INDUSTRY SECTOR IN THE COMPANION DIAGNOSTICS INDUSTRY (%) 149
FIGURE 8 PRODUCTS IN EACH INDUSTRY SECTOR IN THE COMPANION DIAGNOSTICS INDUSTRY (%) 149
TABLE 56 U.S. NET SALES OF ONCOTYPE AND TROFILE, THROUGH 2015 ($ MILLIONS) 150
FIGURE 9 U.S. NET SALES OF ONCOTYPE AND TROFILE 2008-2015 ($ MILLIONS) 150
TABLE 57 ESTIMATE FOR COMPANION DIAGNOSTICS TEST MARKET FOR THERAPY SELECTION, THROUGH 2015 ($ MILLIONS) 151
FIGURE 10 ESTIMATE FOR COMPANION DIAGNOSTICS TEST MARKET FOR THERAPY SELECTION 2010 AND 2015 ($ MILLIONS) 152
Chapter-6: SELECTED COMPANIES OVERVIEW
ABBOTT LABORATORIES 153
BIOMERIEUX SA 154
CELERA CORP 155
CLINICAL DATA INC. 156
DAKO A/S 157
LABCORP 158
QIAGEN MANCHESTER LTD. (FORMER DXS LTD) 159
QUEST DIAGNOSTICS INC. 160
ROCHE DIAGNOSTICS (DIVISION OF ROCHE GROUP) 161
Chapter-7: DIRECTORY OF COMPANIES
DIRECTORY OF COMPANIES 162
DIRECTORY OF COMPANIES (CONTINUED) 163
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Diagnostics Industry: Companion Diagnostics: Technologies and Global Markets
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