搭配診斷：技術及全球市場 是由出版商BCC Research在2010年11月所出版的。
這份英文市場調查報告書包含175 Pages 價格從美金4850起跳。
本報告為，匯整搭配診斷市場概要及結構、重要性、目前應用領域、市場參與企業簡介等，以下列摘要形式闡述。
第1章 簡介
第2章 摘要
第3章 搭配診斷產業概要、結構、重要性
- 以個別化醫療為新趨勢之搭配診斷
- 個別改善趨勢
- 目前搭配診斷產業參與者
- 搭配診斷產業挑戰及阻礙
- 以搭配診斷產業為基礎之生物標誌市場
- 搭配診斷現今科技
- 臨床醫生意見及基因數知識帶動搭配診斷市場，其他
第4章 各種研究領域中搭配診斷產業概要
- 癌症搭配診斷產品現況
- 癌症治療藥物市場之搭配診斷分析
- 製造商，其他
第5章 市場概要
第6章 企業概要
- ABBOTT LABORATORIES
- BIOMERIEUX SA
- CELERA CORP
- CLINICAL DATA INC.
- DAKO A/S
- LABCORP
- QIAGEN MANCHESTER LTD. (FORMER DXS LTD)
- QUEST DIAGNOSTICS INC.
- ROCHE DIAGNOSTICS (DIVISION OF ROCHE GROUP)
第7章 企業名錄
Abstract
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%.
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.
Table of Contents
Chapter- 1: INTRODUCTION -- Complimentary 3
- 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 3
- 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 51
- 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�c(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�c(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 REIMBURSMENT 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�c(CONTINUED) 31
- GENERAL IMPACT OF PERSONALIZED�c(CONTINUED) 32
- ADDITIONAL PERSONOLIZED 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�c(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 89
- 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 �c (Continued) 61
- Manufacturers �c (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 �c (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 �c (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 PAHRMACEUTICAL
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 6
- 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 9
- 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 14
- DIRECTORY OF COMPANIES 162
- DIRECTORY OF COMPANIES (CONTINUED) 163
- DIRECTORY OF COMPANIES (CONTINUED) 164
- DIRECTORY OF COMPANIES (CONTINUED) 165
- DIRECTORY OF COMPANIES (CONTINUED) 166
- DIRECTORY OF COMPANIES (CONTINUED) 167
- DIRECTORY OF COMPANIES (CONTINUED) 168
- DIRECTORY OF COMPANIES (CONTINUED) 169
- DIRECTORY OF COMPANIES (CONTINUED) 170
- DIRECTORY OF COMPANIES (CONTINUED) 171
- DIRECTORY OF COMPANIES (CONTINUED) 172
- DIRECTORY OF COMPANIES (CONTINUED) 173
- DIRECTORY OF COMPANIES (CONTINUED) 174
- DIRECTORY OF COMPANIES (CONTINUED) 175
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