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市場調査レポート

コンパニオン診断:技術および世界市場

Companion Diagnostics: Technologies and Markets

発行 BCC Research 商品コード 140110
出版日 ページ情報 英文 187 Pages
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コンパニオン診断:技術および世界市場 Companion Diagnostics: Technologies and Markets
出版日: 2013年11月30日 ページ情報: 英文 187 Pages
概要

世界のコンパニオン診断市場は、2012年に11億米ドルに達しました。同市場は、2013年には12億米ドルとなる見込みで、その後は23.9%のCAGRで拡大し、2018年には35億米ドルにまで成長することが予測されています。

当レポートでは、世界のコンパニオン診断市場について調査し、市場概要、開発状況、既存の市販製品、競合環境、および個別化医療市場におけるアッセイ開発に及ぼす影響などに関する分析を提供しており、市場参入企業のプロファイルなどをまとめ、概略以下の構成でお届けします。

第1章 イントロダクション

第2章 サマリー

第3章 コンパニオン診断業界の概要、構造および重要性

  • 個別化医療における新たな動向としてのコンパニオン診断
  • コンパニオン診断業界における現在の参入企業
  • コンパニオン診断業界発展の課題と障壁

第4章 コンパニオン診断業界の基礎としてのバイオマーカー・診断市場

  • コンパニオン診断業界の基礎としてのバイオマーカー市場
  • コンパニオン診断分野の基礎・促進因子としての対外診断産業

第5章 コンパニオン診断業界に規制状況、コストおよび医療費償還政策が及ぼす影響

第6章 個別化医療の動向がその他の産業の製品開発に及ぼす影響

  • 概要
  • 栄養・健康市場
  • 医療サービス・医療情報技術
  • 個別化医療における診断・治療市場
  • 直販もしくは在宅遺伝子検査
  • ヒトゲノムシーケンシング

第7章 コンパニオン診断・バイオマーカーの特許アプリケーション

  • 概要
  • コンパニオン診断産業における特許アプリケーション・供与特許

第8章 現行技術・コンパニオン診断技術

  • 概要
  • コンパニオン診断アッセイ開発における新しい動向・技術

第9章 コンパニオン診断市場の促進因子としての遺伝子に関する情報知識・医師の見解

  • 概要

第10章 コンパニオン診断業界の市場評価

  • 概要
  • 主なコンパニオン診断市場参入企業
  • 買収のメリット
  • コンパニオン診断企業と提携を形成する主な製薬企業
  • コンパニオン診断開発市場の推計

第11章 各調査領域におけるコンパニオン診断業界の概要

  • 癌におけるコンパニオン診断製品
  • 乳癌予測の遺伝子アッセイ
  • 乳癌インデックス・癌タイプの特定
  • 乳癌予測検査市場の分析
  • 薬物反応向けコンパニオン診断としての補助的分子マーカー・製品
  • 癌の統計、医療費および薬剤市場がコンパニオン診断の発展に及ぼす影響
  • 新しい医療エコノミクスモデル例としてのKRAS肉腫コンパニオン診断
  • 薬剤市場がコンパニオン診断の発展に及ぼす影響、ほか

第12章 市場サマリー

第13章 企業プロファイル

  • ABBOTT LABORATORIES
  • BIOMERIEUX SA
  • CELERA
  • DAKO (AGILENT TECHNOLOGIES)
  • GENOMIC HEALTH INC.
  • LABCORP
  • QIAGEN N.V.
  • QUEST DIAGNOSTICS INC.
  • ROCHE DIAGNOSTICS

第14章 本レポートで言及した企業

図表リスト

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目次
Product Code: BIO077B

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.

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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