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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

発行 BCC Research 商品コード 140110
出版日 ページ情報 英文 352 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: 2017年03月01日 ページ情報: 英文 352 Pages
概要

世界のコンパニオン診断(CDX)市場は、2015年に32億米ドルに達しました。同市場は、2016年には43億米ドルとなる見込みで、その後は32.3%のCAGRで拡大し、2021年には176億米ドル近く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、およびオーダーメード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、その結果をお届けします。

第1章 イントロダクション

第2章 サマリー

第3章 オーダーメード医療の概要

  • 概要
  • 主要な市場成長促進因子としての腫瘍学
  • コンパニオン診断の概要
  • 一般的な用途のカテゴリー
  • FDAの定義
  • FDA認証(許可)取得のためのFDA 510(k)申請および
  • 市販前承認(PMA)
  • 「FDA指定コンパニオン診断薬」以外のコンパニオン診断薬
  • 製薬会社によるコンパニオン診断薬の取引
  • 企業の種類
  • コンパニオン診断の歴史
  • 規制面
  • 主要企業
  • 癌市場部門
  • 技術概要
  • 償還制度
  • 導入促進因子
  • 導入障壁
  • コンパニオン診断薬の開発コスト
  • コンパニオン診断薬規制問題

第4章 癌以外のコンパニオン診断薬の適用

  • 範囲
  • 定着した臨床応用
  • ゲノム薬理学における現在の成功
  • 課題および将来の方向性
  • 検証
  • 感染症向けCDX
  • HIVの統計データおよび医療費
  • HIV治療薬市場
  • 代表的な製薬会社
  • VIIV(HIV/AIDS領域に特化したヴィーブヘルスケア)
  • HIVアッセイ用トロピズム
  • TROFILE アッセイの競合企業
  • 過敏症検査 HLA-B 5701
  • ワクチン開発における応用
  • 感染症向けコンパニオン診断薬の企業間提携および協業
  • HIV以外の適用
  • 市場予測

第5章 FDA指定コンパニオン診断:癌

  • 概要
  • 癌について
  • 乳癌
  • ハーセプチン(トラスツズマブ):ROCHE(GENENTECH)
  • KADCYLA: ROCHE (GENENTECH)
  • PERJETA: ROCHE (GENENTECH)
  • CDX FOR HERCEPTIN
  • HER2アッセイ企業
  • 上皮成長因子受容体 他
  • 市場予測

第6章 最新の技法・技術および市場構造

  • 概要
  • 組織診断:組織病理学
  • 組織診断の主な種類
  • 併用例
  • 組織診断市場
  • 細胞診断:免疫組織化学、原位置ハイブリッド形成法、DNA、定量的ポリメラーゼ連鎖反応
  • 免疫組織化学
  • 蛍光原位置ハイブリッド形成
  • ポリメラーゼ連鎖反応
  • 利点と問題点
  • 遺伝子配列解明技術(シーケンシング)
  • 市場動向
  • 要約
  • 成長促進因子としての次世代シーケンシング(NGS)
  • 市場を支配する用意のできているNGS
  • NGSプラットフォームにおけるプライマー
  • 薬事未承認検査法(LDTS)
  • 規制促進因子
  • 市場の反応
  • 市場予測

第7章 FDAの承認が不要なもの

  • 概要
  • 薬事未承認検査法(LDTS)
  • 乳癌業界
  • 疾患概要
  • 非浸潤性乳管癌(DCIS)の再発
  • ホルモン感受性
  • 予防
  • 過剰診断
  • 治療
  • 乳癌の標的治療
  • ハーセプチン向けコンパニオン診断
  • 新しい治療法
  • 診断方法およびトレンド
  • スクリーニング
  • 生体組織検査
  • 臨床検査
  • 市場成長促進因子
  • 最新の商業的状況
  • 技術
  • 癌の予測
  • 早期発見・スクリーニング検査
  • 薬事未承認検査法(LDTS):展望
  • 市場予測

第8章 新しい液体細胞診市場

  • 概要
  • 導入期
  • 現在の病気診断方法の限界
  • エクソソーム:実験(2015年7月)
  • 液体細胞診の手引きとしての非侵襲的出生前検査
  • 市場予測

第9章 世界共通のコンパニオン診断

  • 概要
  • 成長促進因子
  • ゲノム解読全体のアンメットニーズ
  • 市場予測

第10章 将来的な適用:循環器系疾患・代謝性疾患

  • 概要
  • 適用
  • 心筋虚血症・梗塞
  • 運動負荷テスト
  • アルコール中隔アブレーション 他
  • 市場

第11章 代表的な企業買収および企業プロファイル

図表リスト

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目次
Product Code: BIO077C

Report Highlights

The global market for companion diagnostics reached nearly $3.2 billion in 2015. This market is expected to increase from $4.3 billion in 2016 to nearly $17.6 billion in 2021 at a compound annual growth rate (CAGR) of 32.3% for 2016-2021.

Report Includes

  • 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 2015 and 2016, and projections of compound annual growth rates (CAGRs) through 2021.
  • 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.
  • Profiles of major players as well as a list of current companies that have new companion diagnostics products in development.

Report Scope

The scope of the report encompasses the major types of diagnostics technologies that have been used, the various industry structures such as the lab developed tests (LDTs) sector, and the major applications being commercialized and developed by a wide range of company types. It analyzes current market status, examines future market drivers and presents forecasts of growth over the next five years. Technology developments, including the latest trends, are discussed.

Analyst Credentials

Robert G. Hunter is a senior management consultant, commercialization consultant and technology and market analyst with over 20 years of experience in life sciences and healthcare. Recent consulting includes market/technology analysis and forecasting of customer adoption and revenue for a high content screening (HCS) technology leader. He is an early investor in a company using stem cells for predictive drug safety testing in vitro. He has a B.S. in Mechanical Engineering from Clemson University and Master of Business Administration from The Tuck School of Business at Dartmouth.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • SCOPE OF REPORT
  • INTENDED AUDIENCE
  • INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 - SUMMARY

  • SUMMARY TABLE: GLOBAL COMPANION DIAGNOSTICS MARKET BY CATEGORY, THROUGH 2021 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL COMPANION DIAGNOSTICS MARKET BY CATEGORY, 2015-2021 ($ MILLIONS)

CHAPTER 3 - PERSONALIZED MEDICINE OVERVIEW

  • OVERVIEW
    • TABLE 1: NOVEL NEW DRUG APPROVALS, 2011-2015
    • TABLE 2: NOVEL NEW DRUGS AND PERCENTAGE PERSONALIZED
    • TABLE 3: 2015 NEWLY APPROVED MEDICINES
    • 2015 PRECISION MEDICINE INITIATIVE
  • ONCOLOGY AS MAJOR DRIVER
    • POTENTIAL FOR PERSONALIZED MEDICINE
      • TABLE 4: POTENTIAL MARKETS FOR PERSONALIZED MEDICINE ($ BILLIONS)
      • Personalized Medicine Tests
        • TABLE 5 EXAMPLES OF PERSONALIZED MEDICINE TESTS
    • BIOMARKERS
      • TABLE 6: BIOMARKER APPLICATIONS (% OF R &D APPLICATIONS)
      • TABLE 7: BIOMARKERS USED IN COMPANION DIAGNOSTICS
  • COMPANION DIAGNOSTICS OVERVIEW
  • GENERAL APPLICATION CATEGORIES
  • FDA DEFINITION
    • COMPLEMENTARY DX
  • FDA CLEARED (510K) AND APPROVED (PMA) MARKET
    • FDA FULL CDX DESIGNATION
      • TABLE 8: FDA DESIGNATED CDX
    • BEYOND "FDA DESIGNATED CDX"
      • TABLE 9: PARTIAL LIST OF FDA CLEARED AND APPROVED TESTS FOR CDX APPLICATIONS
      • TABLE 10: PARTIAL LIST OF BIOMARKERS FOR FDA CLEARED AND APPROVED CDX TESTS
      • TABLE 11: CANCER BIOMARKERS IMPLEMENTED AS FDA CDX VS FDA CLEARED/APPROVED VS LDTS
      • TABLE 12: TOTAL TESTS CLEARED OR APPROVED BY FDA SINCE 2003
    • LDTS
  • PHARMACEUTICAL-DIAGNOSTIC DEALS
  • COMPANY TYPES
    • CURRENT MARKET PARTICIPANTS IN THE COMPANION DIAGNOSTICS FIELD ARE COMPRISED OF FOUR MAJOR GROUPS.
    • IN VITRO DIAGNOSTICS COMPANIES
      • IVD Diagnostics Industry
        • TABLE 13: MARKET SHARES OF MAJOR IN VITRO DIAGNOSTICS COMPANIES (%)
    • MOLECULAR DIAGNOSTICS INDUSTRY
      • TABLE 14: MOLECULAR DIAGNOSTICS COMPANIES AND REPRESENTATIVE REVENUE, 2013
      • TABLE 15: MARKET SHARE OF MDX SECTORS (%)
    • COMPANION DIAGNOSTICS COMPANIES
      • TABLE 16: REPRESENTATIVE LIST OF CDX COMPANIES
    • LABORATORY TEST SERVICES COMPANIES
    • BIOMARKER RESEARCH COMPANIES
    • MEDICAL CENTERS
  • HISTORY OF COMPANION DIAGNOSTICS
  • REGULATORY ASPECTS
  • KEY COMPANIES
  • CANCER MARKET SEGMENT
  • TECHNOLOGIES OVERVIEW
  • REIMBURSEMENT
  • DRIVERS OF ADOPTION
    • TABLE 17: PRICING FOR COMMON CANCER DRUGS ($)
    • TABLE 18: NINE FACTORS THAT INFLUENCE COMPANION DIAGNOSTIC DEVELOPMENT AND ADOPTION
  • BARRIERS TO ADOPTION
  • COST OF CDX DEVELOPMENT
  • CDX REGULATORY ISSUES
    • FDA ROUTE
    • LABORATORY-DEVELOPED TESTS ROUTE
    • CHOOSING A REGULATORY PATHWAY
    • OBSTACLES

CHAPTER 4 - CDX APPLICATIONS OTHER THAN CANCER

  • SCOPE
    • TABLE 19: ESTABLISHED AND EMERGING CDX APPLICATIONS
  • ESTABLISHED CLINICAL APPLICATIONS
    • OVERVIEW
    • BACKGROUND ON CLINICAL GENOMICS
    • EARLY FOCUS ON RARE DISEASES
    • CHALLENGE OF RARE DISEASE CLINICAL TRIALS
    • CYSTIC FIBROSIS EXPERIENCE
    • DRIVER FOR LABORATORY DEVELOPED TESTS
    • NEWBORN SCREENING PANEL
      • Key Learnings
    • DATA AGGREGATION AND MANAGEMENT
    • PATIENT BIAS VS ASYMPTOMATIC SCREENING
    • CYSTIC FIBROSIS
      • Diagnosis
      • Tests for Cystic Fibrosis
        • TABLE 20: TESTS FOR CYSTIC FIBROSIS
      • Targeted Drugs for Cystic Fibrosis
    • CTFR DIAGNOSTICS
    • NEXT-GENERATION SEQUENCING LEADERSHIP
    • PHARMACOGENOMICS
    • PHARMACOGENOMICS ADOPTION
  • CURRENT SUCCESSES IN PHARMACOGENOMICS
    • WARFARIN
    • SIMVASTATIN
    • CANCER DRUGS
      • Cisplatin Chemotherapy
      • Anthracyclines
      • G6PD Deficiency
        • TABLE 21: G6PD TESTING COMPANIES
      • Example: Elitek and Tumor Lysis Syndrome
    • LIVER ENZYME CYP2C19 AND CYP2D6
      • TABLE 22: CYP SENSITIVE DRUGS
    • CLOPIDIGREL
    • CODEINE
    • HUMAN LEUKOCYTE ANTIGEN B
      • Example: Abacavir
    • CARBAMAZEPINE
    • AZATHIOPRINE
    • MENTAL HEALTH
    • ANTIDEPRESSANTS
    • SEROTONIN
    • CATECHOL METHYL TRANSFERASE
    • PHARMACOKINETIC AND PHARMACODYNAMIC GENES
      • Commercial Example
  • CHALLENGES AND FUTURE DIRECTIONS
  • VALIDATION
  • INFECTIOUS DISEASE CDX
  • HIV STATISTICS AND HEALTHCARE COST
  • HIV DRUG MARKET
    • TABLE 23: GLOBAL HUMAN IMMUNODEFICIENCY VIRUS DRUG MARKET, 2013 AND 2018 ($ BILLIONS)
  • REPRESENTATIVE DRUG COMPANIES
  • VIIV
    • HIV DRUG-RESISTANCE TESTS
  • TROPISM FOR HIV ASSAY
  • COMPETITORS OF TROFILE ASSAY
  • HYPERSENSITIVITY TEST HLA-B 5701
    • TABLE 24: COMPANION DIAGNOSTIC TESTS ON THE MARKET FOR INFECTIOUS DISEASES, 2013
  • APPLICATIONS IN VACCINE DEVELOPMENT
  • PARTNERSHIPS AND COLLABORATIONS FOR COMPANION DIAGNOSTICS FOR INFECTIOUS DISEASES
    • TABLE 25: PARTNERSHIPS IN THE FIELD OF COMPANION DIAGNOSTICS FOR INFECTIOUS DISEASES BETWEEN DIAGNOSTICS AND PHARMACEUTICAL COMPANIES, 2009-2012
  • OTHER APPLICATIONS BEYOND HIV
    • HEPATITIS C- GENETIC TEST FOR IL28B
  • MARKET FORECAST
    • TABLE 26: GLOBAL MARKET FOR FDA CLEARED/APPROVED APPLICATIONS OTHER THAN CANCER BY CATEGORY, THROUGH 2021 ($ MILLIONS)

CHAPTER 5 - FDA DESIGNATED CDX--CANCER

  • OVERVIEW
    • TABLE 27: FDA DESIGNATED CDX BY RX
  • OVERVIEW OF CANCER
    • BACKGROUND: DOCETAXEL CHEMOTHERAPY
  • BREAST CANCER
    • OVERVIEW
    • HER2-POSITIVE BREAST CANCER
  • HERCEPTIN (TRASTUZUMAB): ROCHE (GENENTECH)
    • HERCEPTEST (DAKO NOW PART OF AGILENT)
  • KADCYLA: ROCHE (GENENTECH)
  • PERJETA: ROCHE (GENENTECH)
  • CDX FOR HERCEPTIN
    • TABLE 28: HER2 CDX TESTS FDA REQUIRED FOR HERCEPTIN
  • MANUFACTURERS OF HER2 ASSAYS
    • DAKO CORP - IHC ANTIBODY
    • FISH, EX PATHVYSION (ABBOTT LABORATORIES)
    • LIFE TECHNOLOGIES (THERMO FISHER)
    • OTHERS
    • OTHER HER2 DRUGS: TYKERB (LAPATINIB), NOVARTIS
    • HER2 FOR OTHER CANCERS
    • UNMET NEEDS
  • EPIDERMAL GROWTH FACTOR RECEPTOR
    • TABLE 29: FDA REQUIRED EGFR CDX TESTS
    • NON-SMALL-CELL LUNG CANCER
  • ERBITUX FOR NON-SMALL-CELL LUNG CANCER
  • TARCEVA (ERLOTINIB): ROCHE/ASTELLAS
  • IRESSA (GEFITINIB): ASTRAZENECA
  • GILOTRIF (AFATINIB): BOEHRINGER INGELHEIM
  • T790M MUTATION RESISTANCE
  • TAGRISSO (OSIMERTINIB OR AZD9291, ASTRAZENECA)
  • COBAS EGFR MUTATION TEST V2: ROCHE
  • OTHER DRUGS FOR LUNG CANCER
  • CDX: THERASCREEN (PCR)
  • COLORECTAL CANCER
    • BACKGROUND: AVASTIN: ROCHE (GENENTECH)
    • CDX: IHC AND FISH
    • VECTIBIX (PANITUMUMAB): AMGEN
    • CDX: EGFR PHARMDX KIT (DAKO)
    • ERBITUX (CETUXIMAB): ELI LILLY (IMCLONE)
  • EXCLUDING KRAS MUTATIONS
    • HEAD AND NECK CANCERS
  • EGFR CDX: LEADERS AND FOLLOWERS
    • DIFFERENCES IN THE U.S. AND EU
  • KRAS MARKET
    • TABLE 30: FDA REQUIRED KRAS CDX TESTS
  • KRAS LEADERS
  • ANAPLASTIC LYMPHOMA RECEPTOR TYROSINE KINASE
    • XALKORI (CRIZOTINIB), PFIZER'S APPROVED NSCLC THERAPY
    • CDX: ABBOTT VYSIS FISH FOR XALKORI
    • CDX: VENTANA
      • TABLE 31: FDA REQUIRED ALK CDX TESTS
  • ROS-1
  • IBRANCE
  • BRAF
    • ZELBORAF (VEMURAFENIB) MELANOMA: GENENTECH (ROCHE)
    • COBAS 4800 BRAF V600 MUTATION TEST
    • MEKINIST (TRAMETINIB) IN COMBINATION WITH TAFINLAR (DABRAFENIB): NOVARTIS
    • THXID-BRAF KIT (BIOMERIEUX INC.)
      • TABLE 32: FDA REQUIRED BRAF CDX TESTS
    • VENTANA BRAF V600 (VE1) ANTIBODY
    • BRAF FUTURE RESEARCH
  • BCR-ABL FOR CHRONIC MYELOGENOUS LEUKEMIA
    • OVERVIEW
      • TABLE 33: FDA REQUIRED CDX TESTS FOR GLEEVEC
    • CHRONIC MYELOGENOUS LEUKEMIA
    • BCR-ABL
    • GLEEVEC
    • TESTS FOR GLEEVEC TREATMENT
    • GASTROINTESTINAL STROMAL TUMOR
    • CDX: DAKO CYTOMATION'S C-KIT (9.7) PHARMDX S2
    • ASM AND MDS/MPD S2
    • CDX: LDTS BY ARUP LABORATORIES
  • BRCA1/2
    • OVERVIEW
  • CDX: BRACANALYSIS (MYRIAD GENETICS)
    • TABLE 34: FDA REQUIRED BRAC1/2 CDX TESTS
  • IMMUNE CHECKPOINT INHIBITORS: KEYTRUDA AND OPDIVO
  • PD-1 AND PD-L1 INHIBITORS: PROTEIN MARKERS
    • CDX: PD-L1 IHC 22C3 PHARMDX (DAKO)
  • MARKET FORECAST
    • TABLE 35: GLOBAL MARKET FOR FDA CLEARED/APPROVED CANCER APPLICATIONS BY CATEGORY, THROUGH 2021 ($ MILLIONS)

CHAPTER 6 - CURRENT TECHNIQUES, TECHNOLOGIES AND MARKET STRUCTURES

  • OVERVIEW
  • FOUNDATION: TISSUE DX- HISTOPATHOLOGY
  • MAJOR TYPES OF TISSUE DIAGNOSTICS
    • HEMATOXYLIN & EOSIN (H&E)
    • IMMUNOHISTOCHEMISTRY (IHC)
    • IN SITU HYBRIDIZATION (ISH)
  • IN PRACTICE USED TOGETHER
    • EXAMPLE: VENTANA (ROCHE)
  • TISSUE DX MARKET
    • DRIVER: FFPE COMPATIBILITY
      • Example: NanoString
    • DIGITAL PATHOLOGY AND QUANTITATIVE IMMUNOSTAINING
    • FUTURE DIGITAL TRANSFORMATION
    • IMAGING
  • CELL DX: IMMUNOHISTOCHEMISTRY, IN SITU HYBRIDIZATION, DNA, AND QUANTITATIVE POLYMERASE CHAIN REACTION
    • PROTEIN-BASED
    • CHROMOSOME-BASED
    • DNA-BASED
    • MRNA-BASED
    • MICRORNA-BASED
    • METABOLITE-BASED
    • IMAGING-BASED
  • IMMUNOHISTOCHEMISTRY (IHC)
    • EXAMPLE: DAKO (NOW PART OF AGILENT)
    • PRACTICAL APPLICATION
    • TISSUE CONTEXT IS KEY
    • CHALLENGES: QUANTIFICATION
    • NEWER IHC: QUANTITATIVE IMMUNOFLUORESCENCE (QIF)
    • FUTURE PERSPECTIVES
  • FLUORESCENT IN SITU HYBRIDIZATION
    • EXAMPLE: ABBOTT MOLECULAR DIAGNOSTICS
    • FISH VS IHC
    • CHROMOGENIC IN SITU HYBRIDIZATION
      • Example: Dako (Agilent)
  • POLYMERASE CHAIN REACTION
  • PROS AND CONS
    • TABLE 36: ADVANTAGES AND DISADVANTAGES OF THE MOST COMMON TECHNIQUES FOR COMPANION DIAGNOSTICS, 2013
    • DISCUSSION
  • GENE SEQUENCING
    • OVERVIEW
    • FUNCTIONAL GENOMICS
    • SOMATIC VS GERMLINE SEQUENCING
    • TOOLS USED IN FUNCTIONAL GENOMICS
      • Microarrays
    • HISTORY OF DNA SEQUENCING
    • OVERVIEW OF DNA SEQUENCING
    • RNA SEQUENCING
      • Next-Gen RNA Sequencing
      • Example: Qiagen
    • INCREASING SHARE
    • HEREDITARY CANCER MARKET LEADER
  • TRENDS
    • CURRENT TESTS MOSTLY SINGLE-TARGET
    • FUTURE: MORE MULTI-GENE PANELS
    • NOVEL PANELS DRIVE GROWTH AND COMPLEXITY
    • MOST COMMON GENES INCLUDED IN MYRIAD OF PRODUCTS
    • OTHER SEQUENCING APPROACHES
      • miRNA
        • Example: mRNA
    • OTHER TECHNOLOGIES
      • Proteomics
        • Proteomics Platforms
      • Metabolomics
      • Use in Multiplex Assays
  • RECAP
  • NGS AS A GROWTH DRIVER
  • NGS POISED TO DOMINATE
    • ENVISIONING NGS PANELS
    • ENABLING NEW PARADIGM: DX DRIVES RX
  • PRIMER ON NGS PLATFORMS
    • FDA-CLEARED MISEQDX
    • CLINICAL CHALLENGES FOR NGS
    • STANDARDIZATION CHALLENGES FOR NGS
  • LDTS: KEY MARKET STRUCTURE
    • BACKGROUND
    • LDT SHARE OF CDX
    • NGS DRIVING LDTS
  • REGULATORY DRIVERS
    • STRICTER REGULATION OF LDTS
  • MARKET RESPONSE
    • IMPLICATIONS
    • NGS DRIVING LIQUID BIOPSY TECHNOLOGY
  • MARKET FORECAST
    • TABLE 37: GLOBAL MARKET FOR FDA CLEARED/APPROVED CANCER APPLICATIONS BY CATEGORY, THROUGH 2021 ($ MILLIONS)

CHAPTER 7 - NOT FDA REQUIRED

  • OVERVIEW
    • FDA-APPROVED KITS OR TESTS: 510(K) AND PMA
  • LABORATORY-DEVELOPED TESTS
    • LDT SHARE OF CDX
    • LDT ADVANTAGES
    • INNOVATION: PANELS
    • LDT INDUSTRY STRUCTURE
    • REGULATORY OUTLOOK AND IMPACT
    • NEXT GEN INDUSTRY LEADERSHIP
    • KEY CONTEXT OF BREAST CANCER
  • BREAST CANCER INDUSTRY
    • OVERVIEW OF BREAST CANCER
    • BREAST CANCER TESTS
    • DRUG PIPELINE
    • KING OF PROGNOSTIC AND PREDICTIVE
    • TESTS TO GUIDE TREATMENT
    • NEXT-GEN DX DRIVERS
  • DISEASE OVERVIEW
    • CLASSIFICATION OF BREAST CANCER
    • BREAST CANCER EVALUATION
    • STAGE OF DISEASE
      • TABLE 38: BREAST CANCER STAGES AND SPECIFIC DIAGNOSIS
      • TABLE 39: SEER SUMMARY STAGE SYSTEM FOR BREAST CANCER
  • DUCTAL CARCINOMA IN SITU RECURRENCE
    • ONCOTYPE DX BREAST CANCER TEST
  • HORMONE SENSITIVITY
    • ESTROGEN RECEPTOR
    • HER2 TYPE
    • TRIPLE NEGATIVE
    • CAUSES, INCIDENCE AND RISK FACTORS
    • PATHOPHYSIOLOGY
    • ER POSITIVE
    • METASTATIC BREAST CANCER
  • PREVENTION
  • OVERDIAGNOSIS
  • TREATMENT
    • OVERVIEW
    • CANCER TREATMENT: LOCAL OR SYSTEMIC
    • DRIVEN BY STAGE
      • TABLE 40: BREAST CANCER STAGES
    • TREATMENT GUIDELINES
    • PROGNOSIS AFTER TREATMENT
    • HORMONE THERAPY
      • TABLE 41: HORMONE THERAPY TYPES FOR BREAST CANCER
      • TABLE 42: HORMONE THERAPY DRUGS FOR BREAST CANCER
      • Tamoxifen
    • AROMATASE INHIBITORS
      • TABLE 43: AROMATASE INHIBITORS FOR TREATING BREAST CANCER
      • Medications for Risk Reduction
      • Potential Harms of Medications for Risk Reduction
      • Current Guidelines
    • TRADITIONAL DRUGS
    • OVERVIEW
    • CHEMOTHERAPY
      • TABLE 44: CHEMOTHERAPY DRUGS FOR TREATING BREAST CANCER
    • DRUGS TO CONTROL SIDE EFFECTS OF BREAST CANCER TREATMENT
    • PLATINUM-BASED CHEMOTHERAPY
    • ADJUVANT AND NEO-ADJUVANT THERAPY
    • LIST OF FDA-APPROVED DRUGS
      • TABLE 45: DRUGS APPROVED TO TREAT BREAST CANCER
  • TARGETED THERAPIES FOR BREAST CANCER
    • HERCEPTIN (TRASTUZUMAB)
      • HER2 Status Testing
      • Herceptin for HER2-Low Breast Cancer
      • Herceptin as Adjuvant
        • TABLE 46: TARGETED THERAPEUTICS FOR BREAST CANCER
    • AVASTIN
    • KADCYLA: ROCHE (GENENTECH)
    • PERJETA: ROCHE (GENENTECH)
    • TYKERB (LAPATINIB): NOVARTIS
    • HER2 FOR OTHER CANCERS
    • UNMET NEEDS
  • CDX FOR HERCEPTIN
    • TABLE 47: HER2 CDX TESTS FDA REQUIRED FOR HERCEPTIN
  • EMERGING THERAPIES
    • TRIPLE NEGATIVE BREAST CANCER
    • PARP INHIBITORS
    • BRCA TARGETED OLAPARIB
  • DIAGNOSIS AND TRENDS
    • UNMET NEED: EARLY DETECTION AND DIAGNOSIS
      • TABLE 48: RECURRENCE RATES AT FIVE YEARS IN PATIENTS WITH LYMPH NODES THAT ARE POSITIVE FOR CANCER (%)
      • TABLE 49: FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE
  • SCREENING
    • EARLY IMAGING TESTS
    • MAMMOGRAPHY
      • Digital Mammograms
      • Usefulness of Mammography
    • MAGNETIC RESONANCE IMAGING OF THE BREAST
      • Breast Ultrasound
      • Ductal Lavage and Nipple Aspiration
        • TABLE 50: IMAGING TESTS THAT DETERMINE IF BREAST CANCER HAS SPREAD
  • BIOPSY
    • FINE NEEDLE ASPIRATION BIOPSY
    • CORE NEEDLE BIOPSY
    • VACUUM-ASSISTED BIOPSIES
    • SURGICAL (OPEN) BIOPSY
  • LABORATORY EXAMINATION
    • GRADES OF BREAST CANCER
      • TABLE 51: GRADES OF BREAST CANCER
  • MARKET DRIVERS
    • TISSUE DIAGNOSTICS
      • Three Major Types of Tissue Diagnostics
      • In Practice Used Together
        • Example: Ventana (Roche)
      • Market Dynamics
        • Driver: FFPE Compatibility
        • Example: NanoString
        • Future Digital Transformation
    • RESPONSE TO CHEMOTHERAPY
      • Chemotherapy Response Market
        • Examples: Genomic Health and Myriad Genomics
        • Extension: Colon Cancer
      • Oncotype DX for Colon Cancer
      • Myriad's Colaris
        • Extension: Lung Cancer
    • GENOMICS REVOLUTION
      • Hereditary Cancer Market
      • BRCA1/2
      • Myriad's Strategy
        • BRACAnalysis CDx
        • Hereditary Next Gen: MyRisk Panel
    • DNA REPAIR PATHWAYS
      • Platinum-based Chemo
      • PARP Inhibitors
      • New Myriad CDx HRD 2015
      • Tesaro HRD
        • TABLE 52: MYRIAD GENETICS/CDX PARTNERSHIPS
    • TREATMENT SELECTION
      • Breast Cancer: Decisions on Adjuvant Chemotherapy
        • Extension: Prostate Surveillance
          • Prostate Oncotype
          • Prostate RNA Expression Test
        • Extension: Melanoma Indeterminate Diagnosis
    • AUTOIMMUNE PROGRESSION (FUTURE)
      • Example: Vectra DA
  • CURRENT COMMERCIAL STATUS
  • TECHNOLOGIES
    • OVERVIEW
    • IMMUNOHISTOCHEMICAL
      • Example: Mammostrat
    • FLUORESCENT IN SITU HYBRIDIZATION
      • Chromogenic In Situ Hybridization
        • TABLE 53: IHC AND FISH HER2 TESTS
    • GENOMIC
      • TABLE 54: GENETIC TESTS FOR BREAST CANCER TREATMENT
      • Microarrays
      • Examples: Rotterdam vs Amsterdam
    • RT-PCR
      • Platform Comparison
        • TABLE 55: LEADING BREAST CANCER GENOMIC TESTS
      • Genomic Adoption Pre-NGS
        • Example: Hereditary Cancer Testing
        • Current Tests Mostly Single-Target
      • Next-generation Sequencing
      • Implications: More Multi-Gene Panels
    • LEADING BREAST CANCER GENOMIC TESTS
      • Oncotype DX Assay
      • MammaPrint by Agendia
      • Mammostrat
      • Comparison
    • OTHER GENOMIC TESTS
      • NanoString
      • ARUP
      • IHC4 Test
      • Ipsogen
    • OTHERS
      • TABLE 56: GENE EXPRESSION PROFILING TESTS
    • MOSTLY LDTS
  • CANCER PREDICTION
    • EXAMPLE: BRCA (MYRIAD)
      • TABLE 57: LABORATORIES OFFERING BRCA TESTS
  • EARLY DETECTION/SCREENING TESTS
  • RISK ASSESSMENT TESTS
    • TABLE 58: NEXT-GENERATION BREAST CANCER TESTS
    • DISCUSSION
  • LAB-DEVELOPED TESTS: OUTLOOK
    • BACKGROUND
      • TABLE 59: LABORATORY-DEVELOPED TEST PROVIDERS
    • STRICTER REGULATION OF LAB-DEVELOPED TESTS
    • MARKET RESPONSE
    • IMPLICATIONS
    • REIMBURSEMENT
  • MARKET FORECAST
    • TABLE 60: GLOBAL MARKET FOR LDT CANCER APPLICATIONS BY CATEGORY, THROUGH 2021 ($ MILLIONS)

CHAPTER 8 - EMERGING LIQUID BIOPSY MARKET

  • OVERVIEW
  • PHASES OF ADOPTION
  • LIMITATIONS OF CURRENT DISEASE DIAGNOSIS
    • LIMITATIONS OF MINIMALLY INVASIVE METHODS
    • UNMET NEED: LUNG CANCER
      • Lung Tissue Biopsy
        • TABLE 61: ADVANTAGES OF LIQUID BIOPSY
    • EXAMPLE: ROCHE DIAGNOSTICS
    • EXAMPLE: GENESTRAT AND VERISTRAT BY BIODESIX
    • UNMET NEED: BLADDER CANCER
      • Limitations of Urine Cytology
      • Limitations of Cystoscopy
    • EXAMPLE: ONCOCYTE TECHNOLOGY
    • UNMET NEED: THYROID CANCER
      • Example: Veracyte
    • SCREENING OPPORTUNITIES
    • EXAMPLE: LUNG CANCER COMPLEMENT TO CT SCANNING
      • Background
      • LDCT Scans for Smokers
    • EXAMPLE: ONCOCYTE
    • HUGE INCREASE IN SCREENING OPPORTUNITY
      • Example: Percepta by Veracyte
      • Follow-on Complementary Need: Pulmonology Idiopathic Pulmonary Fibrosis
    • TECHNOLOGY OVERVIEW
      • Circulating Tumor Cells
    • EARLIER APPROACHES
      • Example: CellSearch (Janssen Diagnostics, LLC)
        • TABLE 62: CTC PHENOTYPE CRITERIA USED BY CELLSEARCH
    • OTHER COMPANIES
      • ApoCell
    • LATER APPROACHES
    • WHOLE CELL APPROACH
      • iChip from MGH
    • CELL-FREE DNA AND CIRCULATING TUMOR DNA
      • Challenges in Circulating Tumor DNA Analysis
        • Sensitivity
        • Accuracy
        • Multiplexing
      • Example: Boreal Genomics
      • Example: Guardant Health
      • Largest Study to Date
    • ADDITIONAL APPLICATIONS
      • Breast Cancer Diagnostic Tests
        • Overview
        • Indeterminate Mammogram Problem
        • Confirmatory Application
        • Screening for MRI Recommended
        • Huge Screening Opportunity
      • Urine-Based Tests
        • Overview
        • Trovagene
        • Proprietary Sample Preparation
        • Business Strategy
        • Focus on BRAF and KRAS
        • Melanoma Monitoring Opportunity
      • BRAF Mutation Assay
        • KRAS Mutations
        • Colorectal Monitoring
    • KRAS PANCREATIC: SMALL BUT CLEARLY DEFINED
    • NSSCLC: SECONDARY EGFR MUTATION
    • KRAS AND RESPONSE TO ANTI-EGFR DRUGS
      • EGFR Mutation Assays
    • PD-L1 IN IMMUNO-ONCOLOGY
    • EXAMPLE: BIOCEPT
    • EXOSOMES
      • Example: Exosome Diagnostics
      • Example: Exosome Diagnostics
    • PANCREATIC CANCER
  • EXOSOMES: EXPERIMENT JULY 2015
    • MARKET DRIVERS
    • SHORTCOMINGS
    • UNMET: EARLY DETECTION
      • Example: Illumina Launching Grail
  • NONINVASIVE PRENATAL TESTING AS GUIDE FOR LIQUID BIOPSY
    • OVERVIEW
    • FROM NONINVASIVE PRENATAL TESTING TO MATERNAL CANCERS
    • NONINVASIVE PRENATAL TESTING ACCELERATES CELL-FREE DNA
      • TABLE 63: NONINVASIVE PRENATAL TESTING ADOPTION CYCLE
    • REIMBURSEMENT
    • STRENGTH OF NONINVASIVE PRENATAL TESTING COMPANIES
      • TABLE 64: GENETIC TESTING COMPANIES MARKET SHARES (%)
    • RECENT VENTURE FUNDING
      • TABLE 65: RECENT VENTURE FUNDING OF LIQUID BIOPSY COMPANIES
    • NONINVASIVE PRENATAL TESTING TESTS AND LEADING COMPANIES
      • Sequenom
      • Ariosa Now Roche
      • Verinata - Illumina
    • PATENT POOLING
      • Natera
    • HIGH RISK ONLY, SO FAR
    • NONINVASIVE PRENATAL TESTING MARKET OUTLOOK
    • NONINVASIVE PRENATAL TESTING PLANS FOR LIQUID BIOPSY
    • STATUS OF LIQUID BIOPSY MARKET
      • Example: Roche
      • Example: Foundation Medicine
      • Plan to Submit First CDx with Clovis
      • Foundation Sues Guardant
    • REGULATORY BACKDROP
      • Example: Pathway Genomics Reprimanded
      • Illumina Grail Strategy
    • TECHNICAL ISSUES
      • Circulating Tumor Cells
      • Cell-free DNA
    • FUTURE OUTLOOK
  • MARKET FORECAST
    • TABLE 66: GLOBAL MARKET FOR LIQUID BIOPSY TECHNOLOGY, THROUGH 2021 ($ MILLIONS)

CHAPTER 9 - UNIVERSAL CDX

  • OVERVIEW
    • TABLE 67: UNIVERSAL CDX COMPANIES
  • DRIVERS
    • RAPID INCREASE IN TARGETED THERAPIES
    • LIMITED AND POOR TISSUE QUALITY
    • PHYSICIAN DIFFICULTY WITH COMPLEXITY
    • OFF-LABEL PRESCRIPTION
    • DIFFICULTY INTEGRATING INTO CLINICAL PRACTICE
    • INCREASING FOCUS ON COMMUNITY PRACTICES
    • REGULATORY CHALLENGES
    • TECHNOLOGY DISRUPTION
    • ECONOMIC DISINCENTIVES
    • BIOMARKER CHALLENGES
    • PROGRESS FROM PROTEOMICS
    • METABOLOMICS ADVANTAGE
    • INCREASING MOLECULAR AND GENOMICS DRIVEN
    • EXISTING SINGLE MARKER AND GENE PANEL APPROACHES
  • UNMET NEED FOR WHOLE GENOME SEQUENCING
    • EXAMPLE: NANTHEALTH-GPS CANCER
    • CHALLENGES TO ADOPTION OF COMPREHENSIVE MOLECULAR ANALYSIS
    • EXAMPLES AND INITIAL ADOPTION
      • Foundation Medicine's One CDx Platform
        • Target Market
        • Community-based Focus
        • Early Adopters
        • Future Expansion
        • Future Market
        • Precision Medicine Exchange Consortium
        • Advocate Organizations
        • Progress and Reimbursement Challenges
        • Strategic Opptys via Biopharm Services
        • FoundationCore Insights
        • Molecular Profiling
          • Example: LUNG-MAP Trial
        • CDx Services
        • Progress Update
      • NantHealth: Universal CDX Platform
        • Decision Support Systems
        • Competitive Positioning
        • Potential Market
        • Cancer MoonShot 2020 Network
  • MARKET FORECAST
    • TABLE 68: GLOBAL MARKET FOR DECISION SUPPORT TOOLS FROM UNIVERSAL CDX DEVELOPERS BY CATEGORY, THROUGH 2021 ($ MILLIONS)

CHAPTER 10 - FUTURE APPLICATIONS: CARDIOVASCULAR AND METABOLIC DISEASE

  • OVERVIEW
  • APPLICATIONS
  • PLANNED MYOCARDIAL ISCHEMIA AND INFARCTION
  • EXERCISE STRESS TESTING
  • ALCOHOL SEPTAL ABLATION
  • NITRIC OXIDE METABOLIC PATHWAY
  • ANTHRACYCLINE-INDUCED CARDIOTOXICITY
  • ATRIAL FIBRILLATION
  • PULMONARY ARTERIAL HYPERTENSION
  • PULMONARY HYPERTENSION AS MITOCHONDRIA DYSFUNCTION
  • PULMONARY HYPERTENSION AND INSULIN RESISTANCE
  • ATHEROSCLEROSIS RISK
  • LIPID PROFILES
  • CHOLESTEROL
  • PARTICLES
  • CHOLESTEROL TESTING CLINICAL USES
  • STATINS
  • POSSIBLE ADVERSE DRUG REACTIONS
  • SERUM MARKERS
  • STATIN DOSE MARKER
  • COADMINISTRATION
  • METABOLIZATION DIFFERENCES
  • GENETIC VARIABILITY
  • LIPID PROFILE
  • BEYOND STATINS TO MULTIMARKER APPROACH
    • JUPITER TRIAL
  • JUPITER EXPANDS STATIN USE
  • JUPITER ALSO RAISES DIABETES RISK
  • GUIDELINES
  • SYSTEMIC AND VASCULAR INFLAMMATION
  • HIGH-SENSITIVITY C-REACTIVE PROTEIN
  • MYELOPEROXIDASE
  • LIPOPROTEIN-ASSOCIATED PHOSPHOLIPASE-A2
  • ADVANCED LIPID TESTING
  • APOLIPOPROTEIN B AND A1 (APOA1)
  • SMALL-DENSE LDL
  • LIPOPROTEIN (A)
  • HDL2B
  • PARTICLE TYPE
  • COMPANIES OFFERING ADVANCED LIPID TESTING
  • LIPOSCALE TEST
  • PRIMARY CARE PHYSICIANS
  • CLEVELAND HEARTLAB
  • NON-FASTING TRIGLYCERIDES
  • METABOLOMIC APPLICATIONS
  • LIPIDOMICS
  • CHOLINE METABOLISM
  • ACYLCARNITINES
  • TRIMETHYLAMINE N-OXIDE
  • MICROFLORA-DERIVED CHOLINE METABOLITES
  • LINK WITH GUT MICROFLORA
  • DIABETES AND PRE-DIABETES
  • INSULIN RESISTANCE
  • LINK WITH OBESITY NOT CONCLUSIVE
  • TOOLS TO DETECT INSULIN RESISTANCE
  • COMPANIES OFFERING INSULIN-RESISTANCE TESTING
  • OTHER INSULIN-RESISTANCE TESTING
    • BRANCHED-CHAIN AMINO ACIDS: INSULIN RESISTANCE VIA EXERCISE STRESS TESTING
    • BRANCHED-CHAIN AMINO ACIDS AND GASTRIC BYPASS
  • LIVER DISEASES
  • METHYLATION DEFICIENCY
  • FOLATE DEFICIENCY
  • CLINICAL LIVER DISEASE
    • DIAGNOSIS
    • TREATMENT
    • RESEARCH
    • PROGRESS ON NON-ALCOHOLIC FATTY LIVER DISEASE
    • ONE WAY LIVER GENOMICS
    • EUROPEAN ASSOCIATION FOR THE STUDY OF THE LIVER
    • APPLICATIONS IN LIVER RESEARCH
    • LIVER METABOLISM OVERVIEW
    • LIVER FUNCTION AND STRUCTURE
      • Hepatocytes or Parenchymal Cells
      • Specialized Liver Endothelial Cells
      • Non-Parenchymal Stellate and Kupffer Cells
      • Morphogen Signaling
      • In Vitro Applications
  • DRUG-INDUCED LIVER INJURY
    • EXAMPLE: KIYATEC
  • LIVER INFLAMMATION MODELS
    • EXAMPLE: HEPREGEN
    • LIVER REGENERATION
  • COMMERCIAL CONSIDERATIONS
    • LABORATORY-DEVELOPED TESTS
      • Example: Cleveland HeartLab
  • MARKET
    • TABLE 69: GLOBAL METABOLOMICS MARKET BY BIOMARKER, THROUGH 2020 ($ MILLIONS)

CHAPTER 11 - REPRESENTATIVE ACQUISITIONS AND COMPANY PROFILES

  • TABLE 70: REPRESENTATIVE ACQUISITIONS
  • ABBOTT DIAGNOSTICS INC.
  • ADVANCED CELL DIAGNOSTICS INC.
  • AGENDIA INC.
  • ALMAC GROUP
  • ALTHEADX
  • AMERITOX
  • AMGEN INC.
  • APPLIED BIOCODE
  • APOCELL INC.
  • ARRAYIT CORP.
  • ARUP LABORATORIES
  • ASSUREX HEALTH
  • ASTUTE MEDICAL INC.
  • ASURAGEN INC.
  • AUTOGENOMICS INC.
  • BECKMAN COULTER INC.
  • BIOCARTIS NV
  • BIOCEPT INC.
  • BIODESIX
  • BIOMERIEUX
  • BIO-RAD INC.
  • BIOTHERANOSTICS INC.
  • BOREAL GENOMICS
  • CANCER GENETICS INC.
  • CYPROTEX PLC
  • DNAVISION
  • ENZO LIFE SCIENCES INC.
  • EPIC SCIENCES
  • EPITHELIX SARL
  • EXACT SCIENCES CORP.
  • FLAGSHIP BIOSCIENCES INC.
  • GENEDATA
  • GENELEX CORP.
  • GENOMIC HEALTH
  • GENTRONIX LTD.
  • GUARDANT HEALTH INC.
  • HORIZON DISCOVERY LTD.
  • HTG MOLECULAR DIAGNOSTICS INC.
  • ILLUMINA INC.
  • IMSTAR S.A.
  • INIVATA INC.
  • IN VITRO TECHNOLOGIES
  • INTELLICYT CORP.
  • INTERTEK
  • IRIS BIOTECHNOLOGIES
  • JOHNSON & JOHNSON INC.
  • KIYATEC INC.
  • LABCORP
  • MDXHEALTH
  • MYRIAD GENETICS INC.
  • NATERA INC.
  • NEOGENOMICS LABORATORIES
  • NEUROPROOF GMBH
  • NOVARTIS INTERNATIONAL AG
  • PAMGENE INTERNATIONAL B.V.
  • PANACEA GLOBAL INC.
  • PATHWAY GENOMICS INC.
  • PFIZER INC.
  • PRECISION FOR MEDICINE
  • QIAGEN N.V.
  • QUEST DIAGNOSTICS
  • RANDOX BIOSCIENCES
  • ROCHE DIAGNOSTICS
  • SEQUENOM INC.
  • SIEMENS MEDICAL SOLUTIONS USA INC.
  • STEMINA BIOMARKER DISCOVERY INC.
  • SYNVIVO INC.
  • SYSMEX CORP.
  • THERANOSTICS HEALTH INC.
  • THERMO FISHER SCIENTIFIC INC.
  • TROVAGENE INC.
  • VENTANA MEDICAL SYSTEMS INC.
  • VIIV HEALTHCARE

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL COMPANION DIAGNOSTICS MARKET BY CATEGORY, THROUGH 2021 ($ MILLIONS)
    • TABLE 1: NOVEL NEW DRUG APPROVALS, 2011-2015
    • TABLE 2: NOVEL NEW DRUGS AND PERCENTAGE PERSONALIZED
    • TABLE 3: 2015 NEWLY APPROVED MEDICINES
    • TABLE 4: POTENTIAL MARKETS FOR PERSONALIZED MEDICINE ($ BILLIONS)
    • TABLE 5: EXAMPLES OF PERSONALIZED MEDICINE TESTS
    • TABLE 6: BIOMARKER APPLICATIONS (% OF R &D APPLICATIONS)
    • TABLE 7: BIOMARKERS USED IN COMPANION DIAGNOSTICS
    • TABLE 8: FDA DESIGNATED CDX
    • TABLE 9: PARTIAL LIST OF FDA CLEARED AND APPROVED TESTS FOR CDX APPLICATIONS
    • TABLE 10: PARTIAL LIST OF BIOMARKERS FOR FDA CLEARED AND APPROVED CDX TESTS
    • TABLE 11: CANCER BIOMARKERS IMPLEMENTED AS FDA CDX VS FDA CLEARED/APPROVED VS LDTS
    • TABLE 12: TOTAL TESTS CLEARED OR APPROVED BY FDA SINCE 2003
    • TABLE 13: MARKET SHARES OF MAJOR IN VITRO DIAGNOSTICS COMPANIES (%)
    • TABLE 14: MOLECULAR DIAGNOSTICS COMPANIES AND REPRESENTATIVE REVENUE, 2013
    • TABLE 15: MARKET SHARE OF MDX SECTORS (%)
    • TABLE 16: REPRESENTATIVE LIST OF CDX COMPANIES
    • TABLE 17: PRICING FOR COMMON CANCER DRUGS ($)
    • TABLE 18: NINE FACTORS THAT INFLUENCE COMPANION DIAGNOSTIC DEVELOPMENT AND ADOPTION
    • TABLE 19: ESTABLISHED AND EMERGING CDX APPLICATIONS
    • TABLE 20: TESTS FOR CYSTIC FIBROSIS
    • TABLE 21: G6PD TESTING COMPANIES
    • TABLE 22: CYP SENSITIVE DRUGS
    • TABLE 23: GLOBAL HUMAN IMMUNODEFICIENCY VIRUS DRUG MARKET, 2013 AND 2018 ($ BILLIONS)
    • TABLE 24: COMPANION DIAGNOSTIC TESTS ON THE MARKET FOR INFECTIOUS DISEASES, 2013
    • TABLE 25: PARTNERSHIPS IN THE FIELD OF COMPANION DIAGNOSTICS FOR INFECTIOUS DISEASES BETWEEN DIAGNOSTICS AND PHARMACEUTICAL COMPANIES, 2009-2012
    • TABLE 26: GLOBAL MARKET FOR FDA CLEARED/APPROVED APPLICATIONS OTHER THAN CANCER BY CATEGORY, THROUGH 2021 ($ MILLIONS)
    • TABLE 27: FDA DESIGNATED CDX BY RX
    • TABLE 28: HER2 CDX TESTS FDA REQUIRED FOR HERCEPTIN
    • TABLE 29: FDA REQUIRED EGFR CDX TESTS
    • TABLE 30: FDA REQUIRED KRAS CDX TESTS
    • TABLE 31: FDA REQUIRED ALK CDX TESTS
    • TABLE 32: FDA REQUIRED BRAF CDX TESTS
    • TABLE 33: FDA REQUIRED CDX TESTS FOR GLEEVEC
    • TABLE 34: FDA REQUIRED BRAC1/2 CDX TESTS
    • TABLE 35: GLOBAL MARKET FOR FDA CLEARED/APPROVED CANCER APPLICATIONS BY CATEGORY, THROUGH 2021 ($ MILLIONS)
    • TABLE 36: ADVANTAGES AND DISADVANTAGES OF THE MOST COMMON TECHNIQUES FOR COMPANION DIAGNOSTICS, 2013
    • TABLE 37: GLOBAL MARKET FOR FDA CLEARED/APPROVED CANCER APPLICATIONS BY CATEGORY, THROUGH 2021 ($ MILLIONS)
    • TABLE 38: BREAST CANCER STAGES AND SPECIFIC DIAGNOSIS
    • TABLE 39: SEER SUMMARY STAGE SYSTEM FOR BREAST CANCER
    • TABLE 40: BREAST CANCER STAGES
    • TABLE 41: HORMONE THERAPY TYPES FOR BREAST CANCER
    • TABLE 42: HORMONE THERAPY DRUGS FOR BREAST CANCER
    • TABLE 43: AROMATASE INHIBITORS FOR TREATING BREAST CANCER
    • TABLE 44: CHEMOTHERAPY DRUGS FOR TREATING BREAST CANCER
    • TABLE 45: DRUGS APPROVED TO TREAT BREAST CANCER
    • TABLE 46: TARGETED THERAPEUTICS FOR BREAST CANCER
    • TABLE 47: HER2 CDX TESTS FDA REQUIRED FOR HERCEPTIN
    • TABLE 48: RECURRENCE RATES AT FIVE YEARS IN PATIENTS WITH LYMPH NODES THAT ARE POSITIVE FOR CANCER (%)
    • TABLE 49: FIVE-YEAR SURVIVAL RATES CORRELATED WITH TUMOR STAGE
    • TABLE 50: IMAGING TESTS THAT DETERMINE IF BREAST CANCER HAS SPREAD
    • TABLE 51: GRADES OF BREAST CANCER
    • TABLE 52: MYRIAD GENETICS/CDX PARTNERSHIPS
    • TABLE 53: IHC AND FISH HER2 TESTS
    • TABLE 54: GENETIC TESTS FOR BREAST CANCER TREATMENT
    • TABLE 55: LEADING BREAST CANCER GENOMIC TESTS
    • TABLE 56: GENE EXPRESSION PROFILING TESTS
    • TABLE 57: LABORATORIES OFFERING BRCA TESTS
    • TABLE 58: NEXT-GENERATION BREAST CANCER TESTS
    • TABLE 59: LABORATORY-DEVELOPED TEST PROVIDERS
    • TABLE 60: GLOBAL MARKET FOR LDT CANCER APPLICATIONS BY CATEGORY, THROUGH 2021 ($ MILLIONS)
    • TABLE 61: ADVANTAGES OF LIQUID BIOPSY
    • TABLE 62: CTC PHENOTYPE CRITERIA USED BY CELLSEARCH
    • TABLE 63: NONINVASIVE PRENATAL TESTING ADOPTION CYCLE
    • TABLE 64: GENETIC TESTING COMPANIES MARKET SHARES (%)
    • TABLE 65: RECENT VENTURE FUNDING OF LIQUID BIOPSY COMPANIES
    • TABLE 66: GLOBAL MARKET FOR LIQUID BIOPSY TECHNOLOGY, THROUGH 2021 ($ MILLIONS)
    • TABLE 67: UNIVERSAL CDX COMPANIES
    • TABLE 68: GLOBAL MARKET FOR DECISION SUPPORT TOOLS FROM UNIVERSAL CDX DEVELOPERS BY CATEGORY, THROUGH 2021 ($ MILLIONS)
    • TABLE 69: GLOBAL METABOLOMICS MARKET BY BIOMARKER, THROUGH 2020 ($ MILLIONS)
    • TABLE 70: REPRESENTATIVE ACQUISITIONS

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL COMPANION DIAGNOSTICS MARKET BY CATEGORY, 2015-2021 ($ MILLIONS)
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