The World Market for Companion Diagnostic Tests

The World Market for Companion Diagnostics

The World Market for Companion Diagnostics examines revenues for companion diagnostic and personalized medicine diagnostics. Market analysis in this market review includes regional coverage – North America, Europe, rest of world – of the world IVD companion diagnostics test market (in vitro diagnostic kits) for 2015-2020, coverage by disease segment – cancer and other – of the world IVD companion diagnostics test market for 2015, and coverage of the worldwide companion diagnostics test services market for 2015 and 2020. The report reviews emerging and current applications of personalized medicine, including selected major biomarkers in oncology personalized medicine tests and selected companies with personalized medicine tests for oncology, cardiovascular disease/disorders, and neurological disorders. Pfizer, Inc., Novartis AG, Roche (F. Hoffmann-La Roche Ltd.), Merck & Co., Inc., and GlaxoSmithKline plc are among the manufacturers analyzed of the selected pharmaceutical companies that are active in the fields of companion diagnostics or personalized medicine.


  • Executive Summary
    • OVERVIEW
    • SCOPE AND METHODOLOGY
    • MARKET OVERVIEW
      • Table Worldwide IVD Companion Diagnostic Market, 2015 and 2020
    • PROGNOSIS FOR GROWTH
  • Introduction
    • TERMS USED IN COMPANION DIAGNOSTICS AND PERSONALIZED MEDICINE
    • DEFINITIONS OF COMPANION DIAGNOSTICS AND PERSONALIZED MEDICINE USED IN THIS REPORT
    • TYPES OF TESTS INCLUDED IN COMPANION DIAGNOSTICS MARKET DATA
    • TECHNOLOGY USED IN PERSONALIZED MEDICINE
    • POINT OF VIEW
  • Current and Emerging Applications of Personalized Medicine
    • Table FDA Cleared/Approved Companion Diagnostic Tests
    • ONCOLOGY (SOLID TUMORS AND HEMATOLOGICAL CANCERS)
      • Table Selected Major Biomarkers in Oncology Personalized Medicine Tests
      • Table Selected Companies with Personalized Medicine Tests for Oncology
    • CARDIOVASCULAR DISEASE
      • Table Selected Companies with Personalized Medicine Tests for Cardiovascular Disease/Disorders
    • NEUROLOGICAL DISORDERS
      • Table Selected Companies with Personalized Medicine Tests for Neurological Disorders
    • AUTOIMMUNE AND INFLAMMATORY DISORDERS; OTHER IMMUNE RELATED CONDITIONS
      • Table Selected Companies with Personalized Medicine Tests for Autoimmune and Inflammatory Disorders; Other Immune Related Conditions
    • INFECTIOUS DISEASE
      • Antibiotic Resistance
        • Table Selected Biomarkers and Other Tests for Antibiotic Resistance, and Companies Developing/Marketing these Biomarkers
      • Other Infectious Disease Personalized Medicine Tests
        • Table Selected Companies with Other Personalized Medicine Infectious Disease Tests
    • THERAPEUTIC DRUG MONITORING
      • Table Selected Companies with Personalized Medicine Tests for Therapeutic Drug Monitoring of Biological Drugs
    • DRUG METABOLISM
      • Table Pharmacogenomic Biomarkers in Drug Labeling
      • Table Selected Companies with Personalized Medicine Tests for Drug Metabolism Genes
    • OTHER APPLICATIONS OF PERSONALIZED MEDICINE TESTS
      • Table Selected Companies with Other Personalized Medicine Tests
  • Business Models and Deals – Personalized Medicine and Companion Diagnostics
    • BUSINESSMODELS
      • Business Models for Pharmaceutical Companies in Personalized Medicine
      • Business Models for Diagnostic Companies in Personalized Medicine
    • INVESTMENTS AND FINANCING AGREEMENTS
      • Table Investments and Financings in Personalized Medicine/Companion Diagnostics
      • Table Selected Examples of Pharmaceutical Companies and Other Companies That Invested in Diagnostic Companies in Personalized Medicine
    • MERGERS AND ACQUISITIONS
      • Table Mergers and Acquisitions in Personalized Medicine/Companion Diagnostics
      • Table Selected Examples of Pharmaceutical Companies That Acquired Diagnostic Companies or Have Diagnostic Divisions
    • COLLABORATIONS BETWEEN PHARMACEUTICAL AND DIAGNOSTIC COMPANIES
      • Table Collaborations between Pharmaceutical and Diagnostic Companies
      • Table Selected Examples of Pharmaceutical That Entered into Agreements with Diagnostic Companies
    • OTHER PHARMACEUTICAL COMPANY AGREEMENTS
      • Table Selected Other Pharmaceutical Company Agreements
    • DIAGNOSTIC COMPANY COLLABORATIONS WITH OTHER (NON-PHARMACEUTICAL) COMPANIES
      • Table Collaborations between Two Diagnostic Companies
      • Table Diagnostic Company Agreements with Clinical Laboratories
      • Table Diagnostic Company Agreements with Other Companies
    • DIAGNOSTIC COMPANY COLLABORATIONS WITH UNIVERSITIES AND NON-PROFIT RESEARCH INSTITUTES
      • Table Diagnostic Company Collaborations with Universities and Other Non-Profit Research Institutes (Including Government)
  • Personalized Medicine and Companion Diagnostics – Market Drivers and Challenges
    • CANCER DIAGNOSTIC MARKET DRIVERS
    • COMPANION DIAGNOSTIC TESTS IN DRUG DEVELOPMENT – OPPORTUNITIES AND CHALLENGES
    • CLINICAL VALIDATION OF NOVEL BIOMARKERS OR GENETIC SIGNATURES
    • REGULATION OF COMPANION DIAGNOSTICS
    • COMPLEXITIES OF COMPANION DIAGNOSTIC TESTS AND CORRESPONDING THERAPEUTIC PRODUCTS; HARMONIZATION OF COMPANION DIAGNOSTIC TESTS ACROSS A CLASS OF TARGETED THERAPIES
    • GUIDELINES
    • LABORATORY DEVELOPED TESTS AND THE FDA
    • LIMITED TISSUE FROM BIOPSIES FOR GROWING NUMBER OF CANCER TESTS
    • ADVANCES IN TECHNOLOGY CHANGING THE FUTURE OF PERSONALIZED MEDICINE DIAGNOSTICS
    • REIMBURSEMENT
    • PHYSICIAN EDUCATION, ACCEPTANCE, AND USE OF NOVEL PERSONALIZED MEDICINE TESTS
    • COMPETITION
    • WORKING TOGETHER ON PERSONALIZED MEDICINE –ALLIANCES, CONSORTIUMS, AND OTHER GROUPS
    • FUTURE PROSPECTS
  • Personalized Medicine and Companion Diagnostics – Market Analysis
    • GLOBAL PERSONALIZED MEDICINE AND COMPANION DIAGNOSTIC TEST MARKET BY GEOGRAPHICAL REGION
      • Table World IVD Companion Diagnostics Test Market (In Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020
    • PERSONALIZED MEDICINE AND COMPANION DIAGNOSTIC TESTMARKET BY DISEASE INDICATION
      • Table World IVD Companion Diagnostics Test Market by Disease Segment, 2015 (Cancer, Other)
    • COMPANION DIAGNOSTICS TESTING SERVICES MARKET
      • Table Worldwide Companion Diagnostics Test Services Market, 2015 and 2020
  • Company Profiles: Pharmaceutical Companies (Focusing on Companion Diagnostic Activities)
    • ABBVIE INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ACUMEN PHARMACEUTICALS, INC.
    • ADAPTIMMUNE THERAPEUTICS PLC
      • Recent Revenue History
      • Company Overview
    • AMGEN INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ARCA BIOPHARMA, INC.
      • Recent Revenue History
      • Company Overview
    • ARIAD PHARMACEUTICALS, INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ARNO THERAPEUTICS, INC.
      • Recent Revenue History
      • Company Overview
    • ARRAY BIOPHARMA INC.
      • Recent Revenue History
      • Company Overview
    • ASTELLAS PHARMA INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ASTRAZENECA
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ATHERA BIOTECHNOLOGIES AB
    • AVEO ONCOLOGY
      • Recent Revenue History
      • Company Overview
    • BAYER AG
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • BOEHRINGER INGELHEIM
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • BRISTOL-MYERS SQUIBB COMPANY
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • CELLDEX THERAPEUTICS, INC.
      • Recent Revenue History
      • Company Overview
    • CLOVIS ONCOLOGY, INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ELI LILLY
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • GALENA BIOPHARMA, INC.
      • Recent Revenue History
      • Company Overview
    • GLAXOSMITHKLINE PLC
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • IDERA PHARMACEUTICALS, INC.
      • Recent Revenue History
      • Company Overview
    • JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON &JOHNSON
    • MERCK&CO., INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • MERCK KGAA (EMD SERONO)
    • NOVARTIS AG
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • PFIZER INC.
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
    • ROCHE (F. HOFFMANN-LA ROCHE LTD.) AND GENENTECH (AMEMBER OF THE ROCHE GROUP)
      • Recent Revenue History
      • Companion Diagnostics/Personalized Medicine Activities
  • Company Profiles: Diagnostic Companies and Clinical Laboratories
    • 20/20 GENESYSTEMS, INC.
    • A&G PHARMACEUTICAL, INC.
    • ABACUS DIAGNOSTICA OY
    • ABBOTT LABORATORIES
      • Recent Revenue History
      • Company Overview – Focusing on Personalized Medicine and Companion Diagnostics
      • Agreements with Pharmaceutical Companies
      • Acquisitions and Other Agreements with Other Companies
    • ACCELERATE DIAGNOSTICS, INC.
      • Recent Revenue History
      • Company Overview
    • ACOBIOM
    • ACT GENOMICS CO., LTD.
    • ADAPTIVE BIOTECHNOLOGIES CORPORATION
    • ADMERA HEALTH (A GENEWIZ COMPANY)
    • ADVANCED CELL DIAGNOSTICS
      • Products
      • Services for Pharmaceutical Companies
      • Companion Diagnostics Agreements
    • AELAN CELL TECHNOLOGIES
    • AFFYMETRIX, INC. (ACQUIRED BY THERMO FISHER SCIENTIFIC)
      • Recent Revenue History
      • Company Overview
      • eBioscience
      • Affymetrix Core
      • Selected Affymetrix Agreements
    • AGENA BIOSCIENCE INC.
    • AGENDIA NV
    • ALMAC GROUP LIMITED
    • ALTHEADX, INC.
    • AMARANTUS BIOSCIENCE HOLDINGS, INC.
      • Amarantus Diagnostics
    • AMOY DIAGNOSTICS CO., LTD.
    • ANGLE PLC
    • ARKRAY, INC.
    • ASSUREX HEALTH, INC.
    • ASURAGEN, INC.
      • Diagnostic Products
      • Translational/Companion Diagnostics
      • Agreements
    • ATLAS GENETICS LTD
    • AUTOGENOMICS, INC.
    • AVANT DIAGNOSTICS, INC.
    • BACTERIOSCAN, INC.
    • BECKMAN COULTER, INC. (SUBSIDIARY OF DANAHER CORPORATION)
      • Recent Revenue History
      • Company Overview
      • Flow Cytometry
      • Beckman Coulter Genomics
      • Other Tests and Services
      • Agreements
    • BECTON, DICKINSON AND COMPANY (BD)
      • Recent Revenue History
      • Company Overview
      • Microbiology and Molecular Diagnostic Testing for Infectious Diseases
      • Fluorescence-Activated Cell Sorters and Analyzers
      • Oncology
    • BGMEDICINE, INC.
      • Recent Revenue History
      • Company Overview
    • BIOCARTIS
      • Recent Revenue History
      • Company Overview
      • Startup History
      • Technology/Products
      • Investors/Financings and IPO
      • Pharmaceutical Company Agreements
      • Other Agreements
    • BIOCEPT, INC.
      • Recent Revenue History
      • Company Overview
      • Financings
      • Agreements with Pharmaceutical Companies
      • Other Agreements
    • BIODESIX, INC.
      • Investors/Financings
      • Other Agreements
    • BIOFIRE DIAGNOSTICS, LLC. (ACQUIRED BY BIOMÉRIEUX)
      • Recent Revenue History and Other Financial Information
      • Company Overview
    • BIOGENEX
    • BIOLOGICAL DYNAMICS, INC.
    • BIOMARKER STRATEGIES
    • BIOMÉRIEUX SA
      • Recent Revenue History
      • Company Overview
      • Traditional Microbiology
      • Immunodiagnostics for Lab Professionals (Clinical Laboratories)
      • Mass Spectrometry for Clinical Laboratories
      • Molecular Diagnostics
      • Selected Pharmaceutical Company Agreements
      • Other Agreements
    • BIOMOSAICS INC.
    • BIOREFERENCE LABORATORIES, INC. (BRLI) (PART OF OPKO HEALTH, INC.)
      • Recent Revenue History
      • Company Overview
    • BIOTHERANOSTICS, INC.
    • BIOTYPE DIAGNOSTIC GMBH
    • CANCER GENETICS, INC.
      • Recent Revenue History
      • Company Overview
      • Pharmaceutical Company Agreements
      • Other Agreements
    • CAPRION, INC.
    • CARDIODX, INC.
    • CARDIOGENICS HOLDINGS INC.
    • CAREDX, INC.
      • Recent Revenue History
      • Company Overview
    • CARIS LIFE SCIENCES
    • CASTLE BIOSCIENCES, INC.
    • CEPHEID
      • Recent Revenue History
      • Company Overview
    • CLARIENT DIAGNOSTIC SERVICES, INC. (ANEOGENOMICS COMPANY)
      • Recent Revenue History
      • Company Overview
    • COMPANIONDX
    • CRESCENDO BIOSCIENCE (AMYRIAD COMPANY)
    • CUBE DX GMBH
    • CURETIS AG
      • Recent Revenue History
      • Company Overview
    • CYNVENIO BIOSYSTEMS, INC.
    • DAKO A/S (AN AGILENT COMPANY)
      • Recent Revenue History
      • Company Overview
    • DANAHER CORPORATION
      • Recent Revenue History
      • Company Overview
    • DEFINIENS AG (ACQUIRED BY MEDIMMUNE, PART OF ASTRAZENECA)
    • DIACARTA, INC.
    • DIAMIR, LLC
    • DIATECH PHARMACOGENETICS SRL
    • DIAXONHIT
      • Recent Revenue History
      • Company Overview
    • DNA ELECTRONICS LTD. (DNAE)
    • ENTROGEN, INC.
    • ENZO BIOCHEM, INC
      • Recent Revenue History
      • Company Overview
    • EPIC SCIENCES, INC.
    • EUTROPICS PHARMACEUTICALS
    • EXOSOME DIAGNOSTICS, INC.
      • Selected Agreements
    • FOUNDATION MEDICINE, INC.
      • Recent Revenue History
      • Company Overview
      • Pharmaceutical Company Agreements
      • Agreement with Contract Research Organization
      • Agreements with Universities and Other Non-Profit Institutions
      • Agreements with Other (Non-Diagnostic) Companies
    • GENECENTRIC DIAGNOSTICS, INC.
    • GENECTION, INC. (AN INVIVOSCRIBE COMPANY)
    • GENELEX CORPORATION
    • GENENEWS LIMITED AND INNOVATIVE DIAGNOSTIC LABORATORY
    • GENOMAS, INC.
    • GENOMEDX BIOSCIENCES
    • GENOMIC HEALTH, INC.
      • Recent Revenue History
      • Company Overview
    • GENOMICA S.A.U.
    • GENOMIND
    • GENOPTIX (A NOVARTIS COMPANY)
    • GENPATH ONCOLOGY
    • GRIFOLS, S.A.
      • Recent Revenue History
      • Company Overview
    • GUARDANT HEALTH, INC.
    • HALIODX
    • HARMONYX DIAGNOSTICS
    • HELOMICS CORPORATION
    • HTGMOLECULAR DIAGNOSTICS, INC.
      • Recent Revenue History
      • Company Overview
      • Products
      • Pharmaceutical Company Agreements
      • Selected Other Agreements
    • ILLUMINA, INC.
      • Recent Revenue History
      • Company Overview
      • Products and Services – Overview
      • Investing in the Future
      • Companion Diagnostics
      • Agreements with Pharmaceutical Companies
      • Other Companion Diagnostic/Personalized Medicine Agreements
    • INFORM GENOMICS, INC.
      • Financings
      • Other Agreements
    • INIVATA LTD.
    • INSIGHT GENETICS, INC.
      • Selected Agreements
    • INSILIXA, INC.
    • INTEGRAGEN SA
      • Recent Revenue History
      • Company Overview
    • INVIVOSCRIBE TECHNOLOGIES, INC.
    • IRIS BIOTECHNOLOGIES INC.
      • Recent Revenue History
      • Company Overview
    • JANSSEN DIAGNOSTICS
      • Infectious Disease
      • Oncology
    • LAB 21 (PART OF THE NOVACYT GROUP OF COMPANIES)
    • LABORATORY CORPORATION OF AMERICA (LABCORP)
      • Recent Revenue History
      • Company Overview
      • Selected Examples of Companion Diagnostic/Personalized Medicine Agreements between LabCorp or Covance and Other Diagnostic Companies
    • LEICA BIOSYSTEMS INC. (ADANAHER COMPANY)
      • Pharmaceutical Company Agreements in Companion Diagnostics and Personalized Medicine
      • Other Companion Diagnostic/Personalized Medicine Agreements
    • LUMINEX CORPORATION
      • Recent Revenue History
      • Company Overview
    • MAYO MEDICAL LABORATORIES AND MAYO CLINIC
    • MEDICAL &BIOLOGICAL LABORATORIES CO., LTD. (MBL)
      • Recent Revenue History
      • Company Overview
    • METABOLON, INC.
    • METAMARK GENETICS, INC.
    • MIODX
    • MOLECULARMDCORPORATION
    • MONOGRAM BIOSCIENCES (LABCORP SPECIALTY TESTING GROUP)
    • MULTIPLICOM NV
    • MYRIAD GENETICS, INC.
      • Recent Revenue History
      • Company Overview
      • Myriad RBM
      • Pharmaceutical Company Agreements
    • NANOSTRING TECHNOLOGIES, INC.
      • Recent Revenue History
      • Company Overview
    • NANTOMICS (MEMBER OF THE NANTWORKS ECOSYSTEM OF COMPANIES)
    • NEOGENOMICS, INC./NEOGENOMICS LABORATORIES
      • Recent Revenue History
      • Company Overview
    • NEWGENE LTD.
    • NEW ONCOLOGY AG
    • NOVELLUSDX
    • NUCLEA BIOTECHNOLOGIES, INC.
    • ONCODNA SA
    • ONCOMPASS GMBH
    • ONCOPLEX DIAGNOSTICS (ONCOPLEXDX)(PART OF NANTOMICS)
    • ONCOSPIRE GENOMICS
    • ONEWAY LIVER S.L. (OWLMETABOLOMICS)
    • OPKO HEALTH, INC./OPKO DIAGNOSTICS
      • Recent Revenue History
      • Company Overview
      • BioReference Laboratories
      • OPKO Lab and 4Kscore™ Test
      • Point-of-Care Diagnostics – Claros 1 Analyzer and Sangia Microfluidic Assay Cassettes
    • OVAGENE ONCOLOGY INC.
    • OXFORD CANCER BIOMARKERS LTD.
    • OXFORD GENE TECHNOLOGY
    • PANAGENE INC.
    • PERSONAL GENOME DIAGNOSTICS, INC.
    • PROTAGEN AG
    • QIAGEN N.V.
      • Recent Revenue History
      • Company Overview
    • QUANDX INC.
    • QUEST DIAGNOSTICS
      • Recent Revenue History
      • Company Overview
    • QVELLA CORPORATION
    • RIBOMED BIOTECHNOLOGIES, INC.
    • ROCHE
      • Recent Revenue History
      • Company Overview
      • Roche Professional Diagnostics
      • Molecular Diagnostics
      • Tissue Diagnostics
      • Next-Generation Sequencing
    • ROSETTA GENOMICS LTD.
      • Recent Revenue History
      • Company Overview
      • Selected Agreements
    • SIEMENS HEALTHCARE DIAGNOSTICS
      • Recent Revenue History
      • Company Overview
    • SYMBIODX
    • SYSMEX CORPORATION
      • Recent Revenue History
      • Company Overview
    • THERANOSTICS HEALTH INC. (ACQUIRED BY AVANT DIAGNOSTICS, INC.)
    • THERMO FISHER SCIENTIFIC, INC.
      • Recent Revenue History
      • Company Overview
    • TRANSGENOMIC, INC.
      • Recent Revenue History
      • Company Overview
    • TRIMGEN CORPORATION
    • TROVAGENE, INC.
      • Recent Revenue History
      • Company Overview
    • VENTANA MEDICAL SYSTEMS, INC. (MEMBER OF THE ROCHE GROUP)
    • WOUNDCHEK LABORATORIES

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