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World Market for Personalized Medicine Diagnostics (Biomarkers, Pharmacodiagnostics, Tumor Assays, Cardiac Risk and Other Testing)

In this market research report, Kalorama Information defines the current opportunity and a realistic future potential for personalized medicine in clinical testing. In addition to looking at tests on the market currently, the report profiles key competitors and discusses trends important for understanding this much-discussed growth area for the diagnostic industry.

The concept of ‘Personalized Medicine’ currently, as seen by Kalorama clinical diagnostics industry analyst Shara Rosen, is somewhere between dream and road to reality. Fantastic promises have been made over the years in the press and reports of startup concerns. But slowly and surely, real revenues are appearing, and realistic models for future growth will be seen. Developments that are linked in the press to 'personalized medicine' are many and can at times be confusing. But there are several discovered biomarkers that are significant in diagnostic markets. Biomarkers discussed in the report include:

  • Cytochrome P450 and Drug Metabolism
  • Estrogen Receptor and Progesterone
  • Receptor Status for Breast Cancer
  • HER2 Overexpression and Herceptin and Tykerb
  • Epidermal Growth Factor Receptor (EGFR)
  • KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer
  • BRAF Mutations and Cancer Therapy
  • UGT1A1 Genetic Variants
  • 5-Flurouracil Therapy
  • PIK3CA Genetic Variation
  • KIF6 Genetic Variation
  • ALK Genetic Variation

This is a highly active market. A special focus of the report is the amount of collaborations between IVD and pharmaceutical companies, as well as IVD companies and CLIA labs. This report will profile scores of such companies operating in this market and estimate and forecast markets for personalized medicine technologies in the following categories:

  • World Market for Personalized Medicine Diagnostics by Disease (Cardiovascular, Nutritional Conditions, Diabetes, CNS,
  • Blood Transfusion)
  • World Market for Tissue-based Tests Personalized Medicine Diagnostics
  • World Market for Blood Markers Personalized Medicine Diagnostics
  • World Market for Circulating Tumor Cells Personalized Medicine Diagnostics
  • World Market for HIV Personalized Medicine Diagnostics
  • World Market for HBV Personalized Medicine Diagnostics
  • World Market for HCV Personalized Medicine Diagnostics
  • World Market for Hospital Acquired Infection Personalized Medicine Diagnostics
  • World Market for Warfarin Personalized Medicine Diagnostics
  • World Market for Platelet Function Personalized Medicine Diagnostics

Companies profiled in this report include:

The Major IVD Companies

  • Abbott Diagnostics Beckman Coulter Inc.
  • Becton,
  • Dickinson and Company
  • bioMerieux Inc.
  • Celera Corporation
  • Cepheid
  • China Medical Technologies
  • Dako Denmark A/S
  • Fujirebio Diagnostics, Inc.
  • GE Healthcare
  • Gen-Probe Inc.
  • Immucor, Inc.
  • Luminex Corporation
  • PerkinElmer Inc.
  • Phadia AB
  • QIAGEN N.V.
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Ventana Medical Systems Inc.
  • Wako Diagnostics

Participants

  • 20/20 GeneSystems, Inc.
  • 23andMe
  • Accumetrics
  • AdvanDx, Inc.
  • Affymetrix, Inc.
  • Agendia BV
  • Almac Diagnostics
  • AltheaDx, Inc.
  • Ambry Genetics
  • Arrayit Corporation
  • ARUP Laboratories
  • AssureRx Health, Inc.
  • Asuragen, Inc.
  • Autogenomics Inc.
  • BG Medicine, Inc.
  • Biocare Medical, LLC
  • Biocartis SA
  • Biocept, Inc.
  • BioCurex, Inc.
  • Biodesix, Inc.
  • BioReference Laboratories, Inc.
  • BioServe
  • bioTheranostics
  • Clarient Inc.
  • CombiMatrix Molecular Diagnostics, Inc.
  • Corgenix Medical Corporation
  • Cylex, Inc.
  • Dana Farber Cancer Institute
  • DeCode Genetics
  • DxS Ltd.
  • DxTerity Diagnostics Inc.
  • Enzo Clinical Labs
  • Epigenomics AG
  • Euroimmun AG
  • Genelex Corporation
  • Genomic Health, Inc.
  • Genoptix Medical Laboratory
  • Genzyme Genetics
  • Illumina Inc.
  • Interleukin Genetics, Inc.
  • Ipsogen SA
  • Knome, Inc.
  • Lab21 Limited
  • Laboratory Corporation of America Holdings
  • LabCorp)
  • Life Technologies Corporation
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Monogram Biosciences, Inc.
  • Myriad Genetics, Inc.
  • Nanosphere, Inc.
  • Navigenics
  • Pathway Genomics
  • Pathwork Diagnostics, Inc.
  • Power3 Medical Products, Inc.
  • Precision Therapeutics
  • Predictive Biosciences
  • Progenika Inc.
  • Prometheus Laboratories Inc.
  • Quest Diagnostics Incorporated
  • Response Genetics, Inc.
  • Rosetta Genomics
  • Rules-Based Medicine, Inc.
  • Saladax Biomedical, Inc.
  • Sequenom, Inc.
  • TGen (The Translational Genomics
  • Research Institute)
  • TrimGen Corporation
  • TrovaGene, Inc.
  • Veridex, LLC
  • Vermillion Inc.
  • Virco BVBA
  • XDx, Inc.

The Newcomers

  • Abkine Pharmaceuticals
  • Accelerated Medical Diagnostics, LLC
  • Advanced Biological Laboratories
  • Affomix Corporation
  • Ahram Biosystems, Inc.
  • Alacris Theranostics GmbH
  • Amoy Diagnostics Co. Ltd.
  • ApoCell, Inc.
  • Atossa Genetics, Inc.
  • Augurex Life Sciences Corp.
  • Biofortuna Ltd.
  • Biomarker Factory, The
  • BioMarker Strategies
  • Biomedical Diagnostics
  • BlackBio S.L.
  • Bostwick Laboratories
  • Cancer Genetics, Inc.
  • Cancer Treatment Centers of America
  • CancerGuide Diagnostics, Inc.
  • CardioDx, Inc.
  • Caris Life Sciences
  • Chronix Biomedical
  • Crescendo Bioscience, Inc.
  • Critical Diagnostics
  • Curidium Medica Limited
  • CvergenX
  • DermaGenoma, Inc.
  • DiaTech Oncology
  • Eutropics Pharmaceuticals
  • Everist Genomics
  • Evotec AG
  • Exosome Diagnostics Inc.
  • Foundation Medicine Inc.
  • GeneNews Limited
  • Genetic Technologies Limited
  • GenMark Diagnostics Inc.
  • Genomas
  • Genomind, LLC
  • GenoVive LLC
  • GMS Biotech
  • Inostics GmbH
  • Insight Genetics
  • IntegraGen SA
  • IRIS International, Inc.
  • Iverson Genetic Diagnostics, Inc.
  • Linkage Biosciences, Inc.
  • Med BioGene, Inc.
  • Medco Health Solutions Inc.
  • Metamark Genetics, Inc.
  • Mira Dx
  • Molecular Response
  • MolecularMD Corp.
  • Nanostring Technologies, Inc.
  • NaturalNano, Inc.
  • NewGene
  • NobleGen Biosciences
  • Nodality Inc.
  • Novartis Molecular Diagnostics
  • Nuvera Biosciences, Inc.
  • On-Q-ity
  • Orion Genomics
  • OvaGene Oncology, Inc.
  • Pacific Edge Biotechnology Limited
  • Pathogenica
  • Pharmigene
  • Pinpoint Genomics, Inc.
  • Population Diagnostics, Inc.
  • Proctor & Gamble
  • Psynomics Incorporated
  • Radient Pharmaceuticals Corporation
  • ScreenCell
  • Scripps Health
  • Seegene Inc.
  • Signal Genetics
  • Signature Diagnostics AG
  • Sirius Genomics
  • Skyline Diagnostics B.V.
  • Spartan Bioscience Inc.
  • SureGene, LLC
  • TcLand Expression SA
  • Transgenomic, Inc.
  • ViennaLab Diagnostics GmbH

Information Technology Specialists

  • CLC bio
  • CollabRx
  • Definiens
  • Dell Healthcare and Life Sciences
  • DNA Direct
  • GenomeQuest Inc.
  • HolGenTech Inc.
  • IDBS
  • MediSapiens Ltd.
  • Partners HealthCare Center for Personalized
  • Genetic Medicine
  • Selventa
  • Sophic Systems Alliance

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  • Introduction
  • Scope and Methodology
  • Size and Growth of the Market
  • Market Trends

CHAPTER TWO: INTRODUCTION

  • Background
  • Developments since 2000 - Limitations of Personalized Medicine and Future Prospects
  • Personalizing risk and therapies
  • Personalized Therapies - drugs, vaccines and others
  • Aspects of Personalized Medicine
    • Screening for Disease Risk
    • Early diagnosis
    • Therapy Selection and Monitoring

CHAPTER THREE: STRATEGIC ISSUES: THE “COMMERCIALIZATION CONDUNDRUM”

  • Background
  • Reimbursement of Novel Tests
    • United States
    • Europe
  • Payor Perspectives and Policies
  • Regulatory Issues and Personalized Medicine Assays
    • United States
    • Europe
  • IVD vs CLIA or Both
  • Physician Education and Acceptance
  • Patent Issues and Commercializing Personalized Diagnostics
  • Prospects for POC Testing

CHAPTER FOUR: DISEASE TARGETS

  • Background
  • Biomarker Validation and Utility
  • Cytochrome P450 and Drug Metabolism
  • Estrogen Receptor and Progesterone Receptor Status for Breast Cancer
  • HER2 Overexpression and Herceptin and Tykerb
  • Epidermal Growth Factor Receptor (EGFR)
  • KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer
  • BRAF Mutations and Cancer Therapy
  • UGT1A1 Genetic Variants
  • 5-Flurouracil Therapy
  • PIK3CA Genetic Variation
  • KIF6 Genetic Variation
  • ALK Genetic Variation

CHAPTER FIVE: DIAGNOSTIC TECHNOLOGIES

  • PCR-based assays
  • Single nucleotide polymorphism (SNP) genotyping
  • Next-gen sequencing
  • LDTs reign
  • Miniaturization and Multiplexed Assays
  • Multi-Gene/Biomarker Tests in Oncology
  • Mass Spectroscopy
  • Role of Nanobiotechnology
  • Proteomics and Biomarker Detection
  • Molecular Imaging and Personalized Medicine
  • Information Technology

CHAPTER SIX: MARKET ANALYSIS

  • Background
  • Worldwide Opportunities for Personalized Medicine Diagnostics
    • The United States
    • Europe
    • Japan
    • ROW
  • Agreements between Pharmaceutical and Diagnostic Companies
  • Agreements between IVD companies and CLIA labs
  • Major Companies and Labs
  • The Market for Personalized Medicine in Cancer Management
    • Tissue-based Tests
    • Blood Markers
    • Circulating Tumor Cells
  • The Market for Personalized Medicine in Infectious Diseases
    • HIV
    • HBV
    • HCV
    • Hospital Acquired Infections
  • The Market for Personalized Medicine in Coagulation Therapy
    • Warfarin
    • Platelet Function
  • The Market for Personalized Medicine in Autoimmune Diseases
  • The Market for Personalized Medicine in Cardiovascular Diseases
  • The Market for Personalized Medicine in CNS Disorders
  • The Market for Personalized Medicine in Diabetes
  • The Market for Personalized Medicine in Blood Transfusion Safety
  • The Market for Personalized Medicine in Nutrition and Beauty

CHAPTER SEVEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS

CHAPTER EIGHT: COMPANY PROFILES

The Major IVD Companies

  • Abbott Diagnostics Beckman Coulter Inc. Becton,
  • Dickinson and Company
  • bioMérieux Inc.
  • Celera Corporation
  • Cepheid
  • China Medical Technologies
  • Dako Denmark A/S
  • Fujirebio Diagnostics, Inc.
  • GE Healthcare
  • Gen-Probe Inc.
  • Immucor, Inc.
  • Luminex Corporation
  • PerkinElmer Inc.
  • Phadia AB
  • QIAGEN N.V.
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Ventana Medical Systems Inc.
  • Wako Diagnostics

Participants

  • 20/20 GeneSystems, Inc.
  • 23andMe
  • Accumetrics
  • AdvanDx, Inc.
  • Affymetrix, Inc.
  • Agendia BV
  • Almac Diagnostics
  • AltheaDx, Inc.
  • Ambry Genetics
  • Arrayit Corporation
  • ARUP Laboratories
  • AssureRx Health, Inc.
  • Asuragen, Inc.
  • Autogenomics Inc.
  • BG Medicine, Inc.
  • Biocare Medical, LLC
  • Biocartis SA
  • Biocept, Inc.
  • BioCurex, Inc.
  • Biodesix, Inc.
  • BioReference Laboratories, Inc.
  • BioServe
  • bioTheranostics
  • Clarient Inc.
  • CombiMatrix Molecular Diagnostics, Inc.
  • Corgenix Medical Corporation
  • Cylex, Inc.
  • Dana Farber Cancer Institute
  • DeCode Genetics
  • DxS Ltd.
  • DxTerity Diagnostics Inc.
  • Enzo Clinical Labs
  • Epigenomics AG
  • Euroimmun AG
  • Genelex Corporation
  • Genomic Health, Inc.
  • Genoptix Medical Laboratory
  • Genzyme Genetics
  • Illumina Inc.
  • Interleukin Genetics, Inc.
  • Ipsogen SA
  • Knome, Inc.
  • Lab21 Limited
  • Laboratory Corporation of America Holdings (LabCorp)
  • Life Technologies Corporation
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Monogram Biosciences, Inc.
  • Myriad Genetics, Inc.
  • Nanosphere, Inc.
  • Navigenics
  • Pathway Genomics
  • Pathwork Diagnostics, Inc.
  • Power3 Medical Products, Inc.
  • Precision Therapeutics
  • Predictive Biosciences
  • Progenika Inc.
  • Prometheus Laboratories Inc.
  • Quest Diagnostics Incorporated
  • Response Genetics, Inc.
  • Rosetta Genomics
  • Rules-Based Medicine, Inc.
  • Saladax Biomedical, Inc.
  • Sequenom, Inc.
  • TGen (The Translational Genomics Research Institute)
  • TrimGen Corporation
  • TrovaGene, Inc.
  • Veridex, LLC
  • Vermillion Inc.
  • Virco BVBA
  • XDx, Inc.

The Newcomers

  • Abkine Pharmaceuticals
  • Accelerated Medical Diagnostics, LLC
  • Advanced Biological Laboratories
  • Affomix Corporation
  • Ahram Biosystems, Inc.
  • Alacris Theranostics GmbH
  • Amoy Diagnostics Co. Ltd.
  • ApoCell, Inc.
  • Atossa Genetics, Inc.
  • Augurex Life Sciences Corp.
  • Biofortuna Ltd.
  • Biomarker Factory, The
  • BioMarker Strategies
  • Biomedical Diagnostics
  • BlackBio S.L.
  • Bostwick Laboratories
  • Cancer Genetics, Inc.
  • Cancer Treatment Centers of America
  • CancerGuide Diagnostics, Inc.
  • CardioDx, Inc.
  • Caris Life Sciences
  • Chronix Biomedical
  • Crescendo Bioscience, Inc.
  • Critical Diagnostics
  • Curidium Medica Limited
  • CvergenX
  • DermaGenoma, Inc.
  • DiaTech Oncology
  • Eutropics Pharmaceuticals
  • Everist Genomics
  • Evotec AG
  • Exosome Diagnostics Inc.
  • Foundation Medicine Inc.
  • GeneNews Limited
  • Genetic Technologies Limited
  • GenMark Diagnostics Inc.
  • Genomas
  • Genomind, LLC
  • GenoVive LLC
  • GMS Biotech
  • Inostics GmbH
  • Insight Genetics
  • IntegraGen SA
  • IRIS International, Inc.
  • Iverson Genetic Diagnostics, Inc.
  • Linkage Biosciences, Inc.
  • Med BioGene, Inc.
  • Medco Health Solutions Inc.
  • Metamark Genetics, Inc.
  • Mira Dx
  • Molecular Response
  • MolecularMD Corp.
  • Nanostring Technologies, Inc.
  • NaturalNano, Inc.
  • NewGene
  • NobleGen Biosciences
  • Nodality Inc.
  • Novartis Molecular Diagnostics
  • Nuvera Biosciences, Inc.
  • On-Q-ity
  • Orion Genomics
  • OvaGene Oncology, Inc.
  • Pacific Edge Biotechnology Limited
  • Pathogenica
  • Pharmigene
  • Pinpoint Genomics, Inc.
  • Population Diagnostics, Inc.
  • Proctor & Gamble
  • Psynomics Incorporated
  • Radient Pharmaceuticals Corporation
  • ScreenCell
  • Scripps Health
  • Seegene Inc.
  • Signal Genetics
  • Signature Diagnostics AG
  • Sirius Genomics
  • Skyline Diagnostics B.V.
  • Spartan Bioscience Inc.
  • SureGene, LLC
  • TcLand Expression SA
  • Transgenomic, Inc.
  • ViennaLab Diagnostics GmbH

Information Technology Specialists

  • CLC bio
  • CollabRx
  • Definiens
  • Dell Healthcare and Life Sciences
  • DNA Direct
  • GenomeQuest Inc.
  • HolGenTech Inc.
  • IDBS
  • MediSapiens Ltd.
  • Partners HealthCare Center for Personalized Genetic Medicine
  • Selventa
  • Sophic Systems Alliance

LIST OF TABLES

CHAPTER ONE: EXECUTIVE SUMMARY

  • Table 1-1. Exchange Rate Fluctuations, 2005-2010
  • Table 1-2. Worldwide Personalized Medicine Test Sales, 2011-2016

CHAPTER THREE: STRATEGIC ISSUES: THE “COMMERCIALIZATION CONDUNDRUM”

  • Table 3-1. Selected Company Sponsored Certified Labs
  • Table 3-2. Proposed Palmetto non-coverage tests
  • Table 3-3. Selected LDT Companies Cited by the FDA
  • Table 3-4. Selected POC-appropriate Systems

CHAPTER FOUR: DISEASE TARGETS

  • Table 4-1. Selected Drug/Biomarker Targets in the U.S.
  • Table 4-2. Selected drugs that require PMx testing in Europe
  • Table 4-3. Selected Commercial CYP450 Warfarin Tests
  • Table 4-4. Selected drugs associated with CYP450 metabolism
  • Table 4-5. Selected innovations in EFGR tests
  • Table 4-6. Selected KRAS test innovations
  • Table 4-7. Selected BRAF gene test innovations
  • Table 4-8. Selected PIK3CA mutation test innovations
  • Table 4-9. Selected Innovations in CTC Systems
  • Table 4-10. Selected Live Cell Assays

CHAPTER FIVE: DIAGNOSTIC TECHNOLOGIES

  • Table 5-1. Selected Novel Nucleic Acid Testing Platforms, 2008-2011
  • Table 5-2. Major Sequencing Platforms
  • Table 5-3. Selected innovations in sequencing
  • Table 5-4. Selected Company Sponsored Certified Labs
  • Table 5-5. Selected LDT Service Provider Revenues, 2007-2011
  • Table 5-6. Selected PMx tests using microarrays
  • Table 5-7. Selected Gene Expression Tests
  • Table 5-8. Selected innovations in mass spectroscopy for personalized medicine
  • Table 5-9. Selected novel biomarkers under investigation
  • Table 5-10. Selected Innovations in Protein Biomarkers
  • Table 5-11. Selected companies involved in chromosomal analysis of cells
  • Table 5-12. Selected test digital platform innovations
  • Table 5-13. Selected blood-based tests in personalized medicine
  • Table 5-14. IT solutions for personalized medicine

CHAPTER SIX: MARKET ANALYSIS

  • Table 6-1. Worldwide Commercial Personalized Medicine Test Sales, by category
  • Table 6-2. Market Penetration Of PMx Tests, by geographic area, 2011-2016
  • Table 6-3. Selected Agreements between IVD Companies and Lab Services
  • Table 6-4. Worldwide Sales of PMx Tests for Cancer, by category, 2011-2016
  • Table 6-5. Major protein and molecular markers used in tissue staining
  • Table 6-6. Selected Pharmacodiagnostic Histology Tests
  • Table 6-7. Selected chromosome-based cancer tests and services
  • Table 6-8. Selected HPV tests
  • Table 6-9. Selected Tumor Marker Innovations, 2008-2011
  • Table 6-10. Selected Innovations in Molecular PMx Tests for Cancer
  • Table 6-11. PMx Test Sales for Infectious Diseases, worldwide, 2011-2016
  • Table 6-12. Selected PMx tests for infectious diseases
  • Table 6-13. Selected commercial MDR-TB test kits
  • Table 6-14. Selected molecular PMx coagulation tests
  • Table 6-15. Selected innovations in PMx testing for autoimmune diseases
  • Table 6-16. Selected IVD markers of CVD
  • Table 6-17. Worldwide PMx product sales for CVD, by category, 2011-2016
  • Table 6-18. Selected Cardiac Marker Innovations, 2008-2011
  • Table 6-19. Selected innovations in genetic tests for CVD
  • Table 6-20. Selected innovations in personalized tests for CNS diseases
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