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

Mar 1, 2012
430 Pages - Pub ID: KLI6640829
Abstract Table of Contents Search Inside Report Related Reports

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 analysis of tests currently on the market and in development, the report profiles key competitors and discusses trends that are important for understanding this much-discussed growth area of the diagnostic industry.

The concept of 'Personalized Medicine', as seen by Kalorama clinical diagnostics industry analyst Shara Rosen, is currently somewhere between dream and road to reality. Fantastic promises have been made over the years in the press and reports of startup concerns. However, slowly but 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 important 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 bustle of activity with collaborations between IVD and pharmaceutical companies, as well as IVD companies and CLIA labs. This report profiles scores of such companies operating in this market and estimates and forecasts markets (where there are products on the market) for personalized medicine technologies in the following categories:

  • Cardiac Markers, immunoassays
  • Cardiac Risk Markers
  • Cardiac markers, molecular
  • Coagulation, routine
  • Coagulation, molecular
  • Cancer, Tumor Markers
  • Cancer, Molecular
  • Cancer, Tissue-based
  • Psychiatric Disorders
  • Diabetes, BGM
  • Diabetes, HbA1c
  • Microbiology, ID/AST
  • Infectious Diseases, Viral Load (HIV, HCV, HBV)
  • Infectious Diseases, other
  • Blood Bank Molecular
  • Transplant Tissue Typing
  • Lab Developed Tests

The report contains over 125 pages of solid market analysis, which puts the concept of personalized medicine into terms that business planners can understand. What products are on the market earning revenues today? Shara Rosen is the author of eight editions of The Worldwide Market for In Vitro Diagnostic Tests, a complete market research report on the IVD industry. Among the issues Rosen tackles in this research study are the following:

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

Companies profiled in this report include:

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

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