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

Best Price Guarantee Length Publisher Published Date SKU
from $3,500 430 Pages Kalorama Information March, 2012 KLI6640829
Best Price Guarantee
Price from $3,500
Length 430 Pages
Publisher Kalorama Information
Published Date March, 2012
SKU KLI6640829

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


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 PRODUCTS

  • 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 (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, Infectious Diseases, other, Blood Bank Molecular, Transplant Tissue Typing)

  • Table 6-2: Market Penetration Of PMx Tests, by geographic area (N. America, W. Europe, ROW) 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 (Pharmacodiagnostic, Histology, Flow Cytometry, Tumor Markers, HPV, Molecular Assays, Circulating Tumor Cells), 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(Cardiac Markers Immunoassays , Cardiac Risk Markers, Cardiac Markers Molecular), 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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