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

February 2011 | 430 pages | ID: W0C1759AC8EEN
Kalorama Information

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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
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
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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