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
New Platforms
Test Quality Control
Building a Strong Future
The Service Industry Makes Gains
The $1000 Genome
Information Technology and “Apps”
Miniaturization and Multiplexed Assays
Integrated Sample–to-Results Testing
Mass Spectrometry
Tests and Technologies in 2012
CHAPTER THREE: THE COMMERCIALIZATION CONUNDRUM
Background
Commercialization of Molecular Tests
Regulatory Issues and Molecular Assays
Patent Litigation Abounds
Consumer, Payer and Physician Acceptance
Clinical Molecular Test Reimbursement Coding in The U.S.
CHAPTER FOUR: SEQUENCING – HYPE AND REALITY
Background
Companies and Technologies
PCR Not Ready To Take the Back Seat
Pathogen sequencing
Prenatal Fetal Chromosomal Analysis
CHAPTER FIVE: MARKET ANALYSIS: WORLD MARKETS
Background
Market Estimate and Forecast by Region
The United States
RUO/IUO Issues
The Patient Protection and Affordable Care Act
Accountable Care Organizations
Europe
IVD Directive Update
China
India
CHAPTER SIX: THE MARKET FOR BLOOD MARKERS IN CANCER
Overview
Methylation Patterns
Other Tests
Blood Molecular Test Market and Forecasts
LDTs
Radiotherapy Testing
CHAPTER SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY
Flow Cytometry
CHAPTER EIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATION AND CARDIAC CARE
Thrombophilia SNPs
MTHFR
Factor V
CYP4V2
Market and Forecast
Coagulation Molecular Research Projects
Pharmacodiagnostics
Market for PGx testing
Plavix Testing
CHAPTER NINE: HISTOLOGY AND CYTOLOGY
Overview
in situ hybridization
HPV Testing
Tissue Microarrays
Circulating Tumor Cells
Chromosome Analysis
Pharmacodiagnostic Histology
CHAPTER TEN: MICROBIOLOGY AND VIROLOGY
Overview
Microbiology Market and Forecast
Role of ID Testing in the Molecular Diagnostics Market
Markets for Specific Infectious Disease Tests
Genome Sequencing
Roche, Illumina and Life
Other Systems
Mass Spectrometry
Major Companies
Market Estimate
Blood Culture
HIV
Market and Forecast
Hepatitis
Market and Forecast
Sexually Transmitted Diseases (STDs)
Hospital Acquired Infections (HAIs)
Market and Forecast
Respiratory Tract Infections
Tuberculosis
Market and Forecast
Fungal Infections
CHAPTER ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINE
Blood Pathogen Screening
Market and Forecast
Blood Typing
Molecular Blood Typing
CHAPTER TWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENT
HLA Typing
Stem Therapy Matching
HLA Market and Forecast
CHAPTER THIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEONATAL TESTING
Overview
Market and Forecast
FISH testing
Other Developments
Neonatal Testing
CHAPTER FOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASES
Arthritis
Gastrointestinal Conditions
Diabetes
Cardiovascular Disease
Alzheimer’s Disease
Parkinson’s Disease
Psychiatric Disorders
Autism
CHAPTER FIFTEEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS – 2012 AND BEYOND
Expectations and Realities
Four Issues That Will Impact Market Success
CHAPTER SIXTEEN: COMPETITIVE ANALYSIS
Companies and Vendors to Watch
Acquisitions, Alliances and Collaborations
Looking Beyond Borders
CHAPTER SEVENTEEN: COMPANY PROFILES: TOP TIER IVD COMPANIES’ MOLECULAR BUSINESSES
Abbott Diagnostics
Recent Revenue History
HLA
Molecular Histology
Companion Tests
Molecular Diagnostics
Infectious Diseases – Molecular
IntelligentMDx Alliance
PLEX-ID
Alere
Recent Revenue History
ARKRAY
Beckman Coulter Inc./Danaher Fullerton, CA www.beckmancoulter.com
Recent Revenue History
Instrumentation
Becton, Dickinson and Company (BD)
Recent Revenue History
The BD MAX Enterprise
Viper System
Molecular Microbiology
BD GeneOhm
Histology
Oncology, etc.
bioMérieux Inc.
Recent Revenue History
Molecular Oncology
The Biocartis Program
Molecular Microbiology
NucliSENS
Product Development
Bio-Rad Laboratories Inc.
Recent Revenue History
Gen-Probe Inc.
Recent Revenue History
Product development
Expansion
Prostate Cancer
STDs
Panther System
HPV
Transplant/HLA testing
Infectious Diseases
Blood Bank
Hologic, Inc.
Recent Revenue History
Instrumentation Laboratory (IL)
Recent Revenue History
Ortho Clinical Diagnostics
Recent Revenue History
QIAGEN N.V.
Recent Revenue History
Market Expansion
Histology
Infectious diseases
Rotor-Gene
Oncology/Personalized Medicine
TB
HPV
HLA
Automation for the Future
Women’s Health
Point of Care
Sequencing
Roche Diagnostics Indianapolis, IN www.roche.com
Recent Revenue History
Miscellaneous
Viral Load
STDs
Companion Tests
Sample Preparation
Tissue Diagnostics
Blood Bank
Sequencing
Microarrays
Siemens Healthcare Diagnostics
Recent Revenue History
Histology
Molecular
Sequencing
Companion Tests
Sysmex Corporation
Recent Revenue History
Thermo Fisher Scientific Inc.
Recent Revenue History
Allergy
CHAPTER EIGHTEEN: COMPANY PROFILES: MAJOR MOLECULAR TEST COMPANIES
Affymetrix, Inc.
Histology
Whole Genome Analysis
Agilent Technologies Inc.
Research Products
Asuragen, Inc.
Oncology
Inherited Diseases
Controls
Sample Collection
Sequencing
Beijing Genome Institute (BGI)
BGI Projects
BioFire Diagnostics, Inc.
Respiratory Panel
Environmental Testing
Caliper Life Sciences
Clinical Diagnostics
Sequencing
Life Sciences
Celera Diagnostics
Cepheid
Market Expansion
HAI
Personalized Medicine
TB
Infectious Diseases
Eiken Chemical Co., Ltd
Enzo Biochem Inc.
ColonSentry
Alliances
IP Protection
Epigenomics AG
Fluidigm Corporation
Prenatal
Illumina Inc.
BeadXpress
Sequencing
Cytogenetics
Sample Prep
PCR
CLIA Lab Service
Ipsogen SA
Life Technologies
Ion Torrent Systems
Personalized Medicine
PCR
Arrays
IVD Company Deals
Life and Quidel develop diagnostics on the 7500 Fast Dx
Sepsis
HIV
Informatics
International Presence
Novartis Diagnostics
Blood Bank
International Programs
Blood Typing
Molecular IVDs
Companion Tests
PerkinElmer, Inc.
Prenatal and Neonatal Screening
Personalized Medicine
Molecular and Sequencing Diagnostics
Test Services
Human Health Research
RainDance Technologies, Inc.
Product Development
Seegene, Inc.
Instrumentation
Transgenomic, Inc.
Lab Services
Diagnostic Tools Division
CTCs
Sequencing
CHAPTER NINETEEN: MARKET PARTICIPANTS
Alacris Theranostics GmbH
Astra Biotech GmbH
Autogenomics Inc.
Biocartis SA
Biofortuna Ltd.
Biotype Diagnostic GmbH
BlueGnome
DiaGenic ASA
DiagnoCure
ELITech Group
EraGen Biosciences Inc.
Genetic Technologies Limited
Victoria, Australia
www.gtglabs.com
GenMark Diagnostics Inc.
Helicos BioSciences
IRIS International, Inc.
Cytology
Luminex Corporation
IVD Expansion
Cystic Fibrosis
MAGPIX Multiplexing
Meridian Bioscience, Inc.
Bioline
Nanosphere, Inc.
Infectious Diseases
Hospital Acquired Infections
Sony DADC Biosciences
Cell Sorting
Mass Spectrometry
TrimGen Genetic Technology
TrovaGene, Inc.
Prenatal
CHAPTER TWENTY: PROMISING COMPANIES
Ahram Biosystems, Inc.
Allegro Diagnostics Corp
Amoy Diagnostics Co. Ltd.
Anagnostics Bioanalysis GmbH
Sample Preparation
Applied BioCode, Inc.
ArcticDx Inc.
Ariosa Diagnostics
Axela Inc.
BioHelix Corporation
BioNanomatrix/ BioNano Genomics
BJS Biotechnologies
DiagCor Bioscience Inc. Ltd.
DxTerity Diagnostics Inc.
Epistem plc
Exiqon A/S
Exonhit
GeneNews Limited
Genome Diagnostics BV (GenDx)
Genomica S.A.U.
Genorama Ltd.
Great Basin Corporation
Health Discovery Corporation (HDC)
IncellDx, Inc.
Insight Genetics
IntegenX Inc.
Sample Transport
Linkage Biosciences, Inc.
Med BioGene, Inc. (MBI)
Multiplicom
NABsys, Inc.
Nanostring Technologies, Inc.
NIPD Genetics Ltd
OptiGene Ltd
Orion Genomics
Oxford Gene Technology (OGT)
PrimeraDx
Rheonix Inc.
Skyline Diagnostics B.V.
Spartan Bioscience Inc.
Stratos Genomics Inc.
VolitionRx Limited
WaferGen Biosystems, Inc.
CHAPTER TWENTY ONE: MOLECULAR NEWCOMERS
DiaSorin S.p.A.
Fujirebio Diagnostics, Inc.
GE Healthcare
Cell Imaging
Molecular Sequencing
Phadia AB
Quidel Corporation
Alliances
Randox Laboratories Ltd.
TOSOH Corporation
Transasia Bio-Medicals Ltd.
CHAPTER TWENTY TWO: TEST PLATFORM INNOVATIONS
Advanced Liquid Logic, Inc. (ALL)
Aquila Diagnostic Systems
Canon U.S. Life Sciences (CLS)
DNA Medicine Institute (DMI)
Espira, Inc.
Genia Technologies Inc.
Genisphere
Lumora Ltd.
Michigan State University
NobleGen Biosciences
Oxford Nanopore Technologies Ltd.
QuantuMDx Group Limited
SensiQ Technologies, Inc.
Thermal Gradient, Inc.
Vela Diagnostics (VelaDx)
CHAPTER TWENTY THREE: SAMPLE PREPARATION SUPPLIERS
Arcxis Biotechnologies
Argylla Technologies LLC
Biomatrica, Inc.
Fluoresentric, Inc.
New England Biolabs, Inc. (NEB)
NorDiag
Norgen Biotek Corp.
Phthisis Diagnostics
PreAnalytiX GmbH
QIAGEN N.V.
Streck
ZyGEM Corp. Ltd.
CHAPTER TWENTY FOUR: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS
Access Genetics
CLC bio
CollabRx, Inc.
Definiens
DNA Direct
DIYGenomics
GenoSpace, LLC
HolGenTech Inc.
Ingenuity Systems
MediSapiens Ltd.
NextBio
Personalis
Portable Genomics
Sciclips
Selventa
Sophic Systems Alliance
Wellpoint Inc.
CHAPTER TWENTY FIVE: MICROBIOLOGY SPECIALISTS
Advanced Biological Laboratories (ABL)
AdvanDx, Inc.
Akonni Biosystems Inc.
Sample Preparation
Test Systems
Biomagnetics Diagnostics Corporation
BlackBio S.L.
Bruker BioSciences Corporation
CapitalBio Corporation
Ceeram S.A.S.
Cooperative Diagnostics, LLC
Curetis AG
Enigma Diagnostics Limited
Focus Diagnostics, Inc.
GenoID Ltd.
Great Basin Scientific, Inc.
Hain Lifescience GmbH
HiberGene Diagnostics Ltd
Ibis Biosciences
iCubate Incorporated
Immunexpress Group
InDevR
Ingen Biosciences SA
Intelligent Medical Devices, Inc. (IMDx)
IQuum Inc.
Miacom Diagnostics GmbH
MicroPhage, Inc.
Mobidiag Ltd
Molecular Detection Inc. (MDI)
Molzym GmbH & Co. KG
Myconostica
nanoMR Inc.
NetBio
PathGEN Dx Pte. Ltd.
PathoGene
Pathogenica
SIRS-Lab
T2 Biosystems
CHAPTER TWENTY SIX: BLOOD BANK SPECIALISTS
AbSorber AB
AXO Science
GMS Biotech
Grifols, S.A.
Immucor, Inc.
Progenika Inc.
CHAPTER TWENTY SEVEN: COMPANIES SPECILAIZING IN CIRCULATING TUMOR CELLS
ApoCell, Inc.
Biocept, Inc.
Clearbridge BioMedics
Cynvenio Biosystems, Inc.
On-Q-ity
RareCyte, Inc.
ScreenCell
Veridex, LLC
CHAPTER TWENTY EIGHT: COMPANY PROFILES: HISTOLOGY
SPECIALISTS
Advanced Cell Diagnostics
Biocare Medical, LLC
ChipDX, LLC
Cymogen Dx, LLC
Dako A/S
Alliances
Companion Diagnostics
Horizon Discovery Ltd
HTG Molecular Diagnostics
Automation
Mitomics Inc.
Norchip
CHAPTER TWENTY NINE: COMPANY PROFILES: SELECTED TEST SERVICE PROVIDERS
23andMe
Agendia BV
Market Expansion
Product News
AltheaDx Diagnostics, Inc.
Ambry Genetics
Aria Diagnostics, Inc. (formerly Ariosa Diagnostics)
ARUP Laboratories
AssureRx Health, Inc.
Avesthagen Limited
Bio-Reference Laboratories, Inc. (BRLI)
bioTheranostics
Bostwick Laboratories
CardioDx, Inc.
Caris Life Sciences
Castle Biosciences Inc.
CBLPath
Chronix Biomedical Inc.
Clarient Inc.
CombiMatrix Molecular Diagnostics, Inc.
Complete Genomics
Crescendo Bioscience, Inc.
deCode genetics ehf
Gene Variants
DermaGenoma, Inc.
Diagnósticos da América (DASA)
Diatherix Laboratories Inc.
EXACT Sciences Corporation
Exosome Diagnostics
Genelex Corporation
Genetadi Biotech SL
Genomic Health, Inc.
Service Spin off
Expansion
Sequencing
Information Technology
Genoptix Medical Laboratory
GenoVive LLC
Inostics GmbH
IntegraGen SA
Interleukin Genetics, Inc.
Knome, Inc.
Lab21 Limited
Services
Products Division
Expansion
Laboratory Corporation of America Holdings (LabCorp)
LifeCodexx AG
Lineagen Inc.
Lumigenix
Mayo Medical Laboratories
MDxHealth SA (formerly Oncomethylome Sciences)
Medical Diagnostic Laboratories L.L.C. (MDL)
Myriad Genetics, Inc
Alliances
Test Information
Patent Issues
Natera Inc.
Navigenics
NewGene
Pathway Genomics
Pathwork Diagnostics
PGXL Laboratories
Precision Therapeutics
Prometheus Laboratories Inc.
Patent Issues
Quest Diagnostics
Information Technology
Ridge Diagnostics, Inc.
Rosetta Genomics Ltd.
Rules-Based Medicine, Inc. (RBM)
Sequenom Inc.
Sequenom Center for Molecular Medicine
Market Expansion
Prenatal Patent
Genetic Analysis Products
Sequenta, Inc.
Signal Genetics
Sonic Healthcare
SureGene, LLC
Veracyte. Inc.
Verinata Health, Inc.
XDx Inc. – Expression Diagnostics
