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World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas)

January 2013 | 880 pages | ID: W404196199DEN
Kalorama Information

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Molecular diagnostics is becoming a dominant platform in clinical medicine and represents one of the fastest growing segments of the IVD market. As analyst Shara Rosen, R.T., MBA. details, in recent years years the number of assays introduced has been growing at a remarkable clip. This report, The World Market for Molecular Diagnostics (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas) represents the fifth time that Kalorama has conducted a complete study into the market for molecular diagnostics.

The report not only contains current market data for business planning, it goes beyond the numbers to fully assess what is going on in the market and why. Since the last edition of this report, a lot has changed, and a lot has stayed the same. There is intense competition but also opportunities for entrants in some areas. As part of its coverage, the report includes the following:
  • Over 800 Pages of Detailed Market Coverage
  • Over 55 Tables Makes Market Analysis More Accessible
  • Current Market Size and Forecast 2012-2017 for Several Molecular IVD Segments (Infectious Disease, Blood Screening, Histology, Oncology, Prenatal, Coagulation, Tissue Typing, Inherited Diseases, Pharmacodiagnostics and Other)
  • Infectious Disease Molecular Sales by Disease (Hepatitis, HIV, GC/Chlamydia, HAI, Respiratory, Organism ID, Mycobacteria/TB, others)
  • Over 200 Profiles of Molecular Diagnostic Competitors
  • Recent Mergers and Acquisitions
  • Revenues of Test Service Companies
  • Geographic Breakout of the Molecular Diagnostics Market by Region (North America, Europe, China, Japan, ROW)
  • Sample Prep Market, 2012 and 2017
  • Breakout of Molecular Histology/Cytology Market (in situ hybridization, HPV, Tissue Microarrays), 2012 and 2017
More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and have agreed to pay for them. A desire for better and faster test results, a preference for tests that are aimed at the patent, renewed interest in IVD in general and more particularly in molecular IVD has led to the commercialization of a number of technological tools that make more sensitive and specific tests possible. Some of these technological innovations include cost-effective, multiplexed testing platforms coupled with high-powered software capabilities. In addition analyses using saliva, urine, and blood instead of biopsied tissue make for more patient-friendly test systems.

Over 200 Companies Profiled and Ranked

Kalorama provides profiles of over 200 companies participating in the market. All of these companies have different strategies and compete in different areas, and Kalorama acknowledges this by separating the companies in a triage system based on where they stand in the molecular in vitro diagnostics market.
  • 'IVD Leaders' - The top IVD companies participating in molecular diagnostics as well as dominating the rest of testing.
  • 'Molecular Diagnostics Leaders' -The top companies focused on molecular testing.
  • 'Molecular Diagnostics Participants'- Molecular diagnostic companies that are by now established in the market
  • 'Promising Companies'- Those companies that have potential with an innovative approach
  • 'Molecular Diagnostics Newcomers'- IVD Companies that have novel or interesting approaches to keep an eye on
  • 'Platform Innovators'- Companies that have developed new platform technologies
  • 'Information Technology Companies' - Molecular testing relies on strong information systems to handle data. These companies are in the forefront.
  • 'Sample Prep Leaders' - Companies focused on sample preparation for molecular diagnostics
  • 'Specialist Companies' - In various areas (microbiology, histology, blood banking, etc)
A Realistic Look at The Need-To-Know Trends

Molecular diagnostics is a complicated market that requires a thorough analysis to understand. Many reports make bold predictions which later are proved incorrect by market events. In this report, Kalorama Information provides revenues and market forecasts, but also looks deeply at some of the trends in the market and what might impact results in the future. The report summarizes what is working and what is not working in the past few years.
  • Sequencing Hype and Reality: Innovations in DNA Sequencing, Key Players and its Future in Clinical Medicine
  • Pharmacodiagnostics and Where it Stands in 2013
  • The Latest Growth Numbers of LDTs, regulatory activity, and their impact on the Market
  • IVD Directive Update
  • Patent Issues
  • Healthcare Reform, Accountable Care Organizations and Reimbursement Trends
  • Improvements in Platforms
  • Developments in ISH testing, Tissue Microarrays and Mass Spectroscopy
  • Integrated Sample-to-Results Testing
Market size and forecasts in the report are for manufacturer's revenues. Secondary and primary resources, including: trade publications, annual report and interviews with key executives in molecular diagnostics were used for this study.
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


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