SYS-CON MEDIA Authors: Lori MacVittie, Pat Romanski, Elizabeth White, Yeshim Deniz, Glenn Rossman

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

NEW YORK, Feb, 11, 2013 /PRNewswire/ --Reportlinker.com announces that a new market research report is available in its catalogue:

World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas)
http://www.reportlinker.com/p01095493/World-Market-for-Molecular-Diagnostics-5th-Edition-Infectious-Disease-Oncology-Blood-Screening-Pre-Natal-and-Other-Areas-- .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

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.

Comprehensive Coverage of the Molecular Diagnostics Industry

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.


bioMerieux 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


To order this report:
In_Vitro_Diagnostic Industry:
World Market for Molecular Diagnostics, 5th. Edition (Infectious Disease, Oncology, Blood Screening, Pre-Natal and Other Areas)

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