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The World Market for Molecular Diagnostics, 2014-2019, 6th Edition (Microbiology, Oncology, Blood Screening and Typing, Prenatal, Inherited Diseases, Coagulation, Organ Transplant, PCR, Sequencing, cfDNA, CTC, in situ hybridization, Others)

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SKU: KLI5695907 Categories: Diagnostics Market Research, Molecular & Nucleic Acid Testing Pages: 1032
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Description

Molecular tests are used in just about every facet of laboratory medicine: infectious diseases, inherited diseases, coagulation, transplant medicine, prenatal and postnatal screening and cancer.  In The World Market for Molecular Diagnostics, 6th Edition, Kalorama IVD market analyst Shara Rosen, R.T., MBA provides authoritative and complete analysis of the molecular testing industry. In this report, exclusive market sizing and forecasts are provided for the following diagnostic segments:
  • Cancer Markers & PGx
  • Histology (In situ hybridization, HPV)
  • Microbiology/Virology (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory; Organism ID; Mycobacteria, TB; Others)
  • Blood Screening
  • Coagulation & PGx
  • Prenatal Testing
  • Inherited Diseases Testing
  • Tissue Typing
  • Organ Transplant Testing (HLA Typing)
  • Circulating Tumor Cells (CTCs)
  • Clinical Sequencing
  • Flow Cytometry
The amount of activity over the last few years is short of phenomenal with a continuous stream of new platforms, tests and quality control materials for test standardization coming to market. There is intense competition but also opportunities for entrants in some areas.
Comprehensive Coverage of the Molecular Diagnostics Industry
Molecular diagnostics is one of the fastest growth segments in clinical diagnostics, and for the past five years there’s been a considerable rate of growth in the number of assays introduced. Moreover, growth of this segment is fuelled by rising incidence of chronic disorders, an increasing geriatric population and adoption of personalized medicines.
This 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.
As part of its coverage, the report includes the following:
  • Over 1,000 Pages of Detailed Market Coverage
  • Over 70 Tables and Figures Makes Market Analysis More Accessible
  • Current Market Size and Forecast 2014-2019 for Several Specific Molecular IVD Segments 
  • Exome Sequencing, Metabolic Profiling, Hospital Acquired Infections, LDTs, Information Technology,
    Status of China and Emerging Markets and Other Trends
  • Infectious Disease Molecular Sales by Disease 
  • Over 190 Profiles of Molecular Diagnostic Competitors
  • Recent Mergers and Acquisitions
  • Revenues of Test Service Companies
  • Geographic Breakout of the Molecular Diagnostics Market by Region
  • Sample Preparation Trends
  • Breakout of Molecular Histology/Cytology Market 
  • Mergers, Partnerships, Distribution Agreements in Molecular IVD
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.
Who to Watch: Top Leaders and Rising Innovators
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.  Their activities in molecular testing and their results.
• “Major Molecular Diagnostics Leaders” -The top companies focused on molecular testing.
• “Molecular Diagnostics  Participants”– Molecular diagnostic companies that are by now established in the market
• “Great Expectation 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
• “CTC and Liquid Biopsy Test Providers” Biocept, Veridex, Qiagen and other companies in this high-interest molecular testing segment.
• “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
• “Segment Specialist Companies” – In various areas (microbiology, histology, blood banking, etc)
Molecular diagnostics tests are rapidly being developed for genetic testing, infectious diseases testing, blood screening, oncology testing, cardiovascular testing and others. The report looks in detail at market segments, evaluating them in terms of selected tests, test innovations, advanced techniques, and companies in the segment, providing where possible segment revenue and company sales information.
A Global Focus
The various tests, technologies, and trends are discussed from the point of view of their present and potential market impact.   The report focuses on developments at work in both mature markets and in emerging nations, providing market penetration of clinical molecular diagnostics by geographic area for 2014 and 2019. The World Market for Molecular Diagnostics looks at how social and economic events in selected countries may affect the evolution of molecular testing worldwide. 
Regions covered include:
  • North America
  • Western Europe
  • Japan
  • China
  • India
  • Rest of World
 The report covers trends and issues concerning: globalization of markets and diseases, reimbursement of new technologies , Novel test platforms diagnostic biomarkers and genetic indicators.  The application of molecular technologies to clinical analyses has received widespread attention around the world and has made a significant mark in diagnostic systems, and will continue to do so. The report looks at what can be expected in the coming 5 to 10 years, presenting conclusions and strategic implications.
In 2015 the technologies that were used for the Human Genome Project have become tools that molecular pathologists routinely use to diagnose diseases in patients that had remained a mystery for a long time. This is good for patient care but the evolution of sequencing and next generation sequencing-based tests have gone so quickly that government agencies and payers are scurrying to cope with the regulatory, reimbursement and ethical issues that accompany this new generation of tests. Only five years ago it would have been almost inconceivable that hospital and government funded programs would provide whole genome and whole exome sequencing for thousands and even millions of people. 
Information technology (IT) is an important tool that plays three essential roles, as detailed in this report: 1) data sharing to develop well-curated gene variations, 2) interpretation of gene variants to develop testing guidelines and 3) distribution of this information to clinicians for use in patient care. A discussion of developments in information technology and molecular diagnostics merits a report all to itself. Here Kalorama presents a bird’s eye view of the programs and initiatives that suggest how the IT-molecular diagnostics mix is evolving. Hundreds of genome studies are underway, worldwide, involving sometimes hundreds of thousands of patient test results. 
 Companies profiled include:
  • Abbott Diagnostics
  • Alere Inc.
  • Beckman Coulter, Inc. / Danaher
  • Becton, Dickinson and Company (BD)
  • Bio-Rad Laboratories, Inc.
  • bioMérieux Inc.
  • Danaher Corporation
  • General Electric – GE Healthcare
  • Hologic, Inc.
  • QIAGEN N.V.
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Affymetrix Inc.
  • Agilent Technologies
  • Asuragen Inc.
  • BGI
  • Cepheid
  • Eiken Chemical Co., Ltd
  • Enzo Biochem Inc.
  • Illumina
  • Life Technologies Corporation
  • PerkinElmer, Inc. (PE)
  • RainDance Technologies, Inc.
  • AutoGenomics Inc.
  • Biocartis SA
  • DiaSorin S.p.A
  • EKF Diagnostics Holdings Plc
  • ELITech Group
  • Epigenomics
  • Exosome Diagnostics, Inc.
  • Fluidigm Corporation
  • Fujirebio Diagnostics, Inc.
  • GenMark Diagnostics
  • Genome Diagnostics BV (GenDx)
  • Luminex Corporation
  • Menarini Diagnostics
  • Nanostring Technologies, Inc.
  • Pacific Biosciences of California, Inc. (PacBio)
  • Quidel Corporation
  • Rubicon Genomics, Inc.
  • Transgenomic, Inc.
  • TrovaGene, Inc.
  • WaferGen Bio-systems, Inc.
  • Genomic Vision
  • GENOMICA S.A.U.
  • IncellDx, Inc.
  • Inivata
  • IntegenX Inc.
  • Linkage Biosciences, Inc.
  • Savyon Diagnostics
  • Selventa
  • VolitionRx Limited
  • B Braun CeGaT, LLC
  • Canon BioMedical, Inc.
  • DestiNA Genomics Ltd.
  • DiamiR, LLC
  • Randox Laboratories Ltd.
  • 23andMe
  • Adaptive Biotechnologies Corporation
  • Agendia BV
  • AltheaDx Diagnostics, Inc.
  • Ambry Genetics
  • ARUP Laboratories
  • Assurex Health
  • Athena Diagnostics
  • Bio-Reference Laboratories, Inc. (BRLI)
  • bioTheranostics
  • Cancer Genetics, Inc. (CGI)
  • CareDx, Inc.
  • Caris Life Sciences
  • Centogene AG
  • Complete Genomics
  • Counsyl
  • Exact Sciences Corp.
  • Foundation Medicine Inc.
  • Genomic Health, Inc.
  • Helomics Corporation
  • IntegraGen
  • Invitae Corporation
  • LabCorp, Laboratory Corporation of America
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Myriad Genetics
  • Pathway Genomics Corporation
  • Quest Diagnostics
  • Rosetta Genomics Ltd.
  • Veracyte, Inc.
  • Atlas Genetics Ltd.
  • Biomeme, Inc.
  • DiAssess Inc.
  • DNA Electronics Ltd (DNAe)
  • Enigma Diagnostics Limited
  • Entopsis
  • Epistem Holdings plc
  • InSilixa Inc.
  • Lucigen
  • PositiveID Corporation
  • QuantuMDx Group Limited
  • Rheonix, Inc.
  • Scanogen Inc.
  • Ubiquitome
  • Veredus Laboratories Pte Ltd
  • Xagenic
  • Horizon Discovery Group plc
  • MO BIO Laboratories, Inc.
  • PreAnalytiX GmbH
  • QIAGEN N.V.
  • SeraCare Life Sciences, Inc.
  • Advaita Bioinformatics
  • Apple Inc.
  • Cartagenia
  • Cerner Corp.
  • CLC bio
  • CollabRx Inc.
  • DNAnexus
  • GENALICE
  • GenomOncology
  • Google Genomics
  • IBM Healthcare
  • Intel Corporation
  • Knome Inc.
  • N-of-One
  • PierianDx
  • Sophia Genetics
  • Advanced Cell Diagnostics (ACD)
  • Amoy Diagnostics Co. Ltd.
  • Applied Spectral Imaging Inc. (ASI)
  • BioView Ltd.
  • Circulomics Inc.
  • Covaris Inc.
  • Cymogen Dx, LLC
  • Dako A/S
  • Definiens
  • DxTerity Diagnostics Inc.
  • HTG Molecular Diagnostics
  • Leica Biosystems
  • PreTect AS (formerly Norchip)
  • Kapa Biosystems Inc.
  • Ventana Medical Systems Inc.
  • Accelerate Diagnostics, Inc.
  • Advanced Biological Laboratories, S.A. (ABL)
  • AdvanDx, Inc.
  • altona Diagnostics
  • Aperiomics
  • Co-Diagnostics HBDC
  • Curetis AG
  • DxNA, LLC
  • Fast-Track Diagnostics
  • Focus Diagnostics, Inc.
  • Genetic Analysis AS
  • Great Basin Scientific, Inc.
  • Greiner Bio-One International GmbH
  • Hain Lifescience GmbH
  • Hutman Diagnostics AG
  • Intelligent Medical Devices, Inc. (IMDx)
  • Meridian Bioscience, Inc.
  • Mobidiag Ltd
  • Molbio Diagnostics Pvt Ltd.
  • Nanosphere, Inc.
  • PathoGenetix, Inc.
  • Pathogenica
  • Reference Genomics Inc.
  • Seegene, Inc.
  • Specific Technologies
  • T2 Biosystems
  • AXO Science
  • Grifols
  • Immucor, Inc.
  • Ariosa Diagnostics, Inc.
  • Berry Genomics Co. Ltd
  • Combimatrix Corp.
  • Good Start Genetics, Inc.
  • Illumina
  • LifeCodexx AG
  • Multiplicom N.V.
  • Natera
  • Premaitha Health plc
  • Sequenom Inc.
  • Angle plc
  • ApoCell, Inc.
  • Biocept, Inc.
  • Clearbridge BioMedics
  • Cynvenio Biosystems, Inc.
  • Epic
  • Fluxion Biosciences, Inc.
  • Genyo – Centre for Genomics
  • Qiagen Hanover (formerly AdnaGen GmbH)
  • ScreenCell
  • Veridex, LLC
  • WaveSense LLC

The world market for molecular diagnostics is provided in U.S. dollars for the years 2014 to 2019. The report discusses tests and technologies that are currently available and those that are expected to take their place. All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the molecular test market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible.

The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author’s industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics and molecular pathology.

Table of Contents

ONE: EXECUTIVE SUMMARY

Introduction

Scope and Methodology

Report Design

Size and Growth of the Market

Market Trends

TWO: INTRODUCTION

Background

The Buzz Is On

DTC in 2015 – Building Evidence

Sequencing Enters the Clinic

Exome Sequencing

Metabolomic Profiling

Liquid Biopsy

Information Technology Brings Clarity

Forensic Studies – An Emerging Opportunity

Multi-omic IT

Molecular Test Expansion Supported by Quality Measures

Test Platforms

Tests and Technologies in 2014

Molecular Diagnostics and Target Markets

THREE: DELIVERING MOLECULAR TESTS TO THE CLINIC

Background

The Reimbursement Environment

Physician Uptake

The U.S. Experience

Personalized Precision Medicine Advances and Barriers

The Service Industry Is Here to Stay

FOUR: SEQUENCING – HOW FAR CAN WE GO?

Background

Companies and Technologies

Market Analysis

Sequencing Research Projects

Cancer More Personalized

Pathogen Sequencing

FIVE: MARKET ANALYSIS: WORLD MARKETS

Background

Worldwide Opportunities for Molecular Tests

The United States of America

Canada

Europe

China

SIX: THE MARKET FOR BLOOD MARKERS IN CANCER

Introduction

Precision Medicine and a New Molecular Perception

Back to the Status Quo

SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY: CELL-BASED MOLECULAR TESTS

Flow Cytometry

Market Analysis

EIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATION

Thrombophilia SNPs

Pharmacodiagnostics

NINE: HISTOLOGY AND CYTOLOGY

Background

Advanced Analysis Tools

Sample Preparation

In Situ Hybridization

HPV Testing

Circulating Tumor Cells

Pharmacodiagnostic Histology

TEN: MICROBIOLOGY AND VIROLOGY

Introduction

Market Overview

POC and Decentralized Testing

Sample Preparation

Test Services

Antimicrobial Drug Resistance

Next Generation Sequencing in Microbiology

The Human Microbiome

Emerging Disease Threats

Blood Culture & Hospital Acquired Infections

HIV

Hepatitis

Sexually Transmitted Diseases (STDs)

Respiratory Tract Infections

Tuberculosis

Fungal Infections

Miscellaneous Tests

ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINE

Blood Pathogen Screening

Blood Typing

TWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENT

Technological Advancements

Market Analysis

THIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENING

Introduction and Market Data

cfNIPT – Perception, Perception, Perception

Parental Carrier Screening

In Vitro Fertilization

cfDNA Market Expansion

Newborn Screening

FOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASES

Autism

Alzheimer’s Disease

Cardiovascular Disease

Diabetes

Psychiatric Disorders

Gastrointestinal Conditions

Rare Diseases

FIFTEEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS

LDTs to Market Cleared Tests

Esoteric Testing Scenario in Europe

Future Outlook

Strategic Implications

SIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCH

Market Drivers and Leaders

Review of Top Companies

Acquisitions, Alliances and Collaborations

Looking Beyond Borders

SEVENTEEN: COMPANY PROFILES: THE TOP TIER

Abbott Diagnostics

IntelligentMDx Alliance

PLEX-ID

Iridica

Histology

Alere Inc.

Beckman Coulter, Inc. / Danaher

Lab Services

Sequencing

Genomics

Information Technology

Becton, Dickinson and Company (BD)

The BD MAX Enterprise

Oncology

HPV

Sequencing

Initiatives

Mass Spectrometry

Flow Spectrometry

Bio-Rad Laboratories, Inc.

Controls

Digital PCR

bioMérieux Inc

Expansion

Oncology

Molecular Strategy

Sequencing Service

Danaher Corporation

General Electric – GE Healthcare

Clarient Diagnostic Services, Inc.

Hologic, Inc.

Product News

The Gen-Probe Business

Panther System

Blood Bank

Quest Contract

QIAGEN N.V.

Personalized Healthcare

Infectious Disease Testing

Transplant Medicine and HAIs

HPV

Companion Diagnostics

Liquid Biopsy/CTC

Instrumentation Base

Rotor-Gene Q – Clinical Diagnostics

Sequencing

Exosomes

Information Technology

Collaborations

Forensics

Roche Diagnostics

New Enterprises

Global Access Program for HIV

Core Molecular Tests

STDs

A POC Enterprise – Liat

Prenatal and cfDNA

HPV

Blood Bank

Liquid Biopsy

Sequencing – Putting the Pieces Together

Siemens Healthcare Diagnostics

Histology

Molecular

Companion Diagnostics

Sequencing

China

Sysmex Corporation

Inostics GmbH

Intraoperative Test

Flow Cytometry

Thermo Fisher Scientific Inc.

Molecular Microbiology

Microbiology IT

Transplant

Quality Control

Mass Spectrometry

EIGHTEEN: COMPANY PROFILES: MAJOR MOLECULAR COMPANIES

Affymetrix Inc.

Agilent Technologies

Agilent in Genomics

PCR

Sequencing

Arrays

Sample Management

Mass Spectrometry

Expansion

Asuragen Inc.

Controls

Sample Collection

Sequencing

BGI

With Complete Genomics

BGI Projects

Cepheid

Hospital Acquired Infections (HAI)

TB

Infectious Diseases

Virology

Oncology

Eiken Chemical Co., Ltd

Enzo Biochem Inc.

IP Situation

Illumina

Sequencing

Sequencing Kits

Sample Prep

IVD Business

Oncology

HLA Typing

IT

Forensics

CLIA Lab Service

Nanopore Sequencing

Sample to Insight

Making a Market

IP Situation

Life Technologies Corporation

Instrumentation and Applications

Liquid Biopsy

Sequencing

Life Technologies an IVD Company

Partnerships Worldwide

Life and Quidel Develop Diagnostics on the 7500 Fast Dx

Sepsis

HIV

Emerging Pathogens

Bacterial Typing

Personalized Medicine

Forensic

PerkinElmer, Inc. (PE)

Newborn Testing

Prenatal Testing

Sequencing

Mass Spectrometry

Information Technology

China

RainDance Technologies, Inc.

Market Expansion

NINETEEN: COMPANY PROFILES: PARTICIPANTS

AutoGenomics Inc.

Biocartis SA

Connectivity

Instrumentation

Collaborations

Idylla News

DiaSorin S.p.A

EKF Diagnostics Holdings Plc

ELITech Group

Epigenomics

Exosome Diagnostics, Inc.

Fluidigm Corporation

Fujirebio Diagnostics, Inc.

GenMark Diagnostics

Genome Diagnostics BV (GenDx)

Luminex Corporation

Business Expansion

MAGPIX Multiplexing

Next Generation NxTag

Product News

Menarini Diagnostics

Nanostring Technologies, Inc.

Alliances

LDTs

Pacific Biosciences of California, Inc. (PacBio)

Quidel Corporation

Lyra Product Line

Solana Molecular System

AmpliVue Product Line

Savanna (formerly Wildcat)

Acquisitions

Rubicon Genomics, Inc.

Transgenomic, Inc.

Alliances

Lab Services

Diagnostic Tools Division

TrovaGene, Inc.

WaferGen Bio-systems, Inc.

TWENTY: COMPANY PROFILES: GREAT EXPECTATIONS

Genomic Vision

GENOMICA S.A.U.

IncellDx, Inc.

Inivata

IntegenX Inc

Linkage Biosciences, Inc.

Savyon Diagnostics

Selventa

VolitionRx Limited

TWENTY-ONE: COMPANY PROFILES: NEWCOMERS

B Braun CeGaT, LLC

Canon BioMedical, Inc.

DestiNA Genomics Ltd

DiamiR, LLC

Randox Laboratories Ltd.

TWENTY-TWO: COMPANY PROFILES: TEST SERVICE PROVIDERS

23andMe

What a Difference a Few Years Makes

The Move to Building a Research Company

Therapeutics Group

Ancestry

Outside the U.S.

Adaptive Biotechnologies Corporation

Agendia BV

AltheaDx Diagnostics, Inc.

Ambry Genetics

Oncology

Cardiac

Prenatal

Information Technology

ARUP Laboratories

Assurex Health

Athena Diagnostics

Bio-Reference Laboratories, Inc. (BRLI)

bioTheranostics

Cancer Genetics, Inc. (CGI)

The Response Genetics Acquisition

CareDx, Inc.

Caris Life Sciences

Centogene AG

Complete Genomics

Counsyl

Exact Sciences Corp.

Foundation Medicine Inc.

Genomic Health, Inc.

Market Uptake

Sequencing

Liquid Biopsy

Service Spin Off

Helomics Corporation

IntegraGen

Invitae Corporation

LabCorp, Laboratory Corporation of America

Infectious Diseases

Prenatal

Sequencing

Oncology

BRCA Saga

Information Technology

Forensic

Collaborations

Mayo Medical Laboratories

Information Technology

MDxHealth SA

Myriad Genetics

Product News

Companion Tests

Beyond Cancer

The U.S. Market

IP Update

Pathway Genomics Corporation

Quest Diagnostics

Oncology

Toxicology

Prenatal and Women’s Health

Market Expansion

Quest Partners for Market Accessibility

Rosetta Genomics Ltd.

Expansion

Veracyte, Inc.

TWENTY-THREE: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS

Atlas Genetics Ltd.

Biomeme, Inc.

DiAssess Inc

DNA Electronics Ltd (DNAe)

Enigma Diagnostics Limited

Entopsis

Epistem Holdings plc

InSilixa Inc.

Lucigen

PositiveID Corporation

QuantuMDx Group Limited

Rheonix, Inc.

Scanogen Inc.

Ubiquitome

Veredus Laboratories Pte Ltd

Xagenic

TWENTY-FOUR: COMPANY PROFILES: SAMPLE PREPARATION

Horizon Discovery Group plc

MO BIO Laboratories, Inc.

PreAnalytiX GmbH

QIAGEN N.V.

SeraCare Life Sciences, Inc.

TWENTY-FIVE: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS

Advaita Bioinformatics

Apple Inc.

Cartagenia

Cerner Corp.

CLC bio

CollabRx Inc.

DNAnexus

GENALICE

GenomOncology

Google Genomics

IBM Healthcare

Intel Corporation

Knome Inc.

Collaborations

N-of-One

PierianDx

Sophia Genetics

TWENTY-SIX: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS

Advanced Cell Diagnostics (ACD)

Amoy Diagnostics Co. Ltd.

Applied Spectral Imaging Inc. (ASI)

BioView Ltd.

Circulomics Inc.

Covaris Inc.

Cymogen Dx, LLC

Dako A/S

Companion Diagnostics

Digital Imaging

Flow Cytometry

Automation

Alliances

Definiens

DxTerity Diagnostics Inc.

HTG Molecular Diagnostics

Leica Biosystems

Companion Diagnostics

PreTect AS (formerly Norchip)

Kapa Biosystems Inc.

Ventana Medical Systems Inc.

Digital Pathology

Virtuoso Software Update

Product News

Automation

China

Partnerships

TWENTY-SEVEN: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS

Accelerate Diagnostics, Inc.

Advanced Biological Laboratories, S.A. (ABL)

AdvanDx, Inc.

altona Diagnostics

Aperiomics

Co-Diagnostics HBDC

Curetis AG

DxNA, LLC

Fast-Track Diagnostics

Focus Diagnostics, Inc.

Genetic Analysis AS

Great Basin Scientific, Inc.

Greiner Bio-One International GmbH

Hain Lifescience GmbH

Hutman Diagnostics AG

Intelligent Medical Devices, Inc. (IMDx)

Abbott Diagnostics Partnership

Qiagen Partnership

Meridian Bioscience, Inc.

illumigene

Meridian Life Science

Mobidiag Ltd

Molbio Diagnostics Pvt Ltd.

Nanosphere, Inc.

Market Expansion

PathoGenetix, Inc.

Pathogenica

Reference Genomics Inc.

Seegene, Inc.

Instrumentation

Collaborations

Specific Technologies

T2 Biosystems

TWENTY-EIGHT: COMPANY PROFILES: BLOOD BANK SPECIALISTS

AXO Science

Grifols

Blood Transfusion Novartis Business

International Programs

Immucor, Inc.

TWENTY-NINE: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS

Ariosa Diagnostics, Inc.

IP Status

Berry Genomics Co. Ltd

Combimatrix Corp.

Oncology

Good Start Genetics, Inc.

Illumina

IP Issues

Cytogenetics

LifeCodexx AG

Multiplicom N.V.

Natera

Premaitha Health plc

Sequenom Inc

Market Expansion

Product Expansion

IP Issues

Coagulation

THIRTY: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS

Angle plc

ApoCell, Inc.

Biocept, Inc.

Menu Expansion

Reimbursement

Clearbridge BioMedics

Cynvenio Biosystems, Inc.

Epic

Fluxion Biosciences, Inc.

Genyo – Centre for Genomics

Qiagen Hanover (formerly AdnaGen GmbH)

ScreenCell

Veridex, LLC

WaveSense LLC

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

Table 1-1: Common Next Generation Molecular Test Traits

Table 1-2: Selected Salient Developments for Now and the Future

Table 1-3: Exchange Rate Fluctuations, 2009-2014 (Europe, Switzerland, UK, Denmark, Sweden, Norway, Japan, Hungary, Singapore, India)

Table 1-4: Worldwide Molecular Test Sales, 2014 and 2019 (Microbiology/Virology Histology, Blood Screening, Coagulation & PGx, Inherited Diseases & PGx, Tissue Typing, Cancer Markers & PGx, CTCs, Total)

Figure 1-1: Worldwide Molecular Test Sales, 2014-2019 (CTCs, Cancer Markers & PGx,Tissue Typing, Inherited Diseases & PGx, Coagulation & PGx, Blood Screening, Histology, Microbiology/Virology)

Table 1-5: Market Penetration of Clinical Molecular Diagnostics by Geographic Area,2014 and 2019 (N. America, W. Europe [EU5], Japan, China, India, ROW, Total)

TWO: INTRODUCTION

Table 2-1: Common Next Generation Molecular Test Traits

Table 2-2: Selected Salient Developments for Now and the Future

Table 2-3: Selected Exosome Sequencing Tests and Services

Table 2-4: Selected Liquid Biopsy Innovations

Table 2-5: Selected IT Innovations in Molecular Diagnostics

Table 2-6: Selected Innovations in Forensic DNA Testing

Table 2-7: Selected Multi-omic Test Innovations

Table 2-8: Selected Sample Preparation Tools, 2015

Table 2-9: Selected Molecular Test Quality Control Standards

Table 2-10: Key Molecular Technologies

Table 2-11: Selected Molecular Test Platform Innovations

Table 2-12: Worldwide Molecular Test Sales, 2014 and 2019 (Microbiology/Virology, Histology, Blood Screening, Coagulation & PGx, Inherited Diseases & PGx, Tissue Typing, Cancer Markers & PGx, CTCs, Total)

Table 2-13: Key Molecular Test Applications and Technologies

Table 2-14: Selected Rapid Molecular Test Innovations, 2013-2015

THREE: DELIVERING MOLECULAR TESTS TO THE CLINIC

Table 3-1: Diseases with Drug Labels

Table 3-2: Selected Drug/Biomarker Targets in the U.S.

Table 3-3: Selected Drugs That Recommend PGx Testing in Europe

Table 3-4: Selected Personalized Medicine Tests, 2013-2015

Table 3-5: Revenues for a Selection of Molecular Test Service Labs Worldwide, 2010-2014

Table 3-6: Selected New Lab Services, 2015

FOUR: SEQUENCING – HOW FAR CAN WE GO?

Figure 4-1: Flatley’s Law

Table 4-1: Major Sequencing Platforms

Table 4-2: Selected Sequencing-Based Test Services

FIVE: MARKET ANALYSIS: WORLD MARKETS

Table 5-1: Selected International Agreements

Table 5-2: Market Penetration of Clinical Molecular Diagnostics, by Geographic Area, 2014 and 2019 (N. America, W. Europe [EU5], Japan, China, India, ROW, Total)

SIX: THE MARKET FOR BLOOD MARKERS IN CANCER

Table 6-1: Selected Sample Preparation Reagents

Table 6-2: Selected Cancer Test Innovations, 2015

SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY:

CELL-BASED MOLECULAR TESTS

Table 7-1: Selected Innovations in Molecular Cell-Based Tests

EIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATION

Table 8-1: Selected Molecular Pharmacodiagnostics for Anticoagulant Drug Testing, 2014

NINE: HISTOLOGY AND CYTOLOGY

Table 9-1: Worldwide Molecular Histology Sales, by Type, 2014 and 2019 (In situ hybridization, HPV, Histology Total)

Table 9-2: Selected Molecular Histology Innovations, 2015

Table 9-3: Selected FFPE DNA/RNA Sample Preparation Innovations

Table 9-4: Selected HPV Test Innovations

Table 9-5: Selected Innovations in CTC Technology

Table 9-6: Major Pharmacodiagnostic Markers

Table 9-7: Selected Pharmacodiagnostic Histology Tests

TEN: MICROBIOLOGY AND VIROLOGY

Table 10-1: Molecular Test Sales, Microbiology/Virology, 2014 and 2019 (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory; Organism ID; Mycobacteria, TB; Others; Total)

Table 10-2: Molecular Infectious Disease Company Sales, 2014

Table 10-3: Selected New Instruments for Molecular Infectious Disease Testing,2015

Table 10-4: Selected Molecular Test Innovations for Decentralized Use

Table 10-5: Selected Molecular Infectious Diseases Sample Treatment Products

Table 10-6: Selected Molecular Infectious Disease Test Services

Table 10-7: Selected Tests for Antibiotic Resistance

Table 10-8: Selected Microbiology Sequencing Innovations

Table 10-9: Selected Microbiome-Based Diagnostics

Table 10-10: Tests with Emergency Use Designation

Table 10-11: Selected Innovations in Emerging Pathogen Testing

Table 10-12: Selected Advanced Techniques for Hospital Acquired Infections

Table 10-13: Selected Recent Molecular HIV Test Innovations

Table 10-14: Selected Molecular Hepatitis Test Innovations

Table 10-15: Selected Molecular STD Test Innovations

Table 10-16: Selected Molecular Tests for Respiratory Tract Infections

Table 10-17: Selected Molecular Tests for TB

Table 10-18: Selected Molecular Tests for Fungal Infections

Table 10-19: Miscellaneous Molecular Infectious Disease Tests, 2013-2015

ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINE

Table 11-1: Pathogen Commonly Tested in Donated Blood Units

Table 11-2: Selected Pathogen Screening Innovations

Table 11-3: Selected Blood Typing Innovations

TWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENT

Table 12-1: Selected HLA Typing Test Innovations, 2015

Table 12-2: Selected cfDNA Innovations in Transplant Medicine

THIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENING

Table 13-1: Revenue Stream of Selected NIPT Service Companies, 2010-2015

Table 13-2: Selected New IVF Services

Table 13-3: Selected Genomic Newborn Screening Services

FOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASES

Table 14-1: Most Frequently Requested Genetic Tests

Table 14-2: Selected Autism Test Innovations

Table 14-3: Selected Innovations in Genetic Tests for CVD, 2015

Table 14-4: Selected Molecular Diabetes Tests, 2015

Table 14-5: Selected Innovations in Personalized Tests for Psychiatric Disorders

Table 14-6: Selected Tests for Irritable Bowel Diseases

Table 14-7: Selected Molecular Tests for Inherited Diseases, 2015

SIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCH

Table 16-1: Estimated Revenues of the Top Ten Molecular Test Vendors, 2010-2014

Table 16-2: Estimated Revenues of Selected Molecular Test Vendors, 2010-2014

Table 16-3: Selected Acquisitions in Molecular Diagnostics, 2013-2015

Table 16-4: Selected Collaborations and Licensing Agreements, 2013-2015

Table 16-5: Selected Distribution Agreements, 2013-2015

 

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