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
