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World In Vitro Diagnostics (IVD) Market Bundle: Molecular Diagnostics (Microbiology, Oncology, Blood, Prenatal, Inherited, Others), Cancer Diagnostics (HPV, ISH, Cytometry, PSA, FOB, Others), Infectious Diseases (ID/AST, POC, HAIs, STDs, Other)

This Kalorama Information In Vitro Diagnostics (IVD) Market Bundle represents three reports, as published in 2015. These reports, representing over 2,000 pages of market information, delve into some of the fastest-growing and most critical areas of clinical diagnostics: cancer diagnostics, molecular assays and systems, and infectious disease tests.  Together, these three in vitro diagnostic areas represent nearly one-half of the IVD market and the best growth opportunities. The Bundle features the exact published content in each of the three major Kalorama studies, sold as intact PDFs with separate table of contents, including the following:

  • The World Market for Molecular Diagnostics, 6th Edition
    • In the World Market for Molecular Diagnostics, 6th Edition, Kalorama IVD market analyst Shara Rosen, R.T., MBA provides complete analysis of the IVD molecular testing kit and reagent industry by segment. 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.
  • The World Market for Cancer Diagnostics, 6th Edition
    • Kalorama has, in five previous editions of The World Market for Cancer Diagnostics, defined the oncology testing market. This 850-page report contains detailed market data on the following IVD segments for their use in cancer diagnostics:
      • Cancer IVD Market
      • Cancer Test Services Market
      • Sequencing in Cancer Testing
      • Tissue Function Tests
      • PSA, CEA and Other Immunoassays
      • Flow Cytometry
      • Pap and HPV Testing
      • FOB and Other Rapid Tests
      • Molecular Oncology Assays
      • Tissue Microarrays
      • Methylated DNA
      • In situ hybridization (ISH)
      • Immunohistochemistry (IHC)
      • Circulating Tumor Cells
      • Companion Testing and CDX Products
      The report also details investments and financing agreements for cancer diagnostics companies, selected agreements between cancer diagnostic companies, selected agreements between cancer diagnostic companies and other diagnostic companies, pharmaceutical companies and non-profit organizations, and selected acquisitions of cancer diagnostic companies. The report provides detailed company profiles in several sections.

  • The World Market for Infectious Disease Diagnostics
    • This Kalorama Information report, The World Market for Infectious Disease Tests, contains detailed market estimates and forecasts for four major areas of infectious disease testing. Specific market details provided include:
      • ID/AST Test Market by Type (Auto ID/AST Systems, Manual ID/AST Systems, Blood Culture, Chromogenic Media, Rapid Micro)
      • ID/AST Leader Market Shares
      • Infectious Disease Immunoassays by Type (Lab-Based, POC, Home Testing)
      • Laboratory Infectious Disease
      • Immunoassays Sales by Disease(Hepatitis, HIV, Mycology, Parasitology, Respiratory, Sepsis, STDs, ToRCH, Others)
      • Infectious Disease Diagnostic Sales by Region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020)
      • Blood Screening Test Market Size and Company Market Share
      Trends in infectious diseases and in products are discussed. The information contained in this report has been assembled from primary and secondary data. Primary research was conducted via telephone conversations with selected diagnostic marketers of in vitro diagnostics to assess the current market and trends in laboratory medicine


IVD Market Bundle

I.  The World Market for Cancer Diagnostics, 6th Edition (Histology [ISH, IHC, HPV, Pap], Flow Cytometry, PSA, CEA, Liquid Biopsy, FOB and Other Rapid, Image Cytometry, Sequencing, Digital Pathology, Molecular Assays) 

ONE: EXECUTIVE SUMMARY

Overview
Scope and Methodology
Market Overview
Prognosis for Growth

TWO: INTRODUCTION

Diagnosis and Treatment of Cancer
Point of View
THREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS

Chromosome Analysis (Karyotyping)
Cytology/Histology Stains
Tests for Fecal Occult Blood
Immunoassays
Overview - Immunoassays
Immunoassay Instrument Platforms
Immunohistochemistry (IHC)
Flow Cytometry
Fluorescence in situ Hybridization (FISH) and Chromogenic in situ Hybridization(CISH)
Nucleic Acid Amplification Technologies
Analysis of Gene Expression Patterns (Gene Signatures)
Microarrays
Protein Microarrays
DNA Microarrays
Chromosomal Microarrays
Tissue Microarrays
Sequencing Technologies
Sanger Sequencing
Early Next Generation Sequencing Technologies
Sequencing by Synthesis (SBS)
Supported Oligonucleotide Ligation and Detection (SOLiD)
Ion Torrent Sequencing
True Single Molecule Sequencing (tSMS)
Single Molecule Real Time (SMRT) Sequencing
DNA Nanoball Sequencing
Nanopore Sequencing
Other Sequencing Technologies
Mass Spectrometry
Mass Spectrometry Technology
Research and Clinical Applications of Mass Spectrometry
Circulating Tumor DNA (Cell Free DNA)
Circulating Tumor Cells (CTCs)
Cell-Based Assays (Live Cell Cancer Tests)
Digital Pathology and Image Cytometry
Information Technology

FOUR: CANCER DIAGNOSTICS – APPLICATIONS

Assess Risk of Developing Cancer
Cancer Screening
Cancer Screening – Pap Smear and Human Papillomavirus (HPV) Testing
Colorectal Cancer Screening
Prostate Cancer Screening
Screening for Other Cancers
Diagnosis/Prognosis/Monitoring of Cancer
Personalized Medicine/Companion Diagnostics/Precision Testing
Drug Metabolism
Predicting Response to Therapy
FIVE: CANCER DIAGNOSTIC MARKETS

In Vitro Diagnostic Kits Marketed to Clinical Laboratories
Point-of-Care Tests for Cancer
Clinical Laboratory Test Services

SIX: DEALS – CANCER DIAGNOSTICS

Investments and Financing Agreements for Cancer Diagnostic Companies
Agreements with Other Companies
Acquisitions of Cancer Diagnostic Companies
Selected Other Agreements

SEVEN: CANCER DIAGNOSTICS – MARKET DRIVERS AND CHALLENGES

Cancer Diagnostic Market Drivers
Advances in Technology Changing the Future of Cancer Diagnostics
Impact of Companion Diagnostic Tests
Limited Tissue from Biopsies for Growing Number of Cancer Tests
Laboratory Developed Tests and the FDA
Cost and Reimbursement Issues
Physician Education, Acceptance, and Use of New Cancer Tests
Competition
Future Prospects

EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS

In Vitro Cancer Diagnostics Market by Geographical Distribution
Clinical Laboratory Testing Market – Cancer Diagnostics
In Vitro Cancer Diagnostics Market Segments
Histology/Cytology
Immunoassays
Rapid Tests
Molecular (Nucleic Acid-Based) Assays
NINE: COMPANY PROFILES: CANCER DIAGNOSTIC COMPANIES

M Genomics Ltd.
20/20 GeneSystems, Inc.
AB SCIEX
Abbott Laboratories
 Abcodia Ltd.
Abingdon Health Ltd
Abnova Corporation
ACT Genomics Co., Ltd.
Adaptive Biotechnologies Corporation
Admera Health (a GENEWIZ company)
Advanced Cell Diagnostics
Affymetrix, Inc. 
Agena Bioscience Inc.
Agendia NV
Agilent Technologies Inc. 
Alere Inc. 
Ambry Genetics Corp.
Amoy Diagnostics Co., Ltd.
ANGLE plc
ApoCell, Inc.
Applied Proteomics, Inc.
Applied Spectral Imaging, Inc.
Arbor Vita Corporation
ARKRAY, Inc.
ARUP Laboratories
Astra Biotech GmbH
Asuragen, Inc.
AsymmetRx Medical, Inc.
Atossa Genetics Inc.
 AutoGenomics, Inc
Avant Diagnostics, Inc. (formerly Arrayit Diagnostics Inc.)
Axela, Inc
AXO Science
Beckman Coulter, Inc. (subsidiary of Danaher Corporation) 
Becton, Dickinson and Company (BD)
 BGI-Shenzhen
The Binding Site Group Ltd.
Biocare Medical, LLC
Biocartis SA
Biocept, Inc.
 Biodesix, Inc.
BioFluidica
BioGenex
Biological Dynamics Inc.
BioMarker Strategies
bioMérieux SA 
BioMosaics
Bio-Rad Laboratories, Inc. 
Bio-Reference Laboratories, Inc. (BRLI) 
BioSystems
bioTheranostics (a bioMérieux company)
Biotype Diagnostic GmbH
BioView Ltd
Boditech Med Inc.
 Cancer Genetics, Inc.
 Canopus Bioscience Ltd.
Caprion, Inc.
Caris Life Sciences
Castle Biosciences, Inc.
CDx Diagnostics
Celerus Diagnostics, Inc.
Cellmid Ltd.
Centogene AG
Cepheid
 Cernostics
Cirdan Imaging Ltd
Clarient Diagnostic Services, Inc. (a GE Healthcare company)
Clearbridge BioMedics Pte Ltd
Color Genomics, Inc.
Counsyl, Inc.
Cube Dx GmbH
Cynvenio Biosystems, Inc.
CytoTest Inc.
Dako A/S (an Agilent company)
Danaher Corporation
DermTech, Inc.
DiaCarta, Inc.
DiaSorin S.p.A.
DiaTech Oncology
EDP Biotech Corporation
Eiken Chemical Co., Ltd.
 EntroGen, Inc.
Enzo Biochem, Inc
Enzo Life Sciences, Inc.
Enzo Clinical Labs, Inc.
Epic Sciences, Inc.
Epigenomics AG 
Eutropics Pharmaceuticals
Exact Sciences Corporation
 Exosome Diagnostics, Inc.
Fluxion Biosciences, Inc.
Foundation Medicine, Inc. 
Fujirebio Inc.
Fujirebio Diagnositics, Inc.
 GE Healthcare 
Genalyte, Inc.
GeneCentric Diagnostics, Inc.
Genection, Inc. (an Invivoscribe company)
GeneDx
GeneNews Limited
Genetic Technologies Limited / Phenogen Sciences, Inc. (U.S. division) 
GenomeDx Biosciences
Genomica S.A.U.
Genomic Health, Inc.
 Genomic Vision 
Genoptix (a Novartis company)
GenPath / GenPath Women’s Health and GenPath Oncology
Guardant Health, Inc.
HalioDx
Healgen Scientific LLC
Helomics Corporation
Hologic, Inc. 
HTG Molecular Diagnostics, Inc.
 Human Longevity, Inc.
Icellate AB
Ikonisys, Inc.
Illumina, Inc. 
ImCare BioTech
Immunovia AB
IncellDx, Inc.
Inform Genomics, Inc.
Financings
Other Agreements
Inivata Ltd.
Innovations Exchange Pte Ltd (INEX)
Insight Genetics, Inc.
IntegraGen SA 
Integrated Diagnostics, Inc.
Invitae Corporation
 Invivoscribe Technologies, Inc.
Iris BioTechnologies Inc.
Janssen Diagnostics / Janssen Diagnostics BVBA
Janssen Diagnostics, LLC
Laboratory Corporation of America (LabCorp) / Integrated Genetics
 Leica Biosystems Inc. (a Danaher company)
Leica Microsystems (a Danaher company)
Lifecode, Inc.
MagArray, Inc.
Martell Diagnostic Laboratories, Inc.
Matrix-Bio, Inc.
Mayo Medical Laboratories and Mayo Clinic
Medical & Biological Laboratories Co., Ltd. (MBL)
MBL International Corporation
 MDxHealth SA 
Metamark Genetics, Inc.
MetaStat, Inc.
MolecularMD Corporation
Multiplicom NV
Myriad Genetics, Inc.
Myriad RBM, Inc. 
NanoIVD, Inc.
NanoString Technologies, Inc. 
NeoGenomics, Inc. / NeoGenomics Laboratories
 NewGene Ltd.
New Oncology AG
Nuclea Biotechnologies, Inc.
Ohmx Corporation
Omnyx
Oncimmune Ltd.
Oncimmune (USA) LLC (acquired by HDL Inc.)
Health Diagnostic Laboratory, Inc.
OncoCyte Corporation
OncoDNA SA
OncoHealth Corp.
Oncolab, Inc.
Oncolys BioPharma Inc.
Oncompass GmbH
Onconome, Inc.
OncoPlex Diagnostics (OncoPlexDx)
Oncospire Genomics
OPKO Health, Inc. / OPKO Diagnostics
 Orion Genomics
Ortho-Clinical Diagnostics
 OvaGene Oncology Inc.
Oxford Cancer Biomarkers Ltd.
Oxford Gene Technology
Pacific Edge Limited 
Pathway Genomics Corporation
Personal Genome Diagnostics, Inc.
PGXL Laboratories
Phenomenome Discoveries Inc.
Polymedco, Inc.
PreTect AS
PrognosDx Health, Inc.
Provista Diagnostics, Inc.
QIAGEN N.V.
QuanDx
Quanterix Corporation
QuantuMDx Group
Quest Diagnostics
 RainDance Technologies, Inc.
Randox Laboratories Ltd
Rarecells SAS
Response Genetics, Inc.
 Rheonix, Inc.
RiboMed Biotechnologies, Inc.
Roche
 Rosetta Genomics Ltd.
 ScheBo-Biotech AG
ScreenCell
Sequenom, Inc.
 Siemens Healthcare Diagnostics
Symbiodx
Sysmex Corporation 
TeloVISION, LLC
Theranostics Health Inc.
Thermo Fisher Scientific, Inc. 
Tosoh Corporation
Tosoh Bioscience, Inc. 
Transgenomic, Inc.
TrimGen Corporation
TrovaGene, Inc.
 Vela Diagnostics
Ventana Medical Systems, Inc. (member of the Roche Group)
Veracyte, Inc.
 Wako Diagnostics
Wako Pure Chemical Industries, Ltd.,
,
LIST OF EXHIBITS


ONE: EXECUTIVE SUMMARY

Table 1-1: Worldwide Cancer Diagnostic Market, 2014 and 2019 (Global Cancer IVD Market, Clinical Laboratory Services) (in millions USD)

TWO: INTRODUCTION

Table 2-1: Estimated Global Incidence and Mortality due to Cancer, 2012

THREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS

Table 3-1: Selected Examples of Companies Marketing Fecal Occult Blood Tests
Table 3-2: Selected Companies with Immunoassays and/or Automated Immunoassay Platforms on the Market or In Development for Cancer Diagnostics
Table 3-3: Selected Examples of Companies Marketing Rapid Lateral Flow Tests for Tumor Antigens
Table 3-4: Selected Companies with Immunohistochemistry Tests on the Market or In Development for Cancer Diagnostics
Table 3-5: Selected Companies Marketing Flow Cytometry Platforms or Consumables
Table 3-6: Selected Companies with in situ hybridization tests on the Market or In Development for Cancer Diagnostics (Company, Comment, Market Status)
Table 3-7: Selected Companies with PCR or Other Nucleic Acid Amplification Based Tests for Cancer Diagnostics
Table 3-8: Selected Examples of Companies Analyzing Gene Expression Patterns (“Gene Signatures”) in Tissues
Table 3-9: Selected Companies Developing/Marketing Cancer Diagnostic Products Based on Microarray Technologies
Table 3-10: Selected Sequencing Technologies and Platforms
Table 3-11: Selected Diagnostic Companies and Clinical Laboratories with Sequencing-Based Cancer Tests
Table 3-12: Selected Companies Developing/Marketing Mass Spectrometry- Based Oncology Diagnostic Tests
Table 3-13: Selected Examples of Companies Developing/Commercializing Cancer Diagnostic Assays Based on ctDNA
Table 3-14: Selected Companies Working with Circulating Tumor Cells (CTCs)
Table 3-15: Selected Companies Developing or Commercializing Cell-Based Assays for Cancer Diagnostics
Table 3-16: Selected Digital Pathology Companies

FOUR: CANCER DIAGNOSTICS – APPLICATIONS

Table 4-1: Selected Companies Developing/Marketing Assays to Determine Risk of Cancer
Table 4-2: Selected Companies Developing/Marketing Diagnostic Tests for HPV
Table 4-3: Selected Companies Developing/Marketing Cancer IVD Tests for Colorectal Cancer Screening
Table 4-4: Selected Companies Developing/Marketing Screening Tests for Prostate Specific Antigen
Table 4-5: Selected Companies Developing/Marketing Other Tests for Prostate Cancer
Table 4-6: Selected Companies Developing/Marketing Screening Tests for Other Cancers
Table 4-7: Selected Widely Used Tumor Markers
Table 4-8: Selected Companies Developing/Marketing Tests for Diagnosis/Prognosis/Monitoring of Cancer
Table 4-9: Selected Companies Developing/Marketing Tests for Drug Metabolism – To Personalize Treatment of Cancer
Table 4-10: Selected Companies Developing/Marketing Tests to Predict Response to Therapy; Precision Medicine
Table 4-11: Selected FDA Cleared/Approved Companion Diagnostic Tests

FIVE: CANCER DIAGNOSTIC MARKETS

Table 5-1: Selected Examples - Companies Developing and Marketing Cancer Diagnostics Tests and Platforms to Clinical Laboratories
Table 5-2: Selected Examples - Companies Developing and/or Marketing Pointof-Care and/or Rapid Platforms and Tests for Cancer – Moving Beyond Lateral Flow
Table 5-3: Selected Examples - Companies Developing and/or Offering Cancer Diagnostic Tests as Laboratory Developed Tests

SIX: DEALS – CANCER DIAGNOSTICS

Table 6-1: Selected Investments and Other Financing Agreements for CancerDiagnostic Companies
Table 6-2: Selected Agreements Between Cancer Diagnostic Companies and Other Diagnostic Companies or Clinical Laboratories
Table 6-3: Selected Agreements Between Cancer Diagnostic Companies and Pharmaceutical or Biopharmaceutical Companies
Table 6-4: Selected Agreements Between Two Cancer Diagnostic Companies
Table 6-5: Selected Other Cancer Diagnostic Company Agreements
Table 6-6: Selected Acquisitions of Cancer Diagnostic Companies
Table 6-7: Selected Cancer Diagnostic Company Agreements with Academic or Other Non-Profit Organizations

EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS

Table 8-1: World Cancer Test Market (In Vitro Diagnostic Kits) by Region (North America, EU, Japan, ROW), 2014 and 2019 ($ millions)
Table 8-2: World Cancer Test Market (Clinical Laboratory Test Services), 2014 and 2019 ($ millions)
Table 8-3: Worldwide Market for Selected Cancer IVD Tests (Sold to ClinicalLabs) (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, CTCs), 2014 and 2019 ($ millions)
Figure 8-1: Geographical Distribution of Pap Smear Testing, 2013
Table 8-4: Worldwide Histology/Cytology Sales (Pap Smears, Other [non-Pap] Stains, HPV, Immunohistochemistry, and In Situ Hybridization), 2014 and 2019($ millions)
Table 8-5: Cancer Immunoassay Sales, Lab-Based (PSA, CEA, CA 125, AFP,Others), 2014 and 2019 ($ millions)
Table 8-6: Rapid Cancer Test Sales by Test Category (FOB, PSA, NMP22, Other)Worldwide, 2014 and 2019 ($ millions)



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


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



III.  The World Market for Infectious Disease Diagnostic Tests 

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