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)

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from $4,500	2100 Pages	Kalorama Information	January, 2016	KLI5757702

Lowest Prices Guaranteed
Price	from $4,500
Length	2100 Pages
Publisher	Kalorama Information
Published Date	January, 2016
SKU	KLI5757702

Table of Contents
Description

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 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

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)

Infectious Diseases

Virology

Oncology

Eiken Chemical Co., Ltd

Enzo Biochem Inc.

IP Situation

Illumina

Sequencing

Sequencing Kits

Sample Prep

IVD Business

Oncology

HLA Typing

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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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)

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