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The World Market for Companion Diagnostic Tests

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SKU: KLI15021881 Category: Diagnostics Market Research Pages: 810
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Description

The World Market for Companion Diagnostics

The World Market for Companion Diagnostics examines revenues for companion diagnostic and personalized medicine diagnostics. Market analysis in this market review includes regional coverage – North America, Europe, rest of world – of the world IVD companion diagnostics test market (in vitro diagnostic kits) for 2015-2020, coverage by disease segment – cancer and other – of the world IVD companion diagnostics test market for 2015, and coverage of the worldwide companion diagnostics test services market for 2015 and 2020. The report reviews emerging and current applications of personalized medicine, including selected major biomarkers in oncology personalized medicine tests and selected companies with personalized medicine tests for oncology, cardiovascular disease/disorders, and neurological disorders. Pfizer, Inc., Novartis AG, Roche (F. Hoffmann-La Roche Ltd.), Merck & Co., Inc., and GlaxoSmithKline plc are among the manufacturers analyzed of the selected pharmaceutical companies that are active in the fields of companion diagnostics or personalized medicine.

Table of Contents

ONE: EXECUTIVE SUMMARY

Overview

Scope and Methodology

Market Overview

Prognosis for Growth

TWO: INTRODUCTION

Terms Used in Companion Diagnostics and Personalized Medicine

Definitions of Companion Diagnostics and Personalized Medicine Used in This Report

Types of Tests Included in Personalized Medicine

Technology Used in Personalized Medicine

Point of View

THREE: CURRENT AND EMERGING APPLICATIONS OF PERSONALIZED MEDICINE

Oncology (Solid Tumors and Hematological Cancers)

Cardiovascular Disease

Neurological Disorders

Autoimmune and Inflammatory Disorders; Other Immune Related Conditions

Infectious Disease

Antibiotic Resistance

Other Infectious Disease Personalized Medicine Tests

Therapeutic Drug Monitoring

Drug Metabolism

Other Applications of Personalized Medicine Tests

FOUR: BUSINESS MODELS AND DEALS – PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS

Business Models

Business Models for Pharmaceutical Companies in Personalized Medicine

Business Models for Diagnostic Companies in Personalized Medicine

Investments and Financing Agreements

Mergers and Acquisitions

Collaborations between Pharmaceutical and Diagnostic Companies

Other Pharmaceutical Company Agreements

Diagnostic Company Collaborations with Other (Non-Pharmaceutical) Companies

Diagnostic Company Collaborations with Universities and Non-Profit Research

Institutes

FIVE: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS – MARKET DRIVERS AND CHALLENGES

Cancer Diagnostic Market Drivers

Companion Diagnostic Tests in Drug Development – Opportunities and Challenges

Clinical Validation of Novel Biomarkers or Genetic Signatures

Regulation of Companion Diagnostics

Complexities of Companion Diagnostic Tests and Corresponding Therapeutic

Products; Harmonization of Companion Diagnostic Tests across a Class of Targeted

Therapies

Guidelines

Laboratory Developed Tests and the FDA

Limited Tissue from Biopsies for Growing Number of Cancer Tests

Advances in Technology Changing the Future of Personalized Medicine Diagnostics .. 277

Reimbursement

Physician Education, Acceptance, and Use of Novel Personalized Medicine Tests

Competition

Working Together on Personalized Medicine – Alliances, Consortiums, and Other

Groups

Future Prospects

SIX: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS – MARKET ANALYSIS

Global Personalized Medicine and Companion Diagnostic Test Market by

Geographical Region

Personalized Medicine and Companion Diagnostic Test Market by Disease

Indication

Personalized Medicine Testing Services Market

SEVEN: COMPANY PROFILES: PHARMACEUTICAL COMPANIES (FOCUSINGON COMPANION DIAGNOSTIC ACTIVITIES)

AbbVie Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Acumen Pharmaceuticals, Inc.

Adaptimmune Therapeutics plc

Recent Revenue History

Company Overview

Amgen Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

ARCA biopharma, Inc.

Recent Revenue History

Company Overview

ARIAD Pharmaceuticals, Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Arno Therapeutics, Inc.

Recent Revenue History

Company Overview

Array BioPharma Inc.

Recent Revenue History

Company Overview

Astellas Pharma Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

AstraZeneca

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Athera Biotechnologies AB

AVEO Oncology

Recent Revenue History

Company Overview

Bayer AG

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Boehringer Ingelheim

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Bristol-Myers Squibb Company

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Celldex Therapeutics, Inc.

Recent Revenue History

Company Overview

Clovis Oncology, Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Eli Lilly

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Galena Biopharma, Inc.

Recent Revenue History

Company Overview

GlaxoSmithKline plc

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Idera Pharmaceuticals, Inc

Recent Revenue History

Company Overview

Janssen Pharmaceutical Companies of Johnson & Johnson

Merck & Co., Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Merck KGaA (EMD Serono)

Novartis AG

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Pfizer Inc.

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

Roche (F. Hoffmann-La Roche Ltd.) and Genentech (A Member of the

Roche Group)

Recent Revenue History

Companion Diagnostics/Personalized Medicine Activities

EIGHT: COMPANY PROFILES: DIAGNOSTIC COMPANIES AND CLINICAL LABORATORIES

20/20 GeneSystems, Inc

A&G Pharmaceutical, Inc.

Abacus Diagnostica Oy

Abbott Laboratories

Recent Revenue History

Company Overview – Focusing on Personalized Medicine and Companion

Diagnostics

Agreements with Pharmaceutical Companies

Acquisitions and Other Agreements with Other Companies

Accelerate Diagnostics, Inc.

Recent Revenue History

Company Overview

Acobiom

ACT Genomics Co., Ltd.

Adaptive Biotechnologies Corporation

Admera Health (A GENEWIZ Company)

Advanced Cell Diagnostics

Products

Services for Pharmaceutical Companies

Companion Diagnostics Agreements

Aelan Cell Technologies

Affymetrix, Inc. (Acquired by Thermo Fisher Scientific)

Recent Revenue History

Company Overview

eBioscience

Affymetrix Core

Selected Affymetrix Agreements

Agena Bioscience Inc.

Agendia NV

Almac Group Limited

AltheaDx, Inc.

Amarantus BioScience Holdings, Inc.

Amarantus Diagnostics

Amoy Diagnostics Co., Ltd.

ANGLE plc

ARKRAY, Inc.

Assurex Health, Inc.

Asuragen, Inc.

Diagnostic Products

Translational/Companion Diagnostics

Agreements

Atlas Genetics Ltd

AutoGenomics, Inc.

Avant Diagnostics, Inc.

BacterioScan, Inc.

Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)

Recent Revenue History

Company Overview

Flow Cytometry

Beckman Coulter Genomics

Other Tests and Services

Agreements

Becton, Dickinson and Company (BD)

Recent Revenue History

Company Overview

Microbiology and Molecular Diagnostic Testing for Infectious Diseases

Fluorescence-Activated Cell Sorters and Analyzers

Oncology

BG Medicine, Inc.

Recent Revenue History

Company Overview

Biocartis

Recent Revenue History

Company Overview

Startup History

Technology/Products

Investors/Financings and IPO

Pharmaceutical Company Agreements

Other Agreements

Biocept, Inc.

Recent Revenue History

Company Overview

Financings

Agreements with Pharmaceutical Companies

Other Agreements

Biodesix, Inc.

Investors/Financings

Other Agreements

BioFire Diagnostics, LLC. (Acquired by bioMérieux)

Recent Revenue History and Other Financial Information

Company Overview

BioGenex

Biological Dynamics, Inc.

BioMarker Strategies

bioMérieux SA

Recent Revenue History

Company Overview

Traditional Microbiology

Immunodiagnostics for Lab Professionals (Clinical Laboratories)

Mass Spectrometry for Clinical Laboratories

Molecular Diagnostics

Selected Pharmaceutical Company Agreements

Other Agreements

BioMosaics Inc.

BioReference Laboratories, Inc. (BRLI) (Part of OPKO Health, Inc.)

Recent Revenue History

Company Overview

bioTheranostics, Inc.

Biotype Diagnostic GmbH

Cancer Genetics, Inc.

Recent Revenue History

Company Overview

Pharmaceutical Company Agreements

Other Agreements

Caprion, Inc.

CardioDx, Inc.

CardioGenics Holdings Inc.

CareDx, Inc.

Recent Revenue History

Company Overview

Caris Life Sciences

Castle Biosciences, Inc.

Cepheid

Recent Revenue History

Company Overview

Clarient Diagnostic Services, Inc. (A NeoGenomics Company)

Recent Revenue History

Company Overview

CompanionDx

Crescendo Bioscience (A Myriad Company)

Cube Dx GmbH

Curetis AG

Recent Revenue History

Company Overview

Cynvenio Biosystems, Inc.

Dako A/S (An Agilent Company)

Recent Revenue History

Company Overview

Danaher Corporation

Recent Revenue History

Company Overview

Definiens AG (Acquired by MedImmune, Part of AstraZeneca)

DiaCarta, Inc.

DiamiR, LLC

Diatech Pharmacogenetics srl

Diaxonhit

Recent Revenue History

Company Overview

DNA Electronics Ltd. (DNAe)

EntroGen, Inc.

Enzo Biochem, Inc./Enzo Life Sciences, Inc./Enzo Clinical Labs, Inc.

Recent Revenue History

Company Overview

Epic Sciences, Inc.

Eutropics Pharmaceuticals

Exosome Diagnostics, Inc.

Selected Agreements

Foundation Medicine, Inc.

Recent Revenue History

Company Overview

Pharmaceutical Company Agreements

Agreement with Contract Research Organization

Agreements with Universities and Other Non-Profit Institutions

Agreements with Other (Non-Diagnostic) Companies

GeneCentric Diagnostics, Inc.

Genection, Inc. (An Invivoscribe Company)

Genelex Corporation

GeneNews Limited and Innovative Diagnostic Laboratory

Genomas, Inc.

GenomeDx Biosciences

Genomic Health, Inc.

Recent Revenue History

Company Overview

Genomica S.A.U.

Genomind

Genoptix (A Novartis Company)

GenPath Oncology

Grifols, S.A.

Recent Revenue History

Company Overview

Guardant Health, Inc.

HalioDx

Harmonyx Diagnostics

Helomics Corporation

HTG Molecular Diagnostics, Inc.

Recent Revenue History

Company Overview

Products

Pharmaceutical Company Agreements

Selected Other Agreements

Illumina, Inc.

Recent Revenue History

Company Overview

Products and Services – Overview

Investing in the Future

Companion Diagnostics

Agreements with Pharmaceutical Companies

Other Companion Diagnostic/Personalized Medicine Agreements

Inform Genomics, Inc.

Financings

Other Agreements

Inivata Ltd.

Insight Genetics, Inc.

Selected Agreements

InSilixa, Inc.

IntegraGen SA

Recent Revenue History

Company Overview

Invivoscribe Technologies, Inc.

Iris BioTechnologies Inc.

Recent Revenue History

Company Overview

Janssen Diagnostics/Janssen Diagnostics BVBA/Janssen Diagnostics, LLC

Infectious Disease

Oncology

Lab 21 (Part of the Novacyt Group of Companies)

Laboratory Corporation of America (LabCorp)

Recent Revenue History

Company Overview

Selected Examples of Companion Diagnostic/Personalized Medicine Agreements between LabCorp or Covance and Other Diagnostic Companies

Leica Biosystems Inc. (A Danaher Company)

Pharmaceutical Company Agreements in Companion Diagnostics and Personalized Medicine

Other Companion Diagnostic/Personalized Medicine Agreements

Luminex Corporation

Recent Revenue History

Company Overview

Mayo Medical Laboratories and Mayo Clinic

Medical & Biological Laboratories Co., Ltd. (MBL)/MBL International

Corporation

Recent Revenue History

Company Overview

Metabolon, Inc.

Metamark Genetics, Inc.

MIODx

MolecularMD Corporation

Monogram Biosciences (LabCorp Specialty Testing Group)

Multiplicom NV

Myriad Genetics, Inc./Myriad RBM, Inc.

Recent Revenue History

Company Overview

Myriad RBM

Pharmaceutical Company Agreements

NanoString Technologies, Inc.

Recent Revenue History

Company Overview

NantOmics (Member of the NantWorks ecosystem of companies)

NeoGenomics, Inc./NeoGenomics Laboratories

Recent Revenue History

Company Overview

NewGene Ltd.

New Oncology AG

NovellusDx

Nuclea Biotechnologies, Inc.

OncoDNA SA

Oncompass GmbH

OncoPlex Diagnostics (OncoPlexDx)(Part of NantOmics)

Oncospire Genomics

One Way Liver S.L. (OWL Metabolomics)

OPKO Health, Inc./OPKO Diagnostics

Recent Revenue History

Company Overview

BioReference Laboratories

OPKO Lab and 4Kscoreâ„¢ Test

Point-of-Care Diagnostics – Claros 1 Analyzer and Sangia Microfluidic Assay Cassettes 728

OvaGene Oncology Inc.

Oxford Cancer Biomarkers Ltd

Oxford Gene Technology

Panagene Inc.

Personal Genome Diagnostics, Inc.

Protagen AG

QIAGEN N.V.

Recent Revenue History

Company Overview

QuanDx Inc.

Quest Diagnostics

Recent Revenue History

Company Overview

Qvella Corporation

RiboMed Biotechnologies, Inc.

Roche

Recent Revenue History

Company Overview

Roche Professional Diagnostics

Molecular Diagnostics

Tissue Diagnostics

Next-Generation Sequencing

Rosetta Genomics Ltd.

Recent Revenue History

Company Overview

Selected Agreements

Siemens Healthcare Diagnostics/Siemens Clinical Laboratory/Siemens

Recent Revenue History

Company Overview

Symbiodx

Sysmex Corporation

Recent Revenue History

Company Overview

Theranostics Health Inc. (Acquired by Avant Diagnostics, Inc.)

Thermo Fisher Scientific, Inc.

Recent Revenue History

Company Overview

Transgenomic, Inc.

Recent Revenue History

Company Overview

TrimGen Corporation

Trovagene, Inc.

Recent Revenue History

Company Overview

Ventana Medical Systems, Inc. (Member of the Roche Group)

WOUNDCHEK Laboratories

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

Table 1-1: Worldwide Companion Diagnostic Market, 2015 and 2020

THREE: CURRENT AND EMERGING APPLICATIONS OF PERSONALIZED MEDICINE

Table 3-1: FDA Cleared/Approved Companion Diagnostic Tests

Table 3-2: Selected Major Biomarkers in Oncology Personalized Medicine Tests

Table 3-3: Selected Companies with Personalized Medicine Tests for Oncology

Table 3-4: Selected Companies with Personalized Medicine Tests for Cardiovascular Disease/Disorders

Table 3-5: Selected Companies with Personalized Medicine Tests for Neurological Disorders

Table 3-6: Selected Companies with Personalized Medicine Tests for Autoimmune and Inflammatory Disorders; Other Immune Related Conditions

Table 3-7: Selected Biomarkers and Other Tests for Antibiotic Resistance, and Companies Developing/Marketing these Biomarkers

Table 3-8: Selected Companies with Other Personalized Medicine Infectious Disease Tests

Table 3-9: Selected Companies with Personalized Medicine Tests for Therapeutic Drug Monitoring of Biological Drugs

Table 3-10: Pharmacogenomic Biomarkers in Drug Labeling

Table 3-11: Selected Companies with Personalized Medicine Tests for Drug Metabolism Genes

Table 3-12: Selected Companies with Other Personalized Medicine Tests

FOUR: BUSINESS MODELS AND DEALS – PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS

Table 4-1: Investments and Financings in Personalized Medicine/Companion

Diagnostics

Table 4-2: Selected Examples of Pharmaceutical Companies and Other Companies

That Invested in Diagnostic Companies in Personalized Medicine

Table 4-3: Mergers and Acquisitions in Personalized Medicine/Companion

Diagnostics

Table 4-4: Selected Examples of Pharmaceutical Companies That Acquired Diagnostic Companies or Have Diagnostic Divisions

Table 4-5: Collaborations between Pharmaceutical and Diagnostic Companies

Table 4-6: Selected Examples of Pharmaceutical That Entered into Agreements with Diagnostic Companies

Table 4-7: Selected Other Pharmaceutical Company Agreements

Table 4-8: Collaborations between Two Diagnostic Companies

Table 4-9: Diagnostic Company Agreements with Clinical Laboratories

Table 4-10: Diagnostic Company Agreements with Other Companies

Table 4-11: Diagnostic Company Collaborations with Universities and Other Non-Profit Research Institutes (Including Government)

SIX: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS – MARKET ANALYSIS

Table 6-1: World IVD Companion Diagnostics Test Market (In Vitro Diagnostic Kits) by

Region (N. America, EU, ROW), 2015-2020

Table 6-2: World IVD Companion Diagnostics Test Market by Disease Segment, 2015(Cancer, Other)

Table 6-3: Wo.. 287

 

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