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
