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Companion Biomarkers in Drug Development

  • ID: 835992
  • Report
  • August 2013
  • Region: Global
  • 356 Pages
  • TriMark Publications
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Global Companion Biomarker Market to Catapult to $319 Million by 2018


  • Abbott Laboratories
  • Celera
  • Geneva Bioinformatics
  • Johnson & Johnson
  • OmniViz
  • SciTegic
  • MORE
Companion biomarkers are diagnostic tests that are specifically linked to a therapeutic drug either during its development or in the clinic. This linkage can be an important component of the drug development process; alternatively, the companion biomarker can be useful in ameliorating the regulatory process for the drug, or acting as an aid to therapeutic use in the clinic.

Market opportunities for companion biomarkers are focused in drug development targets, drug development efficacy and clinical end points in four main therapeutic areas: oncology, cardiovascular, neurology and autoimmune. Using companion biomarkers yields safer and more efficacious drug products, reduces clinical trial and development costs, improves post-marketing safety profiles and salvages therapies that otherwise would not be granted approval.

This report focuses on the role of companion diagnostic tests in drug development. It provides an in-depth discussion and analysis of the application of companion biomarkers to drug development and targeted therapeutics, as well as their use in clinical trials and the regulatory forum. The examination emphasizes new and developing technology platforms meant to aid in development of drugs for therapeutic use, and sometimes to be available as companion tests for these drugs in the clinic. This report also examines companies that are actively developing and marketing companion biomarkers around the world. Detailed tables and charts with sales forecasts and marketshare data are also included.
Note: Product cover images may vary from those shown
2 of 4


  • Abbott Laboratories
  • Celera
  • Geneva Bioinformatics
  • Johnson & Johnson
  • OmniViz
  • SciTegic
  • MORE
1. Overview
1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Objectives
1.5 Methodology
1.6 Executive Summary

2. Introduction: Companion Diagnostics in Drug Development
2.1 Companion Diagnostics as Biomarkers
2.1.1 Potential Benefits of Biomarkers as Companion Diagnostics
2.2 Biomarkers in Different Phases of Drug Development
2.2.1 Drug Discovery and Development Process
2.2.2 Biomarkers in Drug Development
2.3 Drug Targets
2.3.1 Target Discovery Using Functional Genomics
2.3.2 Functional Genomics
2.3.3 Target Validation Target Discovery Lead Identification
2.3.4 Target and Biomarker Discovery Biomarker Validation
2.4 Biomarkers in Drug Discovery, Development and Clinical Diagnostics
2.4.1 Role of Biomarkers in Drug Discovery, Preclinical, Clinical Development and Diagnostics
2.4.2 The Pipeline Problem
2.4.3 Biomarkers in the Drug Discovery Process
2.4.4 Segmentation of Biomarker Usage
2.4.5 Efficacy of Biomarkers as Surrogate Endpoints
2.4.6 Biomarkers Used to Reduce the Cost of Drug Development
2.4.7 Biomarkers: Challenges and Opportunities
2.4.8 Biomarkers in Early Safety and Toxicity Assessment
2.4.9 Biomarkers in Determining Validation Parameters
2.4.10 Challenges in Development of Biomarkers
2.4.11 Using Biomarkers in Early Clinical Development
2.4.12 Translational Biomarkers
2.4.13 Use of Biomarkers in “Go”/No-Go” Decisions
2.4.14 Diagnostic Tests
2.4.15 Biomarkers in Deal Making
2.4.16 Payors Use Biomarkers in Decision-Making
2.5 World Pharmaceutical Markets
2.5.1 World Market Summary
2.5.2 Forces Affecting the Structure of the Pharmaceutical Industry Threats Competitive Forces
2.6 Companion Diagnostics Market Opportunity
2.6.1 Industry Overview Pharmaceutical Industry Drug Pipeline Asia-Pacific to Replace U.S. and Europe as Pharmaceutical Industry Center The Changing Pharmaceutical Business Model
2.6.2 Benefits for Companion Diagnostic Tests in Drug Development
2.6.3 Strategies for the Creation of Partnerships—Predicting and Overcoming Challenges in Creating Drug Response Profiling Diagnostics
2.6.4 Options and Applications Clinical Applications of Genomics: The Use of Evidence Based Frameworks by Decision-Makers
2.6.5 Challenges, Drivers and Trends Macro Trends in Biomarkers Biomarkers: Industry SWOT Analysis
2.6.6 Collaboration for Companion Diagnostics
2.6.7 Key Stake Holders in Companion Diagnostics
2.7 Impact of CDx/PM on Drug Clinical Trials
2.8 Evolving business models in Companion Dx and Personalized Medicine.
2.9 Current Pharm/Dx Business Model Examples
2.10 Future Developments

3. Biomarker Development Tools
3.1 New Technologies in Functional Genomics
3.1.1 Genomics-Derived Drug Pipeline
3.1.2 Future of Genomics Technologies for Drug Target Identification
3.2 Overview of Microarrays
3.2.1 General Theory of Microarrays
3.2.2 GeneChip Probe Array Technology
3.2.3 DNA Microarrays DNA Microarray Market Size DNA Microarrays in SNP Analysis DNA Microarrays in Cancer
3.2.4 Protein Microarrays Reasons Why Researchers Use Protein Microarrays Factors for Adoption of Protein Microarrays Technology Future Innovations in Protein Microarray Technology
3.2.5 New Technologies Antibody Microarrays Peptide Microarrays Peptide MHC Microarrays Tissue Microarrays Key Points for Developing Microarray Based Applications Reasons Why Researchers use DNA Microarrays Factors for Difficulties Applying DNA Microarrays Technology Emerging Microarray Trends Emerging Microarray Applications Key Findings on Use of Microarrays Advantages and Drivers of Microarrays Limitations and Barriers to Use of Microarrays qRT-PCR Use in Biomarker Identification and Drug Development Microarray Quality Control (MAQC) Project
3.3 Theranostics
3.3.1 Theranostics in Drug Development
3.3.2 Trends in Theranostics
3.3.3 Timeline for Impact on Various Segments in Theranostics
3.3.4 Challenges for Biomarker Based Therapeutics Development
3.4 Pharmaceutical Development and Bioanalytical Services
3.4.1 Wyeth (now part of Pfizer) Singulex's Erenna
3.5 Metabolomics in Drug Discovery
3.6 Bioinformatics
3.6.1 Definition and Role of Bioinformatics
3.6.2 Bioinformatics Sector Overview
3.6.3 Future Status of Bioinformatics Future in Drug Discovery Mergers and Acquisitions Could Deter Bioinformatics Growth Barriers to Bioinformatics Growth Types of Data and Bioinformatics Applications Validated Core Modeling Technology Applicability of Bioinformatics for Biomarker Discovery Biomarker Data Management Compliant with Industry Standards Data Management for Biomarkers Data Transformation for Biomarker Development Biomarker Data Collaboration Interface for Online Data Sources for Genomic Structures Target Markets for Informatics Software Bioinformatics Drivers and Challenges in the Pharmaceutical Industry Products of Bioinformatics Informatics Tools and Functionalities Bioinformatics in Lead Identification and Optimization Bioinformatics in Drug Development and Formulation Role of Bioinformatics in the Drug Discovery Value Chain Bioinformatics Software for Drug Discovery and Biomarker Development Bioinformatics Services
3.7 Biomarkers and Proteomics
3.7.1 Scientific Background
3.7.2 Applying Proteomics to Biomarker Discovery Challenges Facing Biomarker Developers
3.7.3 Limitations of Proteomic Approaches to Biomarker Discovery
3.7.4 Validation of Biomarkers Using LC-MS/MS Systems
3.7.5 Use of Mass Spectrometry in Biomarker Discovery Multiple Reaction Monitoring Assays (MRMs) Gel-based Approaches Non-Gel-based Approaches SELDI-TOF MS SELDI and Prognosis SELDI and Treatment Monitoring Limitations of Mass Spectroscopy
3.7.6 Partnerships for Developing Proteomic Biomarkers
3.7.7 Proteomics in Developing a New Cancer Marker Translating Proteomic Oncology Discoveries to the Clinic: Development of Analytical Reference Materials, Reagents, Data, and Technology Assessment and Validation Challenges of Discovering and Validating Clinical Protein Biomarkers Importance of Proteomics in Biomarker Discovery
3.8 Toxicogenomics
3.8.1 Toxicogenomics Concerns in Drug Safety Data
3.8.2 Toxicogenomics and Prioritization of Drug Candidates
3.8.3 Genomic Biomarkers for Drug-Induced Nephrotoxicity
3.8.4 Use of Biomarkers of Drug-Induced Cardiotoxicity
3.8.5 Use of Biomarkers of Drug-induced Hepatotoxicity
3.8.6 Transgenic Biomarkers for Adverse Drug-Drug Interactions
3.8.7 Challenges to Toxicogenomics
3.8.8 The Future Use of Toxicogenomics in Drug Discovery

4. Market for Biomarkers in Drug Development
4.1 C-KIT (CD117) Expression
4.2 CCR5 -Chemokine C-C Motif Receptor
4.3 CYP2C19 Variants
4.4 CYP2C9 Variants
4.5 CYP2D6 Variants
4.6 CYP2D6 Variants with Alternate Context
4.7 Clinical Biomarkers
4.8 Targeting Kidney Toxicity
4.8.1 Proximal and Distal Tubular Injury (Alpha-GST and Pi-GST)
4.8.2 Collecting Duct and Loop of Henle Injury (RPA-1 and RPA-2)
4.8.3 Glomerular Injury (Collagen IV)
4.8.4 KIM-1
4.9 Targeting Hepatotoxicity
4.9.1 Breast Cancer
4.9.2 Colorectal Cancer
4.9.3 Prostate Cancer
4.9.4 Cystic Fibrosis
4.10 Biomarker Application in Oncology Clinical Development
4.10.1 Specific Example of Companion Biomarkers in Clinical Oncology
4.10.2 Integration of a Companion Diagnostic Strategy into Oncology Drug Development Lilly to Co-Develop Companion IVDs for Cancer Drugs Galena Biopharma and Leica Biosystems Announced a Partnership to Develop a Companion Diagnostic for HER2 Screening in Women with Breast Cancer bioMérieux and Ipsen Sign Theragnostics Agreement to Develop Companion Test for New Breast Cancer Treatment Life Technologies to Partner with Bristol-Myers Squibb for Companion Diagnostics Development Ventana Medical Systems and the Critical Path Institute Siemens Forms New Companion Diagnostics Partnerships with ViiV Healthcare and Tocagen Biomarkers in Development Epigenomics' Methylation Biomarker Septin Quest Diagnostics and Lab Corp Develop IL 28-B Test for Hepatitis C NSLC Patients with EGFR Mutation A Personalized Medicine Program for Chronic Myeloid Leukemia
4.10.2 12 Clarient adopts Qiagen KRAS
4.11 Targeting Diabetes Related Heart Disease
4.12 Key Challenges and Opportunities in Developing Targeted Therapeutics

5. Imaging Biomarkers in Drug Discovery
5.1 Introduction
5.1.1 Validation of Imaging Biomarkers
5.1.2 Types of Imaging Used in Drug Development
5.1.3 Development of Imaging Technologies
5.2 Molecular Imaging
5.2.1 Use in Drug Discovery
5.2.2 Use in Clinical Applications
5.2.3 Use in Clinical Trials
5.2.4 Cell-based Screening Technologies in Drug Development
5.2.5 Optical Biomarkers
5.3 Magnetic Resonance Imaging
5.4 Positron Emission Tomography
5.5 FDG-PET Patient Phase I Studies
5.6 Imaging Biomarkers as Study Endpoints
5.6.1 Oncology
5.6.2 Parkinson's Disease
5.6.3 Cardiac Disease
5.7 IT Solutions for Imaging Biomarkers in Biopharmaceutical Research and Development

6. Clinical Biomarkers Improving Trial Design
6.1 Strategies to Improve the Measurement of Biomarkers for Drug Trials
6.2 Key Opportunities in Biomarker Discovery, Development and Commercialization
6.2.1 Contract Research Companies
6.3 What Strategies Help Translate Biomarkers from Preclinical to Clinical Development?
6.4 How Should Biomarker Data Be Compared to “Traditional” Safety and Efficacy Data?

7. Biomarkers as Surrogate Endpoints
7.1 What is a Surrogate Endpoint?
7.2 Benefits and Drawbacks of Surrogate Endpoints
7.2.1 Benefits
7.2.2 Drawbacks
7.3 Improving the Efficacy of Clinical Surrogate End Points Using Biomarkers
7.4 Surrogate Endpoint Validation
7.5 Effective Use of Surrogates
7.5.1 FDG-PET as a Surrogate Endpoint in Oncology Studies
7.6 Conclusions

8. Market Size, Collaborations and Future Directions for Companion Diagnostics in Drug Development
8.1 Strategies to Improve the Measurement of Biomarkers for Drug Trials
8.1.1 Key Opportunities in Biomarker Discovery, Development and Commercialization
8.1.2 The Rationale Behind Biomarker Strategy
8.1.3 New Development Strategies and their Implications for Deal Making
8.1.4 How Biomarkers are Being Used to Reduce Attrition in Development
8.1.5 Combined Therapeutics and Diagnostics Biomarker Business Makes Sense
8.1.6 Use of Biomarkers In House or Partner with a Diagnostics Company
8.2 What is the Best Balance of Resources to Have the Most Efficient Pathway to Develop Biomarkers?
8.3 Current and Future Trends in Drug Development
8.4 Future Role of Biomarkers in Healthcare
8.5 What are the Current Organizational Obstacles in Biomarker Implementation?

9. Regulatory Issues for Biomarkers in Drug Development
9.1 Introduction
9.1.1 Role of Regulatory Agencies in Development of Biomarkers
9.2 FDA Perspective of Biomarkers in Clinical Trials
9.2.1 FDA as a Gatekeeper of Companion Biomarkers
9.2.2 FDA Criteria for a Valid Biomarker
9.2.3 FDA Product Submission and Review Process
9.2.4 FDA Pipeline for Biomarker Tests
9.2.5 Adaptive Clinical Trial Design
9.2.6 Orphan Drug Act and Biomarkers: Options and Opportunities
9.3 Role of StaRT-PCR™ in Increasing Value of Pharmacogenomic Data
9.4 Supporting IND, NDA, and BLA Submissions
9.5 Performance Characteristics of Biomarker Tools
9.6 Biomarker Initiative and VGDs
9.7 Biomarker Qualification Pilot Process at the FDA
9.7.1 Introduction
9.7.2 Biomarker is Validity
9.7.3 Biomarker Qualification Process Map
9.7.4 Biomarker Qualification Pilot Process
9.7.5 The Pipeline Problem
9.7.6 FDA Critical Path Challenge and Opportunity on the Critical Path to New Medical Products The NIH Roadmap Predictive Safety Testing Consortium FDA Risk-based Approach Examples of drugs being held up due to lack of compliance with FDA directives
9.7.7 Negotiating the Critical Path
9.7.8 Technical Dimensions along the Critical Path
9.7.9 Product Development Toolkit
9.7.10 Tools for Assessing Safety
9.7.11 Tools for Demonstrating Medical Utility
9.7.12 Tools for Manufacturing
9.7.13 Orphan Products Grant Program
9.7.14 Slowdown in New Medical Products
9.7.15 Factors Contributing to the Decline in New Product Applications
9.7.16 Factors that Cause Unnecessary Delays in New Product Approvals
9.7.17 Reducing Avoidable Delays in Time to Approval
9.7.18 Reducing Delays in Medical Device Reviews
9.7.19 Reducing Delays in Animal Drug Reviews
9.7.20 Quality Systems Approach to Medical Product Review Instituting Quality Systems in Review of New Drugs and Biologics Implementing of the Common Technical Document (CTD) and the electronic CTD Implementing Medical Device Quality Initiatives
9.7.21 Case Study: Nephrotoxicity Biomarkers
9.7.22 Role of the FDA
9.8 CMS Regulatory Responsibilities
9.9 Role of National Institute of Standards and Technology in Validation of Biomarkers
9.10 Biomarkers and FDA's Voluntary Genomic Data Submission
9.11 Federal Health Oncology Biomarker Qualification Initiative
9.12 Orphan Drug Act and Pharmacogenomics: Options and Opportunities
9.13 Post-market Covigilance Programs
9.14 Technology Options, Potential Diagnostic Partners and Regulatory Hurdles
9.15 What Regulatory Guidance Is Needed for Companion Biomarkers?
9.16 U.S. Patent and Trademark Office (USPTO)
9.17 IRB Approval in Clinical Trials
9.18 Reimbursement and Value Creation
9.19 FDA Guidance document on co-development
9.20 What is the future role of PBM's in laboratory services
9.21 FDA Guidance document on co-development

10. Business Decisions Using Companion Biomarkers in Drug Development
10.1 Advantages of a Pharmacogenomic Assessment of Biomarkers to Determine Clinical Dose
10.2 Key Opportunities in Biomarker Discovery, Development and Commercialization
10.3 What Are the Current Obstacles in Biomarker Implementation in Clinical Medicine?
10.4 How Do Business Strategies, Such as Those Relating to Acquisition, Drive Biomarker Strategies?
10.5 What is the Right Balance Between Using External Partnerships and Developing Internal Infrastructure?
10.6 How Might Novel Biomarker Development Lead to Acquisition Strategies and Their Implications For Deal Making?
10.7 Which Types of Biomarkers Should Be Developed at Various Stages in the Drug Pipeline?
10.8 What Strategies Help Translate Biomarkers From Preclinical to Clinical Development?
10.9 In What Class of Drugs Is the Value of Using Biomarkers in Decision Making the Highest?
10.10 Increased Clinical Trial Costs in Targeted Phase I Trials
10.11 How Can Big Pharma Co-develop Biomarkers in a Cost-sharing Model for Regulatory Acceptance?
10.12 How are Biomarkers Being Used to Reduce the Attrition Rate in Drug Development?
10.13 How is ROI Measured Using Biomarkers in Drug Development?
10.14 How might Organizational Structures Limit the Use of Biomarkers in Drug Development and How Should R&D Organizations Address this Problem?
10.15 How to Maximize Business Development through Biomarker Strategies
10.16 What Is the Best Type of Business Model for Developing Biomarkers?
10.17 What Are Organizational Impediments Limiting the Use of Biomarkers in Drug Development?
10.18 What Are Internal Capabilities for Novel Biomarker Development and Application?
10.19 How Can Key Biomarker Technical Expertise Be Applied Across a Complex and Highly-Stratified R&D Value Chain?
10.20 At What Stage of Drug Development Have Biomarkers Provided the Most Benefit?
10.21 What Companies Are the Most Innovative in Development of Biomarkers?
10.22 Best Values for Biomarkers in Drug Development and in Diagnostics
10.23 Companion Biomarkers Can Increase Value in an Associated Drug
10.24 What is the role of governmental agencies in driving the adoption of CDx?
10.25 What is the role of the insurance industry in driving the adoption?
10.26 What is the role of the pharma industry in driving the adoption of PGx?
10.27 What is the role of the diagnostic industry in driving the adoption of PGx?

11. Company Profiles
11.1 Abbott Laboratories
11.2 Accelrys
11.3 Affymetrix
11.4 Agilent Technologies
11.5 Almac Diagnostics
11.6 Amgen
11.7 Ananomouse
11.8 Applied Maths
11.9 Ariadne Genomics
11.10 ArrayIt (Integrated Media Holdings)
11.11 AstraZeneca
11.12 AutoGenomics
11.13 Axontologic
11.14 Beckman Coulter (now part of Danaher)
11.15 Becton, Dickinson and Company (BD)
11.16 Bender MedSystems (Affymetrix)
11.17 Bioalma
11.18 BioAnalytics Group
11.19 Biocartis
11.20 Biocept Laboratories
11.21 BioChain
11.22 BioData
11.23 BioDiscovery
11.24 Biodesix
11.25 BioForce Nanosciences
11.26 BioGenex
11.27 Bioinformatics Solutions
11.28 Biomax Informatics
11.29 BioMérieux
11.30 Biomind
11.31 Bio-Rad Laboratories
11.32 BioSystems International (BSI)
11.33 Biotrin (DiaSorin)
11.34 BioWisdom (Instem Scientific Limited)
11.35 Bristol-Myers Squibb Company
11.36 Caliper Life Sciences (A PerkinElmer Company)
11.37 Caprion Proteomics
11.38 Carestream Health
11.39 Celera
11.40 Cepheid
11.41 Chang Bioscience
11.42 Clontech Laboratories
11.43 CombiMatrix Diagnositcs
11.44 Compugen
11.45 Correlogic Systems, Inc. (Vermillion, Inc.)
11.46 Covance
11.47 Cybrdi
11.48 Cytogen Corporation (now EUSA Pharma)
11.49 Dako A/S (Agilent Technologies)
11.50 Decodon
11.51 Definiens
11.52 DiagnoSwiss
11.53 Discerna
11.54 DNAStar
11.55 DNATools
11.56 Eidogen-Sertanty
11.57 Electric Genetics
11.58 Eli Lilly and Company
11.59 Entelos
11.60 ePitope Informatics
11.61 Eurogentec
11.62 Exiqon A/S
11.63 Forensic Bioinformatics
11.64 Fujitsu
11.65 Future Diagnostics
11.66 Gene Codes
11.67 Genedata
11.68 GeneGo
11.69 Gene Network Sciences
11.70 Geneva Bioinformatics
11.71 Genomatica
11.72 Genomic Solutions
11.73 Genomining
11.74 GE Healthcare
11.75 GeneStudio
11.76 Genomatix Software
11.77 GenomeQuest
11.78 Genus BioSystems
11.79 Genzyme (Sanofi-Aventis)
11.80 Geospiza
11.81 GlaxoSmithKline
11.82 Golden Helix
11.83 Grace Bio-Labs
11.84 Gyros AB
11.85 HealthCare IT
11.86 Hologic Gen-Probe
11.87 High Throughput Genomics
11.88 Human Genome Sciences (GSK)
11.89 Illumina, Inc.
11.90 Imgenex Corp.
11.91 Imaxia
11.92 INCOGEN, Inc.
11.93 Incyte
11.94 InforSense
11.95 Ingenuity Systems
11.96 InPharmix
11.97 Insightful Corporation
11.98 Integromics, S.L
11.99 IBM
11.100 IO Informatics
11.101 Ipsen
11.102 Jerini AG
11.103 Johnson & Johnson
11.104 Koada Technology
11.105 KOOPrime
11.106 Life Technologies Corporation
11.107 LINCO Research
11.108 Luminex
11.109 Marligen Biosciences
11.110 Matrix Science
11.111 MDS, Inc. (Nordion, Inc.)
11.112 Merck & Co., Inc.
11.113 Merck KGaA
11.114 Meso Scale Discovery
11.115 Metabolon
11.116 Microbionix
11.117 MicroDiscovery
11.118 Millennium Pharmaceuticals
11.119 Millipore
11.120 MiraiBio
11.121 Molecular Connections
11.122 MolMine AS
11.123 Molsoft
11.124 Monogram Biosciences (Labcorp)
11.125 MTR Scientific
11.126 Multimetrix
11.127 Nanogen, Inc.
11.128 Nanosphere
11.129 NetGenics
11.130 NextGen Sciences
11.131 NimbleGen Systems
11.132 Nonlinear Dynamics
11.133 Novartis
11.134 Nuvera Biosciences
11.135 Ocimum Biosolutions
11.136 OmniViz
11.137 One Lambda (Thermo Fisher's Specialty Diagnostics Segment)
11.138 Oracle
11.139 OriGene Technologies
11.140 Ore Pharmaceuticals, Inc. (Ore Holdings, Inc.)
11.141 Orla Protein Technologies
11.142 Osmetech Plc (Genmark Diagnostics)
11.143 Oxonica
11.144 PamGene BV
11.145 Panomics
11.146 Partek Incorporated
11.147 Pepscan Therapeutics
11.148 Perbio Science
11.149 Perlegen Sciences
11.150 Pfizer
11.151 PharmaSeq, Inc.
11.152 Pierce Biotechnology
11.153 Platypus Technologies, LLC
11.154 Predictive Patterns Software
11.155 Proceryon Biosciences
11.156 Protagen AG
11.157 ProteinOne
11.158 Proteome Sciences
11.159 Pub Gene
11.160 Qiagen
11.161 Radix BioSolutions
11.162 Randox Laboratories
11.163 RayBiotech
11.164 Redasoft
11.165 RedStorm Scientific
11.166 Reel Two (Surechem, Inc.)
11.167 Rescentris
11.168 Roche
11.169 Rosetta Biosoftware
11.170 Rules-Based Medicine (Myriad Genetics, Inc.)
11.171 SAS
11.172 Schleicher & Schuell BioScience
11.173 SciTegic
11.174 Semantx Life Sciences
11.175 Sequenom
11.176 Siemens Heathcare Diagnostics
11.177 Sigma-Aldrich
11.178 Silicon Genetics
11.179 Singulex
11.180 Softberry, Inc.
11.181 SoftGenetics
11.182 SomaLogic
11.183 Spotfire
11.184 SPSS
11.185 Strand Life Sciences
11.186 Stratagene
11.187 SuperBioChips Laboratories
11.188 SurroMed
11.189 Sun Microsystems
11.190 Sygnis Pharma AG
11.191 Techne Corporation
11.192 Tepnel Life Sciences (Hologic Gen-Probe)
11.193 Teranode
11.194 Textco BioSoftware
11.195 TG Services, Inc.
11.196 Thermo Fisher Scientific
11.197 Third Wave Technologies
11.198 Thomson Reuters
11.199 TIBCO Software
11.200 TimeLogic
11.201 TriStar Technology Group
11.202 Tyrian Diagnostics (formerly Proteome Systems)
11.203 VBC-Genomics Bioscience Research GmbH (Phadia Multiplexing Diagnostics GmbH)
11.204 Ventana Medical Systems
11.205 ViaLogy
11.206 Wyeth
11.207 Zeptosens
11.208 Zeus Scientific
11.209 Zyagen

Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission
Appendix 1.1: Introduction
Appendix 1.2: Background
Appendix 1.3: Submission Policy
Appendix 1.3.1: General Principles
Appendix 1.3.2: Specific Uses of Pharmacogenomic Data in Drug Development and Labeling
Appendix 1.3.3: Benefits of Voluntary Submissions to Sponsors and FDA
Appendix 1.4: Submission of Pharmacogenomic Data
Appendix 1.4.1: Submission of Pharmacogenomic Data during the IND Phase
Appendix 1.4.2: Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement
Appendix 1.4.3: Submission to a Previously Approved NDA or BLA
Appendix 1.4.4: Compliance with 21 CFR Part 58
Appendix 1.4.5: Submission of Voluntary Genomic Data from Application-Independent Research
Appendix 1.5: Format and Content of a VGDS
Appendix 1.6: Process for Submitting Pharmacogenomic Data
Appendix 1.7: Agency Review of VGDSs
Appendix 2: Guidance for Industry and Food and Drug Administration Staff—In Vitro Companion Diagnostic Devices
Appendix 2.1: Introduction
Appendix 2.2: Background
Appendix 2.3: Definition and Use of an IVD Companion Diagnostic Device
Appendix 2.4: Review and Approval of IVD Companion Diagnostic Devices and Therapeutic Products
Appendix 2.4.1: Novel Therapeutic Products
Appendix 2.4.2: Approval of a Therapeutic Product without an Approved IVD Companion Diagnostic Device
Appendix 2.4.3: General Policies
Appendix 2.5: Labelling
Appendix 2.5.1: Therapeutic Product Labelling
Appendix 2.5.2: IVD Companion Diagnostic Device Labeling
Appendix 2.6: Investigational Use


Figure 2.1: Drug Discovery and Development Paradigm
Figure 2.2: Paradigm of Drug Discovery and Development Illustrating the Central and Essential Role of Biomarkers in Screening
Figure 2.3: Functional Genomic Process for Drug Development
Figure 2.4: Reimbursement for Diagnostics in Healthcare Decision Making: Percentage Influence on Healthcare Decision Making
Figure 2.5: Reimbursement for Diagnostics in Healthcare Decision Making: Percentage of Healthcare Spending
Figure 2.6: Market Growth and Evolution of Companion Biomarkers
Figure 2.7: Medical Product Development Models
Figure 2.8: Segmentation of the Biomarker Development Market
Figure 2.9: Global Pharmaceutical Drug Sales, 2004-2018
Figure 2.10: Worldwide Generic Pharmaceutical Drug Market, 2003-2018
Figure 2.11: Worldwide OTC Pharmaceutical Drug Market, 2003-2018
Figure 2.12: Worldwide Biopharmaceutical Drug Market, 2003-2018
Figure 2.13: Number of Compounds by Clinical Trial Phase, 2012
Figure 2.14: Biomarkers Market Drivers
Figure 2.15: Challenges in the Biomarkers Space
Figure 2.16: FDA Co-Developed Products
Figure 3.1: Worldwide Microarray Market Size, 2004-2018
Figure 3.2: Informatics Applications Along the Drug Discovery Value Chain
Figure 3.3: Bioinformatics Software Flow Chart
Figure 3.4: Growth of GenBank, 1982-2012
Figure 3.5: Role of Bioinformatics in the Drug Discovery Value Chain
Figure 3.6: Challenges in the Study or Utilization of Proteomic Biomarkers
Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Biomarkers
Figure 3.8: Top Unmet Needs in Products in the Biomarkers Space
Figure 4.1: Companion Biomarker Market Size, 2008-2018
Figure 4.2: Growth and Evolution of the Biomarker Space
Figure 4.3: Revenue Forecast Projections for Global Biomarker Markets by Segments, 2005-2012
Figure 4.4: Biomarker Discovery by Therapeutic Area
Figure 4.5: Kidney Biomarker Paradigm
Figure 4.6: Hepatic Biomarker Paradigm
Figure 9.1: IPRG Biomarker Qualification Process
Figure 9.2: Critical Path for Drug Development
Figure 9.3: Path for R&D Product Development
Figure 9.4: Dimensions of the Critical Path
Figure 9.5: FDA Interactions During Drug Development
Figure 9.6: Problem Resolution During the FDA Review Process
Figure 9.7: VGDS Process Flow
Figure 10.1: Discovery, Validation and Use of Biomarkers


Table 2.1: Utility of Biomarkers as Companion Diagnostics to Drug Development
Table 2.2: Biomarker End Points in Drug Development
Table 2.3: Value of Biomarkers in Phase II Clinical Trials
Table 2.4: Representative Companion Diagnostic Deals
Table 2.5: Selected examples of Companion Diagnostics used in cancer therapies
Table 2.6: Comparative Genome Sizes of Humans and Other Organisms
Table 2.7: Global Pharmaceutical Drug Sales, 2004-2018
Table 2.8: Worldwide Generic Pharmaceutical Drug Market, 2003-2018
Table 2.9: Worldwide OTC Pharmaceutical Drug Market, 2003-2018
Table 2.10: Worldwide Biopharmaceutical Drug Market, 2003-2018
Table 2.11: Threats to Pharmaceutical Industry Productivity
Table 2.12: Competitive Forces Governing the Pharmaceutical Industry
Table 2.13: Time Line for Development of Companion Diagnostics
Table 2.14: Leading Therapy Classes for R&D, 2012
Table 2.15: Global Total Pharmaceutical Industry R&D Spending, 2004-2018
Table 2.16: Pharmaceutical R&D Spend: Top 20 Companies and Total Market, 2011 and 2018
Table 2.17: Global Pharmaceutical Top Markets, 2011
Table 2.18: World's Top-Selling Drugs, 2011 and 2012
Table 2.19: Top Pharmaceutical Companies by Pharmaceutical Sales, 2011 and 2012
Table 2.20: Leading Therapy Classes by Global Pharmaceutical Sales, 2012
Table 2.21: New Molecular Entity Approvals for 2012
Table 2.22: Pharmaceuticals Industry Challenges
Table 2.23: Reasons for Developing Phase I Biomarkers
Table 2.24: Percentage of Non-Responders in Various Drug Classes
Table 2.25: High Profile Drug Withdrawals from the Marketplace
Table 2.26: Market Opportunities in Biomarkers
Table 2.27: Challenges for Market Adoption of the Various Biomarkers Tests
Table 2.28: Biomarkers Industry SWOT
Table 2.29: Stakeholders and their Expectations of Companion Diagnostics
Table 3.1: Worldwide Microarray Market Size, 2004-2018
Table 3.2: List of DNA Array Manufacturers
Table 3.3: U.S. qRT-PCR Market, 2007-2018
Table 3.4: Theranostics Technology Platforms—Timeline of Impact
Table 3.5: Impact of Personalized Medicine on Various Therapeutic Areas
Table 3.6: Hurdles in Biomarkers Development in Therapeutic Areas
Table 3.7: Data Source and Bioinformatic Investigations
Table 3.8: Drivers and Challenges of the Bioinformatics Industry
Table 3.9: Bioinformatics Activities, Sub-Activities and Key Players
Table 3.10: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum
Table 3.11: Device Submission Elements for the FDA
Table 3.12: Toxicogenomic Standards and Their Organizations
Table 3.13: Genomic and Proteomic Technologies
Table 4.1: Companion Biomarker Market Size, 2008-2018
Table 4.2: Kidney Biomarkers
Table 4.3: Herceptin Worldwide Sales, 2000-2017
Table 4.4: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities
Table 4.5: Segmentation of the Cancer Biomarker Market by Type of Cancer Biomarkers and Market Size
Table 4.6: Cancer Biomarker Market Estimates by Tissue of Origin
Table 4.7: Companies Developing New Proteomic Cancer Biomarker Technology Platforms
Table 4.8: Cancer Biomarkers Used to Maximize Likelihood of Response
Table 4.9: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance
Table 6.1: Contract Research Companies
Table 8.1: Stakeholders in Biomarker Development
Table 9.1: Structure of the Critical Path
Table 9.2: Device Submission Elements for the FDA
Table 9.3: Factors that Cause Unnecessary Delays in New Product Approvals
Table 10.1 Companion Diagnostics Deals by Type
Note: Product cover images may vary from those shown
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- Abbott Laboratories
- Accelrys
- Affymetrix
- Agilent Technologies
- Almac Diagnostics
- Amgen
- Ananomouse
- Applied Maths
- Ariadne Genomics
- ArrayIt (Integrated Media Holdings)
- AstraZeneca
- AutoGenomics
- Axontologic
- Beckman Coulter (now part of Danaher)
- Becton, Dickinson and Company (BD)
- Bender MedSystems (Affymetrix)
- Bio-Rad Laboratories
- BioAnalytics Group
- BioChain
- BioData
- BioDiscovery
- BioForce Nanosciences
- BioGenex
- BioMérieux
- BioSystems International (BSI)
- BioWisdom (Instem Scientific Limited)
- Bioalma
- Biocartis
- Biocept Laboratories
- Biodesix
- Bioinformatics Solutions
- Biomax Informatics
- Biomind
- Biotrin (DiaSorin)
- Bristol-Myers Squibb Company
- Caliper Life Sciences (A PerkinElmer Company)
- Caprion Proteomics
- Carestream Health
- Celera
- Cepheid
- Chang Bioscience
- Clontech Laboratories
- CombiMatrix Diagnositcs
- Compugen
- Correlogic Systems, Inc (Vermillion, Inc)
- Covance
- Cybrdi
- Cytogen Corporation (now EUSA Pharma)
- DNAStar
- DNATools
- Dako A/S (Agilent Technologies)
- Decodon
- Definiens
- DiagnoSwiss
- Discerna
- Eidogen-Sertanty
- Electric Genetics
- Eli Lilly and Company
- Entelos
- ePitope Informatics
- Eurogentec
- Exiqon A/S
- Forensic Bioinformatics
- Fujitsu
- Future Diagnostics
- GE Healthcare
- Gene Codes
- Gene Network Sciences
- GeneGo
- GeneStudio
- Genedata
- Geneva Bioinformatics
- Genomatica
- Genomatix Software
- GenomeQuest
- Genomic Solutions
- Genomining
- Genus BioSystems
- Genzyme (Sanofi-Aventis)
- Geospiza
- GlaxoSmithKline
- Golden Helix
- Grace Bio-Labs
- Gyros AB
- HealthCare IT
- High Throughput Genomics
- Hologic Gen-Probe
- Human Genome Sciences (GSK)
- IO Informatics
- Illumina, Inc
- Imaxia
- Imgenex Corp
- InPharmix
- Incyte
- InforSense
- Ingenuity Systems
- Insightful Corporation
- Integromics, SL
- Ipsen
- Jerini AG
- Johnson & Johnson
- KOOPrime
- Koada Technology
- LINCO Research
- Life Technologies Corporation
- Luminex
- MDS, Inc (Nordion, Inc)
- MTR Scientific
- Marligen Biosciences
- Matrix Science
- Merck & Co, Inc
- Merck KGaA
- Meso Scale Discovery
- Metabolon
- MicroDiscovery
- Microbionix
- Millennium Pharmaceuticals
- Millipore
- MiraiBio
- MolMine AS
- Molecular Connections
- Molsoft
- Monogram Biosciences (Labcorp)
- Multimetrix
- Nanogen, Inc
- Nanosphere
- NetGenics
- NextGen Sciences
- NimbleGen Systems
- Nonlinear Dynamics
- Novartis
- Nuvera Biosciences
- Ocimum Biosolutions
- OmniViz
- One Lambda (Thermo Fisher's Specialty Diagnostics Segment)
- Oracle
- Ore Pharmaceuticals, Inc (Ore Holdings, Inc)
- OriGene Technologies
- Orla Protein Technologies
- Osmetech Plc (Genmark Diagnostics)
- Oxonica
- PamGene BV
- Panomics
- Partek Incorporated
- Pepscan Therapeutics
- Perbio Science
- Perlegen Sciences
- Pfizer
- PharmaSeq, Inc
- Pierce Biotechnology
- Platypus Technologies, LLC
- Predictive Patterns Software
- Proceryon Biosciences
- Protagen AG
- ProteinOne
- Proteome Sciences
- Pub Gene
- Qiagen
- Radix BioSolutions
- Randox Laboratories
- RayBiotech
- RedStorm Scientific
- Redasoft
- Reel Two (Surechem, Inc)
- Rescentris
- Roche
- Rosetta Biosoftware
- Rules-Based Medicine (Myriad Genetics, Inc)
- Schleicher & Schuell BioScience
- SciTegic
- Semantx Life Sciences
- Sequenom
- Siemens Heathcare Diagnostics
- Sigma-Aldrich
- Silicon Genetics
- Singulex
- SoftGenetics
- Softberry, Inc
- SomaLogic
- Spotfire
- Strand Life Sciences
- Stratagene
- Sun Microsystems
- SuperBioChips Laboratories
- SurroMed
- Sygnis Pharma AG
- TG Services, Inc
- TIBCO Software
- Techne Corporation
- Tepnel Life Sciences (Hologic Gen-Probe)
- Teranode
- Textco BioSoftware
- Thermo Fisher Scientific
- Third Wave Technologies
- Thomson Reuters
- TimeLogic
- TriStar Technology Group
- Tyrian Diagnostics (formerly Proteome Systems)
- VBC-Genomics Bioscience Research GmbH (Phadia Multiplexing Diagnostics GmbH)
- Ventana Medical Systems
- ViaLogy
- Wyeth
- Zeptosens
- Zeus Scientific
- Zyagen
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown