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  4. > Companion Biomarkers in Drug Development

Companion Biomarkers in Drug Development

  • August 2013
  • -
  • TriMark Publications
  • -
  • 356 pages

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 TriMark Publications 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.

Table Of Contents

Companion Biomarkers in Drug Development

1. Overview 16
1.1 Statement of Report 16
1.2 About This Report 16
1.3 Scope of the Report 16
1.4 Objectives 16
1.5 Methodology 18
1.6 Executive Summary 19
2. Introduction: Companion Diagnostics in Drug Development 25
2.1 Companion Diagnostics as Biomarkers 26
2.1.1 Potential Benefits of Biomarkers as Companion Diagnostics 28
2.2 Biomarkers in Different Phases of Drug Development 28
2.2.1 Drug Discovery and Development Process 28
2.2.2 Biomarkers in Drug Development 30
2.3 Drug Targets 31
2.3.1 Target Discovery Using Functional Genomics 34
2.3.2 Functional Genomics 35
2.3.3 Target Validation 36 Target Discovery 37 Lead Identification 37
2.3.4 Target and Biomarker Discovery 37 Biomarker Validation 38
2.4 Biomarkers in Drug Discovery, Development and Clinical Diagnostics 38
2.4.1 Role of Biomarkers in Drug Discovery, Preclinical, Clinical Development
and Diagnostics 38
2.4.2 The Pipeline Problem 40
2.4.3 Biomarkers in the Drug Discovery Process 41
2.4.4 Segmentation of Biomarker Usage 42
2.4.5 Efficacy of Biomarkers as Surrogate Endpoints 42
2.4.6 Biomarkers Used to Reduce the Cost of Drug Development 43
2.4.7 Biomarkers: Challenges and Opportunities 43
2.4.8 Biomarkers in Early Safety and Toxicity Assessment 44
2.4.9 Biomarkers in Determining Validation Parameters 44
2.4.10 Challenges in Development of Biomarkers 45
2.4.11 Using Biomarkers in Early Clinical Development 45
2.4.12 Translational Biomarkers 45
2.4.13 Use of Biomarkers in “Go”/No-Go” Decisions 46
2.4.14 Diagnostic Tests 46
2.4.15 Biomarkers in Deal Making 46
2.4.16 Payors Use Biomarkers in Decision-Making 47
2.5 World Pharmaceutical Markets 47
2.5.1 World Market Summary 47
2.5.2 Forces Affecting the Structure of the Pharmaceutical Industry 51 Threats 52 Competitive Forces 52
2.6 Companion Diagnostics Market Opportunity 53
2.6.1 Industry Overview 53 Pharmaceutical Industry Drug Pipeline 54 Asia-Pacific to Replace U.S. and Europe as Pharmaceutical Industry
Center 64 The Changing Pharmaceutical Business Model 65
2.6.2 Benefits for Companion Diagnostic Tests in Drug Development 65
2.6.3 Strategies for the Creation of Partnerships—Predicting and Overcoming
Challenges in Creating Drug Response Profiling Diagnostics 67
2.6.4 Options and Applications 68 Clinical Applications of Genomics: The Use of Evidence Based Frameworks
by Decision-Makers 68
2.6.5 Challenges, Drivers and Trends 68 Macro Trends in Biomarkers 69 Biomarkers: Industry SWOT Analysis 72
2.6.6 Collaboration for Companion Diagnostics 72
2.6.7 Key Stake Holders in Companion Diagnostics 73
2.7 Impact of CDx/PM on Drug Clinical Trials 75
2.8 Evolving business models in Companion Dx and Personalized Medicine. 76
2.9 Current Pharm/Dx Business Model Examples 76
2.10 Future Developments 76
3. Biomarker Development Tools 78
3.1 New Technologies in Functional Genomics 78
3.1.1 Genomics-Derived Drug Pipeline 78
3.1.2 Future of Genomics Technologies for Drug Target Identification 78
3.2 Overview of Microarrays 79
3.2.1 General Theory of Microarrays 80
3.2.2 GeneChip Probe Array Technology 81
3.2.3 DNA Microarrays 81 DNA Microarray Market Size 83 DNA Microarrays in SNP Analysis 84 DNA Microarrays in Cancer 85
3.2.4 Protein Microarrays 85 Reasons Why Researchers Use Protein Microarrays 86 Factors for Adoption of Protein Microarrays Technology 87 Future Innovations in Protein Microarray Technology 87
3.2.5 New Technologies 87 Antibody Microarrays 87 Peptide Microarrays 88 Peptide MHC Microarrays 88 Tissue Microarrays 88 Key Points for Developing Microarray Based Appl

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