Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes

Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes

Summary

GBI Research’s new report, “Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes” provides information and analysis on the major trends and issues affecting biomarkers in the drug discovery process. The report describes the history of biomarkers and their role in fulfilling the unmet needs of the conventional drug discovery process. The drivers and barriers for the biomarkers market, along with the key issues faced in the application of biomarkers in the drug discovery process, are highlighted. The report discusses some important technologies being used in the discovery and validation of biomarkers. The integration of different types of biomarkers in each phase of the drug discovery and development process is also studied. Additionally, the report talks about the strategic consolidations that have taken place within the global biomarkers market. These include mergers, acquisitions, and strategic partnerships among companies involved in the manufacturing of biomarkers for drug discovery and research. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

According to Food and Drug Administration (FDA), a biological marker or biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or biological responses to a therapeutic intervention. It can define a physiologic, pathologic or anatomic characteristic or measurement that is thought to relate to some aspect of normal or abnormal biologic function. Changes in biomarkers following treatment may identify safety problems related to a drug candidate or reveal a pharmacological activity that predicts an eventual benefit from treatment. Biomarkers may reduce uncertainty in drug development and evaluation by providing quantitative predictions about drug performance.

Before the application of biomarkers in drug discovery, the process had various drawbacks such as high attrition rates, high costs and erroneous predictions about drug safety and efficacy. The integration of biomarkers has addressed these issues and made the drug discovery process smoother and less costly. The conventional symptom-based drug R&D process, also called the “one-size-fits-all” or “blockbuster” model, is being replaced by personalized medicine so that targeted treatment can be designed for individuals based on their genetic codes

GBI Research analysis indicates that the global biomarkers market has seen substantial growth since 2004, due to improvements in technology and the creation of favorable regulatory norms for the application of biomarkers in drug discovery.

This report focuses on the applications of biomarkers in drug development, the market characterization, and promising biomarkers in various therapy areas. Historic and future trends, strategic consolidations and regulatory norms are the other areas discussed in the report.

Scope

- An overview of biomarkers in the drug discovery process along with their use, efficiency and limitations.
- Annualized market data from 2004 and forecast forward to 2018.
- Key market drivers and restraints for the biomarkers market.
- Important technologies being used in the discovery of biomarkers.
- Promising biomarkers that are expected to be used in the drug discovery process in the future.
- The integration of different types of biomarker in each phase of the drug discovery and development process
- Analysis of partnership and M&A deals from 2011 until August 2012.

Reasons to buy

- Develop better strategies for biomarkers research by understanding the market dynamics for the biomarker drug discovery industry.
- Develop market entry and market expansion strategies by identifying the key areas for high growth and opportunities.
- Understand the factors shaping the biomarkers drug discovery market.
- Reinforce the R&D pipeline by identifying the key biomarker tests that can provide more accurate and early diagnosis of diseases.
- Exploit partnership and acquisition opportunities by identifying the products that could fill the portfolio gaps.

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 9
2 Biomarkers in Drug Discovery - Introduction 10
2.1 Introduction 10
3 Biomarkers in Drug Discovery - Overview 11
3.1 History of Biomarkers 11
3.2 Biomarkers Cater to the Unmet Needs in Drug Discovery 13
3.2.1 High Attrition Rates 14
3.2.2 High Drug Discovery Cost 15
3.2.3 Time Consuming 15
3.2.4 Safety and Efficacy 15
3.2.5 Invasiveness, Selectivity and Sensitivity 15
3.3 Biomarker Discovery and the Validation Process 16
3.3.1 Discovery 16
3.3.2 Development 17
3.3.3 Launch 17
4 Biomarkers in Drug Discovery - Market Characterization 19
4.1 Market Size and Forecasts 19
4.2 Global Biomarkers Market – Geographic Landscape 20
4.2.1 Introduction 20
4.2.2 North America 20
4.2.3 Europe 20
4.2.4 Asia 21
4.2.5 Row 21
4.3 Drivers and Barriers 21
4.3.1 Drivers for the Global Biomarkers Market 22
4.3.2 Barriers for the Global Biomarkers Market 24
5 Biomarkers in Drug Discovery - Time Trends 25
5.1 Historic Trend 25
5.1.1 Predictions Based on Biomarkers 25
5.1.2 Validation Versus Qualification 25
5.1.3 Lack of Synergy between Mechanism and Pattern 25
5.1.4 Regulatory Approval of Biomarkers 26
5.1.5 Difference in Regulation of Single Biomarkers and Panel of Biomarkers 26
5.1.6 Measures of Success 26
5.2 Future Trend – Growing Demand for Personalized Medicine 27
5.2.1 Companion Diagnostics Market 27
5.2.2 Drivers and Barriers for Companion Diagnostics Market 28
5.2.3 Regulations of Companion Diagnostics – EU 28
5.2.4 Regulations of Companion Diagnostics – US 29
6 Biomarkers in Drug Discovery - Technologies Used for Biomarker Discovery 30
6.1 Role of Imaging as a Predictive Biomarker 30
6.2 Biomarker Discovery Using Proteomics via Mass Spectrometry 32
6.3 High-Throughput Proteome Screening for Biomarker Detection 34
7 Biomarkers in Drug Discovery - How Biomarker Development Relates to Drug Discovery 36
7.1 Application of Biomarkers in Drug Discovery 36
7.1.1 Lead Identification and Optimization 38
7.1.2 Potential Role of Biomarkers in Lead Identification and Optimization 39
7.1.3 Target Validation 39
7.1.4 Toxicological Assay (Preclinical and Clinical) 39
7.1.5 Mechanism of Action 40
7.1.6 Monitor Therapy and Dose Response 40
7.1.7 Stratify Patient Population 40
7.1.8 Filing and Post-Marketing Surveillance 41
7.2 Benefits of Biomarker Utilization 41
7.2.1 Disease Understanding 41
7.2.2 Project Prioritization through Early Attrition 41
7.2.3 Streamlining Clinical Trials 41
7.2.4 Reducing Cost of Drug Development 42
7.2.5 Expediting Drug Development 42
7.2.6 Avoiding Adverse Drug Reactions and Rationalizing Dosing Regimen 42
7.2.7 Drug Repositioning 42
7.3 Challenges in Biomarker Utilization 42
7.3.1 Variability 42
7.3.2 Validity 43
7.3.3 Measurement Errors 43
7.4 Biomarker Classification 44
7.4.1 Biomarker Categories 45
7.4.2 Types of Biomarkers 45
7.4.3 Reasons for Surrogate Endpoint ‘Failure’ 47
8 Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development 49
8.1 Discovery 50
8.1.1 Predictive Safety Biomarkers 50
8.1.2 Mechanism of Action Markers 50
8.2 Preclinical Development 50
8.2.1 Prognostic and Epidemiological Biomarkers 50
8.2.2 Diagnostic Biomarkers 51
8.3 Clinical Development 52
8.3.1 Disease Progression Markers or Response to Therapy Markers 52
8.3.2 Surrogate Biomarkers 52
9 Biomarkers in Drug Discovery - Case Study 53
9.1 Role of HER2 Gene in Herceptin Development for Breast Cancer 53
9.1.1 Activation of Antibody-Dependent Cellular Cytotoxicity 53
9.1.2 Prevention of the Formation of p95HER2 53
9.1.3 Inhibition of HER2-activated Cell Proliferation 54
9.1.4 Inhibition of HER2-regulated Angiogenesis 54
9.1.5 Herceptin Side Effects 55
9.2 Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia 57
10 Biomarkers in Drug Discovery - Regulatory Trends 59
10.1 Regulatory Landscape 59
10.1.1 Investigative/Exploratory Biomarker 59
10.1.2 Probable Valid Biomarker 59
10.1.3 Known Valid Biomarker 59
10.1.4 Letter Of Intent to Propose Biomarker Qualification 59
10.1.5 Structure of Biomarker Qualification Briefing Document 60
10.2 Validated Biomarker 62
10.3 Regulatory Acceptance of Valid Biomarkers 65
10.4 Regulatory Guidance from the FDA, EMA and MHLW 65
11 Biomarkers in Drug Discovery - Promising Biomarkers 66
11.1 Biomarkers for Alzheimer’s Disease 66
11.1.1 Imaging Biomarkers 66
11.1.2 Fluid Biomarkers 67
11.2 Biomarkers for Cancer 67
11.2.1 Insulin-like Growth Factor 1 and 2 69
11.2.2 OVA1 69
11.2.3 Risk of Ovarian Malignancy Algorithm 69
11.2.4 Serum Markers 69
11.3 Biomarkers for Multiple Sclerosis 70
11.3.1 Serum Marker: Brain-Derived Neurotrophic Factor 70
11.3.2 Cerebrospinal Fluid Markers 70
11.3.3 Imaging Marker 71
11.4 Biomarkers for Rheumatoid Arthritis 71
11.4.1 Micro RNAs 71
11.4.2 Autoantibodies 72
11.4.3 Inflammatory Markers 72
11.5 Biomarkers for Hepatitis C 73
11.5.1 Serum Markers 73
11.5.2 Imaging Markers 73
11.5.3 Non-Structural 5A Protein 74
11.5.4 Micro RNA-22 74
12 Biomarkers in Drug Discovery - Strategic Consolidations 75
12.1 M&A Deals 75
12.1.1 Micromedic Buys 33% Stake in BioMarCare for $1m 75
12.1.2 ValiRx Plc Acquires Pharmatest’s Biomarkers Business Unit 75
12.1.3 David H. Murdock Research Institute Acquires the Immune Tolerance Institute 76
12.1.4 Health Diagnostic Laboratory Acquires Harris Scientific 76
12.1.5 Myriad Genetics Acquires Rules-based Medicine 76
12.2 Licensing Agreements 77
12.2.1 SomaLogic Enters into Licensing Agreement with AmberGen 77
12.2.2 Advion BioServices Enters into Licensing Agreement with SISCAPA Assay Services 77
12.2.3 AVEO Pharmaceuticals Enters into Licensing Agreement with Centocor Ortho Biotech 78
12.2.4 KineMed Extends Licensing Agreement with Bristol-Myers Squibb 78
12.3 Partnership Deals 79
12.3.1 KineMed Enters Multi-year Agreement with GlaxoSmithKline to Develop Kinetic Biomarkers 80
12.3.2 Affymetrix and Massachusetts General Hospital Seal Deal to Develop Cancer Biomarker Diagnostics 80
12.3.3 Genedata and Roche Extend Collaboration of Biomarker Discovery 80
12.3.4 Isogen Life Science Enters into Co-Marketing Agreement with Axela for Biomarker Analysis Platforms 80
13 Biomarkers in Drug Discovery - Appendix 81
13.1 Market Definitions 81
13.2 Abbreviations 81
13.3 Bibliography 83
13.4 Research Methodology 86
13.4.1 Coverage 86
13.4.2 Secondary Research 86
13.4.3 Primary Research 86
13.4.4 Expert Panel Validation 87
13.5 Contact Us 87
13.6 Disclaimer 87