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

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

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

Summary

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

- 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 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 Contents1 Table of Contents 51.1 List of Tables 81.2 List of Figures 92 Biomarkers in Drug Discovery - Introduction 102.1 Introduction 103 Biomarkers in Drug Discovery - Overview 113.1 History of Biomarkers 113.2 Biomarkers Cater to the Unmet Needs in Drug Discovery 133.2.1 High Attrition Rates 143.2.2 High Drug Discovery Cost 153.2.3 Time Consuming 153.2.4 Safety and Efficacy 153.2.5 Invasiveness, Selectivity and Sensitivity 153.3 Biomarker Discovery and the Validation Process 163.3.1 Discovery 163.3.2 Development 173.3.3 Launch 174 Biomarkers in Drug Discovery - Market Characterization 194.1 Market Size and Forecasts 194.2 Global Biomarkers Market – Geographic Landscape 204.2.1 Introduction 204.2.2 North America 204.2.3 Europe 204.2.4 Asia 214.2.5 Row 214.3 Drivers and Barriers 214.3.1 Drivers for the Global Biomarkers Market 224.3.2 Barriers for the Global Biomarkers Market 245 Biomarkers in Drug Discovery - Time Trends 255.1 Historic Trend 255.1.1 Predictions Based on Biomarkers 255.1.2 Validation Versus Qualification 255.1.3 Lack of Synergy between Mechanism and Pattern 255.1.4 Regulatory Approval of Biomarkers 265.1.5 Difference in Regulation of Single Biomarkers and Panel of Biomarkers 265.1.6 Measures of Success 265.2 Future Trend – Growing Demand for Personalized Medicine 275.2.1 Companion Diagnostics Market 275.2.2 Drivers and Barriers for Companion Diagnostics Market 285.2.3 Regulations of Companion Diagnostics – EU 285.2.4 Regulations of Companion Diagnostics – US 296 Biomarkers in Drug Discovery - Technologies Used for Biomarker Discovery 306.1 Role of Imaging as a Predictive Biomarker 306.2 Biomarker Discovery Using Proteomics via Mass Spectrometry 326.3 High-Throughput Proteome Screening for Biomarker Detection 347 Biomarkers in Drug Discovery - How Biomarker Development Relates to Drug Discovery 367.1 Application of Biomarkers in Drug Discovery 367.1.1 Lead Identification and Optimization 387.1.2 Potential Role of Biomarkers in Lead Identification and Optimization 397.1.3 Target Validation 397.1.4 Toxicological Assay (Preclinical and Clinical) 397.1.5 Mechanism of Action 407.1.6 Monitor Therapy and Dose Response 407.1.7 Stratify Patient Population 407.1.8 Filing and Post-Marketing Surveillance 417.2 Benefits of Biomarker Utilization 417.2.1 Disease Understanding 417.2.2 Project Prioritization through Early Attrition 417.2.3 Streamlining Clinical Trials 417.2.4 Reducing Cost of Drug Development 427.2.5 Expediting Drug Development 427.2.6 Avoiding Adverse Drug Reactions and Rationalizing Dosing Regimen 427.2.7 Drug Repositioning 427.3 Challenges in Biomarker Utilization 427.3.1 Variability 427.3.2 Validity 437.3.3 Measurement Errors 437.4 Biomarker Classification 447.4.1 Biomarker Categories 457.4.2 Types of Biomarkers 457.4.3 Reasons for Surrogate Endpoint 'Failure' 478 Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development 498.1 Discovery 508.1.1 Predictive Safety Biomarkers 508.1.2 Mechanism of Action Markers 508.2 Preclinical Development 508.2.1 Prognostic and Epidemiological Biomarkers 508.2.2 Diagnostic Biomarkers 518.3 Clinical Development 528.3.1 Disease Progression Markers or Response to Therapy Markers 528.3.2 Surrogate Biomarkers 529 Biomarkers in Drug Discovery - Case Study 539.1 Role of HER2 Gene in Herceptin Development for Breast Cancer 539.1.1 Activation of Antibody-Dependent Cellular Cytotoxicity 539.1.2 Prevention of the Formation of p95HER2 539.1.3 Inhibition of HER2-activated Cell Proliferation 549.1.4 Inhibition of HER2-regulated Angiogenesis 549.1.5 Herceptin Side Effects 559.2 Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia 5710 Biomarkers in Drug Discovery - Regulatory Trends 5910.1 Regulatory Landscape 5910.1.1 Investigative/Exploratory Biomarker 5910.1.2 Probable Valid Biomarker 5910.1.3 Known Valid Biomarker 5910.1.4 Letter Of Intent to Propose Biomarker Qualification 5910.1.5 Structure of Biomarker Qualification Briefing Document 6010.2 Validated Biomarker 6210.3 Regulatory Acceptance of Valid Biomarkers 6510.4 Regulatory Guidance from the FDA, EMA and MHLW 6511 Biomarkers in Drug Discovery - Promising Biomarkers 6611.1 Biomarkers for Alzheimer's Disease 6611.1.1 Imaging Biomarkers 6611.1.2 Fluid Biomarkers 6711.2 Biomarkers for Cancer 6711.2.1 Insulin-like Growth Factor 1 and 2 6911.2.2 OVA1 6911.2.3 Risk of Ovarian Malignancy Algorithm 6911.2.4 Serum Markers 6911.3 Biomarkers for Multiple Sclerosis 7011.3.1 Serum Marker: Brain-Derived Neurotrophic Factor 7011.3.2 Cerebrospinal Fluid Markers 7011.3.3 Imaging Marker 7111.4 Biomarkers for Rheumatoid Arthritis 7111.4.1 Micro RNAs 7111.4.2 Autoantibodies 7211.4.3 Inflammatory Markers 7211.5 Biomarkers for Hepatitis C 7311.5.1 Serum Markers 7311.5.2 Imaging Markers 7311.5.3 Non-Structural 5A Protein 7411.5.4 Micro RNA-22 7412 Biomarkers in Drug Discovery - Strategic Consolidations 7512.1 M&A Deals 7512.1.1 Micromedic Buys 33% Stake in BioMarCare for $1m 7512.1.2 ValiRx Plc Acquires Pharmatest's Biomarkers Business Unit 7512.1.3 David H. Murdock Research Institute Acquires the Immune Tolerance Institute 7612.1.4 Health Diagnostic Laboratory Acquires Harris Scientific 7612.1.5 Myriad Genetics Acquires Rules-based Medicine 7612.2 Licensing Agreements 7712.2.1 SomaLogic Enters into Licensing Agreement with AmberGen 7712.2.2 Advion BioServices Enters into Licensing Agreement with SISCAPA Assay Services 7712.2.3 AVEO Pharmaceuticals Enters into Licensing Agreement with Centocor Ortho Biotech 7812.2.4 KineMed Extends Licensing Agreement with Bristol-Myers Squibb 7812.3 Partnership Deals 7912.3.1 KineMed Enters Multi-year Agreement with GlaxoSmithKline to Develop Kinetic Biomarkers 8012.3.2 Affymetrix and Massachusetts General Hospital Seal Deal to Develop Cancer Biomarker Diagnostics 8012.3.3 Genedata and Roche Extend Collaboration of Biomarker Discovery 8012.3.4 Isogen Life Science Enters into Co-Marketing Agreement with Axela for Biomarker Analysis Platforms 8013 Biomarkers in Drug Discovery - Appendix 8113.1 Market Definitions 8113.2 Abbreviations 8113.3 Bibliography 8313.4 Research Methodology 8613.4.1 Coverage 8613.4.2 Secondary Research 8613.4.3 Primary Research 8613.4.4 Expert Panel Validation 8713.5 Contact Us 8713.6 Disclaimer 87

1.1 List of Tables

Table 1: Biomarkers in Drug Discovery, Global, Biomarkers Qualified by EMA for Use in Drug Development, 2012 17Table 2: Biomarkers in Drug Discovery, Global, Biomarkers Qualified by FDA for Use in Drug Development, 2012 18Table 3: Biomarkers in Drug Discovery, Global Biomarker's Market, Revenue ($bn), 2004–2011 19Table 4: Biomarkers in Drug Discovery, Global Biomarker's Market, Revenue Forecast ($bn), 2011–2018 19Table 5: Biomarkers in Drug Discovery, Global, Biomarker Discovery by Mass Spectrometry, Problems and Solutions, 2012 33Table 6: Biomarkers in Drug Discovery, Global, Examples of Biomarkers, 2012 47Table 7: Biomarkers in Drug Discovery, Global, Herceptin Development Timeline, 2012 55Table 8: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in FDA-approved Drugs, 2012 62Table 9: Biomarkers in Drug Discovery, Global, Imaging and Cerebrospinal Fluid Biomarker Categories in Alzheimer's Disease, 2012 66Table 10: Biomarkers in Drug Discovery, Global, Prognostic and Diagnostic Biomarkers for Cancer, 2012 68Table 11: Biomarkers in Drug Discovery, Global, Micro RNAs as Biomarkers of Cancer, 2012 69Table 12: Biomarkers in Drug Discovery, Global, Cerebrospinal Fluid Biomarkers in Multiple Sclerosis, 2012 70Table 13: Biomarkers in Drug Discovery, Global, Micro RNA as Biomarker for Rheumatoid Arthritis, 2012 71Table 14: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Mergers and Acquisitions, 2011–2012 75Table 15: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Licensing Agreement Deals, 2011–2012 77Table 16: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Partnerships Deals, 2011–2012 79`

1.2 List of Figures

Figure 1: Biomarkers in Drug Discovery, Global, Commonly Identified Biomarkers, 2012 10Figure 2: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2012 11Figure 3: Biomarkers in Drug Discovery, Global, Biomarkers Cater to the Unmet Needs of Conventional Drug Discovery Methods, 2012 13Figure 4: Biomarkers in Drug Discovery, Global, Reasons for Attrition, 2012 14Figure 5: Biomarkers in Drug Discovery, Global, Biomarker Discovery and Validation Process, 2012 16Figure 6: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue Forecast ($bn), 2004–2018 19Figure 7: Biomarkers in Drug Discovery, Global, Geographic Landscape – Global Biomarkers Market, 2012 20Figure 8: Biomarkers in Drug Discovery, Global, Market Drivers and Restraints, 2012 21Figure 9: Biomarkers in Drug Discovery, Global, Integration of 'Omics' Drives Global Biomarker Market, 2012 23Figure 10: Biomarkers in Drug Discovery, Global, Roche, Companion Diagnostics Development Process, 2012 27Figure 11: Biomarkers in Drug Discovery, Global, Diagnostic Criteria for Multiple Sclerosis, 2012 30Figure 12: Biomarkers in Drug Discovery, Global, Case Study, 2012 31Figure 13: Biomarkers in Drug Discovery, Global, Protein Identification by Mass Spectrometry, 2012 32Figure 14: Biomarkers in Drug Discovery, Global, Peptide Identification by Tandem Mass Spectrometry, 2012 33Figure 15: Biomarkers in Drug Discovery, Global, Biomarker Discovery – Equalizer Bead Fractionation and ProteinChip SELDI System, 2012 34Figure 16: Biomarkers in Drug Discovery, Global, Biomarker Discovery – Fractionation Schemes, 2012 35Figure 17: Biomarkers in Drug Discovery, Global, Biomarkers' Development and Drug Development Comparison, 2012 36Figure 18: Biomarkers in Drug Discovery, Global, Role of Biomarkers in Drug Discovery and Development, 2012 37Figure 19: Biomarkers in Drug Discovery, Global, Drug Discovery Process, 2012 37Figure 20: Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2012 38Figure 21: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by Top Companies in Drug Discovery, 2012 40Figure 22: Biomarkers in Drug Discovery, Global, Biomarker Classification, Disease and Drug-related Biomarkers, 2012 44Figure 23: Biomarkers in Drug Discovery, Global, Biomarker Categories, 2012 45Figure 24: Biomarkers in Drug Discovery, Global, Types of Biomarkers, 2012 45Figure 25: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 47Figure 26: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 47Figure 27: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 48Figure 28: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 48Figure 29: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012 48Figure 30: Biomarkers in Drug Discovery, Global, Biomarker Application in Each Stage of the Drug Discovery Process, 2012 49Figure 31: Biomarkers in Drug Discovery, Relationship Between Different Types of Biomarkers and New Molecular Entities, 2012 51Figure 32: Biomarkers in Drug Discovery, Global, Gleevec Approval Fact Sheet, 2012 57

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