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

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

  • ID: 2306110
  • November 2012
  • 87 Pages
  • GBI Research

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, READ MORE >

1.1 List of Tables
1.2 List of Figures

2 Biomarkers in Drug Discovery - Introduction
2.1 Introduction

3 Biomarkers in Drug Discovery - Overview
3.1 History of Biomarkers
3.2 Biomarkers Cater to the Unmet Needs in Drug Discovery
3.2.1 High Attrition Rates
3.2.2 High Drug Discovery Cost
3.2.3 Time Consuming
3.2.4 Safety and Efficacy
3.2.5 Invasiveness, Selectivity and Sensitivity
3.3 Biomarker Discovery and the Validation Process
3.3.1 Discovery
3.3.2 Development
3.3.3 Launch

4 Biomarkers in Drug Discovery - Market Characterization
4.1 Market Size and Forecasts
4.2 Global Biomarkers Market – Geographic Landscape
4.2.1 Introduction
4.2.2 North America
4.2.3 Europe
4.2.4 Asia
4.2.5 Row
4.3 Drivers and Barriers
4.3.1 Drivers for the Global Biomarkers Market
4.3.2 Barriers for the Global Biomarkers Market

5 Biomarkers in Drug Discovery - Time Trends
5.1 Historic Trend
5.1.1 Predictions Based on Biomarkers
5.1.2 Validation Versus Qualification
5.1.3 Lack of Synergy between Mechanism and Pattern
5.1.4 Regulatory Approval of Biomarkers
5.1.5 Difference in Regulation of Single Biomarkers and Panel of Biomarkers
5.1.6 Measures of Success
5.2 Future Trend – Growing Demand for Personalized Medicine
5.2.1 Companion Diagnostics Market
5.2.2 Drivers and Barriers for Companion Diagnostics Market
5.2.3 Regulations of Companion Diagnostics – EU
5.2.4 Regulations of Companion Diagnostics – US

6 Biomarkers in Drug Discovery - Technologies Used for Biomarker Discovery
6.1 Role of Imaging as a Predictive Biomarker
6.2 Biomarker Discovery Using Proteomics via Mass Spectrometry
6.3 High-Throughput Proteome Screening for Biomarker Detection

7 Biomarkers in Drug Discovery - How Biomarker Development Relates to Drug Discovery
7.1 Application of Biomarkers in Drug Discovery
7.1.1 Lead Identification and Optimization
7.1.2 Potential Role of Biomarkers in Lead Identification and Optimization
7.1.3 Target Validation
7.1.4 Toxicological Assay (Preclinical and Clinical)
7.1.5 Mechanism of Action
7.1.6 Monitor Therapy and Dose Response
7.1.7 Stratify Patient Population
7.1.8 Filing and Post-Marketing Surveillance
7.2 Benefits of Biomarker Utilization
7.2.1 Disease Understanding
7.2.2 Project Prioritization through Early Attrition
7.2.3 Streamlining Clinical Trials
7.2.4 Reducing Cost of Drug Development
7.2.5 Expediting Drug Development
7.2.6 Avoiding Adverse Drug Reactions and Rationalizing Dosing Regimen
7.2.7 Drug Repositioning
7.3 Challenges in Biomarker Utilization
7.3.1 Variability
7.3.2 Validity
7.3.3 Measurement Errors
7.4 Biomarker Classification
7.4.1 Biomarker Categories
7.4.2 Types of Biomarkers
7.4.3 Reasons for Surrogate Endpoint ‘Failure’

8 Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development
8.1 Discovery
8.1.1 Predictive Safety Biomarkers
8.1.2 Mechanism of Action Markers
8.2 Preclinical Development
8.2.1 Prognostic and Epidemiological Biomarkers
8.2.2 Diagnostic Biomarkers
8.3 Clinical Development
8.3.1 Disease Progression Markers or Response to Therapy Markers
8.3.2 Surrogate Biomarkers

9 Biomarkers in Drug Discovery - Case Study
9.1 Role of HER2 Gene in Herceptin Development for Breast Cancer
9.1.1 Activation of Antibody-Dependent Cellular Cytotoxicity
9.1.2 Prevention of the Formation of p95HER2
9.1.3 Inhibition of HER2-activated Cell Proliferation
9.1.4 Inhibition of HER2-regulated Angiogenesis
9.1.5 Herceptin Side Effects
9.2 Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia

10 Biomarkers in Drug Discovery - Regulatory Trends
10.1 Regulatory Landscape
10.1.1 Investigative/Exploratory Biomarker
10.1.2 Probable Valid Biomarker
10.1.3 Known Valid Biomarker
10.1.4 Letter Of Intent to Propose Biomarker Qualification
10.1.5 Structure of Biomarker Qualification Briefing Document
10.2 Validated Biomarker
10.3 Regulatory Acceptance of Valid Biomarkers
10.4 Regulatory Guidance from the FDA, EMA and MHLW

11 Biomarkers in Drug Discovery - Promising Biomarkers
11.1 Biomarkers for Alzheimer’s Disease
11.1.1 Imaging Biomarkers
11.1.2 Fluid Biomarkers
11.2 Biomarkers for Cancer
11.2.1 Insulin-like Growth Factor 1 and 2
11.2.2 OVA1
11.2.3 Risk of Ovarian Malignancy Algorithm
11.2.4 Serum Markers
11.3 Biomarkers for Multiple Sclerosis
11.3.1 Serum Marker: Brain-Derived Neurotrophic Factor
11.3.2 Cerebrospinal Fluid Markers
11.3.3 Imaging Marker
11.4 Biomarkers for Rheumatoid Arthritis
11.4.1 Micro RNAs
11.4.2 Autoantibodies
11.4.3 Inflammatory Markers
11.5 Biomarkers for Hepatitis C
11.5.1 Serum Markers
11.5.2 Imaging Markers
11.5.3 Non-Structural 5A Protein
11.5.4 Micro RNA-22

12 Biomarkers in Drug Discovery - Strategic Consolidations
12.1 M&A Deals
12.1.1 Micromedic Buys 33% Stake in BioMarCare for $1m
12.1.2 ValiRx Plc Acquires Pharmatest’s Biomarkers Business Unit
12.1.3 David H. Murdock Research Institute Acquires the Immune Tolerance Institute
12.1.4 Health Diagnostic Laboratory Acquires Harris Scientific
12.1.5 Myriad Genetics Acquires Rules-based Medicine
12.2 Licensing Agreements
12.2.1 SomaLogic Enters into Licensing Agreement with AmberGen
12.2.2 Advion BioServices Enters into Licensing Agreement with SISCAPA Assay Services
12.2.3 AVEO Pharmaceuticals Enters into Licensing Agreement with Centocor Ortho Biotech
12.2.4 KineMed Extends Licensing Agreement with Bristol-Myers Squibb
12.3 Partnership Deals
12.3.1 KineMed Enters Multi-year Agreement with GlaxoSmithKline to Develop Kinetic Biomarkers
12.3.2 Affymetrix and Massachusetts General Hospital Seal Deal to Develop Cancer Biomarker Diagnostics
12.3.3 Genedata and Roche Extend Collaboration of Biomarker Discovery
12.3.4 Isogen Life Science Enters into Co-Marketing Agreement with Axela for Biomarker Analysis Platforms

13 Biomarkers in Drug Discovery - Appendix
13.1 Market Definitions
13.2 Abbreviations
13.3 Bibliography
13.4 Research Methodology
13.4.1 Coverage
13.4.2 Secondary Research
13.4.3 Primary Research
13.4.4 Expert Panel Validation
13.5 Contact Us
13.6 Disclaimer

1.1 List of Tables

Table 1: Biomarkers in Drug Discovery, Global, Biomarkers Qualified by EMA for Use in Drug Development, 2012
Table 2: Biomarkers in Drug Discovery, Global, Biomarkers Qualified by FDA for Use in Drug Development, 2012
Table 3: Biomarkers in Drug Discovery, Global Biomarker’s Market, Revenue ($bn), 2004–2011
Table 4: Biomarkers in Drug Discovery, Global Biomarker’s Market, Revenue Forecast ($bn), 2011–2018
Table 5: Biomarkers in Drug Discovery, Global, Biomarker Discovery by Mass Spectrometry, Problems and Solutions, 2012
Table 6: Biomarkers in Drug Discovery, Global, Examples of Biomarkers, 2012
Table 7: Biomarkers in Drug Discovery, Global, Herceptin Development Timeline, 2012
Table 8: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in FDA-approved Drugs, 2012
Table 9: Biomarkers in Drug Discovery, Global, Imaging and Cerebrospinal Fluid Biomarker Categories in Alzheimer’s Disease, 2012
Table 10: Biomarkers in Drug Discovery, Global, Prognostic and Diagnostic Biomarkers for Cancer, 2012
Table 11: Biomarkers in Drug Discovery, Global, Micro RNAs as Biomarkers of Cancer, 2012
Table 12: Biomarkers in Drug Discovery, Global, Cerebrospinal Fluid Biomarkers in Multiple Sclerosis, 2012
Table 13: Biomarkers in Drug Discovery, Global, Micro RNA as Biomarker for Rheumatoid Arthritis, 2012
Table 14: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Mergers and Acquisitions, 2011–2012
Table 15: Biomarkers in Drug Discovery, Global, Strategic Consolidations, Licensing Agreement Deals, 2011–2012
Table 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
Figure 2: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2012
Figure 3: Biomarkers in Drug Discovery, Global, Biomarkers Cater to the Unmet Needs of Conventional Drug Discovery Methods, 2012
Figure 4: Biomarkers in Drug Discovery, Global, Reasons for Attrition, 2012
Figure 5: Biomarkers in Drug Discovery, Global, Biomarker Discovery and Validation Process, 2012
Figure 6: Biomarkers in Drug Discovery, Global Biomarkers Market, Revenue Forecast ($bn), 2004–2018
Figure 7: Biomarkers in Drug Discovery, Global, Geographic Landscape – Global Biomarkers Market, 2012
Figure 8: Biomarkers in Drug Discovery, Global, Market Drivers and Restraints, 2012
Figure 9: Biomarkers in Drug Discovery, Global, Integration of ‘Omics’ Drives Global Biomarker Market, 2012
Figure 10: Biomarkers in Drug Discovery, Global, Roche, Companion Diagnostics Development Process, 2012
Figure 11: Biomarkers in Drug Discovery, Global, Diagnostic Criteria for Multiple Sclerosis, 2012
Figure 12: Biomarkers in Drug Discovery, Global, Case Study, 2012
Figure 13: Biomarkers in Drug Discovery, Global, Protein Identification by Mass Spectrometry, 2012
Figure 14: Biomarkers in Drug Discovery, Global, Peptide Identification by Tandem Mass Spectrometry, 2012
Figure 15: Biomarkers in Drug Discovery, Global, Biomarker Discovery – Equalizer Bead Fractionation and ProteinChip SELDI System, 2012
Figure 16: Biomarkers in Drug Discovery, Global, Biomarker Discovery – Fractionation Schemes, 2012
Figure 17: Biomarkers in Drug Discovery, Global, Biomarkers’ Development and Drug Development Comparison, 2012
Figure 18: Biomarkers in Drug Discovery, Global, Role of Biomarkers in Drug Discovery and Development, 2012
Figure 19: Biomarkers in Drug Discovery, Global, Drug Discovery Process, 2012
Figure 20: Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2012
Figure 21: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by Top Companies in Drug Discovery, 2012
Figure 22: Biomarkers in Drug Discovery, Global, Biomarker Classification, Disease and Drug-related Biomarkers, 2012
Figure 23: Biomarkers in Drug Discovery, Global, Biomarker Categories, 2012
Figure 24: Biomarkers in Drug Discovery, Global, Types of Biomarkers, 2012
Figure 25: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012
Figure 26: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012
Figure 27: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012
Figure 28: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012
Figure 29: Biomarkers in Drug Discovery, Global, Reasons for Surrogate Endpoint Failure, 2012
Figure 30: Biomarkers in Drug Discovery, Global, Biomarker Application in Each Stage of the Drug Discovery Process, 2012
Figure 31: Biomarkers in Drug Discovery, Relationship Between Different Types of Biomarkers and New Molecular Entities, 2012
Figure 32: Biomarkers in Drug Discovery, Global, Gleevec Approval Fact Sheet, 2012

Biomarkers Offer Personal Touch to Patient Treatment

The traditional ‘blockbuster model’ of drug development is coming under fire, as scientists increasingly look towards personalized medicines as the future of pharmaceuticals, states a new report by healthcare experts GBI Research.

The new report* argues that biomarkers are making waves in drug discovery, revealing the possibility of analyzing an individual’s medical nature and needs remotely.

According to the Food and Drug Administration (FDA), a biomarker is a characteristic that can be objectively measured and evaluated as an indicator of biologic processes, or as biological responses to a therapeutic treatment, generally existing as specific enzyme or hormone concentrations. The report notes that biomarkers therefore hold the potential to predict disease susceptibility, can detect and monitor disease progression for CNS, CVS, cancer, autoimmune, metabolic and infectious diseases, and can also act as a guiding force in drug development and evaluation.

Historically, drug R&D processes considered the response to a drug on the majority of patients, representing a ‘one-size-fits-all’ approach, or ’blockbuster’ model. Now, an emergence of personalized medicine allows an individual’s treatment to be designed according to genetic codes, ensuring a reduction in drug discovery costs and an increase in treatment success.

Promising biomarkers that have already been discovered include biomarkers of neurodegeneration, which correlate better than Aß biomarkers with the clinical symptoms of Alzheimer’s Disease (AD) and are better suited for use in clinical trials. A huge number of potential biomarkers of prognosis and diagnosis in Rheumatoid Arthritis (RA) have also been investigated, and autoantibody tests and inflammatory markers are routinely tested in clinical practice. In addition to this, novel, new, non-invasive serum markers are being developed to monitor the progression of Hepatitis C and its response to therapy, in comparison to previously-used liver biopsies.

GBI Research valued the biomarkers market at $3.5 billion in 2004, increasing to $13 billion in 2011 at a Compound Annual Growth Rate (CAGR) of 20.1%. The majority of revenue was generated through the application of biomarkers in the discovery, testing and prescription of oncology therapeutics, according to their analysis, with other leading therapeutics areas being Central Nervous System (CNS) and Cardiovascular System (CVS) disorders.

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

This report provides information and analysis on the major trends and issues affecting biomarkers in the drug discovery process. It 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 also highlighted.

The 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.

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