Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Biomarkers in Drug Discovery – Executive Summary
2.1 Use of Biomarkers in Oncology Therapeutics is one of the Biggest Application Areas with Main Emphasis on Predictive and Personalized Medicine
2.2 Application of Biomarkers in Each Stage of Drug Discovery Assisting Fast Turnover of Drugs
2.3 Biomarkers Market Expects Significant Growth
3 Biomarkers in Drug Discovery – Introduction
3.1 Introduction
3.2 GBI Research Report Guidance
4 Biomarkers in Drug Discovery – Overview
4.1 History of Biomarkers
4.2 Biomarker Classification
4.2.1 Biomarker Categories
4.2.2 Types of Biomarkers
4.2.3 Example of Type 0, I and II Biomarker
4.2.4 Reasons Surrogate Endpoints ‘Fail’
4.3 Biomarker Discovery and the Validation Process
4.3.1 Product Development Process from Discovery to Launch
4.4 General Application of Biomarkers
4.4.1 Biomarkers in Drug Discovery and Drug Development
4.4.2 Role of Biomarkers in the Drug Discovery Process
4.4.3 Application of Biomarkers in Disease Diagnosis and Prognosis
4.4.4 Potential Impact of Biomarkers on Disease States
4.4.5 Population Genetics Study
4.4.6 Environmental Health and Risk Assessment
4.4.7 Role of Biomarkers in Environmental Health and Risk Assessment
4.4.8 Toxicology Studies in Dietary Items or Nutraceuticals
4.5 Application of Biomarkers in Drug Discovery
4.5.1 Lead Identification and Optimization
4.5.2 Potential Role of Biomarkers in Lead Identification and Optimization
4.5.3 Target Validation
4.5.4 Toxicological Assay (Preclinical and Clinical)
4.5.5 Mechanism of Action
4.5.6 Monitor Therapy and Dose Response
4.5.7 Stratify Patient Population
4.5.8 Filing and Post Marketing Surveillance
4.6 Benefits of Biomarker Utilization
4.6.1 Disease Understanding
4.6.2 Project Prioritization through Early Attrition
4.6.3 Streamlining Clinical Trials
4.6.4 Reducing Cost of Drug Development
4.6.5 Speeding Drug Development
4.6.6 Avoiding Adverse Drug Reactions (ADR) and Rationalizing Dosing Regimen
4.6.7 Drug Repositioning
4.7 Challenges in Biomarker Utilization
4.7.1 Variability
4.7.2 Validity
4.7.3 Measurement Errors
5 Biomarkers in Drug Discovery – Case Study
5.1 Cell Signaling Technology Enters Into Co-Marketing Agreement with Astellas Pharma
5.1.1 Definition
5.1.2 About Lung Cancer
5.1.3 Company Profile
5.1.4 Technology Used
5.1.5 Market Information
5.1.6 Advantages
5.1.7 Future Prospect
6 Biomarkers in Drug Discovery – Market Characterization
6.1 Market Overview
6.2 Market Size and Forecasts
6.2.1 Global Biomarkers Market Size
6.2.2 Global Biomarkers Drug Discovery Market
6.2.3 Global Biomarker’s Molecular Diagnostics Market
6.2.4 Global Biomarkers Others Market
6.2.5 Global Biomarkers Market Segmentation
6.2.6 Drivers and Restraints
6.2.7 Drivers for the Global Biomarkers Market
6.2.8 Barriers for the Global Biomarkers Market
6.3 Unmet Needs – Biomarkers Fulfilling the Unmet Needs of Drug Discovery
6.3.1 High Attrition Rates
6.3.2 High Drug Discovery Cost
6.3.3 Time Consuming
6.3.4 Safety and Efficacy
6.3.5 Invasiveness, Selectivity and Sensitivity
7 Biomarkers in Drug Discovery – Trends Analysis
7.1 Regulatory Landscape (Current and Future)
7.1.1 Investigative/Exploratory Biomarker
7.1.2 Probable Valid Biomarker
7.1.3 Known Valid Biomarker
7.1.4 Regulatory Biomarker
7.1.5 Letter Of Intent to Propose Biomarker Qualification
7.1.6 Structure of Biomarker Qualification Briefing Document
7.2 Validated Biomarker
7.3 Regulatory Acceptance of Valid Biomarkers
7.4 Regulatory Guidance from the FDA, EMEA, and MHLW (Japan)
8 Biomarkers in Drug Discovery – Technology Adoptions
8.1 Unmet Need - Drug Discovery
8.1.1 Biomarkers Technology Exists to Fulfill Unmet Drug Discovery Needs
8.2 Increased Awareness among Pharmaceutical and Research Sector
8.3 Increasing Adoption Due to Wide Application
8.4 Biomarkers’ Future – Drug Discovery Unmet Needs Fulfilled
9 Biomarkers in Drug Discovery – Competitive Landscape
9.1 Key Biomarkers Players
9.1.1 Quest Diagnostics
9.1.2 Life Technologies Corporation
9.1.3 Vermillion
9.1.4 BG Medicine
9.1.5 Menarini
9.1.6 Abbott
9.1.7 Roche
9.1.8 Genentech
9.1.9 Affymetrix
9.1.10 Amgen
9.2 Global Biomarkers Market – Geographic Landscape
10 Biomarkers in Drug Discovery – Pipeline Analysis
10.1 Pipeline Analysis
10.1.1 Biomarkers in Discovery Phase
10.1.2 Biomarkers in Phase I
10.1.3 Biomarkers in Phase II
10.1.4 Biomarkers in Phase III
10.1.5 Biomarkers in Phase IV
10.1.6 Pipeline Analysis by Phase
10.1.7 Pipeline Analysis – Therapeutic Class
10.1.8 Pipeline Analysis by Geography
11 Biomarkers in Drug Discovery – Strategic Consolidations
11.1 Strategic Consolidations by Deal Type
11.2 Mergers and Acquisitions
11.2.1 Mergers and Acquisitions by Geography
11.2.2 Major M&A Deals
11.3 Licensing Agreement Deals
11.3.1 Licensing Agreement Deals by Geography
11.3.2 Major Licensing Agreements
11.4 Partnership Deals
11.4.1 Major Partnership Deals
12 Biomarkers in Drug Discovery – Appendix
12.1 Market Definitions
12.2 Abbreviations
12.3 Research Methodology
12.3.1 Biomarkers in Drug Discovery- Overview
12.3.2 Biomarkers in Drug Discovery- Case Study
12.3.3 Biomarkers in Drug Discovery- Market Characterisation
12.3.4 Biomarkers in Drug Discovery- Trends Analysis
12.3.5 Biomarkers in Drug Discovery- Technology Adoptions
12.3.6 Biomarkers in Drug Discovery- Competitive Landscape
12.3.7 Biomarkers in Drug Discovery- Pipeline Analysis
12.3.8 Biomarkers in Drug Discovery- Strategic Consolidations
12.3.9 Coverage
12.3.10 Secondary Research
12.3.11 Primary Research
12.3.12 Expert Panel Validation
12.4 Contact Us
12.5 Disclaimer
12.6 Sources