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Biomarkers in Drug Discovery - Earlier Usage of Biomarkers in Optimization Stage to Reduce Drug Attrition Rate Significantly.

  • Published: Oct-2011
  • Report Code: GBIHC116MR
  • Report Format: pdf

Description

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

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