Biomarkers in Drug Discovery - Optimizing Drug Discovery Timeline and Costs

Published by: GBI Research

Published: Feb. 1, 2010 - 76 Pages

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Biomarkers in Drug Discovery - Facilitating a Quick Turnaround Time: Overview

2.1 Introduction

2.2 GBI Research Report Guidance

2.3 History of Biomarkers

2.4 Biomarker Discovery and the Validation Process

2.4.1 Product Development Process from Discovery to Launch

2.5 General Application of Biomarkers

2.5.1 Biomarkers in Drug Discovery and Drug Development

2.5.2 Role of Biomarkers in the Drug Discovery Process

2.5.3 Application of Biomarkers in Disease Diagnosis and Prognosis

2.5.4 Potential Impact of Biomarkers on Disease States

2.5.5 Population Genetics Study

2.5.6 Environmental Health and Risk Assessment

2.5.7 Role of Biomarkers in Environmental Health and Risk Assessment

2.5.8 Toxicology Studies in Dietary Items or Nutraceuticals

2.6 Application of Biomarkers in Drug Discovery

2.6.1 Lead Identification & Optimization

2.6.2 Potential Role of Biomarkers in Lead Identification and Optimization

2.6.3 Target Validation

2.6.4 Toxicological Assay (Preclinical & Clinical)

2.6.5 Mechanism of Action

2.6.6 Monitor Therapy and Dose Response

2.6.7 Stratify Patient Population

2.6.8 Filing and Post Marketing Surveillance

3 Biomarkers in Drug Discovery - Case Studies

3.1 Vermillion’s Hepcidin Biomarker for Ovarian Oancer

3.1.1 Definition

3.1.2 Hepcidin Biomarker

3.1.3 About Ovarian Cancer

3.1.4 Company Profile

3.1.5 Technology Used

3.1.6 Market Information

3.1.7 Advantages

3.1.8 Future Prospect

3.2 Epigenomic’s Septin 9 Biomarker for Colorectal Cancer

3.2.1 DNA Methylation

3.2.2 Septin 9

3.2.3 Septin Biomarker

3.2.4 About Colorectal Cancer

3.2.5 Advantages

3.2.6 Future Perspective

3.2.7 Clinical Study

3.2.8 Company Profile

3.2.9 Technology Overview

3.2.10 Market Information

3.3 BiPar Science’s PARP 1 Gene Biomarker for Multiple Cancer Types

3.3.1 PARP 1 Gene

3.3.2 PARP 1 Inhibitors

3.3.3 BSI-201

3.3.4 TNBC (Triple Negative Breast Cancer)

3.3.5 Technology

3.3.6 Advantage

3.3.7 Company Profile

3.3.8 Market Information

3.3.9 Clinical Study

4 Biomarkers in Drug Discovery - Market Characterization

4.1 Market Overview

4.2 Market Size and Forecasts

4.2.1 Driver and Restraints

4.2.2 Drivers for the Global Biomarkers Market

4.2.3 Barriers for the Global Biomarkers Market

4.3 Unmet Needs - Biomarkers Fulfilling the Unmet Needs of Drug Discovery

4.3.1 High Attrition Rates

4.3.2 High Drug Discovery Cost

4.3.3 Time consuming

4.3.4 Safety and Efficacy

4.3.5 Invasiveness, Selectivity and Sensitivity

5 Trends Analysis

5.1 Regulatory Landscape (Current and Future)

5.1.1 Investigative/ Exploratory Biomarker

5.1.2 Probable Valid Biomarker

5.1.3 Known Valid Biomarker

5.1.4 Regulatory Biomarker

5.2 Validated Biomarker

5.2.1 Validated Biomarkers Applied by Top Pharmaceuticals Players in their FDA Approved Drugs

5.3 Regulatory Acceptance of Valid Biomarkers

5.4 Regulatory Guidance from the FDA, EMEA, and MHLW (Japan)

6 Technology Adoptions

6.1 Unmet Need - Drug Discovery

6.1.1 Biomarkers Technology Exists to Fulfill Unmet Drug Discovery Needs

6.2 Increased Awareness Among Pharmaceutical and Research Sector

6.3 Increasing Adoption Due to Wide Application

6.4 Biomarkers’ Future - Drug Discovery Unmet Needs Fulfilled

7 Global Biomarkers Market- Competitive Landscape

7.1 Key Biomarkers Players

7.1.1 Quest Diagnostics

7.1.2 Applied Biosystems

7.1.3 Vermillion

7.1.4 BGMedical

7.1.5 Menarini

7.1.6 Abbott

7.1.7 Roche

7.1.8 Genentech

7.1.9 Affymetrix

7.1.10 Amgen

7.2 Global Biomarkers Market - Geographic Landscape

8 Biomarkers in Drug Discovery - Pipeline Analysis

8.1 Pipeline Analysis

8.1.1 Pipeline analysis by Phase

8.1.2 Pipeline Analysis - Therapeutic class

8.1.3 Pipeline Analysis by Geography

9 Global Biomarkers market - Strategic Consolidations

9.1 Mergers and Acquisitions

9.1.1 Thermo Fisher Scientific Inc. Merges with B.R.A.H.M.S. AG

9.1.2 Clinical Data Inc to Acquire Avlon Pharmaceuticals

9.1.3 OSI Pharmaceuticals and AVEO Enter Collaborative Alliance

9.1.4 PEP Products Inc. and Interleukin Genetics Inc. Enter Collaborative Alliance

9.1.5 Pfizer Canada signs Alliance Deal with the Centre of Excellence For The Prevention of Organ Failure (Proof)

9.1.6 Millipore Corporation Acquires Guava Technologies

9.1.7 SuperGen Inc. Acquires Montigen Pharmaceuticals, Inc.

9.1.8 National Institute of Allergy and Infectious Diseases (NIAID) Enters Collaborative Alliance with Caprion Proteomics Inc.

9.1.9 Entelos Inc Acquires Iconix Biosciences

9.1.10 Vermillion Inc Acquires Ciphergen Biosystems

9.1.11 Cleveland Biolabs, Inc. Enters Collaborative Alliance with CBMS-MITS JPMO

9.2 Mergers and Acquisition Analysis by Deal Type

9.3 Mergers and Acquisition by Year of Consolidations

9.4 Mergers and Acquisitions by Geography

9.5 Mergers and Acquisitions by Deal value

10 Appendix

10.1 Abbreviations

10.2 Research Methodology

10.2.1 Coverage

10.2.2 Secondary Research

10.2.3 Primary Research

10.2.4 Expert Panel Validation

10.3 Contact Us

10.4 Disclaimer

1.1 List of Tables

Table 1: Biomarkers in Drug Discovery, Historical Revenue, Global Biomarkers Market,

($bn, 2000-2008)

Table 2: Biomarkers in Drug Discovery, Historical Revenue, Global Biomarkers Market,

($bn, 2008-2015)

Table 3: Biomarkers in Drug Discovery, Historical Revenue, Biomarker’s Drug Discovery Market Revenue ($bn), 2000-2008

Table 4: Biomarkers in Drug Discovery, Historical Revenue, Global Biomarkers Drug Discovery Market Revenue ($bn), 2008-2015

Table 5: Biomarkers in Drug Discovery, Historical Revenues, Biomarker’s Molecular Diagnostics Market Revenue ($bn), 2000-2008

Table 6: Biomarkers in Drug Discovery, Historical Revenue, Biomarkers Molecular Diagnostics Market Revenue ($bn), 2008-2015

Table 7: Biomarkers in Drug Discovery, Historical Revenue, Others Market Revenue ($bn), 2000-2008

Table 8: Biomarkers in Drug Discovery, Historical Revenue, Others Market Revenue ($bn), 2008-2015

Table 9: Biomarkers in Drug Discovery, Global, Regulatory Filings for Biomarkers, 2009

Table 10: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied in FDA Approved Drugs, 2009

Table 11: Biomarkers in Drug Discovery, Global,Biomarkers in Discovery Phase, 2009

Table 12: Biomarkers in Drug Discovery, Global, Biomarkers in Preclinical Phase, 2009

Table 13: Biomarkers in Drug Discovery, Global, Biomarkers in Phase I, 2009

Table 14: Biomarkers in Drug Discovery, Global, Biomarkers in Phase II, 2009

Table 15: Biomarkers in Drug Discovery, Global, Biomarkers in Phase III, 2009

Table 16: Biomarkers in Drug Discovery, Global, Merger and Acquisitions, 2009

1.2 List of Figures

Figure 1: Biomarkers in Drug Discovery, Global, History of Biomarkers, 2009

Figure 2: Biomarkers in Drug Discovery, Global, Biomarker Discovery and Validation Process, 2009

Figure 3: Biomarkers in Drug Discovery, Global, General Application of Biomarkers, 2010

Figure 4: Biomarkers in Drug Discovery, Global, Application of Biomarkers in Diagnosis, 2009

Figure 5: Biomarkers in Drug Discovery, Global, Potential Impact of Biomarkers on Disease States, 2009

Figure 6: Biomarkers in Drug Discovery, Global, Application of Biomarkers in Population Genetic Studies, 2009

Figure 7: Biomarkers in Drug Discovery, Global, Role of Biomarkers in Risk Assessment, 2009

Figure 8: Biomarkers in Drug Discovery, Global, Biomarkers Accelerate the Drug Discovery Process, 2009

Figure 9: Biomarkers in Drug Discovery, Global, Adoption of Biomarkers by Top Companies in Drug Discovery, 2009

Figure 10: Biomarkers in Drug Discovery, Global, Case Studies, 2009

Figure 11: Biomarkers in Drug Discovery, Global, Hepicidine Biomarker Case Study, 2009

Figure 12: Biomarkers in Drug Discovery, Global, Septin 9 Biomarker Case Study, 2009

Figure 13: Biomarkers in Drug Discovery, Global, PARP1 Gene Biomarker Case Study, 2009

Figure 14: Biomarkers in Drug Discovery, Global, Global Biomarkers Market Revenues ($bn), 2000-2015

Figure 15: Biomarkers in Drug Discovery, Global, Biomarker’s Drug Discovery Market Revenues ($bn), 2000-2015

Figure 16: Biomarkers in Drug Discovery, Historical Revenue, Biomarkers Molecular Diagnostics Market Revenue ($bn), 2000-2008

Figure 17: Biomarkers in Drug Discovery, Global, Others Market Revenues ($bn), 2000-2015

Figure 18: Biomarkers in Drug Discovery, Global, Global Biomarkers Market Segmentation, 2009

Figure 19: Biomarkers in Drug Discovery, Global, Market Drivers and Restrains, 2009

Figure 20:Biomarkers in Drug Discovery, Global, Integration of ‘Omics’ Drive Global Biomarker Market, 2009

Figure 21: Biomarkers in Drug Discovery, Global, Biomarkers Fulfill Unmet Needs of Conventional Drug Discovery Methods, 2009

Figure 22: Biomarkers in Drug Discovery, Global, Validated Biomarkers Applied by Pharmaceutical Companies in Drug Discovery, 2009

Figure 23: Biomarkers in Drug Discovery, Global, Biomarkers Technology Adoption Framework, 2009

Figure 24: Biomarkers in Drug Discovery, Global, Company Profile - Quest Diagnostics, 2009

Figure 25: Biomarkers in Drug Discovery, Global, Company Profile - Applied Biosystems, 2009

Figure 26: Biomarkers in Drug Discovery, Global, Company Profile - Vermillion, 2009

Figure 27: Biomarkers in Drug Discovery, Global, Company Profile- BGMedical, 2009

Figure 28: Biomarkers in Drug Discovery, Global, Company Profile - Menarini, 2009

Figure 29: Biomarkers in Drug Discovery, Global, Company Profile- Abbott, 2009

Figure 30: Biomarkers in Drug Discovery, Global, Company Profile-Roche, 2009

Figure 31: Biomarkers in Drug Discovery, Global, Company Profile-Genentech, 2009

Figure 32: Biomarkers in Drug Discovery, Global, Company Profile- Affymetrix, 2009

Figure 33: Biomarkers in Drug Discovery, Global, Company Profile- Amgen, 2009

Figure 34: Biomarkers in Drug Discovery, Global, Geographic Landscape-Global Biomarkers Market, 2009

Figure 35: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Phase, 2009

Figure 36: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Therapeutic Class, 2009

Figure 37: Biomarkers in Drug Discovery, Global, Pipeline Analysis by Geography, 2009

Figure 38: Biomarkers in Drug Discovery, Global, Global Biomarkers Market - Deal Analysis, 2009

Figure 39: Biomarkers in Drug Discovery, Global, Mergers and Acquisition by Year of Consolidation, 2009

Figure 40: Biomarkers in Drug Discovery, Global, Mergers and Acquisitions - Geographical Distribution, 2009

Figure 41: Biomarkers in Drug Discovery, Global, Mergers and Acquisitions - Deal Value ($m), 2009

Figure 42: GBI Research Methodology

Abstract

The scope of this report includes:
• Market Potential and Pipeline Analysis of biomarkers by phase of development, therapeutic class and geography.
• Market Size and forecast of global biomarkers market and biomarkers drug discovery market from 2000 to 2008, forecast forward to 2015.
• Analysis of Key geographies including the US (United States), Europe the UK (United Kingdom), France, Germany, Italy and Spain), Australia and Southeast Asia.
• Investments and Funding Analysis for top companies (Quest Diagnostics, Applied Biosystems, Vermillion, BGMedical, Menarini, Abbott, Roche, Genetech, Affymetrix and Amgen) in the biomarker-based assay development arena. This includes biomarker research on the application and development of novel biomarkers by the top companies and analysis of the competitive factors affecting the global biomarkers market.
• Qualitative analysis of market drivers, market trends, and challenges.
• M&A landscape in the biomarkers space segmented by deal value, geography and phase.

The report will improve decision making and will enable you to:
• Develop business strategies by understanding the trends and developments that are driving the biomarkers-based drug research and development.
• Design, develop and expand your product development, marketing and sales strategies based on forecast of global biomarkers and biomarkers drug discovery market till 2015
• Develop business strategies to exploit biomarkers-based drug discovery market in emerging geographies
• Identify the key players positioned to take advantage of the emerging market opportunities
• Exploit M&A opportunities by identifying key market players with the most novel pipeline

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