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

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

Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes - GBI Research Reports
Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes
Published Nov 09, 2012
87 pages — Published Nov 09, 2012
Price US$ 3,500.00  |  Buy this Report Now

About This Report

  
Abstract:

Summary

GBI Researchs 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, primary and secondary research and in-house analysis by GBI Researchs team of industry experts.

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

- An overview of biomarkers in the drug discovery process along with their use, efficiency and limitations.
- 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 better strategies for biomarkers rese

  
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Document ID
GBIHC257MR
Industry
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Sections

TitleStarting PageNumber of Pages
Table of Contents55
  List of Tables81
  List of Figures91
Biomarkers in Drug Discovery - Introduction101
  Introduction101
Biomarkers in Drug Discovery - Overview118
  History of Biomarkers112
  Biomarkers Cater to the Unmet Needs in Drug Discovery131
    High Attrition Rates141
    High Drug Discovery Cost151
    Time Consuming151
    Safety and Efficacy151
    Invasiveness, Selectivity and Sensitivity151
  Biomarker Discovery and the Validation Process161
    Discovery161
    Development171
      Reproduction and Assay171
      Verification171
      Assay Development171
      Preclinical and Clinical Development171
    Launch171
      Regulatory Submission and Market Planning172
Biomarkers in Drug Discovery - Market Characterization196
  Market Size and Forecasts191
  Global Biomarkers Market Geographic Landscape201
    Introduction201
    North America201
    Europe201
    Asia211
    Row211
  Drivers and Barriers211
    Drivers for the Global Biomarkers Market221
      Time and Cost-Saving221
      Better Regulatory Norms and Validation Procedures221
      Extensive Range of Applications in Different Industrial Sectors221
      Integration of Omics Increases the Scope of Application for Biomarkers in Other Technologies231
      Advantageous Over Conventional Drug Discovery Methods241
    Barriers for the Global Biomarkers Market241
      Lack of Awareness about Intelligent and Novel Technological Advances241
      Complex Biomarker-based Techniques May Lead to False Positive Results Misleading the Clinical Trials241
      Funding Organizations Require Strong Clinical Data and Validation241
      Cumbersome and Lengthy Development241
Biomarkers in Drug Discovery - Time Trends255
  Historic Trend251
    Predictions Based on Biomarkers251
    Validation Versus Qualification251
    Lack of Synergy between Mechanism and Pattern251
    Regulatory Approval of Biomarkers261
    Difference in Regulation of Single Biomarkers and Panel of Biomarkers261
    Measures of Success261
  Future Trend Growing Demand for Personalized Medicine271
    Companion Diagnostics Market271
    Drivers and Barriers for Companion Diagnostics Market281
    Regulations of Companion Diagnostics EU281
    Regulations of Companion Diagnostics US291
Biomarkers in Drug Discovery - Technologies Used for Biomarker Discovery306
  Role of Imaging as a Predictive Biomarker302
  Biomarker Discovery Using Proteomics via Mass Spectrometry322
  High-Throughput Proteome Screening for Biomarker Detection342
Biomarkers in Drug Discovery - How Biomarker Development Relates to Drug Discovery3613
  Application of Biomarkers in Drug Discovery362
    Lead Identification and Optimization381
    Potential Role of Biomarkers in Lead Identification and Optimization391
    Target Validation391
    Toxicological Assay (Preclinical and Clinical)391
    Mechanism of Action401
    Monitor Therapy and Dose Response401
    Stratify Patient Population401
    Filing and Post-Marketing Surveillance411
  Benefits of Biomarker Utilization411
    Disease Understanding411
    Project Prioritization through Early Attrition411
    Streamlining Clinical Trials411
    Reducing Cost of Drug Development421
    Expediting Drug Development421
    Avoiding Adverse Drug Reactions and Rationalizing Dosing Regimen421
    Drug Repositioning421
  Challenges in Biomarker Utilization421
    Variability421
    Validity431
    Measurement Errors431
      Bias431
      Confounding431
      Cost431
      Acceptability431
  Biomarker Classification441
    Biomarker Categories451
    Types of Biomarkers451
      Type 0 Markers451
      Type I Marker461
      Type II Biomarker461
    Reasons for Surrogate Endpoint Failure 472
Biomarkers in Drug Discovery - Integration of Biomarkers in Different Phases of Drug Development494
  Discovery501
    Predictive Safety Biomarkers501
    Mechanism of Action Markers501
  Preclinical Development501
    Prognostic and Epidemiological Biomarkers501
    Diagnostic Biomarkers511
  Clinical Development521
    Disease Progression Markers or Response to Therapy Markers521
    Surrogate Biomarkers521
Biomarkers in Drug Discovery - Case Study536
  Role of HER2 Gene in Herceptin Development for Breast Cancer531
    Activation of Antibody-Dependent Cellular Cytotoxicity531
    Prevention of the Formation of p95HER2531
    Inhibition of HER2-activated Cell Proliferation541
    Inhibition of HER2-regulated Angiogenesis541
    Herceptin Side Effects552
  Role of BCR-ABL Fusion Protein in Development of Gleevec for Chronic Myelogenous Leukemia572
Biomarkers in Drug Discovery - Regulatory Trends597
  Regulatory Landscape591
    Investigative/Exploratory Biomarker591
    Probable Valid Biomarker591
    Known Valid Biomarker591
    Letter Of Intent to Propose Biomarker Qualification591
      Administrative Structure591
      Biomarker Qualification Overview591
      Overall Summaries of the Following (as appropriate)591
      Questions for the FDA591
    Structure of Biomarker Qualification Briefing Document602
  Validated Biomarker623
  Regulatory Acceptance of Valid Biomarkers651
  Regulatory Guidance from the FDA, EMA and MHLW651
Biomarkers in Drug Discovery - Promising Biomarkers669
  Biomarkers for Alzheimer s Disease661
    Imaging Biomarkers661
      Magnetic Resonance Imaging661
      Positron Emission Tomography Scans661
    Fluid Biomarkers671
      Cerebrospinal Fluid Biomarkers671
      Plasma Biomarkers671
  Biomarkers for Cancer672
    Insulin-like Growth Factor 1 and 2691
    OVA1691
    Risk of Ovarian Malignancy Algorithm691
    Serum Markers691
      Micro RNAs691
  Biomarkers for Multiple Sclerosis701
    Serum Marker: Brain-Derived Neurotrophic Factor701
    Cerebrospinal Fluid Markers701
    Imaging Marker711
  Biomarkers for Rheumatoid Arthritis711
    Micro RNAs711
    Autoantibodies721
      Rheumatoid Factor721
      Antibodies against Cyclic Citrullinated Peptide721
    Inflammatory Markers721
      Erythrocyte Sedimentation Rate721
      C-Reactive Protein721
  Biomarkers for Hepatitis C731
    Serum Markers731
    Imaging Markers731
    Non-Structural 5A Protein741
    Micro RNA-22741
Biomarkers in Drug Discovery - Strategic Consolidations756
  M&A Deals751
    Micromedic Buys 33% Stake in BioMarCare for $1m751
    ValiRx Plc Acquires Pharmatest s Biomarkers Business Unit751
    David H. Murdock Research Institute Acquires the Immune Tolerance Institute761
    Health Diagnostic Laboratory Acquires Harris Scientific761
    Myriad Genetics Acquires Rules-based Medicine761
  Licensing Agreements771
    SomaLogic Enters into Licensing Agreement with AmberGen771
    Advion BioServices Enters into Licensing Agreement with SISCAPA Assay Services771
    AVEO Pharmaceuticals Enters into Licensing Agreement with Centocor Ortho Biotech781
    KineMed Extends Licensing Agreement with Bristol-Myers Squibb781
  Partnership Deals791
    KineMed Enters Multi-year Agreement with GlaxoSmithKline to Develop Kinetic Biomarkers801
    Affymetrix and Massachusetts General Hospital Seal Deal to Develop Cancer Biomarker Diagnostics801
    Genedata and Roche Extend Collaboration of Biomarker Discovery801
    Isogen Life Science Enters into Co-Marketing Agreement with Axela for Biomarker Analysis Platforms801
Biomarkers in Drug Discovery - Appendix817
  Market Definitions811
  Abbreviations812
  Bibliography833
  Research Methodology862
    Coverage861
    Secondary Research861
    Primary Research861
    Expert Panel Validation871
  Contact Us871
  Disclaimer871

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Cite this Report

  
MLA:
GBI Research Reports. "Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes" Nov 09, 2012. Alacra Store. May 04, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Biomarkers-in-Drug-Discovery-Integration-in-Early-Stage-Promotes-Use-of-Companion-Diagnostics-to-Optimize-Therapeutic-Outcomes-2115-530>
  
APA:
GBI Research Reports. (2012). Biomarkers in Drug Discovery - Integration in Early Stage Promotes Use of Companion Diagnostics to Optimize Therapeutic Outcomes Nov 09, 2012. New York, NY: Alacra Store. Retrieved May 04, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Biomarkers-in-Drug-Discovery-Integration-in-Early-Stage-Promotes-Use-of-Companion-Diagnostics-to-Optimize-Therapeutic-Outcomes-2115-530>
  
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