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

GBI Research
November 9, 2012
87 Pages - SKU: XGBR4910241


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

Summary

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, primary and secondary research and in-house analysis by GBI Research’s 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 research by understanding the market dynamics for the biomarker drug discovery industry.
  • Develop market entry and market expansion strategies by identifying the key areas for high growth and opportunities.
  • Understand the factors shaping the biomarkers drug discovery market.
  • Reinforce the R&D pipeline by identifying the key biomarker tests that can provide more accurate and early diagnosis of diseases.
  • Exploit partnership and acquisition opportunities by identifying the products that could fill the portfolio gaps.


Additional Information

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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