Biomarker-based tests have been in existence for over a few decades now but their relevance to drug development and diagnostics applications in particular has gained momentum only recently. This is apparent from the increased research interest, and patent and regulatory activity with regards to biomarkers.
Biomarker discovery has been a major by-product of genomic sequencing since the completion of the Human Genome Project. The recent modernization in the molecular profiling techniques has moved biomarker discovery to the front-line of medical research. We were also interested in analyzing the impact of the various omics technologies on molecular biomarker identification.
The compelling need for classifying molecular markers based on the understanding of disease mechanisms has received immense emphasis owing to the significant challenges encumbering the drug development pipeline. It has been recognized that integration of biomarkers through the different phases of drug development can yield safer drugs with enhanced therapeutic efficacy in a cost-effective manner. Hence, we were interested in examining the role of biomarkers in early-stage drug discovery, preclinical studies and late-stage clinical trials of drug development. In order to confidently use biomarkers to assess the biological end-point of a target therapy, clinical validation of the marker is critical before using them on the candidate compounds.
We were also interested in gaining insight on biomarker validation from a regulatory perspective. Biomarkers have been playing a significant role in molecular diagnostics as well, and we analyzed the potential of these biomarkers to address unmet needs in different facets of disease management. These include disease screening and predisposition, monitoring disease progression and predicting therapeutic response.
The confluence of therapeutics and diagnostics known as theranostics is emerging and is expected to influence the use of molecular biomarkers in personalized medicine. We were particularly interested in identifying the advances in pharmacogenomic testing and examined their emerging potential as companion diagnostics to targeted therapies.
This report contains:
- Descriptions of various types of biomarkers including genomics, proteomics, bioformatics and metabolomics
- The current market status of biomarkers, trends, and forecasts for growth over the next 5 years
- Technological issues including the latest trends and findings in different therapeutic research areas
- An examination of the regulatory role of different federal agencies in U.S., Europe and the rest of the world that play an active role in biomarker discovery research
- Analysis of the biomarkers industry on a global basis, both from a market and application perspective.
BCC's methodology for market analysis and forecast projections made in the report encompassed primary and secondary data sources and calculations. Based on interaction with industry stakeholders and experts, we analyzed the potential of the omics technologies for biomarker discovery, disease-related biomarkers, validated biomarker applications in clinical trials and molecular diagnostics. Revenue projections for the aforementioned segments were developed and corroborated through primary interviews with respondents from participating organizations.
BCC interacted with over 68 biomarker discovery platform, pharmaceutical and diagnostics companies to obtain data for this study. In addition, data was also compiled from government and other public research data sources.
Vanita Khetan is an entrepreneur and market analyst. She holds a bachelors degree in Chemistry and a Post Graduate degree in management. During the course of her career, she has analyzed U.S., European and Asian markets in biotechnology, pharmaceuticals, medical devices, wound care and surgical goods.
Report Code: BIO061A, Published: November 2007, Analyst: Vanita Khetan
