August 3rd 2010
108
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Few would contest the need for pharmaceutical research to be productive. Despite significant increases in the cost of drug discovery and drug development, the number of new NCE and biological products reaching the market has not improved. A new way of conducting research has to be found and much hope and investment is being set by Biomarkers.
While Biomarker research is still in its infancy, great strides have been made in the discovery and utilisation of biomarkers in the development of targeted cancer therapeutics and companion diagnostics. Furthermore, there are still significant opportunities in other disease areas to improve productivity by identifying the most suitable developmental candidates earlier during the R&D process.
Stakeholder engagement is critical
All stakeholders have an important part to play. Regulators across the globe are in the process of establishing the necessary guidelines and framework in which to assess biomarker data. This in turn should encourage the pharma and diagnostic industries to adopt new technologies which will help to transform the drug and diagnostic development process to a “learn and confirm” model. The application of biomarker techniques will shift attrition rates to earlier in the R&D process, enable the reallocation of resources to high probability candidates and help with the development of diagnostics.
A maturing industry capable of providing real advances is emerging
Numerous companies and service providers are beginning to emerge which can provide the industry with a host of innovative bioinformatic, chemogenomic, genomic, glycoproteomic, metabolomic, peptidomic, pharmacogenomic, proteomic and transcriptomic technology platforms targeting biomarker discovery, development and qualification. Advances in these fields will continue to drive biomarker research forward increasing sample throughput, enhancing levels of detection and leading to the multiplex detection of multiple biomarker panels for use in preclinical research, the clinic and the commercialisation of diagnostics.
Biomarkers used in clinical trials set to take centre stage
Despite tough economic conditions, innovative companies continue to attract attention from the investment community – a balance between scientific, regulatory and financial resources will be critical for future growth.
The biomarker discovery segment is the largest revenue generator and accounted for nearly half of sales in 2009. Biomarkers for use in clinical trials, which currently account for a relatively small segment of sales are forecast to grow significantly by 2015 with a CAGR of 37.6%.
Whilst the return on investment is difficult to assess due to the immaturity of the market, key opinion leaders believe biomarkers hold great promise towards the development of a new generation of therapeutics and diagnostics which in the longer term can enhance the personalisation of medicine and help to alleviate the burden of healthcare across the globe.