Pharma adopts wait-and-see stance on toxicogenomics
strongly over the next five years, but needs the catalyst of
recognition by regulatory authorities.
Pharmaceutical and biotechnology companies are continually striving to identify toxicity in new drug candidates earlier in development, but so far have held back from a wholesale adoption of toxicogenomics, i.e. the study of how an individual's gene and protein expression profiles alters in response to exposure to toxic substances.
The hope is that toxicogenomics will allow researchers to screen their candidate drugs to see if they stimulate the expression of genes that are associated with toxicity. However, a new report from Front Line Strategic Consulting suggests that companies are waiting for the US Food and Drug Administration (FDA) to recognise the technology before implementing it into their drug discovery processes.
The compound annual growth rate (CAGR) of the overall toxicogenomics market will be 15 per cent over the next five years, rising from an estimated value of $120 million (€104m) in 2003 to $245 million in 2008.
The gene expression based toxicology and toxicoinformatics segments dominate the market at present with an 89 per cent combined share, but toxicoproteomics, projected to grow at a CAGR of 23 per cent, will account for 15 per cent of the toxicogenomics market by 2008.
"The toxicoproteomics market is the only segment that will gain market share by 2008, as the focus of research groups shifts from genomic to proteomic studies and the existing proteomic technologies make improvements in reproducibility and accuracy of data, as well as flexibility of platforms," according to Front Line. The report suggests that this market will be worth around $40 million in 2008.
Growth in the overall toxicogenomics market will be driven by the adoption of large-scale research processes - including high-throughput screening - in the pharma and biotech industries, the acceptance of microarray technologies by regulatory bodies around the world and standardisation of array-based research and database annotations.
"With the vast amount of data resulting from high-throughputmicroarray experiments, the scientific community is working tocreate a single protocol to conduct studies and annotate results," according to Front Line.
Nevertheless, the report also notes that the toxicogenomics market is maturing with the release of a number of new tools. These include Agilent Technologies' Mouse and Rat Oligo Microarray kits, Affymetrix' GeneChip Rat Toxicology U34 array and BD Clontech's Atlas Nylon Human, Rat and Mouse Toxicology 1.2 Arrays.
In addition, emerging toxicoinformatics databases, such as Genedata's Expressionist System and PHASE-1 Molecular Toxicology's ToxHunter database suite, will help drive the market in the future, notes Front Line.
However, a number of obstacles to widespread adoption of the technologies still remain, including poor reliability of the data at present (especially for gene-expression based toxicology and toxicoproteomics), the high cost of the available tools and complicated software packages.
For further information about the report, contact the publisher.
