The potential of absorption, distribution, metabolism, elimination (ADME) or toxicity technologies is set to offer the promise of reducing attrition rates during clinical development - a cost that few pharmaceutical companies can ill afford.
Estimates have placed the price of failure at $50-$70 million with approximately 90 per cent of clinical candidates failing at development stage
As companies try to decrease costs by increasingly outsourcing drug development functions, failure rates become more controlled in-silico technologies become more widely adopted.
In addition, a better understanding of ADME/Tox and pharmacokinetic properties motivates the use of innovative solutions and early ADME/Tox screening, the European ADME/Tox technologies market will grow from its current size of $384.0 million to $776.0 million by 2011.
With an increasing number of multinational pharmaceutical and biotechnology companies adopting a 'fail early, fail cheaply' approach, the early introduction of ADME/Tox technologies now offer the promise of reducing attrition rates during clinical development.
Thus, the trend has been to introduce ADME/Tox screens as early as possible in the drug discovery process. Already, innovative technologies and solutions are facilitating ADME/Tox optimisation earlier in the drug discovery pipeline.
"The ADME/Tox technology market is highly competitive and profitable, however, the market also has tendencies to be unstable at times," said Frost & Sullivan healthcare analyst, Amarpreet Dhiman.
"It is becoming increasingly clear that the ability to detect issues with pharmacokinetics before the drug moves into clinical testing will ultimately save considerable resources in time and money for pharmaceutical and biotechnology companies," she added.
ADME/Tox tests have traditionally been associated with the later stages (and thus higher risk) stages of drug development. However, with the number of drug targets as well as the volume of assay points performed in high-throughput screens rapidly expanding, it has become vital to rapidly and efficiently triage 'potential hits,' having significant ADME and toxicity profiles.
One consequence that has arisen from the ADME/Tox revolution is the mass of data generated, which needs to be analysed and interpreted. The report was quick to acknowledge the design of advanced software with the ability to distil compound leads with promising drug development potential, as well as predict biological properties currently in use. Complete solutions that include tools are also poised to amplify their presence within the ADME/Tox tools market.
The report highlights the use of in-silico techniques where complex and accurate models for rationalising and predicting ADME properties are allowing enhanced prediction of complex systems (for hepatoxicity and cardiotoxicity).
The report predicted that these computational technologies and predictive solutions were likely to enhance the scope and speed at which drugs develop from a research to clinical stage.
At the same time, however, in order for ADME/Tox studies to be truly beneficial, data generation needs to be of high quality, reliable and accurate.
"The key would be to develop tools that facilitate data consolidation and information sharing," said Dhiman.
"Standardised systems and solutions that integrate data from numerous tools and experiments need to be developed while manufacturers should develop opportunities to offer services in data management, training, tool maintenance and others, functioning as both a service providers and product developers," she added.
Currently, ADME/Tox services comprise the largest market segment in Europe for ADME/Tox technologies, accounting for nearly three-fourths of overall market revenues. It is followed by ADME /Tox tools (including systems & consumables) and in-silico ADME /Tox.
One key global trend is likely to be the rising uptake of in-vitro screening technologies (for screening toxic compounds). A stream of novel compounds moving through the clinical process is likely to support the rapid development of assays for ADME/Tox properties, creating, in turn, significant long-term market growth opportunity for in-vitro screening technologies.
The report: "Strategic Analysis of the ADME/Tox Technologies Markets in Europe," is published by market researchers Frost and Sullivan and is available from the company's website.