The market for the tools and services in combinatorial chemistry and high-throughput screening approached $3 billion in 2003 (€2.43bn), but a new set of challenges is shifting customers' focus, according to a new study.
The new study - Early Stage Drug Discovery 2004: Combi-chem and HTS revisited - has found that areas such as information technology and newer methods of compound synthesis are showing the greatest potential growth. And in assay development, cell-based assays that emphasise so-called high-content screening and technologies that enable multiplexing are generating the most activity, says the publisher Kalorama.
"Five years ago, the emphasis was on bigger and faster," notes Jack Gardner, the author of the study's report. "The disappointing results of that approach have led developers to focus on quality rather than quantity. More information about fewer, more promising compounds is replacing the old HTS paradigm. Just one end-point from a chemical assay is not enough."
According to the study, although big capital expenditures in HTS and ultra HTS have flattened considerably, sales in certain niche areas are soaring.
Discovery-related information technology, for example, is showing approximately 20 per cent growth with certain subsegments such as in silico modeling leading the way with near 40 per cent growth. Other rapidly developing areas include microwave-assisted compound synthesis and chip/array instruments.
The driver for the change is the oft-reported decline in R&D productivity, which Kalorama attributes to a diminution in the number of 'low-hanging fruit' among validated drug targets, escalating clinical trial costs, an unpredictable regulatory environment and product liability concerns.
All these factors have led to company to estimate the costs of developing a successful drug - taking into account attrition rates - at a whopping $1.4 billion, well above the much used figure of $800 million determined by the Tufts Centre for the Study of Drug Development.
"The pressure is on: get better lead compounds faster and at less cost," according to the report. It notes that the amount of money wasted on leads that fail is excessive, and the attrition rate to get a lead is huge.
One estimate is that for every 10,000 compounds screened, about 250 makeit to preclinicals. But just 10 of these compounds make it into clinicals and only one gets through to market approval.
Overall, Kalorama estimates that Between 40 and 60 per cent of lead compounds fail ADMET (absorption, distribution, metabolism, excretion and toxicology) testing, and only 10 per cent of drugs that start clinical trials ever get approved. Overall, this means that 72 per cent of drug development costs are wasted on failures.
This has created a general theme in drug discovery to get much more information about drug compounds earlier in the process, to cut attrition rates by making compounds 'fail faster'. This involves much more use of computer modeling, high-content screening and miniaturised assays, it notes.
Meanwhile, big drug companies will increasingly outsource to specialist companies, and capital investment will continue to be flat for the next couple of years, as the big companies shift their funding into preclinical and clinical research to push compounds through the pipeline.