Global ADME – Toxicology Testing Market Update

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Issues with toxicity remain one of the key reasons why promising drug candidates fail to make it beyond the lab – at a cost to both the company and ultimately the patient.

Introducing toxicology screening earlier in the drug development process appears to be a strong investment when the new drug development costs of $1 billion (£624 million) are taken into account.

A number of industry factors are also combining to give companies an added imperative to develop successful drug candidates. The patent cliff is looming ever closer on the horizon as the era of blockbuster drugs come to an end and the costs associated with regulatory compliance are on the rise.

By 2017, the global ADME toxicology testing market is expected to exceed $10 billion, with the United States market for In-Vivo Toxicology testing alone expected to hit $1 billion by 2015, according to a report from Global Industry Analysts (GIA).

"The increasing number of drug targets and volume of assay points in drug discovery process are necessitating the need for identifying and eliminating potential hits with high ADME and toxicity profiles," the report added.

As more companies step up their investment in toxicology testing, techniques are developing accordingly.

The Hamner Institutes for Health Sciencesand PBM Capital Grouprecently announced the launch of a new joint venture in predictive toxicology testing to offer greater insurance to biopharma companies.

Ivin Silver, Ph.D., formerly director of DMPK (Drug Metabolism and Pharmacokinetics) at GlaxoSmithKline, and Shiloh Barfield, formerly vice president of sales and marketing for the CellzDirect Inc, are to lead the new venture, which they believe can potentially save the pharmaceutical industry billions of dollars.

GIA's report sees silico predictive testing growing at a significant rate, thanks to its ability to reduce the costs associated with poor ADME toxicology being identified when it has already travelled along the drug pipeline.

At the same time, the use of computer modelling in the field is predicted to rise because of the significant benefits in high throughput screening. Analysis of transporter proteins is set to increase thanks to both the major role played by drug transporters and the chances of such analysis forming part of regulatory applications for new drugs.

"Cell-based assays are expected to emerge as a vital technology in in-vitro test methods in toxicity testing, given their role either as a part of a tiered testing scheme or as test batteries in predicting human toxicity endpoints," the report added.

Toxicology testing has even taken on a new national importance in the United States, with the announcement by President Barack Obama that the National Institutes of Health (NIH) and the Defense Advanced Research Projects Agency are to collaborate on the development of a new chip to determine the toxicity of compounds both more quickly and efficiently than current methods.

The chip will be preloaded with cell types designed to reflect human biology and will be able to provide a number of different readouts regarding the safety of a compound.

Francis S Collins, M.D., Ph.D., NIH director, said: "Drug toxicity is one of the most common reasons why promising compounds fail.

 "We need to know which ones are safe and effective much earlier on in the process. This is an unprecedented opportunity to speed development of effective therapies, while saving time and money."

Looking ahead, the United States is expected to retain its dominant position within the toxicology testing market, although as with many areas of the pharmaceutical industry, the greatest levels of growth are expected to be seen in Asia Pacific.

Contract research organisations are expected to be the other big winners as the market continues to grow, although in the longer term, if all goes to plan, the entire industry and those it serves should be reaping the benefits.

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