U.S. ADME/Tox in Drug Development Markets

Research Overview

Complexity of ADME/Tox Restrains Greater Uptake of the Solution

One of the main market challenges is the lack of a technology that is truly reliable for absorption, distribution, metabolism, excretion, and toxicology (ADME/Tox) prediction, despite customers using many technologies simultaneously. Although the business aspect will require market participants to adopt a risk analysis approach, the technical and scientific limitations are likely to impose constraints.

This Frost & Sullivan research service provides an overview of the U.S. ADME/Tox markets. The study has been divided into in vitro, in vivo, and in silico ADME/Tox segments. The research service provides industry challenges to both vendors and consumers as well as offers a SWOT analysis of market dynamics for each market segment. The study enables companies to align their positioning strategies to benefit from the changing markets and obtain maximum return on investment.

Disruptive, Novel Technologies to Find Significant Market Uptake

Although new approaches can generate a spurt in revenue, they could also attract away other parts of the market. For instance, developing newer methods for multiplexing or reducing the number of animals per analysis could help generate more insights or complementary information, possibly at an earlier stage.

"However, it is difficult for novel technologies to break into the in vivo market, because the customers are doing their best to preserve the status quo," states the analyst of the research. "Every assurance by vendors to customers needs to be brought to bear, showing that trends are moving toward widespread acceptance of such technologies, beyond the proof of concept."

Predictive Value of Certain Technologies Needs to Be Proven

Market participants have to sort out another issue of the exact correlation of some methods on humans. Although the processes may closely replicate the respective systems during tests, allowances should be made for complications that might arise in the actual implementation on humans. For example, the range of pH or other environmental conditions is likely to complicate even simple measurements such as solubility, which are necessary for accurate predictions.

Over time, this may result in a shakeout in terms of the technologies that are widely viewed as having predictive value," notes the analyst. "This would result in regulatory guidance or action, and some methods may become obsolete."