Histotechnology is the preparation of tissues and generation of slides which are stained and evaluated under a microscope in order to study the shape and distribution of cells to determine the critical endpoint of regulatory toxicology studies.
Dr. Jürgen Laufs, Project Manager at Swiss Contract Research Organisation (CRO) Anapath, told Outsourcing-Pharma.com “it is the result of the histopathological evaluation of the pre-clinical study which sets the judgement at which dosage a drug being tested has a toxic effect. In turn the preclinical effect of the drug defines the starting dose for the clinic.”
Demand for such services is increasing, he continued, and Anapath has already seen a strong start for 2016 after reporting a 35% increase in order volume year-on-year for processing tissues to slides in 2015.
Demand is coming directly from pharma firms looking to move their studies faster into clinical trials, Laufs said.
However, while generally the slide generation (histotechnology) is done by the CRO which does the animal study Anapath has also seen a growing client base made up of other preclinical CROs subcontracting the service due to their own lack of capacity.
“We know that the internal capacity in the histotechnology department of certain CROs cannot keep in line with the demand. It is getting too much.”
Part of the issue he said is the trend of consolidation in the industry, with mid-sized CROs being swallowed up by larger preclinical CROs. For example, Charles River Laboratories recently acquired WIL Research, and Huntingdon Life Sciences bought Harlan Laboratories in 2014.
“Consolidation wipes out mid-sized companies leaving a service desert behind,” Laufs said, though “young small and specialized CRO’s have their chance to jump in and fill the space.”