In the next 2-5 years, large pharmaceutical companies plan to increase outsourcing of preclinical work, with emphasis on Discovery and non-GLP Toxicology. This trend is driven by the reductions in internal preclinical capability within Big Pharma. In an apparent reversal of the current trend towards use of a limited number of preferred providers, capacity will necessitate increasing the number of contract research organizations (CRO) involved. An offshore trend is anticipated despite the rapidly narrowing price differentials between Chinese and Western CROs for nonclinical work. A survey suggested that the offshore CROs best positioned to secure the early-stage drug development business from large pharmaceutical companies are Covance, WuXi, BioDuro, and ShangPharma. As an example, ShangPharma recently opened a new facility to accommodate a multi-year contract with Eli Lilly, with emphasis on in vivo pharmacology, oncology, and metabolic disease work.
Contract Research Organization (CRO)
Growth in demand for nonclinical toxicology services will be weak for the foreseeable future analysts said after the Society of Toxicology (SOT) annual meeting in San Francisco this past week. “Most agree that the industry is not merely going through a prolonged cyclical slowdown, but has also structurally changed, with less of an emphasis by clients on maximizing the number of drug candidates flowing into preclinical testing,” stated John Kreger, equity analyst at William Blair. In addition, chronic toxicity testing is being delayed until the later stages of compound development; this reduces preclinical development costs for compounds that fail. Among other factors, this has led to excess capacity at contract research organizations (CRO), price restrictions, and site closures. Tim Evans, senior analyst at Wells Fargo, expects the overall nonclinical toxicology market to grow by 2% in 2012 due to higher outsourcing penetration. In their selection of preferred service providers, global bio/pharmaceutical companies generally favor large CROs with broad capabilities. These “strategic partnership” deals, which are the cornerstones of global bio/pharmaceutical companies’ current outsourcing strategies, seek to leverage their massive buying power, reduce the cost of overhead, and improve coordination with the CRO. Sourcing models will continue to evolve, however, and will eventually threaten the business model upon which the recent megadeals are based.
On a related note due in part to ongoing capacity cuts, large pharmaceutical companies are seeking co-development deals with CROs and biotechnology firms to handle excess intellectual property. Shared risk and reward features are found in some of the more creative models. CROs that have made major acquisitions in order to leverage capacity, however, could be outmaneuvered by evolving sourcing models.