The Veterinary Contract Research Organisations (CRO) phenomenon began during the second half of the last century. In this article we will take a look at their development into becoming an integral component of pharmaceutical, feed additive and diagnostics development. A CRO is defined by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) in GL9 (VICH, 2000) as “an individual or organisation contracted by the sponsor or investigator to perform one or more of the obligations of the sponsor or investigator”. Although this guideline is restricted to Good Clinical Practice, nonetheless, the definition is useful throughout industry.
Veterinary CROs, independent of universities and pharmaceutical companies, originated to service a commercial need arising with veterinary pharmaceutical companies where R&D facilities within those companies were either over committed or did not exist in house. Outsourcing of R&D components of product development offered veterinary pharmaceutical companies flexibility in both resource allocation and risk management. It also provided a means of reducing the substantial overhead cost of an in-house physical facility with accompanying specialised staff.
Origins
Whilst veterinary CROs were generally originally small businesses, they originated in several different ways (Figure 1). Vetspin is an example of a CRO that originated as a spin out from a university, in this case the University of Bologna, Italy, some 20 years ago. Ridgeway Research Ltd (RRL) began as an overflow facility for Pfizer when its United Kingdom (UK) base was located in Sandwich, Kent, where since 1954 it had developed both human and veterinary pharmaceuticals. NorthWest Biopharm (NWB) represents a start-up CRO established in the Republic of Ireland by personnel with industry and regulatory experience in 2012. Each of these CROs has a physical site which enables studies to be conducted under controlled conditions.
Other CROs, notably Klifovet which was established in 1997 in Germany, did not have its own physical site to conduct animal studies and instead focused on coordinating clinical studies across a number of other sites.
Changing Landscapes
Since their inception, CROs have grown against a backdrop of pharmaceutical and feed additive companies choosing to outsource components of their R&D projects. Meanwhile, the outsourcing companies have not remained static, national companies have been acquired by multinationals and, in turn, multinationals have taken over other multinationals. Standalone animal health companies have been spun out from their original parent human/animal health companies. Hence CROs have had the challenge of developing relationships with a changing customer base.
The CRO development timeline is overlaid by radical changes in the animal populations that are the eventual targets for animal medicines and feed additives. For example, in the UK, the dog and cat populations have approximately doubled since the 1980s (PFMA, 2024), whilst the UK cattle population, including both milking and beef animals, has reduced by approximately two thirds (Table 1). Over the same time, whilst red meat consumption has decreased, chicken consumption has increased, with UK broiler production more than doubling to 1113.3 million birds by 2023 from 439.3 million birds in 1982. In contrast, the layer population has stayed relatively constant (UK government, 2024).