Vaccine development from a commercial point of view.

The development of a commercial vaccine comprises distinct stages. Initiation of a research project is triggered by demands from the market. If commercial and technical requirements are met, a feasibility study is carried out. Research is started, and aimed at formulating the product profile (what the product looks like). The product profile is subject to requirements set by the market (e.g. whether the product will fit into existing vaccination schedules) and very often technical aspects affect the product profile (e.g. whether the freeze-dried product is easy to reconstitute). Only after a cost-profit analysis is positive, the development phase is entered. During this phase, experiments are carried out to obtain registration. After the product has been registered it is ready for production and marketing. Only few vaccines for hemoparasitic diseases have reached the market. These comprise: attenuated parasites (Toxoplasma gondii, Eimeria species); killed vaccines (Anaplasma marginale) and subunit vaccines (Babesia canis). Factors relating to the product potential of these vaccines are discussed.