Abstract

Many structural factors may influence the choice of the value chain's governance in a specific industry and push towards the change of the dominant model. Among the others, change in risk/rewards structure arising from new technology's development may play an important role in the choice of a more decentralized approach of the R&D process. This move can be seen as an entrepreneurial opportunity for some specific kind of new entrepreneurial venture. Life Science Industry (LSI) is a very interesting field to analyze such dynamics: companies have changed their R&D processes model from a vertically integrated activity to a more decentralized one. As a result the Contract Research Organization (CRO) industry emerged along the time. The aim of the study was to better understand the role of CROs into the innovation system of the Life Science Industry. This work investigated the business models adopted by CROs and a first profile of the Italian CROs could be sketched in the new open biopharmaceutical system. CROs resulted to cover many important market segments in the value chain of the drug development process, with a wide range of services from the applied research, in the early phase of development of a new drug, to the marketing activities in the latest phase. It was interesting to find out through this analysis that CROs over time developed different business modes to meet the needs of all their clients, while preserving the core value of efficiency and innovation.