- 産業学会研究年報 (ISSN:09187162)
- vol.2015, no.30, pp.95-111, 2015 (Released:2016-04-01)
In recent years, particularly since the first decade of the 21st century, the movement toward restructuring of production systems in the Japanese pharmaceutical industry has become more energetic. Focusing on production sections in the pharmaceutical industry, this paper examines the actual facts of the transformations that have occurred in recent years. It also shows that these transformations in production systems resulted from the following five factors arising in parallel or interacting with each other: The first is restructuring and consolidation to eliminate overlapping functions and excess facilities in connection with mergers and acquisitions, which have seen increased activity recently. The second is the expansion and intensification of overseas production facilities as a result of the progress of globalization. The third consists of the expansion of outsourcing of production by major pharmaceutical firms and the consolidation of their production facilities, as well as the rise of contract manufacturing organizations (CMOs) and enhancements to their production capacities, all resulting from the deregulation of contract manufacturing due to the 2005 amendments to the Pharmaceutical Affairs Law. The fourth is the enhancement of production capacity among generic drug companies in response to the growth of the generic drug market, through construction of their own new plants and expansion of existing ones or acquisition of production facilities from other companies. The fifth is the establishment of production facilities for biopharmaceuticals by existing pharmaceutical companies and new non-pharmaceutical entrants, accompanying the growth of the biopharmaceutical market.