This article examines how variations in cross-border coordination pressures resulted in a divergence of regulatory categories and sectoral trajectories in the field of regenerative medicine in the UK and Japan. In the UK/EU, the pressures for coordination across member states led to the formation of precise, attribute-based categories. In Japan, the comparative lack of such pressures between actors within a shared context allowed for the formation of more context-specific, goal-based categories that flexibly accommodated domestic interests.
Existing scholarship has shown how regulatory categorization unfolds as a highly politicized, multiplayer contest between regulators, firms and other category audiences (Ozcan and Gurses, 2018; Manjunath and Bhuwania, 2022). Indeed, through a range of case studies, prior research has shown how firms have strategically influenced regulatory categories to their advantage, whether by altering category meaning (Buchter, 2023) or engaging in regulatory arbitrage (Holden et al., 2020). A number of recent studies have also captured the historical contingencies of regulatory categorization (Klopf et al., 2024), illuminating the temporal and institutional specificities that can lead to different categorizations (Tharchen and Garud 2022). Such focus on regulatory categorization is important, as these categories determine the viability of firms (Ozcan and Gurses, 2018).
Indeed, the divergent regulatory categories in the UK and Japan shaped sectoral trajectories in each setting. For instance, many British firms distanced themselves from developing tissue engineering products, which, categorized as advanced therapies, were unlikely to become profitable. In Japan, academia and industry actors collectively sought to develop a “regenerative medicine” industry – which included tissue engineering firms. Following each of these settings, the article illustrates how coordination pressures between actors shaped regulatory categorization, which in turn, shaped dissonant pathways of development in an emergent field.