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This article follows the evolution of the regenerative medicine industry in the UK and Japan. It builds upon business history scholarship on therapeutics and addresses the growing body of work in the fields of comparative business systems and comparative institutional analysis, in which frequent associations are made between specific institutional environments and innovative competences. To focus on firms’ abilities to engage in novel product innovation, the article examines the evolution of an industry at the technological frontier. The article follows the emergence of the regenerative medicines industry in Japan and the UK, across key institutional spheres: intra-firm relations; the financial system; the research and training system; and the role of the state. The evolutionary perspective demonstrates considerably different paths in pioneering an industry at the technological frontier. The article also considers the role of institutional legacies in shaping new industries, and the association between certain institutional environments and innovative competences.