Abstract
The field of health-related new product development (NPD), in particular nutraceutical and functional foods (NFFs) is one of the most interesting areas of research and innovation, since variety of different products can be designed to enhance public health, reduce the probability of specific types of diseases, and even prevent and treat some illnesses (MarkHerbert, 2004; Menrad, 2003). Probiotics (friendly live microbs) present a rather young, but very versatile product group, that has been introduced into the international market as a part of the NFFs concept. NFFs emerged at the boundaries of the food and pharma industries, as a result, the position of the regulatory system within existing categories became vague and quite unclear (Arora, 2015). In this industry, there are rising concerns that the overly strict and outdated regulatory framework hampers innovation, and delays state of the art technology becoming available for consumers. Considering the economic, social and technological challenges in the probiotic industry, and a lack of studies on innovation in this industry, an in-depth understanding of the relevant regulation and its influence became the objective of the present study, which could be valuable for governments and policymakers, as well as to firms and other stakeholders. Thus, this thesis focuses on probiotics, marketed with health claims (HC), and is based on empiricall and quantitative secondary data covering the last 23 years. It aims to answer the following research question “What role has regulation played in shaping the market for probiotic applications in Europe and the U.S. since 2000?”. Probiotics industry is highly innovative industry and NPD represents a science-based innovation trajectory, carried out by a network of interrelated actors with various interests and perspectives. To guide the investigation, the National Innovation System Framework by Kuhlmann and Arnold (2001) will be adopted in this context. The academic literature view on the ultimate impact of regulation on innovation indicates that regulatory influence is a tradeoff between between innovation-inducing factors and innovation-constraining ones including compliance costs generated by regulation (Pelkmans et al., 2014). In order to study the main relationship and interactions between regulation and innovation, the conceptual model based on the BERR report (2008), further modified by Pelkmans & Renda in 2014 will be used. It shows that this relationship between regulation and innovation is complex, multi-dimensional, ambiguous and dynamic (BERR, 2008).
The academic literature suggests several regulatory mechanisms and dimensions to influence firms’ decisions to innovate: stringency, uncertainty, compliance cost, timing, information and flexibility. From the holistic examination of the probiotics innovation systems, the probiotic industry, the regulation, and the relationship between the regulation and innovation, the results show that the probiotic industry in the U.S. developed as a leader in development of supplements and therapeutic applications, such as LBPs and medical foods, while the probiotic industry in Europe developed as a lagger behind focusing mainly on functional foods and less on development of supplements and therapeutic applications. Hence, this dissertation identifies that the regulatory agencies, the level of stringency of the safety and health claim regulation, together with their views and the way of exercising their power determine the different direction of the probiotic innovation and product trajectory, of often same industry players on global level into contest the convergence of products and regulations to more pharmaceutical resemblance.
Educations | MSc in Business Administration and Bioentrepreneurship, (Graduate Programme) Final Thesis |
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Language | English |
Publication date | 2023 |
Number of pages | 111 |
Supervisors | Karin Hoisl |