An interdisciplinary analysis of genetically modified vaccines: from clinical trials to market

Abstract

Background: Immunization is considered the most effective strategy for infectious disease control and maintaining global health. Conventional vaccines have successfully targeted a broad spectrum of pathogens. However, a large number of untargeted diseases still remain. Introduction of novel Genetically Modified (GM) vaccines allow development of new improved vaccines and immunotherapeutics. Moreover, GM vaccines can also target non-communicable diseases outside the range of infectious diseases, including cancer, autoimmune diseases, and allergies. Methods: We compiled novel and unique datasets encompassing data from literature, patent documents, clinical trials, and vaccine registers in order to provide a thorough overview of the GM market. Results: Based on patent data, we found that most patent applications were filed in North America, Asia, and Europe, which coincides with the locations of the largest companies and institutes. Looking at clinical trial data we forecast marketing of two next generation GM vaccines, targeting cancer and malaria. In addition, we calculated phase transition success rates of 82% (phase 1-2) and 76% (phase 2-3). Conclusions: These findings indicate viable regions for GM vaccine research and development. Phase transition success rates of 82% (phase 1-2) and 76% (phase 2-3) predict a relatively high chance of marketing approval. Increased registrations of GM vaccines complemented by rising numbers of patent applications suggest global growth of the GM vaccine market, which currently holds a proportion of nearly 20% of the total vaccine market.