ABSTRACT

Skyrocketing interest in probiotics and dietary supplements is evidenced in increasingly aging population and their eagerness to ensure continuing tness and good health as long as possible. In addition, there has been wide coverage in the media in the recent years about the expiry of patents owned by the big pharma and companies’ quests to expand their product pipeline by obtaining licenses in new biotech products. Some are now looking to extend their product range outside drugs with big and specialty pharmaceutical companies starting to expand into the

Introduction ............................................................................................................ 183 What Are Probiotics? ............................................................................................. 184 Mechanisms of Action ........................................................................................... 184 From Clinic to Market: The Regulatory Hurdle .................................................... 185 The Application of Probiotics in Food Products .................................................... 188 Safety of Probiotics ................................................................................................ 188 What Is Next? ........................................................................................................ 189 Conclusion ............................................................................................................. 190 References .............................................................................................................. 191

probiotic eld. As a result, this is becoming a growth market. Increased activity in this area has included, for example, Nestlé’s €50 million investment in Swedish probiotic player BioGaia, Pzer’s acquisition of a Danish company, Ferrosan and Reckitt Benckiser’s acquisition of Schiff Nutrition in the United States, and Soho Flordis International’s acquisition of U.S. healthcare professional probiotic player ProThera a few years ago. Probiotics are regulated differently than drugs and so it is necessary to consider different factors when looking to acquire or obtain a license for such products.