TABLE 1.
Hypothetical comparison, based on expert opinion, of the development costs and return for a probiotic food (PF), probiotic dietary supplements (PDS), medical foods/foods for specific medical purposes (MF/FSMP), and live biotherapeutics (LBPs) probiotic products.
| Comparative parameters | PF | PDS | MF/FSMP | LBPs | “Zone” impact* |
| Reimbursement schemes | No | No | Same as other MF/FSMP | Yes, same as other drugs | |
| Average R&D cost | Low-Medium | Low-Medium | Medium-high | Medium-high | |
| Available R&D funding | Limited | Limited | Limited | Medium | |
| Patenting possibilities | Limited | Limited | Yes | Yes | |
| Manufacturing costs | Medium-high | Medium-high | High | High | |
| Extent of regulatory requirements | Low | Low-Medium | Medium-High | High | |
| Market size | Broad | Broad | Broad | Broad | |
| Product revenue | Low | Low | Medium | High | |
| Cost to bring to market | Medium | Medium | Medium | High | |
| Total value of markets | Low | Low | Medium | Medium-High | |
| Return on investment | Low | Low | Low-medium | Medium |
The levels indicated assume that PF and PDS are indeed foods and supplements and as such should be affordable and cannot claim effects on disease. MF and FSMP are also foods but serve a specific medical purpose that needs to be documented and can be marketed at a somewhat higher price than their regular counterparts. LBP’s on the other hand are drugs that require thorough documentation and can be sold at drug prices. These comparisons between the product categories are intended to give an indication of hierarchy/rank/weight on the various elements, not as an empirical grading system. Many of these elements would be notoriously difficult to objectively quantify which is not within the scope of this article. *Column “zone impact”: the system of the traffic lights means that there are significant differences for, e.g., health claims, reimbursement schemes, etc., according to the jurisdiction where one operates. Red indicates that there are differences that will most likely influence the final cost. Orange indicates that there may exist influence on the final cost. Green indicates there are little or no influence on the final costs expected.