Market definition and commercialization of a bay set allowing for repurposing of outdated platelet concentrates

Abstract

Red Cross Flanders has developed a bag set that allows for the production of human platelet lysate (hPL) and allogeneic platelet rich plasma (PRP) from outdated platelet concentrates. This project includes a market research on PRP and hPL, which are produced using the bag set. A separate market research had to be executed for hPL and PRP, as they have different usages, target markets, competitive advantages and proof of effectiveness. On the one hand, hPL has an indirect clinical use and is considered to be a raw material, which means that there are less stringent regulations. Furthermore, the indirect clinical use of hPL has already been proven effective by existing literature. The target market of hPL are vaccine production, biopharmaceuticals and cell and tissue culture. Fetal bovine serum (FBS) is an existing cell and tissue culture medium that has been dominating the cell and tissue culture market. However, due to the ethical and clinical issues related to the production and use of FBS, hPL can be considered as a potential alternative. Further FBS market insights were gained through the assessment of the FBS market size, segments, regional market shares and pricing. Furthermore, established companies producing hPL have already obtained a significant size of the hPL market. However, there exist various types of hPL, depending on their grade and type of heparin used in the fibrinogen depletion step. Red Cross Flanders aims to produce and sell a xeno-free GMP clinical grade hPL. This type of hPL is the most expensive relative to all other types of hPL on the market. The bag set can be considered as an alternative hPL production method relative to two other widely used methods, being the freeze-thaw method and the high CaCl2 method. The bag set allows for the production of hPL in a closed system, requires less hands-on time and is more simple due to the decrease in number of activities relative to the existing production methods. HPL producers will be able to make use of the bag set in their production process once bag set development companies could be persuaded about the potential market size. Furthermore, if Red Cross Flanders would obtain a patent on the bag set, then potential licensees would have to pay royalties, which would provide an additional revenue stream to Red Cross Flanders. On the other hand, allogeneic PRP has a direct clinical use and will be considered either a blood product or a pharmaceutical drug, which would imply more stringent regulations. Furthermore, existing literature has not yet proven the effectiveness of the direct clinical use of PRP. Moreover, a PRP injection does not result in a positive outcome for all patients treated. Currently, an autologous PRP injection requires three steps, in which a person’s blood is drawn, processed in a centrifuge and the layer consisting of PRP is injected into the treatment area. However, various differences that occur during the PRP injection procedure, including centrifugation speed and time, quantity of blood withdrawn, quantity of PRP injected, could have an influence on the outcome of the treatment. In contrast, the allogeneic PRP produced through the bag set will be a standardized, off-the-shelf product. EXPLANATIONFurthermore, a unique value proposition has been created in order to define how hPL, PRP and the bag set would be positioned in their respective markets. The unique value proposition has also been assessed by professionals through surveys and online interviews. Additionally, a 5C’s analysis has been performed for both the direct and indirect clinical markets in order to assess the market environment that Red Cross Flanders would be operating in. A calculation of the return on investment has been executed based on the potential selling prices, costs and speed of adoption. First, the potential selling price of hPL has been calculated through secondary research by comparing the selling prices of the existing companies offering a xeno-free GMP clinical grade hPL. The potential selling price of PRP has been based on primary research, where the price preferences of doctors have been estimated through the Van Westendorp price sensitivity meter.Second, the cost calculation has not been restricted to the cumulative cost of inventing the bag set, but includes an analysis and estimation of all potential additional costs that need to be taken into account. Moreover, primary research has been conducted in order to gain insights on the potential cost of the outdated platelet concentrates of other European blood banks. (expanding prod cap). Third, the speed of adoption was estimated through insights gained from primary and secondary research. First, primary research was conducted by sending surveys to the relevant doctors, which provided us with insightful information on the potential use of a standardized, off-the-shelf but allogeneic PRP. Second, the framework of Roger’s five factors has been used in order to gain insights on the speed of diffusion of hPL, PRP and the bag set. The above mentioned insights and calculations have been combined in order to calculate the potential return on investment. ON WHAT and this for diff scenarios and over multiple years. Finally, the NPV and IRR were then calculated by taking the discounted cash flow and success rate into account.