There are two major business models in cell therapy and regenerative medicine industry – autologous and allogeneic. Each model has pros and cons. I’d briefly summarize features of each model as the following:
- personalized/ highly customized therapy
- medical procedure-like;
- scale out manufacturing;
- very high manufacturing cost (cost of goods (COGs), series of quality control assays for each patient = 1 batch, labor);
- complicated regulatory path;
- complicated logistics;
- low-to-no risk of immunogenicity;
- hard to commercialize and standardize;
- possible slow adoption in clinic.
- not personalized (one similar product for many)
- traditional Pharma/ Biotech-like – “off-the-shelf”;
- clear logistics;
- scale up manufacturing;
- lower cost of manufacturing (low COGs, one series of quality control assays per batch);
- clear and easier regulatory path;
- highly dependent from donor raw material availability;
- cell banks-based (master/ working/ clinical cell banks);
- risks associated with allogeneic cells (more tests for donor raw materials, immunogenicity);
- easier to commercialize;
- requires larger storage facility and shipment department;
- potentially easy adoption in clinic.
Considerably, allo- model is more pro-industry and more suitable for successful commercialization. Some professionals don’t even believe that auto- models could be successfully commercialized and adopted on the medical market. Nevertheless, we can see multiple companies in the field, which pursue either allo- or auto- business models.
I was curious to look at clinical trials data for the last couple of years. The graph below represents the number of industry-sponsored cell therapy clinical trials, registered in 2011 and 2012:
I’ve found that, despite general assumption, cell therapy industry companies pretty much equally develop auto- and allo- therapies. Even though, clinical development stage doesn’t yet mean market approval, clinical adoption and successful commercialization, it could indicate to the real interest of cell product business developers.