Autologous versus allogeneic business model

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:

Autologous:

• 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.

Allogeneic:

• 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.

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Tagged as: allogeneic, autologous, business, business model, cell therapy, RegenMed