The use of bone grafts is a hot topic in the orthopedic world right now. Whether discussing the INFUSE controversy
or the escalating incidence of cadaver theft for tissue, the bone graft substitute (BGS) market has made it into the mainstream media.
One thing that you don?t hear about too often that I find particularly interesting is how drastically the popularity of different types of bone grafts can change depending on what country you?re in. While most people prefer to use autografts?which are from your own tissues?where possible, BGS are gaining popularity because they don?t require a second, often quite painful, procedure to harvest the autograft. BGS are available in a wide variety of forms, including synthetics, demineralized bone matrices, non-proprietary allografts, xenografts, and growth factors.
And here's where things get interesting. Allografts are human-derived, meaning that they?re sourced from cadavers. While this definitely places a limit on their availability?there isn?t an unlimited supply of people willing to donate their tissue?their use is also severely hindered in some countries where there are strict regulations on the use of these products due to a strong cultural aversion to using cadaver tissue. For example, in Brazil, there is an import ban on allografts, meaning that they can only be used if sourced domestically. In Europe, regulations around tissue banks have recently become a lot stricter, forcing some smaller tissue banks that can?t afford the overhead to close.
In other countries, the cultural aversion is stronger in response to animal-derived products. In India, for instance, bovine-derived products aren?t used because of the widely held Hindu belief that cows are sacred. It seems safe to assume that similar beliefs would be held for porcine-derived products in countries that are largely Jewish or Muslim. And in the US?the mother of all medical device markets?xenografts are barely used, if at all, likely partially driven by concerns over catching mad cow disease from bovine tissue?even though there's no evidence of this actually ever happening.
In China and Japan, there is a general aversion to using animal or cadaver tissue in general, resulting in extremely tiny xenograft and allograft markets in the countries. If you?re a synthetic BGS manufacturer in these countries, all the better for you.
The fact that these nuances exist can and has caused the BGS market landscape to vary across countries, dramatically in some cases. One thing is for sure: the ?issue with tissue? makes market analytics all the more important in informing strategic decisions.