Biomedical Engineering Reference
In-Depth Information
6.3 The iPS cell industry?
The broader question that might be asked about the future of iPSC
research is whether or not a viable and sustainable industry will
emerge. While it is too early to tell at this stage whether some of the
more radical possibilities of iPSC research - like whole organs being
made to order by individuals walking into a clinic - will ever
eventuate, what has been established so far is an increasingly viable
market in tools and supplies for drug manufacturing. This in itself is
lucrative enough to sustain a smallish niche industry within the
biotechnology sector. As more cell lines are derived adopting the
disease-in-a-dish approach it might be expected that further interest
from pharmaceutical companies will follow.
Many of the prospective commercial models identified above for
iPS cells are based on a number of established industry models.
These include a traditional manufacturing base, the franchise model,
the education delivery and information-communication industry
model and lastly the biotech industry model. There is also much
room for cross-over between different cell products and the kinds of
commercial models that might be adopted. Other issues affecting the
commercial development of the iPSC market, however, include
concerns about the role of patenting and its impact on
commercialization (Eisenstein, 2010), the increasing lack of rarity
around pluripotency (Sipp, 2009) and the effect any patent reforms
will have on business (Harrison, 2011).
Patenting issues have been widely debated in the stem cell sciences
for some time. As noted previously, there was some initial speculation
that a patent thicket would emerge around iPSCs as broad patent
claims would be staked out over the production of iPSCs as has
occurred with hESC (Eisenstein, 2010). Yet it has also been suggested
that lessons learnt from patenting in hESC research will lead to a
more cautious approach to broad patent rights being granted early
in the development of iPSCs (Eisenstein, 2010). Also, the diversity of
production methods used in inducing pluripotency may potentially
see a more diverse range of patents established over time (Eisenstein,
2010).
