Product Portfolio and Pipeline
There are over 15 cell therapy products commercially distributed by companies in the U.S. including: Dermagraft, Osteocel, PureGen, BioDfactor, BioDfence, Provenge, Carticel, Epicel, Nucel, Appligraf, GINTUIT, Trinity, Grafix, DeNovoET, Prokera, and AmnioGraft.
As the only cell-based immune therapy, Provenge falls out of cellular therapy. Two stem cell products (HemaCord and Clinimmune) were recently granted a BLA by the FDA and are now being commercially distributed in the U.S. by the nonprofit entities that own these products.
There are many stem cell sector products commercially distributed by companies in select countries in Europe, including: MySkin, CryoCell, ReCell, Carticel, Epicel, MACI, ChrondroCelect, AlloStem, BioSeed-C, co.don chondrospheres, Epidex, EpiGraft, and Diabecell. Additionally there are two point-of-care devices (by Therakos and Cytori) commercially marketed in Europe for cell-based treatments.
There are a similar number of stem cell sector products commercially distributed and only available in other similarly regulated countries including: Cupistem (S. Korea), Heartcelligram (S. Korea), Cartistem (S. Korea), J-TEC Epidermis (Japan), J-TEC Cartilage (Japan), J-TEC Corneal Epithelium (Japan), Prochymal (Canada and NZ), and CureXcell (Israel).
This excludes products commercially distributed in countries such as China and India where currently the regulations for these products are less defined.
The cell therapy products distributed in the U.S. and Europe in total are expected to generate approximately $900M in revenues in 2012. Removing Provenge revenue, the bona fide stem cell sector is expected to generate in the range of $550M in 2012. Despite the relative small size of the sector, it is trending in the right direction as this is twice what the sector is estimated to have generated in 2010.
While no cell therapy products received regulatory approval between 2001 and 2009, the sector has had 8 such approvals in the past 36 months.