There have been a couple interesting and unexpected events in the orthopedic biomaterial market over the last few weeks. First, BioMimetic Therapeutics has not yet received Food and Drug Administration approval for its Augment Bone Graft, which was originally anticipated to enter the market in 2012 following a positive recommendation for approval in May 2011. Although the FDA has not requested additional clinical trials, it did ask the company for further information from the clinical trials that have already been performed, which will likely be time-consuming for BioMimetic Therapeutics to gather. This is not good news for the beleaguered growth factor market in the US, where controversies over products such as Medtronic Spinal & Biologics. INFUSE and AMPLIFY are continuing to cause surgeons to switch back toward other bone graft substitutes. Because the Augment product is platelet-derived, as opposed to a bone morphogenetic protein (BMP) like currently available products, it is expected that its approval would prompt surgeons that have shied away from using BMPs to readopt growth factors into their practice. Furthermore, Augment is anticipated to be approved for indications where currently available products are not, namely hindfoot and ankle fusions. Millennium Research Group had anticipated a decline in growth factor unit sales until Augment became available in 2012; however, this reversal will now likely not be experienced until 2013 or 2014.
In the hyaluronic acid (HA) viscosupplementation market, an unexpected move by the U. S. District Court in Massachusetts prohibited Seikagaku from selling its new single-injection product at a price lower than Genzyme's Synvisc-One and also limited its commercial launch. Because Synvisc-One is the only other single-injection product on the market, this will curb competition and potentially prevent Seikagaku from gaining as strong a foothold in the market. Although this preliminary injunction is only valid until a formal trial in April, it seems unlikely that Seikagaku will be able to overturn the injunction in court. This is obviously a positive ruling for Genzyme (which is now owned by Sanofi), although surgeons may not view the situation the same way. In fact, surgeons interviewed by Millennium Research Group expressed a need for lower-priced yet effective products in light of economic and reimbursement challenges this ruling may therefore prevent some surgeons from switching to single-injection products overall. On the flip side, however, this decision does keep the cost of single-injection products higher, which will support total revenues; if Seikagaku entered the market offering a lower-priced product, rapid price erosion would occur as surgeons adopted the product. Genzyme will, however, have to deal with Anika Therapeutics. MONOVISC, which is also anticipated to become available in 2012. Originally, MRG anticipated that the single-injection HA viscosupplementation market would grow at a CAGR of more than 25% from 2011 to 2016, reaching nearly 45% of all HA viscosupplementation treatment volumes. Because of the potential for extremely strong growth, interest in these events will be high and followed closely over the next few months.