A gene therapy will receive either FDA or EMA approval in the next two years, according to a nearly two-to-one majority in our poll.Of those who voted, 61.4% see rapid growth for gene therapy, while 32.9% do not believe a gene therapy will reach the market by 2013, and 5.7% were undecided about the fate of this segment.
One report predicts the market will grow to $316 million by 2015, driven by high demand. Yet while the science behind gene therapy has come a long way, proving efficacy and navigating the regulatory pathway remain roadblocks. Most recently, for example, EMA’s Committee for Medicinal Products for Human Use recommend that Amsterdam Molecular Therapeutics’ (AMT’s) gene therapy Glybera should not be approved for lipoprotein lipase deficiency. Had AMT received the green light for Glybera, it would have become the first gene therapy approved outside of China.