Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the cellular therapies drug market will experience robust growth in the United States over the next decade, reaching $1.5 billion in 2017. According to the new special report entitled Cellular Therapies, the launch of second-generation cellular therapies, the approval of novel stem-cell-based therapies and dendritic cell vaccines, and the continuous adoption of existing cellular products will drive this market to grow at an annual rate of least 31 percent in the United States from 2007 to 2017.
While market growth will be strong in the United States, new centralized regulations in Europe that take effect at the end of 2008 will introduce uncertainties for cellular therapies marketed in Europe, according to the report. Among emerging therapies, TiGenix's ChondroCelect will be the first therapy to be reviewed under the new centralized European Medicines Agency guidelines.
The report forecasts that, of the 10 or more cellular therapies that will launch over the next decade in the United States and/or Europe, Dendreon's Provenge will be the first market entrant following its approval for prostate cancer in 2009 in the United States. Another cellular therapy that will launch in the near-term, Osiris/Genzyme's Prochymal, will garner sales of $235 million in 2017 for the treatment of Crohn's disease, although its initial regulatory approval will be for graft-versus-host disease in 2010 in the United States and in 2011 in Europe.
"First-to-market cellular therapies have had disappointing sales performances to date," said Irene Koulinska, M.D., analyst at Decision Resources. "However, researchers have made significant progress in the development of cellular therapies in recent years, despite facing considerable financial and ethical challenges. Additionally, the availability of noncontroversial cell sources and the establishment of a regulatory framework in the United States and Europe have prompted increased interest among large biomedical companies in the development and commercialization of cellular therapies."
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