At least 14 new molecular imaging agents are being groomed for clinical use, with approval of three major radiotracers expected by 2016, according to an August 2013 GlobalData report entitled “The Future of Molecular Imaging.”
Topping the list of upcoming developments are the expected FDA and European Medicines Agency (EMA) approval of F-18 flutemetamol by GE Healthcare and F-18 florbetaben by Piramal Imaging, both expected by 2015, and F-18 flurpiridaz by Lantheus Medical Imaging by 2016.
Major events within the industry this past year include the CMS draft decision regarding Amyvid, or F-18 florbetapir, and the agreement to expand reimbursement for oncologic FDG PET. Lilly’s acquisition of two Siemens tau-imaging agents and the takeover of Molecular Insight Pharmaceuticals by Progenics were marked as high-impact developments in the molecular imaging industry. In addition to new radiotracers, a handful of new technologies are also slated for development.
Enthusiasm for personalized medicine is said to be driving the molecular imaging industry, but several specific unmet needs were noted. These included a need for further radiation exposure reduction, improved instrumentation and physician cross-training, as well as data reading and reporting standardization with a focus on inter-reader agreement.
Some clear challenges in the commercial industry remain, most notably costs of development, including capital investment required for imaging equipment, regulatory research requirements and the expensive process of developing new imaging agents. Other mentionable snags included reimbursement, budgetary and distribution challenges, and concerns about an impending isotope shortage and radiation dose.
These barriers are expected to affect the market worldwide and in the long-term, allowing only slow growth over the long haul.
“The [key opinion leaders] interviewed for this report were in agreement and indicated that the euphoria surrounding MI is much greater than the actual rate of growth of the field,” the market research and consulting firm announced. “Although there is both immense investment for developing new imaging probes and continuous innovation in imaging modalities, which together are fueling interest in personalized medicine, due to significant market barriers, growth is impeded and these factors are dragging down the market.”
Still, the promise of “precision medicine,” or a wholly personalized approach, makes earlier diagnoses possible, which in turn is more cost-effective for treatment. One such area of perceived growth is in hyperpolarized magnetic resonance spectroscopy (MRS) and molecular imaging methods that aid in the development of novel drug therapies.