The U.S. Alzheimer's imaging agent market will grow dramatically over the next 10 years, according to Decision Resources Group. Currently, Eli Lilly's Amyvid, launched in June 2013, is the only FDA-approved product available, but GE Healthcare, Piramal Enterprises and Navidea Biopharmaceuticalsare all poised to launch products in the U.S. in the next few years.
Alzheimer's imaging agents are radiotracers capable of detecting beta-amyloid plaque in the brain, a pathological hallmark of Alzheimer's. Despite the high prevalence of Alzheimer's disease in the U.S., in 2013, this market was worth less than $3 million. There continues to be a lack of reimbursement for these procedures, which has severely restricted demand. In fact, many of the procedures that are performed are using free doses offered by Eli Lilly in order to spread awareness of the agent. Additionally, the benefits of the procedure remain under debate because there currently is no treatment for Alzheimer's disease itself.
"Going forward, a number of key events will dramatically reshape this market," said Jeremy Seath, Decision Resources Group analyst. "First, the Coverage with Evidence Development program will provide reimbursement for patients enrolled in approved clinical trials. Second, evidence from these trials is expected to result in a broad coverage decision a few years later, further improving access to these procedures and driving market growth. Finally, Eli Lilly's solanezumab, currently in phase III clinical trials, is expected to gain approval in the U.S. and will represent the first disease-modifying therapeutic drug available. Because the drug targets the buildup of beta-amyloid plaque, its launch will significantly increase the value of the imaging agents, driving revenues."
Along with growing demand for these products, the expanding installed base of systems capable of performing Alzheimer's imaging agent procedures, including positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MRI) systems, will improve accessibility of these procedures for patients.