Decision Resources Group finds that the approval of new indications—particularly chronic heart failure, obesity and epilepsy—will expand the patient pool and market potential for neurostimulation devices in the United States considerably, allowing the market to reach a value approaching $4 billion by 2022. Most notably, because neurostimulation is already well accepted as a treatment for epilepsy, the Food and Drug Administration’s (FDA) approval in 2013 of NeuroPace’s deep brain stimulation (DBS) device for this indication will lead to rapid adoption of this product.

Other key findings from the Medtech 360 report entitled US Markets for Neurostimulation Devices 2014:

• Replacement devices: Demand for replacement of implantable pulse generators will drive market expansion. Through 2022, many devices that were implanted in first-time patients will reach the end of their life spans, and replacement devices will be required.
• Complex reimbursement process: Although reimbursement is available for most indications, the approval process for eligible patients is extensive and complex; the process carries high up-front costs in some cases and can be so lengthy that some patients decide to forgo this treatment altogether.
• Alternative treatments: Due to the invasive nature of neurostimulation therapy, some patients will also prefer alternative treatments such as lifestyle and medical management for most indications where feasible.
• Market leader Medtronic: Medtronic holds more than half of the overall revenues in this market. The company has a first-mover advantage and has thus far maintained its monopoly in the DBS, sacral nerve stimulation and gastric electric stimulation device segments.

Comments from Decision Resources Group Analyst Roald Dhoska:

• “Many companies are attempting to enter the U.S. neurostimulation device market to capitalize on strong revenue growth. Boston Scientific is seeking FDA approval of its DBS system, Nevro Corp and Spinal Modulation are both running clinical trials for spinal cord stimulation products and numerous competitors are racing to capitalize on the market potential by expanding indications in the vagus nerve stimulation segment.”
• “Penetration into the eligible patient populations for most devices is low because many referring physicians are not exposed to neurostimulation in medical school. New manufacturers looking to enter the market will be well positioned for success if they can implement educational campaigns that target these physicians.”