Neuromodulation is one of the fastest-growing medical device markets. Abbott has recently received FDA breakthrough designation for its deep brain stimulation (DBS) system in treatment-resistant depression, which expands the indication of neuromodulation devices. According to GlobalData analysis, the neuromodulation market was valued at $6.8 billion globally in 2021, and will reach $10.7 billion in 2030, at a steady compound annual growth rate (CAGR) of 5.2%.

The neuromodulation market is expected to grow through the expansion of therapeutic areas. Currently, the market focuses on refractory patients, in regards to neurological disorders. However, the market is shifting towards targeting other indications including depression. For example, DBS systems are commonly used to treat movement disorders such as Parkinson’s disease and essential tremor by sending electrical stimulation through surgically implanted electrodes to specific targets in the brain. After receiving breakthrough device designation from the FDA, Abbott is working on evaluating safety and efficacy in using DBS to regulate mood for reducing symptoms of treatment-resistant depression. The breakthrough device designation will provide priority review regarding device development and assessment to help provide patients and healthcare providers timely access to devices. According to GlobalData’s epidemiology analysis, there were over 53.8 million people with major depressive disorder in eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and Canada) in 2021. Around 30% to 40% of them—17.9 million patients—do not respond to pharmacological treatments. DBS systems may provide a new option to treat patients with treatment-resistant depression after further research.

The neuromodulation market is shifting towards targeting the early-onset patient population. A pilot clinical trial at Vanderbilt University Medical Center reported five-year outcomes of using the subthalamic nucleus DBS in early-stage Parkinson’s disease. It shows that DBS implanted in early-stage Parkinson’s disease decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone. Additionally, the Vercise DBS system from Functional Neuromodulation received breakthrough device designation from the FDA in 2021 in treating patients with mild probable Alzheimer’s disease. The company’s ADvance II pivotal study is currently enrolling up to 210 patients in a double-blind, randomized, controlled trial in the US, Canada, and Germany. With rising procedural success rates, increasing understanding of the stimulation mechanism, and positive outcomes from clinical trials, GlobalData expects the market to penetrate early-onset neurological disorders to improve patient quality of life prior to deterioration.