The emerging market is showing signs of promising returns for both entrepreneurs and investors in clinical application areas such as refractory epilepsy, treatment resistant depression, stroke rehabilitation, incontinence, and retinal degenerative disorders. The availability of a huge amount of clinical results published in reputed domestic and international journals on the efficacy and safety of neurostimulation technologies supports their capability to penetrate several end-user markets and drive reimbursement to quantifiable success.
Despite an emerging market, major market share worldwide has been limited to four leading participants: Medtronic, St. Jude Medical, Boston Scientific Corporation and Cyberonics. High spurt in industrial activities and increase in competition is expected in the next two years, where most of the innovative neurostimulation technologies will be introduced in the global market.
New analysis from Frost & Sullivan (technicalinsights.frost.com), Advances in Neurostimulators, finds that the expanding aging population and high demand among patients resistant to other medications has triggered a demand upswing for neurostimulation therapies.
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"Although neurostimulators have proven to be viable alternatives to drug therapies in targeting a variety of neurological and psychiatric disorders, the market remains grossly under penetrated," notes Technical Insights Research Associate Arjunvasan Ambigapathy. "Therapies such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS) have offered clinical benefits to end-users globally. However, a slow pace in technology movement from concept to market has limited awareness on its benefits and subsequent demand among patient population."
Improvements in the existing technology portfolio and implementing defensive intellectual property (IP) strategies will clear the decks for long-term success of neurostimulation technologies.
Innovators in this space have found it challenging to improve awareness among end users on the benefits of neurostimulation therapies. Technologies such as VNS, DBS, and SCS have been commercially successful for over a decade. Despite this, lackluster technological improvement has remained a deterrent for small businesses and start-ups.
Navigated brain stimulation (NBS) and other transcranial magnetic stimulation (TMS) technologies have successfully overcome regulatory barriers in both diagnostic and therapeutic arenas. Regulatory and reimbursement requirements are posing impediments, and companies are obliged to frame clinical protocols to synchronize with them.
"Internal regulation of activities involved in the transfer of technology from design to manufacturing team is vital in ensuring product's quality and preventing risk during an FDA inspection," says Ambigapathy. "A competitive strategy for technology developers in US might be to hold a preliminary investigation device exemption (pre-IDE) meeting before applying for FDA approval in order to understand the outcomes of a clinical study as expected by the regulatory authorities."
Companies improving their presence in new geographies are dealing with these issues by collaborating with domestic market experts who will provide them with adequate knowledge and skills on the local regulatory requirements and reimbursement scenario. Currently, most of the neurostimulation technologies are in the clinical evaluation phase and their commercial availability might be expected in two to three years in high growth markets such as the US and Europe. These hurdles have encouraged companies to target patient groups in Japan, China, Brazil, and Mexico where the demand for innovation is high. However, political and economic uncertainties in these regions have curtailed the penetration of neurostimulation technologies.
Intense competition is observed among technology developers targeting diseases such as epilepsy, depression, Parkinson's, urinary incontinence, and stroke rehabilitation, which also shows signs of immediate returns. Strategic collaborations with technology and market experts to extend the technology's capability in aspects such as battery longevity, form factor, data informatics, and wireless communication might ensure market push for the technology in today's competitive environment. Going forward, innovators must roll out neurostimulators that target obesity, eye disorders, epilepsy, and depression. The focus is set to intensify on safe and effective non-invasive therapies that address these diseases.
Advances in Neurostimulators, a part of the Technical Insights subscription, provides a need-based analysis of the technical capabilities of neurostimulators, followed by a value chain analysis. Further, this research service includes detailed technology analysis and industry trends evaluated following extensive interviews with market participants.
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Advances in Neurostimulators / D1E6