Internal Neuromodulation Devices Market Poised to Exceed USD 44.57 Billion by 2033 | Astute Analytica

The internal neuromodulation devices market is surging, powered by personalized AI and smaller hardware. As these smart, responsive therapies expand beyond pain relief, they are delivering better patient outcomes and accelerating adoption worldwide.

Chicago, Nov. 20, 2025 (GLOBE NEWSWIRE) — The global internal neuromodulation devices market was valued at US$ 11.81 billion in 2024 and is expected to reach 44.57 billion by 2033, growing at a CAGR of 15.9% during the 2025–2033 forecast period.

The internal neuromodulation devices market is undergoing a profound transformation. A convergence of demographic shifts and clinical needs is creating powerful momentum. With the global population aging, the prevalence of chronic neurological and pain disorders is on the rise. Consequently, healthcare providers are urgently seeking durable alternatives to long-term drug therapies. This search opens a significant opportunity for medical technology. Innovation is answering the call, with 2024 and 2025 emerging as landmark years for technological progress. Advanced devices now feature highly personalized therapy, driven by sophisticated closed-loop feedback and artificial intelligence.

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These systems offer a new level of precision and patient comfort. Miniaturization has also made the devices less invasive and more appealing. Supporting these advancements is a growing wave of positive clinical evidence, which is building strong confidence among physicians. Favorable changes in the reimbursement landscape are also making these life-altering treatments more accessible to patients who need them most. This dynamic environment is setting the stage for substantial growth and intense competition within the internal neuromodulation devices market. The following analysis explores the key trends and quantitative insights shaping this exciting field.

Key Findings in Internal Neuromodulation Devices Market

Accelerated Regulatory Clearances Signal Robust Confidence in Neuromodulation Technology

A surge of recent regulatory approvals is injecting significant optimism into the sector. Key competitors in the internal neuromodulation devices market are successfully bringing their latest innovations to patients. For instance, Medtronic secured FDA approval for its Inceptiv™ closed-loop SCS in April 2024. Shortly after, Boston Scientific received an expanded FDA indication in February 2024 for its WaveWriter™ SCS Systems. This new approval specifically addresses non-surgical back pain (NSBP), effectively widening the potential patient base.

The positive momentum across the internal neuromodulation devices market continued throughout the year. Nevro Corp. celebrated the FDA approval of its HFX iQ™ system with HFX AdaptivAI™ in September 2024, followed by a CE Mark for the same system in Europe in November 2024. In a similar vein, Saluda Medical achieved two critical FDA approvals back-to-back. Its next-generation EVA™ sensing technology was approved in December 2024, and its automated EVA™ patient programming platform received clearance in January 2025.

Expansive Clinical Trial Data Cements Device Efficacy and Drives Physician Trust

Comprehensive clinical research provides the essential foundation for market adoption. Medtronic’s DTM™ SCS European Randomized Controlled Trial was a major international effort, conducted at 12 sites across 4 different countries. The company also ran its Australian closed-loop SCS study at 7 distinct sites. The scale of these trials within the internal neuromodulation devices market demonstrates a deep commitment to generating globally recognized, high-quality evidence.

Other companies are pursuing equally ambitious research. Saluda Medical’s ECAP IDE Study is notable for being the largest SCS IDE study to date, having enrolled a cohort of 220 patients. Looking ahead, Medtronic’s UPGRADE registry, which is designed to study DTM programming, aims to enroll up to 600 participants across approximately 25 centers in the United States. Furthermore, a Medtronic Product Surveillance Registry for primary cell batteries has already tracked 1,983 devices and 1,699 patients across 66 sites, yielding 3,531 device-years of valuable follow-up data.

AI and Closed-Loop Systems Revolutionize Personalized Therapy and Patient Outcomes

Technological prowess is the main arena for competition in the internal neuromodulation devices market. Advanced systems are setting new standards for care. Medtronic’s Inceptiv™ SCS, for example, has the ability to sense the body’s response to therapy 50 times every second. Saluda Medical’s Evoke® System can adjust its therapy more than 100 times per second, offering even faster responsiveness. In another innovation, Abbott’s Proclaim™ Plus system with FlexBurst360™ therapy provides pain coverage for up to 6 different areas of the trunk and limbs.

Artificial intelligence is becoming a cornerstone of this technological evolution. Nevro’s HFX iQ™ system operates on an algorithm trained on over 20 million data points from a dataset of more than 80,000 implanted patients, incorporating 10 years of patient care innovation data. Saluda Medical has now measured over 1 trillion Evoked Compound Action Potentials (ECAPs) with its Evoke® System, where the ECAP signal travels faster than 50 meters per second. Not to be outdone, BIOTRONIK’s Prospera™ system introduced a novel multiphase stimulation paradigm known as RESONANCE.

Intense Patent Activity and R&D Investment Underscore Fierce Market Competition

The high-value nature of the internal neuromodulation devices market is reflected in its vigorous intellectual property landscape. Medtronic’s 2024 patent lawsuit against Axonics involved 3 separate technological elements. While a jury found Axonics did not infringe on 3 of Medtronic’s patents in September 2024, the U.S. Patent Trial and Appeal Board upheld the validity of 5 other Medtronic patents in the dispute as of March 2024. A 2024 study identified 6 distinct patent lawsuits related to spinal cord stimulation alone. Out of 14 concluded neuromodulation patent disputes by December 2024, 2 resulted in infringement findings.

This competitive spirit fuels tremendous investment in research domain of the internal neuromodulation devices market. Medtronic presented 26 accepted clinical abstracts at the 2024 NANS annual meeting and is highlighting 22 data presentations at the 2025 meeting. Saluda Medical made a strong showing at NANS 2025 with 11 total abstracts and 4 oral presentations, 2 of which received a “Top Oral Abstract” award. The company will also feature 11 abstracts and 1 oral presentation at the ASPN 2025 conference. As of July 2025, Saluda Medical has amassed over 37 total publications on its technology.

Key Players Execute Aggressive Global Launch Strategies to Capture Market Share

Leading companies are not waiting to capitalize on their innovations. They are pursuing strategic, multi-regional product launches. Medtronic’s Inceptiv™ device, for example, received its CE Mark in Europe and regulatory approval in Japan before its official FDA approval in 2024. This calculated global rollout helps build market awareness and a solid international foundation. Such strategies are becoming a hallmark of the modern internal neuromodulation devices market.

Nevro is following a similar path with its latest technology. The company is planning to launch its HFX iQ system in select European countries in the first quarter of 2025. This follows the system’s full U.S. market release, which is anticipated in the fourth quarter of 2024. Saluda Medical has already demonstrated strong early traction with its new technology. Its EVA™ platform was used in over 3,000 commercial patient visits during its limited market release by July 2025, indicating high physician interest.

Focus on Patient Experience Drives Innovation in Device Longevity and MRI Safety in the Internal Neuromodulation Devices Market

Improving the patient journey is paramount for long-term success. Manufacturers are innovating to make devices smaller, longer-lasting, and more convenient. Medtronic’s Inceptiv™ is the world’s thinnest implantable SCS device at just 6mm. The average battery life for new rechargeable SCS devices ranges from 7 to 10 years, with some lasting 10 years or more. While non-rechargeable batteries average 2 to 5 years, Abbott’s Proclaim™ Plus can last up to 10 years on its lowest settings. Notably, Nevro’s HFX™ is the only rechargeable device designed for a battery life of over 10 years with no programming restrictions.

Ease of use and compatibility are also major focus areas across the internal neuromodulation devices market. The Inceptiv SCS battery recharges from empty to full in about 1 hour, while Nevro’s Smart Power feature may reduce charging to as few as 6 times per year. A 2025 study highlighted that 9 FDA-approved SCS devices are on the U.S. market. With up to 84 out of 100 SCS patients needing an MRI within 5 years and 74 out of 100 needing one within 10 years, MRI compatibility is non-negotiable. BIOTRONIK’s Prospera and Medtronic’s Inceptiv now lead the way with approvals for 3T full-body MRI scans.

Compelling Clinical Data Demonstrates Significant Pain Reduction and Functional Improvement

The ultimate validation for any medical device lies in its ability to improve patient lives. Recent clinical results from the internal neuromodulation devices market have been outstanding. In Boston Scientific’s SOLIS trial, patients using the WaveWriter system showed a mean 25-point improvement on the Oswestry Disability Index (ODI). A Medtronic study on DTM™ SCS found that the average morphine milligram equivalent for opioid users fell from 73.5 to 54 within three months.

The positive outcomes are consistent across different technologies and studies. A Boston Scientific FAST™ Therapy study recorded a 5.5-point drop in the numeric rating scale (NRS) for pain, from 7.8 down to 2.3. A European study of the same therapy reported a 29-point reduction in the ODI. At the 12-month mark, the same study showed a 5.1-point NRS pain reduction, which improved further to a 5.6-point reduction after 24 months. Medtronic’s 12-month data for its Inceptiv™ trial was also impressive, showing a mean reduction of 67% in the Low-back Visual Analog Scale (VAS) pain score.

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Workflow Automation and Expanded Indications Unlock New Avenues for Market Growth

Innovations are also being developed to streamline the clinical workflow for healthcare providers in the internal neuromodulation devices market. Saluda Medical’s EVA™ automated programming platform, for instance, successfully generated a closed-loop program in 94 out of 100 sessions. The platform achieved this with a median time of less than 13 minutes per program. In a similar effort to improve efficiency, BIOTRONIK’s Embrace One care model facilitates automatic and objective remote patient monitoring every day.

Simultaneously, the market is expanding beyond its traditional focus. Nevro’s HFX iQ™ now includes indication-specific algorithms for at least 4 different types of pain, such as painful diabetic neuropathy and chronic upper limb and neck pain. Medtronic has also completed 2 randomized controlled trials comparing DTM™ SCS to conventional stimulation for back pain. Patient preference is overwhelmingly in favor of these newer, smarter systems. A Medtronic study found that 86 out of 100 subjects preferred closed-loop stimulation over open-loop. After 12 months, 88 out of 100 patients preferred to keep the closed-loop feature activated.

Internal Neuromodulation Devices Market Major Players:

• Abbott
• Accellent Technologies, Inc.
• ALEVA NEUROTHERAPEUTICS SA
• Bioness Inc.
• Bioventus
• Boston Scientific Corporation
• Cyberonics, Inc.
• Inspire Medical Systems, Inc.
• Integer Holdings Corporation
• LivaNova PLC
• Medtronic
• NeuroPace, Inc.
• NEVRO CORP
• ReShape Lifesciences, Inc.
• Soterix Medical Inc.
• SPR Therapeutics
• Synapse Biomedical Inc.
• Other Prominent Players

Key Market Segmentation:

By Application / Therapy Area

• Chronic Pain Management
• Parkinson’s Disease
• Epilepsy
• Essential Tremor
• Depression & Psychiatric Disorders
• Urinary & Fecal Incontinence
• Gastroparesis
• Othes

By Device Type

• Spinal Cord Stimulators (SCS)
• Deep Brain Stimulators (DBS)
• Vagus Nerve Stimulators (VNS)
• Sacral Nerve Stimulators (SNS)
• Gastric Electrical Stimulators (GES)
• Others

By Patient Demographics

• Adult Patients (18–64 years)
• Geriatric Patients (65+ years)
• Pediatric Patients

By Technology / Stimulation Mode

• Electrical Stimulation (traditional)
• Magnetic / Adaptive Stimulation
• Closed-Loop / Responsive Neuromodulation
• Multi-site / Hybrid Stimulation Systems

By Component

• Implantable Pulse Generators (IPGs)
• Leads & Electrodes
• Rechargeable vs. Non-rechargeable Batteries
• External Controllers & Programmers
• Software & Data Analytics Platforms

By End-User

• Hospitals (neurosurgery & pain centers)
• Specialty Clinics (neurology, psychiatry, pain management)

By Price / Product Tier

• Standard Neuromodulation Systems (basic, lower-cost IPGs)
• Mid-tier Rechargeable Systems

By Region

• North America
• Europe
• Asia Pacific
• Middle East and Africa
• South America

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