Diaphragm Pacing Therapy System Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (External Diaphragm Pacemaker, Diaphragm Pacemaker), By Application (Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 7.92 Billion
CAGR (2026-2031)	4.15%
Fastest Growing Segment	Spinal Cord Injury
Largest Market	North America
Market Size (2031)	USD 10.11 Billion

Market Overview

The Global Diaphragm Pacing Therapy System Market will grow from USD 7.92 Billion in 2025 to USD 10.11 Billion by 2031 at a 4.15% CAGR. The Diaphragm Pacing Therapy System is an implantable medical device designed to assist patients with chronic respiratory insufficiency by electrically stimulating the phrenic nerve to induce diaphragm contraction and simulate natural breathing. The market is primarily driven by the increasing incidence of high-level spinal cord injuries and Amyotrophic Lateral Sclerosis, which necessitates long-term respiratory support alternatives to traditional mechanical ventilation. Furthermore, the clinical imperative to reduce ventilator-associated pneumonia and improve patient quality of life by enhancing mobility accelerates the adoption of these pacing systems globally.

However, the high cost associated with the device and the surgical implantation procedure poses a significant barrier to market expansion, particularly in cost-sensitive healthcare regions with limited insurance coverage. Inconsistent reimbursement policies further complicate patient access to this life-enhancing technology, limiting its reach despite the growing patient pool. According to the World Health Organization, in 2024, over 15 million people globally were reported to be living with a spinal cord injury, representing a critical demographic requiring sustainable respiratory management solutions.

Key Market Drivers

The Rising Prevalence of Spinal Cord Injuries and Amyotrophic Lateral Sclerosis serves as a primary catalyst for the Global Diaphragm Pacing Therapy System Market, creating an urgent clinical necessity for advanced respiratory aid devices. High-level spinal cord trauma often results in diaphragm paralysis, necessitating permanent ventilatory support that significantly impacts patient mobility and quality of life. The adoption of diaphragm pacing systems is accelerating as healthcare providers seek to restore natural breathing mechanics in this expanding patient population. Highlighting the scale of this clinical burden, according to the National Spinal Cord Injury Statistical Center, 2024, in the 'Traumatic Spinal Cord Injury Facts and Figures at a Glance' data sheet, the annual incidence of traumatic spinal cord injury in the United States is approximately 54 cases per one million people, equating to about 18,421 new cases each year. This steady influx of patients requiring long-term respiratory management underscores the critical market demand for implantable pacing technologies that offer a viable alternative to lifelong mechanical dependence.

Concurrently, the Clinical Shift Away from Long-Term Mechanical Ventilation is propelling market growth, driven by the need to mitigate high operational costs and clinical complications such as ventilator-associated pneumonia. Hospitals are increasingly prioritizing diaphragm pacing to facilitate earlier weaning from invasive ventilators, thereby reducing the financial strain on healthcare systems associated with prolonged intensive care stays. Validating the economic incentive for this transition, according to the Journal of Critical Care Medicine, April 2024, in the article 'Ventilator-Associated Events Cost in ICU Patients Receiving Mechanical Ventilation', the direct additional cost per ventilator-associated event episode was calculated to be €3,227.84. This substantial cost burden incentivizes the adoption of pacing systems that minimize infection risks. Furthermore, the market is bolstered by the significant prevalence of neurodegenerative conditions requiring such interventions; according to the Centers for Disease Control and Prevention, in 2025, estimates indicated that there were close to 33,000 cases of Amyotrophic Lateral Sclerosis in the United States, representing a key demographic for device utilization.

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Key Market Challenges

The substantial financial burden associated with the Diaphragm Pacing Therapy System and its implantation procedure constitutes a primary restraint on the global market. High acquisition and operative costs create significant barriers to entry, particularly in regions where healthcare budgets are strictly monitored. This economic pressure forces many healthcare providers to rely on traditional mechanical ventilation, which involves lower upfront capital expenditure, despite the long-term clinical benefits of pacing systems. Consequently, the high price point directly reduces the rate of device adoption and limits the number of hospitals willing to invest in this specialized technology.

Furthermore, the lack of consistent reimbursement coverage exacerbates the challenge by shifting the financial liability to patients who are already managing severe economic strain. When insurance policies deny or limit coverage for these devices, the out-of-pocket expense becomes prohibitive for the majority of the eligible patient population. According to the ALS Association, in 2025, the estimated annual cost for caring for a person with the disease was approximately 250,000 dollars. This immense existing financial load makes the additional cost of pacing technology untenable for many families, thereby narrowing the addressable market and hampering the overall revenue growth of the industry.

Key Market Trends

The Emergence of Transvenous Pacing Solutions for Ventilator Weaning represents a fundamental technological shift in the market, moving beyond traditional surgical implantation toward less invasive, catheter-based approaches. This trend is characterized by the development of temporary neurostimulation systems designed to be inserted via a central vein, thereby eliminating the need for laparoscopic surgery and reducing the risks of infection and surgical trauma in critically ill patients. These systems are specifically engineered to provide temporary support to strengthen the diaphragm during the weaning process, rather than offering permanent pacing for chronic paralysis. Validating the clinical progress of this technology, according to Lungpacer Medical, February 2025, in the 'Lungpacer Medical Announces Positive Results from STIMULUS Trial' press release, the study successfully enrolled 19 patients to investigate the application of transvenous diaphragm neurostimulation in improving hemodynamic performance during mechanical ventilation.

Concurrently, the Expansion of Clinical Indications to Ventilator-Induced Diaphragm Dysfunction (VIDD) is broadening the addressable patient population from chronic spinal cord injury cases to acute intensive care settings. Healthcare providers are increasingly recognizing the rapid onset of diaphragm atrophy caused by positive-pressure ventilation, prompting the application of pacing therapies to mitigate VIDD and accelerate liberation from mechanical support. This clinical expansion aims to address the significant volume of patients who fail to wean due to diaphragm weakness, transforming the device from a niche orphan product into a critical care tool. Highlighting the scale of this new clinical focus, according to Lungpacer Medical, March 2025, in the 'Lungpacer Medical Announces Investigational Device Exemption (IDE) for STARI, Phase 2 Feasibility Clinical Trial' press release, the investigational therapy targets the nearly 2.5 million United States patients who are mechanically ventilated each year, aiming to reduce the incidence of ventilator-associated injury.

Segmental Insights

The Spinal Cord Injury segment is currently the fastest-growing category within the Global Diaphragm Pacing Therapy System Market. This expansion is primarily driven by the rising global incidence of traumatic injuries that result in long-term ventilator dependence. Clinicians are increasingly adopting diaphragm pacing as it offers superior patient outcomes compared to mechanical ventilation, including reduced infection risks and improved mobility. Furthermore, the recent transition from humanitarian exemptions to full Premarket Approval by the U.S. Food and Drug Administration for manufacturers like Synapse Biomedical has significantly streamlined hospital access, thereby accelerating widespread clinical adoption.

Regional Insights

North America holds a dominant position in the Global Diaphragm Pacing Therapy System Market, primarily driven by the high prevalence of spinal cord injuries and Amyotrophic Lateral Sclerosis (ALS). The region benefits from a strong presence of major market players, such as Avery Biomedical Devices and Synapse Biomedical, which ensures consistent product innovation and availability. Furthermore, the U.S. Food and Drug Administration (FDA) provides a favorable regulatory environment that expedites device approvals. This, combined with comprehensive reimbursement frameworks and established healthcare infrastructure, facilitates the widespread clinical adoption of diaphragm pacing therapies across the region.

Recent Developments

• In December 2025, Lungpacer Medical announced that physicians at a major U.S. healthcare institution had successfully performed the first commercial procedures using the FDA-approved AeroPace System. This event marked the official transition of the technology from a clinical research setting to real-world patient care application within the Global Diaphragm Pacing Therapy System Market. The company confirmed that the system was utilized to treat critically ill patients who had experienced prolonged ventilator dependence and diaphragm weakness. This commercial deployment followed the device's earlier regulatory approval and the granting of a New Technology Add-on Payment (NTAP) status, which facilitated broader hospital adoption.
• In March 2025, Lungpacer Medical reported that it had secured an Investigational Device Exemption (IDE) from the U.S. FDA to initiate the STARI Phase 2 feasibility clinical trial. This new study was designed to evaluate the safety and effectiveness of the company's AeroNova System, a next-generation neurostimulation device intended for patients suffering from moderate to severe Acute Hypoxemic Respiratory Failure. Unlike the earlier model, the AeroNova system was developed to deliver continuous diaphragm stimulation in synchrony with mechanical ventilation, aiming to mitigate ventilator-induced diaphragm dysfunction and reduce the risk of multi-organ injury in critically ill patients.
• In February 2025, Lungpacer Medical shared the results of its STIMULUS phase 1 clinical trial at the Transcatheter Heart Therapies (THT) conference. The study, which was conducted in collaboration with Toronto General Hospital, investigated the impact of diaphragm neurostimulation on hemodynamic performance in patients requiring invasive mechanical ventilation. The presented data indicated that increasing the levels of diaphragm stimulation resulted in statistically significant improvements in cardiac index and stroke volume index. These findings suggested that the therapy could enhance heart performance and blood flow, supporting the potential for hemodynamic stability in addition to its primary respiratory benefits.
• In December 2024, Lungpacer Medical announced that it had received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for its AeroPace System. This regulatory milestone authorized the commercial distribution of the device for treating adult patients who have been mechanically ventilated for at least 96 hours and have failed to wean. The system employs a novel transvenous approach to electrically stimulate the phrenic nerve, thereby strengthening the diaphragm muscle to facilitate liberation from ventilators. The company noted that this was the first therapy of its kind to be approved for this specific clinical indication in the critical care environment.

Key Market Players

• LUNGPACER MEDICAL INC.
• Avery Biomedical Devices, Inc.
• Synapse Biomedical Inc
• Astrotech Corp.
• AstraZeneca PLC
• Novartis AG
• Boehringer Ingelheim
• Respironics Ltd
• Johnson & Johnson
• PneumRx, LLC

By Product	By Application	By Region
External Diaphragm Pacemaker Diaphragm Pacemaker	Spinal Cord Injury Amyotrophic Lateral Sclerosis Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Diaphragm Pacing Therapy System Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Diaphragm Pacing Therapy System Market, By Product:

• External Diaphragm Pacemaker
• Diaphragm Pacemaker

• Diaphragm Pacing Therapy System Market, By Application:

• Spinal Cord Injury
• Amyotrophic Lateral Sclerosis
• Others

• Diaphragm Pacing Therapy System Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE