Diaphragm Pacing Device Market Size, Share, and Industry Analysis, By Product Type (External Pacing Device and Internal Pacing Device), By Application (Spinal Cord Injuries, Central Sleep Apnea, Diaphragm Paralysis, and Others), By End-user (Hospitals, Specialty Clinics, and Others), and Regional Forecast, 2025-2032

The global diaphragm pacing device market is witnessing substantial growth due to the increasing prevalence of respiratory disorders such as amyotrophic lateral sclerosis, sleep apnea, chronic obstructive pulmonary disease (COPD), and spinal cord injury. This leads to severe diaphragm muscle weakness and interrupts the normal breathing functions of the body. Such conditions propel the product adoption, impelling the growth of the market.

Diaphragm pacing devices are designed to assist patients with breathing difficulties through the stimulation of the diaphragm muscles. The devices are used in patients with ventilator failure due to severe weakness or paralysis of the diaphragm. This device reduces the need for the ventilator support. Further, they are lightweight, battery-powered systems that electrically stimulate the diaphragm muscles and nerves. Thus, the diaphragm pacing devices improve breathing, speech, and quality of life for people with spinal cord injuries, sleep apnea, and diaphragm paralysis.

• For instance, in April 2024, according to a report by the World Health Organization (WHO), 15.4 million people globally are living with spinal cord injury (SCI) in 2021 due to trauma, including falls, road traffic injuries, or violence. Spinal cord injuries impair the person's nervous system and the ability to control the diaphragm, leading to the respiratory failure. Such conditions require pacing devices to restore control and thus increase the demand for diaphragm pacing devices in the market.

Additionally, some of the benefits associated with the use of diaphragm pacing devices include the reduction in hospital stays, providing mobility to the patient, and reducing head expenses associated with mechanical ventilators and hospital costs. Such factors drive the growth of the market.

Diaphragm Pacing Device Market Driver

Usage of these Devices to Reduce Hospital Stays and Cost Augments Market Growth

The increasing prevalence of chronic respiratory disorders and spinal cord injuries are contributing to the market growth. In these conditions, patients are unable to breathe on their own and require mechanical ventilation (MV). However, mechanical ventilation increases the hospital stay of the patient and the hospital costs associated with it. Additionally, the patients with intact phrenic nerve function can be partially or completely removed from mechanical ventilation through the direct stimulation of the diaphragm motor points with a diaphragm pacing system (DPS). Such scenarios decrease the hospital stays, vent days, and costs, drive the adoption of diaphragm pacing devices and propels the growth of the market.

• For instance, in January 2022, according to a report published by Groningen Research Institute for Asthma and COPD (GRIAC), the research institution performed a study across three centers with 47 patients with spinal cord injury (SCI) who were fitted with diaphragm pacing devices, and required the mechanical ventilation. It was found that the devices are a successful therapy for patients on MV with high SCI. Further, patients were able to reduce their daily use of MV, and eight of them were completely removed from MV. Such studies promote the adoption of diaphragm pacing devices and drives the growth of the market.

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According to a research study published by the Frontiers in Neurology in December 2023, it was estimated that around 9.0 million people had spinal cord injuries worldwide in 2019. Furthermore, in April 2024, the World Health Organization (WHO) estimated that in 2021, an estimated 15.4 million individuals were living with spinal cord injuries.

Diaphragm Pacing Device Market Restraint

Product Recalls Related to the Devices May Hamper Market Growth

Despite the various ongoing technological advancements in the diaphragm pacing devices arena, a rise in the number of product recalls is projected to hamper the global market growth during the study period.

• In July 2022, the U.S. Food and Drugs Association (FDA) published a Class 1 Device Recall for Synapse Biomedical Inc.’s NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG) due to a defect on the EPG controller printed circuit board assembly, and device performance was degraded over time. Further, potential adverse events were reported that included pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device stopped unexpectedly. Such product recalls with life-threatening adverse events may deplete the customer's trust and hamper the growth of the market.

Diaphragm Pacing Device Market Opportunity

Rising Regulatory Policies to Create Lucrative Prospects for Industry Players

In recent years, the demand for diaphragm pacing devices has surged due to the rising prevalence of key diseases and benefits associated with devices that reduce the hospital costs. Further, the increasing regulatory approvals for novel and advanced devices have led to the shift of focus of key players to launch new devices in the market. Thus, this is leading to the market growth during the forecast period.

• For instance, in April 2023, Synapse Biomedical, Inc. received a U.S. Food and Drug Administration grant for premarket approval (PMA) for the NeuRx Diaphragm Pacing System for patients with spinal cord injuries who rely on mechanical ventilation. Such approvals are propelling the growth of the market during the forecast period.

Key Insights

The report covers the following key insights:

• Prevalence of Key Disease, By Key Countries/Regions, 2023
• Regulatory & Reimbursement Scenario, By Key Countries/Regions, 2023
• New Product Launches By Key Players
• Key Industry Developments: Mergers, Acquisitions, Partnerships
• Impact of COVID-19 on the Market

Segmentation

Analysis by Product Type

Based on product type, the market is categorized into external pacing device and internal pacing device.

The internal pacing device segment held a substantial share of the market. The devices are surgically implanted within the body and function by delivering impulses to the phrenic nerve. The growth of the segment is attributed to increasing benefits associated with the internal pacing device. Once implanted, the device provides continuous and reliable stimulation to the diaphragm and reduces the need for external intervention. Further, there is an increasing preference for these products by surgeons and patients due to their convenience and lower maintenance.

Additionally, increasing product launches by key players leads to the growth of the segment in the market.

• For instance, in July 2021, Synapse Biomedical, Inc. received the Breakthrough Therapy Device designation to TransAeris by the U.S. Food and Drug Administration. It is a temporary percutaneous intramuscular diaphragm stimulator designed to aid in weaning from the mechanical ventilation. Such grants boost the growth of the segment in the market.

Analysis by Application

Based on application, the market is divided into spinal cord injuries, central sleep apnea, diaphragm paralysis, and others.

The spinal cord injuries segment held a significant share of the global diaphragm pacing device market. The growth of the segment is attributed to the rising number of cases related to spinal cord injuries that lead to the weakness or paralysis of the diaphragm. Thus, diaphragm pacing devices support the patient in normal breathing and remove from mechanical ventilation support.

• For instance, according to the National Spinal Cord Injury Statistical Center, in 2023, the estimated annual incidence of traumatic spinal cord injury (tSCI) is approximately 54 cases per 1 million people in the U.S., which equals about 18,000 new tSCI cases each year. Such conditions damage the normal respiratory functioning and require the external support. This boosts the adoption of diaphragm pacing devices and propels the segment growth.

Analysis by End-user

Based on end-user, the market is fragmented into hospitals, specialty clinics, and others.

The hospitals segment held a significant share of the market. The growth of the segment is attributed to the presence of advanced facilities and skilled professionals. Further, the presence of organized reimbursement facilities for these devices leads to an increased shift of patients to these settings. Additionally, the increasing awareness programs by hospitals that offer 24-hour breathing support to patients using diaphragm pacing devices, also contributes to the segmental growth.

• For instance, Children’s Hospital Los Angeles has started congenital central hypoventilation syndrome (CCHS) and Diaphragm Pacing Program for children and adults suffering from CCHS. The program offers care and treatment to the children with 24-hour breathing support using diaphragm pacing devices. Such programs boost the growth of the segment in the market.

Regional Analysis

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By region, the market has been analyzed across North America, Asia Pacific, Europe, Latin America, and the Middle East & Africa.

North America accounted for a substantial share of the global diaphragm pacing device market in 2023. The growth of the market in the region is attributed to the increasing prevalence of respiratory disorders, including COPD, sleep apnea, and spinal cord injuries leading to the respiratory failure. Furthermore, the presence of key players in the market with advanced product offerings and rising research and development with regulatory approvals for the devices boosts the regional growth in the market.

• For instance, in April 2020, the diaphragm pacing system developed by Dr. Raymond Onders, a general and gastrointestinal surgeon of University Hospitals Cleveland Medical Center, U.S., was approved for the use of COVID-19 patients as it improved the functionality of the diaphragm in patients using ventilators. Such innovations lead to the expansion of the regional market.

Europe has a considerable share of the market based on the demand for diaphragm pacing devices. The strong presence of key players with advanced product offerings and launches augments the growth of the region. In addition, increasing research and development and awareness regarding the benefits associated with the devices for reducing hospital stays and costs is set to boost regional expansion.

• In January 2020, Lungpacer Medical, Inc. announced the successful completion of enrollment and follow-up for its RESCUE 2 European CE Mark randomized clinical trial in France and Germany. The trial aimed to assess the safety and efficacy of the Lungpacer Therapy System in individuals anticipated to experience ventilator-induced diaphragm dysfunction (VIDD). Such clinical trials boost the regional market growth.

Moreover, the Asia Pacific region is expected to grow robustly during the forecast period. The growth of the region is attributed to a rising patient pool and increasing collaborations to expand the adoption of diaphragm pacing devices.

• For instance, in July 2019, the Indian Spinal Injuries Centre partnered with renowned U.S. gastrointestinal surgeon Dr. Raymond P. Onders to launch a program for Diaphragmatic Pacing in India. This innovative procedure, developed by Dr. Onders, allows patients who are paralyzed and reliant on ventilators to breathe independently by using diaphragm pacing devices. Such collaborations boost the adoption and propel the growth of the region in the market.

Key Players Covered

The global diaphragm pacing device market has a semi-consolidated competitive structure, with the increasing presence of established and emerging companies.

The report includes the profiles of the following key players:

• Synapse Biomedical Inc. (U.S)
• Avery Biomedical Devices, Inc. (U.S.)
• Lungpacer Medical Inc. (Canada)
• Atrotech (Finland)
• ZOLL Medical Corporation (U.S.)

Key Industry Developments

• In September 2022, ZOLL Medical Corporation announced that remedē System therapy is covered under the expanded insurance coverage of SelectHealth and its affiliates across Utah, Idaho, and Nevada.
• In February 2022, Lungpacer Medical Inc. announced the introduction of the AeroPace System into the RESCUE 3 pivotal clinical study. This introduction fastened the study for device approval and helped patients to wean off mechanical ventilation.
• In August 2021, ZOLL Medical Corporation received U.S. Food and Drug Administration (FDA) approval for the remedē EL-X System used to treat moderate to severe central sleep apnea (CSA) in adult patients.
• In November 2019, Avery Biomedical Devices, Inc. received FDA approval for the new diaphragm pacemaker transmitter, Spirit, and is now commercially available for patients utilizing a pacing system.