Inhaled Nitric Oxide Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product Type (Gas, Delivery Systems), By Application (Neonatal Respiratory Treatment, Asthma and COPD, Acute Respiratory Distress Syndrome, Malaria Treatment, Tuberculosis Treatment, Other Applications), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 789.21 Million
CAGR (2026-2031)	7.23%
Fastest Growing Segment	Asthma and COPD
Largest Market	North America
Market Size (2031)	USD 1199.75 Million

Market Overview

The Global Inhaled Nitric Oxide Market will grow from USD 789.21 Million in 2025 to USD 1199.75 Million by 2031 at a 7.23% CAGR. Inhaled nitric oxide is a specialized gaseous blend administered via inhalation to function as a selective pulmonary vasodilator, primarily indicated for treating term and near-term neonates suffering from hypoxic respiratory failure associated with pulmonary hypertension. The growth of this market is fundamentally driven by the rising incidence of neonatal respiratory diseases and the critical necessity for effective, non-invasive therapeutic interventions within neonatal intensive care units globally, which collectively ensure a consistent demand for pharmaceutical-grade gas and compatible delivery systems.

Despite these strong drivers, the market encounters impediments regarding the high cost of therapy and stringent reimbursement policies that can restrict widespread adoption in budget-constrained healthcare settings. This sustained clinical need is highlighted by recent health statistics which indicate a persistent burden of conditions requiring respiratory support; for instance, according to the March of Dimes, in 2024, the preterm birth rate in the United States remained historically high at 10.4 percent, underscoring the continuous demand for advanced neonatal respiratory care.

Key Market Drivers

The Rising Global Prevalence of Preterm Births and Neonatal Intensive Care Admissions serves as a primary catalyst for market expansion, as premature infants frequently exhibit underdeveloped lungs and conditions like Persistent Pulmonary Hypertension of the Newborn (PPHN) that necessitate immediate vasodilatory support. This demographic trend ensures a steady patient pipeline for nitric oxide therapies, which remain the standard of care for hypoxic respiratory failure in term and near-term neonates. The persistence of this clinical burden is evident in recent vital statistics; according to the Centers for Disease Control and Prevention, April 2025, in the 'Births: Provisional Data for 2024' report, the preterm birth rate in the United States was recorded at 10.41 percent. This sustained demand translates into significant commercial volume for established pharmaceutical-grade gas providers, verified by financial performance where, according to Mallinckrodt plc, March 2025, in the 'Fourth Quarter and Fiscal Year 2024 Financial Results', the INOmax franchise generated net sales of $60.8 million in the fourth quarter alone.

Technological Advancements in Portable and Precision Nitric Oxide Delivery Systems are simultaneously reshaping the competitive landscape by addressing the logistical limitations of traditional gas cylinder reliance. New tankless devices that generate nitric oxide from ambient air are gaining traction, facilitating easier transport and broader adoption in resource-limited settings outside the conventional intensive care unit. These innovations reduce the operational footprint for hospitals and simplify supply chains, driving rapid uptake of next-generation solutions. The commercial viability of this technological shift is reflected in the surging results of emerging players; for instance, according to Beyond Air, Inc., June 2025, in the 'Fourth Quarter and Full Year 2025 Financial Results' report, revenue for the tankless LungFit PH system increased by 220 percent year-over-year to $3.7 million. These advancements expand the addressable market by enabling therapy administration during patient transport and in lower-acuity wards where heavy cylinders were previously impractical.

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Key Market Challenges

The high cost of therapy and stringent reimbursement policies serve as a significant barrier to the expansion of the Global Inhaled Nitric Oxide Market. Healthcare institutions, particularly in budget-constrained environments, often face difficulties in justifying the substantial expenditure required for pharmaceutical-grade gas and specialized delivery systems. This financial pressure forces hospitals to restrict the use of inhaled nitric oxide to only the most severe cases, thereby preventing broader adoption across neonatal intensive care units. Consequently, the market struggles to penetrate price-sensitive regions where alternative or less expensive treatments are prioritized over this premium intervention.

This economic burden is substantial when calculated over the duration of a standard treatment course. According to the National Institutes of Health, in 2024, the cost of inhaled nitric oxide therapy was estimated to be approximately $220 per hour. Such high operational expenses complicate the reimbursement landscape, prompting insurance providers to enforce strict inclusion criteria to manage healthcare spending. These rigorous policies frequently lead to claim denials or limited coverage, which discourages healthcare facilities from stocking or routinely administering the therapy, directly hampering overall market growth.

Key Market Trends

The focus on Non-Invasive Delivery for Chronic Respiratory Conditions is fundamentally altering the market landscape, shifting therapeutic applications beyond the traditional neonatal intensive care unit. Industry players are increasingly investing in the development of lightweight, ambulatory devices capable of generating nitric oxide on-demand, which enables the long-term management of adult indications such as pulmonary hypertension associated with interstitial lung disease in home settings. This strategic pivot toward treating chronic patient populations is supported by substantial capital inflows aimed at commercializing next-generation technologies; for instance, according to Third Pole Therapeutics, March 2025, in the 'Company Information' update, the company secured a $16.9 million funding round to accelerate the development and deployment of its portable, cylinder-free nitric oxide platform designed specifically for these expanded care environments.

Simultaneously, there is a significant acceleration in Strategic Alliances for Integrated Respiratory Care Solutions to facilitate global market penetration and streamline therapy delivery. Manufacturers are moving away from exclusive direct sales models in international territories, opting instead to execute partnership agreements with regional distributors to navigate complex regulatory frameworks and bundle nitric oxide therapies with complementary respiratory products. This expansion strategy is evidenced by recent commercial developments where, according to Beyond Air, Inc., December 2025, in the 'Beyond Air Signs New International LungFit PH Distribution Agreements' press release, the company successfully broadened its global commercial footprint to 39 countries by finalizing new distribution contracts for key markets including Germany and Brazil.

Segmental Insights

The Asthma and Chronic Obstructive Pulmonary Disease segment is currently recognized as the fastest-growing category within the Global Inhaled Nitric Oxide Market. This rapid expansion is primarily driven by the rising global prevalence of chronic respiratory conditions and the technological transition toward portable delivery systems. Unlike traditional treatments restricted to hospital settings, recent innovations in lightweight devices allow for effective ambulatory care and home-based disease management. Consequently, the increasing demand for accessible long-term therapeutic solutions is significantly accelerating the adoption of nitric oxide for treating these non-critical respiratory indications.

Regional Insights

North America currently holds the dominant position in the global inhaled nitric oxide market, driven by a well-established healthcare infrastructure and high healthcare expenditure. This leadership is primarily supported by the strong presence of key product manufacturers and proactive regulatory support from the US Food and Drug Administration. The region sees consistent demand due to the prevalence of neonatal hypoxic respiratory failure and pulmonary hypertension. Furthermore, widespread availability of specialized neonatal intensive care units and favorable reimbursement policies for respiratory therapies continue to facilitate market adoption throughout the United States and Canada.

Recent Developments

• In February 2025, Linde Gas & Equipment Inc. submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for the NOXBOX I PLUS, a new nitric oxide delivery and monitoring system. This submission represented an advancement over the company’s previous technology, incorporating targeted enhancements such as improved ergonomic design, streamlined setup procedures, and precise flow controls. The system was developed to deliver the company's nitric oxide gas product for inhalation to neonates with hypoxic respiratory failure, with the goal of improving user experience for clinicians and ensuring compatibility with various mechanical ventilators.
• In October 2024, Mallinckrodt plc announced the nationwide commercial rollout of its next-generation inhaled nitric oxide delivery system, the INOmax EVOLVE DS, in hospitals across the United States. This expansion followed a successful pilot program for the device, which had previously received FDA clearance. The new system was designed with enhanced automation, a proprietary mini-cylinder technology, and a streamlined profile to improve workflow efficiency and safety in neonatal intensive care units. The launch aimed to support healthcare professionals in treating term and near-term neonates suffering from hypoxic respiratory failure associated with pulmonary hypertension.
• In October 2024, Beyond Air, Inc. entered into a strategic partnership with Healthcare Links, a healthcare advisory and contracting firm, to broaden market access for its LungFit PH system. This collaboration was established to facilitate the entry of the company's generator-based nitric oxide delivery technology into Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) throughout the United States. The LungFit PH system, which generates nitric oxide from ambient air, was positioned to replace traditional cylinder-based logistics, and the partnership aimed to accelerate its adoption by streamlining contracting processes with major hospital networks.
• In February 2024, Third Pole Therapeutics announced the successful completion of an early feasibility study for its eNOfit device, a portable, tankless inhaled nitric oxide delivery system. The study, conducted under an Investigational Device Exemption, evaluated the safety and practicality of the wearable device for treating patients with pulmonary hypertension associated with interstitial lung disease. The results validated the system's ability to generate nitric oxide on demand using electricity and air, supporting the company's plan to advance to larger clinical trials and expand the use of inhaled nitric oxide therapy from hospital settings to home and ambulatory care.

Key Market Players

• Linde PLC
• Air Liquide Healthcare
• BOC Healthcare
• Matheson Tri-Gas Inc.
• Merck KGaA
• Nu-Med Plus Inc.
• Perma Pure LLC
• Praxair Distribution Inc.
• HALMA PLC

By Product Type	By Application	By Region
Gas Delivery Systems	Neonatal Respiratory Treatment Asthma and COPD Acute Respiratory Distress Syndrome Malaria Treatment Tuberculosis Treatment Other Applications	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Inhaled Nitric Oxide Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Inhaled Nitric Oxide Market, By Product Type:

• Gas
• Delivery Systems

• Inhaled Nitric Oxide Market, By Application:

• Neonatal Respiratory Treatment
• Asthma and COPD
• Acute Respiratory Distress Syndrome
• Malaria Treatment
• Tuberculosis Treatment
• Other Applications

• Inhaled Nitric Oxide 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