Global Inhaled Nitric Oxide Market: By System, Type, Component, Application, End Users, Region - Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2025-2033

The inhaled nitric oxide (iNO) market is experiencing substantial growth, with its valuation reaching approximately US$ 266.17 million in 2024. Projections indicate that this market will nearly double by 2033, reaching an estimated value of US$ 474.72 million. This growth corresponds to a compound annual growth rate (CAGR) of 6.64% between 2025 and 2033, reflecting strong and sustained demand for iNO therapies across various healthcare sectors.

One of the primary drivers behind the market's robust expansion is the increasing focus on neonatal care, where inhaled nitric oxide plays a critical role in treating respiratory complications in newborns. Alongside this, the development of portable iNO systems has revolutionized respiratory therapy by offering greater flexibility and accessibility, particularly during patient transfers and in resource-limited settings. These portable devices enhance the ability of clinicians to deliver timely and effective care outside traditional intensive care environments.

Noteworthy Market Developments

The inhaled nitric oxide (iNO) market is characterized by a highly competitive landscape, dominated by key global players, such as Mallinckrodt Pharmaceuticals, Linde plc, and Air Liquide. These companies continuously vie for market leadership through innovative product development, strategic partnerships, and efforts to broaden their global presence. Their competition drives advancements in technology and service, ensuring that healthcare providers have access to reliable and effective iNO therapies. In 2024, this competitive spirit is reflected in significant investments to increase production capacity, aiming to meet the growing and steady demand for inhaled nitric oxide in clinical settings worldwide.

For instance, Linde plc enhanced its production capabilities by activating a specialized wing at its facility in the Netherlands dedicated exclusively to manufacturing high-purity nitric oxide canisters. This expansion underscores Linde's strategic focus on maintaining robust and dependable supply chains, which are critical for continuous patient care. Similarly, Air Liquide has expanded its operations in the United States by commissioning a new production site in Texas.

Meanwhile, Praxair in Poland has optimized its packaging and distribution network by dedicating four separate hubs to the processing and packaging of nitric oxide cylinders. This strategic move minimizes downtime between batch production and delivery, allowing for a smoother and more efficient supply chain. By reducing delays, Praxair helps ensure that healthcare facilities can maintain adequate inventories of inhaled nitric oxide, ultimately supporting better patient outcomes.

Core Growth Drivers

Efforts to enhance neonatal care on a global scale are significantly driving the expansion of the inhaled nitric oxide (iNO) market by bringing increased attention to respiratory complications that affect the earliest stages of life. The growing recognition of the critical need to address these conditions has motivated public health organizations to actively promote and subsidize iNO solutions, especially in resource-limited areas where access to advanced respiratory therapies remains a challenge. These initiatives aim to bridge gaps in neonatal care by improving the availability and affordability of inhaled nitric oxide treatments, which are essential for managing life-threatening conditions such as persistent pulmonary hypertension of the newborn (PPHN).

Emerging Opportunity Trends

A significant transformation is underway in respiratory care with the increasing adoption of portable inhaled nitric oxide (iNO) systems, which are progressively replacing traditional cylinder-based setups in intensive care units (ICUs) and surgical theaters. This shift is driven by the growing demand for more flexible and convenient delivery methods that can better accommodate the dynamic nature of patient care. Over the past nine months, more than 50 tertiary care hospitals across North America have integrated mobile iNO units into their treatment protocols. These portable systems allow clinicians to administer nitric oxide therapy with greater ease, especially during patient transfers between departments or facilities, ensuring continuous and effective respiratory support without interruption.

Barriers to Optimization

Device calibration complexities are posing significant challenges to achieving consistent dosing of inhaled nitric oxide (iNO) across various care settings, which is crucial for effective therapeutic administration. Industry reports reveal that 70 mobile healthcare units operating in remote regions have encountered calibration discrepancies, resulting in variations in iNO concentration by several parts per million. Such fluctuations can compromise treatment efficacy and patient safety, highlighting the critical need for precise calibration to maintain the intended therapeutic dose. These challenges are particularly pronounced in mobile or resource-limited settings, where environmental factors and equipment constraints may further complicate calibration efforts.

Detailed Market Segmentation

By System, cylinder-based systems have emerged as the dominant technology in the inhaled nitric oxide market, commanding a revenue share exceeding 53.1%. This leadership position is largely due to their well-established reliability and broad compatibility with various ventilator models used in critical care settings. These systems have become the preferred choice for healthcare providers because they consistently deliver precise and controlled doses of nitric oxide, which is essential for managing severe respiratory conditions. Their robust design and ease of integration with existing respiratory equipment ensure that they remain a trusted solution in intensive care units worldwide.

By Type, in 2024, the pediatric segment of the inhaled nitric oxide market captured a dominant share of over 77.5%, due to the therapy's critical importance in treating newborns with respiratory complications. This strong market presence is largely driven by the proven efficacy of inhaled nitric oxide in managing persistent pulmonary hypertension of the newborn (PPHN) and respiratory failure, conditions that require immediate and effective intervention to prevent long-term damage or mortality. For many neonates facing hypoxic respiratory challenges, inhaled nitric oxide provides a lifesaving alternative to more invasive procedures, helping to improve oxygenation and reduce the risk of complications associated with mechanical ventilation or surgery.

By Component, Acute Respiratory Distress Syndrome (ARDS) continues to be the leading component driving the inhaled nitric oxide market, holding over 59% of the market share. The widespread use of inhaled nitric oxide for ARDS is mainly due to its proven ability to enhance oxygenation and reduce pulmonary hypertension, both of which are critical factors in managing this severe respiratory condition. ARDS patients often suffer from severe hypoxemia, a dangerously low level of oxygen in the blood, and inhaled nitric oxide serves as an effective adjunct therapy to improve their respiratory function and overall outcomes.

By End Users, hospitals remain the predominant end users in the inhaled nitric oxide market, commanding a substantial market share of over 85.59%. This dominance is clearly reflected in the heightened procurement and utilization of nitric oxide therapies across some of the world's leading medical institutions. For instance, the Mayo Clinic has reported administering more than 4,500 nitric oxide treatments within the current year, underscoring the critical role this therapy plays in managing severe respiratory and critical care cases. The widespread acceptance of inhaled nitric oxide in hospital settings highlights its importance as a lifesaving intervention for patients with complex respiratory conditions.

Segment Breakdown

• By System
• Cylinder-Based System
• Electric System
• Chemical-Based System

By Type

• Adults
• Pediatrics

By Components

• Hardware
• Mechanical Ventilator
• Flow Sensor
• Respiratory Circuits Connectors
• Nitric Oxide Container
• Nitric Oxide Analyzer
• Inlet & Outlet Pipe
• Digital Monitor
• Services
• Managed Services
• Professional Services
• Consulting
• Support & Maintenance

By Applications

• Pulmonary Hypertension
• Tuberculosis Treatment
• Malaria Treatment
• Chronic Obstructive Pulmonary Disease (COPD)
• Acute Respiratory Distress Syndrome (ARDS)
• Others

By End User

• Hospitals
• Clinics
• Ambulatory Centers

By Region

• North America
• The U.S.
• Canada
• Mexico
• Europe
• Western Europe
• The UK
• Germany
• France
• Italy
• Spain
• Rest of Western Europe
• Eastern Europe
• Poland
• Russia
• Rest of Eastern Europe
• Asia Pacific
• China
• India
• Japan
• Australia & New Zealand
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East & Africa (MEA)
• Saudi Arabia
• South Africa
• UAE
• Rest of MEA
• South America
• Argentina
• Brazil
• Rest of South America

Geography Breakdown

• Europe holds a commanding position in the inhaled nitric oxide (iNO) market, capturing 41.3% of the global market share. This dominance is largely attributed to the region's sophisticated healthcare infrastructure, well-established clinical research networks, and extensive experience in managing complex respiratory conditions. These factors collectively enable Europe to lead in the adoption and utilization of iNO therapies. The region's commitment to advancing patient care is evident through the high volume of iNO-based interventions carried out in neonatal wards.
• Germany stands out as the leader within Europe, performing close to 4,000 neonatal iNO procedures monthly, indicating its advanced neonatal care capabilities. The United Kingdom follows, with nearly 900 specialized iNO generators deployed across National Health Service hospitals, ensuring broad access to this critical therapy. France also contributes significantly, with cardiology departments conducting around 2,500 nitric oxide-assisted procedures during the first half of 2023, highlighting the treatment's importance beyond neonatal care into cardiovascular applications.

Leading Market Participants

• Air Liquide Healthcare
• Bellerophon Therapeutics
• Beyond Air
• Circassia Pharmaceuticals
• Getinge
• International Biomedical
• LINDE
• Mallinckrodt Pharmaceuticals
• Praxair (NoxBox)
• SLE
• Vero Biotech
• Other major players