The global inhaled nitric oxide market, which is expected to be valued at USD 1.31 billion in 2025, is on a trajectory of rapid expansion. Projections indicate a USD 2.21 billion valuation by 2032, exhibiting a CAGR of 7.7% during the forecast period. The market expansion is driven by the increasing incidence of respiratory and pulmonary conditions, such as neonatal hypoxic respiratory failure (HRF) and persistent pulmonary hypertension (PPHN). Moreover, rising investments in sophisticated respiratory therapies, expanding use of inhaled nitric oxide in critical care, and innovation in drug delivery systems are driving the market growth.
Key Market Insights
- By product type, the inhaled nitric oxide delivery systems segment is expected to dominate the market with 40.6% in 2025. The growing use of sophisticated delivery systems in critical care and innovation in inhalation therapy are propelling this segment's growth.
- By application, the neonatal respiratory treatment segment is expected to lead the market with 35.62% share in 2025. The rising prevalence of neonatal hypoxic respiratory failure (HRF) and growing adoption of inhaled nitric oxide therapy in neonatal intensive care units (NICUs) are key factors fueling this demand.
- By strength, the 100 ppm segment is expected to lead the market with 46.62% share in 2025. This expansion is due to its extensive application in the treatment of respiratory disorders, especially in neonates, where accurate and efficient dosing is paramount for patient outcome.
- In terms of region, the North America region is projected to lead the market and account for 39.7% of the entire market share in 2025. This growth is driven by the high prevalence of pulmonary diseases, strong healthcare infrastructure, increased adoption of advanced respiratory therapies, and a rising number of preterm births requiring inhaled nitric oxide therapy.
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Inhaled Nitric Oxide Market Report Coverage
Report Coverage |
Details |
Market Revenue in 2025 |
USD 1.31 billion |
Estimated Value by 2032 |
USD 2.21 billion |
Growth Rate |
7.7% |
Historical Data |
2020–2024 |
Forecast Period |
2025–2032 |
Forecast Units |
Value (USD billion) |
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
Segments Covered |
By Product Type, By Application, By Strength, and By End User |
Geographies Covered |
North America, Latin America, Europe, Asia Pacific, Middle East, and Africa |
Growth Drivers |
· Increasing Incidence of Preterm Births and Respiratory Complications in Neonates · Rising Research and Development Activities in Therapeutic Applications of Inhaled Nitric Oxide |
Restraints & Challenges |
· High Costs Associated with Inhaled Nitric Oxide Therapy · Limited Availability of Inhaled Nitric Oxide Delivery Systems in Developing Regions |
Market Dynamics
The inhaled nitric oxide market is witnessing robust growth as a result of the growing incidence of respiratory diseases, especially in neonatal and critical care. Increasing awareness regarding the advantages of inhaled nitric oxide therapy, along with improvements in delivery systems, is also fueling the market growth.
In October 2024, the INOmax Evolve DS system was employed at SSM Health St. Mary's Hospital in Madison, Wisconsin, marking the first U.S. hospital to adopt the technology. This next-generation nitric oxide delivery device is integrated with mechanical ventilation and provides automated calibration and simplified setup for maximizing efficiency in respiratory therapy for critical-care patients.
Moreover, the rising use of inhaled nitric oxide in the management of pulmonary hypertension, acute respiratory distress syndrome (ARDS), and chronic obstructive pulmonary disease (COPD) is driving demand.
Market Trends
Advancements in Portable and Cylinder-Free iNO Delivery Systems
The inhaled nitric oxide market is witnessing a shift toward cylinder-free and portable delivery systems due to the increasing demand for enhanced accessibility, safety, and ease of use. Traditional cylinder-based delivery methods are being replaced by on-demand nitric oxide generators, reducing storage and transportation challenges in hospital settings.
For instance, in June 2022, VERO Biotech received the FDA clearance for its third-generation GENOSYL Delivery System (GENOSYL DS). The tankless system produces iNO at the bedside using a small disposable cassette, eliminating the need for large, cumbersome tanks and simplifying clinical workflows.
Expansion of Inhaled Nitric Oxide Therapy in Emerging Markets
Emerging markets, particularly across Asia Pacific and Latin America, are witnessing a notable surge in the demand for inhaled nitric oxide (iNO) therapy, fueled by rapid advancements in healthcare infrastructure and the increased awareness of advanced respiratory treatments. The growing incidence of neonatal hypoxic respiratory failure (HRF), pulmonary hypertension, acute respiratory distress syndrome (ARDS), and chronic obstructive pulmonary disease (COPD) has enhanced the need for efficient pulmonary treatments in these markets. Therefore, the government and hospitals are taking strenuous efforts in extending the facility for iNO therapy to maximize availability so that new-born and serious patients gain benefit from instant and life-restoring therapy.
For instance, in February 2022, in a study involving doctors from Amrita Hospital, Kochi, and scientists from the School of Biotechnology at Amrita Vishwa Vidyapeetham, a novel intervention for COVID-19 has been explored with the well-known gas Nitric Oxide (NO). This gas has for many years been used worldwide for the treatment of medical conditions like the Blue Baby Syndrome and for the treatment of heart or lung transplant patients. The study conducted by Amrita scientists has found that inhaled Nitric Oxide (iNO) is virucidal and kills SARS-COV-2 virus, apart from preventing its effective attachment to human host cells.
Market Opportunities
Growing Popularity of iNO Therapy beyond Neonatal Care
While inhaled nitric oxide has been primarily used in neonatal hypoxic respiratory failure (HRF), its application is expanding into pulmonary hypertension, acute respiratory distress syndrome (ARDS), and chronic obstructive pulmonary disease (COPD). Increasing clinical data on its effectiveness in adult critical care and outpatient respiratory treatment are enhancing its use in emergency medicine and home therapy.
In March 11, 2025, Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company with an emphasis on tapping the healing potential of nitric oxide (NO) for better patient lives, announced adding four new global distribution channels to LungFit PH in several agreements, which cover France, Romania, Turkey, and Morocco.
Rising Adoption of iNO Therapy in Postoperative Cardiac Care
The application of inhaled nitric oxide (iNO) therapy is gaining significant traction in postoperative cardiac care, especially for cardiac surgery and heart-lung transplantation patients. iNO has emerged as an efficient drug to control pulmonary hypertension, augment oxygenation, and maintain hemodynamic stability in postoperative patients. Due to the increase in cardiac surgeries around the globe, hospitals and intensive care units are adapting iNO therapy as a routine postoperative procedure for cardiac patients to enhance recovery as well as prevent complications.
Analyst’s View
“The inhaled nitric oxide market is poised for substantial growth, driven by increasing adoption in critical care and expanding applications beyond neonatal therapy,” said Ghanshyam Shrivastava, a senior analyst. "Technological advancements, such as portable and cylinder-free iNO delivery systems, are transforming respiratory therapy, enhancing access and lessening logistical difficulties in hospital and home-care environments.”
“Additionally, increased investment in research and development is propelling the adoption of iNO for treating pulmonary hypertension, acute respiratory distress syndrome (ARDS), and postoperative cardiac management. New markets in Asia Pacific and Latin America are experiencing high demand growth, driven by improved healthcare infrastructure and government policies aimed at enhancing respiratory care. Through ongoing drug delivery system innovation and broadening therapeutic areas, the inhaled nitric oxide market is poised to witness sustained growth in the future.”
Recent Developments
- In December 2023, Mallinckrodt plc, a global specialty pharmaceutical company, announced that the INOmax EVOLVEDS delivery system has been cleared by the U.S. Food and Drug Administration (FDA) for the delivery of INOmax (nitric oxide) gas, for inhalation. The INOmax EVOLVE DS delivers INOmax into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the gas delivery system waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with the ventilators and respiratory care devices for which INOmax EVOLVE DS has been validated.
Market Segmentation
- Product Type Insights
- Inhaled Nitric Oxide Delivery Systems
- Consumables
- Nitric Oxide Cylinders
- Delivery Accessories
- Others
- Application Insights
- Neonatal Respiratory Treatment
- Chronic Obstructive Pulmonary Disease (COPD)
- Acute Respiratory Distress Syndrome (ARDS)
- Tuberculosis Treatment
- Malaria Treatment
- Others
- Strength Insights
- 100 ppm
- 800 ppm
- Others
- End User Insights
- Hospitals
- Ambulatory Surgical Centers
- Home Care Settings
Regional Insights
-
- North America
- U.S.
- Canada
- Latin America
- Brazil
- Argentina
- Mexico
- Rest of Latin America
- Europe
- Germany
- U.K.
- Spain
- France
- Italy
- Russia
- Rest of Europe
- Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- ASEAN
- Rest of Asia Pacific
- Middle East
- GCC Countries
- Israel
- Rest of Middle East
- Africa
- South Africa
- North Africa
- Central Africa
- North America