Press Release

The global inhaled nitric oxide market revenue surpassed US$ 266.17 million in 2024 and is predicted to attain around US$ 474.72 million by 2033, growing at a CAGR of 6.64% during the forecast period from 2025 to 2033.

The growth of this market is primarily driven by the increasing incidence of respiratory and related diseases, along with ongoing research and development efforts. A significant factor contributing to this growth is the rise in chronic respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), and tuberculosis (TB).

The prevalence of COPD differs across regions and demographic groups. In 2019, the global prevalence of COPD among individuals aged 30 to 79 years was 10.3%. In India, the prevalence for those aged 30 and older was around 7%. Severe asthma is particularly prevalent in emerging markets in the Middle East, Africa, and Latin America, while North America and Europe experience a moderate prevalence.

Additionally, the increasing number of reported malaria cases worldwide is driving up the demand for inhaled nitric oxide. This treatment helps decrease endothelial activation and parasite buildup in the brain, improving survival rates in cases of cerebral malaria. According to a July 2022 report from the World Health Organization (WHO), there were an estimated 241 million malaria cases globally in 2020.

Inhaled Nitric Oxide Market Key Takeaways:

• The inhaled nitric oxide market is projected to reach a valuation of US$ 474.72 million by 2033, growing at a compound annual growth rate (CAGR) of 6.64% during the forecast period from 2025 to 2033. This growth underscores the increasing recognition of inhaled nitric oxide as a vital therapeutic option in various medical applications.
• In terms of system type, the cylinder-based system has emerged as the leading segment within the inhaled nitric oxide market, accounting for over 53.1% of the revenue share. This dominance can be attributed to the systems' proven reliability and compatibility with a wide range of ventilators, making them a preferred choice in clinical settings.
• By type, the pediatric segment holds a significant position, representing over 77.5% of the market share in 2024. This segment's growth is primarily driven by the therapy's effectiveness in managing persistent pulmonary hypertension and respiratory failure in newborns, highlighting the critical role of inhaled nitric oxide in neonatal care.
• When examining components, Acute Respiratory Distress Syndrome (ARDS) remains a leading indication for inhaled nitric oxide therapy, with over 59% market share. The therapy is favored for its ability to enhance oxygenation and reduce pulmonary hypertension in ARDS patients. Notably, the National Heart, Lung, and Blood Institute has reported 36 active clinical trials investigating nitric oxide as a complementary treatment for ARDS patients suffering from severe hypoxemia, demonstrating its potential in critical care scenarios.
• In terms of end users, hospitals dominate the inhaled nitric oxide market, comprising over 85.59% of the market share. This trend is evidenced by the increased procurement and utilization of iNO across leading medical centers. For instance, the Mayo Clinic has reported administering over 4,500 nitric oxide treatments this year, underscoring the therapy's significance in critical care applications and its growing acceptance in hospital protocols.

Europe Leads the Global Inhaled Nitric Oxide Market, Capturing 41% of Revenue Share

Europe maintains a dominant position in the inhaled nitric oxide (iNO) market, commanding 41.3% of the market share. This leadership is attributed to several factors, including advanced healthcare systems, extensive clinical research networks, and well-established expertise in managing complex respiratory conditions. The region’s commitment to innovative medical practices and high-quality patient care has fostered an environment conducive to the growth of iNO therapies.

The burgeoning demand for inhaled nitric oxide in Europe is primarily driven by specialized sectors such as neonatal departments, critical care units, and cardiac surgery theaters. These areas rely heavily on iNO to provide targeted breathing support and to reduce the duration of mechanical ventilation. The application of iNO in these settings has proven essential, particularly in managing patients with severe respiratory challenges or critical conditions requiring advanced therapeutic interventions.

Frontline clinicians in the UK are also increasingly exploring the role of iNO in respiratory rehabilitation programs. Reports indicate that patients undergoing such programs experience robust outcomes, showcasing the therapy's effectiveness in enhancing respiratory function and overall recovery. This innovative approach demonstrates the region’s commitment to advancing treatment options and improving patient care.

Market Overview

Nitric oxide is an important molecule in vascular homeostasis and the maintenance of multiorgan viability. It is useful in cardio-cerebrovascular, respiratory disorders, and antimicrobial properties. By predominantly widening circulating pulmonary arteries, inhaled nitric oxide enhances ventilation-perfusion matching and arterial oxygenation by increasing blood flow toward ventilated parts of the lungs. Nitric oxide supplementation is popular among athletes and fitness enthusiasts. It enhances exercise performance by increasing blood flow, oxygen delivery, and muscle nutrient uptake. Major key players involved in the market revolve around the distribution of nitrogen, argon, hydrogen, carbon monoxide, and oxygen through their industries' pipeline connections. The distribution is done under observation by the key players in various end-user industries include healthcare and pharmaceuticals.

Inhaled Nitric Oxide Market Growth Factors

Driver

Growing Neonatal Care Expansions: The field of neonatal care is experiencing significant expansions, with a strong emphasis on prioritizing advanced inhaled nitric oxide (iNO) treatments for infants with respiratory distress. As the understanding of neonatal conditions like hypoxic respiratory failure deepens, healthcare providers are increasingly recognizing the benefits of iNO therapy in improving oxygenation and reducing the need for mechanical ventilation. 

Increased ARDS Management Protocols: In acute respiratory distress syndrome (ARDS) management, there is a noticeable shift towards utilizing novel nitric oxide dispensing technologies. As ARDS presents a significant challenge in critical care settings, healthcare providers are exploring innovative approaches to enhance patient treatment protocols. New iNO delivery systems, which offer precision dosing and real-time monitoring capabilities, are being integrated into ARDS management strategies. 

Surging Demand for Combined Cardiopulmonary Therapies: The demand for combined cardiopulmonary therapies is surging, driven by a collective push to enhance patient recovery outcomes in various clinical settings. This surge is fueled by emerging evidence that supports the synergistic effects of combining therapies to optimize oxygenation and reduce pulmonary hypertension. As recent clinical studies highlight the benefits of such combinations, healthcare facilities are increasingly adopting these integrated treatment protocols.

Restraint

Device Calibration Complexities: The complexities of device calibration present significant challenges in ensuring consistent dosing of inhaled nitric oxide (iNO) across various care settings. Accurate calibration is crucial for the effective delivery of nitric oxide, as even minor discrepancies can lead to variations in dosage that could affect patient outcomes. 

Supply Chain Disruptions: Supply chain disruptions have emerged as a critical barrier to accessing specialized components necessary for the production and delivery of nitric oxide systems. Factors such as global logistics issues, raw material shortages, and manufacturing delays can significantly impact the availability of essential components, including tanks, delivery systems, and monitoring equipment. These disruptions not only delay the rollout of new technologies but can also hinder the maintenance and servicing of existing systems. 

Clinical Outcome Disparities: Disparities in clinical outcomes across different hospital networks significantly influence the adoption rates of inhaled nitric oxide therapy. Variations in patient populations, treatment protocols, and the experience of healthcare providers can lead to inconsistent results in the efficacy of iNO therapy. In some institutions, positive outcomes and successful case studies may drive enthusiasm and investment in iNO technologies, while in others, negative experiences or lack of tangible benefits may result in skepticism and hesitance to adopt. 

Top Trends

Transition to Portable iNO Systems: The move towards portable inhaled nitric oxide (iNO) systems is revolutionizing the landscape of critical care environments. These systems are designed for easy transport and can be utilized in a range of settings, from neonatal intensive care units to emergency transport situations. 

Collaborative Clinical Trials for Personalized Therapy: Collaborative clinical trials are playing a pivotal role in advancing our understanding of personalized inhaled nitric oxide therapy. These trials bring together diverse teams of researchers, clinicians, and institutions to explore the efficacy and safety of iNO therapy tailored to individual patient needs.

Digital Integration in Respiratory Monitoring: The integration of digital technologies is transforming the field of respiratory monitoring and nitric oxide delivery. With the advent of smart devices and real-time data analytics, healthcare professionals can now monitor patients’ respiratory parameters more effectively. This real-time monitoring allows for rapid adjustments to therapy based on patient response, ensuring optimal delivery of nitric oxide.

Recent Developments

• In December 2023, Mallinckrodt plc, a global specialty pharmaceutical company, revealed that the INOmax® EVOLVE™ DS delivery system has received clearance from the U.S. Food and Drug Administration (FDA) for delivering INOmax® (nitric oxide) gas for inhalation.
• In February 2023, Vero Biotech announced the FDA's approval of its second-generation Genosyl system for use with rebreathing anesthesia in the operating room. This system, designed specifically for inhaled nitric oxide (iNO) delivery, marks a significant advancement in the company's technology.
• In January 2023, VERO Biotech Inc., a healthcare company focused on neonatal intensive care and acute care hospitals, announced the successful completion of a $30 million financing with Petrichor, a prominent healthcare growth capital provider. The funds will support the continued development and commercialization of VERO Biotech's GENOSYL Delivery System (DS), a tankless inhaled nitric oxide (iNO) delivery solution.

Global Inhaled Nitric Oxide Market Key Players

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

Market Segmentation

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 Applications (COPD)
• Acute Respiratory Distress Syndrome (ARDS)
• Others

By End User

• Hospitals
• Clinics
• Ambulatory Centers

By Geography

• North America
• Europe
• Asia Pacific
• South America
• Middle East & Africa (MEA)

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