Global Inhaled Nitric Oxide Market By Product Type (Gas and Delivery System), By Application (Asthma & COPD, Neonatal Respiratory Treatment, Malaria Treatment, Acute Respiratory Distress Syndrome, and Tuberculosis Treatment), By End-user (Hospitals, Clinics, and Ambulatory Care), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Global Inhaled Nitric Oxide Market size is expected to be worth around USD 1.9 billion by 2033 from USD 0.9 billion in 2023, growing at a CAGR of 7.5% during the forecast period 2024 to 2033.

The rising demand for inhaled nitric oxide (iNO) therapies stems from their crucial role in treating respiratory and cardiovascular conditions such as pulmonary hypertension, asthma, and neonatal hypoxemia. The market benefits from the growing focus on non-invasive treatment options for these conditions, with applications spanning neonatology, cardiology, and respiratory care.

Inhaled nitric oxide’s ability to improve oxygenation and reduce pulmonary pressures makes it a vital tool in managing critical care patients. For instance, in March 2022, the Government of Canada reported 4.7 active TB cases per 100,000 persons, highlighting the need for respiratory therapies like iNO.

Additionally, an article published by Scientific Reports in August 2022 indicated that 3.8 million people in Canada were living with asthma during the COVID-19 pandemic, further emphasizing the opportunity for inhaled nitric oxide treatments. Recent trends include advancements in portable iNO delivery systems and increased research into its therapeutic potential beyond traditional applications, offering new growth avenues in the market.

Key Takeaways

• Market Size: Inhaled Nitric Oxide Market size is expected to be worth around USD 1.9 billion by 2033 from USD 0.9 billion in 2023.
• Market Growth: The market growing at a CAGR of 7.5% during the forecast period 2024 to 2033.
• Product Type Analysis: The gas segment led in 2023, claiming a market share of 54.7% in 2023
• Application Analysis: The neonatal respiratory treatment held a significant share of 24.1%.
• End-Use Analysis: The hospitals segment had a tremendous growth rate, with a revenue share of 60.2% in 2023
• Regional Analysis: In 2023, North America dominated the market with the highest revenue share of 38.7%.

By Product Type Analysis

The gas segment led in 2023, claiming a market share of 54.7% owing to the increasing adoption of nitric oxide therapy for treating various respiratory and cardiovascular conditions. Rising incidences of neonatal respiratory failure and pulmonary hypertension have driven the demand for nitric oxide gas, particularly in hospital settings. Technological advancements in gas production and delivery systems, which ensure precise dosing and patient safety, are expected to support the segment’s expansion.

Additionally, increased awareness of the therapeutic benefits of nitric oxide in reducing pulmonary vascular resistance and improving oxygenation is anticipated to drive its use across various medical conditions, further boosting demand for the gas segment.

By Application Analysis

The neonatal respiratory treatment held a significant share of 24.1% due to the rising prevalence of neonatal respiratory disorders such as persistent pulmonary hypertension of the newborn (PPHN). The increasing incidence of preterm births globally has heightened the demand for effective respiratory therapies.

Inhaled nitric oxide is widely recognized for its ability to improve oxygenation and reduce the need for invasive mechanical ventilation, making it an essential therapy in neonatal intensive care units. Ongoing research and clinical trials aimed at expanding the use of nitric oxide for additional neonatal respiratory conditions are likely to further propel growth in this segment.

By End-user Analysis

The hospitals segment had a tremendous growth rate, with a revenue share of 60.2% owing to the increasing number of hospital admissions for severe respiratory conditions requiring advanced therapies. Hospitals offer the infrastructure and expertise needed to administer nitric oxide therapy, particularly in intensive care units where critically ill patients, including neonates, require continuous monitoring.

The growing number of specialized hospital facilities equipped to handle complex respiratory cases, along with the rising adoption of advanced medical technologies, is expected to boost demand. Additionally, the emphasis on providing comprehensive care for acute respiratory distress syndrome (ARDS) and other life-threatening conditions is likely to further support the growth of the hospitals segment.

Key Market Segments

By Product Type

• Gas
• Delivery System

By Application

• Asthma & COPD
• Neonatal Respiratory Treatment
• Malaria Treatment
• Acute Respiratory Distress Syndrome
• Tuberculosis Treatment

By End-user

• Hospitals
• Clinics
• Ambulatory Care

Drivers

Growing respiratory Issues in Neonates

Rising respiratory issues in neonates are expected to drive the inhaled nitric oxide market. Premature infants, especially those with extremely low birth weight (ELBW), often experience severe respiratory complications, leading to frequent hospital readmissions. Data published by the National Institute of Health in 2022 indicate that former premature neonates face significantly higher respiratory illness rates during the first years of life, with this increased risk persisting until they reach 8–10 years of age.

These ongoing respiratory challenges elevate the need for therapies like inhaled nitric oxide, which helps improve oxygenation and reduce pulmonary hypertension in newborns. As the incidence of such neonatal respiratory disorders grows, demand for this therapy is anticipated to increase, driving market expansion.

Restraints

Rise in Regulatory Hurdles

Rising regulatory hurdles hamper the growth of the inhaled nitric oxide market. Strict regulations governing the use of inhaled nitric oxide, particularly in neonates, create challenges for manufacturers in gaining approvals for new indications or formulations. Regulatory agencies impose stringent clinical trial requirements to ensure patient safety, delaying the time to market for new products.

These extended approval timelines and additional costs associated with regulatory compliance are projected to impede the entry of innovative therapies into the market. Furthermore, variations in regulatory standards across different regions further complicate global distribution strategies, creating additional restraints for the overall market growth.

Opportunities

Increasing Research & Development

Increasing research and development in respiratory therapeutics presents a substantial opportunity for the inhaled nitric oxide market. Ongoing innovation in drug delivery systems and the exploration of new therapeutic applications are driving interest in this field. For instance, in May 2023, Pieris Pharmaceuticals, Inc. announced a successful safety survey of its 10 mg dry powder formulation in a multi-center, placebo-controlled phase 2a study targeting respiratory disorders.

Such advancements highlight the potential for expanding the use of inhaled nitric oxide in treating a wider range of respiratory conditions. As R&D investments continue to rise, this is projected to lead to the development of more effective and accessible inhaled nitric oxide therapies, thereby fueling market growth.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors significantly impact the inhaled nitric oxide market, influencing both growth opportunities and challenges. Economic downturns in certain regions can limit healthcare spending, affecting the adoption of advanced treatments. Geopolitical instability, including trade restrictions and supply chain disruptions, can cause delays in the delivery of essential medical gases, increasing costs for healthcare providers.

On the positive side, government initiatives to improve respiratory care and the expansion of healthcare infrastructure in emerging markets drive demand for inhaled nitric oxide treatments. Furthermore, growing awareness of its therapeutic benefits in treating respiratory conditions has created promising growth avenues, despite the existing challenges.

Latest Trends

Increasing Investments in Nitric Oxide-based Therapeutics

Increasing investments in nitric oxide-based therapeutics represent a key trend driving the inhaled nitric oxide market. Pharmaceutical companies are focusing on innovative applications of nitric oxide in treating a variety of medical conditions. In August 2022, SaNOtize Research & Development Corp. secured an oversubscribed USD 24 million Series B funding to advance its nitric oxide-based therapeutics pipeline, with its lead product, a nitric oxide nasal spray (NONS), showing efficacy in treating and preventing COVID-19.

This trend is anticipated to further accelerate research and development in the field, driving future market expansion. Rising interest in nitric oxide’s therapeutic potential is likely to generate more investment, fostering innovation and improved patient outcomes.

Regional Analysis

North America is leading the Inhaled Nitric Oxide Market

North America dominated the market with the highest revenue share of 38.7% owing to the increasing recognition of its therapeutic benefits, particularly in treating neonatal hypoxia and pulmonary hypertension. The expansion of healthcare facilities equipped to administer this therapy has further supported market dynamics.

A pivotal development occurred in January 2021, when VERO Biotech secured a loan of US$ 50 million from Runway Growth Capital LLC to advance the GENOSYL Delivery System, a tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration. This innovation addresses the demand for more efficient and portable delivery methods, enhancing the treatment’s accessibility.

Additionally, ongoing clinical research and positive outcomes associated with inhaled nitric oxide therapy have spurred adoption among healthcare providers, contributing to robust market growth across the region.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Asia Pacific is expected to grow with the fastest CAGR owing to rising healthcare investments and an increasing prevalence of respiratory disorders. Countries like India and China are projected to lead this growth, driven by enhanced awareness of the benefits of nitric oxide therapy in critical care settings.

In January 2021, SOL strengthened its position in the Indian technical and medical gases market by increasing its 85% stake in the joint venture “SICGILSOL,” which was the first operator in India to provide inhaled nitric oxide therapy. This strategic move demonstrates the growing commitment to developing advanced medical gas distribution systems in line with international standards. As healthcare infrastructure improves and more hospitals adopt this therapy, the market is likely to experience accelerated growth, driven by the demand for innovative respiratory treatments.

Key Regions and Countries

North America

• US
• Canada

Europe

• Germany
• France
• The UK
• Spain
• Italy
• Russia
• Netherland
• Rest of Europe

Asia Pacific

• China
• Japan
• South Korea
• India
• Australia
• New Zealand
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• South Africa
• Saudi Arabia
• UAE
• Rest of MEA

Key Players Analysis

The major players in the Inhaled Nitric Oxide market are actively engaged in the development and introduction of innovative products, as well as implementing strategic initiatives aimed at enhancing their competitive positioning. Key players in the inhaled nitric oxide market focus on developing portable and user-friendly delivery systems to improve patient access and convenience.

They engage in strategic collaborations with hospitals and healthcare providers to expand their distribution networks. Companies prioritize clinical trials to demonstrate the efficacy of nitric oxide therapy in treating various respiratory conditions, enabling regulatory approvals and market expansion. Many also invest in entering emerging markets, where respiratory diseases are on the rise.

Additionally, these players emphasize ongoing research to explore new therapeutic applications, ensuring sustained market growth.

Top Key Players

• Zylo Therapeutics Inc.
• Vero Biotech
• SOL
• Praxair, Inc.
• Mallinckrodt Pharmaceuticals
• International Biomedical
• Bellerophon Therapeutics

Recent Developments

• In February 2023, Vero Biotech announced that the FDA accepted its second-generation Genosyl system for use with rebreathing anesthesia in functional room settings. Genosyl delivers inhaled nitric oxide, an important therapeutic gas, and the upcoming third-generation device, which recently received FDA approval, is yet to be validated for use with rebreathing anesthesia. This advancement is relevant to the growth of the inhaled nitric oxide market by expanding its applications in clinical settings, particularly in anesthesia.
• In August 2022, Zylo Therapeutics Inc. received a two-year USD 600,000 Small Business Innovation Research (SBIR) grant to finalize the formulation of its proprietary nitric oxide-releasing topical drug for the treatment of onychomycosis. The grant was awarded by the National Institute of Allergy and Infectious Diseases, part of the NIH. While focused on a topical drug, this development highlights the ongoing innovation in nitric oxide delivery methods, supporting the overall expansion of the nitric oxide market, including inhaled applications.

Report Scope