INHALED NITRIC OXIDE MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

Inhaled Nitric Oxide Market Size and Trends

The Inhaled Nitric Oxide Market is estimated to be valued at USD 1.22 Bn in 2024 and is expected to reach USD 2.03 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 7.5% from 2024 to 2031.

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The non-invasive nature of inhaled nitric oxide and its selective vasodilating property helps in improving oxygenation in newborn babies suffering from hypoxic respiratory failure. This makes inhaled nitric oxide an attractive therapeutic option over other conventional vasodilators. Furthermore, rising incidences of pre-term births worldwide has significantly contributed to the rising cases of neonatal pulmonary hypertension, thereby increasing the demand for inhaled nitric oxide. Growing awareness regarding the benefits of inhaled nitric oxide and strong clinical evidence supporting its efficacy are further expected to support the market growth during the forecast period.

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Insights By Product Type – Inhaled Nitric Oxide Delivery Systems Segment Leads with Growing Demand for Precise Delivery

The Inhaled Nitric Oxide Delivery Systems segment dominates the market with 40.1% in 2024 due to its critical role in treating severe respiratory conditions, particularly in neonates and patients with hypoxemic respiratory failure. These systems ensure precise and continuous delivery of nitric oxide, enhancing oxygenation, and reducing pulmonary hypertension. The increasing prevalence of respiratory diseases and advancements in portable delivery technologies further drive demand, making these systems essential in both hospital and outpatient settings

Insights By Application - Expanding Treatment Avenues Stimulate Neonatal Respiratory Segment Growth

The neonatal respiratory treatment segment is expected to lead the market with 35.12% share in 2024, driven by rising preterm birth rates and increased awareness of nitric oxide. According to WHO, 1 in 10 babies are born preterm, often facing respiratory complications. Inhaled nitric oxide therapy is the standard for preterm neonates, reducing issues like pulmonary hypertension. With higher survival rates and rising chronic lung diseases, hospitals are adopting nitric oxide therapies for respiratory health.

Insights By Strength - 100 ppm Dominates on Account of Established Efficacy and Dosing Flexibility

The 100 ppm segment is expected to lead the market with 46.12% share in 2024, due to its effectiveness in treating pulmonary hypertension across varying severities. Clinical evidence supports 100 ppm as optimal dosing for both neonatal and adult conditions while minimizing toxicity risks. Its flexibility in titration based on individual response and widespread use in hospitals for conditions like persistent pulmonary hypertension makes it the preferred choice over higher concentrations like 800 ppm.

Regional Insights

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Regional Analysis:

Dominating Region: North America

North America dominates the inhaled nitric oxide market with a 39.2% market share in 2024 due to its advanced healthcare infrastructure, extensive research and development, and the presence of key industry players. Supportive government policies, such as funding for innovation and regulatory frameworks, further enhance market growth, driving technological advancements and broad adoption of new treatment options in the region.

Fastest-Growing Region: Asia Pacific

The Asia Pacific region is the fastest-growing market for inhaled nitric oxide due to rising healthcare investments, increasing respiratory disease prevalence, expanding healthcare access, and growing awareness of inhaled Nitric Oxide benefits. These factors are driving the adoption of advanced medical therapies like inhaled nitric oxide, fueling the market growth in the region.

Inhaled Nitric Oxide Market Outlook for Key Countries

U.S.: Growth Driven by Robust Healthcare Infrastructure and Regulatory Support

The U.S. inhaled nitric oxide industry growth is fueled by advanced healthcare infrastructure and a high prevalence of respiratory disorders. Increased government initiatives supporting respiratory health further enhance the market growth, making the U.S. a key player in the global inhaled nitric oxide landscape. For instance, on February 9, 2024, a study by the University of Alabama found that high-dose inhaled nitric oxide therapy improved oxygenation and reduced mortality risk in critically ill Black COVID-19 patients with acute respiratory distress syndrome (ARDS) offering significant benefits over standard treatments for respiratory distress.

Canada: Boosted by Clinical Trials and Government Backing for Innovative Therapies

A rise in clinical trials and research activities drive the inhaled nitric oxide industry in Canada. Key drivers include robust healthcare infrastructure, government support for innovative therapies, and increasing demand for new respiratory treatments. For instance, in April 2020, Mallinckrodt and Novoteris received Health Canada's approval for a clinical trial using high-dose inhaled nitric oxide (iNO) therapy to treat COVID-19-related lung infections.

China: Expanding Healthcare Sector and Government Investment Propel Market Growth

China’s inhaled nitric oxide market is growing on the account of its expanding healthcare sector, increasing incidence of respiratory diseases, and rising government investment in advanced medical technologies. With a growing emphasis on enhancing healthcare infrastructure and regulatory support for innovative treatments, China is becoming a key player in the inhaled nitric oxide market.

Japan: Increased Use of iNO in Extremely Premature Infants Drives the Market Expansion

In Japan, the growth of the inhaled nitric oxide market is driven by its increased use in the treatment of extremely premature infants. For instance, in September 2022, according to Minute Medicine, Inc., a publishing organization, a study in Japan (2003-2016) showed an increase in the use of inhaled nitric oxide and survival rates in extremely premature infants. However, there were no differences in long-term neurological outcomes at age 3 between those treated with iNO and those who were not.

India: Proven Efficacy in COVID-19 Treatment Enhances iNO Market Position

 In India, the inhaled nitric oxide market is expanding due to its proven efficacy in treating critical COVID-19 patients. A study conducted by Amrita Institute of Medical Sciences and Amrita Vishwa Vidyapeetham in February 2022 demonstrated that iNO reduced complications and resulted in zero mortality, outperforming standard treatments. This success, along with iNO’s established role in treating respiratory conditions, enhances its position as a vital therapy in India’s healthcare system, driving the market growth.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Inhaled Nitric Oxide Market Players

• Established Players: Leading companies heavily invest in research and development to introduce advanced products. For example, IPSEN spends over 15% of its annual revenue on R&D to develop novel drug delivery systems and specialty pharmaceuticals for use in inhaled nitric oxide therapy. Major players also form strategic partnerships with other industry giants
• Mid-Level Players: Companies at this level focus on providing cost-effective solutions to attract price-sensitive customers. For example, Air Liquide produces generic inhaled nitric oxide concentrators at 30-50% lower costs than branded equivalents. They collaborate with local distributors and hospitals to promote their affordable products.
• Small-Scale Players: Small companies identify specialized therapeutic areas to occupy underserved niche markets. For instance, Beyond Air concentrated only on developing a solid-state inhaled nitric oxide generator for treating severe lung infections in infants.

Emerging Startups in the Inhaled Nitric Oxide Market

• Innovative Technologies: Numerous startups are focusing on advanced technologies like Vero Biotech which is developing smart sensor-based nitric oxide delivery systems powered by AI algorithms. Their smart NO delivery platform could transform existing treatment methods by precisely adjusting dosage in real-time.
• Sustainable Solutions: Some startups deliver eco-friendly options - Ekosia produces recyclable concentrators using 70% recycled plastics. They aim to reduce dependence on single-use equipment which generates 1,200 tons of medical waste annually. Ekosia's sustainable model promotes a greener respiratory care industry.
• Market Contribution: Startups often address unavailable or underserved market segments. For example, Nu-Ox focused solely on developing an ultra-portable inhaled nitric oxide generator for use in emergency transport situations. They partnered with various ambulance services to boost accessibility of the life-saving therapy during transport. Such collaborations facilitate startups in overcoming commercialization hurdles.

Inhaled Nitric Oxide Industry News

• On August 6, 2024, Beyond Air, Inc. a commercial stage medical device and biopharmaceutical company, shared data from a study indicating that on high-dose inhaled nitric oxide (iNO) for COVID-19 viral pneumonia showed that intermittent 150-ppm iNO treatment is safe and effective in reducing oxygen support needs and improving recovery times. Patients treated with iNO required less oxygen, achieved better oxygen saturation, and showed a trend toward earlier discharge compared to those on standard care. No treatment-related adverse events were observed, underscoring the therapy's safety. These results highlight the potential of high-dose iNO in managing viral pneumonia, suggesting further study to explore its benefits across other respiratory illnesses.
• In May 2023, Pieris Pharmaceuticals, Inc., a clinical-stage biotechnology company developing novel biotherapeutics through its proprietary Anticalin technology for respiratory disorders and cancer, announced the safety review of a 10 mg dry powder dose cohort from its recent multicenter, placebo-controlled phase 2a study.
• In February 2023, Vero Biotech announced the U.S. FDA approval for its second-generation Genosyl device, designed to deliver inhaled nitric oxide for use with rebreathing anesthesia in operating room settings. Although the third-generation Genosyl device has also recently received FDA approval, it has not yet been validated for rebreathing anesthesia.

Key Takeaways from Analyst

• The inhaled nitric oxide market is expected to grow due to rising preterm births and increasing use in treating respiratory conditions. North America leads the market, while the Asia Pacific region is poised for rapid growth due to higher healthcare spending and expanding infrastructure. Challenges include high treatment costs and expensive delivery systems. Opportunities lie in targeting emerging markets, innovating delivery equipment to reduce costs, and broadening clinical indications.

Market Report Scope

Market Dynamics

Market Driver - Increasing incidence of preterm births and respiratory complications in neonates

The incidence of preterm birth has been steadily increasing in both developed and developing countries, with significant implications for neonatal health. For instance, according to a WHO report in May 2023, the rise in preterm births correlates with higher rates of respiratory complications in neonates, such as pulmonary hypertension and respiratory failure. This situation has heightened the demand for effective treatments like inhaled nitric oxide (iNO) therapy, which is crucial for managing conditions associated with respiratory distress syndrome due to surfactant deficiency.

Market Challenge - High costs associated with inhaled nitric oxide therapy

A major challenge in the inhaled nitric oxide market is the high cost of therapy, which includes complex delivery systems, gas handling equipment, and expensive gas itself. Annual costs per patient range from US$ 30,000 to US$ 50,000, with one treatment averaging over US$ 1,000. This financial burden limits adoption, especially in price-sensitive markets. Reducing equipment and operational costs through innovation is crucial to making INO therapy more accessible and driving long-term market growth.

Market Opportunity- Strategic partnerships drive inhaled nitric oxide market growth

Strategic partnerships in the inhaled nitric oxide market offer substantial growth opportunities by integrating expertise, resources, and technologies to enhance product portfolios. For instance, October 2, 2024, Beyond Air, a medical device and biopharmaceutical company, partnered with Healthcare Links, a healthcare advisory and contracting firm, to expand the availability of its LungFit PH system, a groundbreaking inhaled nitric oxide (NO) generator and delivery system.

Key Stakeholders of Market

What Growth in Inhaled Nitric Oxide Market Mean for Different Stakeholders?

The inhaled nitric oxide market has multiple players with varied designations and offers multiple opportunities based on their scope of operations.

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Market Segmentation

•  Product Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Inhaled Nitric Oxide Delivery Systems
  • Consumables
    • Nitric Oxide Cylinders
    • Delivery Accessories
  • Others
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
• • Neonatal Respiratory Treatment
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Acute Respiratory Distress Syndrome (ARDS)
  • Tuberculosis Treatment
  • Malaria Treatment
  • Others
•  Strength Insights (Revenue, USD Bn, 2019 - 2031)
• • 100 ppm
  • 800 ppm
  • Others
•  End User Insights (Revenue, USD Bn, 2019 - 2031)
• • Hospitals
  • Ambulatory Surgical Centers
  • Home Care Settings
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • 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
• Key Players Insights
  • Mallinckrodt plc
  • Linde PLC
  • Nippon Sanso Holdings Corporation
  • SOL Group
  • Air Liquide S.A.
  • Air Water Inc.
  • Chemix Specialty Gases and Equipment
  • Vero Biotech LLC
  • Sichuan Salman Chemical Products Co., Ltd.
  • Chengdu Taiyu Industrial Gases Co., Ltd.
  • Bellerophon Therapeutics Inc.
  • Merck KGaA
  • GE Healthcare
  • Mitsubishi Tanabe Pharma Corporation
  • Messer Group
  • Nu-Med Plus Inc.
  • Beyond Air Inc.
  • Praxair Technology Inc.
  • Getinge Group
  • Circassia Pharmaceuticals