Inhaled Nitric Oxide Delivery Systems Market Size, Share & Trends Analysis Report By Type (Pediatric, Adult), By Application (HRF, AHRF), By Product (Disposables, Systems), By End User, And Segment Forecasts, 2021 - 2028

Report Overview

The global inhaled nitric oxide delivery systems market size was valued at USD 247.5 million in 2020 and is projected to grow at a compound annual growth rate (CAGR) of 6.9% from 2021 to 2028. Inhaled Nitric Oxide (INO), a minimally invasive therapy, is proposed to treat conditions associated with reversible pulmonary vasoconstriction and pulmonary hypertension in children and adults. Improved safety and efficacy, a rapid offset of action, reduced toxicity, high concentration of drug at the target organ, avoidance of systemic adverse reaction, and reduced dose of medication are some of the advantages of INO over other medication. This is leading to the improved adoption of INO, potentially driving the market growth.

In vitro studies suggest that INO is effective in suppressing the SARS-CoV-2 virus treating the diseases as efficiently as the current medication. In addition, INO is effective in treating Acute Respiratory Distress Syndrome (ARDS), the main characteristic of COVID-19–positive patients. Furthermore, studies suggest that INO increases the oxygenation within the bloodstream of COVID-positive patients but has no effect on mortality.

Leading market players like Mallinckrodt Pharmaceuticals are demonstrating the inhibitory effect of INO against the SARS-CoV-2 virus. It is proved to be effective in improving blood oxygen levels, reduction in supplemental oxygen, and a reduction in the amount of ventilator support. Further studies by researchers would confirm the benefits of nitric oxide in the treatment of coronavirus. Interestingly, the year 2020, witnessed an alarming need for nitric oxide devices and disposables, however, global lockdowns, closure of supply chains, and lack of raw material availability led to the drop in sales, negatively impacting the market.

Type Insights

The pediatric segment accounted for the largest revenue share of 77.6% in 2020. Inhaled nitric oxide is proved to be the most effective in treating neonatal diseases like Hypoxic Respiratory Failure (HRF). In the U.S. alone, nearly 25,000 to 30,000 neonatal HRF cases are reported annually and nearly 50% are cured using INO therapy. The average cost of this therapy per hour is nearly USD 150, which accounts for a total of USD 97,000 to 130,000 per patient for 72 to 96 hours.

Hence, to fulfill the large medical expense, the government in most countries has established favorable reimbursement policies, which improves the adoption of INO therapy in the neonatal segment. Inhaled nitric oxide needs to be administered in large concentrations in most adult infected diseases and a lack of clinical evidence has led to the reduced adoption of this therapy in the adult segment.

Application Insights

Hypoxic Respiratory Failure (HRF) inhaled nitric oxide delivery system held the largest segment share of 80.2% in 2020. This disease is mainly observed in pre-term and near-term neonates due to underlining diseased conditions like pneumonia, sepsis, persistent pulmonary hypertension, and others. It affects 2% of all live births and is responsible for >33% of all neonatal mortality. In the United States, HRF is responsible for the deaths of nearly 18 in 1000 babies, and most of them are born prematurely. Studies suggest that INO is the first line of treatment for HRF and is effectively administered for more than 10 days without the signs of complication. Studies suggest that INO therapy costs nearly USD 1129.46 per baby affected with HRF. Thus, cost-effectiveness and high treatment efficacy lead to the increased adoption of INO therapy, boosting the segment growth.

Acute Hypoxemic Respiratory Failure (AHRF) is another critical illness needing INO therapy as a treatment regime. The mortality rate associated with this condition is nearly 30% but moves up to 50% as it develops complications of sepsis leading to multi-organ failure. Thus, local acting vasodilators like INO have proven to be an effective first-line treatment. Chronic Obstructive Pulmonary Disorder (COPD) and Bronchopulmonary Dysplasia (BPD) are among a few other application areas of INO therapy.

Product Insights

The disposables product segment accounted for the largest revenue share of 65.1% in 2020. On the basis of product, the market is bifurcated into systems and disposables. The presence of a number of manufacturers and increased demand for nebulizer masks in hospitals have led to the increased demand for disposables, thereby driving the segment growth.

Factors, such as the low cost of raw materials, abundant resource availability, and a large consumer base, are also anticipated to boost segment growth. INO delivery devices are priced at USD 1400-1700, which makes it difficult for low-tier end-user settings to adopt such equipment as they focus on minimizing the bills. Thus, only large-scale hospitals with the availability of skilled staff and numerous ICU beds can acquire INO systems, which, in turn, leads to a lower share of the system segment.

End-user Insights

The hospitals segment captured the highest revenue share of 86.2% in 2020 owing to the ease of delivery, ability to liquidate for establishing INO delivery device and monitor system, a large number of staff to track device operations, and presence of emergency department. On the basis of end user, the market is segmented into hospitals, surgical centers, and clinics.

Mortality rates due to ARFare around 30% in the world. Hence, it is essential to provide these patients with life support and critical care, such as that in hospital ICUs. A rise in the number of hospital admissions is leading to the growth of this segment. On the other hand, ambulatory centers and clinics lack the necessary infrastructure and medical budget, which leads to reduced patient admissions and a lower market share of these segments.

Regional Insights

North America is expected to be the fastest-growing regional market registering a CAGR of 7.84% during the forecast period. This growth can mainly be attributed to the increasing incidences of neonatal mortality due to the rising cases of HRF. In the United States alone, the annual number of term and late preterm newborns with HRF is estimated at 80,000. And about 15% of term infants and 29% of late-preterm infants admitted in Neonatal Intensive Care Units(NICU) develop respiratory morbidity.

In addition, a rise in the adoption of INO therapy, favorable government initiative, and the presence of advanced medical infrastructure boosts regional growth. On the other hand, APAC held the largest revenue share in 2020 and will continue the trend during the forecast period due to the growing pediatric population, a rise in the number of patients suffering from respiratory failure, and the presence of local manufacturers of nitric oxide disposables&systems.

Key Companies & Market Share Insights

The market is highly exploited due to the presence of local manufacturers and sellers in most regions. Large-scale manufacturers are undergoing research to prove the treatment efficacy of INO against COVID-19-infected patients. Once they establish positive clinical trial results, the quicker they receive FDA approval to market their product. Hence, competition to market their product and increase their profit margins is in process. Product development and manufacturing outsourcing are a few strategies adopted by leaders to maintain their market position. Some of the prominent players operating in the global inhaled nitric oxide delivery systems market include:

• Mallinckrodt Pharmaceuticals

• Getinge

• Vero Biotech

• LINDE

• Beyond Air

• SLE

• NU MED

• Bellerophon Therapeutics

• Air Liquide Healthcare

• Circassia Pharmaceuticals

Inhaled Nitric Oxide Delivery Systems Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global inhaled nitric oxide delivery systems market report on the basis of type, application, product, end user, and region:

• Type Outlook (Revenue, USD Million, 2016 - 2028)

  • Pediatrics

  • Adult

• Application Outlook (Revenue, USD Million, 2016 - 2028)

  • Hypoxic Respiratory Failure (HRF)

  • Acute Hypoxemic Respiratory Failure (AHRF)

  • Others

• Product Outlook (Revenue, USD Million, 2016 - 2028)

  • Disposables

  • System

• End-user Outlook (Revenue, USD Million, 2016 - 2028)

  • Hospitals

  • Ambulatory Centers

  • Clinics

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Norway

    • Sweden

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • Thailand

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Turkey