Inhaled Nitric Oxide Market

Market Overview

The global inhaled nitric oxide market size was valued at USD 749.02 million in 2021. It is expected to reach USD 1,547.95 million by 2030, growing at a CAGR of 8.4% during the forecast period (2022–2030).

Inhaled nitric oxide is a pulmonary vasodilator that regulates vascular muscle tone significantly. It has emerged as a treatment for hypoxemic respiratory failure in newborns with persistently high pulmonary vascular pressure and resulting right-to-left blood shunting (persistent pulmonary hypertension of the newborn).

For example, around 2% of all live births and over 33% of newborn mortality occur annually owing to neonatal hypoxia respiratory failure (HRF). In contrast, 0.4-6.8/1000 live birth years are affected by persistent pulmonary hypertension of the newborn (PPHN). The mortality rate for those with moderate to severe forms of the illness remains around 10%. Neonatal hypoxic respiratory failure is characterized by persistent pulmonary hypertension of the infant and various disorders that contribute to pulmonary arterial hypertension, such as meconium aspiration syndrome, sepsis, birth asphyxia, and respiratory distress syndrome.

Nitric oxide is a selective pulmonary vasodilator administered to the patient by mechanical ventilation following dilution with an oxygen/air mixture nitric oxide delivery device. 100 ppm and 800 ppm quantities of nitric oxide are available depending on the therapy. In addition, clinical trials explore using inhaled nitric oxide for several diseases. The potential therapeutic effect of inhaled nitric oxide in adults is still unknown, and indications approved by the FDA are limited to pediatric practice.

Market Dynamics

Market Driving Factors

Increasing Demand in the Healthcare Industry to Augment Market Growth Prospect

Many areas of physiologic research have been revolutionized with a better understanding of nitric oxide's role in the cardiovascular, immune, and nervous systems and the therapeutic. This understanding is also having an impact on clinical therapy. For example, inhaled nitric oxide (inhaled nitric oxide) causes preferential pulmonary vasodilatation and reduces vascular resistance. These effects enhance hypoxic pulmonary vasoconstriction and increase lung patients' oxygenation. It is becoming increasingly clear that the healthcare industry will be one of the primary drivers of expansion in the world economy in the years to come. Changes in healthcare can be challenging to adopt and enforce due to the many aspects involved, such as the government's policies, which can be difficult to alter and take a long time. Environmental and technical factors are also contributors to changes in healthcare.

Additionally, it is anticipated that the cost of hospital treatment is predicted to climb. As a result, the requirement for novel and efficient treatments will likely drive the expansion of the market for inhaled nitric oxide over the period covered by this estimate.

Rise in Chronic Diseases Worldwide

Children and adults afflicted with a mixture of ailments may benefit from receiving treatment that involves inhaling nitric oxide. It effectively cures numerous respiratory distress syndrome treatments involving inhaled nitric oxide in adults. Half a million people in the United States who suffered from pulmonary hypertension due to various factors had undergone nitric oxide inhalation therapy. Inhaled nitric oxide treats multiple cardiopulmonary disorders in children and adults. These conditions include chronic obstructive pulmonary disorder (COPD), hypoxic respiratory failure, and pulmonary hypertension. But because of the logistical and financial challenges involved, the use of inhaled nitric oxide is not as prevalent as it could be.

According to the report published by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), chronic obstructive pulmonary disease (COPD) affects 65 million people. It caused 3 million deaths annually, making it the third leading cause of death across the globe. In addition, according to the findings that the Pulmonary Hypertension Association published, it is anticipated that between 30 and 70 % of people who have COPD also have pulmonary hypertension (PH), which is another name for high blood pressure in the lungs. Therefore, an increase in the prevalence of chronic diseases is likely to increase the use of inhaled nitric oxide.

Intense competition from the market players

The major market participants for inhaled nitric oxide delivery systems have been implementing various tactics to strengthen the growth prospects in the upcoming years. Significant corporations employ new product launches, mergers, partnerships, acquisitions, geographical expansion, and strategic alliances to develop their market expansion opportunities. Additionally, it is predicted that fierce competition for product launches among the market's well-established competitors will foster the industry's growth possibilities.

Market Restraining Factors

High Costs Incurred with the Procedure to Restrict Market Growth

Inhaled nitric oxide therapy is a relatively new treatment that has arisen in recent years as an option for treating newborns who exhibit chronic pulmonary hypertension. According to a study published in the respiratory care journal, the direct cost of using nitric oxide was $100 per hour regardless of the dose. The overall cost of providing inhaled nitric oxide to patients across the university was roughly $1.8 million annually. The cost of inhaled nitric oxide treatment in the European Community was €150 ($182.79) per hour, up to a limit of 96 hours for each individual, after which there was no additional payment. In addition, according to research, only 3.6 % of the trials that used probabilistic sensitivity analysis found inhaled nitric oxide to be more expensive and have a worse outcome than conventional therapy alone.

On the other hand, 35.7 % of the trials found inhaled nitric oxide cheaper and more effective than traditional treatment alone. Therefore, from a societal point of view, inhaled nitric oxide as a treatment for PPHN in babies is cost-effective, but it does not save money.

Product recalls

The market growth for delivery methods for inhaled nitric oxide is anticipated to be constrained in the years to come by product recalls. For instance, Mallinckrodt Pharmaceuticals recalled the INOmax DSIR Plus delivery system in November 2016 because the manometer's valve calibration was incorrect. The US FDA categorized the recall as a Class 2 device recall.

Key Market Opportunities

Growing Research and Development Leading to New Applications to Boost Market Opportunities

In many different contexts, the treatment with inhaled nitric oxide has not yet reached its full potential. As a result, numerous clinical trials involving inhaled nitric oxide have been carried out in the past three to four years to discover novel therapy options. For instance, clinical trials were undertaken for newborns with acute bronchiolitis in June 2020. Nowadays, no medicines are approved for treating infants with acute bronchiolitis, which is the most common reason for the hospitalization of children around the world. Bronchiolitis is responsible for $1.7 billion in hospitalization expenditures in the United States alone.

Despite the availability of supportive oxygen therapy and hydration, there is currently no treatment that is proven to be successful. As a result, the findings indicate that a hefty dose of inhaled nitric oxide produces a good effect. In addition, a clinical trial using inhaled nitric oxide was carried out in March of 2020 to control platelet hyper-reactivity in patients diagnosed with acute submassive pulmonary embolism. According to this study's findings, there is no significant influence on platelet O₂ consumption; however, there is a reduction in platelet and platelet sGC activity, indicating a limited capacity for it to cure submassive pulmonary embolism. In addition, research and development efforts have been focused on adult sickle cell disease, bronchopulmonary dysplasia, and malaria.

Regional Analysis

The global inhaled nitric oxide market is primarily classified into three regions, namely North America, Europe, and Asia-Pacific.

North America Maintains the Top Position in the Global Inhaled Nitric Oxide Market

North America contributed the most revenue and is expected to grow at a CAGR of 8.4% during the forecast period. The United States holds the largest market share for inhaled nitric oxide in North America. North America is predicted to conquer the global market for inhaled nitric oxide, owing to its large customer base and rising expenditure on R&D by regional market participants. Increased prevalence of disorders in newborns, such as persistent pulmonary hypertension and neonatal hypoxic respiratory failure, is one of the factors driving the growth of the inhaled nitric oxide market (HRF). Europe is predicted to hold second in the global inhaled nitric oxide market. In Europe, inhaled nitric oxide (inhaled nitric oxide) has been used for several years to treat acute respiratory failure and pulmonary hypertension in the operating room and critical care unit.

Asia-Pacific is anticipated to be a growing region shortly due to the highest live birth rate per 1000 people and the increase in the prevalence of respiratory distress syndrome, neonatal jaundice, and hypoxic respiratory failure associated with persistent pulmonary hypertension in newborns (PPHN). The development of a competitive market due to introducing regional suppliers of nitric oxide therapy systems helps expand the Asia-Pacific market. Children and adults exhibit increased respiratory diseases, chronic obstructive pulmonary disease (COPD), and acute respiratory distress syndrome (ARDS). This is one of the primary contributors to expanding the Asia-Pacific market for inhaled nitric oxide.

Europe is anticipated to be the prominent market throughout the analysis. The market for inhaled nitric oxide (NO) delivery systems is expected to develop in this region due to rising chronic illness prevalence, increased number of older adults, and the adoption of cutting-edge medical equipment.

During the projection period, a modest rate of market growth is anticipated for Latin America, the Middle East, and Africa.

Segmental Analysis

The global inhaled nitric oxide market share is segmented by Application.

Based on application, the global inhaled nitric oxide market is classified into Neonatal Respiratory Treatment, Chronic Obstructive Pulmonary Disease (COPD), and Acute Respiratory Distress Syndrome (ARDS).

Neonatal respiratory treatment is the most dominant and is expected to grow at a CAGR of 8.4% during the forecast period. In 1992, inhaled nitric oxide (inhaled nitric oxide) was first employed in newborn medicine. In 1999, the United States Food and Drug Administration (US FDA) authorized its use to treat hypoxic respiratory failure associated with pulmonary hypertension. Neonatal hypoxic respiratory failure may be caused by chronic pulmonary hypertension of the infant and various disorders that contribute to pulmonary arterial hypertension, such as meconium aspiration syndrome, sepsis, birth asphyxia, and respiratory distress syndrome. Consequently, inhaled nitric oxide is an approved treatment for the term and near-term infants with hypoxic respiratory failure due to pulmonary hypertension. It minimizes the requirement for extracorporeal membrane oxygenation. In addition, inhaled nitric oxide has a short half-life (2s to 6s) and has been administered to newborns at dosages ranging from 1 ppm to 80 ppm; hence, the FDA recommends a starting dose of 20 ppm for term infants.

Chronic obstructive pulmonary disease (COPD) is a lung condition that restricts airflow and makes it difficult to breathe. It is caused by inflammation of the lungs and airways, resulting in chronic bronchitis and pulmonary emphysema. Frequently, severe chronic obstructive pulmonary disease (COPD) is accompanied by secondary pulmonary hypertension (PH). Thus, nitric oxide is a crucial mediator in pulmonary circulation vascular responses. Numerous studies have been undertaken to determine the effect of inhaled nitric oxide on pulmonary gas exchange in COPD.

Acute respiratory distress syndrome (ARDS) is compelled by fluid accumulation in the lungs' tiny, elastic air sacs (alveoli). The fluid keeps the lungs adequately inflated with air, resulting in less oxygen entering the bloodstream. This hinders the organ from sufficient functioning. The death rate for individuals with acute respiratory distress syndrome (ARDS) ranges from 45 to 92 %, with the majority dying within the first two weeks of sickness. The most prevalent cause of ARDS is sepsis, a severe and widespread bloodstream infection.

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• January 2023 - For its Industrial Merchant business line, Air Liquide signed a record 52 new contracts in 2022 for the on-site production of gases.
• January 2023 - Bellerophon Therapeutics announced that enrollment in the INOpulse® Phase 3 REBUILD Study for Fibrotic Interstitial Lung Disease has been completed.
• December 2022 -Pre-clinical data from Beyond Cancer® demonstrating its tumor ablation method using ultra-high concentration nitric oxide (UNO) induced a systemic response that prevents metastases was published in the journal cancer cell international.