Nitric Oxide Test Market Size & Share, by Product Type (Nitric Oxide Test Strips, Nitric Oxide Monitors); Indication; End use - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2025-2037

  • Report ID: 6944
  • Published Date: Jan 07, 2025
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2025-2037

Nitric Oxide Test Market size was USD 1.6 billion in 2024 and is estimated to reach USD 3.9 billion by the end of 2037, expanding at a CAGR of 7.1% during the forecast period, i.e., 2025-2037. In 2025, the industry size of nitric oxide test is assessed at USD 1.7 billion.  

The nitric oxide test market is expanding due to the increasing burden of respiratory diseases such as asthma and allergic disorders, there’s an increase in demand for accurate diagnostic solutions to manage related conditions effectively. According to the World Health Organization, an estimated 262 million people had asthma in 2019, and it caused 455,000 fatalities. People with asthma can live normal, active lives by controlling their symptoms with inhaled medicine. Clinicians can evaluate airway inflammation with nitric oxide testing, which helps with early diagnosis and individualized treatment of asthma. The use of NO testing is expected to increase significantly as awareness of the value of prompt diagnosis and aggressive management rises, propelling additional nitric oxide test market expansion.


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Nitric Oxide Test Sector: Growth Drivers and Challenges

Growth Drivers

  • Increased rate of hypoxemic respiratory failure in pediatrics: Children and infants with hypoxemic respiratory failure can also be treated with inhaled nitric oxide. According to the National Institutes of Health (NHI), neonatal hypoxic respiratory failure (HRF) is a serious respiratory condition that accounts for almost 33% of all neonatal deaths and affects 2% of live births.  This condition develops when the blood lacks adequate oxygen levels which can be due to several underlying illnesses, including bronchiolitis, pneumonia, and asthma. Inhaled nitric oxide (iNO) increases the quantity of oxygen that reaches the body's tissues by relaxing the muscles in the lungs' blood vessel walls, which permits blood to flow more freely. A growing number of juvenile patients are experiencing hypoxemic respiratory failure as a result of chronic illnesses, infections, changing lifestyles, and rising environmental pollutants. For infants and kids with hypoxemic respiratory failure, the iNO delivery system works well.
  • Growing advancements in non-invasive nitric oxide testing: Conventional approaches frequently entail invasive procedures or heavy equipment, restricting patient compliance and accessibility. For instance, NHI’s recent research on non-invasive nitric oxide testing showed mixed results, finding that inhaled nitric oxide did not decrease the incidence or severity of bronchopulmonary dysplasia in premature newborns. Despite this, researchers continue to explore the potential of non-invasive nitric oxide testing as a diagnostic tool for various respiratory conditions.

    Moreover, new technologies provide portable, user-friendly tools that precisely monitor exhaled nitric oxide levels, supporting the diagnosis and treatment of asthma. Innovations increase airway inflammation monitoring, lower healthcare costs, and improve patient experience. Additionally, by connecting with digital platforms, they allow for remote monitoring and data analysis, giving patients and medical professionals access to real-time insights for individualized treatment plans.
  • Supportive government initiatives: Favorable reimbursement practices and supportive government measures are also significantly contributing to the market's expansion. Government rules also have a big effect on the nitric oxide test market. The Food and Drug Administration (FDA) in the United States, maintains strict regulations for the approval and use of inhaled nitric oxide devices, including post-market surveillance and thorough clinical trials. Nitric oxide is also classified as hazardous under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), which calls for cautious handling and disposal.

Challenges

  • Stringent regulatory laws: Before medical gadgets and diagnostic instruments can be sold, they must undergo significant clinical trials and receive permits from government agencies due to strict requirements. These costly and time-consuming regulatory processes significantly obstruct nitric oxide test market growth. The commercialization of products is further delayed by the complexity created by regional variations in regulatory norms. As a result, businesses that invest in nitric oxide asthma testing have to spend a lot of money and effort to get beyond these legal restrictions, which impedes market expansion and innovation.
  • Lack of awareness: Many patients and medical professionals are unfamiliar with this diagnostic technique, although it has the potential to completely transform the treatment of asthma. The underuse of nitric oxide testing in clinical settings is a result of educational barriers, such as insufficient resources and training. Furthermore, nitric oxide test market penetration is further hampered by ingrained diagnostic procedures and opposition to new technologies. Comprehensive education efforts targeting patients and healthcare professionals are necessary to address these problems and improve their comprehension of the advantages of nitric oxide testing in the treatment of asthma.

Nitric Oxide Test Market: Key Insights

Base Year

2024

Forecast Year

2025-2037

CAGR

7.1%

Base Year Market Size (2024)

USD 1.6 billion

Forecast Year Market Size (2037)

USD 3.9 billion

Regional Scope

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, South Korea, Malaysia, Australia, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)

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Nitric Oxide Test Segmentation

End use (Diagnostics Centers, Hospitals & Clinics, Home Care Settings)

Hospitals & clinics segment is predicted to dominate nitric oxide test market share of around 79.8% by the end of 2037. The segment growth can be attributed to the large number of patients in need of critical care and specialist respiratory therapies. Inhaled nitric oxide therapy is primarily administered in hospitals because of its sophisticated medical facilities and highly qualified medical staff. Hospitals also frequently have the resources needed for round-the-clock observation and prompt action, which are essential for patients receiving inhaled nitric oxide treatment. Furthermore, the high cost of therapy and the comprehensive care offered in hospital settings is another factor driving the growth of the segment.

Indication (Chronic Obstructive Pulmonary Disease, Asthma, Pulmonary Arterial Hypertension, Cystic Fibrosis, Hypoxic Respiratory Failure)

The hypoxic respiratory failure segment in nitric oxide test market will garner a notable share in the forecast period. The high prevalence of infant respiratory disorders such as hypoxemic respiratory failure (HRF) and persistent pulmonary hypertension of the newborn (PPHN), which can be successfully treated with inhaled nitric oxide therapy, is driving the segment's growth. With about 1.3 million fatalities annually, the majority of which are preventable, pneumonia continues to be the leading cause of childhood mortality. The most prevalent non-communicable disease among children is asthma. Among nations with high incidence, up to 20% of tuberculosis (TB) cases are among children.

The therapy is a vital intervention in neonatal intensive care units (NICUs) worldwide due to its capacity to increase oxygenation and lessen the need for more invasive procedures like ECMO. Moreover, poor nutrition, indoor air pollution, and tobacco smoking are examples of environmental exposures that are frequently linked to both acute and chronic respiratory illnesses. According to the WHO, an estimated 3.2 million deaths annually, including more than 237,000 deaths of children under the age of five, were attributed to household air pollution in 2020.

Our in-depth analysis of the global market includes the following segments:

Product Type

  • Nitric Oxide Test Strips
  • Nitric Oxide Monitors
  • Others

Indication

  • Chronic Obstructive Pulmonary Disease
  • Asthma
  • Pulmonary Arterial Hypertension
  • Cystic Fibrosis
  • Hypoxic Respiratory Failure

End use

  • Diagnostic Centers
  • Hospitals & Clinics
  • Home Care Settings
  • Others

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Nitric Oxide Test Industry - Regional Synopsis

North America Market Statistics

North America nitric oxide test market is predicted to dominate revenue share of over 36.3% by 2037. The proliferation of nitric oxide test strips, coupled with an increasing demand for medical equipment and devices within hospitals and diagnostic laboratories, is contributing significantly to the growth of the market. Additionally, the rising need for diagnostic services related to various pulmonary conditions is further driving this expansion. Enhanced initiatives by government entities and healthcare providers aimed at managing asthma through comprehensive state and national surveillance are accelerating nitric oxide test market growth in this region.

Furthermore, the increasing prevalence of asthma and COPD in the U.S. and increasing healthcare expenditures are escalating the growth of the nitric oxide test market. According to the U.S. Centers for Medicare & Medicaid Services, in 2023, U.S. healthcare spending increased by 7.5% to USD 4.9 trillion, or USD 14,570 per person. Approximately 17.6% of the country's GDP was allocated to health care.

Canada’s universal healthcare system and government initiatives have led to increased access to diagnostic testing, including nitric oxide testing. Also, the presence of a well-established network of hospitals and clinics, as well as a strong healthcare research sector, has increased the adoption of advanced diagnostic technologies, such as non-invasive nitric oxide testing, driving the market growth in the country.

Europe Market Analysis

Europe nitric oxide test market will hold a significant share by 2037. The market growth can be attributed to the region's well-established healthcare infrastructure, growing knowledge of respiratory medicines, and encouraging government policies. The market is anticipated to increase due to European nations' investments in healthcare technologies and the expansion of their medical device industry. According to MedTech Europe, in 2023, the European medical technology sector is projected to be worth approximately USD 166.1 billion. Germany, France, the United Kingdom, Italy, and Spain are the top five nitric oxide test markets. The European medical device industry will account for 26.1% of the global market based on manufacturer prices. After the US, it has the second-largest medical device market (47.2%).

The adoption of cutting-edge respiratory medicines has been fueled by the UK's established healthcare system as well as rising investment in medical research and development. The UK is a major player in the European nitric oxide test market due to its emphasis on raising the standard of care and improving patient outcomes.

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Companies Dominating the Nitric Oxide Test Landscape

    Key players in the nitric oxide test market are using various strategies to maintain their position. They are focusing on innovative product launches, to expand their portfolio. Strategic acquisitions like Caire Inc.’s acquisition of Spirosure Inc., are also being used to use technology and enhance product offerings. Also, investments in research and development as well as partnerships and collaborations, are crucial for advancing therapeutic and maintaining a competitive edge in the nitric oxide test market.

    • CVC Health
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Bedfont Scientific Ltd.
    • Spirosure Inc.
    • UniScience Laboratories
    • ATP Nutrition
    • Berkley Health LTD
    • NIOX Group PLC
    • Medisoft Group
    • Eco Medics AG
    • VERO Biotech

In the News

  • In December 2024, Bedfont Scientific Limited, a global leader in breath analysis with over 47 years of experience designing and manufacturing medical breath analysis devices, partnered with Tebaba Medical Services, a leading supplier of high-quality medical supplies to healthcare providers in Africa and the Middle East. Following the successful registration, Tebaba will disseminate Bedfont's cutting-edge technology to healthcare professionals in the region, assisting in the diagnosis and management of respiratory and gastrointestinal problems.
  • In February 2019, Spirosure Inc. announced that the FDA has cleared its patent-protected Fenom Pro Asthma Monitor for use by allergists, immunologists, and pulmonologists to assist patients manage asthma by detecting the fraction of exhaled nitric oxide (FeNO) in their breath.

Author Credits:  Rajrani Baghel


  • Report ID: 6944
  • Published Date: Jan 07, 2025
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

In the year 2024, the industry size of nitric oxide test was over USD 1.6 billion.

The market size for nitric oxide test is projected to cross USD 3.9 billion by the end of 2037 expanding at a CAGR of 7.1% during the forecast period i.e., between 2025-2037.

The major players in the market are CVC Health, Bedfont Scientific Ltd., Spirosure Inc., UniScience Laboratories, ATP Nutrition, Berkley Health LTD, NIOX Group PLC, Medisoft Group, Eco Medics AG, VERO Biotech, and others.

The hospitals segment is anticipated to garner a share/size of 79.8% during 2025-2037.

The North America nitric oxide test sector is poised to hold 36.3% share by the end of 2037.
Nitric Oxide Test Market Report Scope
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