FeNO 검사 시장 보고서 : 동향, 예측, 경쟁 분석(-2031년)

The future of the global FeNO testing market looks promising with opportunities in the hospital and clinic markets. The global FeNO testing market is expected to grow with a CAGR of 14.1% from 2025 to 2031. The major drivers for this market are the rising prevalence of respiratory diseases, growing awareness of early diagnosis & personalized medicine, and the rising air pollution levels.

• Lucintel forecasts that, within the type category, nitric oxide standalone monitor is expected to witness higher growth over the forecast period due to increasing prevalence of asthma and chronic respiratory diseases.
• Within the application category, hospital is expected to witness the higher growth due to advanced healthcare infrastructure and high awareness for respiratory care programs.
• In terms of region, North America is expected to witness the highest growth over the forecast period.

Emerging Trends in the FeNO Testing Market

The FeNO testing market is evolving rapidly, driven by advancements in technology, healthcare policies, and growing demand for non-invasive diagnostic methods. These emerging trends reflect broader changes in healthcare, including personalized medicine and the push for more effective chronic disease management. Below are five key trends shaping the future of the FeNO testing market.

• Increasing Adoption of Home-Use Devices: Portable, user-friendly FeNO testing devices are being developed to allow patients to monitor their condition at home. This trend is transforming asthma management by providing patients with real-time data, enabling more personalized treatment plans. Home-use devices allow patients to track their condition outside of medical appointments, improving adherence to treatment and reducing hospital visits. As healthcare shifts towards more patient-centric models, these devices play a crucial role in empowering individuals to manage their respiratory health more effectively.
• Integration with Digital Health Platforms: FeNO testing devices are increasingly being integrated with digital health platforms, enabling seamless data transfer to healthcare providers. This trend allows for better monitoring of asthma and other respiratory conditions, with real-time data helping doctors make more informed decisions. The integration of FeNO testing with electronic health records (EHRs) and telemedicine platforms is also improving patient care by enhancing communication between patients and healthcare professionals, ensuring timely adjustments to treatment plans and improving outcomes.
• Advancements in Device Miniaturization and Portability: The market is seeing continuous innovation in making FeNO testing devices smaller, more portable, and easier to use. Miniaturization makes it possible for healthcare providers to use these devices in more settings, such as mobile clinics or remote areas. This trend is making FeNO testing more accessible in regions with limited healthcare infrastructure, where mobile or compact devices are easier to transport and deploy. Portable FeNO testing is particularly beneficial in rural areas and developing countries.
• Growing Demand for Non-Invasive Diagnostic Tools: FeNO testing is part of a broader trend towards non-invasive diagnostics in healthcare. As patient preferences shift towards less invasive methods, FeNO testing is gaining popularity because it can measure airway inflammation without requiring blood draws or other invasive procedures. This trend is particularly relevant in the management of chronic diseases like asthma, where frequent monitoring is necessary. Non-invasive testing methods improve patient comfort and are expected to become a standard part of chronic disease management protocols.
• Expansion of Reimbursement Policies: Reimbursement policies for FeNO testing are expanding in many countries, including the U.S. and European nations, as the clinical benefits of the test become more recognized. The inclusion of FeNO testing in insurance coverage helps reduce the cost barrier, making it more accessible to a broader population. In many regions, FeNO testing is being integrated into clinical guidelines for asthma management, ensuring that healthcare providers use it as part of a comprehensive treatment plan. This trend is contributing to the widespread adoption of FeNO testing.

Emerging trends such as home-use devices, digital integration, device miniaturization, demand for non-invasive diagnostics, and expanded reimbursement policies are significantly reshaping the FeNO testing market. These trends are driving growth by improving access to FeNO testing and enhancing its integration into routine healthcare practices, which will ultimately improve the management of respiratory diseases globally.

Recent Developments in the FeNO Testing Market

The FeNO testing market has seen numerous developments in recent years as the technology becomes more advanced and widely adopted. These developments reflect innovations in product design, increasing awareness of respiratory conditions, and advancements in healthcare infrastructure. The following are key recent developments that are shaping the FeNO testing market across various regions.

• Introduction of Handheld FeNO Testers: One of the most significant developments in the FeNO testing market is the launch of handheld and portable FeNO testing devices. These devices allow for point-of-care testing, making it easier for healthcare providers to assess patients' airway inflammation quickly. Handheld testers are increasingly used in emergency rooms, clinics, and even at home for monitoring asthma. This development enhances the convenience and accessibility of FeNO testing, particularly in resource-limited settings.
• Integration of FeNO Testing with Telemedicine: With the rise of telemedicine, FeNO testing devices are being integrated into telehealth platforms. This integration allows patients to take FeNO measurements at home and share the data with healthcare providers remotely. This trend is particularly beneficial for patients with chronic respiratory conditions, as it allows for continuous monitoring and timely adjustments to treatment plans. It also improves access to specialized care, particularly in rural or underserved areas.
• Improvements in Device Sensitivity and Accuracy: Recent advancements have focused on improving the sensitivity and accuracy of FeNO testing devices. New models are able to detect lower concentrations of nitric oxide, providing more accurate readings and enabling earlier diagnosis of airway inflammation. These improvements are critical in ensuring that FeNO testing is a reliable tool for asthma and COPD management, leading to more precise and effective treatment decisions.
• Expansion of FeNO Testing in Clinical Guidelines: FeNO testing is becoming increasingly integrated into clinical guidelines for asthma management worldwide. In many countries, national healthcare systems have recognized the importance of FeNO measurements in diagnosing and managing asthma, leading to more widespread use of the technology. This development is increasing the acceptance of FeNO testing among healthcare professionals and encouraging its adoption in routine clinical practice.
• Launch of Affordable FeNO Testing Kits: To increase accessibility, some manufacturers have launched affordable FeNO testing kits aimed at low-income populations or developing countries. These cost-effective kits provide a viable option for large-scale deployment in areas where expensive equipment might be unaffordable. The availability of affordable FeNO testing options is expected to drive market growth in emerging markets, where respiratory conditions are prevalent but healthcare infrastructure may be limited.

Recent developments in FeNO testing, such as handheld devices, telemedicine integration, improved accuracy, clinical guideline inclusion, and affordable kits, are enhancing the accessibility, accuracy, and integration of FeNO testing. These innovations are contributing to the growth and expansion of the market, making FeNO testing an essential tool in the management of asthma and respiratory diseases.

Strategic Growth Opportunities in the FeNO Testing Market

As the FeNO testing market continues to expand, numerous growth opportunities exist across various applications. These opportunities are driven by the increasing prevalence of asthma and other respiratory conditions, technological advancements, and the growing demand for personalized healthcare. Below are five key strategic growth opportunities by application that can propel the FeNO testing market forward.

• Growth in Point-of-Care Testing: Point-of-care testing is a significant growth opportunity for the FeNO testing market. The increasing demand for faster diagnostics in emergency rooms, clinics, and even in home settings is driving the adoption of portable FeNO testing devices. Point-of-care testing enables immediate assessment of airway inflammation, improving decision-making for asthma management and treatment. As healthcare systems move toward more accessible, patient-centered care, the demand for point-of-care FeNO testing solutions will continue to grow.
• Expansion in Telemedicine Applications: Telemedicine offers a key growth opportunity for the FeNO testing market, particularly as more healthcare providers embrace remote patient monitoring. FeNO testing devices integrated into telehealth platforms allow for continuous asthma management, offering patients the convenience of monitoring their condition at home. This trend is especially valuable in rural areas or regions with limited access to healthcare specialists, making FeNO testing more accessible and effective in managing chronic respiratory conditions.
• Increasing Use in Clinical Research: FeNO testing is increasingly being used in clinical research to study the effects of different asthma treatments and interventions. Researchers are adopting FeNO measurements to monitor inflammation and treatment response, making it a valuable tool for drug development and clinical trials. This growing use of FeNO testing in research provides opportunities for manufacturers to expand their market presence and target the pharmaceutical and clinical research sectors.
• Focus on Emerging Markets: Emerging markets, particularly in regions such as Asia-Pacific and Latin America, present significant growth opportunities for the FeNO testing market. The rising prevalence of asthma and other respiratory diseases in these regions, coupled with improvements in healthcare infrastructure, is increasing demand for advanced diagnostic tools like FeNO testing. Expanding into these markets with cost-effective and portable solutions can drive market growth and improve access to high-quality asthma management in underserved regions.
• Development of Personalized Medicine Applications: As personalized medicine becomes more prevalent, there is an increasing opportunity for FeNO testing to play a pivotal role in individualized treatment plans for asthma and COPD patients. By measuring airway inflammation in real-time, FeNO testing provides critical information that helps tailor treatments based on the patient's specific needs. The integration of FeNO testing into personalized medicine frameworks will drive its adoption and further establish its importance in chronic disease management.

Strategic growth opportunities in point-of-care testing, telemedicine, clinical research, emerging markets, and personalized medicine are driving the FeNO testing market forward. These opportunities are broadening the scope of FeNO testing and making it more accessible, efficient, and effective in managing asthma and respiratory diseases.

FeNO Testing Market Driver and Challenges

The FeNO testing market is influenced by a range of drivers and challenges, including technological advances, regulatory changes, and economic factors. These elements shape the growth trajectory and adoption of FeNO testing across different regions and applications. Below are five key drivers and three main challenges impacting the market, providing a comprehensive overview of the factors at play.

The factors responsible for driving the FeNO testing market include:

1. Increasing Prevalence of Respiratory Diseases: The rising global incidence of asthma and COPD is a major driver for the FeNO testing market. As the number of patients with these conditions increases, the demand for effective and non-invasive diagnostic tools like FeNO testing grows. FeNO testing helps in early detection and personalized treatment, making it an essential tool in managing respiratory diseases.

2. Technological Advancements in FeNO Testing Devices: Recent innovations in FeNO testing devices, including portable, handheld models and improved sensitivity, are driving market growth. These advancements make FeNO testing more accessible and accurate, allowing for wider adoption in both clinical and home settings. The continuous improvement of FeNO testing technology is enhancing the device's usability and increasing its clinical relevance.

3. Government Initiatives and Support for Respiratory Health: Governments around the world are investing in better healthcare infrastructure and promoting disease prevention programs, especially for chronic diseases like asthma. These initiatives support the adoption of FeNO testing as a valuable tool for early diagnosis and management. Policies that expand reimbursement for FeNO testing also boost market growth by making the technology more affordable and accessible.

4. Rising Demand for Personalized Healthcare: The shift towards personalized medicine, where treatments are tailored to individual patient needs, is driving demand for tools like FeNO testing. By measuring inflammation in the airways, FeNO testing helps healthcare providers personalize asthma management plans, ensuring better treatment outcomes. This growing trend toward individualized care is a strong driver for the market.

5. Expanding Healthcare Access in Emerging Markets: As healthcare access improves in emerging markets, the demand for advanced diagnostic tools like FeNO testing increases. The availability of portable and cost-effective FeNO testing devices is facilitating market growth in regions like Asia-Pacific, where the prevalence of asthma is on the rise. Expanding access to FeNO testing in these regions is a key driver for the market.

Challenges in the FeNO testing market are:

1. High Costs of FeNO Testing Devices: Despite the benefits of FeNO testing, the high cost of devices and related testing can be a barrier to adoption, particularly in low-income regions. While prices are decreasing with technological advancements, affordability remains a challenge for broader market penetration.

2. Regulatory Hurdles and Approval Delays: The approval process for medical devices, including FeNO testing equipment, can be lengthy and complex, with varying regulatory standards across regions. These hurdles may slow the introduction of new devices to the market and impact the speed of innovation, limiting the potential for rapid market growth.

3. Lack of Awareness and Training: In some regions, healthcare providers may lack awareness of FeNO testing or may not be trained in its use. This can lead to underutilization of the technology, particularly in emerging markets. Education and training programs are needed to ensure that healthcare providers can effectively integrate FeNO testing into their practice.

The FeNO testing market is being shaped by drivers such as the increasing prevalence of respiratory diseases, technological advancements, government support, demand for personalized healthcare, and expanded access in emerging markets. However, challenges like high device costs, regulatory delays, and a lack of awareness must be addressed to unlock the full potential of the market.

List of FeNO Testing Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies FeNO testing companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the FeNO testing companies profiled in this report include-

• Guangzhou Kingmed Diagnostics
• Hangzhou Clongene Biotech
• Shanghai Fosun Long March Medical Science
• Nanjing Norman Biological Technology
• Beijing Eastwest Harmony Medical Devices
• Guangzhou Yercon Diagnostic
• Aeonmed

FeNO Testing Market by Segment

The study includes a forecast for the global FeNO testing market by type, application, and region.

FeNO Testing Market by Type [Value from 2019 to 2031]:

• Nitric Oxide Standalone Monitor
• Nitric Oxide Handheld Monitor
• Others

FeNO Testing Market by Application [Value from 2019 to 2031]:

• Hospital
• Clinic
• Others

FeNO Testing Market by Region [Value from 2019 to 2031]:

• North America
• Europe
• Asia Pacific
• The Rest of the World

Country Wise Outlook for the FeNO Testing Market

The FeNO (Fractional exhaled Nitric Oxide) testing market has experienced significant growth due to its role in the diagnosis and management of respiratory conditions like asthma. This non-invasive method helps measure airway inflammation, offering a critical tool for clinicians in assessing asthma severity and treatment effectiveness. As healthcare systems evolve and patient care becomes more personalized, the adoption of FeNO testing is increasing globally. Below, we highlight recent developments in FeNO testing across key markets such as the United States, China, Germany, India, and Japan, showcasing innovations, regulatory changes, and growing adoption.

• United States: In the U.S., FeNO testing is gaining popularity as a standard tool for managing asthma and chronic obstructive pulmonary disease (COPD). The increased focus on precision medicine and personalized healthcare has fueled the demand for more accurate and non-invasive diagnostic tools. Recent advancements in FeNO testing devices, such as portable and handheld devices, have improved accessibility and patient compliance. Additionally, healthcare providers are increasingly incorporating FeNO measurements alongside traditional tests for better asthma control. Medicare and private insurers have expanded reimbursement policies for FeNO testing, facilitating its wider adoption in clinical practices across the country.
• China: China has seen a rising adoption of FeNO testing due to the country's growing healthcare demands, particularly in urban areas. With an increasing prevalence of asthma and other respiratory diseases, Chinese healthcare providers are turning to FeNO testing as an effective diagnostic tool. The market is also benefiting from government efforts to enhance healthcare infrastructure and improve chronic disease management. Local manufacturers are developing cost-effective FeNO testing devices tailored to meet the needs of a broader population, which is helping to make the technology more accessible. Awareness campaigns and improvements in the overall healthcare system are driving market growth.
• Germany: Germany's healthcare system is well-established, and the country has seen steady adoption of FeNO testing within clinical and research settings. In line with broader European healthcare trends, Germany has been focusing on improving early diagnosis and personalized treatment plans for asthma and other respiratory conditions. The country's regulatory environment supports the use of FeNO testing, with strong integration into clinical guidelines for asthma management. Moreover, German medical device manufacturers are advancing FeNO testing technologies, incorporating features such as wireless connectivity for data sharing and integration with electronic health records, enhancing overall patient care.
• India: In India, FeNO testing is still emerging but gaining momentum, particularly in larger cities with better healthcare infrastructure. The increasing awareness of asthma, along with the rising prevalence of air pollution-related respiratory conditions, has highlighted the need for advanced diagnostic tools. However, the adoption of FeNO testing is hampered by cost-related concerns, though the growing availability of affordable, portable devices is expected to increase adoption. Local healthcare initiatives are also working to improve access to non-invasive diagnostic tools for asthma and COPD, which could drive further growth in the FeNO testing market in the coming years.
• Japan: Japan has been a leader in adopting advanced diagnostic tools, and FeNO testing is becoming more integrated into the management of respiratory conditions, especially in asthma. The country is focusing on advancing precision medicine and improving the monitoring of chronic diseases through non-invasive technologies. FeNO testing is included in national guidelines for asthma management, increasing its usage among healthcare professionals. The Japanese market is seeing innovations in FeNO measurement devices, including improved sensitivity and the development of home-use testing kits, offering more convenient and patient-friendly options for asthma monitoring and management.

Features of the Global FeNO Testing Market

• Market Size Estimates: FeNO testing market size estimation in terms of value ($B).
• Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
• Segmentation Analysis: FeNO testing market size by type, application, and region in terms of value ($B).
• Regional Analysis: FeNO testing market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
• Growth Opportunities: Analysis of growth opportunities in different type, application, and regions for the FeNO testing market.
• Strategic Analysis: This includes M&A, new product development, and competitive landscape of the FeNO testing market.

Analysis of competitive intensity of the industry based on Porter's Five Forces model.

This report answers following 11 key questions:

• Q.1. What are some of the most promising, high-growth opportunities for the FeNO testing market by type (nitric oxide standalone monitor, nitric oxide handheld monitor, and others), application (hospital, clinic, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
• Q.2. Which segments will grow at a faster pace and why?
• Q.3. Which region will grow at a faster pace and why?
• Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
• Q.5. What are the business risks and competitive threats in this market?
• Q.6. What are the emerging trends in this market and the reasons behind them?
• Q.7. What are some of the changing demands of customers in the market?
• Q.8. What are the new developments in the market? Which companies are leading these developments?
• Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
• Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
• Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?

Table of Contents

1. Executive Summary

2. Market Overview

• 2.1 Background and Classifications
• 2.2 Supply Chain

3. Market Trends & Forecast Analysis

• 3.1 Macroeconomic Trends and Forecasts
• 3.2 Industry Drivers and Challenges
• 3.3 PESTLE Analysis
• 3.4 Patent Analysis
• 3.5 Regulatory Environment

4. Global FeNO Testing Market by Type

• 4.1 Overview
• 4.2 Attractiveness Analysis by Type
• 4.3 Nitric Oxide Standalone Monitor: Trends and Forecast (2019-2031)
• 4.4 Nitric Oxide Handheld Monitor: Trends and Forecast (2019-2031)
• 4.5 Others: Trends and Forecast (2019-2031)

5. Global FeNO Testing Market by Application

• 5.1 Overview
• 5.2 Attractiveness Analysis by Application
• 5.3 Hospital: Trends and Forecast (2019-2031)
• 5.4 Clinic: Trends and Forecast (2019-2031)
• 5.5 Others: Trends and Forecast (2019-2031)

6. Regional Analysis

• 6.1 Overview
• 6.2 Global FeNO Testing Market by Region

7. North American FeNO Testing Market

• 7.1 Overview
• 7.4 United States FeNO Testing Market
• 7.5 Mexican FeNO Testing Market
• 7.6 Canadian FeNO Testing Market

8. European FeNO Testing Market

• 8.1 Overview
• 8.4 German FeNO Testing Market
• 8.5 French FeNO Testing Market
• 8.6 Spanish FeNO Testing Market
• 8.7 Italian FeNO Testing Market
• 8.8 United Kingdom FeNO Testing Market

9. APAC FeNO Testing Market

• 9.1 Overview
• 9.4 Japanese FeNO Testing Market
• 9.5 Indian FeNO Testing Market
• 9.6 Chinese FeNO Testing Market
• 9.7 South Korean FeNO Testing Market
• 9.8 Indonesian FeNO Testing Market

10. ROW FeNO Testing Market

• 10.1 Overview
• 10.4 Middle Eastern FeNO Testing Market
• 10.5 South American FeNO Testing Market
• 10.6 African FeNO Testing Market

11. Competitor Analysis

• 11.1 Product Portfolio Analysis
• 11.2 Operational Integration
• 11.3 Porter's Five Forces Analysis
  • Competitive Rivalry
  • Bargaining Power of Buyers
  • Bargaining Power of Suppliers
  • Threat of Substitutes
  • Threat of New Entrants
• 11.4 Market Share Analysis

12. Opportunities & Strategic Analysis

• 12.1 Value Chain Analysis
• 12.2 Growth Opportunity Analysis
  • 12.2.1 Growth Opportunities by Type
  • 12.2.2 Growth Opportunities by Application
• 12.3 Emerging Trends in the Global FeNO Testing Market
• 12.4 Strategic Analysis
  • 12.4.1 New Product Development
  • 12.4.2 Certification and Licensing
  • 12.4.3 Mergers, Acquisitions, Agreements, Collaborations, and Joint Ventures

13. Company Profiles of the Leading Players Across the Value Chain

• 13.1 Competitive Analysis
• 13.2 Guangzhou Kingmed Diagnostics
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.3 Hangzhou Clongene Biotech
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.4 Shanghai Fosun Long March Medical Science
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.5 Nanjing Norman Biological Technology
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.6 Beijing Eastwest Harmony Medical Devices
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.7 Guangzhou Yercon Diagnostic
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing
• 13.8 Aeonmed
  • Company Overview
  • FeNO Testing Business Overview
  • New Product Development
  • Merger, Acquisition, and Collaboration
  • Certification and Licensing

14. Appendix

• 14.1 List of Figures
• 14.2 List of Tables
• 14.3 Research Methodology
• 14.4 Disclaimer
• 14.5 Copyright
• 14.6 Abbreviations and Technical Units
• 14.7 About Us
• 14.8 Contact Us