North America Pulmonary Function Testing Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

North America Pulmonary Function Testing Market Size

• The North America pulmonary function testing market size was valued at USD 1.62 billion in 2024 and is expected to reach USD 2.60 billion by 2032, at a CAGR of 6.10% during the forecast period
• The market growth is primarily driven by the increasing incidence of chronic respiratory conditions such as COPD, asthma, and pulmonary fibrosis, which is boosting the demand for early and accurate diagnostic solutions
• Moreover, rising healthcare expenditure, growing awareness of lung health, and technological advancements in portable and user-friendly pulmonary testing devices are further accelerating market adoption, positioning it as a vital segment in respiratory care

North America Pulmonary Function Testing Market Analysis

• North Pulmonary function testing, which enables the assessment of lung capacity and airflow efficiency, is becoming increasingly critical in the U.S. healthcare landscape due to its role in early detection and management of chronic respiratory diseases in both hospital and outpatient settings
• The growing prevalence of asthma, COPD, and other pulmonary conditions, along with heightened awareness of respiratory health and preventive care, is fueling the demand for accurate and non-invasive lung diagnostics
• U.S. dominated the pulmonary function testing market in North America with the largest revenue share of 39.9% in 2024, supported by its advanced healthcare infrastructure, increased healthcare spending, and rapid adoption of digital and portable diagnostic technologies across clinical environments
• Canada is expected to expected to be the fastest growing country in the pulmonary function testing market during the forecast period due to government-led respiratory health initiatives and rising incidences of environment-related lung disorders, contributing to wider deployment of PFT systems
• The hardware segment dominated the pulmonary function testing market with a market share of 47.6% in 2024, driven by continuous advancements in spirometers and plethysmographs

Report Scope and North America Pulmonary Function Testing Market Segmentation

North America Pulmonary Function Testing Market Trends

Technological Advancements in Portable and Digital Pulmonary Devices

• A significant and accelerating trend in the North America pulmonary function testing market is the widespread adoption of portable and digitally enabled lung diagnostic systems that allow testing beyond hospital settings and support real-time data integration for improved care coordination
  • For instance, NDD Medical Technologies’ EasyOne Air offers Bluetooth-enabled spirometry, allowing physicians to conduct lung function tests remotely and access patient data instantly through cloud-based platforms. Similarly, Vyaire Medical’s PFT solutions integrate with electronic medical records to streamline diagnostics and workflow
• The incorporation of digital connectivity enables healthcare providers to monitor patients more effectively, especially in chronic disease management programs for asthma and COPD. Devices with mobile compatibility and cloud access also support the shift toward telehealth and remote patient care
• Furthermore, AI-driven software is enhancing the accuracy of test interpretation and offering smart alerts for abnormal readings, reducing human error and supporting clinicians in decision-making
• These innovations are expanding the reach of pulmonary diagnostics to primary care settings, home care environments, and rural locations with limited access to full-scale hospital facilities
• This trend toward portable, intelligent, and connected pulmonary diagnostic solutions is transforming the landscape of respiratory care, making testing more accessible, timely, and aligned with modern healthcare delivery models

North America Pulmonary Function Testing Market Dynamics

Driver

Rising Prevalence of Respiratory Diseases and Focus on Early Diagnosis

• The growing prevalence of chronic respiratory diseases such as asthma, COPD, and pulmonary fibrosis in the U.S. is a key driver fueling demand for pulmonary function testing across clinical and outpatient settings
  • For instance, according to the CDC, COPD affects over 16 million Americans, while asthma impacts more than 25 million individuals, highlighting the need for routine and early diagnostic testing to manage disease progression
• Pulmonary function tests offer non-invasive, reliable assessments of lung health, making them essential tools for physicians managing both acute and long-term respiratory conditions
• Healthcare providers are increasingly integrating PFTs into standard diagnostic protocols to improve early detection rates and support personalized treatment strategies
• Moreover, national health initiatives promoting preventive care and chronic disease monitoring are boosting the uptake of portable spirometry and full PFT systems in hospitals, clinics, and mobile testing units
• The growing awareness of lung health and the importance of routine screenings is expected to further accelerate the demand for pulmonary diagnostics across North America

Restraint/Challenge

High Equipment Costs and Reimbursement Barriers in Outpatient Setting

• Despite the growing need for pulmonary function testing, the high cost of advanced diagnostic equipment remains a significant barrier to widespread adoption, particularly in smaller clinics and rural healthcare centers
• Comprehensive PFT systems, which include diffusion capacity and lung volume measurement, often require significant capital investment and trained personnel, limiting their use in resource-constrained settings
  • For instance, reimbursement for spirometry is more common, but coverage for advanced tests can be inconsistent, leading to financial challenges for providers offering full pulmonary testing services
• In addition, the complexity of insurance approval processes and varying coverage policies can deter healthcare facilities from investing in PFT equipment
• Although portable and affordable devices are entering the market, the cost of ownership and maintenance for advanced systems remains a concern, especially for outpatient care models
• Addressing these cost and reimbursement challenges through supportive policies, expanded insurance coverage, and technological innovation will be critical to ensuring equitable access to pulmonary diagnostics across North America

North America Pulmonary Function Testing Market Scope

The market is segmented on the basis of type, patient type, application, and end user.

• By Type

On the basis of type, the North America pulmonary function testing market is segmented into hardware, services, and software. The hardware segment dominated the market with the largest market revenue share of 47.6% in 2024, driven by the widespread use of core diagnostic devices such as spirometers, body plethysmographs, and gas diffusion systems in clinical environments. The demand for advanced pulmonary diagnostic hardware continues to rise due to increasing cases of chronic respiratory conditions and the adoption of portable and digital testing equipment across healthcare facilities. Hospitals and diagnostic laboratories rely heavily on these devices for routine and critical assessments of lung function.

The software segment is anticipated to witness the fastest growth rate of 19.4% from 2025 to 2032, fueled by increasing integration of PFT systems with electronic health records (EHRs), remote monitoring platforms, and AI-powered diagnostic support tools. These software solutions enhance test interpretation, streamline workflow, and improve clinician efficiency, contributing to their growing adoption across both large hospitals and smaller clinics.

• By Patient Type

On the basis of patient type, the North America pulmonary function testing market is segmented into pediatric, adult, and geriatric. The adult segment dominated the market with the largest market revenue share of 52.6% in 2024, driven by the high prevalence of asthma, chronic obstructive pulmonary disease (COPD), and occupational lung disorders among the adult population. Adults often require regular pulmonary assessments for disease management, surgical clearance, or workplace health screenings, making this group a key focus area for healthcare providers.

The geriatric segment is anticipated to witness the fastest growth rate of 20.1% from 2025 to 2032, supported by a growing aging population in North America and an increased risk of age-related pulmonary decline. The demand for pulmonary function testing in elderly patients is being driven by routine screenings, pre-operative evaluations, and chronic care needs associated with long-term respiratory conditions.

• By Application

On the basis of application, the North America pulmonary function testing market is segmented into obstructive lung disease and restrictive lung disease. The obstructive lung disease segment dominated the market with the largest market revenue share of 61.3% in 2024, driven by the widespread incidence of conditions such as asthma and COPD across North America. Pulmonary function tests, particularly spirometry, are essential tools for diagnosing and monitoring these diseases, leading to consistent demand in both primary and specialty care settings.

The restrictive lung disease segment is expected to grow steadily during the forecast period due to increasing awareness and diagnosis of conditions such as pulmonary fibrosis, sarcoidosis, and neuromuscular disorders. As healthcare providers focus more on comprehensive respiratory assessment, the need for full PFTs that include lung volume and diffusion testing is rising.

• By End User

On the basis of end user, the North America pulmonary function testing market is segmented into hospitals, specialty clinics, diagnostic laboratories, home care settings, and others. The hospital segment dominated the market with the largest market revenue share of 44.6% in 2024, attributed to high patient volumes, advanced infrastructure, and the availability of full-service respiratory diagnostic departments. Hospitals remain the primary centers for conducting complex pulmonary function tests, especially for inpatients and pre-surgical evaluations.

The home care settings segment is anticipated to witness the fastest growth rate of 21.5% from 2025 to 2032, fueled by the rising adoption of portable spirometry devices, remote patient monitoring solutions, and the shift toward decentralized care. Increased demand for chronic disease management, convenience in home-based testing, and improved telehealth support are major contributors to this trend.

North America Pulmonary Function Testing Market Regional Analysis

• U.S. dominated the pulmonary function testing market in North America with the largest revenue share of 39.9% in 2024, supported by its advanced healthcare infrastructure, increased healthcare spending, and rapid adoption of digital and portable diagnostic technologies across clinical environments
• Patients and healthcare providers in the U.S. and Canada are increasingly adopting pulmonary function tests due to their non-invasive nature, diagnostic accuracy, and importance in managing conditions such as asthma, COPD, and interstitial lung diseases
• This widespread utilization is further supported by well-established healthcare infrastructure, favorable reimbursement policies, and a rising demand for portable and home-based testing solutions, positioning pulmonary function testing as a critical tool in North America’s respiratory care landscape

U.S. North America Pulmonary Function Testing Market Insight

The U.S. pulmonary function testing market captured the largest revenue share of 82% in 2024 within North America, fueled by the increasing burden of chronic respiratory conditions and the country’s robust healthcare and insurance infrastructure. Advanced hospital settings, high adoption of digital health solutions, and rising geriatric population are major contributors to market expansion. Moreover, government initiatives such as the CDC’s support for chronic disease prevention, and growing investments in AI-enabled respiratory diagnostics, continue to boost the adoption of pulmonary function testing in clinical and outpatient settings.

Canada Pulmonary Function Testing Market Insight

The Canada pulmonary function testing market is anticipated to grow at a healthy CAGR throughout the forecast period, supported by expanding healthcare access and a rising number of respiratory illness cases. The country’s emphasis on preventive healthcare, coupled with strong government support for chronic disease management, encourages routine pulmonary screening, particularly among the aging population. Increasing deployment of mobile testing units and integration of digital spirometry into primary care practices are further enhancing diagnostic reach and efficiency in Canada.

Mexico Pulmonary Function Testing Market Insight

The Mexico pulmonary function testing market is expected to expand at a steady CAGR during the forecast period, driven by rising awareness of respiratory health and growing investments in healthcare infrastructure. Increasing incidences of asthma, COPD, and pollution-related lung conditions are prompting demand for early and accurate diagnostic solutions. The government’s efforts to improve access to public healthcare services, along with expanding private diagnostic laboratories, are contributing to wider adoption of pulmonary function tests. Moreover, the gradual introduction of portable testing devices and digital health technologies is enhancing diagnostic capabilities in both urban and semi-urban regions.

North America Pulmonary Function Testing Market Share

The North America pulmonary function testing industry is primarily led by well-established companies, including:

• MGC Diagnostics Corporation (U.S.)
• Vyaire Medical, Inc. (U.S.)
• ndd Medical Technologies, Inc. (Switzerland)
• Schiller AG (Switzerland)
• COSMED Srl (Italy)
• CareFusion Corporation (U.S.)
• Medical Graphics Corporation (U.S.)
• Morgan Scientific, Inc. (U.S.)
• Vitalograph Ltd. (U.K.)
• Nihon Kohden Corporation (Japan)
• SDI Diagnostics (U.S.)
• Labtech Ltd. (Hungary)
• Medisoft SA (Belgium)
• Futuremed America Inc. (U.S.)
• Seegene Medical Foundation (South Korea)
• Recorders & Medicare Systems Pvt. Ltd. (India)
• Ganshorn Medizin Electronic GmbH (Germany)
• Jones Medical Instrument Company (U.S.)
• ERT (U.S.)
• Spirohome (Turkey)

What are the Recent Developments in North America Pulmonary Function Testing Market?

• In June 2024, Vyaire Medical Inc., a key player in respiratory diagnostics, launched its new Vyntus PFT System in the U.S., designed to offer high-precision pulmonary measurements with improved patient comfort. The system integrates seamlessly with electronic health records (EHRs) and features advanced calibration and touchscreen controls. This launch reaffirms Vyaire’s commitment to enhancing diagnostic accuracy and clinical efficiency in pulmonary care settings
• In May 2024, MGC Diagnostics Corporation announced a collaboration with a network of community health centers across Canada to provide mobile pulmonary function testing services. This initiative is aimed at increasing access to respiratory diagnostics in underserved and rural areas. Through this partnership, MGC is advancing its mission to improve early detection of chronic respiratory diseases while supporting health equity
• In March 2024, NDD Medical Technologies Inc. introduced the EasyOne Air Next, a wireless spirometer approved by Health Canada and the FDA. Designed for point-of-care and remote testing, the device supports Bluetooth connectivity and cloud integration for real-time data sharing. This innovation supports a growing shift toward decentralized testing and empowers clinicians with portable, accurate diagnostic tools
• In February 2024, the American Thoracic Society (ATS) and the Canadian Thoracic Society jointly released updated guidelines on pulmonary function testing practices, emphasizing the use of AI-supported systems for improved interpretation accuracy. These guidelines are influencing procurement decisions across hospitals and clinics, driving greater adoption of AI-enhanced PFT devices across North America
• In January 2024, Hill-Rom Holdings, Inc. expanded its diagnostic solutions portfolio by integrating respiratory diagnostic modules into its Welch Allyn product line. This integration allows clinicians to conduct spirometry testing directly from existing diagnostic stations, improving workflow and streamlining respiratory assessments. The initiative underscores the growing demand for multifunctional diagnostic platforms in North American healthcare facilities

SKU-72777