Pulmonary Function Testing Devices Market Size & Share, by Component (Hardware, Software, Services); Product Type; Test Type; Application; End user - Global Supply & Demand Analysis, Growth Forecasts, Statistical Report 2026 2035

Pulmonary Function Testing Devices Market - Regional Analysis

North America Market Insight

In North America, the market for pulmonary function testing devices is expected to hold the highest share of 36%. This expansion is due to the extensive support provided by initiatives such as the ATS Pulmonary Function Laboratory Registry and its uniform management manual, which ensure that in case of a shortage of national accreditation, there is consistency with uniform testing protocols, thus generating demand for quality, compliant diagnostic hardware. Furthermore, according to the American Cancer Society in 2025, approximately 226,650 new cases of lung cancer were diagnosed in the U.S., leading to nearly 124,730 deaths.

The U.S. market for pulmonary function testing equipment is growing at a fast pace with the increasing prevalence of lung diseases such as cystic fibrosis, COPD, lung cancer, and asthma. The American Cancer Society 2025 states that lung cancers are most prevalent in people 65 or older, and the average age of diagnosis is 70. The U.S. market is greatly influenced by aggressive R&D spending, with companies investing in artificial intelligence integration, wearable diagnostics, and point-of-care test technology to ride early detection, patient monitoring, and remote care solutions for clinical and home care settings.

Canada pulmonary function testing devices market is aided by Health Canada's robust regulatory environment. According to a report by the Government of Canada 2021, 272 new Class III and 45 new Class IV medical devices were approved in 2021. With 140 investigational test applications for medical devices cleared, based on technology on the respiratory system, Canada continues to promote innovation, safety, and availability of diagnostic solutions in respiratory medicine.

Asia Pacific Market Insight

APAC pulmonary function testing device market is growing and expected to register fastest growth market with a significant market share during the forecast period, owing to increased respiratory diseases and increasing demand for early diagnosis. Government initiatives such as China's Healthy China 2030 and India's National Digital Health Mission encourage early detection and universal access to respiratory care. In addition, regulatory agencies in nations such as India are simplifying medical device approval to make it easier for new products to enter the market more quickly.

China's pulmonary function testing devices market is evolving with the technology of devices such as the Yue Cloud portable spirometer. According to a report by NLM 2022, primary respiratory parameters peak expiratory flow (PEF), maximal expiratory flow at 25%, 50%, and 75% of FVC (MEF25, MEF50, MEF75), and maximal mid-expiratory flow (MMEF), were compared with conventional devices through correlation analyses and Bland-Altman analyses and correlated well. The findings verify the accuracy of the device and the agreement of the automatic interpretation.

India's pulmonary function testing device market is developing, fueled by government-backed screening programs such as ASHA-based initiatives with peak flow meters and portable spirometers. As awareness of COPD rises, the market for pulmonary function testing devices in India is growing, driven by increasing demand for portable diagnostic tool solutions. Demand in the primary care segment is increasing, and there is scope for offering portable diagnostic solutions. Domestic R&D is centered on low-cost rugged devices for rural rollouts.

Europe Market Insight

Europe's market for pulmonary function test equipment is growing and expected to hold a considerable share due to rigid respiratory health requirements and increasing demand for infection-safe diagnosis following COVID-19. Efforts by organizations such as the European Respiratory Society (ERS) have accelerated the uptake of next-generation LFT technology. R&D efforts under coordinated initiatives focus on infection control, sterilization of equipment, and innovative contact-minimized spirometry technologies.

The UK pulmonary function testing equipment market is expanding with the help of government-sponsored respiratory screening requirements and NHS-funded early diagnosis initiatives for asthma and COPD. Industry players are launching digitally interfaced handheld spirometers and AI-assisted diagnostic equipment. Constant focus on R&D and streamlined innovation support schemes, such as the Office for Life Sciences, continue to nurture a nimble and future-proof respiratory diagnostics ecosystem.

Germany pulmonary function testing devices market is based on substantial R&D expenditure, advanced medical facilities, and regulatory capability. Drägerwerk and Geratherm are the leaders in spirometry and lung diagnosis, whereas tele-spirometry and respiratory homecare solutions are rising in prominence. The market is fortified with manufacturing hub benefits, given the very collaborative environment fostered between universities, industry, and medical associations in the country.