Pulmonary Function Testing Systems Market Size

Pulmonary Function Testing Systems Market Size

Pulmonary Function Testing Systems Market size was valued at USD 2 billion in 2022 and is estimated to reach USD 3.7 billion by 2032. This significant market growth is primarily attributed to several variables comprising the growing prevalence of lung diseases, the rise in demand for pulmonary function testing, and technological advancements in spirometry diagnostic devices among others.

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In developing nations, the prevalence of pulmonary diseases is highest due to socioeconomic status and people living a sedentary lifestyle. This increasing prevalence of lung disease is anticipated to drive market growth globally. Pulmonary disease is one of the leading causes of death globally that in turn leads to the increasing demand for lung diagnostic devices in hospitals and diagnostic centers. Additionally, the severe health concerns associated with respiratory diseases are anticipated to stimulate the demand for testing.

A pulmonary function testing (PFTs) systems utilizes non-invasive techniques to assess lungs functioning. The tests measure lung volume, capacity, rates of flow, and gas exchange among others. This data can help healthcare professional diagnose and decide the treatment of certain lung disorders.
 

However, the stringent regulatory framework related to pulmonary function testing systems devices may hamper the market revenue. The U.S. FDA has rigid regulatory compliances and complex approval procedures that may obstruct the pulmonary function testing systems market growth. The majority of pulmonary function testing equipments need a premarket notification, or 510(k) process prior to their commercialization in the market. Such stringent product regulations may lead to penalties and loss of market access in a global marketplace.
 

Further, regulations majorly delay the approval of these products due to time-consuming documentation and review protocols. These products usually require the optimum level of scrutiny and a set of entire preclinical & clinical reviews through pre-market approvals, with the majority requiring clinical studies and subsequent information. These additional controls include mandates such as post-market surveillance, special labelling requirements, and meeting the pre-set performance standards.