Pulmonary Function Testing Systems Market - By Product Type (Handheld, Tabletop), By Test Type (Spirometry, Exercise Stress Test), By Application (Chronic Obstructive Pulmonary Disease), By Distribution Channel (Brick & Mortar, E-commerce), By End-use & Forecast, 2023 – 2032

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.
 

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.
 

COVID-19 Impact

The COVID-19 arose as an unprecedented public health concern across the globe and has positively impacted the pulmonary function testing systems business growth. The significant demand for COVID-19 diagnosis & treatment had augmented in order to prevent infections due to coronavirus. The usage of lung diseases testing in COVID-19 treatment was rising at a significant pace owing to associated advantages in reducing mortality rates. As per the Johns Hopkins University research studies, around 50% of cases admitted to the intensive care unit required some form of respiratory care.

In order to meet this huge demand, in the U.S. the CDC Strategic National Stockpile (SNS) stored and maintained respiratory care devices that can be utilized on request through suitable networks. The FDA was robustly working to assist surging the availability of respiratory care equipments and accessories for combating the covid-19 pandemic. Further, the World Health Organization (WHO) functioned in association with business players, government bodies, and Pandemic Supply Chain Network among others to boost the production of these products to meet increasing worldwide demand for critically affected and at-risk nations.
 

Pulmonary Function Testing Systems Market Trends

Increasing incidence of patients suffering from chronic respiratory diseases will primarily drive the market share. Chronic respiratory diseases are one of the leading causes of death across the globe. The disease progression is marked by recurring exacerbations and a steady loss in patients' functional level, culminating in a significant socioeconomic burden. This incremental rise in patient population has substantially increased the hospitalization rate, thereby augmenting the demand for diagnostic products.
 

The clinical advantages associated with pulmonary function testing systems has increased the product adoption in several healthcare facilities. Diseases such as asthma, cystic fibrosis, chronic obstructive pulmonary disease (COPD), and other occupational lung diseases are some of the diseases that are contributing to the augmenting market revenue. According to the U.S. Department of Health & Human Services and CDC data, in 2020, around 15 million Americans were suffering from chronic obstructive pulmonary disease and is anticipated to increase during the estimated timeframe. The rising number of COPD cases is attributed to the risk factors such as smoking and indoor & outdoor air quality.
 

Pulmonary Function Testing Systems Market Analysis

Based on product type, the pulmonary function testing systems market is segmented as handheld and tabletop. The handheld pulmonary function testing devices segment held majority market share in 2022 and was valued at over USD 1.2 billion. This segment share is primarily attributed to significant technological advancement and an increase in the awareness of benefits related to the use of portable pulmonary function testing systems. The biggest advantage of a portable devices is that it can remotely monitor the condition and progression of the health of these patients in emergency conditions.
 

Market players are focusing on commercializing handheld testing products that can monitor multiparameter essential symptoms comprising respiratory rate, heart rate, body temperature, and SpO2. Recently introduced portable spirometer including Respinos is designed in the form of a tube that can be ergonomically inflated by the patient and is integrated with a precise and disposable turbine-based air flow sensor to assess the patient's respiratory condition.
 

As per the research studies, continuous pulmonary function monitoring can serve as a diagnostic tool for several lung conditions including asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and lung cancer among others. Moreover, according to the American Lung Association, one of the key advantages of this device is that it’s non-invasive as there are no incisions or breaks in patients’ skin and assess every variation that can be the cause of lung disease.
 

Based on test type, the pulmonary function testing systems market is segmented as spirometry, lung volume test, gas diffusion test, exercise stress test, high altitude simulation testing, and others. The spirometry segment was valued at USD 926 million in 2022. This is owing to the growing technological advancements in spirometers, increase in R&D activities, and surging adoption of non-invasive diagnostic techniques among others. The new generations spirometry testing systems have evolved from fixed, volume-based devices to portable, flow-based devices that can be transported easily. Market players are focusing on the designing of sleek & efficient recorder for patient comfort & for streamlined workflow as per the individual patient requirements.
 

Improving set-up features comprising simple navigation buttons, large on-board display, automatic power on self-test, and lightweight design is assisting in faster operation along with enhanced comfort. Smart  spirometers embedded with AI technology can collect data and monitor a patient's condition. As a result, simple, secure and smart spirometers with accurate solutions that help to reduce complexity and shorten the path to diagnosis will expand the market size.
 

Based on application, the pulmonary function testing systems market is segmented as chronic obstructive pulmonary disease, asthma, chronic shortness of breath, pulmonary fibrosis, and others. The asthma segment held considerable share with more than 25% revenue share in 2022 and is forecasted to witness a similar trend during the analysis period. This is attributable to the growing prevalence of asthma, preference for technologically advanced lung diagnostic tests, etc. People with asthma have a greater risk of certain allergic conditions, such as eczema or hay fever. According to the National Institute of Health, in 2022, around 300 million people were suffering with asthma across the globe.  
 

Spirometry is the recommended test to confirm asthma. It measures the amount of air patient able to breathe in and out and its rate of flow. Moreover, benefits associated with testing such as reliability in disease screening and reduced severity of infection with a better diagnosis are forecasted to positively impact the industry growth.
 

Based on distribution channel, the pulmonary function testing systems market is segmented as the hospital & clinics pharmacies, brick & mortar, and e-commerce. The brick & mortar stores segment is estimated to progress at substantial growth rate to reach over USD 1.6 billion by 2032. This substantial segment share is owing to several advantages offered by the medical retail stores in medical diagnostic devices distribution including the availability of a wide array of products and substantial discounts.
 

Additionally, various market players are focusing on marketing products through medical retail stores that increase the salability of a wide variety of product, thus propelling segment landscape. Some medical retail stores also offer educational programs for precise product awareness and focus on combating health issues including lung diseases, etc. Moreover, well-defined safety, effective services, and security policies are boosting the segment revenue.
 

Based on end-use, the pulmonary function testing systems market is segmented diagnostic centers, homecare settings, and others. The hospitals & clinics segment is projected to reach more than USD 1.7 billion by 2032. The soaring use of novel portable pulmonary function testing devices in hospital settings delivering rapid and reliable outcomes is estimated to surge the patient preference for these healthcare facilities. The availability of a broad spectrum of pulmonary function tests that supports continuous monitoring with proven accuracy is set to drive product preference in hospitals & clinics.
 

Growing admissions with lung ailments and growing disease screening initiatives along with the accessibility to board-certified healthcare professionals are some other variables that are augmenting the segment growth positively. Furthermore, the rising disease burden in developed economies with enhanced healthcare infrastructure is projected to stimulate the diagnosis & treatment rate at hospitals.
 

The U.S. pulmonary function testing systems market is anticipated to exceed USD 1.6 billion by 2032. This majority market share is credited to several factors such as the presence of major industry players, an upsurge in the demand for respiratory diseases continuous monitoring services, rise in the prevalence of lung diseases conditions, and growing number of hospital admissions across the country among others. As per the American Lung Association data 2021, around 236,000 people were diagnosed with lung cancer in the U.S.
 

Additionally, according to the Asthma and Allergy Foundation of America, currently, around 26 million people in the U.S. have asthma. These adverse events are anticipated to upsurge the adoption rate of pulmonary function testing systems devices for better disease management. This is further driving the entry of new players in the market that are projected to increase over the forecast timeframe.
 

Pulmonary Function Testing Systems Market Share

Some of the major market players operating in the pulmonary function testing systems industry are :

• Koninklijke Philips N.V.
• Medical Equipment Europe
• Medtronic
• Minato Holdings Inc
• Morgan Scientific Inc
• ndd Medizintechnik AG 

Major market players are adopting strategic formulations such as forward integration, new product development, geographical expansion, and research collaborations to garner maximum industry share and promote company growth.
 

Pulmonary Function Testing Systems market News:

• In January 2021, NuvoAir announced the partnership with Roche to make its technology available in selected cystic fibrosis (CF) centers. NuvoAir’s platform has been developed for patients to conduct lung function assessments at home. This strategic move assisted the company in bolstering its product portfolio and offered a competitive edge.
   
• In August 2019, Resmed completed the acquisition of HB Healthcare that provides home medical equipment such as sleep and respiratory care devices to the patients. This acquisition helped the company to enhance their product portfolio in mechanical ventilators and increase their market value thereby enhancing their business revenue.
   

Pulmonary function testing systems market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD (million) and volume (units) from 2018 to 2032 for the following segments:

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By Product Type, 2018 - 2032 (USD Million & Units)

• Handheld
• Tabletop

By Test Type, 2018 - 2032 (USD Million)

• Spirometry
• Lung Volume Test 
• Gas Diffusion Test
• Exercise Stress Test
• High Altitude Simulation Testing
• Others

By Application, 2018 - 2032 (USD Million)

• Chronic Obstructive Pulmonary Disease
• Asthma
• Chronic Shortness of Breath
• Pulmonary Fibrosis
• Others

By Distribution Channel, 2018 - 2032 (USD Million)

• Hospital & clinics pharmacies
• Brick & Mortar
• E-commerce

By End-use, 2018 - 2032 (USD Million)

• Hospitals & Clinics
• Diagnostic Centers
• Homecare Settings
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Sweden
  • The Netherlands
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
  • Indonesia
  • Philippines
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Colombia
  • Chile
  • Peru
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Israel
  • Turkey
  • Iran