Respiratory Devices Market Research On Size, Growth Trends, Segments, Regions & Competition

Global Respiratory Devices Market Trends and Insights

Surge in Prevalence of Respiratory Disorders

Continuing growth in COPD and asthma cases is underpinning sustained equipment demand. The American Lung Association reported that 44.2 million U.S. residents had asthma diagnoses in 2023, with adults aged 18-55 recording the highest lifetime incidence at 16.8%. Females faced higher asthma prevalence than males, widening the addressable user base for inhalers, spirometers, and smart peak-flow meters. Meanwhile, World Health Organization data frames COPD as a silent killer concentrated in low- and middle-income economies.^{[1]World Health Organization, “Chronic Respiratory Diseases (Asthma, COPD),” who.int} This pattern spurs donor-funded purchases of affordable concentrators and mobile diagnostic vans.

Technological Advancements

Manufacturers now embed adaptive pressure algorithms into CPAP units, cutting mask-leak discomfort and elevating therapy adherence. NovaResp clinched USD 3 million to refine such AI engines in 2024. University of Cincinnati engineers introduced VortexPAP, which uses vortex airflow to supply the required airway pressure without a tight facial seal, promising greater patient convenience.^{[2]University of Cincinnati, “Researchers Develop New CPAP Device,” uc.edu Source: NovaResp, “AI-Driven CPAP Therapy Software Funding,” novaresp.ai} Lightweight humidifiers, cloud-linked oximeters, and Bluetooth-enabled nebulizers illustrate a pipeline oriented toward seamless data capture and clinician dashboards.  

Rapid Penetration of Respiratory Devices in Home-Healthcare

The shift toward home-based respiratory care represents a fundamental transformation in healthcare delivery models, driven by cost pressures on healthcare systems and patient preference for treatment in familiar environments. This trend has accelerated the development of portable, user-friendly devices with enhanced connectivity features. For instance, in October 2024, Inogen, Inc., a medical technology firm specializing in homecare respiratory solutions, unveiled its latest product, the Inogen Rove 4 Portable Oxygen Concentrator, in the United States.

Rising Adoption of Non-Invasive Ventilation (NIV)

Non-invasive ventilation has emerged as a first-line intervention for various respiratory conditions, transforming treatment protocols and patient outcomes. The initiatives taken by the market players, such as the development of technically advanced NIV products, are driving the adoption of these devices. For instance, in August 2024, OxiWear secured FDA 510(k) clearance for its innovative ear pulse oximeter, a device tailored for continuous and real-time monitoring of blood oxygen saturation (SpO2) and pulse rate. Similarly, in February 2024, Masimo revealed that its MightySat Medical received FDA clearance, marking it as the sole FDA-cleared medical fingertip pulse oximeter accessible Over-The-Counter (OTC) directly to consumers without the need for a prescription. 

High Cost of Devices

Premium ventilators, CPAP platforms, and lab-grade diagnostic gear carry five-figure price tags and recurring service contracts, limiting penetration in resource-constrained settings. The World Health Organization underscores that more than 90% of COPD fatalities occur in low-income regions lacking sufficient device access, magnifying the affordability gap. Researchers have responded with modular systems combining oxygen generation and ventilation at lower cost, exemplified by a cross-over trial validating such a portable solution for acute-lung-injury care in 2025.

Stringent Regulatory Requirements

The U.S. FDA amended its Quality System Regulation in February 2024 to align with ISO 13485, compelling manufacturers to update documentation, audit trails, and design controls.^{[3]U.S. Food and Drug Administration, “Medical Devices; Quality System Regulation Amendments,” federalregister.gov} Moreover, the agency’s predetermined change-control-plan framework allows faster software updates but imposes upfront planning burdens. Parallel moves in the European Union under the Medical Device Regulation increase technical-file scrutiny, extending time-to-market for start-ups. Compliance complexity can raise development costs and slow the respiratory devices market trajectory.

Segment Analysis

By Device Type: Therapeutic Dominance and Diagnostics Momentum

Therapeutic platforms held 45.33% of 2024 sales, reflecting entrenched use of ventilators, CPAPs, and oxygen concentrators for acute and chronic care. The respiratory devices market size for therapeutic systems is forecast to advance at a mid-single-digit rate, supported by rising elective-surgery volumes and chronic-disease surveillance programs. Intensive-care wards increasingly prefer turbine-based ventilators that reduce compressed-air requirements, curbing utility costs and broadening deployment in field hospitals. Parallel progress in humidifier miniaturization and closed-loop oxygen control enhances patient comfort, reinforcing demand.

Diagnostic and monitoring equipment, including spirometers, capnographs, and wireless pulse oximeters, is the fastest-growing branch, charting an 8.53% CAGR through 2030. Population-screening campaigns for occupational lung disease and at-home sleep-test kits are key catalysts. Artificial-intelligence analysis of flow-volume loops now flags early obstruction with greater specificity, encouraging pre-symptomatic intervention. As these tools converge with telemedicine portals, payers recognize their preventive value, boosting reimbursement adoption and widening the respiratory devices market.

Note: Segment shares of all individual segments available upon report purchase

By Indication: COPD Leadership and Sleep Apnea Upswing

COPD accounted for 42.25% of revenue in 2024, reflecting its chronicity and frequent exacerbations that necessitate nebulizers, long-term oxygen therapy, and NIV. An aging smoker population and prolonged exposure to biomass smoke in emerging markets sustain device demand. Programs integrating spirometry into primary care are widening diagnostic catchment, and digital inhalers that confirm dose delivery are resetting adherence metrics.

Sleep-apnea therapies are projected to record the strongest momentum, with an 8.93% CAGR over 2025-2030. Rising obesity prevalence, heightened cardiovascular-risk recognition, and extensive marketing of home sleep-apnea tests underpin growth. The FDA-cleared NightOwl HSAT, introduced in April 2025, underscores a self-administered diagnostic shift. CPAP designs now incorporate fabric masks and quiet turbine housings to elevate patient comfort, a critical variable in long-term adherence, thereby expanding the respiratory devices market.

By Patient Age Group: Adults Lead, Pediatrics Rise

Adult segment represented 79.56% of 2024 revenue, a share aligned with higher COPD, sleep-apnea, and post-operative respiratory-support needs. Degenerative lung elasticity and co-morbidities drive sustained equipment utilization. Manufacturers target this cohort with user-friendly interfaces, voice-prompted setup guides, and connected applications that sync with fitness trackers.

The pediatric/neonatal segment, while smaller, is registering a 7.23% CAGR. Innovations encompass neonatal ventilators capable of delivering precise tidal volumes as low as 2 mL, pressure-controlled surfactant nebulizers, and simulation-based training tools. Such enhancements mitigate ventilator-induced lung injury risks and improve survival outcomes, elevating professional acceptance and widening the respiratory devices market.

By End User: Hospitals Hold, Home Care Accelerates

Hospitals controlled 48.42% of 2024 demand, reflecting their role in critical-care ventilation, acute exacerbation management, and surgery-related airway support. Capital-budget cycles favor high-acuity ventilators with dual-mode invasive and non-invasive capabilities, bedside ultrasound for recruitment maneuver guidance, and automated cuff-pressure regulation. Integration with electronic health-record systems streamlines workflow and underpins purchase decisions.

Other end users, chiefly home-health providers, are the fastest-growing cohort at a 9.12% CAGR. Portable concentrators under 2.5 kg, wearable metrology for SpO₂ and respiration rate, and insurance models that bundle hardware with cloud analytics fuel uptake. Remote-device-management portals cut unplanned service calls, saving payer costs and accelerating adoption, reinforcing the respiratory devices market.

Geography Analysis

North America contributed 39.35% of 2024 revenue, anchored by high device penetration, structured reimbursement, and robust research funding. The National Institutes of Health earmarked USD 148 million for COPD research in 2024 and USD 149 million for 2025, supporting translational programs that spawn next-generation ventilator algorithms. Market dynamics are also influenced by recall cycles, such as Philips’ 2023-2024 CPAP foam-degradation event, which spurred replacement demand and intensified regulatory scrutiny. Evolving FDA expectations regarding cybersecurity and software updates further shape supplier strategies within the respiratory devices market.

Asia-Pacific is projected to log an 8.47% CAGR through 2030. Rapid urbanization, growing middle-class incomes, and policy measures that subsidize oxygenic devices elevate demand. WHO data indicate that over 90% of global COPD deaths occur in low- and middle-income economies, many situated in this region. Undiagnosed COPD remains widespread, exemplified by Japan’s 8.4% diagnostic rate despite regular pulmonary tests. This diagnostic gap, once addressed through awareness campaigns and affordable spirometry drives, can unlock substantial volumes for the respiratory devices market.

Europe sustains a sizeable share through strong public-health infrastructure and stringent clinical protocols. The United Kingdom reported 2.4 million asthma patients in fiscal year 2023-2024, reinforcing recurring demand for inhalers, spacers, and emergency nebulizers. Budget pressures are prompting procurement frameworks that balance upfront cost with life-cycle value, favoring devices offering predictive-maintenance analytics. Growing focus on eco-design, such as reusable water chambers and recyclable mask components, is gradually shaping product-development pipelines.