Respiratory Devices Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Respiratory Devices Market Trends and Insights

Surge in Prevalence of Respiratory Disorders

More than 545 million people live with chronic respiratory diseases, and COPD caused 3.2 million deaths in 2024. Dual-exposure patterns magnify the burden: older adults in wealthy countries experience age-linked lung decline, whereas low-income settings face indoor biomass combustion and severe outdoor particulate pollution. India’s National Health Profile noted a 23% jump in asthma admissions among urban children under 15 during 2025 winter spikes of PM2.5 to 89 µg/m³. In the United States, sleep apnea prevalence reached 38% among adults over 50 in 2025, a trend tied to obesity plateaus and broader use of home sleep tests^{[1]Centers for Disease Control and Prevention, “Sleep and Sleep Disorders,” cdc.gov}. Infectious diseases add to the load: tuberculosis recorded 10.8 million new cases in 2024, many requiring long nebulized regimens. These epidemiological realities keep demand high for diagnostic spirometers and therapeutic systems across the respiratory devices market.

Technological Advancements in Diagnostic & Therapeutic Devices

Miniaturization and connectivity shift sophisticated pulmonary testing from the lab to primary care. In 2025, the FDA cleared 14 AI-enabled spirometry platforms with 91% sensitivity for early COPD detection. Philips launched the DreamStation 3 CPAP in late 2024, integrating leak-compensation algorithms that reduced therapy abandonment by 19%. Mesh nebulizers attained 85% lung-deposit efficiency in 2025 trials, trimming medication waste. Portable oxygen concentrators now run eight hours at 2 l/min on lithium-iron-phosphate power packs. Ventilators featuring closed-loop automation cut ventilator-induced injury 27% in ICU environments, closing the performance gap between hospital and home devices.

Rapid Penetration of Home-Healthcare Respiratory Equipment

Coverage reform, not patient preference, drives the shift to home-based therapy. CMS removed prior authorization for home ventilators in 2025 and raised monthly rental caps to USD 850. Private insurers mirrored the move, linking reimbursement to readmission reduction. Germany approved home CPAP for mild sleep apnea in 2024, citing cardiovascular risk reduction. Japan now subsidizes 70% of device costs for adults over 75, aiming to migrate 120,000 ventilator users to home care by 2028. Fiscal math underpins adoption: home ventilation costs around USD 12,000 annually versus USD 180,000 in hospital settings. Infrastructure gaps in rural regions remain a constraint, but the economic imperative favors continued diffusion.

Government Initiatives & Reimbursement Expansion

Universal health programs increasingly embed respiratory devices to curb downstream acute-care expenditure. India’s Ayushman Bharat added nebulizers and pulse oximeters to its essential list in 2024, subsidizing 80% of costs for 500 million beneficiaries. China instituted provincial reimbursement for home oxygen in 2025, capping 5-liter concentrators at CNY 3,500 (USD 480). Australia’s Therapeutic Goods Administration halved clearance timelines for connected respiratory monitors, enabling faster commercialization. These measures widen access and accelerate revenue capture across the respiratory devices market.

High Cost of Advanced Devices

A hospital ICU ventilator lists for USD 25,000–50,000, while a home CPAP system ranges from USD 800–2,500—figures far above annual per-capita health budgets in many low-income nations. Only 18% of Indian COPD patients prescribed oxygen therapy actually acquire concentrators, underscoring affordability gaps. Tiered product lines aim to bridge the divide; ResMed’s USD 650 AirMini CPAP omits cellular connectivity to hit cash-pay price points. Pay-per-use leasing via Kenya’s M-TIBA lowers the barrier to USD 3 per day but still reaches less than 5% of potential users.

Stringent Multi-Jurisdiction Regulatory Clearance

Europe’s CE-MDR now mandates clinical investigations for Class IIb respiratory devices, pushing review cycles to 18–24 months and costing roughly USD 380,000 per submission^{[2]European Commission, “Medical Device Regulation (MDR),” ec.europa.eu} . China’s NMPA reclassified connected nebulizers as Class III in 2025, adding 14 months to approvals. Although FDA 510(k) median review times remain near 150 days, software updates that alter clinical claims now require fresh submissions. Larger incumbents manage these burdens, but startups face capital and time hurdles that can slow innovation diffusion within the respiratory devices market.

Segment Analysis

By Device Type: Therapeutic Devices Extend Their Lead

Therapeutic platforms held 47.55% of revenue in 2025, and the segment is projected to grow 11.25% through 2031. The respiratory devices market size attributed to CPAP and BiPAP systems continues to swell on the back of rising obstructive sleep apnea diagnoses among adults over 50. Portable oxygen concentrators, now able to support eight-hour outdoor use, are also expanding access for ambulatory COPD patients. Home ventilators benefit from CMS reimbursement changes, while smart inhalers with Bluetooth dose logging reached 12% penetration in 2025. 

Diagnostic and Monitoring systems captured 32% of 2025 revenue with a slower 5.8% CAGR as commoditization pressures margins. The respiratory devices market share for handheld, AI-guided spirometry is increasing, but average selling prices fell for pulse oximeters due to Chinese competition. Consumables such as single-use masks and tubing represented 20.45% of 2025 revenue and will track overall procedure volumes, especially as infection-control protocols remain stringent.

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

By Indication: Infectious Diseases Gain Momentum

COPD generated 35.53% of 2025 sales, anchored by lifelong oxygen and bronchodilator needs. Yet Infectious Diseases—led by tuberculosis and pandemic preparedness spending—show the fastest 10.85% CAGR, lifting the respiratory devices market size allocated to mesh nebulizers and portable ventilators. Asthma retains a strong 28% share, with adherence-tracking inhalers now a payer focus. Sleep apnea remains significant in developed economies, while Other Respiratory Disorders, including cystic fibrosis, secure steady growth as survival rates improve.

By Patient Age Group: Adults Dominate, Pediatrics Trails

Adults contributed 71.63% of 2025 revenue and will grow 8.87% to 2031 as the global 65-plus population rises. Higher reimbursement ceilings and co-morbid obesity support demand for advanced BiPAP devices. Pediatric and neonatal segments grow at a slower 5.2%, constrained by declining birth rates in wealthier countries and stricter regulatory pathways. Neonatal ventilators still see incremental volume increases in emerging markets adding NICU beds.

By End User: Home Settings Accelerate

Hospitals retained 56.23% of 2025 sales, but Home Settings are advancing at an 11.7% CAGR on the strength of tele-connected equipment and payer incentives to cut readmissions. Respiratory and sleep clinics remain important for diagnostic throughput, while ambulatory centers grow in tandem with same-day bronchoscopy volumes. Devices conceived for intuitive home use are best positioned to capture the high-growth end-user shift shaping the respiratory devices market.

Geography Analysis

North America generated 39.13% of 2025 revenue, with the United States alone spending USD 9.8 billion on respiratory equipment. Growth moderates to 6.2% as CPAP penetration approaches saturation, but software-enabled upgrades and home ventilator adoption still lift value. Canada’s Assistive Devices Program added portable concentrators, and Mexico’s social security institute widened CPAP coverage, adding incremental volumes.

Asia-Pacific is the fastest-growing region at a 10.51% CAGR. China’s provincial reimbursement for home oxygen aims at 100 million COPD patients, while India’s Ayushman Bharat subsidizes nebulizers for 500 million citizens. Japan’s subsidy covering 70% of device costs for seniors accelerates the move to home ventilation, and South Korea broadened CPAP coverage to mild cases. Australia’s expedited pathway for connected monitors further catalyzes product launches.

Europe accounted for 28% of 2025 revenue but grows at a muted 5.9% as CE-MDR bottlenecks slow new device rollouts. Germany remains the largest national market after approving home CPAP for mild cases. The United Kingdom boosted home respiratory allocations under its NHS Long Term Plan, and France raised monthly reimbursements for home ventilators, improving supplier economics. 

Middle East and Africa held 6% of sales, powered by GCC hospital investments and South Africa’s public-sector purchase of concentrators. South America contributed 5.87% as Brazil’s SUS added home CPAP coverage for 1.2 million patients, offering fresh demand in a historically under-penetrated market.