Italy Respiratory Devices - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

The italy respiratory devices market size is projected to be USD 0.74 billion in 2025, USD 0.79 billion in 2026, and reach USD 1.10 billion by 2031, growing at a CAGR of 6.80% from 2026 to 2031. This report is Segmented by Device Type (Diagnostic & Monitoring, Therapeutic, Disposables), Disease Indication (COPD, Asthma, Sleep Apnea, Pneumonia, and More), Age (Adult, Geriatric, Pediatric), End-User (Hospitals & Clinics, Home Healthcare, Ascs, and More). Market Forecasts are Provided in Terms of Value (USD).

Italy Respiratory Devices Market Trends and Insights

Increasing Prevalence of Chronic Respiratory Diseases (COPD, Asthma, OSA)

A combined 6.5 million Italians live with COPD or asthma, and an estimated 80% of moderate-to-severe sleep-apnea cases remain undiagnosed. During the 2023/2024 winter, co-circulating SARS-CoV-2 and influenza viruses led to a spike in hospital admissions for acute exacerbations among older adults. RSV alone drives roughly 26,000 hospitalizations and 1,800 deaths each year in citizens aged 60+, underscoring the need for early detection tools and ventilatory support systems. Expanding home-sleep testing and broader reimbursement of CPAP devices are expected to surface latent demand, lifting unit shipments of diagnostic polysomnography recorders and auto-adjusting positive airway pressure devices across the respiratory devices market.

Rising Adoption of Home-Care Respiratory Support & Tele-Monitoring

The National Recovery and Resilience Plan earmarks EUR 4.75 billion (USD 5.1 billion) for primary-care hubs equipped with digital monitoring platforms that push real-time oximetry, spirometry, and CPAP-adherence data to pulmonologists. Lombardy’s COD19 project showed a 20% cut in COPD readmissions by deploying connected pulse oximeters and chat-based nurse triage. A 2025 survey of 150 Italian payers highlighted reimbursement ambiguity and privacy compliance as leading obstacles, signaling that national procurement standards and clear data-governance rules will unlock faster scale-up.

High Upfront Cost of Advanced Devices & Limited Reimbursement

Portable oxygen concentrators, adaptive servo-ventilation systems, and connected nebulizers cost EUR 1,500-8,000 but receive partial reimbursement only for narrowly defined indications under Servizio Sanitario Nazionale. Patients with moderate disease often self-finance or delay therapy, dampening unit growth in the respiratory devices market. Administrative complexity, multi-form authorization, specialist referrals, and annual recertification discourage uptake among elderly users with limited digital literacy, perpetuating a two-tier device landscape.

Other drivers and restraints analyzed in the detailed report include:

• EU Climate Policy Driving Switch to Low-GWP Inhalers
• Regional Tele-Health Pilots Accelerating Digital Device Uptake
• Stringent EU-MDR Compliance Timelines

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Therapeutic equipment generated 47.67% of 2025 revenue as hospitals renewed ICU ventilator fleets and home-care providers expanded CPAP rental programs. Disposables, however, are projected to grow at an 8.8% CAGR, the highest among product lines in the respiratory devices market. Single-patient breathing circuits, antibacterial HME filters, and CPAP masks require quarterly replacement, creating a predictable consumables annuity. Diagnostic products, portable spirometers, pulse oximeters, and capnographs capture the remainder but gain relevance as tele-monitoring pilots transition from proof-of-concept to reimbursed standard of care.

Rising awareness of ventilator-associated pneumonia is driving stricter hospital protocols that favor single-use circuits, propelling volume for local converters that customize tubing lengths and connectors. At the same time, connected disposables embed RFID chips that track change intervals, enabling predictive reordering. Multinationals bundle disposables with equipment leases, locking customers into contracts for three to five years. Italian SMEs defend their market share through rapid prototyping and customization, helping the respiratory devices market maintain a competitive balance between global and domestic suppliers.

COPD still accounted for 33.34% of 2025 sales, reflecting over 3.5 million clinically diagnosed cases that require long-term oxygen therapy, nebulized bronchodilators, and pressure support ventilators. Sleep apnea is projected to grow 9.58% annually to 2031, the fastest rate among indications. Expanded reimbursement for home polysomnography and auto-titrating CPAP devices is boosting the market size for this category. Seasonal spikes in pneumonia and viral infections also drive purchases of ventilators and high-flow oxygen, an episodic driver that peaks during winter but has plateaued after COVID-19 ICU upgrades.

Improved awareness campaigns by pulmonology societies and general practitioners lead to earlier referrals, raising CPAP initiation rates within six months of diagnosis. Meanwhile, emerging niche indications such as bronchiectasis and pulmonary fibrosis receive attention through compassionate-use programs that seed future demand for portable oxygen concentrators and oscillatory PEP devices.

Complete Report Scope:

• By Device Type
  • Diagnostic & Monitoring Devices
    • Spirometers
    • Sleep Test Devices
    • Peak Flow Meters
    • Pulse Oximeters
    • Capnographs
    • Other Diagnostic & Monitoring
  • Therapeutic Devices
    • CPAP Devices
    • BiPAP Devices
    • Humidifiers
    • Nebulizers
    • Oxygen Concentrators
    • Ventilators
    • Inhalers
    • Other Therapeutic Devices
  • Disposables
    • Masks
    • Breathing Circuits
    • Other Disposables
• By Disease Indication
  • COPD
  • Asthma
  • Sleep Apnea
  • Pneumonia & Acute Respiratory Infections
  • Others
• By Age
  • Adult
  • Geriatric
  • Pediatric
• By End-User
  • Hospitals & Clinics
  • Home Healthcare Settings
  • Ambulatory Surgical Centers
  • Others

List of Companies Covered in this Report:

• Air Liquide
• Allied Healthcare Products
• Breas Medical AB (Fosun Pharma)
• Chiesi Farmaceutici
• Dragerwerk
• Fisher & Paykel Healthcare
• GE Healthcare
• Getinge
• Hamilton Medical
• Invacare
• Koninklijke Philips
• Lowenstein Medical
• Masimo
• Medtronic
• OMRON
• Resmed
• Siare Engineering International Group
• Smiths Medical (ICU Medical)
• Teleflex
• Vyaire Medical

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support