지능형 천식 모니터링 디바이스 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the intelligent asthma monitoring devices market size was valued at USD 1.17 billion in 2025 and is estimated to grow from USD 1.27 billion in 2026 to reach USD 1.89 billion by 2031, at a CAGR of 8.28% during the forecast period (2026-2031).

Global Intelligent Asthma Monitoring Devices Market Trends and Insights

Rising Asthma Prevalence and Underdiagnosis

Asthma created a substantial need for improved follow-up, particularly in settings with incomplete diagnosis and treatment. The Global Burden of Disease study estimated that 363 million people had asthma in 2024, causing 442,000 deaths annually. The World Health Organization reported that essential asthma medicines were unavailable in more than one-third of public primary care facilities in low- and lower-middle-income countries. Incidence was highest among children younger than 5 years, while prevalence peaked among adults aged 95 years and older, creating distinct monitoring requirements. China had an estimated 45.7 million adults with asthma, representing 4.2% of its adult population. As screening identified more patients, the intelligent asthma monitoring devices market expanded through active case management without an increase in underlying disease incidence.

Medication Nonadherence and Inhaler-Technique Errors

Medication nonadherence reinforced the business value of connected asthma management tools. The 2025 APPaRENT 3 survey found that 55% of patients demonstrated erratic nonadherence, including occasionally forgetting to use an inhaler, while 49% used controller inhalers less than once daily. Physicians estimated adherence at 73%. A Spanish cross-sectional study found that 24.6% of patients with chronic respiratory diseases had adherence below 50%, based on electronic prescription records. A 2026 study found that only 6.6% of metered-dose inhaler users demonstrated correct technique at baseline, increasing to 50.6% after device-guided training. The intelligent asthma monitoring devices market, therefore, extended beyond dose reminders by identifying errors in inspiratory flow, inhaler orientation, and inhalation duration.

Limited Reimbursement and Unclear Ownership of Monitoring Workflows

Reimbursement for intelligent asthma monitoring remained inconsistent across jurisdictions. A CMS proposed rule expanded remote monitoring billing, but the respiratory RTM code 98XX4 remained subject to contractor pricing rather than a national fee schedule. This approach resulted in varying reimbursement rates across U.S. jurisdictions. European assessment bodies required additional clinical and economic evidence, while many Asia-Pacific markets relied on out-of-pocket payments for digital health tools. The intelligent asthma monitoring devices market also faced workflow gaps. Prescribers, pharmacists, and disease-management nurses did not always have reimbursed responsibility for reviewing continuous monitoring data. Without a defined care-coordinator role, providers could collect device data without initiating a clinical response.

Other drivers and restraints analyzed in the detailed report include:

1. Remote Patient Monitoring and Value-Based Care
2. AI-Enabled Exacerbation Prediction and Personalized Intervention
3. Clinical and Economic Evidence Variability

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

Segment Analysis

Smart inhalers held 38.56% of product revenue in 2025, supported by established prescribing practices and recognized U.S. Food and Drug Administration (FDA) clearance pathways. Pharmaceutical manufacturers also support connected drug-device combinations using existing inhaler therapies. Wearable asthma monitoring devices are forecast to grow at a CAGR of 10.89% from 2026 to 2031, as they monitor respiratory patterns during sleep and activity. The intelligent asthma monitoring devices market size for smart inhalers benefits from their established treatment-delivery role, while wearables address broader monitoring needs.

AptarGroup received FDA clearance in October 2025 for HeroTracker Sense, a Bluetooth-enabled metered-dose inhaler add-on for patients aged 12 and older. AstraZeneca's BREZTRI Aerosphere received U.S. FDA approval for asthma in patients aged 12 and older in April 2026. Spirometers and peak flow meters have a limited diagnostic role, while connected nebulizers remain concentrated in severe asthma and pediatric care. Vitalograph AIM training increased correct inhaler technique from 6.6% to 50.6% among patients who initially used a metered-dose inhaler incorrectly. FindAir received FDA 510(k) clearance for FindAir ONE in June 2026, supporting integration with more than 90 inhaler formats and remote monitoring platforms.

Medication adherence represented 58.67% of application value in 2025, providing payers and health systems with a clear rationale to monitor missed or incorrect doses. The APPaRENT 3 survey found that 55% of asthma patients had erratic nonadherence. Exacerbation prevention is forecast to grow at a CAGR of 12.34% from 2026 to 2031, supported by predictive tools that can generate warnings 24 to 72 hours before a potential event. Inhaler-technique improvement and diagnostic support remain relevant but are increasingly integrated into broader device offerings.

Remote therapeutic monitoring and real-world evidence collection are gaining adoption as reimbursement pathways develop. The FDA accepted Sibel Health's Letter of Intent for the Aria wearable cough sensor into its Drug Development Tool Qualification Program in February 2026, indicating interest in device-generated measures for respiratory trials. A 2026 study of Chinese children aged 6 to 12 reported 89.2% medication adherence with real-time monitoring and reminders, compared with 58.0% with conventional outpatient follow-up. It also reported a 42.9% reduction in airway inflammation markers, compared with 17.1% in the control group, supporting connected management in capacity-constrained clinical settings.

Complete Report Scope:

• By Product Type
  • Wearable Asthma Monitoring Devices
  • Wearable Sensors and Patches
  • Smart Inhalers
    • Metered Dose Inhalers
    • Dry Powder Inhalers
  • Spirometers
  • Peak Flow Meters
  • Connected Nebulizers
  • Others
• By Application
  • Medication Adherence
  • Inhaler-Technique Improvement
  • Asthma Diagnosis Support
  • Asthma Control and Self-Management
  • Exacerbation Prevention
  • Remote Therapeutic Monitoring
  • Clinical Trials and Real-World Evidence
  • Others
• By Patient Group
  • Pediatric Patients
  • Adults
  • Older Adults
• By End User
  • Hospitals
  • Specialty Respiratory Clinics
  • Primary-Care Clinics
  • Homecare
  • Others
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies and E-Commerce
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 38.78% of global market value in 2025, supported by Medicare reimbursement infrastructure, a large connected inhaler base, and digital health investment. The CMS proposed CY 2026 rule would reduce the remote monitoring billing threshold to two days per month and include physician time-management codes for monitoring reviews. Adherium reported 9.4-fold growth in recurring RPM revenue during the 12 months through June 2026, 5,300 Hailie Smartinhaler shipments, and a pipeline of 68,000 insurance-verified asthma patients. Clinical workflow adoption remained more important than device availability for near-term market expansion.

Europe is the second-largest geographic area, with public reimbursement systems supporting adoption in Germany, the United Kingdom, France, Italy, and Spain. NICE's 2024 review showed that the UK National Health Service was assessing evidence for smart inhalers. In 2025, AstraZeneca received a positive EU CHMP opinion for Trixeo Aerosphere, which uses a next-generation near-zero global-warming-potential propellant. GDPR adds compliance requirements for platforms handling cross-border respiratory biometric data, while the Middle East, Africa, and South America benefit from urban respiratory disease and government digital health programs. Iraq launched an advanced asthma inhaler production line with an annual capacity of 9 million units in July 2026.

Asia-Pacific is forecast to record the highest regional CAGR of 12.25% from 2026 to 2031, supported by China's estimated 45.7 million adults with asthma and India's growing wearable sector. A 2026 Chinese study involving 208 children reported 89.2% adherence with cloud-based intelligent management, compared with 58.0% under conventional outpatient care, and a 12.3% FEV1 improvement versus 4.2% in the control group. A 2025 home spirometry study supported remote lung-function monitoring for children aged 5 to 12 while identifying cost, insurance, and data security as barriers. Japan, South Korea, and Singapore support regional adoption, while India can benefit from products tailored to retail channels beyond major cities.

1. Adherium
2. AEvice Health Pte. Ltd.
3. Amiko Digital Health
4. AptarGroup, Inc.
5. AstraZeneca
6. Boehringer Ingelheim
7. BreatheSuite
8. Cognita Labs LLC
9. FindAir Sp. z o.o.
10. GlaxoSmithKline
11. Health Care Originals, Inc.
12. Koninklijke Philips
13. Novartis
14. NuvoAir AB
15. Resmed
16. Respiri Limited
17. Sensirion
18. Teva Pharmaceutical Industries
19. Vectura Group Limited
20. Vitalograph Limited

Additional Benefits:

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

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Asthma Prevalence and Underdiagnosis
  • 4.2.2 Medication Nonadherence and Inhaler-Technique Errors
  • 4.2.3 Remote Patient Monitoring and Value-Based Care
  • 4.2.4 AI-Enabled Exacerbation Prediction and Personalized Intervention
  • 4.2.5 Continuous Trigger and Environmental Exposure Correlation
  • 4.2.6 Pediatric and Caregiver-Centered Digital Monitoring
• 4.3 Market Restraints
  • 4.3.1 Limited Reimbursement and Unclear Ownership of Monitoring Workflows
  • 4.3.2 Clinical and Economic Evidence Variability
  • 4.3.3 Patient Privacy, Cybersecurity and Consent Burden
  • 4.3.4 Device Fragmentation, Battery Waste and Interoperability Burden
• 4.4 Value/Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porters Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 Wearable Asthma Monitoring Devices
  • 5.1.2 Wearable Sensors and Patches
  • 5.1.3 Smart Inhalers
    • 5.1.3.1 Metered Dose Inhalers
    • 5.1.3.2 Dry Powder Inhalers
  • 5.1.4 Spirometers
  • 5.1.5 Peak Flow Meters
  • 5.1.6 Connected Nebulizers
  • 5.1.7 Others
• 5.2 By Application
  • 5.2.1 Medication Adherence
  • 5.2.2 Inhaler-Technique Improvement
  • 5.2.3 Asthma Diagnosis Support
  • 5.2.4 Asthma Control and Self-Management
  • 5.2.5 Exacerbation Prevention
  • 5.2.6 Remote Therapeutic Monitoring
  • 5.2.7 Clinical Trials and Real-World Evidence
  • 5.2.8 Others
• 5.3 By Patient Group
  • 5.3.1 Pediatric Patients
  • 5.3.2 Adults
  • 5.3.3 Older Adults
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Respiratory Clinics
  • 5.4.3 Primary-Care Clinics
  • 5.4.4 Homecare
  • 5.4.5 Others
• 5.5 By Distribution Channel
  • 5.5.1 Hospital Pharmacies
  • 5.5.2 Retail Pharmacies
  • 5.5.3 Online Pharmacies and E-Commerce
  • 5.5.4 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Adherium Limited
  • 6.3.2 AEvice Health Pte. Ltd.
  • 6.3.3 Amiko Digital Health Limited
  • 6.3.4 AptarGroup, Inc.
  • 6.3.5 AstraZeneca plc
  • 6.3.6 Boehringer Ingelheim International GmbH
  • 6.3.7 BreatheSuite Inc.
  • 6.3.8 Cognita Labs LLC
  • 6.3.9 FindAir Sp. z o.o.
  • 6.3.10 GlaxoSmithKline plc
  • 6.3.11 Health Care Originals, Inc.
  • 6.3.12 Koninklijke Philips N.V.
  • 6.3.13 Novartis AG
  • 6.3.14 NuvoAir AB
  • 6.3.15 ResMed Inc.
  • 6.3.16 Respiri Limited
  • 6.3.17 Sensirion AG
  • 6.3.18 Teva Pharmaceutical Industries Limited
  • 6.3.19 Vectura Group Limited
  • 6.3.20 Vitalograph Limited

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment