폐용 약물전달 시스템 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the pulmonary drug delivery system market size was valued at USD 64.20 billion in 2025 and estimated to grow from USD 68.07 billion in 2026 to reach USD 91.15 billion by 2031, at a CAGR of 6.02% during the forecast period (2026-2031).

This report is Segmented by Product (Dry Powder Inhalers, Metered Dose Inhalers, and Nebulizers[Jet Nebulizer and More]), Application (Asthma, COPD, and More), End User (Hospitals, Diagnostic Centers, and More), Technology (Manually-Operated Devices and Digitally-Operated / Smart Devices) and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Pulmonary Drug Delivery Systems Market Trends and Insights

Technological Advancements in Device Engineering

Smart actuators, breath-actuated triggers, and vibrating mesh nebulizers now deliver more drug into the small airways than earlier jet models, improving the sub-5 µm particle fraction from 54.6% to 59.25%. The FDA clearance of Adherium's Smartinhaler adds real-time adherence feeds for Airsupra and Breztri, giving clinicians objective dose data. Meta-analysis confirms that vibrating mesh systems outperform jet nebulizers in COPD care, lowering exacerbations and treatment time. Manufacturers are testing AI modules that adjust flow rates in response to a patient's inspiratory profile, a feature that improves pediatric and geriatric outcomes. These engineering gains make inhalers easier to train on, reducing technique errors and hospital readmissions.

Rising Respiratory-Disease Burden & Shift to Inhalation Route

COPD affected 213.39 million people in 2021 and accounted for 4.0 million deaths, solidifying inhalation as the preferred route for both symptom relief and preventive care. China alone reports 45.7 million asthma and 99.9 million COPD patients, a volume that strains clinical capacity and lifts demand for devices that deliver drug directly to the lungs. Air pollution contributes 41.79% of COPD burden among young adults, pushing governments to subsidize inhaled therapies. Benralizumab, the first major asthma-COPD advance in five decades, demonstrated a 30% drop in treatment failures versus steroid regimens, reinforcing the relevance of targeted pulmonary delivery. Payers see inhaled formulations as a path to fewer systemic side effects and shorter hospital stays, underpinning formulary shifts toward aerosol products.

Stringent Multi-Jurisdiction Device & Drug-Combo Approvals

Combination inhalers must satisfy both drug efficacy and device-performance tests, prolonging development cycles by years and inflating trial budgets. Intellectual-property overlaps around actuator geometries complicate generic entry, limiting price relief in many regions. Digital add-ons invite an additional layer of software validation, often triggering separate submissions under medical-device directives. Smaller firms lack capital to navigate dual pathways, risking innovation attrition and narrowing patient choice.

Other drivers and restraints analyzed in the detailed report include:

1. Ageing Population & Chronic-Care Medication Adherence Push
2. Environmental Regulations Spurring Propellant-Free Inhalers
3. Propellant Phase-Out Costs & Supply Bottlenecks

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

Segment Analysis

Metered-dose inhalers claimed 43.10% of the pulmonary drug delivery system market share in 2025 but face mounting environmental pressure to replace high-GWP propellants with sustainable alternatives. Dry-powder inhalers are gaining ground at 9.12% CAGR through 2031, appealing to elderly patients who struggle with MDI coordination and environmentally conscious consumers seeking propellant-free options. Nebulizers remain essential for acute care and patients with limited dexterity, though the segment is shifting from traditional jet models toward advanced vibrating mesh and soft-mist technologies that deliver medication more efficiently.

AstraZeneca's AIRSUPRA launch as the first FDA-approved anti-inflammatory rescue inhaler demonstrates how product innovation can reshape treatment protocols and create new market segments. Soft-mist nebulizers are gaining traction due to their reusable design and reduced environmental impact, with studies confirming 57-71% carbon footprint reduction compared to traditional pMDIs. Ultrasonic nebulizers are experiencing renewed interest as technological advances improve droplet formation control and reduce treatment times, making them particularly valuable for pediatric applications where patient compliance presents challenges. The pulmonary drug delivery system market size for dry-powder inhalers is projected to expand at 9.12% CAGR between 2026-2031, reflecting growing preference for coordination-free devices.

Asthma applications dominated with 39.05% of the pulmonary drug delivery system market in 2025, reflecting high disease prevalence and established treatment protocols across global healthcare systems. Cystic fibrosis emerges as the fastest-growing application segment with 8.31% CAGR through 2031, driven by breakthrough gene therapy developments including the LENTICLAIR 1 trial testing BI 3720931 inhalable gene therapy across multiple European countries. COPD applications are benefiting from innovative treatments like ensifentrine (Ohtuvayre), which represents the first novel mechanism of action for COPD in over two decades by combining bronchodilator and anti-inflammatory effects. Allergic rhinitis applications are expanding with needle-free delivery systems like Neffy nasal spray for severe allergic reactions, broadening the addressable patient population beyond traditional inhaler users.

The application landscape is undergoing transformation through mRNA and gene therapy innovations, with multiple clinical trials demonstrating the potential for lung-targeted genetic interventions that could fundamentally change treatment paradigms. BioNTech's BNT116 lung cancer vaccine trials across seven countries represent a significant expansion of pulmonary delivery beyond respiratory diseases into oncology applications. Other applications are advancing through specialized formulations, such as novel hyaluronic acid-vancomycin complex powders for pulmonary infections in cystic fibrosis patients, which demonstrate extended release profiles exceeding 24 hours. The pulmonary drug delivery system market size for cystic fibrosis applications is forecast to grow at 8.31% CAGR through 2031, reflecting the impact of these therapeutic innovations.

Complete Report Scope:

• By Product
  • Dry Powder Inhalers
  • Metered Dose Inhalers
  • Nebulizers
    • Jet Nebulizers
    • Soft-Mist Nebulizers
    • Ultrasonic Nebulizers
• By Application
  • Asthma
  • COPD
  • Cystic Fibrosis
  • Allergic Rhinitis
  • Other Applications
• By End User
  • Hospitals
  • Diagnostic Centres
  • Home-Care Settings
  • Other End Users
• By Technology
  • Manually-Operated Devices
  • Digitally-Operated / Smart Devices
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • 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 commanded45.10% of the pulmonary drug delivery system market in2025, benefiting from robust insurance coverage, early uptake of smart inhalers, and swift FDA approvals for breakthrough devices. Recent launches such as AIRSUPRA and Yutrepia sustain demand while public-private R&D programs speed next-generation propellant transitions. Canada and Mexico expand steadily on the back of aging populations and broader access to maintenance therapies, though premium-device use trails the United States.

Asia Pacific is advancing at a9.29% CAGR through2031, propelled by large asthma and COPD pools, widening reimbursement, and local manufacturing that trims device costs. China alone counts45.7million asthma and99.9million COPD patients, driving bulk tenders for dry-powder and mesh-nebulizer systems. India is preparing for Afrezza inhaled insulin, signalling openness to innovative aerosols. Japan, Australia, and South Korea lead regional adoption of connected inhalers as governments push telehealth.

Europe focuses on sustainability, with the UK's approval of HFO-1234ze(E) propellant inhalers setting a low-carbon benchmark. Germany and France supply critical valve and actuator technology, while EU-wide shortages of salbutamol expose supply-chain risk during propellant changeovers. Eastern Europe, the Middle East & Africa, and South America register rising volumes as funding flows toward air-quality initiatives and local assembly plants.

1. AstraZeneca
2. Boehringer Ingelheim
3. Chiesi Farmaceutici
4. Cipla
5. ElevateBio / Aerogen
6. GF Health Products
7. GlaxoSmithKline
8. Gilbert Technologies
9. H&T Presspart
10. Koninklijke Philips
11. Merck
12. Novartis
13. OMRON
14. PARI Pharma
15. Propeller Health
16. Resmed
17. Sunovion Pharma
18. Teva Pharmaceutical Industries
19. Vectura Group
20. Aptar Pharma

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 Technological Advancements In Device Engineering
  • 4.2.2 Rising Respiratory-Disease Burden & Shift To Inhalation Route
  • 4.2.3 Ageing Population & Chronic-Care Medication Adherence Push
  • 4.2.4 Environmental Regulations Spurring Propellant-Free Inhalers
  • 4.2.5 mRna / Gene-Therapy Pipelines Targeting Lung Delivery
  • 4.2.6 Home-Based Smart, Prefillable Inhalers For Connected Care
• 4.3 Market Restraints
  • 4.3.1 Stringent Multi-Jurisdiction Device & Drug-Combo Approvals
  • 4.3.2 Propellant Phase-Out Costs & Supply Bottlenecks
  • 4.3.3 Reimbursement Uncertainty For Digital Add-On Sensors
  • 4.3.4 Micro-Plastic & Lithium-Ion Waste Scrutiny On Disposable Pens
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technology Outlook
• 4.7 Porter's 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 Intensity of Competitive Rivalry

5 Market Size and Growth Forecasts (Value-USD)

• 5.1 By Product
  • 5.1.1 Dry Powder Inhalers
  • 5.1.2 Metered Dose Inhalers
  • 5.1.3 Nebulizers
    • 5.1.3.1 Jet Nebulizers
    • 5.1.3.2 Soft-Mist Nebulizers
    • 5.1.3.3 Ultrasonic Nebulizers
• 5.2 By Application
  • 5.2.1 Asthma
  • 5.2.2 COPD
  • 5.2.3 Cystic Fibrosis
  • 5.2.4 Allergic Rhinitis
  • 5.2.5 Other Applications
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Diagnostic Centres
  • 5.3.3 Home-Care Settings
  • 5.3.4 Other End Users
• 5.4 By Technology
  • 5.4.1 Manually-Operated Devices
  • 5.4.2 Digitally-Operated / Smart Devices
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 for key companies, Products and Services, and Recent Developments)
  • 6.3.1 AstraZeneca
  • 6.3.2 Boehringer Ingelheim
  • 6.3.3 Chiesi Farmaceutici
  • 6.3.4 Cipla
  • 6.3.5 ElevateBio / Aerogen
  • 6.3.6 GF Health Products
  • 6.3.7 GlaxoSmithKline
  • 6.3.8 Gilbert Technologies
  • 6.3.9 H&T Presspart
  • 6.3.10 Koninklijke Philips
  • 6.3.11 Merck & Co.
  • 6.3.12 Novartis
  • 6.3.13 Omron Healthcare
  • 6.3.14 PARI GmbH
  • 6.3.15 Propeller Health
  • 6.3.16 ResMed
  • 6.3.17 Sunovion Pharma
  • 6.3.18 Teva Pharmaceuticals
  • 6.3.19 Vectura Group
  • 6.3.20 Aptar Pharma

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment