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

The connected drug delivery devices market is expected to grow from USD 1.59 billion in 2025 to USD 2.13 billion in 2026 and is forecast to reach USD 9.29 billion by 2031 at 34.2% CAGR over 2026-2031.

Continuous expansion aligns with the worldwide rise in chronic illnesses, rapid digital-health uptake, and a regulatory pivot that treats real-world evidence as equal to randomized trials. The FDA's 2024 Real-World Evidence Program expansion has reshaped how pharmaceutical firms validate device value, while breakthroughs in graphene-based energy harvesting financed by a USD 904,000 federal grant promise battery-free sensors. Parallel progress in value-based reimbursement-confirmed by CMS's 2025 Physician Fee Schedule-creates direct incentives for adherence-capturing hardware. At the same time, the FDA's March 2024 draft guidance compels developers to embed robust cybersecurity frameworks into every connected device submission.

Global Connected Drug Delivery Devices Market Trends and Insights

Rising Prevalence of Chronic Diseases

Long-term medication courses are replacing acute regimens, pushing developers to craft connected auto-injectors that patients can use at home for complex biologics once limited to infusion clinics. Biogen's move to subcutaneous forms of LEQEMBI shows how remote dosing broadens access for neurodegenerative therapies. Rare-disease populations spread across geographies also need remote oversight, and real-time biomarker feedback supports personalised dose adjustment. With non-adherence costing the U.S. system USD 100 billion yearly, payers now view connectivity as an economic necessity.

Growing Demand for Remote Monitoring & Tele-Health

Remote platforms now analyse live streams to predict exacerbations before symptoms surface. FDA acceptance of connected device data enables post-market studies that strengthen label claims. Bidirectional tele-health lets clinicians send dosing tweaks directly to devices.The COVID-19 shock compressed adoption cycles, while Japan and Singapore have created accelerated approval lanes that encourage rapid launches. Inhalation systems from MannKind illustrate 5G-enabled, edge-processed feedback loops that support real-time insulin titration.

High Device Cost vs. Conventional Disposables

Price gaps of 200-400% versus legacy inhalers or pens deter adoption among uninsured populations. Beyond hardware, ongoing cloud-service fees add recurring expenses. While device-as-a-service bundles offer an alternative, payer skepticism remains high. Market fragmentation prevents scale efficiencies that could compress unit costs. Lack of dedicated billing codes still clouds return-on-investment assessments.

Other drivers and restraints analyzed in the detailed report include:

1. Advances in BLE & NFC Miniaturisation
2. Direct-to-Cloud Low-Power Cellular IoT Adoption
3. Cyber-Security & Patient-Data-Privacy Gaps

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

Segment Analysis

Integrated Connected Devices represented 59.62% of 2025 revenues, equal to USD 0.95 billion of connected drug delivery devices market size, as pharma companies favour turnkey systems that guarantee measurement accuracy and regulatory alignment. Smart insulin pens form the largest sub-segment; Eli Lilly's USD 3 billion investment in capacity aims to meet GLP-1 drug demand. Sensor retrofits, although capturing a smaller base, are growing 35.45% a year by enabling connectivity without altering drug formulations.

Connected inhaler sensors, such as Adherium's Hailie platform, recorded 180% adherence improvement in paediatric tests. Wearable-injector add-ons target large-volume biologics, while injection-pen sensors unlock legacy franchises. Hybrid architectures are emerging, letting firms offer premium integrated devices alongside cost-efficient retrofits within unified dashboards.

Bluetooth Low Energy commanded 64.38% deliveries in 2025, yet NFC is projected to rise at 36.4% CAGR. NFC's passive mode curbs standby current to near zero, allowing multi-year lifespan. Short-range comms cut hacking exposure, answering regulator scrutiny. Low-power cellular modules, meanwhile, target global reach without phone pairing, resonating with elderly demographics.

RFID or QR identifiers remain relevant where price sensitivity trumps elaborate connectivity. Multi-protocol chips from Nordic now embed BLE, NFC, Thread, and Zigbee on a single die, equalising bill-of-materials across options and broadening design freedom.

Connected Drug Delivery Devices Market Report is Segmented by Product Type(Connected Sensors [Connected Inhaler Sensors and More] and Integrated Connected Devices [Connected Inhalers and More), Technology (Bluetooth, Near-Field Communication and More), End User (Healthcare Providers, Homecare and More), Application (Respiratory Diseases, Diabetes and More) and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America's 44.10% share stems from Medicare coverage, mature EHR penetration, and FDA support for real-world data. CMS reimbursement for adherence monitoring cushions provider investment, while federal cybersecurity guidance sets uniform guardrails. Canada and Mexico leverage regulatory alignment pacts that simplify cross-border launches.

Asia-Pacific is the fastest-growing theatre, advancing 36.2% CAGR. Japan's PMDA opened a Washington DC office to coach foreign applicants, and China's record 48 first-in-class drug approvals in 2024 signal growing innovation appetite. Regional semiconductor capacity and pervasive 5G coverage underpin device connectivity. India, buoyed by government incentives for med-tech localisation, shows promise though price controls pose margin pressure.

Europe offers harmonised MDR rules but layers on GDPR and an upcoming AI Act, lengthening compliance cycles. The United Kingdom maintains broad MDR parity post-Brexit yet courts global suppliers with fast-track options. Germany and France anchor substantial demand; Nordic nations experiment with national reimbursement for connected inhalers, spurring early adoption.

South America, the Middle East, and Africa collectively post double-digit growth, driven by rising chronic disease incidence and tele-health pilots. Infrastructure gaps and fragmented reimbursement still temper near-term penetration rates, but global donors fund pilot programs that familiarise clinicians with connected delivery.

1. Resmed
2. FindAir Sp. z o.o.
3. Novo Nordisk
4. Teva Pharmaceutical Industries
5. Adherium
6. West Pharmaceutical Services
7. Aptar Pharma
8. Ypsomed
9. Phillips-Medisize (Molex)
10. Medtronic
11. Insulet
12. Becton Dickinson & Co.
13. Amiko Digital Health Limited.
14. Enable Injections
15. Insulclock S.L.
16. Johnson & Johnson
17. NuvoAir Inc.
18. Amgen
19. GlaxoSmithKline

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 prevalence of chronic diseases
  • 4.2.2 Growing demand for remote monitoring & tele-health
  • 4.2.3 Advances in BLE & NFC miniaturisation
  • 4.2.4 Direct-to-cloud low-power cellular IoT adoption
  • 4.2.5 Energy-harvesting power modules reduce battery waste
  • 4.2.6 Value-based reimbursement rewarding adherence data
• 4.3 Market Restraints
  • 4.3.1 High device cost vs. conventional disposables
  • 4.3.2 Cyber-security & patient-data-privacy gaps
  • 4.3.3 E-waste compliance pressure on single-use electronics
  • 4.3.4 Lack of interoperability standards across EHRs
• 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 Connected Sensors
    • 5.1.1.1 Connected Inhaler Sensors
    • 5.1.1.2 Connected Injection-Pen Sensors
    • 5.1.1.3 Wearable-Injector Add-on Sensors
  • 5.1.2 Integrated Connected Devices
    • 5.1.2.1 Connected Inhalers
      • 5.1.2.1.1 Metered-Dose Inhalers
      • 5.1.2.1.2 Dry-Powder Inhalers
    • 5.1.2.2 Connected Injection Devices
      • 5.1.2.2.1 Smart Insulin Pens
      • 5.1.2.2.2 Connected Auto-Injectors
      • 5.1.2.2.3 Wearable Injectors
    • 5.1.2.3 Connected Nebulizers
• 5.2 By Technology
  • 5.2.1 Bluetooth Low Energy (BLE)
  • 5.2.2 Near-Field Communication (NFC)
  • 5.2.3 Low-Power Cellular (LTE-M / NB-IoT)
  • 5.2.4 RFID / QR Code
  • 5.2.5 Other Technologies
• 5.3 By End User
  • 5.3.1 Healthcare Providers (Hospitals, Clinics)
  • 5.3.2 Patients / Homecare
  • 5.3.3 Pharma & Biotech Companies
  • 5.3.4 Payers & Remote-Monitoring Platforms
• 5.4 By Application
  • 5.4.1 Respiratory Diseases
  • 5.4.2 Diabetes
  • 5.4.3 Oncology
  • 5.4.4 Other Chronic Diseases
• 5.5 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 ResMed Inc.
  • 6.3.2 FindAir Sp. z o.o.
  • 6.3.3 Novo Nordisk A/S
  • 6.3.4 Teva Pharmaceutical Industries Ltd
  • 6.3.5 Adherium Limited
  • 6.3.6 West Pharmaceutical Services Inc.
  • 6.3.7 Aptar Pharma
  • 6.3.8 Ypsomed AG
  • 6.3.9 Phillips-Medisize (Molex)
  • 6.3.10 Medtronic plc
  • 6.3.11 Insulet Corporation
  • 6.3.12 Becton Dickinson & Co.
  • 6.3.13 Amiko Digital Health Limited.
  • 6.3.14 Enable Injections
  • 6.3.15 Insulclock S.L.
  • 6.3.16 Johnson & Johnson (Janssen)
  • 6.3.17 NuvoAir Inc.
  • 6.3.18 Amgen Inc.
  • 6.3.19 GlaxoSmithKline plc

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment