당뇨병 치료 기기 시장 : 디바이스 유형별, 기술별, 투여 방법별, 인슐린 유형별, 유통 채널별, 최종사용자별 - 세계 예측(2025-2032년)

The Diabetes Care Devices Market is projected to grow by USD 12.58 billion at a CAGR of 19.11% by 2032.

The diabetes care devices landscape is at a pivotal moment, driven by rapid technological maturation, shifting care delivery models, and intensifying expectations from patients and payers alike. Advances in sensor accuracy, algorithmic control, and wireless interoperability have recalibrated what clinicians and people living with diabetes expect from devices: continuous insights, actionable automation, and seamless integration into daily life and clinical workflows. At the same time, healthcare systems are emphasizing outcomes and value, prompting reimbursement pathways and procurement decisions to prioritize devices that demonstrably improve glycemic control, reduce complications, and lower total cost of care.

As these forces converge, manufacturers, technology partners, and healthcare providers are refining product roadmaps and commercial strategies. Innovation is increasingly patient-centric, focusing on ease of use, reduced device burden, and data transparency. Regulatory authorities are evolving guidance to accommodate software driven therapeutics and combination products, while supply chain and manufacturing considerations now play an outsized role in commercial viability. Taken together, these dynamics set the stage for a period of accelerated disruption where clinical efficacy, connectivity, regulatory agility, and operational resilience will determine market leadership.

How closed-loop automation, real-time connectivity, smart delivery options, and decentralized care models are reshaping diabetes device development and commercialization

The landscape of diabetes care devices has undergone transformative shifts that are redefining therapeutic paradigms and commercial playbooks. First, closed-loop systems that combine continuous sensing with automated insulin delivery have transitioned from niche research prototypes to commercially viable therapeutic options. As a result, clinical pathways are adapting to incorporate algorithmic decision support and remote monitoring, moving care from episodic encounters to continuous care relationships.

Concurrently, the proliferation of connected devices and cloud platforms has created richer longitudinal datasets that enable more personalized therapy adjustments and population-level analytics. This data availability is catalyzing partnerships between device manufacturers, software developers, and payers, fostering an ecosystem where interoperability and secure data exchange are commercial differentiators. In parallel, the rise of smart pens and advanced injection aids has broadened the options for insulin delivery, offering alternatives that can bridge the gap between lifestyle convenience and clinical efficacy. Finally, the industry is witnessing a shift toward decentralization of care: telehealth, home diagnostics, and remote titration are reducing the reliance on centralized clinics, and in doing so, reshaping distribution strategies, educational outreach, and customer support models.

Assessment of the 2025 United States tariff measures and their cascading effects on sourcing strategies, pricing dynamics, and manufacturing footprints across diabetes devices

The imposition of tariffs in the United States during 2025 has introduced a set of cumulative effects that ripple across procurement, pricing strategies, and supply chains for diabetes care devices. Manufacturers that rely on cross-border component sourcing have encountered escalated input costs, prompting immediate reassessment of sourcing strategies and supplier contracts. In response, some organizations accelerated nearshoring initiatives or diversified supplier bases to mitigate exposure, while others sought contractual clauses to share or absorb tariff related costs. These operational adjustments have implications for production lead times and inventory management as firms balance cost containment with service level commitments.

From a commercial perspective, tariffs have created pressure on device pricing and reimbursement negotiations. Payers and purchasing groups have become more vigilant about unit costs and lifecycle expenditures, which in turn influences formulary decisions and tender outcomes for hospitals and clinics. Some manufacturers opted to absorb tariff impacts temporarily to preserve market access, while others introduced price adjustments tied to specific product lines. At the same time, the tariff environment has incentivized investment in domestic manufacturing capabilities and strategic partnerships with local contract manufacturers, reflecting a longer-term pivot to reduce trade risk. Ultimately, the tariff episode accelerated structural shifts in sourcing, manufacturing footprint decisions, and commercial terms that will influence competitive dynamics beyond the immediate fiscal cycle.

Deep segmentation analysis revealing how device type, sensing and delivery technologies, insulin formulations, channels, and end user settings intersect to shape product strategies

A nuanced view of segmentation reveals divergent growth vectors and differentiated clinical value across device families, technologies, delivery modes, insulin formulations, channels, and end users. When examined by device type, the market composition ranges from fully automated artificial pancreas systems comprising full closed loop and hybrid closed loop architectures to glucose monitoring devices that cover continuous glucose monitoring, flash glucose monitoring, and self-monitoring blood glucose. The injection aids spectrum includes infusion sets, pen needles, and syringe needles, while insulin pens span prefilled disposable pens, reusable pens, and increasingly sophisticated smart pens. Insulin pumps are further categorized into patch pumps and tubed pumps, each offering distinct tradeoffs in wearability and reservoir capacity.

Looking through a technology lens, continuous glucose monitoring itself bifurcates into real-time continuous glucose monitoring and retrospective continuous glucose monitoring, and remains distinct from flash glucose monitoring and self-monitoring blood glucose approaches; the latter includes glucose meters, lancets, and test strips. Delivery mode segmentation divides offerings into continuous delivery and intermittent delivery, which align to different clinical profiles and patient preferences. Insulin types span intermediate acting through ultra long acting formulations, with commonly used long acting analogues such as detemir and glargine and rapid acting analogues including aspart, glulisine, and lispro shaping device compatibility and dosing algorithms. Distribution channel dynamics encompass direct sales, hospital pharmacies, online channels, and retail pharmacies, with retail channels further split between chain and independent pharmacies. Finally, end user segmentation covers diagnostic centers, home care settings, and hospitals and clinics, where the latter includes specialized diabetes clinics as well as general clinics.

Taken together, these segmentation layers intersect to inform product design priorities, clinical positioning, and go-to-market approaches. For example, smart pens and continuous technologies align strongly with home care adoption and online distribution, while hybrid and full closed loop systems require integrated support from hospitals, diabetes clinics, and specialized diagnostic services during early adoption phases. Manufacturers should therefore map technology choices to distribution and end user pathways to optimize clinical impact and commercial uptake.

Comparative regional intelligence on regulatory frameworks, reimbursement drivers, and adoption pathways across the Americas, Europe, Middle East & Africa, and Asia-Pacific that determine commercial success

Regional dynamics materially influence regulatory pathways, reimbursement frameworks, and adoption tempos across the Americas, Europe, Middle East & Africa, and Asia-Pacific. In the Americas, payer models and a strong emphasis on value-based contracting have pushed manufacturers to demonstrate outcomes and cost offsets. This has favored devices that enable measurable reductions in acute events and hospital utilization, and has accelerated uptake of connected systems in populations with established coverage pathways. Conversely, Europe, Middle East & Africa presents a mosaic of regulatory regimes and procurement practices; centralized approvals and national pricing negotiations in some European markets contrast with heterogeneous access in other jurisdictions, requiring differentiated market entry and evidence generation strategies.

Asia-Pacific markets exhibit diverse demand drivers, where high population density and rising prevalence create scale opportunities, while variable reimbursement and income levels necessitate tiered product offerings and channel innovation. In several markets, local manufacturing partnerships and licensing arrangements have been critical to navigating import duties and securing preferred provider status. Across regions, technology adoption curves differ: while some countries rapidly embrace continuous monitoring and closed-loop approaches, others prioritize cost-effective intermittent delivery solutions and robust supply chain resilience. Manufacturers should therefore calibrate clinical evidence dossiers, pricing approaches, and partnership models in accordance with regional payer expectations and regulatory realities to maximize adoption and reimbursement success.

Strategic behaviors and competitive moves among leading diabetes device manufacturers focused on platform integration, partnerships, evidence generation, and supply resilience

Leading companies in the diabetes devices space are aligning product innovation with ecosystem partnerships and capital discipline. Key strategic behaviors include platform expansion to deliver end-to-end solutions that combine sensing, delivery, and analytics; vertical partnerships with insulin manufacturers and digital health firms; and selective investments in manufacturing capabilities to enhance control over supply continuity. Some organizations emphasize software as a service models, monetizing analytics and care management features alongside device hardware, while others double down on hardware differentiation through miniaturization, improved wearability, and enhanced user experience.

Competitive dynamics are also shaped by M&A, licensing, and co-development agreements that accelerate time to market for complex combination products. Companies that succeed tend to integrate clinical evidence generation into commercialization plans early, aligning randomized and real-world evidence to payer decision needs. Additionally, leaders invest in customer education, professional training, and post-market surveillance to reinforce clinical trust and reduce device attrition. Finally, a growing number of firms are committing to sustainability in manufacturing and packaging as a reputational and cost consideration, recognizing that procurement teams increasingly factor environmental impact into purchasing decisions.

Actionable strategic imperatives for device manufacturers to align clinical value, supply resilience, interoperability, and regional commercialization approaches for sustained growth

Industry leaders should pursue a set of pragmatic actions to secure durable advantage in a landscape defined by technological acceleration and payer scrutiny. First, prioritize end-to-end clinical value by aligning product design with measurable outcomes that matter to payers and providers, and embed evidence generation in product lifecycles to shorten reimbursement timelines. Second, diversify supply chains by combining nearshore manufacturing options with multi-tier supplier agreements to mitigate tariff exposure and component disruptions. Third, invest in interoperability and open standards to ensure devices can integrate into electronic health records and population health platforms, thereby increasing adoption by health systems.

Fourth, develop tiered commercial offerings that address distinct regional affordability profiles, pairing premium, fully integrated systems with simplified, cost-effective alternatives for resource constrained markets. Fifth, cultivate strategic partnerships with insulin producers, digital therapeutics firms, and telehealth providers to create bundled solutions that align incentives across stakeholders. Sixth, accelerate post-market programs that support clinician training and patient onboarding, reducing friction in adoption and improving retention. Together, these actions will enable manufacturers to navigate regulatory complexities, respond to evolving clinical expectations, and capture long-term share in an increasingly outcomes-oriented market.

Rigorous mixed methods research combining regulatory, clinical, and commercial evidence with expert interviews and scenario analysis to validate insights and recommendations

This report synthesizes evidence using a mixed-methods approach that combines comprehensive secondary research with primary qualitative inquiry and triangulation to ensure robustness. Secondary inputs include regulatory filings, peer-reviewed clinical literature, company technical disclosures, and policy announcements that establish the factual backdrop and regulatory context. Primary research incorporated structured interviews with clinical opinion leaders, procurement specialists, and senior commercial executives, along with targeted discussions with payers and diabetes care coordinators to validate commercial and reimbursement dynamics.

Analytical processes included cross-validation of qualitative insights against published clinical outcomes and regulatory guidance, scenario analysis to stress test the implications of tariffs and supply disruptions, and thematic coding of interview outputs to surface recurring adoption barriers and enablers. Quality assurance steps encompassed independent review by subject matter experts and reconciliation of divergent viewpoints to create balanced conclusions. Ethical research conduct and data privacy protocols were maintained throughout, ensuring that proprietary commercial information was handled under confidentiality and that synthesized findings reflect consensus where possible rather than single-source assertions.

Synthesis of strategic imperatives underscoring the transition to integrated, evidence-driven diabetes care solutions and the operational resilience required for scale

In conclusion, the diabetes care devices sector is transitioning from incremental improvement to systems-level transformation, driven by automation, connectivity, and shifting care paradigms. Stakeholders who move beyond product centric thinking to embrace integrated solutions that deliver measurable clinical and economic value will be best positioned to capture emerging opportunities. At the same time, operational resilience-manifested through diversified supply chains, regional manufacturing partnerships, and proactive tariff mitigation-has become a competitive necessity rather than a back-office concern.

Looking ahead, success will hinge on the ability to translate rich device-generated data into actionable clinical workflows, to secure payer alignment through strong evidence packages, and to offer flexible commercial models adapted to regional contexts. For manufacturers, investors, and healthcare systems alike, the mandate is clear: pursue innovations that make diabetes care simpler, safer, and more accessible, while building the commercial and operational muscle to deliver those innovations at scale.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Integration of continuous glucose monitoring with AI-powered predictive analytics platforms for proactive glycemic control
• 5.2. Development of non-invasive glucose monitoring sensors utilizing spectroscopic technologies and microneedle arrays
• 5.3. Emergence of closed-loop insulin delivery systems combining automated dosing algorithms and personalized data feedback
• 5.4. Expansion of telehealth-enabled insulin pens with Bluetooth connectivity for remote dose tracking and adherence monitoring
• 5.5. Investment in multi-parameter wearable biosensors for simultaneous monitoring of glucose, heart rate and activity metrics
• 5.6. FDA clearance trends for bi-hormonal artificial pancreas prototypes delivering both insulin and glucagon through closed-loop systems
• 5.7. Adoption of standardized interoperability protocols to integrate CGM data across diverse diabetes management apps and electronic health records
• 5.8. Growth of patient-centric device designs focusing on wearable comfort and simplified interfaces for elderly and pediatric users

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Diabetes Care Devices Market, by Device Type

• 8.1. Artificial Pancreas Systems
  • 8.1.1. Full Closed Loop
  • 8.1.2. Hybrid Closed Loop
• 8.2. Glucose Monitoring Devices
  • 8.2.1. Continuous Glucose Monitoring
  • 8.2.2. Flash Glucose Monitoring
  • 8.2.3. Self Monitoring Blood Glucose
• 8.3. Injection Aids
  • 8.3.1. Infusion Sets
  • 8.3.2. Pen Needles
  • 8.3.3. Syringe Needles
• 8.4. Insulin Pens
  • 8.4.1. Prefilled Disposable Pens
  • 8.4.2. Reusable Pens
  • 8.4.3. Smart Pens
• 8.5. Insulin Pumps
  • 8.5.1. Patch Pumps
  • 8.5.2. Tubed Pumps
• 8.6. Insulin Syringes

9. Diabetes Care Devices Market, by Technology

• 9.1. Continuous Glucose Monitoring
  • 9.1.1. Real Time Continuous Glucose Monitoring
  • 9.1.2. Retrospective Continuous Glucose Monitoring
• 9.2. Flash Glucose Monitoring
• 9.3. Self Monitoring Blood Glucose
  • 9.3.1. Glucose Meters
  • 9.3.2. Lancets
  • 9.3.3. Test Strips

10. Diabetes Care Devices Market, by Delivery Mode

• 10.1. Continuous Delivery
• 10.2. Intermittent Delivery

11. Diabetes Care Devices Market, by Insulin Type

• 11.1. Intermediate Acting
• 11.2. Long Acting
  • 11.2.1. Detemir
  • 11.2.2. Glargine
• 11.3. Rapid Acting
  • 11.3.1. Aspart
  • 11.3.2. Glulisine
  • 11.3.3. Lispro
• 11.4. Short Acting
• 11.5. Ultra Long Acting

12. Diabetes Care Devices Market, by Distribution Channel

• 12.1. Direct Sales
• 12.2. Hospital Pharmacies
• 12.3. Online Channels
• 12.4. Retail Pharmacies
  • 12.4.1. Chain Pharmacies
  • 12.4.2. Independent Pharmacies

13. Diabetes Care Devices Market, by End User

• 13.1. Diagnostic Centers
• 13.2. Home Care
• 13.3. Hospitals And Clinics
  • 13.3.1. Diabetes Clinics
  • 13.3.2. General Clinics

14. Diabetes Care Devices Market, by Region

• 14.1. Americas
  • 14.1.1. North America
  • 14.1.2. Latin America
• 14.2. Europe, Middle East & Africa
  • 14.2.1. Europe
  • 14.2.2. Middle East
  • 14.2.3. Africa
• 14.3. Asia-Pacific

15. Diabetes Care Devices Market, by Group

• 15.1. ASEAN
• 15.2. GCC
• 15.3. European Union
• 15.4. BRICS
• 15.5. G7
• 15.6. NATO

16. Diabetes Care Devices Market, by Country

• 16.1. United States
• 16.2. Canada
• 16.3. Mexico
• 16.4. Brazil
• 16.5. United Kingdom
• 16.6. Germany
• 16.7. France
• 16.8. Russia
• 16.9. Italy
• 16.10. Spain
• 16.11. China
• 16.12. India
• 16.13. Japan
• 16.14. Australia
• 16.15. South Korea

17. Competitive Landscape

• 17.1. Market Share Analysis, 2024
• 17.2. FPNV Positioning Matrix, 2024
• 17.3. Competitive Analysis
  • 17.3.1. Abbott Laboratories
  • 17.3.2. Medtronic plc
  • 17.3.3. Roche Holding AG
  • 17.3.4. Dexcom, Inc.
  • 17.3.5. Becton, Dickinson and Company
  • 17.3.6. Insulet Corporation
  • 17.3.7. Tandem Diabetes Care, Inc.
  • 17.3.8. Terumo Corporation
  • 17.3.9. Kyowa Kirin Co., Ltd.
  • 17.3.10. Ypsomed Holding AG