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시장보고서
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인슐린 전달 기기 : 시장 인사이트, 경쟁 구도 및 시장 예측(2034년)Insulin Delivery Device - Market Insights, Competitive Landscape, and Market Forecast - 2034 |
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DelveInsight
인슐린 전달 기기는 당뇨병 환자에게 인슐린을 투여하는 데 사용되는 의료기기입니다. 인슐린은 경구로 섭취할 수 없으며 피하 조직에 투여해야 하기 때문입니다. 본 조사의 대상 범위에는 인슐린 펜이 포함됩니다. 여기에는 노보 노르디스크의 ‘NovoPen 6’이나 일라이 릴리의 ‘Tempo Pen’과 같은 재사용 가능한 펜, 노보 노르디스크의 ‘FlexTouch’, 일라이 릴리의 ‘KwikPen’,사노피(Sanofi)의 ‘SoloStar’와 같은 일회용 프리필드 펜, 그리고 메드트로닉(Medtronic)의 ‘InPen’이나 노보 노디스크(Novo Nordisk)의 ‘NovoPen Echo Plus’와 같은 스마트 펜 및 커넥티드 펜이 포함됩니다. 인슐린 펌프에는 메드트로닉(Medtronic)의 ‘MiniMed’ 플랫폼, 탠덤 당뇨병 케어(Tandem Diabetes Care)의 ‘t:slim X2’ 및 ‘Tandem Mobi’, 입소메드(Ypsomed)의‘YpsoPump’, SOOIL의 ‘DANA’ 펌프와 같은 유선형 또는 내구성 있는 펌프, 그리고 Insulet의 ‘Omnipod’, EOFLOW의 ‘EOPatch’, CeQur사의 ‘Simplicity’와 같은 패치형 또는 튜브리스형 펌프가 포함됩니다;펌프, 지속 혈당 모니터, 투여 알고리즘을 통합한 자동 인슐린 투여(AID) 시스템. 여기에는 메드트로닉(Medtronic)의 ‘MiniMed 780G’, 탠덤(Tandem)사의 ‘Control-IQ+’ 플랫폼, 인슐렛(Insulet)의‘Omnipod 5’, Beta Bionics의 ‘iLet Bionic Pancreas’ 등이 포함됩니다; Becton Dickinson, Terumo, Owen Mumford 각사의 인슐린 주사기; 및 인슐린 제트 주입기나 무바늘 투여 시스템. 이 시장은 제1형 및 2형 당뇨병 환자를 대상으로 하며, 재택 의료, 병원, 당뇨병 클리닉 등 다양한 의료 현장에 걸쳐 있습니다.
인슐린 전달 기기 시장의 주요 성장 촉진요인
인슐린 전달 기기 시장의 성장에 기여하는 요인
시장 촉진요인
세계 당뇨병 유병률의 증가
인슐린 전달 기기 시장의 근본적인 촉진요인은 전 세계 당뇨병 유병률의 증가입니다. 2025년에는 전 세계적으로 약 5억 9,100만 명이 당뇨병을 앓고 있는 것으로 추정되며, 이 수치는 2050년까지 약 8억 5,400만 명으로 증가하여 46%의 성장률을 보일 것으로 예상됩니다. 이 중 90% 이상은 2형 당뇨병이며, 질병이 진행됨에 따라 경구약이나 기타 치료법만으로는 부족해지기 때문에 인슐린 요법이 필요한 환자의 비율이 증가하고 있습니다. 고령화, 비만 유병률 상승, 도시화를 배경으로 전 세계 당뇨병 환자 수가 계속 증가함에 따라, 정기적이고 정확한 인슐린 투여가 필요한 환자층도 그에 따라 확대되어, 예측 기간 동안 모든 종류의 인슐린 전달 기기에 대한 수요가 유지될 것으로 전망됩니다.
자동 인슐린 투여 시스템으로의 전환 가속화
자동 인슐린 투여(AID) 및 폐쇄 루프 시스템으로의 전환이 가속화되고 있으며, 이에 따라 인슐린 전달 기기 시장의 경쟁 구도와 기술의 중심이 재편되고 있습니다. 메드트로닉(Medtronic)의 ‘MiniMed 780G’, 인슬렛(Islet)사의 ‘Omnipod 5’, 탠덤(Tandem)사의 ‘Control-IQ+’ 플랫폼,Beta Bionics의 ‘iLet Bionic Pancreas’ 등의 시스템은 연속 혈당 모니터링 데이터와 자동 투여 알고리즘을 통합하여 인슐린 투여를 실시간으로 조정함으로써, 수동 투여 판단의 부담을 줄이고 목표 범위 내 체류 시간을 개선하고 있습니다. 2024년 3월, FDA는 「Sequel Twist AID」 시스템을 승인했습니다. 이는 투여되는 인슐린의 체적과 유량을 직접 측정하는 최초의 자동 인슐린 투여 시스템으로, 막힘이나 투여상의 문제를 감지하는 정확도를 향상시켰습니다. AID 시스템이 혈당 조절 및 삶의 질(QOL)에 미치는 이점이 임상적 증거를 통해 지속적으로 입증되고, 규제 당국의 승인으로 적격 환자군이 확대됨에 따라, AID 기술에 대한 수요는 예측 기간 동안 가장 빠르게 성장하는 시스템 유형으로 증가하고 있습니다.
시장 제약요인
인슐린 전달 기기 시장은 성장을 저해하는 몇 가지 상호 연관된 제약요인에 직면해 있습니다. 2형 당뇨병 환자의 상당수에게 경구용 당뇨병 치료제가 계속해서 이용 가능하며 임상적 유효성을 보이고 있기 때문에 많은 환자에서 주사제나 펌프를 이용한 인슐린 요법으로의 전환이 지연되고 있습니다. 최근 몇 년간 의료기기 관련 제품 리콜 건수가 증가함에 따라 환자, 임상의, 규제 당국 사이에서 안전성과 신뢰성에 대한 우려가 높아지고 있으며, 제조업체들은 품질 관리 체제 개선에 투자할 수밖에 없는 상황입니다. 기기 및 소모품의 높은 비용에 더해, 북미와 서유럽 이외의 많은 지역에서는 보험 환급이 제한적이기 때문에 특히 가격에 민감한 시장이나 자원이 부족한 시장에서 첨단 인슐린 펌프, AID 시스템, 스마트 펜의 보급이 제약을 받고 있습니다. 최근 미국에서 도입된 의료기기 및 부품 수입 관세로 인해, 세계 공급망에 의존하는 제조업체의 생산 비용이 증가하고 있습니다. 이러한 비용 압박은 환자에게 전가될 가능성이 있으며, 특히 보험 적용 범위가 제한적인 환자의 경우 첨단 인슐린 투여 기기에 대한 접근이 제한될 우려가 있습니다. 첨단 펌프나 AID 시스템의 기술은 익히는 데 시간이 걸리기 때문에 고령 환자나 네트워크 연결형 디지털 헬스 도구에 익숙하지 않은 환자의 도입을 방해할 가능성이 있습니다. 상호 운용 가능한 자동 인슐린 투여 구성요소를 지원하기 위한 규제 프레임워크가 있음에도 불구하고, 서로 다른 제조사의 기기 간에 완전한 상호 운용성이 부족하여 환자의 선택권과 시스템의 유연성이 여전히 제한되고 있습니다. 이러한 요인들이 복합적으로 작용하여 도입 속도가 더뎌지고 있으며, 공급업체들은 성장을 유지하기 위해 신뢰성, 합리적인 가격, 사용 편의성을 입증해야 합니다.
Insulin Delivery Device Market Summary
Insulin delivery devices are medical tools used to administer insulin to people with diabetes, since insulin cannot be taken orally and must be delivered into subcutaneous tissue. The scope encompasses insulin pens, including reusable pens such as Novo Nordisk's NovoPen 6 and Eli Lilly's Tempo Pen, disposable prefilled pens such as Novo Nordisk's FlexTouch, Eli Lilly's KwikPen, and Sanofi's SoloStar, and smart or connected pens such as Medtronic's InPen and Novo Nordisk's NovoPen Echo Plus; insulin pumps, including tethered or durable pumps such as Medtronic's MiniMed platform, Tandem Diabetes Care's t: slim X2 and Tandem Mobi, Ypsomed's YpsoPump, and SOOIL's DANA pumps, and patch or tubeless pumps such as Insulet's Omnipod, EOFLOW's EOPatch, and CeQur's Simplicity; automated insulin delivery (AID) systems that bundle a pump, continuous glucose monitor, and dosing algorithm, including Medtronic's MiniMed 780G, Tandem's Control-IQ+ platform, Insulet's Omnipod 5, and Beta Bionics' iLet Bionic Pancreas; insulin syringes from Becton Dickinson, Terumo, and Owen Mumford; and insulin jet injectors and needle-free delivery systems. The market spans homecare, hospital, and diabetes clinic settings across type 1 and type 2 diabetes populations.
Insulin Delivery Device Market Key Growth Drivers
Key Companies in Insulin Delivery Device Market
The leading participants in the insulin delivery device market include the following:
Factors Contributing to the Growth of the Insulin Delivery Device Market
Market Drivers
Rising Global Prevalence of Diabetes
The foundational driver of the insulin delivery device market is the rising global prevalence of diabetes, with an estimated 591 million people living with diabetes worldwide in 2025 and this figure projected to rise to approximately 854 million by 2050, a 46% increase. More than 90% of these cases are type 2 diabetes, and a growing share of this population requires insulin therapy as oral medications and other therapies become insufficient over the course of disease progression. As the global diabetic population continues to expand, driven by aging populations, rising obesity prevalence, and urbanization, the base of patients requiring regular and precise insulin administration grows correspondingly, sustaining demand across the full range of insulin delivery device categories throughout the forecast period.
Accelerating Shift Toward Automated Insulin Delivery Systems
The accelerating shift toward automated insulin delivery (AID) and closed-loop systems is reshaping the competitive and technological center of gravity of the insulin delivery device market. Systems including Medtronic's MiniMed 780G, Insulet's Omnipod 5, Tandem's Control-IQ+ platform, and Beta Bionics' iLet Bionic Pancreas integrate continuous glucose monitoring data with automated dosing algorithms to adjust insulin delivery in real time, reducing the burden of manual dosing decisions and improving time-in-range outcomes. In March 2024, the FDA cleared the Sequel Twist AID system, the first automated insulin delivery system to directly measure the volume and flow of delivered insulin, enhancing detection of blockages and delivery issues. As clinical evidence continues to demonstrate the glycemic and quality-of-life benefits of AID systems, and as regulatory clearances expand the eligible patient population, demand for AID technology grows as the fastest-growing system type across the forecast period.
Market Restraints
The insulin delivery device market faces several interrelated restraints that temper its growth. The continued availability and clinical effectiveness of oral antidiabetic medications for a substantial share of the type 2 diabetes population delays the transition to injectable or pump-based insulin therapy for many patients. An increased number of device-related product recalls in recent years has raised safety and reliability concerns among patients, clinicians, and regulators, and has required manufacturers to invest in quality system improvements. High device and consumable costs, combined with limited insurance reimbursement in many geographies outside North America and Western Europe, constrain adoption of advanced pumps, AID systems, and smart pens, particularly in price-sensitive and lower-resource markets. Recently implemented tariffs on imported medical devices and components in the United States have increased production costs for manufacturers reliant on global supply chains, a cost pressure that may be passed through to patients and could reduce access to advanced insulin delivery devices, particularly among patients with limited insurance coverage. The steep learning curve associated with advanced pump and AID system technology can limit adoption among older patients and those less comfortable with connected digital health tools. The lack of full interoperability between devices from different manufacturers, despite regulatory frameworks intended to support interoperable automated insulin dosing components, continues to limit patient choice and system flexibility. Together, these factors moderate the pace of adoption and require vendors to demonstrate reliability, affordability, and ease of use to sustain growth.
Insulin Delivery Device Market Segment Analysis
The global insulin delivery device market is segmented by product type (insulin pens [reusable, disposable/prefilled, and smart/connected], insulin pumps [tethered/durable and patch/tubeless], insulin syringes, insulin jet injectors, and others), by system type (automated insulin delivery (AID)/closed-loop systems and conventional/open-loop insulin delivery), by diabetes type (type 1 diabetes and type 2 diabetes), by end-user (homecare settings, hospitals, diabetes and specialty clinics, and others), and by geography (North America, Europe, Asia-Pacific, and the Rest of the World).
By Product Type
Dominant Subsegment: Insulin Pens.
The insulin pens category is expected to dominate the market. The insulin pens segment accounted for a 43% share of the insulin delivery device market in 2025. Insulin pens, spanning reusable pens such as Novo Nordisk's NovoPen 6, disposable prefilled pens such as Eli Lilly's KwikPen and Sanofi's SoloStar, and smart connected pens such as Medtronic's InPen and Novo Nordisk's NovoPen Echo Plus, are the leading product category because pens remain the most widely prescribed insulin delivery method globally, particularly among the much larger type 2 diabetes population and in emerging markets where pump therapy penetration remains limited. The dominance of the segment reflects the breadth of pen options across price points and features, and the sustained global volume of prefilled pen prescriptions, even as smart and connected pens represent the fastest-growing pen subcategory. While insulin pumps, syringes, and jet injectors are substantial and, in the case of patch and AID-integrated pumps, faster-growing categories, particularly within the type 1 diabetes population, the breadth of global pen prescribing and the scale of the type 2 diabetes population sustain the leadership of the segment across the forecast period.
By System Type
Dominant Subsegment: Conventional (Open-Loop) Insulin Delivery.
Conventional, open-loop insulin delivery, encompassing standard pens, syringes, and manually programmed insulin pumps without integrated automated dosing algorithms, accounted for the largest share of the insulin delivery device market in 2025, reflecting the scale of the installed base of pen and syringe users worldwide who are not candidates for or have not yet adopted pump therapy. Automated insulin delivery (AID) systems, including Medtronic's MiniMed 780G, Insulet's Omnipod 5, Tandem's Control-IQ+ platform, and Beta Bionics' iLet Bionic Pancreas, represented the fastest-growing system type in 2025, as expanding regulatory indications, growing clinical evidence of glycemic benefit, and continued device miniaturization drive adoption beyond the historical type 1 diabetes core market. As AID systems continue to expand into type 2 diabetes, pediatric, and pregnancy indications, the system type segmentation is expected to shift progressively toward automated delivery, even as conventional delivery methods retain the larger share of overall device volume by unit count across the forecast period.
Insulin Delivery Device Market Region Analysis
Dominant Region: North America
North America accounted for a 36% share of the global insulin delivery device market in 2025, representing the highest regional market share globally. The leadership of the region reflects the high burden of diabetes, with more than 38 million people, or 11.6% of the United States population, living with diabetes according to the Centers for Disease Control and Prevention, combined with a robust healthcare infrastructure and strong adoption of innovative medical technologies. The United States is the largest national market, supported by high healthcare expenditure, favorable reimbursement policies for advanced pumps, AID systems, and smart pens, and the concentration of leading manufacturers including Medtronic, Insulet, Tandem Diabetes Care, and Beta Bionics. The concentration of vendors, reimbursement maturity, and diabetes prevalence reinforce the position of North America as the largest regional market across the forecast period.
Fastest Growing Region: Asia-Pacific
Asia-Pacific is projected to register the fastest compound annual growth rate through 2034. The region faces a rapidly escalating diabetes burden driven by urbanization, increasingly sedentary lifestyles, and evolving dietary habits, with China and India at the forefront; recent estimates indicate that 77 million people over the age of 18 in India live with type 2 diabetes, with an additional 25 million considered prediabetic. China, Japan, and India are the principal national markets, supported by expanding healthcare infrastructure, government-led diabetes awareness and early diagnosis campaigns, and the growing presence of global manufacturers establishing local partnerships and pursuing regulatory approvals tailored to regional affordability needs. As diagnosis rates rise and modern insulin delivery devices become more accessible and affordable, the region increases its adoption of insulin delivery devices from a growing base, positioning Asia-Pacific as the fastest-growing regional market across the forecast period.
Regional Commentary
North America
North America leads the market, supported by high diabetes prevalence, a mature healthcare infrastructure, favorable reimbursement, and the concentration of leading device manufacturers. The United States dominates the region through its concentration of manufacturers, healthcare expenditure, and diabetes awareness programs.
Europe
Europe is a significant market shaped by robust healthcare infrastructure, rising diabetes prevalence approaching 60 million people in 2024 and projected to reach 72.4 million by 2050 according to the International Diabetes Federation, and favorable reimbursement policies that support adoption of reusable pens, insulin pumps, and smart devices. Germany, the United Kingdom, France, Italy, and Spain are the principal national markets, and the region continues to be a hub for regulatory innovation, exemplified by Medtronic's 2025 CE Mark label expansion for the MiniMed 780G system.
Asia-Pacific
Asia-Pacific is the fastest-growing region, driven by a rapidly escalating diabetes burden, expanding healthcare infrastructure, and increasing government investment in diabetes awareness and early diagnosis across China, Japan, and India.
Rest of World
The Rest of World, spanning Latin America, the Middle East, and Africa, represents an emerging opportunity as diabetes prevalence rises and healthcare infrastructure expands, though adoption of advanced insulin delivery devices remains concentrated in leading urban centers and private healthcare systems.
Insulin Delivery Device Market Competitive Landscape
The global insulin delivery device market is classified as Consolidated. A small group of established medical technology and pharmaceutical companies holds the majority of the market through comprehensive portfolios spanning pens, pumps, and AID systems, supported by digital platforms that connect devices to mobile applications and cloud-based data systems. Competition centers on the breadth of the automated insulin delivery portfolio, integration with continuous glucose monitoring ecosystems, device miniaturization and tubeless form factors, and the ability to secure regulatory approvals and insurance reimbursement across major markets. The competitive landscape is evaluated across the following dimensions:
Insulin Delivery Device Market Recent Developmental Activities
Insulin Delivery Device Market Segmentation
Insulin Delivery Device Market Assessment by Product Type
◦ Reusable Insulin Pens
◦ Disposable/Prefilled Insulin Pens
◦ Smart/Connected Insulin Pens
◦ Tethered/Durable Pumps
◦ Patch/Tubeless Pumps
Insulin Delivery Device Market Assessment by System Type
Insulin Delivery Device Market Assessment by Diabetes Type
Insulin Delivery Device Market Assessment by End-User
Insulin Delivery Device Market Assessment by Geography
Key Takeaways from the Insulin Delivery Device Market Report Study
Target audience who can benefit from this insulin delivery device market report study
Q1. At what rate is the insulin delivery device market expected to grow?
The global insulin delivery device market is projected to grow at a compound annual growth rate of 8.6% during the forecast period from 2026 to 2034.
Q2. What is the current and projected size of the insulin delivery device market?
The global insulin delivery device market was valued at USD 20.4 billion in 2025 and is projected to reach USD 42.8 billion by 2034.
Q3. Which region dominates the insulin delivery device market?
North America dominated the insulin delivery device market with a 36% share in 2025, driven by high diabetes prevalence, a mature healthcare infrastructure, and the concentration of leading manufacturers. Asia-Pacific is projected to record the fastest compound annual growth rate through 2034, driven by a rapidly escalating diabetes burden and expanding healthcare infrastructure across China, Japan, and India.
Q4. What are the key factors driving growth in the insulin delivery device market?
The principal drivers are the rising global prevalence of diabetes; the accelerating shift toward automated insulin delivery and closed-loop systems; growing adoption of smart and connected insulin pens; expanding regulatory indications to insulin-requiring type 2 diabetes, pregnancy, and pediatric populations; and rising preference for home-based diabetes management.
Q5. Who are the major players in the insulin delivery device market?
The market is consolidated and led by Medtronic plc, Insulet Corporation, and Tandem Diabetes Care, Inc., alongside Novo Nordisk A/S, Eli Lilly and Company, Sanofi, Ypsomed Holding AG, Becton, Dickinson and Company, Beta Bionics, Inc., and Terumo Corporation.
For illustrative purposes, only the top 10 companies are listed in the Table of Contents. The report may include analysis and references to additional companies where relevant to the market assessment.