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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

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 150 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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개요:

  • 세계 인슐린 전달 기기 시장은 2025년 204억 달러로 평가되었으며, 2034년까지 428억 달러에 달할 것으로 예측됩니다.
  • 2026년부터 2034년까지의 예측 기간 동안 전 세계 당뇨병 유병률의 증가, 자동화된 인슐린 투여 및 폐쇄 루프 시스템으로의 전환 가속화,스마트 및 연결 가능한 인슐린 펜의 보급 확대, 그리고 주요 기기 플랫폼의 적응증이 인슐린이 필요한 2형 당뇨병 환자층으로 확대되고 있는 것을 배경으로, 해당 시장은 연평균 성장률(CAGR) 8.6%로 성장할 것으로 전망됩니다.
  • 제품 유형별로는 2025년에 인슐린 펜 부문이 43%의 점유율을 차지하며 인슐린 전달 기기 시장을 주도했습니다.
  • 시스템 유형별로는 2025년 기존 방식(오픈 루프) 인슐린 투여가 시장에서 가장 큰 점유율을 차지한 반면, 자동 인슐린 투여(AID) 시스템이 가장 빠르게 성장한 시스템 유형이 되었습니다.
  • 당뇨병 유형별로는 2025년 2형 당뇨병 부문이 인슐린 전달 기기 시장에서 58%의 점유율을 차지하여, 전 세계적으로 2형 당뇨병 환자 수가 훨씬 더 많다는 사실을 반영했습니다. 한편, 인슐린 펌프 및 AID 시스템 사용의 대부분은 여전히 1형 당뇨병 환자가 차지하고 있습니다.
  • 최종사용자별로는 2025년에 재택 간호 부문이 66%의 점유율을 차지하며 인슐린 전달 기기 시장을 주도했습니다.
  • 2025년에는 북미가 인슐린 전달 기기 시장에서 36%라는 가장 큰 점유율을 차지했으나, 2034년까지 아시아태평양이 가장 빠른 성장을 기록할 것으로 예상됩니다.

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

  • 세계 당뇨병 유병률의 증가입니다. 2025년에는 약 5억 9,100만 명이 당뇨병을 앓을 것으로 추정되며, 이 수치는 2050년까지 8억 5,400만 명에 근접할 것으로 예측되어 인슐린 전달 기기에 대한 폭넓은 수요가 지속될 것으로 보입니다.
  • 환자의 부담을 줄이고 혈당 조절을 개선하기 위해 펌프, 연속 혈당 모니터링, 투여 알고리즘을 통합한 자동 인슐린 투여(AID) 및 폐쇄 루프 시스템으로의 전환이 가속화되고 있습니다.
  • 하루에 여러 번 주사를 맞아야 하는 환자를 위해 투여량 기록, 체내 잔여 인슐린량 계산 및 연속 혈당 모니터링 기능을 통합한 스마트하고 네트워크에 연결된 인슐린 펜의 채택이 확대되고 있습니다.
  • 주요 기기 플랫폼의 적응증이 인슐린이 필요한 2형 당뇨병 환자, 임산부 및 소아 연령층으로 확대되면서 대상 환자층이 넓어지고 있습니다.
  • 병원에서의 인슐린 요법보다 자가 투여가 가능하고 눈에 띄지 않으며, 네트워크 연결 기능을 갖춘 인슐린 투여 기기를 선호하는 등, 가정에서의 당뇨병 관리에 대한 선호도가 높아지고 있습니다.
  • 당뇨병 관련 단체 및 의료 종사자에 의한 환자 교육 및 계몽 활동의 증가로 인해, 첨단 인슐린 투여 기술의 조기 도입이 촉진되고 있습니다.
  • 주요 제조사 간의 지속적인 제품 혁신과 경쟁적인 신제품 출시 활동. 여기에는 차세대 패치형 펌프, 튜브리스 AID 시스템, 상호 운용 가능한 자동 인슐린 투여 구성요소 등이 포함됩니다.

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.

자주 묻는 질문

  • 세계 인슐린 전달 기기 시장 규모는 어떻게 예측되나요?
  • 2025년 인슐린 전달 기기 시장에서 제품 유형별 점유율은 어떻게 되나요?
  • 2025년 인슐린 전달 기기 시장에서 시스템 유형별 점유율은 어떻게 되나요?
  • 2025년 인슐린 전달 기기 시장에서 당뇨병 유형별 점유율은 어떻게 되나요?
  • 2025년 인슐린 전달 기기 시장에서 최종 사용자별 점유율은 어떻게 되나요?
  • 2025년 인슐린 전달 기기 시장에서 지역별 점유율은 어떻게 되나요?
  • 인슐린 전달 기기 시장의 주요 성장 촉진 요인은 무엇인가요?

목차

제1장 인슐린 전달 기기 시장 : 소개

제2장 인슐린 전달 기기 시장 : 주요 요약

제3장 인슐린 전달 기기 시장 : 주요 요인 분석

제4장 AI, 지정학, 무역 및 경제 동향

제5장 규제 분석

제6장 Porter's Five Forces 분석

제7장 인슐린 전달 기기 시장 : 평가

제8장 인슐린 전달 기기 시장 : 경쟁 구도

제9장 인슐린 전달 기기 시장 : 스타트업 자금 조달 및 투자 동향

제10장 인슐린 전달 기기 시장 : 기업 개요 및 제품 프로파일

제11장 KOL의 견해

제12장 프로젝트 접근법

제13장 DelveInsight 소개

제14장 면책사항 및 문의

KSM 26.09.01

Insulin Delivery Device Market Summary

Overview:

  • 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.
  • The market is expected to expand at a CAGR of 8.6% during the forecast period 2026-2034, supported by 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, and the expanding indications of leading device platforms to insulin-requiring type 2 diabetes populations.
  • By product type, the insulin pens segment dominated the insulin delivery device market with a 43% share in 2025.
  • By system type, conventional (open-loop) insulin delivery accounted for the largest share of the market in 2025, while automated insulin delivery (AID) systems represented the fastest-growing system type.
  • By diabetes type, the type 2 diabetes segment dominated the insulin delivery device market with a 58% share in 2025, reflecting the much larger global type 2 patient population, while type 1 diabetes continues to account for the majority of insulin pump and AID system usage.
  • By end-user, the homecare settings segment dominated the insulin delivery device market with a 66% share in 2025.
  • North America accounted for the largest share of the insulin delivery device market at 36% in 2025, while Asia-Pacific is anticipated to register the fastest growth through 2034.

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

  • Rising global prevalence of diabetes, with an estimated 591 million people living with diabetes in 2025 and this figure projected to approach 854 million by 2050, sustaining broad-based demand for insulin administration devices.
  • Accelerating shift toward automated insulin delivery (AID) and closed-loop systems that bundle pump, continuous glucose monitoring, and dosing algorithms to reduce patient burden and improve glycemic control.
  • Growing adoption of smart and connected insulin pens that provide dose logging, insulin-on-board calculation, and continuous glucose monitor integration for patients on multiple daily injections.
  • Expanding regulatory indications of leading device platforms to insulin-requiring type 2 diabetes populations, pregnancy, and pediatric age groups, broadening the eligible patient base.
  • Rising preference for home-based diabetes management that favors self-administered, discreet, and connected insulin delivery devices over hospital-based insulin therapy.
  • Increasing patient education and awareness initiatives from diabetes associations and healthcare providers that drive earlier adoption of advanced insulin delivery technology.
  • Ongoing product innovation and competitive launch activity among leading manufacturers, including next-generation patch pumps, tubeless AID systems, and interoperable automated insulin dosing components.

Key Companies in Insulin Delivery Device Market

The leading participants in the insulin delivery device market include the following:

  • Medtronic plc
  • Insulet Corporation
  • Tandem Diabetes Care, Inc.
  • Novo Nordisk A/S
  • Eli Lilly and Company
  • Sanofi
  • Ypsomed Holding AG
  • Becton, Dickinson and Company
  • Beta Bionics, Inc.
  • Terumo Corporation

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:

  • Market concentration: Consolidated, with Medtronic, Insulet, Tandem Diabetes Care, Novo Nordisk, Sanofi, Eli Lilly, Roche, and Ypsomed collectively dominating the market, alongside specialist and regional vendors including Becton Dickinson, Beta Bionics, Terumo, Abbott, CeQur, EOFLOW, and Biocon.
  • Leading players: Medtronic and Insulet lead in automated insulin delivery systems through the MiniMed 780G and Omnipod 5 platforms, respectively; Tandem Diabetes Care leads in tethered pump miniaturization through the Tandem Mobi; Novo Nordisk, Eli Lilly, and Sanofi lead in global insulin pen volume; and Beta Bionics leads in autonomous, algorithm-driven closed-loop delivery through the iLet Bionic Pancreas.
  • Geographic reach: Medtronic, Novo Nordisk, Sanofi, and Eli Lilly operate global commercial and regulatory organizations, while specialist vendors including Beta Bionics, CeQur, and EOFLOW maintain more concentrated footprints centered on specific regions and device categories.
  • Product portfolio strength: Competitive advantage rests on the breadth across pens, pumps, and AID systems, and on the integration of devices with continuous glucose monitoring ecosystems and mobile health platforms.
  • Pipeline strength: Development is concentrated in tubeless and miniaturized AID systems, interoperable automated insulin dosing components, and smart pen and CGM interoperability.
  • Strategic partnerships: Collaboration spans CGM integration partnerships, exemplified by Insulet's compatibility agreement for the Abbott FreeStyle Libre 2 Plus sensor with Omnipod 5, and Abbott's collaboration with Medtronic linking its CGM platform to Medtronic's insulin pump ecosystem.
  • M&A activity: Consolidation has shaped the field, exemplified by Novo Nordisk's acquisition of Biocorp to strengthen its connected insulin pen portfolio and Abbott's acquisition of Bigfoot Biomedical, a developer of smart insulin management systems.
  • Innovation focus: Innovation is concentrated in tubeless and miniaturized AID systems, direct insulin flow measurement technology such as the Sequel Twist system, and interoperable, algorithm-driven closed-loop platforms.
  • Regulatory standing: FDA clearance and CE Mark approval, particularly for automated insulin dosing system components and expanded pediatric, pregnancy, and type 2 diabetes indications, are decisive competitive credentials across this consolidated, innovation-driven market.

Insulin Delivery Device Market Recent Developmental Activities

  • In July 2025, Medtronic received CE Mark approval to expand the indicated population for its MiniMed 780G automated insulin delivery system to include individuals as young as two years old, pregnant women, and people with insulin-requiring type 2 diabetes. Strategic significance: the expansion broadened Medtronic's addressable AID market beyond its historical type 1 diabetes core base.
  • In May 2025, GO-Pen ApS received FDA 510(k) clearance for the GO-PEN, a user-filled reusable insulin pen compatible with standard insulin vials. Strategic significance: the clearance introduced a more affordable and sustainable alternative to traditional prefilled disposable pens.

Insulin Delivery Device Market Segmentation

Insulin Delivery Device Market Assessment by Product Type

  • Insulin Pens

◦ Reusable Insulin Pens

◦ Disposable/Prefilled Insulin Pens

◦ Smart/Connected Insulin Pens

  • Insulin Pumps

◦ Tethered/Durable Pumps

◦ Patch/Tubeless Pumps

  • Insulin Syringes
  • Insulin Jet Injectors
  • Others

Insulin Delivery Device Market Assessment by System Type

  • Automated Insulin Delivery (AID)/Closed-Loop Systems
  • Conventional (Open-Loop) Insulin Delivery

Insulin Delivery Device Market Assessment by Diabetes Type

  • Type 1 Diabetes
  • Type 2 Diabetes

Insulin Delivery Device Market Assessment by End-User

  • Homecare Settings
  • Hospitals
  • Diabetes and Specialty Clinics
  • Others

Insulin Delivery Device Market Assessment by Geography

  • North America
  • United States Insulin Delivery Device Market Size in USD million (2023-2034)
  • Canada Insulin Delivery Device Market Size in USD million (2023-2034)
  • Mexico Insulin Delivery Device Market Size in USD million (2023-2034)
  • Europe
  • Germany Insulin Delivery Device Market Size in USD million (2023-2034)
  • United Kingdom Insulin Delivery Device Market Size in USD million (2023-2034)
  • France Insulin Delivery Device Market Size in USD million (2023-2034)
  • Italy Insulin Delivery Device Market Size in USD million (2023-2034)
  • Spain Insulin Delivery Device Market Size in USD million (2023-2034)
  • Rest of Europe Insulin Delivery Device Market Size in USD million (2023-2034)
  • Asia-Pacific
  • China Insulin Delivery Device Market Size in USD million (2023-2034)
  • Japan Insulin Delivery Device Market Size in USD million (2023-2034)
  • India Insulin Delivery Device Market Size in USD million (2023-2034)
  • Australia Insulin Delivery Device Market Size in USD million (2023-2034)
  • South Korea Insulin Delivery Device Market Size in USD million (2023-2034)
  • Rest of Asia-Pacific Insulin Delivery Device Market Size in USD million (2023-2034)
  • Rest of the World
  • Middle East Insulin Delivery Device Market Size in USD million (2023-2034)
  • Africa Insulin Delivery Device Market Size in USD million (2023-2034)
  • South America Insulin Delivery Device Market Size in USD million (2023-2034)

Key Takeaways from the Insulin Delivery Device Market Report Study

  • Market size analysis for the current insulin delivery device market size (2025), and market forecast for 9 years (2026 to 2034).
  • Top key product and technology developments, mergers, acquisitions, partnerships, and joint ventures that happened over the last 3 years.
  • Key companies dominating the global insulin delivery device market.
  • Various opportunities available for competitors in the insulin delivery device market space.
  • What are the top-performing segments in 2025? How will these segments perform in 2034?
  • Which are the top-performing regions and countries in the current insulin delivery device market scenario?
  • Which are the regions and countries where companies should concentrate their opportunities for insulin delivery device market growth in the future?

Target audience who can benefit from this insulin delivery device market report study

  • Insulin delivery device and diabetes technology providers
  • Research organizations and consulting companies
  • Diabetes and endocrinology-related organizations, associations, forums, and other alliances
  • Government and corporate offices
  • Start-up companies, venture capitalists, and private equity firms
  • Distributors and traders dealing in insulin delivery devices
  • Various end-users who want to know more about the insulin delivery device market and the latest technological developments in the insulin delivery device market.

Frequently Asked Questions:

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.

Table of Contents

1. Insulin Delivery Device Market Introduction

  • 1.1. Scope of the Report
  • 1.2. Market Segmentation
  • 1.3. Market Overview at a Glance

2. Insulin Delivery Device Market Executive Summary

  • 2.1. Key Highlights and Market Snapshot

3. Insulin Delivery Device Market Key Factors Analysis

  • 3.1. Market Drivers
    • 3.1.1. Rising Global Prevalence of Diabetes
    • 3.1.2. Accelerating Shift Toward Automated Insulin Delivery Systems
    • 3.1.3. Growing Adoption of Smart and Connected Insulin Pens
    • 3.1.4. Expanding Regulatory Indications to Type 2 Diabetes and Broader Populations
  • 3.2. Market Restraints
    • 3.2.1. Availability of Oral Antidiabetic Medications
    • 3.2.2. Product Recalls and Reliability Concerns
    • 3.2.3. High Cost and Limited Reimbursement
  • 3.3. Market Opportunities
    • 3.3.1. Interoperable Automated Insulin Dosing Components
    • 3.3.2. Expansion into the Type 2 Diabetes Population

4. Impact Analysis: AI, Geopolitical, Trade, and Economic Developments

  • 4.1. AI-Powered Innovations and Applications
  • 4.2. U.S. Tariff Impact Analysis

5. Regulatory Analysis

  • 5.1. The United States
  • 5.2. Europe
  • 5.3. Japan
  • 5.4. China

6. Insulin Delivery Device Market Porter's Five Forces Analysis

  • 6.1. Bargaining Power of Suppliers
  • 6.2. Bargaining Power of Consumers
  • 6.3. Threat of New Entrants
  • 6.4. Threat of Substitutes
  • 6.5. Competitive Rivalry

7. Insulin Delivery Device Market Assessment

  • 7.1. By Product Type
    • 7.1.1. Insulin Pens
      • 7.1.1.1. Reusable Insulin Pens
      • 7.1.1.2. Disposable/Prefilled Insulin Pens
      • 7.1.1.3. Smart/Connected Insulin Pens
    • 7.1.2. Insulin Pumps
      • 7.1.2.1. Tethered/Durable Pumps
      • 7.1.2.2. Patch/Tubeless Pumps
    • 7.1.3. Insulin Syringes
    • 7.1.4. Insulin Jet Injectors
    • 7.1.5. Others
  • 7.2. By System Type
    • 7.2.1. Automated Insulin Delivery (AID)/Closed-Loop Systems
    • 7.2.2. Conventional (Open-Loop) Insulin Delivery
  • 7.3. By Diabetes Type
    • 7.3.1. Type 1 Diabetes
    • 7.3.2. Type 2 Diabetes
  • 7.4. By End-User
    • 7.4.1. Homecare Settings
    • 7.4.2. Hospitals
    • 7.4.3. Diabetes and Specialty Clinics
    • 7.4.4. Others
  • 7.5. By Geography
    • 7.5.1. North America
      • 7.5.1.1. United States Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.1.2. Canada Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.1.3. Mexico Insulin Delivery Device Market Size in USD million (2023-2034)
    • 7.5.2. Europe
      • 7.5.2.1. Germany Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.2.2. United Kingdom Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.2.3. France Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.2.4. Italy Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.2.5. Spain Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.2.6. Rest of Europe Insulin Delivery Device Market Size in USD million (2023-2034)
    • 7.5.3. Asia-Pacific
      • 7.5.3.1. China Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.3.2. Japan Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.3.3. India Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.3.4. Australia Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.3.5. South Korea Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.3.6. Rest of Asia-Pacific Insulin Delivery Device Market Size in USD million (2023-2034)
    • 7.5.4. Rest of the World
      • 7.5.4.1. Middle East Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.4.2. Africa Insulin Delivery Device Market Size in USD million (2023-2034)
      • 7.5.4.3. South America Insulin Delivery Device Market Size in USD million (2023-2034)

8. Insulin Delivery Device Market Competitive Landscape

  • 8.1. Competitive Analysis
  • 8.2. Company Share Analysis (Premium Offering)

9. Insulin Delivery Device Market Startup Funding and Investment Trends

10. Insulin Delivery Device Market Company and Product Profiles

  • 10.1. Medtronic plc
    • 10.1.1. Company Overview
    • 10.1.2. Company Snapshot
    • 10.1.3. Financial Overview
    • 10.1.4. Product Portfolio
    • 10.1.5. Strategic Initiatives / Entropy
  • 10.2. Insulet Corporation
    • 10.2.1. Company Overview
    • 10.2.2. Company Snapshot
    • 10.2.3. Financial Overview
    • 10.2.4. Product Portfolio
    • 10.2.5. Strategic Initiatives / Entropy
  • 10.3. Tandem Diabetes Care, Inc.
    • 10.3.1. Company Overview
    • 10.3.2. Company Snapshot
    • 10.3.3. Financial Overview
    • 10.3.4. Product Portfolio
    • 10.3.5. Strategic Initiatives / Entropy
  • 10.4. Novo Nordisk A/S
    • 10.4.1. Company Overview
    • 10.4.2. Company Snapshot
    • 10.4.3. Financial Overview
    • 10.4.4. Product Portfolio
    • 10.4.5. Strategic Initiatives / Entropy
  • 10.5. Eli Lilly and Company
    • 10.5.1. Company Overview
    • 10.5.2. Company Snapshot
    • 10.5.3. Financial Overview
    • 10.5.4. Product Portfolio
    • 10.5.5. Strategic Initiatives / Entropy
  • 10.6. Sanofi
    • 10.6.1. Company Overview
    • 10.6.2. Company Snapshot
    • 10.6.3. Financial Overview
    • 10.6.4. Product Portfolio
    • 10.6.5. Strategic Initiatives / Entropy
  • 10.7. Ypsomed Holding AG
    • 10.7.1. Company Overview
    • 10.7.2. Company Snapshot
    • 10.7.3. Financial Overview
    • 10.7.4. Product Portfolio
    • 10.7.5. Strategic Initiatives / Entropy
  • 10.8. Becton, Dickinson and Company
    • 10.8.1. Company Overview
    • 10.8.2. Company Snapshot
    • 10.8.3. Financial Overview
    • 10.8.4. Product Portfolio
    • 10.8.5. Strategic Initiatives / Entropy
  • 10.9. Beta Bionics, Inc.
    • 10.9.1. Company Overview
    • 10.9.2. Company Snapshot
    • 10.9.3. Financial Overview
    • 10.9.4. Product Portfolio
    • 10.9.5. Strategic Initiatives / Entropy
  • 10.10. Terumo Corporation
    • 10.10.1. Company Overview
    • 10.10.2. Company Snapshot
    • 10.10.3. Financial Overview
    • 10.10.4. Product Portfolio
    • 10.10.5. Strategic Initiatives / Entropy

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.

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer and Contact Us

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