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市場調查報告書
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2118839

胰島素輸注裝置：市場洞察、競爭格局及市場預測 - 2034 年

Insulin Delivery Device - Market Insights, Competitive Landscape, and Market Forecast - 2034
出版日期: | 出版商: DelveInsight | 英文 150 Pages | 商品交期: 2-10個工作天內

價格

概述：

  • 2025年全球胰島素輸注設備市場價值為204億美元，預計2034年將達到428億美元。
  • 在 2026 年至 2034 年的預測期內，市場預計將以 8.6% 的複合年成長率成長，這主要得益於全球糖尿病患病率的上升、向自動化胰島素給藥和閉合迴路系統的加速過渡、智慧互聯胰島素筆的日益普及，以及主要設備平台適應症的擴大，包括需要胰島素治療的 2 型糖尿病患者。
  • 按產品類型分類，預計到 2025 年，胰島素筆市佔率將達到 43%，進而推動胰島素輸注設備市場的發展。
  • 按系統類型分類，預計到 2025 年，傳統（開放回路）胰島素輸送系統將佔最大的市場佔有率，而自動胰島素輸送（AID）系統預計將成為成長最快的系統類型。
  • 依糖尿病類型分類，預計2025年，第2型糖尿病患者將佔胰島素輸注設備市場的58%，反映出全球第2型糖尿病患者數量遠超過其他類型。同時，胰島素幫浦和輔助胰島素治療系統（AID）的大部分使用者仍將是第1型糖尿病患者。
  • 按最終用戶分類，預計到 2025 年，居家照護行業將佔市場佔有率的 66%，在胰島素輸送設備市場佔主導地位。
  • 到 2025 年，北美將佔胰島素輸送設備市場 36% 的最大佔有率，但預計到 2034 年，亞太地區將實現最快的成長。

胰島素輸注裝置是一種用於給糖尿病患者皮下注射胰島素的醫療器械，因為胰島素不能口服。本研究涵蓋胰島素筆，包括可重複使用的胰島素筆，例如諾和諾德的NovoPen 6和禮來公司的Tempo Pen；一次性預填充胰島素筆，例如諾和諾德的FlexTouch、禮來公司的KwikPen和賽諾菲的SoloStar；以及智慧胰島素筆和聯網胰島素筆，例如美敦力的InPvo和 Echo諾德的。胰島素泵包括有線或耐用型胰島素泵，例如美敦力公司的「MiniMed」平台、Ta​​ndem Diabetes Care公司的「t:slim X2」和「Tandem Mobi」、Ypsomed公司的「YpsoPump」以及SOOIL公司的「DANA」泵；以及貼片式或無導管胰島素泵，例如Insulet公司的「Omnipod」、EOFLOW公司的「EOPatch」以及CeQur公司的「Simplicity」； 780G」、Tandem公司的「Control-IQ+」平台、Insulet公司的「Omnipod 5」以及Beta Bionics公司的「​​iLet Bionic Pancreas」；來自貝克頓·迪金森公司、泰爾茂公司和歐文·芒福德公司的胰島素注射器；以及胰島素噴射注射器和無針注射器。該市場涵蓋各種醫療保健機構，包括居家醫療、醫院和糖尿病診所，目標客戶為 1 型和 2 型糖尿病患者。

胰島素輸注裝置市場的主要市場促進因素

  • 全球糖尿病盛行率正在上升。據估計，到2025年，全球將有5.91億人患有糖尿病，預計到2050年，這一數字將接近8.54億，這表明對胰島素輸注裝置的需求將持續旺盛。
  • 為了減輕患者負擔並改善血糖控制，人們正在加速轉向自動化胰島素輸送 (AID) 和閉合迴路系統，這些系統整合了胰島素幫浦、持續血糖監測和給藥演算法。
  • 對於需要每天多次注射的患者來說，智慧連網胰島素筆的使用正在不斷增加，它提供劑量追蹤、剩餘胰島素水平計算和持續血糖監測等整合功能。
  • 主要設備平台的適應症正在擴大，包括需要胰島素治療的 2 型糖尿病患者、孕婦和兒童，擴大了目標患者群體。
  • 人們越來越傾向於在家中進行糖尿病管理，患者更喜歡使用可連網的、隱藏的自我注射胰島素裝置，而不是在醫院接受胰島素治療。
  • 糖尿病相關組織和醫療保健專業人員加強病患教育和意識提升活動，正在加速先進胰島素給藥技術的早期應用。
  • 主要製造商之間持續進行產品創新並產品推出。這包括新一代貼片式胰島素幫浦、無導管輔助胰島素輸注系統以及可互通的自動胰島素輸注組件。

推動胰島素輸注裝置市場成長的因素

市場促進因素

全球糖尿病盛行率不斷上升

胰島素輸注裝置市場的主要促進因素是全球糖尿病盛行率的不斷上升。據估計，到2025年，全球糖尿病患者將達到5.91億，預計到2050年這一數字將增至約8.54億，增幅達46%。其中超過90%的病例為第2型糖尿病，隨著病情進展，口服藥物和其他治療方法將難以有效控制病情，導致需要胰島素治療的患者比例不斷增加。由於人口老化、肥胖盛行率上升和都市化加快，全球糖尿病患者數量持續成長，需要規律、精準胰島素輸注的患者群體也將相應擴大，預計在預測期內，各類胰島素輸注裝置的需求將保持強勁。

向自動化胰島素給藥系統的過渡正在加速。

向自動化胰島素輸注系統 (AID) 和閉合迴路系統的轉變正在加速，重塑胰島素輸注設備市場的競爭格局和技術重點。美敦力 (Medtronic) 的 MiniMed 780G、Inslet 的 Omnipod 5、Tandem 的 Control-IQ+ 平台以及 Beta Bionics 的 iLet 仿生胰腺等系統，將持續血糖監測數據與自動給藥演算法相結合，即時調整胰島素輸注量，從而減輕手動給藥決策的負擔，並提高血糖控制在目標範圍內的準確性。 2024 年 3 月，FDA 批准了 Sequel Twist AID 系統，這是第一個能夠直接測量胰島素輸注量和流速的自動化胰島素輸注系統，提高了檢測阻塞和給藥問題的準確性。隨著臨床證據不斷證實 AID 系統在血糖控制和生活品質 (QOL) 方面的益處，以及監管機構批准擴大了合格患者群體，預計在預測期內，對 AID 技術的需求將成為成長最快的系統類型。

市場限制因素

胰島素輸注設備市場面臨許多相互關聯的限制因素，阻礙其成長。許多第2型糖尿病患者難以接受注射或胰島素幫浦治療，因為口服降血糖藥物對相當一部分患者仍然有效且療效顯著。近年來，醫療設備召回事件的增加加劇了病患、臨床醫生和監管機構對安全性和可靠性的擔憂，迫使製造商加強投入，改善品管系統。設備和耗材的高成本，加上北美和西歐以外許多地區醫保覆蓋範圍有限，限制了先進胰島素幫浦、自動胰島素輸注系統（AID）和智慧胰島素筆的普及，尤其是在價格敏感且資源匱乏的市場。美國近期對醫療設備和零件徵收的進口關稅，增加了依賴全球供應鏈的製造商的生產成本。這種成本壓力可能會轉嫁給患者，從而限制他們獲得先進胰島素輸注設備的機會，尤其是那些醫療保險覆蓋範圍有限的患者。此外，先進胰島素幫浦和AID系統技術操作耗時，也可能阻礙老年患者和不熟悉連網數位健康工具的患者接受這些設備。儘管法律規範旨在支援可互通的自動化胰島素輸注組件，但不同製造商的設備之間缺乏完全互通性仍然限制了患者的選擇和系統的柔軟性。這些因素共同減緩了技術的普及速度，供應商需要證明其產品的可靠性、經濟性和易用性才能維持成長。

目錄

第1章：胰島素輸注裝置市場：引言

  • 調查範圍
  • 市場區隔
  • 市場概覽

第2章：胰島素輸注裝置市場：摘要整理

  • 主要亮點和市場概覽

第3章：胰島素輸注裝置市場：關鍵因素分析

  • 市場促進因素
    • 全球糖尿病盛行率正在上升。
    • 向自動化胰島素給藥系統的過渡正在加速。
    • 智慧互聯胰島素筆的廣泛應用。
    • 擴大了對第 2 型糖尿病的適應症，並適用於更廣泛的患者群體。
  • 市場限制因素
    • 口服糖尿病藥物的供應情況
    • 產品召回與可靠性問題
    • 高成本和有限的保險覆蓋範圍。
  • 市場機遇
    • 可互通的自動化胰島素輸注組件
    • 針對第2型糖尿病患者族群

第4章：人工智慧、地緣政治、貿易與經濟趨勢

  • 人工智慧驅動的創新和應用
  • 美國關稅影響分析

第5章：監理分析

  • 美國
  • 歐洲
  • 日本
  • 中國

第6章：波特五力分析

第7章：胰島素輸注裝置市場：評估

  • 依產品類型
    • 胰島素筆
    • 胰島素幫浦
    • 胰島素注射器
    • 胰島素噴射注射器
    • 其他
  • 依系統類型
    • 自動胰島素輸注（AID）/閉合迴路系統
    • 常規（開放回路）胰島素給藥
  • 糖尿病的類型
    • 1型糖尿病
    • 2型糖尿病
  • 最終用戶
    • 居家照護環境
    • 醫院
    • 糖尿病專科診所
  • 按地區
    • 北美洲
    • 歐洲
    • 亞太地區
    • 世界其他地區

第8章：胰島素輸注裝置市場：競爭格局

  • 競爭分析
  • 企業市場占有率分析（加值服務）

第9章 胰島素輸注設備市場：新創企業資金籌措與投資趨勢

第10章 胰島素輸注裝置市場：公司概況及產品概況

  • 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

第11章：KOL的觀點

第12章：專案式教學方法

第13章：關於 DelveInsight

第14章 免責聲明與聯絡方式

Product Code: DIMDCL0069

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

List of Tables

  • Table 1: Global Insulin Delivery Device Market Size in USD million (2023-2034)
  • Table 2: Global Insulin Delivery Device Market Size by Product Type in USD million (2023-2034)
  • Table 3: Global Insulin Delivery Device Market Size by System Type in USD million (2023-2034)
  • Table 4: Global Insulin Delivery Device Market Size by Diabetes Type in USD million (2023-2034)
  • Table 5: Global Insulin Delivery Device Market Size by End-User in USD million (2023-2034)
  • Table 6: Insulin Delivery Device Market Size in North America in USD million (2023-2034)
  • Table 7: Insulin Delivery Device Market Size in the United States in USD million (2023-2034)
  • Table 8: Insulin Delivery Device Market Size in Canada in USD million (2023-2034)
  • Table 9: Insulin Delivery Device Market Size in Mexico in USD million (2023-2034)
  • Table 10: Insulin Delivery Device Market Size in Europe in USD million (2023-2034)
  • Table 11: Insulin Delivery Device Market Size in Germany in USD million (2023-2034)
  • Table 12: Insulin Delivery Device Market Size in the United Kingdom in USD million (2023-2034)
  • Table 13: Insulin Delivery Device Market Size in France in USD million (2023-2034)
  • Table 14: Insulin Delivery Device Market Size in Italy in USD million (2023-2034)
  • Table 15: Insulin Delivery Device Market Size in Spain in USD million (2023-2034)
  • Table 16: Insulin Delivery Device Market Size in the Rest of Europe in USD million (2023-2034)
  • Table 17: Insulin Delivery Device Market Size in Asia-Pacific in USD million (2023-2034)
  • Table 18: Insulin Delivery Device Market Size in China in USD million (2023-2034)
  • Table 19: Insulin Delivery Device Market Size in Japan in USD million (2023-2034)
  • Table 20: Insulin Delivery Device Market Size in India in USD million (2023-2034)
  • Table 21: Insulin Delivery Device Market Size in Australia in USD million (2023-2034)
  • Table 22: Insulin Delivery Device Market Size in South Korea in USD million (2023-2034)
  • Table 23: Insulin Delivery Device Market Size in the Rest of Asia-Pacific in USD million (2023-2034)
  • Table 24: Insulin Delivery Device Market Size in the Rest of the World in USD million (2023-2034)
  • Table 25: Insulin Delivery Device Market Size in the Middle East in USD million (2023-2034)
  • Table 26: Insulin Delivery Device Market Size in Africa in USD million (2023-2034)
  • Table 27: Insulin Delivery Device Market Size in South America in USD million (2023-2034)
  • Table 28: Insulin Delivery Device Market Competitive Landscape
  • Table 29: Insulin Delivery Device Market Startup Funding and Investment Trends

List of Figures

  • Figure 1: Insulin Delivery Device Market Drivers
  • Figure 2: Insulin Delivery Device Market Restraints
  • Figure 3: Insulin Delivery Device Market Opportunities
  • Figure 4: Impact Analysis: AI, Geopolitical, Trade, and Economic Developments
  • Figure 5: Regulatory Analysis of the Insulin Delivery Device Market (the United States)
  • Figure 6: Regulatory Analysis of the Insulin Delivery Device Market (Europe)
  • Figure 7: Regulatory Analysis of the Insulin Delivery Device Market (Japan)
  • Figure 8: Regulatory Analysis of the Insulin Delivery Device Market (China)
  • Figure 9: Porter's Five Forces Analysis of the Insulin Delivery Device Market
  • Figure 10: Competitive Analysis of the Insulin Delivery Device Market
  • Figure 11: Global Insulin Delivery Device Market Size in USD million (2023-2034)
  • Figure 12: Global Insulin Delivery Device Market Size by Product Type in USD million (2023-2034)
  • Figure 13: Global Insulin Delivery Device Market Size by System Type in USD million (2023-2034)
  • Figure 14: Global Insulin Delivery Device Market Size by Diabetes Type in USD million (2023-2034)
  • Figure 15: Global Insulin Delivery Device Market Size by End-User in USD million (2023-2034)
  • Figure 16: Insulin Delivery Device Market Size in North America in USD million (2023-2034)
  • Figure 17: Insulin Delivery Device Market Size in the United States in USD million (2023-2034)
  • Figure 18: Insulin Delivery Device Market Size in Canada in USD million (2023-2034)
  • Figure 19: Insulin Delivery Device Market Size in Mexico in USD million (2023-2034)
  • Figure 20: Insulin Delivery Device Market Size in Europe in USD million (2023-2034)
  • Figure 21: Insulin Delivery Device Market Size in Germany in USD million (2023-2034)
  • Figure 22: Insulin Delivery Device Market Size in the United Kingdom in USD million (2023-2034)
  • Figure 23: Insulin Delivery Device Market Size in France in USD million (2023-2034)
  • Figure 24: Insulin Delivery Device Market Size in Italy in USD million (2023-2034)
  • Figure 25: Insulin Delivery Device Market Size in Spain in USD million (2023-2034)
  • Figure 26: Insulin Delivery Device Market Size in the Rest of Europe in USD million (2023-2034)
  • Figure 27: Insulin Delivery Device Market Size in Asia-Pacific in USD million (2023-2034)
  • Figure 28: Insulin Delivery Device Market Size in China in USD million (2023-2034)
  • Figure 29: Insulin Delivery Device Market Size in Japan in USD million (2023-2034)
  • Figure 30: Insulin Delivery Device Market Size in India in USD million (2023-2034)
  • Figure 31: Insulin Delivery Device Market Size in Australia in USD million (2023-2034)
  • Figure 32: Insulin Delivery Device Market Size in South Korea in USD million (2023-2034)
  • Figure 33: Insulin Delivery Device Market Size in the Rest of Asia-Pacific in USD million (2023-2034)
  • Figure 34: Insulin Delivery Device Market Size in the Rest of the World in USD million (2023-2034)
  • Figure 35: Insulin Delivery Device Market Size in the Middle East in USD million (2023-2034)
  • Figure 36: Insulin Delivery Device Market Size in Africa in USD million (2023-2034)
  • Figure 37: Insulin Delivery Device Market Size in South America in USD million (2023-2034)