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全球植入式胰岛素帮浦市场 - 2025 - 2033Global Implantable Insulin Pumps Market - 2025 - 2033 |
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2024年,全球植入式胰岛素帮浦市场规模达32亿美元,预计2033年将达69亿美元,2025-2033年预测期间复合年增长率为9.0%。
植入式胰岛素帮浦是一种医疗设备,设计用于持续向糖尿病患者输送胰岛素。与佩戴在身体上的外部胰岛素帮浦不同,植入式胰岛素帮浦透过手术放置在皮肤下,通常位于腹部区域,作为胰岛素治疗的长期解决方案。植入式胰岛素帮浦的主要功能是以精确剂量输送胰岛素,模仿健康胰臟的功能。本设备使用小型导管或储液器在指定时间内将胰岛素注入血液中,确保血糖值保持稳定。
在技术进步、糖尿病盛行率增加和向个人化医疗转变的推动下,植入式胰岛素帮浦市场正在经历显着成长。例如,根据美国行动论坛的数据,美国不断增加的糖尿病人口中约有 830 万依靠胰岛素来控制血糖水平,预计到 2030 年,全球胰岛素使用量将增加 20%。胰岛素使用量的增加增加了对植入式胰岛素帮浦的需求。
驱动程式和限制
糖尿病盛行率上升
糖尿病盛行率的上升极大地推动了植入式胰岛素帮浦市场的成长,预计将在预测期内推动该市场的成长。根据国际糖尿病联盟的数据,2021 年,20 岁至 79 岁之间的十分之一(5.366 亿)成年人患有糖尿病。到2030年,这一数字预计将增加至6.428亿,到2045年将达到7.837亿。超过四分之三的糖尿病患者居住在低收入和中等收入国家。到 2021 年,糖尿病将导致 670 万人死亡,即每五秒钟就有一人死亡。糖耐量受损 (IGT) 使 5.41 亿人面临罹患第 2 型糖尿病的高风险。不断增长的糖尿病人口是胰岛素输送设备的主要动力。
需要持续注射胰岛素的第 1 型糖尿病的诊断率正在上升,特别是在儿童和青少年中。该族群更有可能受益于先进的胰岛素输送解决方案,例如植入式泵,与传统注射相比,它提供了更一致和自动化的治疗形式。例如,根据美国疾病管制与预防中心 (CDC) 的数据,170 万名 20 岁或以上的人报告患有第 1 型糖尿病并使用胰岛素,占美国所有成人糖尿病患者的 5.7%。
植入式胰岛素帮浦提供连续、精确的胰岛素输送,有助于更有效地管理血糖水平。随着越来越多的糖尿病患者寻求透过每日多次注射来减轻管理病情的负担,对植入式帮浦等更复杂设备的需求也在增加。
许多醣尿病患者,尤其是第 1 型糖尿病患者,需要频繁注射胰岛素。植入式胰岛素帮浦透过提供一致的 24/7 胰岛素输送,为这些患者提供改善血糖控制、减少低血糖和更好的整体糖尿病管理的机会。
临床资料有限
植入式胰岛素帮浦的临床资料有限是市场成长的重大障碍。儘管这些设备提供了先进的糖尿病管理解决方案,但缺乏全面、长期的临床证据,在采用、监管批准和市场信心方面带来了挑战。
虽然植入式胰岛素帮浦显示出良好的前景,但与外部帮浦相比,其长期有效性和安全性的临床资料有限。 FDA 等监管机构需要长期临床试验的大量资料,以确保这些设备可以安全地持续使用。此类资料的缺乏增加了医疗保健提供者和患者的怀疑,限制了采用。
例如,植入式胰岛素帮浦需要严格的临床试验来证明其有效性和安全性。这些试验是漫长且昂贵的,而且结果可能需要数年时间才能累积。取得临床资料的延迟减缓了新设备的审批流程和市场进入。
人们担心植入胰岛素帮浦会引起感染、设备故障或併发症。例如,虽然外部帮浦因其易于更换和维护而闻名,但植入式帮浦需要进行手术才能植入和移除。这引起了人们对手术感染、设备故障以及重新植入的需要等潜在风险的担忧,所有这些都需要透过临床资料来证实。
The global implantable insulin pumps market reached US$ 3.2 billion in 2024 and is expected to reach US$ 6.9 billion by 2033, growing at a CAGR of 9.0% during the forecast period 2025-2033.
An implantable insulin pump is a medical device designed for the continuous delivery of insulin to individuals with diabetes. Unlike external insulin pumps that are worn on the body, an implantable insulin pump is surgically placed under the skin, typically in the abdominal area and functions as a long-term solution for insulin therapy. The primary function of an implantable insulin pump is to deliver insulin in precise doses, mimicking the function of a healthy pancreas. The device uses a small catheter or reservoir to administer insulin into the bloodstream over a specified period, ensuring blood sugar levels remain stable.
The implantable insulin pumps market is experiencing significant growth, driven by technological advancements, increasing diabetes prevalence and a shift towards personalized medicine. For instance, according to the American Action Forum, about 8.3 million of the United States increasing diabetic population depend on insulin to control their blood sugar levels, and by 2030, it's predicted that insulin use will rise by 20% globally. This rising insulin use boosts the demand for implantable insulin pumps.
Market Dynamics: Drivers & Restraints
Rising prevalence of diabetes
The rising prevalence of diabetes is significantly driving the growth of the implantable insulin pumps market and is expected to drive the market over the forecast period. According to the International Diabetes Federation, In 2021, 1 in 10 adults (536.6 million) between the ages of 20 and 79 have diabetes. By 2030, this figure is expected to increase to 642.8 million, and by 2045, it will reach 783.7 million. More than three out of four diabetic individuals reside in low- and middle-income nations. In 2021, diabetes will be the cause of 6.7 million fatalities or one every five seconds. Impaired Glucose Tolerance (IGT) puts 541 million persons at high risk of developing type 2 diabetes. This growing diabetic population is a major driver for insulin delivery devices.
Type 1 diabetes, which requires constant insulin administration, is seeing a rise in diagnoses, particularly in children and adolescents. This population is more likely to benefit from advanced insulin delivery solutions like implantable pumps, which provide a more consistent and automated form of treatment compared to traditional injections. For instance, according to the Centers for Disease Control and Prevention (CDC), type 1 diabetes and insulin use were reported by 1.7 million persons aged 20 years or older, or 5.7% of all adults with diabetes in the United States.
Implantable insulin pumps offer continuous and precise insulin delivery, which helps manage blood glucose levels more effectively. As more people with diabetes seek to reduce the burden of managing their condition with multiple daily injections, the demand for more sophisticated devices like implantable pumps increases.
Many individuals with diabetes, particularly those with Type 1 diabetes, require frequent insulin injections. Implantable insulin pumps, by providing consistent, 24/7 insulin delivery, offer these patients the opportunity for improved blood sugar control, reduced hypoglycemia, and better overall diabetes management.
Limited clinical data
The limited clinical data surrounding implantable insulin pumps is a significant barrier to the growth of the market. Although these devices offer advanced diabetes management solutions, the lack of comprehensive, long-term clinical evidence presents challenges in terms of adoption, regulatory approval and market confidence.
While implantable insulin pumps show promise, there is limited clinical data on their long-term effectiveness and safety compared to external pumps. Regulatory bodies like the FDA require extensive data from long-term clinical trials to ensure these devices are safe for sustained use. The absence of such data increases skepticism among healthcare providers and patients, limiting adoption.
For instance, implantable insulin pumps require rigorous clinical trials to prove their efficacy and safety. These trials are lengthy and expensive, and the results can take years to accumulate. This delay in obtaining clinical data slows down the approval process and market entry for new devices.
There are concerns about infections, device malfunctions or complications arising from the implantation of insulin pumps. For instance, while external pumps are known for their ease of replacement and maintenance, implantable pumps require surgery for both implantation and removal. This raises concerns over potential risks like surgical infections, device failures, and the need for re-implantation, all of which need to be substantiated through clinical data.
The global implantable insulin pumps market is segmented based on type, disease, end-user and region.
The closed-loop insulin pumps segment is expected to dominate the implantable insulin pumps market share
The closed-loop insulin pumps segment is emerging as a dominant force in the implantable insulin pumps market due to its advanced technology, superior control over blood glucose levels, and patient-centric benefits. Closed-loop insulin pumps, also known as artificial pancreas systems, offer the ability to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) data. This functionality makes them a highly attractive solution for people with diabetes, driving their growing demand.
For instance, in May 2024, Arecor Therapeutics plc announced a research collaboration with Medtronic plc to develop a novel, high-concentration, thermostable insulin for use by Medtronic's Diabetes business in a next-generation implantable pump. The collaboration adds to Arecor's broad program of diabetes-focused activities, led by its two lead proprietary clinical development programs AT278 and AT247, two ultra-rapid acting insulin candidates that offer the potential to simplify and improve blood glucose control for people living with diabetes and could enable the development of next-generation miniaturized insulin delivery systems and a fully closed loop artificial pancreas system.
Closed-loop insulin pumps are integrated with CGM systems that measure blood glucose levels continuously. These pumps use real-time glucose data to automatically adjust insulin delivery, optimizing blood sugar levels without requiring manual intervention from the patient. This automated insulin delivery significantly reduces the risk of both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar).
North America is expected to hold a significant position in the implantable insulin pumps market share
North America, particularly the United States, has one of the highest rates of diabetes worldwide. According to the Centers for Disease Control and Prevention (CDC), over 38 million Americans are living with diabetes i.e., 1 in 10 people, with nearly 90-95% of them having Type 2 diabetes. The rising prevalence of diabetes fuels the demand for advanced insulin delivery solutions, such as implantable insulin pumps.
In addition to Type 2 diabetes, the number of people with Type 1 diabetes is also significant. Type 1 diabetes requires constant insulin delivery, which is a key driver for the adoption of insulin pumps. According to the National Institute of Health (NIH), more than 5 million Americans are predicted to have Type 1 diabetes by 2050, with an estimated 1.6 million now living with the disease and an additional 64,000 being diagnosed annually, which is a major target market for implantable insulin pumps.
North America leads in adopting and integrating advanced medical technologies such as closed-loop systems, continuous glucose monitoring (CGM) and insulin pumps. The region is home to major players like Medtronic and other emerging players, which are leading the development of implantable insulin pumps and related technologies.
For instance, in April 2024, Senseonics Holdings, Inc. announced that Eversense was granted an integrated CGM (iCGM) designation by the US Food and Drug Administration (FDA). As the first fully implantable device in the category, Eversense is authorized to be marketed as an iCGM through the FDA's De Novo pathway, by establishing the special controls that will serve as a predicate device for 510(k) submissions in the future for devices of the same type.
Asia-Pacific is growing at the fastest pace in the implantable insulin pumps market
The Asia Pacific region is witnessing a dramatic increase in the number of diabetes cases, particularly in countries like China, India, and Japan. According to the International Diabetes Federation (IDF), approximately 160 million people in the Asia-Pacific region were living with diabetes in 2021, a figure expected to rise to 225 million by 2045. This escalating prevalence of diabetes directly contributes to the rising demand for advanced insulin delivery systems like implantable insulin pumps.
Countries in the Asia-Pacific region, especially in East Asia and Southeast Asia, have made significant strides in improving their healthcare systems, especially in urban areas. Increased healthcare investments are making advanced diabetes care, including implantable insulin pumps, more accessible to patients.
For instance, according to the National Institute of Health (NIH), India holds the dubious title of "Diabetes Capital of the World" due to having the greatest number of diabetes patients worldwide. A number of recent articles have provided extensive documentation of the issue. Diabetes prevention and treatment account for 5% to 10% of the country's health expenditure.
Several healthcare organizations, including the International Diabetes Federation (IDF) and local diabetes associations in APAC countries, have been running educational campaigns to raise awareness about the benefits of insulin pumps over traditional insulin therapy. These initiatives are helping patients in the region understand the advantages of insulin pumps, contributing to the segment's growth.
The major global players in the implantable insulin pumps market include Medtronic plc, Senseonics Holdings, Inc. Arecor Therapeutics plc and among others.
The global Implantable Insulin Pumps market report delivers a detailed analysis with 41 key tables, more than 43 visually impactful figures, and 125 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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