市場調查報告書
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1634213
全球植入式胰島素幫浦市場 - 2025 - 2033Global Implantable Insulin Pumps Market - 2025 - 2033 |
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2024年,全球植入式胰島素幫浦市場規模達32億美元,預計2033年將達69億美元,2025-2033年預測期間複合年成長率為9.0%。
植入式胰島素幫浦是一種醫療設備,設計用於持續向糖尿病患者輸送胰島素。與佩戴在身體上的外部胰島素幫浦不同,植入式胰島素幫浦透過手術放置在皮膚下,通常位於腹部區域,作為胰島素治療的長期解決方案。植入式胰島素幫浦的主要功能是以精確劑量輸送胰島素,模仿健康胰臟的功能。本設備使用小型導管或儲液器在指定時間內將胰島素注入血液中,確保血糖值保持穩定。
在技術進步、糖尿病盛行率增加和向個人化醫療轉變的推動下,植入式胰島素幫浦市場正在經歷顯著成長。例如,根據美國行動論壇的數據,美國不斷增加的糖尿病人口中約有 830 萬依靠胰島素來控制血糖水平,預計到 2030 年,全球胰島素使用量將增加 20%。胰島素使用量的增加增加了對植入式胰島素幫浦的需求。
驅動程式和限制
糖尿病盛行率上升
糖尿病盛行率的上升極大地推動了植入式胰島素幫浦市場的成長,預計將在預測期內推動該市場的成長。根據國際糖尿病聯盟的數據,2021 年,20 歲至 79 歲之間的十分之一(5.366 億)成年人患有糖尿病。到2030年,這一數字預計將增加至6.428億,到2045年將達到7.837億。超過四分之三的糖尿病患者居住在低收入和中等收入國家。到 2021 年,糖尿病將導致 670 萬人死亡,即每五秒鐘就有一人死亡。糖耐量受損 (IGT) 使 5.41 億人面臨罹患第 2 型糖尿病的高風險。不斷成長的糖尿病人口是胰島素輸送設備的主要動力。
需要持續注射胰島素的第 1 型糖尿病的診斷率正在上升,特別是在兒童和青少年中。該族群更有可能受益於先進的胰島素輸送解決方案,例如植入式泵,與傳統注射相比,它提供了更一致和自動化的治療形式。例如,根據美國疾病管制與預防中心 (CDC) 的數據,170 萬名 20 歲或以上的人報告患有第 1 型糖尿病並使用胰島素,占美國所有成人糖尿病患者的 5.7%。
植入式胰島素幫浦提供連續、精確的胰島素輸送,有助於更有效地管理血糖水平。隨著越來越多的糖尿病患者尋求透過每日多次注射來減輕管理病情的負擔,對植入式幫浦等更複雜設備的需求也在增加。
許多醣尿病患者,尤其是第 1 型糖尿病患者,需要頻繁注射胰島素。植入式胰島素幫浦透過提供一致的 24/7 胰島素輸送,為這些患者提供改善血糖控制、減少低血糖和更好的整體糖尿病管理的機會。
臨床資料有限
植入式胰島素幫浦的臨床資料有限是市場成長的重大障礙。儘管這些設備提供了先進的糖尿病管理解決方案,但缺乏全面、長期的臨床證據,在採用、監管批准和市場信心方面帶來了挑戰。
雖然植入式胰島素幫浦顯示出良好的前景,但與外部幫浦相比,其長期有效性和安全性的臨床資料有限。 FDA 等監管機構需要長期臨床試驗的大量資料,以確保這些設備可以安全地持續使用。此類資料的缺乏增加了醫療保健提供者和患者的懷疑,限制了採用。
例如,植入式胰島素幫浦需要嚴格的臨床試驗來證明其有效性和安全性。這些試驗是漫長且昂貴的,而且結果可能需要數年時間才能累積。取得臨床資料的延遲減緩了新設備的核准流程和市場進入。
人們擔心植入胰島素幫浦會引起感染、設備故障或併發症。例如,雖然外部幫浦因其易於更換和維護而聞名,但植入式幫浦需要進行手術才能植入和移除。這引起了人們對手術感染、設備故障以及重新植入的需要等潛在風險的擔憂,所有這些都需要透過臨床資料來證實。
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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