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市場調査レポート
商品コード
1634213
植え込み型インスリンポンプの世界市場 - 2025年~2033年Global Implantable Insulin Pumps Market - 2025 - 2033 |
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カスタマイズ可能
適宜更新あり
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植え込み型インスリンポンプの世界市場 - 2025年~2033年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 125 Pages
納期: 即日から翌営業日
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植え込み型インスリンポンプの世界市場は2024年に32億米ドルに達し、2033年には69億米ドルに達すると予測され、予測期間2025年から2033年のCAGRは9.0%で成長します。
植え込み型インスリンポンプは、糖尿病患者にインスリンを持続的に投与するために設計された医療機器です。体に装着する外付けインスリンポンプとは異なり、植え込み型インスリンポンプは外科的に皮膚の下、通常は腹部に設置され、インスリン治療の長期的なソリューションとして機能します。植え込み型インスリンポンプの主な機能は、健康な膵臓の機能を模倣して、正確な量のインスリンを投与することです。この装置は、小型のカテーテルまたはリザーバーを使用して、指定された期間にわたってインスリンを血流に投与し、血糖値を安定させる。
植え込み型インスリンポンプ市場は、技術の進歩、糖尿病罹患率の増加、個別化医療へのシフトに牽引され、大きな成長を遂げています。例えば、American Action Forumによると、米国では増加する糖尿病人口のうち約830万人が血糖値をコントロールするためにインスリンに依存しており、2030年までにインスリンの使用量は世界全体で20%増加すると予測されています。このインスリン使用量の増加が、植え込み型インスリンポンプの需要を押し上げています。
促進要因と抑制要因
糖尿病有病率の上昇
糖尿病有病率の上昇が植え込み型インスリンポンプ市場の成長を大きく牽引しており、予測期間中も市場を牽引していくと予想されます。国際糖尿病連合によると、2021年には20~79歳の成人の10人に1人(5億3,660万人)が糖尿病を患っています。2030年にはこの数字は6億4,280万人に増加し、2045年には7億8,370万人に達すると予想されています。糖尿病患者の4人に3人以上が低・中所得国に居住しています。2021年には、糖尿病が670万人、つまり5秒に1人の割合で死亡の原因となります。耐糖能異常(IGT)により、5億4,100万人が2型糖尿病を発症するリスクが高いです。この糖尿病人口の増加は、インスリン送達装置の主要な推進力となっています。
常時インスリン投与を必要とする1型糖尿病は、特に小児と青少年において診断件数が増加しています。このような人々は、従来の注射に比べ、より一貫性のある自動化された治療を提供する、植え込み型ポンプのような高度なインスリン送達ソリューションの恩恵を受ける可能性が高いです。例えば、米国疾病予防管理センター(CDC)によると、20歳以上の170万人、すなわち米国の糖尿病成人の5.7%が、1型糖尿病とインスリンの使用を報告しています。
植え込み型インスリンポンプは、持続的で正確なインスリン分泌を提供し、血糖値をより効果的に管理するのに役立ちます。より多くの糖尿病患者が、毎日何度も注射をする負担の軽減を求める中、植え込み型ポンプのような、より洗練された機器への需要が高まっています。
糖尿病患者、特に1型糖尿病患者の多くは、頻繁なインスリン注射を必要としています。植え込み型インスリンポンプは、24時間365日の安定したインスリン投与を可能にすることで、これらの患者に血糖コントロールの改善、低血糖の減少、全体的な糖尿病管理の改善をもたらす機会を提供します。
限られた臨床データ
植え込み型インスリンポンプを取り巻く臨床データが限られていることが、市場成長の大きな障壁となっています。これらのデバイスは先進的な糖尿病管理ソリューションを提供するが、包括的かつ長期的な臨床エビデンスがないため、採用、規制当局の承認、市場の信頼性の点で課題があります。
植え込み型インスリンポンプは有望ではあるが、外部ポンプと比較した長期的な有効性と安全性に関する臨床データは限られています。FDAのような規制機関は、これらのデバイスが持続的に安全に使用できることを保証するために、長期臨床試験による広範なデータを必要としています。そのようなデータがないため、ヘルスケアプロバイダーや患者の懐疑的な見方が増え、採用が制限されています。
例えば、植え込み型インスリンポンプは、その有効性と安全性を証明するために厳格な臨床試験を必要とします。このような臨床試験には長い時間と費用がかかり、その結果が蓄積されるまでには何年もかかります。このような臨床データの取得の遅れは、新しい機器の承認プロセスや市場参入を遅らせる。
インスリンポンプの植え込みによる感染症、機器の故障、合併症が懸念されます。例えば、体外式ポンプは交換やメンテナンスが簡単なことで知られているが、植え込み型ポンプは植え込みと取り外しの両方に手術が必要です。このため、手術による感染、装置の故障、再植込みの必要性など、潜在的なリスクに対する懸念が生じるが、これらはすべて臨床データによって立証される必要があります。
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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