市場調查報告書
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全球體內給藥設備市場 - 2024-2031Global On-body Drug Delivery Devices Market - 2024-2031 |
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概述
2023年,全球體內給藥裝置市場規模達379億美元,預計2031年將達733億美元,2024-2031年預測期間複合年成長率為8.6%。
體內藥物輸送裝置是設計為佩戴在身體上以將藥物直接輸送給患者或將其他治療物質輸送到作用部位的醫療設備。這些裝置旨在透過皮膚、黏膜或其他身體表面釋放藥物,從而提供受控和有針對性的藥物輸送。
這些裝置包括各種形式,例如貼片、幫浦和注射器,可以附著在衣服下方或外面的身體上。這些設備的主要目的是提供持續和受控的藥物輸送,從而允許在預定時間精確給藥或連續輸注。
用於小分子藥物皮下給藥的體內給藥裝置的容量可達 3 ml。它被貼在身體上。典型的應用是幾個小時內的推注和基礎治療方案。這種貼片式裝置可皮下輸送大分子(生物製劑),專為定期需要一定總量的配製藥物的治療而設計。典型應用包括單株抗體 (mAb) 等蛋白質。
司機
慢性病發生率上升以及患者轉向先進的給藥系統
全球體內給藥裝置市場的需求是由多種因素所驅動的。關鍵因素之一是慢性病發病率的上升和患者轉向先進的藥物傳輸系統。
糖尿病、關節炎、高血壓和癌症等慢性病的盛行率不斷上升,是推動體內給藥裝置需求的主要因素。這些設備可實現精確劑量、提高依從性並減少治療反應的變異性,從而更有效地管理慢性病。
患者越來越喜歡體內藥物輸送裝置,因為它們比傳統藥物輸送方法更有優勢。這些優點包括更高的精度、更低的劑量增量、家庭使用功能、自動針插入和縮回、閉塞檢測以及標準玻璃藥筒的使用。準確靶向特定細胞或組織,同時最大限度地減少副作用和提高治療效果的能力正在推動這些先進藥物傳輸系統的採用。
此外,合作夥伴關係和協作以及產品發布和批准等行業策略的關鍵參與者將推動該市場的成長。例如,2023 年 3 月,Stevanato Group SpA 宣布與 Thermo Fisher Scientific 合作,將用於皮下給藥的完全整合的體內輸送系統平台推向市場。
此外,2023 年 4 月,美敦力 (Medtronic) 宣布美國食品藥物管理局 (FDA) 批准其 MiniMed 780G 系統,該系統配備 Guardian 4 感測器,在使用 Smart Guard 技術時無需進行指尖採血。這一里程碑標誌著唯一採用進餐檢測技術的系統獲得批准,該系統每 5 分鐘自動調整和校正血糖水平,以滿足基礎(背景)和推注(進餐時)胰島素需求。該系統提供胰島素,以幫助解決用戶偶爾忘記推注或低估膳食中碳水化合物含量的情況。
限制
設備和治療的高成本、針刺傷害和患者不適的風險、監管挑戰以及人們缺乏意識等因素預計將阻礙市場。
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Overview
The global on-body drug delivery devices market reached US$ 37.9 billion in 2023 and is expected to reach US$ 73.3 billion by 2031 growing with a CAGR of 8.6% during the forecast period 2024-2031.
On-body drug delivery devices are medical devices that are designed to be worn on the body to deliver medications directly to patients or other therapeutic substances to the site of action. These devices are designed to release drugs through the skin, mucous membranes, or other body surfaces, providing a controlled and targeted delivery of medication.
These devices include various forms such as patches, pumps, and injectors, which can be attached to the body either under or over clothing. The primary purpose of these devices is to provide sustained and controlled delivery of medications, allowing for precise dosing at predetermined times or continuous infusion.
The on-body drug delivery device for the subcutaneous administration of small-molecule drugs is available for volumes up to 3 ml. It is patched onto the body. Typical applications are bolus and basal regimens over several hours. This patched-on device delivers large molecules (biologics) subcutaneously and is designed for therapies that periodically require a certain total quantity of a formulated drug. Typical applications include proteins such as monoclonal antibodies (mAbs).
Market Dynamics: Drivers
Rise in incidences of chronic diseases & patients' shift toward advanced drug delivery systems
The demand for the global on-body drug delivery devices market is driven by multiple factors. One of the key factors is the rise in incidences of chronic diseases & patients' shift toward advanced drug delivery systems.
The increasing prevalence of chronic conditions such as diabetes, arthritis, hypertension, and cancer is a major factor driving the demand for on-body drug delivery devices. These devices enable more effective management of chronic diseases by allowing for precise dosing, improved adherence, and reduced variability in treatment response.
Patients are increasingly preferring on-body drug delivery devices due to their advantages over traditional drug delivery methods. These advantages include higher precision, lower dosing increments, home-use capabilities, automatic needle insertion and retraction, occlusion detection, and the use of standard glass cartridges. The ability to accurately target specific cells or tissues while minimizing side effects and increasing therapeutic efficacy is driving the adoption of these advanced drug delivery systems.
Moreover, key players in the industry strategies such as partnerships & collaborations, and product launches & approvals would propel this market growth. For instance, in March 2023, Stevanato Group S.p.A. announced its collaboration with Thermo Fisher Scientific to bring a fully integrated on-body delivery system platform for subcutaneous administration to the market.
Also, in April 2023, Medtronic announced the U.S. Food and Drug Administration (FDA) approval of its MiniMed 780G system with the Guardian 4 sensor requiring no finger sticks while in Smart Guard technology. This milestone marks the approval of the only system with meal detection technology that provides automatic adjustments and corrections to sugar levels every 5 minutes for both basal (background) and bolus (mealtime) insulin needs. The system provides insulin to help account for when users occasionally forget to bolus or underestimate the number of carbs in their meals.
Restraints
Factors such as the high costs of devices & treatment, the risk of needlestick injuries & patient discomfort, regulatory challenges, and lack of awareness among people, are expected to hamper the market.
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The global on-body drug delivery devices market is segmented based on device type, molecule type, application, distribution channels, and region.
The wearable injectors segment accounted for approximately 62.8% of the global on-body drug delivery devices market share
The wearable injectors segment is expected to hold the largest market share over the forecast period. Wearable injection systems are drug-delivery devices that adhere to the body, automatically delivering set doses to the patient at optimal times. Wearable injection systems represent the natural evolution of chronic disease management. As wearable injection systems have emerged in response to these conditions, so has a completely new set of challenges regarding device design and testing.
Moreover, key players in the industry product launches and approvals help to drive this segment growth in the market. For instance, in February 2024, LTS LOHMANN Therapie-Systeme AG launched its UDENYCA on-body injector (OBI) utilizing the LTS Sorrel wearable drug delivery platform. UDENYCA (pegfilgrastim-cbqv) is a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
Also, in September 2023, Enable Injections, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse) for the subcutaneous delivery of EMPAVELI (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients' daily lives.
In addition, major players' innovative developments, investments, and mergers & acquisitions drive this segment's growth in the market. For instance, in January 2023, Eitan Medical opened a new manufacturing facility for a wearable drug delivery platform. The new manufacturing facility at its headquarters to support drug-delivery device production.
Similarly, in April 2023, LTS Lohmann acquired the Sorrel wearable injection device business headquartered in Netanya, Israel, a part of Eitan Medical Ltd.
North America accounted for approximately 42.1% of the global on-body drug delivery devices market share
North America region is expected to hold the largest market share over the forecast period owing to the rising incidence of chronic diseases, demand for self-administration medications, and well-advanced healthcare infrastructure propelling the market growth in this region.
Moreover, a major number of key players' presence, technological advancements, and product launches & approvals drive the market growth. For instance, in February 2024, Tandem Diabetes Care, Inc. announced the United States commercial launch of its new Tandem Mobi, the world's smallest, durable automated insulin delivery system for people living with diabetes. The company has begun taking orders and shipping to eligible customers in the United States.
Also, in October 2022, after five years and two unsuccessful attempts, scPharmaceuticals finally pushed its on-body infusor for congestive heart failure across the FDA finish line. With the approval, Furoscix becomes the first self-administered, subcutaneous loop diuretic for those with worsening HF.
The Food and Drug Administration (FDA) approved Furoscix (furosemide injection) for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.
The major global players in the on-body drug delivery devices market include Gerresheimer AG, NOVO Engineering, West Pharmaceutical Services, Inc., Enable Injections, Stevanato Group, LTS Lohmann Therapie-Systeme AG, BD, Coherus BioSciences, Inc., Tandem Diabetes Care, Inc, and Battelle among others.
The global on-body drug delivery devices market report would provide approximately 70 tables, 63 figures, and 184 pages.
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