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市場調査レポート
商品コード
1634218
オンボディドラッグデリバリーデバイスの世界市場 - 2025年~2033年Global On-body Drug Delivery Devices 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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オンボディドラッグデリバリーデバイスの世界市場 - 2025年~2033年 |
出版日: 2025年01月13日
発行: DataM Intelligence
ページ情報: 英文 157 Pages
納期: 即日から翌営業日
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オンボディドラッグデリバリーデバイスの世界市場は2024年に405億4,000万米ドルに達し、2033年には827億4,000万米ドルに達すると予測され、予測期間2025年~2033年のCAGRは8.6%で成長する見込みです。
オンボディドラッグデリバリーデバイス(OBDDs)は、患者の身体に装着したまま薬剤、特に生物製剤を皮下投与する新しい医療機器です。これらのデバイスは多くの場合、パッチで装着され、モノクローナル抗体のような大きな分子を送達するように設計されており、正確な投与量とタイミングが要求されます。OBDDの基本的な目的は、より予測しやすく制御されたドラッグデリバリーシステムを構築し、患者のコンプライアンスを向上させ、治療反応のばらつきを抑えることです。これらのデバイスは、自宅での自己投与を可能にし、頻繁な通院や針を刺す必要性を減らし、慢性疾患患者の生活の質を大幅に向上させます。
オンボディドラッグデリバリーデバイスに対する需要の増加は、予測期間中の市場を牽引する要因です。糖尿病やがんなどの慢性疾患の頻度増加により、常に効果的な薬剤投与が必要となっており、これが体内ドラッグデリバリーシステムに対する需要拡大の原動力となっています。これらのデバイスは自己投与を強化し、患者が自宅で治療を管理できるようにするため、治療レジメンのアドヒアランスが向上します。さらに、技術の向上により、より使いやすく効率的な流通システムが実現し、その価値が高まっています。
促進要因と抑制要因
オンボディドラッグデリバリーデバイス需要の増加
オンボディドラッグデリバリーデバイスに対する需要の増加は、世界のオンボディドラッグデリバリーデバイス市場の成長において重要な要因となることが予想されます。オンボディドラッグデリバリーデバイスの需要が増加している背景には、慢性疾患の有病率の上昇、技術の進歩、最近の発売や承認があります。
慢性疾患の有病率の増加は、オンボディドラッグデリバリーデバイスの需要を牽引する主な要因です。糖尿病、心血管疾患、がんなどの慢性疾患は、持続的かつ頻繁に高度な管理レジメンを必要とするが、これは強化されたドラッグデリバリーシステムによって効率的にサポートすることができます。慢性疾患の頻度が高まるにつれ、従来のヘルスケア環境以外でも患者が薬を自己投与できるような新しいソリューションに対する需要が高まっています。例えば、米国心臓病学会(American College of Cardiology Foundation)によると、収縮期血圧の高値は、年齢標準化CVD障害調整生存年(DALYs)に最も寄与しており、全世界で人口10万人当たり2,564.9人でした。
オンボディドラッグデリバリーデバイスに対する需要の高まりは、その機能性、安全性、患者のコンプライアンスを向上させる技術的改善と密接な関係があります。最近の体内ドラッグデリバリー技術の動向には、生物製剤やその他の薬剤を正確に投与するための高度なデバイスの開発が含まれます。ウェアラブル注射器や輸液ポンプなどのこれらのデバイスは、糖尿病やがんなどの慢性疾患への対応に不可欠な、長時間かつ制御された薬物放出を実現するように設計されています。最新の体内ドラッグデリバリーシステムは、薬剤を投与するだけでなく、その機能を向上させるスマートな機能も備えています。現在、多くの機器が投与量のモニタリングや追跡機能を備えており、患者が治療計画をより効果的に守ることができます。
例えば、2023年4月、医療技術の世界的リーダーであるメドトロニック社は、SmartGuard技術を使用しながらフィンガースティックが不要なGuardian 4センサーを搭載したMiniMed 780GシステムがFDA認証を取得したと発表しました。このマイルストーンは、食事検出技術を使用して5分ごとに自動的に糖レベルを調整・修正する唯一のシステムの認証を意味します。
厳しい規制要件
厳しい規制要件などの要因が、世界のオンボディドラッグデリバリーデバイス市場を阻害すると予想されています。これらのデバイスを管理する規制の複雑さは、薬とデバイスの両方のコンポーネントを持つコンビネーション商品として指定されていることから生じています。この二重の分類により、メーカーは、特に米国と欧州のように地域によって大きく異なる複雑な規制システムのネットワークを横断する必要があります。各地域には独自のガイドラインと承認プロセスがあり、これが新規製品の市場投入に混乱と遅れをもたらすことがあります。
規制状況は、ドラッグデリバリーシステムにおける技術の急速な進歩によってさらに複雑になっています。新技術が開発されるにつれ、規制当局による追加規制が必要となる新機能が頻繁に提供されるようになります。例えば、ネットワーク化された薬物送達システムは、厳しい安全性、性能、サイバーセキュリティの要件を満たす必要があり、承認前に広範な試験と検証が必要となります。企業は、すべての関連規制へのコンプライアンスを確保するために、多大な時間とリソースを割かなければならないため、市販前申請に対するこのような厳しい要件は、技術革新サイクルを遅らせる可能性があります。
The global on-body drug delivery devices market reached US$ 40.54 billion in 2024 and is expected to reach US$ 82.74 billion by 2033, growing at a CAGR of 8.6% during the forecast period 2025-2033.
On-body drug delivery devices (OBDDs) are novel medical devices that dispense drugs, notably biologics, subcutaneously while remaining attached to the patient's body. These devices are often patched on and designed to deliver large molecules like monoclonal antibodies, which require precise dosing and timing. The basic aim of OBDDs is to create a more predictable and controlled drug delivery system, which improves patient compliance and reduces treatment response variability. These devices enable self-administration at home, which reduces the need for frequent hospital visits and needle pricks, greatly enhancing the quality of life for patients with chronic diseases.
The increasing demand for on-body drug delivery devices is the driving factor that drives the market over the forecast period. The growing frequency of chronic diseases, such as diabetes and cancer, necessitates constant and effective medication administration, which is driving the growing demand for on-body drug delivery systems. These devices enhance self-administration, allowing patients to manage their treatments at home and therefore increasing adherence to therapy regimens. Furthermore, technological improvements have resulted in more user-friendly and efficient distribution systems, increasing their perceived value.
Market Dynamics: Drivers & Restraints
Increasing demand for on-body drug delivery devices
The increasing demand for on-body drug delivery devices is expected to be a significant factor in the growth of the global on-body drug delivery devices market. The demand for on-body drug delivery devices is increasing owing to the rising prevalence of chronic diseases, technological advancements, and recent launches and approvals.
The growing prevalence of chronic diseases is a major driver that drives the demand for on-body drug delivery devices. Chronic diseases, such as diabetes, cardiovascular diseases, and cancer, necessitate persistent and frequently sophisticated management regimens, which can be efficiently supported by enhanced drug delivery systems. As chronic diseases become more frequent, there is a growing demand for novel solutions that allow patients to self-administer medications outside of traditional healthcare settings. For instance, according to the American College of Cardiology Foundation, High systolic blood pressure contributed the most to age-standardized CVD disability-adjusted life years (DALYs), with 2,564.9 per 100,000 people worldwide.
The growing demand for on-body medication delivery systems is closely connected to technological improvements that improve their functionality, safety, and patient compliance. Recent advancements in on-body drug delivery technology include the development of sophisticated devices for administering biologics and other drugs with accuracy. These devices, such as wearable injectors and infusion pumps, are designed to deliver prolonged and controlled drug release, which is critical for addressing chronic diseases such as diabetes and cancer. The latest on-body drug delivery systems are not only designed to provide medication, but they also have smart features that improve their functionality. Many devices now have dose monitoring and tracking capabilities, which can help patients adhere to treatment plans more effectively.
For instance, in April 2023, Medtronic plc, a global leader in medical technology, announced that its MiniMed 780G system with the Guardian 4 sensor, which requires no fingersticks while using SmartGuard technology, has received FDA certification. This milestone signifies the certification of the only system that uses meal detection technology to automatically regulate and correct sugar levels every 5 minutes.
Stringent Regulatory Requirements
Factors such as stringent regulatory requirements are expected to hamper the global on-body drug delivery devices market. The complexity of regulations controlling these devices emerges partly from their designation as combination goods, which have both medication and device components. This dual classification requires manufacturers to traverse an intricate network of regulatory systems that varies greatly across locations, particularly between the United States and Europe. Each region has its own set of guidelines and approval processes, which can cause confusion and delays in introducing novel products to the market.
The regulatory landscape is further complicated by the rapid advancement of technology in drug delivery systems. As new technologies are developed, they frequently provide new functionalities that necessitate additional regulation from regulatory organizations. For instance, networked medicine delivery systems must meet stringent safety, performance, and cybersecurity requirements, necessitating extensive testing and validation prior to approval. This stringent requirement for pre-market submissions can slow down the innovation cycle since companies must devote significant time and resources to ensuring compliance with all relevant regulations.
The global on-body drug delivery devices market is segmented based on product, application, age group, end-user, and region.
Wearable Injectors segment is expected to dominate the global on-body drug delivery devices market share
The wearable injectors segment is anticipated to dominate the global on-body drug delivery devices market owing to its growing importance as a convenient and effective solution for managing chronic diseases. As healthcare shifts toward more patient-centered techniques, wearable injectors provide an easy and effective way to manage chronic conditions. These devices are designed to deliver medication subcutaneously over an extended period of time, allowing patients to self-administer their therapies while going about their regular lives. This convenience is especially compelling for people with chronic disorders like diabetes, cancer, and autoimmune diseases, which frequently necessitate daily medicine administration.
Furthermore, the design and functionality of on-body wearable injectors play a crucial role in their market dominance. These devices are often worn as skin patches, with a user-friendly interface that streamlines medicine delivery. Their water-resistant characteristics and adaptability for home usage add to their appeal, allowing patients to maintain their treatments without frequent visits to hospitals and clinics. The capacity of these devices to efficiently distribute complicated medications increases patient comfort while also lowering healthcare expenditures by reducing hospital admissions and associated charges.
Wearable injectors are also growing in popularity due to technological developments. Automated warming systems for cold pharmaceuticals and increased dosing flexibility make these devices attractive to both patients and healthcare practitioners. The spring-based injector method, which allows for exact subcutaneous injection with no effort, has acquired significant acceptance because of its ease of use. There have been recent launches and approvals in recent times. For instance, in October 2023, Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) approved the EMPAVELI Injector. The EMPAVELI Injector is a compact, single-use, on-body device designed to enhance self-administration of EMPAVELI (pegcetacoplan), which is approved for adults with paroxysmal nocturnal hemoglobinuria (PNH).
North America is expected to hold a significant position in the global on-body drug delivery devices market share
North America will likely account for a significant share of the global on-body drug delivery devices market, owing to its advanced healthcare infrastructure, a high prevalence of chronic diseases, technological advancements, and recent launches and approvals. The increased prevalence of chronic diseases in North America has a substantial impact on the growth of the on-body drug delivery device market.
For instance, according to the National Institute of Health, common types of cardiovascular disease include coronary heart disease (CHD), stroke, hypertension, and congestive heart failure. An estimated 16.3 million Americans aged 20 and older have CHD, a prevalence of 7 percent. The prevalence for men is 8.3 percent and for women is 6.1 percent. About 7 million Americans aged 20 or older have had a stroke. Each year approximately 610,000 experience their first stroke and another 185,000 experience a recurrence. Approximately 87 percent of all strokes are ischemic of which 10 percent result from intracerebral hemorrhage and 3 percent result from subarachnoid hemorrhage. Cardiovascular disease, diabetes, and autoimmune disorders are becoming more prevalent in the population.
The regulatory environment in North America also influences the on-body drug delivery device market. The United States Food and Drug Administration (FDA) has set defined rules for approving combination items that incorporate both medications and devices. This regulatory framework promotes innovation while protecting patient safety. Companies benefit from a streamlined clearance procedure, which enables them to bring new products to market faster than in regions with more complex regulatory regulations.
The region has a strong healthcare infrastructure and a high emphasis on R&D, which encourages innovation in drug delivery technology. These developments are critical to fulfill the growing demand for effective, patient-friendly chronic disease management options. The incorporation of smart technologies is a significant technological advancement in the on-body drug delivery devices industry. Many current wearable injectors now include connection features that enable them to communicate with smartphones and other digital health systems. This connectivity enables real-time monitoring of medication adherence and patient health parameters, delivering useful information to both patients and healthcare practitioners. For instance, in May 2023, Coherus BioSciences, Inc., announced that the single-dose (6mg/0.6mL), prefilled autoinjector presentation of UDENYCA (pegfilgrastim-cbqv) is now available for commercial sale in the United States. UDENYCA is a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. UDENYCA AI's streamlined design offers a simple option for in-office and at-home settings of care that administers pegfilgrastim in less than 10 seconds.
Asia Pacific is growing at the fastest pace in the global on-body drug delivery devices market
The Asia Pacific region is emerging as the fastest-growing market for on-body drug delivery devices, owing to a combination of demographic trends, increased healthcare investment, recent launches, technological advancements, and a rising number of chronic diseases. The rising prevalence of chronic diseases such as diabetes, cardiovascular disease, and respiratory ailments is a major contributor to this growth. The rising prevalence of chronic diseases increases the demand for on-body drug delivery devices.
For instance, according to the National Institute of Health, coronary heart disease prevalence rates in India have been estimated over the past several decades and have ranged from 1.6% to 7.4% in rural populations and from 1% to 13.2% in urban populations. These medical conditions necessitate continuing treatment and control, resulting in an increased demand for dependable and user-friendly medication delivery systems. The surge in chronic diseases needs innovative approaches that enable patients to successfully self-administer drugs at home, improving treatment adherence and overall health outcomes.
The major global players in the global on-body drug delivery devices market include BD, Gerresheimer AG, NOVO Engineering, West Pharmaceutical Services, Inc., Enable Injections, Stevanato Group, LTS Lohmann Therapie-Systeme AG, Coherus BioSciences, Inc., Tandem Diabetes Care, Inc, Battelle among others.
Emerging Players
Hera Health Solutions, Vensica Medical, and Bigfoot Biomedical among others
The global on-body drug delivery devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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