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藥物遞輸設備

市場調查報告書

商品編碼

1634218

全球體內給藥設備市場 - 2025 - 2033

Global On-body Drug Delivery Devices Market - 2025 - 2033

出版日期: 2025年01月13日 | 出版商:

DataM Intelligence | 英文 157 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

2024年，全球體內給藥裝置市場規模達405.4億美元，預估至2033年將達827.4億美元，2025-2033年預測期間複合年成長率為8.6%。

體內藥物輸送裝置 (OBDD) 是一種新型醫療裝置，可在皮下分配藥物（特別是生物製劑），同時保持附著在患者身體上。這些設備通常經過修補並設計用於輸送單株抗體等大分子，這需要精確的劑量和時間。 OBDD 的基本目標是創建一個更可預測和可控的藥物傳遞系統，從而提高患者的依從性並減少治療反應的變異性。這些設備可以在家中進行自我管理，從而減少了頻繁去醫院和針刺的需要，大大提高了慢性病患者的生活品質。

對體內給藥設備的需求不斷成長是預測期內推動市場的促進因素。糖尿病和癌症等慢性病的發生率不斷增加，需要持續有效的藥物管理，這推動了對體內給藥系統的需求不斷成長。這些設備增強了自我管理能力，使患者能夠在家中管理他們的治療，從而提高對治療方案的依從性。此外，技術進步帶來了更方便用戶使用和高效的分銷系統，提高了其感知價值。

市場動態：

驅動程式和限制

對體內給藥裝置的需求不斷增加

對體內藥物輸送裝置的需求不斷成長預計將成為全球體內藥物輸送裝置市場成長的重要因素。由於慢性病盛行率上升、技術進步以及最近的推出和批准，對體內給藥裝置的需求不斷增加。

慢性病的日益普及是推動體內給藥設備需求的主要驅動力。糖尿病、心血管疾病和癌症等慢性疾病需要持續且複雜的治療方案，而增強的藥物傳遞系統可以有效地支持這些治療方案。隨著慢性病變得越來越頻繁，對新解決方案的需求不斷成長，這些解決方案允許患者在傳統醫療保健環境之外自行給藥。例如，根據美國心臟學會基金會的數據，高收縮壓對年齡標準化 CVD 傷殘調整生命年 (DALY) 的貢獻最大，全世界每 10 萬人中有 2,564.9 人患有高收縮壓。

對體內藥物輸送系統不斷成長的需求與提高其功能、安全性和患者依從性的技術改進密切相關。體內藥物傳輸技術的最新進展包括開發用於精確施用生物製劑和其他藥物的複雜設備。這些設備，例如穿戴式注射器和輸液泵，旨在提供延長和受控的藥物釋放，這對於解決糖尿病和癌症等慢性疾病至關重要。最新的體內藥物傳輸系統不僅旨在提供藥物，而且還具有改善其功能的智慧功能。現在許多設備都具有劑量監測和追蹤功能，可以幫助患者更有效地遵守治療計劃。

例如，2023年4月，全球醫療技術領導者美敦力公司宣布，其配備Guardian 4感測器的MiniMed 780G系統已獲得FDA認證，該系統在使用SmartGuard技術時無需進行指尖採血。這一里程碑標誌著唯一一個使用膳食檢測技術每 5 分鐘自動調節和糾正血糖水平的系統獲得認證。

嚴格的監管要求

嚴格的監管要求等因素預計將阻礙全球體內給藥設備市場。控制這些設備的法規的複雜性部分源於它們被指定為組合商品，其中既有藥物又有設備組件。這種雙重分類要求製造商穿越複雜的監管系統網路，這些系統在不同地區（尤其是美國和歐洲）差異很大。每個地區都有自己的一套指導方針和核准流程，這可能會導致新產品推向市場的混亂和延誤。

由於藥物輸送系統技術的快速進步，監管環境變得更加複雜。隨著新技術的發展，它們經常提供新的功能，需要監管組織進行額外的監管。例如，網路藥物輸送系統必須滿足嚴格的安全、效能和網路安全要求，在批准之前需要進行廣泛的測試和驗證。這種對上市前提交的嚴格要求可能會減慢創新週期，因為公司必須投入大量時間和資源來確保遵守所有相關法規。

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.

Segment Analysis

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).

Geographical Analysis

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.

Competitive Landscape

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

Key Developments

In December 2024, Aptar Digital Health and Gerresheimer developed an integrated cancer therapy solution. By Connecting Aptar Digital Health's proprietary SaDM platform with Gx SensAir, Gerresheimer's on-body device for subcutaneous delivery of large biologics molecules, this integrated solution is intended to improve overall treatment adherence and clinical outcomes.
In February 2024, Tandem announced the launch of Mobi automated insulin delivery system in the U.S. The Tandem Mobi is the world's smallest insulin delivery system to be fully controllable by a smartphone. With full integration, Tandem Mobi users are able to use their insulin pump with the Dexcom G7.

Why Purchase the Report?

Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
Post-market Surveillance: Uses post-market data to enhance product safety and access.
Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

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

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Devices Type
3.2. Snippet by Molecule Type
3.3. Snippet by Application
3.4. Snippet by Distribution Channel
3.5. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Increasing Demand for the On-Body Drug Delivery Devices
- 4.1.3. Restraints
- 4.1.4. Stringent Regulatory Requirements
- 4.1.5. Opportunity
- 4.1.6. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
5.5. Reimbursement Analysis
5.6. Patent Analysis
5.7. SWOT Analysis
5.8. DMI Opinion

6. By Devices Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
- 6.1.2. Market Attractiveness Index, By Devices Type
6.2. Wearable Injectors*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Infusion Pumps
6.4. Others

7. By Molecule Type

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
- 7.1.2. Market Attractiveness Index, By Molecule Type
7.2. Small Molecule*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Large Molecule

8. By Application

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
8.2. Cardiovascular Diseases*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Cancer
8.4. Diabetes
8.5. Auto-immune Disease
8.6. Others

9. By Distribution Channel

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 9.1.2. Market Attractiveness Index, By Distribution Channel
9.2. Hospital Pharmacies*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Retail Pharmacies
9.4. Online Pharmacies

10. By Region

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.2.7.1. U.S.
  - 10.2.7.2. Canada
  - 10.2.7.3. Mexico
10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.3.7.1. Germany
  - 10.3.7.2. U.K.
  - 10.3.7.3. France
  - 10.3.7.4. Spain
  - 10.3.7.5. Italy
  - 10.3.7.6. Rest of Europe
10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.4.7.1. Brazil
  - 10.4.7.2. Argentina
  - 10.4.7.3. Rest of South America
10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 10.5.7.1. China
  - 10.5.7.2. India
  - 10.5.7.3. Japan
  - 10.5.7.4. South Korea
  - 10.5.7.5. Rest of Asia-Pacific
10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Devices Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Molecule Type
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

11. Competitive Landscape

11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis

12. Company Profiles

12.1. BD*
- 12.1.1. Product Portfolio
  - 12.1.1.1. Product Description
  - 12.1.1.2. Product Key Performance Indicators (KPIs)
  - 12.1.1.3. Historic and Forecasted Product Sales
  - 12.1.1.4. Product Sales Volume
- 12.1.2. Financial Overview
  - 12.1.2.1. Company Revenue's
  - 12.1.2.2. Geographical Revenue Shares
  - 12.1.2.3. Revenue Forecasts
- 12.1.3. Key Developments
  - 12.1.3.1. Mergers & Acquisitions
  - 12.1.3.2. Key Product Development Activities
  - 12.1.3.3. Regulatory Approvals etc.
12.2. Gerresheimer AG
12.3. NOVO Engineering
12.4. West Pharmaceutical Services, Inc.
12.5. Enable Injections
12.6. Stevanato Group
12.7. LTS Lohmann Therapie-Systeme AG
12.8. Coherus BioSciences, Inc.
12.9. Tandem Diabetes Care, Inc
12.10. Battelle