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药物递输设备

市场调查报告书

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1629891

全球自动注射器市场 - 2025-2033

Global Auto-Injectors Market - 2025-2033

出版日期: 2024年12月30日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2024年全球自动注射器市场规模达103.7亿美元，预计到2033年将达到398.4亿美元，2025-2033年预测期间复合年增长率为17.2%。

自动注射器是一种专门的医疗设备，用于自行注射预定剂量的药物，通常用于紧急情况或治疗慢性疾病。这些设备通常有一个弹簧注射器，允许使用者註射药物而无需手动压下柱塞，这使得它们对使用者友好，甚至对于那些没有医疗经验的人来说也很容易使用。自动注射器的设计可以实现更快的药物输送，这对于过敏反应等需要快速治疗以防止严重过敏反应的情况至关重要。

自动注射器的监管批准和推出不断增加是预测期内推动市场的驱动因素。例如，2023 年3 月，Coherus Biosciences 宣布FDA 批准了其聚乙二醇非格司亭生物仿製药的单剂量预装自动注射器版本，用于治疗和预防发热性中性粒细胞减少症，这是一种与化疗相关的常见併发症。自动注射器装置将允许患者在接受化疗后的第二天注射聚乙二醇非格司亭，从而降低患者发生发烧性嗜中性白血球减少症的风险。 Udenyca 自动注射器透过皮肤按压启动来触发，从而能够可靠、立即输送总聚乙二醇非格司亭剂量。

市场动态：

驱动程式和限制

增加自动注射器的监管批准和推出

自动注射器越来越多的监管批准和推出预计将成为全球自动注射器市场成长的重要因素。随着全球对自我给药设备的需求不断扩大，FDA 和 EMA 等监管机构正在修改其框架，以便快速批准新型自动注射器技术。这一趋势至关重要，因为它不仅改善了患者获得重要药物的机会，而且还让医疗保健提供者和患者对这些设备的安全性和实用性产生了乐观情绪。

近年来，各製造公司获得了许多监管部门的批准并推出了新的自动注射器。例如，2023 年 6 月，Halozyme Therapeutics, Inc. 宣布 argenx 获得美国食品和药物管理局 (FDA) 批准 VYVGART Hytrulo 注射与 ENHANZE 皮下注射用于治疗成年患者的全身性重症肌无力 (gMG)。受体（AChR）抗体阳性。

此外，2023 年5 月，美国食品药物管理局(FDA) 批准了Cyltezo Pen，这是Cyltezo (adalimumab-adbm) 的新型自动注射器替代品，Cyltezo (adalimumab-adbm) 是FDA 批准的Humira (adalimumab)的可互换生物相似药。 Cyltezo 最初被批准作为预填充注射器，用于治疗各种慢性发炎。因此，批准数量的增加正在扩大市场。

自动注射器成本高

自动注射器的高成本等因素预计将阻碍全球自动注射器市场的发展。虽然这些设备为需要自行给药的人提供了舒适性和易用性，但有时它们的价格却高得令人望而却步。这种财务障碍可能会阻碍获得服务，特别是在医疗保健预算紧张的低收入和中等收入国家。患者和医疗保健专业人员可能很难证明成本合理，特别是因为替代药物传输技术（例如传统注射器或鼻喷剂）更便宜。例如，根据《过敏与临床免疫学杂誌》的报导，自动注射器的平均零售价格已从 2010 年之前的 < 100 美元上涨到某些设备的 > 600 美元。肾上腺素自动注射器的平均每年自付费用为 115.80 美元。这些高成本阻碍了市场转移客户去探索替代选择。

Auto-injectors are specialized medical devices used to self-administer premeasured dosages of medication, typically in emergency situations or for chronic diseases. These devices often have a spring-loaded syringe that allows users to inject medication without the need for manual plunger depression, making them user-friendly and accessible even to those with no prior medical experience. The design of auto-injectors allows for faster drug delivery, which is critical in situations like anaphylaxis, where quick treatment is required to prevent severe allergic reactions.

The increasing regulatory approvals and launches for autoinjectors are the driving factors that drive the market over the forecast period. For instance, in March 2023, Coherus Biosciences announced that the FDA approved a single-dose, prefilled autoinjector version of its pegfilgrastim biosimilar for the treatment and prevention of febrile neutropenia, a common complication related to chemotherapy treatment. The autoinjector device will allow patients to be administered pegfilgrastim the day after receiving chemotherapy, decreasing the risk of patients developing febrile neutropenia. The Udenyca autoinjector is triggered by push-on-skin activation, allowing for reliable and immediate delivery of a total pegfilgrastim dose.

Market Dynamics: Drivers & Restraints

Increasing regulatory approvals and launches for autoinjectors

The increasing regulatory approvals and launches for autoinjectors are expected to be a significant factor in the growth of the global auto-injector market. As the global demand for self-administration devices expands, regulatory bodies like the FDA and EMA are modifying their frameworks to allow for quick approvals of novel auto-injector technology. This trend is critical because it not only improves patient access to important pharmaceuticals but also instills optimism regarding the safety and usefulness of these devices among healthcare providers and patients alike.

In recent times, there have been many regulatory approvals and new launches of auto-injectors by various manufacturing companies. For instance, in June 2023, Halozyme Therapeutics, Inc., announced that argenx received U.S. Food and Drug Administration (FDA) approval for VYVGART Hytrulo injection with ENHANZE for subcutaneous use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Moreover, in May 2023, The U.S. Food and Drug Administration (FDA) approved the Cyltezo Pen, a new autoinjector alternative for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira (adalimumab). Cyltezo was initially approved as a pre-filled syringe and is utilized for treating a variety of chronic inflammatory conditions. Thus increase in the number of approvals is expanding the market.

High cost of auto-injectors

Factors such as the high cost of auto-injectors are expected to hamper the global auto-injector market. While these devices provide comfort and ease of use for people who require self-administration of medications, they are sometimes prohibitively expensive. This financial barrier can impede access, especially in low- and middle-income countries where healthcare budgets are tight. Patients and healthcare professionals may struggle to justify the cost, especially since alternate drug delivery techniques, such as traditional syringes or nasal sprays, are more affordable. For instance, according to the Journal of Allergy and Clinical Immunology, The average retail price for autoinjectors has increased from < $100 prior to 2010, to > $600 for some devices. Mean annual out-of-pocket costs for epinephrine autoinjectors were $115.80. These high costs hamper the market diverting the customers to explore alternative options.

Segment Analysis

The global auto-injector market is segmented based on type, technology, route of administration, therapy, end-user, and region.

Automated autoinjectors segment is expected to dominate the global auto-injector market share

Several compelling factors are driving the automated autoinjector segment to dominate the global autoinjector market. First and foremost, these devices are intended to improve the user experience by making self-administration of drugs easier. Automated autoinjectors reduce the need for manual injection techniques, making them ideal for patients who are nervous or unsure about using standard syringes. This ease of use is especially important for people with chronic diseases that necessitate frequent medicine administration, such as diabetes or rheumatoid arthritis. As a result, demand for automated solutions is likely to increase, contributing to their market domination.

In recent times, there have been new launches that use the latest technology. For instance, in August 2024, the U.S. Food and Drug Administration approved Zurnai, the first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. The agency approved the first nasal spray formulation of nalmefene in May 2023. Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure (hypotension). The newly approved product delivers 1.5 milligrams (mg) of nalmefene under the skin (subcutaneous) or into muscle (intramuscular). Zurnai is a single-dose, pre-filled auto-injector and is available only by prescription.

The ease of use and recent launches using the latest technology increases the demand of automated autoinjectors and makes this segment the most dominating one.

Geographical Analysis

North America is expected to hold a significant position in the global auto-injector market share

This dominance of auto-injector market in the North American region can be due to a number of causes, including a highly established healthcare infrastructure, recent approvals and launches, rising chronic disease prevalence, and extensive acceptance of self-administration techniques by patients. The increasing prevalence of chronic diseases such as diabetes is one the major driving factor for the market in this region. For instance, according to the Centers for Disease Control and Prevention, in 2024 more than 38 million Americans have diabetes (about 1 in 10), and about 90% to 95% of them have type 2 diabetes. Type 2 diabetes most often develops in people 45 or older, but more and more children, teens, and young adults are also developing it.

There are recent launches of auto-injectors in the region that are manufactured using latest technology. For instance, in October 2024, Instron has announced the release of the next-generation Autoinjector Testing System for comprehensive functionality testing of pens and autoinjectors to ISO 11608. This system, developed in close collaboration with pharmaceutical firms and CDMOs, measures a wide range of critical performance requirements, including cap removal, dose accuracy, activation force, injection duration, needle depth, and needle guard lockout.

Moreover, in May 2023, Coherus BioSciences, Inc. has 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 that is given the day following chemotherapy to reduce the risk of infection, as indicated by febrile neutropenia. So, the increasing prevalence of chronic diseases and recent launches and approvals drives the market in this region.

Asia Pacific is growing at the fastest pace in the global auto-injector market

The Asia Pacific region is experiencing rapid growth in the global auto-injector market. Several significant factors contribute to this expansion, including increasing prevalence of chronic diseases, increasing demand for self-administration and technological advancements. For instance, according to the National Institute of Health, the expected number of cancer cases in India for 2022 is 14,61,427 (crude rate: 100.4 per 100,000). In India, one out of every nine people is likely to develop cancer over his or her lifetime. Males and females were most likely to develop lung and breast cancer, respectively.

Competitive Landscape

The major global players in the global auto-injector market include Eli Lilly and Company, SHL Medical AG, Amgen Inc., Owen Mumford Ltd., Ypsomed AG, Teva Pharmaceutical Industries Ltd., Biogen, Mylan Inc., Pfizer Inc., and Sanofi among others.

Emerging Players

Midas Pharma, Jiangsu Delfu Medical Device, and Oval Medical Technologies among others

Key Developments

In September 2023, Burgdorf - Ypsomed has concluded a long-term supply agreement with Novo Nordisk for large quantities of autoinjectors. The autoinjectors will be used to administer drugs for the self-treatment in various metabolic indications. Ypsomed is in the process of substantially increasing its annual manufacturing capacity in several steps until 2031.
In February 2023, Phillips-Medisize, a Molex firm that designs and manufactures drug delivery, diagnostic, and MedTech devices, has expanded its product portfolio by introducing a disposable pen injector. Phillips-Medisize, which is ideal for high-volume manufacturing, provides pharmaceutical companies with a well-known, highly competitive pen injector to help them enter the market faster, more efficiently, more affordably.

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 auto-injector 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 Type
3.2. Snippet by Technology
3.3. Snippet by Route of Administration
3.4. Snippet by Therapy
3.5. Snippet by End-User
3.6. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
- 4.1.2. Increasing Regulatory Approvals and Launches for Autoinjectors
- 4.1.3. Restraints
- 4.1.4. High Cost of Auto-Injectors
- 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 Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 6.1.2. Market Attractiveness Index, By Type
6.2. Disposable Autoinjectors*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Reusable Autoinjectors

7. By Technology

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 7.1.2. Market Attractiveness Index, By Technology
7.2. Manual Autoinjectors*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Automated Autoinjectors

8. By Route of Administration

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 8.1.2. Market Attractiveness Index, By Route of Administration
8.2. Intramuscular*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Intravenous and Subcutaneous

9. By Therapy

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
- 9.1.2. Market Attractiveness Index, By Therapy
9.2. Rheumatoid Arthritis*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Multiple Sclerosis
9.4. Diabetes
9.5. Anaphylaxis
9.6. Others

10. By End-User

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.1.2. Market Attractiveness Index, By End-User
10.2. Hospitals*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Home Care Setting
10.4. Ambulatory Surgical Centers

11. By Region

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 11.1.2. Market Attractiveness Index, By Region
11.2. North America
- 11.2.1. Introduction
- 11.2.2. Key Region-Specific Dynamics
- 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Type
- 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
- 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 11.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 11.2.9. The U.S.
- 11.2.10. Canada
- 11.2.11. Mexico
11.3. Europe
- 11.3.1. Introduction
- 11.3.2. Key Region-Specific Dynamics
- 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Type
- 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
- 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 11.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 11.3.9. Germany
- 11.3.10. UK
- 11.3.11. France
- 11.3.12. Italy
- 11.3.13. Spain
- 11.3.14. Rest of Europe
11.4. South America
- 11.4.1. Introduction
- 11.4.2. Key Region-Specific Dynamics
- 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Type
- 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
- 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 11.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 11.4.9. Brazil
- 11.4.10. Argentina
- 11.4.11. Rest of South America
11.5. Asia-Pacific
- 11.5.1. Introduction
- 11.5.2. Key Region-Specific Dynamics
- 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Type
- 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
- 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
- 11.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 11.5.9. China
- 11.5.10. India
- 11.5.11. Japan
- 11.5.12. South Korea
- 11.5.13. Rest of Asia-Pacific
11.6. Middle East and Africa
- 11.6.1. Introduction
- 11.6.2. Key Region-Specific Dynamics
- 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), Type
- 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
- 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
- 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
- 11.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

12. Competitive Landscape

12.1. Competitive Scenario
12.2. Market Positioning/Share Analysis
12.3. Mergers and Acquisitions Analysis

13. Company Profiles

13.1. Eli Lilly and Company*
- 13.1.1. Company Overview
- 13.1.2. Product Portfolio and Description
- 13.1.3. Financial Overview
- 13.1.4. Key Developments
13.2. SHL Medical AG
13.3. Amgen Inc.
13.4. Owen Mumford Ltd.
13.5. Ypsomed AG
13.6. Teva Pharmaceutical Industries Ltd.
13.7. Biogen
13.8. Mylan Inc.
13.9. Pfizer Inc.
13.10. Sanofi

LIST NOT EXHAUSTIVE