自動注射器の世界市場 - 2025年～2033年

自動注射器の世界市場は2024年に103億7,000万米ドルに達し、2033年には398億4,000万米ドルに達すると予測され、予測期間2025年のCAGRは17.2%で成長します。

自動注射器は、一般的に緊急時や慢性疾患において、あらかじめ計量された量の薬剤を自己投与するために使用される特殊な医療機器です。これらの医療機器には多くの場合、手動でプランジャーを押すことなく薬剤を注入できるバネ式シリンジが搭載されており、医療経験のない人でも使いやすく、利用しやすいものとなっています。自動注射器の治療デザインは、ドラッグデリバリーの迅速化を可能にし、これは、重篤なアレルギー反応を防ぐために迅速な治療が必要とされるアナフィラキシーのような状況において極めて重要です。

自動注射器に対する規制当局の承認や発売の増加は、予測期間にわたって市場を牽引する要因です。例えば、2023年3月、コーヘラス・バイオサイエンシズ社は、化学療法に関連する一般的な合併症である発熱性好中球減少症の治療と予防のために、ペグフィルグラスチムバイオシミラー製剤の単回投与プレフィルドオートインジェクターバージョンをFDAが承認したと発表しました。この自動注射器は、化学療法を受けた翌日にペグフィルグラスチムを投与することを可能にし、患者が発熱性好中球減少症を発症するリスクを低減します。Udenyca autoinjectorは、プッシュオンスキン作動により作動し、ペグフィルグラスチムの全用量を確実かつ即時に投与することができます。

市場力学：

促進要因と抑制要因

自動注射器の承認と上市の増加

自動注射器に対する規制当局の承認や発売の増加は、世界の自動注射器市場の成長における重要な要因になると予想されます。自己注射器に対する世界の需要が拡大するにつれて、FDAやEMAのような規制機関は、新規の自己注射器技術を迅速に承認できるように枠組みを変更しつつあります。この動向は、患者の重要な医薬品へのアクセスを向上させるだけでなく、医療従事者や患者にこれらのデバイスの安全性や有用性に関する楽観的な見方を植え付けるため、非常に重要です。

最近、様々な製造会社による自動注射器の承認や新発売が相次いでいます。例えば、2023年6月、Halozyme Therapeutics, Inc.は、argenx社が抗アセチルコリン受容体（AChR）抗体陽性の成人患者における全身型重症筋無力症（gMG）治療用の皮下用ENHANZE配合VYVGART Hytrulo注射剤の米国食品医薬品局（FDA）の承認を取得したと発表しました。

さらに、2023年5月、米国食品医薬品局（FDA）は、ヒュミラ（一般名：アダリムマブ）の代替バイオシミラーとしてFDAに承認されたサイルテゾ（一般名：アダリムマブ-adbm）の新しい自動注射器代替品であるサイルテゾ・ペンを承認しました。シルテゾは当初、プレフィルドシリンジとして承認され、様々な慢性炎症疾患の治療に使用されています。このように承認数の増加が市場を拡大しています。

自動注射器の高コスト

自動注射器の高コストなどの要因が、世界の自動注射器市場の妨げになると予想されます。これらのデバイスは、薬の自己投与を必要とする人々に快適さと使いやすさを提供する一方で、時には法外に高価です。この経済的障壁は、特にヘルスケア予算が厳しい中低所得国でのアクセスを妨げる可能性があります。特に、従来の注射器や点鼻薬のようなドラッグデリバリー技術の方がより手頃な価格であるため、患者や医療従事者は、そのコストを正当化するのに苦労するかもしれないです。例えば、Journal of Allergy and Clinical Immunology誌によると、自己注射器の平均小売価格は、2010年以前は100ドル未満でしたが、一部の機器では600ドルを超えるようになりました。エピネフリン自己注射器の年間平均自己負担額は115.80ドルでした。このような高コストが市場を阻害し、顧客は別の選択肢を探すようになった。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
  • 自動注射器の規制承認と発売の増加
  • 抑制要因
  • 自動注射器のコストが高い
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• 償還分析
• 特許分析
• SWOT分析
• DMIの見解

第6章 タイプ別

• 使い捨て自動注射器
• 再利用可能なオートインジェクター

第7章 技術別

• 手動オートインジェクター
• 自動オートインジェクター

第8章 投与経路別

• 筋肉内
• 静脈内および皮下

第9章 セラピー別

• 関節リウマチ
• 多発性硬化症
• 糖尿病
• アナフィラキシー
• その他

第10章 エンドユーザー別

• 病院
• 在宅ケア環境
• 外来手術センター

第11章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州地域
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第12章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第13章 企業プロファイル

• Eli Lilly and Company
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• SHL Medical AG
• Amgen Inc.
• Owen Mumford Ltd.
• Ypsomed AG
• Teva Pharmaceutical Industries Ltd.
• Biogen
• Mylan Inc.
• Pfizer Inc.
• Sanofi

第14章 付録

The global auto-injectors market reached US$ 10.37 billion in 2024 and is expected to reach US$ 39.84 billion by 2033, growing at a CAGR of 17.2% during the forecast period 2025-2033.

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.

Table of Contents

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

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us