자동 주사기 세계 시장은 2024년에 103억 7,000만 달러에 달한 것으로 추정됩니다. 2033년에는 398억 4,000만 달러에 달할 것으로 예상되며, 2025년까지 연평균 17.2%의 연평균 복합 성장률(CAGR)을 나타낼 전망입니다.
자동 주사기는 일반적으로 응급 상황이나 만성 질환에서 미리 계량된 양의 약물을 자가 투여하는 데 사용되는 특수 의료기기입니다. 이러한 의료기기에는 종종 수동으로 플런저를 누르지 않고도 약물을 주입할 수 있는 스프링식 주사기가 장착되어 있어 의료 경험이 없는 사람들도 쉽게 사용할 수 있습니다. 자동 주사기의 치료 설계는 약물 전달을 빠르게 할 수 있으며, 이는 심각한 알레르기 반응을 예방하기 위해 신속한 치료가 필요한 아나필락시스와 같은 상황에서 매우 중요합니다.
자동 주사기에 대한 규제 당국의 승인 및 출시 증가는 예측 기간 동안 시장을 견인하는 요인으로 작용할 것입니다. 예를 들어, 2023년 3월, 코헬라스 바이오사이언시스(Coherus Biosciences)는 화학요법과 관련된 일반적인 합병증인 발열성 호중구감소증 치료 및 예방을 위해 페그필그라스팀 바이오시밀러의 1회용 프리필드시린지 자동주사기 버전이 FDA 승인을 받았다고 발표했습니다. 승인했습니다. 이 자동주사기는 화학요법 다음 날 페그필그라스팀을 투여할 수 있어 환자가 발열성 호중구감소증에 걸릴 위험을 줄일 수 있으며, 푸쉬온 스킨 작동 방식으로 작동해 페그필그라스팀의 전 용량을 확실하고 즉각적으로 투여할 수 있습니다. 투여할 수 있습니다.
성장 촉진요인과 억제요인
자동주사기 승인 및 출시 증가
자율주사기에 대한 규제 당국의 승인 및 출시 증가는 세계 자동주사기 시장 성장에 중요한 요인이 될 것으로 예상됩니다. 전 세계적으로 자동주사기에 대한 수요가 증가함에 따라 FDA 및 EMA와 같은 규제 기관은 새로운 자동주사기 기술을 신속하게 승인할 수 있도록 규제 프레임워크를 변경하고 있습니다. 이러한 추세는 환자의 중요한 의약품에 대한 접근성을 향상시킬 뿐만 아니라 의료진과 환자들에게 이러한 장치의 안전성과 유용성에 대한 낙관적인 시각을 심어주기 때문에 매우 중요합니다.
최근 다양한 제조업체의 자동주사기 승인 및 신규 출시가 잇따르고 있습니다. 예를 들어, 2023년 6월 Halozyme Therapeutics, Inc.는 argenx사가 항아세틸콜린 수용체(ACHR) 항체 양성 성인 환자의 전신성 중증 근무력증(gMG) 치료를 위한 피하용 ENHANZE 성분의 VYVGART Hytrulo 주사제에 대해 미국 식품의약국(FDA)의 승인을 받았다고 발표했습니다. 의약품국(FDA)의 승인을 획득했다고 발표했습니다.
또한, 2023년 5월 미국 식품의약국(FDA)은 휴미라(성분명: 아달리무맙)의 대체 바이오시밀러로 FDA 승인을 받은 실테조(성분명: 아달리무맙-adbm)의 새로운 자동주사기 대체품인 실테조 펜(Siltezo Pen)을 승인했습니다. 실테조는 초기에는 프리필드시린지로 승인되어 다양한 만성 염증성 질환의 치료에 사용되어 왔습니다. 이러한 승인 건수 증가로 시장이 확대되고 있습니다.
자동주사기의 높은 비용
자동 주사기의 높은 비용과 같은 요인이 세계 자동 주사기 시장을 저해할 것으로 예상됩니다. 이러한 장치는 약물 자가 투여가 필요한 사람들에게 편안함과 사용 편의성을 제공하지만, 때로는 엄청나게 비쌉니다. 이러한 경제적 장벽은 특히 의료 예산이 부족한 중저소득 국가에서 접근성을 저해할 수 있습니다. 특히, 기존의 주사기나 비강 점적과 같은 약물 전달 기술이 더 저렴하기 때문에 환자와 의료진은 그 비용을 정당화하기 어려울 수 있습니다. 예를 들어, Journal of Allergy and Clinical Immunology 저널에 따르면, 2010년 이전에는 100달러 미만이었던 자동 주사기의 평균 소매가격이 일부 기기의 경우 600달러를 넘어섰다고 합니다. 에피네프린 자동 주사기의 연간 평균 본인 부담금은 115.80달러였습니다. 이러한 높은 비용으로 인해 시장은 위축되었고, 고객들은 다른 대안을 찾게 되었습니다.
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.
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.
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.
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
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
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