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全球肾上腺素自动注射器市场-增长、趋势、COVID-19 影响和预测 (2023-2028)

Epinephrine Autoinjector Market - Growth, Trends, and Forecasts (2023- 2028)

出版日期: | 出版商: Mordor Intelligence | 英文 110 Pages | 商品交期: 2-3个工作天内

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简介目录

在预测期内,全球肾上腺素自动注射器市场的复合年增长率预计为 8.5%。

COVID-19 大流行对所有疾病患者都产生了深远的影响,在 COVID-19 大流行期间过敏性疾病的流行呈现出异质性模式,肾上腺素自动注射器已被证明可以增加患者帮助对抗 由于在 COVID-19 疫苗接种后报告的严重过敏反应,在 COVID 期间肾上腺素自动注射器的采用增加,预计将有助于流行期间的市场增长。 例如,FDA 2020 年 10 月的更新和疾病控制与预防中心 (CDC) 题为“预防 COVID-19 疫苗的紧急使用授权”的指南指出,在接种 COVID-19 疫苗后会发生急性过敏反应。如果发生这种情况时,管理设施应始终备有至少三剂适合年龄的肾上腺素,并且应能够在肾上腺素用完后迅速获得和补充。

多种产品版本的可用性、针对患者需求量身定制的创新给药技术、自我给药意识的增强、采用比传统注射方法更昂贵的自动注射器、医疗基础设施的加强等因素是主要因素推动所研究市场的增长。 此外,发达国家有利的报销政策有望推动市场增长。

世界卫生组织报告称,由于注射次数的增加推动了自动注射器市场的发展,到 2021 年全球每年将进行超过 160 亿次注射。 因此,全球肾上腺素自动注射器市场有望在未来发展,由于药物注射器使用和处置的便利性和自动注射器的接受度,定位于加速研究行业的市场扩张在整个预测期内,增加。

此外,市场主要参与者的新产品发布、合併/收购、近期发展、合资企业、合作和伙伴关係等战略活动对研究市场的增长产生了积极影响。 例如,Catalent 计划在 2022 年 11 月为比利时 Adamis Pharmaceuticals Co. 生产新一批 SYMJEPI,并在 2023 年第一季度末之前重新推出和商业化 SYMJEPI。我预计。

因此,由于上述因素,所研究的市场预计在分析期内会出现增长。 然而,肾上腺素自动注射器的监管限制和成本上升可能会阻碍市场增长。

主要市场趋势

预计0.3mg剂量在预测期内占很大份额

一些社会和心理变量导致青少年和成人出现过敏反应的频率很高。 如果患者年满 12 岁,卫生专业人员建议使用安全剂量(通常为 0.3 毫克)的肾上腺素自动注射器。 RCUK 2008/2021 在英国有效,EAACI 2014/2021 适用于欧洲地区,世界过敏组织过敏反应指南 2020 适用于全球约 100 个国家,以及许多其他指南允许在紧急情况下安全实用地进行准备和注射。在什么被认为是,剂量根据年龄组减少。 此外,该指南指出,对于 6 至 12 岁的儿童,肌肉注射 0.3 毫克肾上腺素是首选,以确保安全性和有效性。

多项研究表明,许多食物过敏病例(包括过敏反应)发生在学校和托儿所。 美国国家过敏和传染病研究所的指南建议将肾上腺素作为一线药物。 此外,越来越多的成人患者接受更高剂量的建议也推动了这一细分市场的扩张。 此外,经营者正着力降低仿製药价格。 例如,在 2022 年 11 月,Anfastar Pharmaceuticals 预计肾上腺素销售额在截至 2022 年 9 月 30 日的三个月内将增加 330 万美元,原因是平均售价较高,其余增长来自竞争对手。他表示,这是由于由于其他公司的产品短缺而导致数量增加。

因此,人们越来越需要开发新的治疗药物来抑製过敏反应。 例如,2022 年 10 月,ARS Pharmaceuticals, Inc. 提交了 ARS“neffy”的新药申请(NDA),这是第一个用于紧急治疗过敏反应(I 型)的非注射製剂,包括过敏反应,成人和儿童。) 已被 FDA 接受审查。 此外,主要市场参与者持续推出的产品对该细分市场的增长产生了积极影响。 例如,2022 年 1 月,总部位于马萨诸塞州的 Windgap Medical 报告了 3900 万美元的资金,表明了基于其 Andipen 自动注射器技术开发产品的计划。

肾上腺素自动注射器市场预计将由北美主导

预计在预测期内,北美将占全球一次性自动注射器市场的很大份额。 过敏反应发生率的上升和过敏治疗的改善,包括食品、食品添加剂、乳胶和粉尘过敏,以及产品可用性和仿製药替代品的推出等因素,都是推动该地区市场增长的一个因素

据美国国家医学图书馆称,2021 年发表在 PubMed 上的一篇论文估计,每年有 1.6% 到 5.1% 的美国公民经历或患有过敏反应。 此外,2022 年 3 月,美国哮喘与过敏基金会宣布,约 7.7% 的成年人和约 7.2% 的儿童被诊断患有季节性过敏性鼻炎。 对肾上腺素自动注射器快速应急反应的需求不断增长是推动市场扩张的主要因素。

主要产品发布、市场参与者高度集中以及製造商在美国的存在是推动该国肾上腺素自动注射器市场增长的一些因素。 例如,2021 年 6 月,总部位于底特律的食品过敏管理公司 Alerje Inc. 开发了一款带有自动注射器的智能手机外壳,可以快速输送肾上腺素以应对严重的过敏反应。 当从病例中取出药物时,Alerje 的智能手机应用程序会立即改变患者的支持网络。 2022 年 8 月,赛诺菲再次宣布 FDA 批准 Auvi-Q,这是首款用于威胁生命的过敏症患者的语音引导肾上腺素自动注射器。 获得 Intelliject Inc .在北美将 Auvi-Q 商业化的许可,并保留在其他地方的商业化权利。

竞争格局

肾上腺素自动注射器市场本质上是整合,一些老牌供应商持有多数股份并在全球开展业务。 竞争对手包括 Adamis Pharmaceuticals Corporation、Alk-Abello A/S、Amneal Pharmaceuticals、Mylan NV、Antares Pharma、Pfizer Inc、Teva Pharmaceutical Industries Ltd、Bausch & Lomb Incorporated、Sanofi SA 和 Novartis International AG。包括对几个高国际和本地公司。

其他好处

  • Excel 格式的市场预测 (ME) 表
  • 3 个月的分析师支持

内容

第1章介绍

  • 研究假设和市场定义
  • 调查范围

第2章研究方法论

第 3 章执行摘要

第4章市场动态

  • 市场概览
  • 市场驱动力
    • 出现了具有成本效益且功能强大的肾上腺素自动注射器仿製药
    • 越来越意识到自我注射是治疗的首选
    • 过敏反应和食物过敏的发生率增加
  • 市场製约因素
    • 自动注射器的高成本和注射替代品的数量
  • 行业吸引力 - 波特五力分析
    • 新进入者的威胁
    • 买方/消费者议价能力
    • 供应商的议价能力
    • 替代品的威胁
    • 竞争公司之间的敌对关係

第 5 章市场细分(基于价值的市场规模 - 百万美元)

  • 按剂量
    • 0.15 毫克
    • 0.30 毫克
    • 0.5毫克
  • 按年龄段
    • 0-6岁
    • 6 至 12 岁
    • 12 岁以上
  • 最终用户
    • 医院
    • 诊所
    • 在家
  • 按地区
    • 北美
      • 美国
      • 加拿大
      • 墨西哥
    • 欧洲
      • 德国
      • 英国
      • 法国
      • 意大利
      • 西班牙
      • 其他欧洲地区
    • 亚太地区
      • 中国
      • 日本
      • 印度
      • 澳大利亚
      • 韩国
      • 其他亚太地区
    • 中东和非洲
      • 海湾合作委员会
      • 南非
      • 其他中东地区
    • 南美洲地区
      • 巴西
      • 阿根廷
      • 其他南美洲

第6章竞争格局

  • 公司简介
    • Adamis Pharmaceuticals Corporation
    • Alk-Abello A/S
    • Amneal Pharmaceuticals
    • Antares Pharma
    • Bausch & Lomb Inc.
    • Kaleo Inc.
    • Mylan NV
    • Pfizer Inc
    • Sandoz
    • Sanofi SA
    • Teva Pharmaceutical Industries Ltd

第7章 市场机会与今后动向

简介目录
Product Code: 93218

The epinephrine autoinjector market is expected to register a CAGR of 8.5% over the forecast period.

The COVID-19 pandemic had a substantial impact on patients with any disease, the prevalence of allergic diseases showed heterogeneous patterns during the COVID-19 pandemic, and epinephrine autoinjectors helped the patients to combat its effect. The rising adoption of epinephrine autoinjectors during the COVID due to severe allergic reactions reported after the administration of COVID-19 vaccines is expected to contribute to the growth of the market during the pandemic period. For instance, the FDA's October 2020 update and the Centers for Disease Control and Prevention (CDC) guidance entitled 'Emergency Use Authorization for Vaccines to Prevent COVID-19's state that if an acute anaphylactic reaction occurs after the administration of a COVID-19 vaccine, the administering facility should always have at least 3 doses of age-appropriate epinephrine available, as well as the ability to quickly obtain additional doses to replenish supplies after epinephrine runs out.

The rise in availability of several versions of products, innovative drug administration techniques that match the demands of patients, increasing awareness about self-administration, and adoption of more expensive auto-injectors over traditional injecting methods, as well as enhanced healthcare infrastructure, are among the major factors driving the growth of the studied market. Furthermore, favorable reimbursement policies in developed countries are anticipated to fuel the growth in the market.

According to World Health Organization reports, over 16 billion injections were administered annually worldwide in 2021, stimulated by the increasing number of injections administered boosting the autoinjector market. As a result, the global epinephrine autoinjector market is anticipated to develop in the future due to the convenience of use and disposal of drug injectors and the acceptance of autoinjectors, which are positioned to accelerate market expansion for the researched industry throughout the projected period.

In addition, new product launches and strategic activities, such as mergers/acquisitions, recent developments, joint ventures, collaborations, and partnerships by major players in the market are positively affecting the growth of the studied market. For instance, Catalent scheduled to manufacture a new batch of SYMJEPI in November 2022, for Adamis Pharmaceuticals Co. in Belgium, anticipating the relaunch of SYMJEPI and commercial availability before the end of the first quarter of 2023.

Therefore, owing to the aforementioned factors the studied market is anticipated to witness growth over the analysis period. However, regulatory constraints and the inflated cost of epinephrine autoinjectors are likely to impede the market growth.

Key Market Trends

0.3 mg Dosage is Expected to Hold a Significant Share Over the Forecast Period

Several social and psychological variables contribute to the high frequency of anaphylaxis in teen and adult populations. Healthcare professionals recommend that patients utilize epinephrine auto-injectors at a safe dose if they are 12 years of age or older (often 0.3 mg). Numerous guidelines, including RCUnited Kingdom 2008/2021 valid in United Kingdom, EAACI 2014/2021 applicable in the European region, and World Allergy Organization Anaphylaxis Guidance 2020 applicable in nearly 100 countries around the globe reduced the dosing regimen to age groups based on what is regarded to be safe and practical to prepare and inject in an emergency. Further, these guidelines stated to provide 0.3 mg of epinephrine intramuscularly to children aged 6 to 12 in order as an advisable dosage to ensure their safety and efficacy.

According to several studies, most cases of food allergies, including anaphylaxis, happen at schools or daycare facilities. Epinephrine is suggested as a first-line therapy option in the guidelines of the National Institute of Allergy and Infectious Diseases. The rising recommendation of high doses for adult patients is promoting the segment's expansion. Players in the business are also concentrating on offering generic goods at low prices. For instance, in November 2022, Amphastar Pharmaceuticals indicated that their Epinephrine sales increased by USD 3.3 million for the three months ended September 30, 2022, due to an increase in average selling price, with the remainder of the increase due to increased unit volumes as a result of competitor shortages.

As a result, there is a growing demand for the development of new therapeutics to control anaphylactic reactions. For instance, in October 2022, ARS Pharmaceuticals, Inc. announced that FDA has accepted for review ARS' New Drug Application (NDA) for 'neffy', which is the first non-injectable treatment for the emergency treatment of allergic reactions (type I) including anaphylaxis in adults and children. Furthermore, continuous product launches by major players in the market are positively affecting the growth of the segment. For instance, in January 2022, Massachusetts-based Windgap Medical reported raising USD 39 million and indicated its plans in developing products based on its Andipen autoinjector technology.

North America is Expected to Dominate the Epinephrine Autoinjector Market

North America is expected to hold a significant share of the global disposable auto-injectors market during the forecast period. Factors, such as the easy availability of products and the launch of generic substitutes as well as the rising incidence of anaphylaxis, such as allergies caused by food items, food additives, latex, and dust, coupled with better access to treatment for anaphylaxis boost the market in the region.

According to the National Library of Medicine, an article published in 2021 in PubMed, between 1.6% and 5.1% of US citizens annually is estimated to have experienced anaphylaxis or suffer from this condition. Also, in March 2022, the Asthma and Allergy Foundation of America, about 7.7% of adults and 7.2% of children have been diagnosed with seasonal allergic rhinitis. The growing need for epinephrine auto-injectors for quick emergency response is a major factor propelling market expansion.

Key product launches, the high concentration of market players, and the manufacturer's presence in United States are some of the factors driving the growth of the epinephrine autoinjector market in the country. For instance, in June 2021, Alerje Inc., a Detroit-based food allergy management firm developed a smartphone case with an auto-injector that quickly delivers epinephrine for severe allergic reactions. The Alerje smartphone app will immediately alter the patients' support network if a dosage is taken out of the case. Again, in August 2022 Sanofi, announced FDA approval for Auvi-Q, its first voice-guided epinephrine auto-injector for patients with life-threatening allergies., granting the company a license to commercialize Auvi-Q from Intelliject Inc. in North America while retaining commercialization rights for the rest of the world.

Competitive Landscape

The epinephrine autoinjector market is consolidated in nature with the presence of a few established vendors holding the majority of the shares and operating globally. The competitive landscape includes an analysis of a few international as well as local companies which hold market shares and are well known, including Adamis Pharmaceuticals Corporation, Alk-Abello A/S, Amneal Pharmaceuticals, Mylan NV, Antares Pharma, Pfizer Inc., Teva Pharmaceutical Industries Ltd., Bausch & Lomb Incorporated, Sanofi SA, Novartis International AG, among others.

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

  • 1.1 Study Assumptions and Market Definition
  • 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Advent of Cost-Effective and Robust Generic Epinephrine Autoinjectors
    • 4.2.2 Increasing Awareness about Self-Injection with First-Line of Treatment
    • 4.2.3 Rise in Incidences of Anaphylaxis and Food Allergies
  • 4.3 Market Restraints
    • 4.3.1 High Cost of Autoinjectors and Multiple Alternatives for Injections
  • 4.4 Industry Attractiveness - Porter's Five Force Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers/Consumers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD Million)

  • 5.1 By Dosage Type
    • 5.1.1 0.15 mg
    • 5.1.2 0.30 mg
    • 5.1.3 0.5 mg
  • 5.2 By Age-group
    • 5.2.1 0 to 6 Years
    • 5.2.2 6 to 12 Years
    • 5.2.3 Over 12 Years
  • 5.3 By End-User
    • 5.3.1 Hospitals
    • 5.3.2 Clinics
    • 5.3.3 Home-based
  • 5.4 By Geography
    • 5.4.1 North America
      • 5.4.1.1 United States
      • 5.4.1.2 Canada
      • 5.4.1.3 Mexico
    • 5.4.2 Europe
      • 5.4.2.1 Germany
      • 5.4.2.2 United Kingdom
      • 5.4.2.3 France
      • 5.4.2.4 Italy
      • 5.4.2.5 Spain
      • 5.4.2.6 Rest of Europe
    • 5.4.3 Asia-Pacific
      • 5.4.3.1 China
      • 5.4.3.2 Japan
      • 5.4.3.3 India
      • 5.4.3.4 Australia
      • 5.4.3.5 South Korea
      • 5.4.3.6 Rest of Asia-Pacific
    • 5.4.4 Middle East & Africa
      • 5.4.4.1 GCC
      • 5.4.4.2 South Africa
      • 5.4.4.3 Rest of Middle East & Africa
    • 5.4.5 South America
      • 5.4.5.1 Brazil
      • 5.4.5.2 Argentina
      • 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

  • 6.1 Company Profiles
    • 6.1.1 Adamis Pharmaceuticals Corporation
    • 6.1.2 Alk-Abello A/S
    • 6.1.3 Amneal Pharmaceuticals
    • 6.1.4 Antares Pharma
    • 6.1.5 Bausch & Lomb Inc.
    • 6.1.6 Kaleo Inc.
    • 6.1.7 Mylan NV
    • 6.1.8 Pfizer Inc
    • 6.1.9 Sandoz
    • 6.1.10 Sanofi SA
    • 6.1.11 Teva Pharmaceutical Industries Ltd

7 MARKET OPPORTUNITIES AND FUTURE TRENDS