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市場調查報告書
商品編碼
1190770
全球腎上腺素自動注射器市場-增長、趨勢、COVID-19 影響和預測 (2023-2028)Epinephrine Autoinjector Market - Growth, Trends, and Forecasts (2023- 2028) |
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在預測期內，全球腎上腺素自動注射器市場的複合年增長率預計為 8.5%。
COVID-19 大流行對所有疾病患者都產生了深遠的影響，在 COVID-19 大流行期間過敏性疾病的流行呈現出異質性模式，腎上腺素自動注射器已被證明可以增加患者幫助對抗 由於在 COVID-19 疫苗接種後報告的嚴重過敏反應，在 COVID 期間腎上腺素自動注射器的採用增加，預計將有助於流行期間的市場增長。 例如，FDA 2020 年 10 月的更新和疾病控制與預防中心 (CDC) 題為“預防 COVID-19 疫苗的緊急使用授權”的指南指出，在接種 COVID-19 疫苗後會發生急性過敏反應。如果發生這種情況時，管理設施應始終備有至少三劑適合年齡的腎上腺素，並且應能夠在腎上腺素用完後迅速獲得和補充。
多種產品版本的可用性、針對患者需求量身定制的創新給藥技術、自我給藥意識的增強、採用比傳統注射方法更昂貴的自動注射器、醫療基礎設施的加強等因素是主要因素推動所研究市場的增長。 此外，發達國家有利的報銷政策有望推動市場增長。
世界衛生組織報告稱，由於注射次數的增加推動了自動注射器市場的發展，到 2021 年全球每年將進行超過 160 億次注射。 因此，全球腎上腺素自動注射器市場有望在未來發展，由於藥物注射器使用和處置的便利性和自動注射器的接受度，定位於加速研究行業的市場擴張在整個預測期內，增加。
此外，市場主要參與者的新產品發布、合併/收購、近期發展、合資企業、合作和夥伴關係等戰略活動對研究市場的增長產生了積極影響。 例如，Catalent 計劃在 2022 年 11 月為比利時 Adamis Pharmaceuticals Co. 生產新一批 SYMJEPI，並在 2023 年第一季度末之前重新推出和商業化 SYMJEPI。我預計。
因此，由於上述因素，所研究的市場預計在分析期內會出現增長。 然而，腎上腺素自動注射器的監管限制和成本上升可能會阻礙市場增長。
主要市場趨勢
預計0.3mg劑量在預測期內佔很大份額
一些社會和心理變量導致青少年和成人出現過敏反應的頻率很高。 如果患者年滿 12 歲，衛生專業人員建議使用安全劑量（通常為 0.3 毫克）的腎上腺素自動注射器。 RCUK 2008/2021 在英國有效，EAACI 2014/2021 適用於歐洲地區，世界過敏組織過敏反應指南 2020 適用於全球約 100 個國家，以及許多其他指南允許在緊急情況下安全實用地進行準備和注射。在什麼被認為是，劑量根據年齡組減少。 此外，該指南指出，對於 6 至 12 歲的兒童，肌肉注射 0.3 毫克腎上腺素是首選，以確保安全性和有效性。
多項研究表明，許多食物過敏病例（包括過敏反應）發生在學校和托兒所。 美國國家過敏和傳染病研究所的指南建議將腎上腺素作為一線藥物。 此外，越來越多的成人患者接受更高劑量的建議也推動了這一細分市場的擴張。 此外，經營者正著力降低仿製藥價格。 例如，在 2022 年 11 月，Anfastar Pharmaceuticals 預計腎上腺素銷售額在截至 2022 年 9 月 30 日的三個月內將增加 330 萬美元，原因是平均售價較高，其餘增長來自競爭對手。他表示，這是由於由於其他公司的產品短缺而導致數量增加。
因此，人們越來越需要開發新的治療藥物來抑製過敏反應。 例如，2022 年 10 月，ARS Pharmaceuticals, Inc. 提交了 ARS“neffy”的新藥申請（NDA），這是第一個用於緊急治療過敏反應（I 型）的非注射製劑，包括過敏反應，成人和兒童。) 已被 FDA 接受審查。 此外，主要市場參與者持續推出的產品對該細分市場的增長產生了積極影響。 例如，2022 年 1 月，總部位於馬薩諸塞州的 Windgap Medical 報告了 3900 萬美元的資金，表明了基於其 Andipen 自動注射器技術開發產品的計劃。
腎上腺素自動注射器市場預計將由北美主導
預計在預測期內，北美將佔全球一次性自動注射器市場的很大份額。 過敏反應發生率的上升和過敏治療的改善，包括食品、食品添加劑、乳膠和粉塵過敏，以及產品可用性和仿製藥替代品的推出等因素，都是推動該地區市場增長的一個因素
據美國國家醫學圖書館稱，2021 年發表在 PubMed 上的一篇論文估計，每年有 1.6% 到 5.1% 的美國公民經歷或患有過敏反應。 此外，2022 年 3 月，美國哮喘與過敏基金會宣布，約 7.7% 的成年人和約 7.2% 的兒童被診斷患有季節性過敏性鼻炎。 對腎上腺素自動注射器快速應急反應的需求不斷增長是推動市場擴張的主要因素。
主要產品發布、市場參與者高度集中以及製造商在美國的存在是推動該國腎上腺素自動注射器市場增長的一些因素。 例如，2021 年 6 月，總部位於底特律的食品過敏管理公司 Alerje Inc. 開發了一款帶有自動注射器的智能手機外殼，可以快速輸送腎上腺素以應對嚴重的過敏反應。 當從病例中取出藥物時，Alerje 的智能手機應用程序會立即改變患者的支持網絡。 2022 年 8 月，賽諾菲再次宣布 FDA 批准 Auvi-Q，這是首款用於威脅生命的過敏症患者的語音引導腎上腺素自動注射器。 獲得 Intelliject Inc .在北美將 Auvi-Q 商業化的許可，並保留在其他地方的商業化權利。
競爭格局
腎上腺素自動注射器市場本質上是整合，一些老牌供應商持有多數股份並在全球開展業務。 競爭對手包括 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。包括對幾個高國際和本地公司。
其他好處
- Excel 格式的市場預測 (ME) 表
- 3 個月的分析師支持
內容
第1章介紹
- 研究假設和市場定義
- 調查範圍
第2章研究方法論
第 3 章執行摘要
第4章市場動態
- 市場概覽
- 市場驅動力
- 出現了具有成本效益且功能強大的腎上腺素自動注射器仿製藥
- 越來越意識到自我注射是治療的首選
- 過敏反應和食物過敏的發生率增加
- 市場製約因素
- 自動注射器的高成本和注射替代品的數量
- 行業吸引力 - 波特五力分析
- 新進入者的威脅
- 買方/消費者議價能力
- 供應商的議價能力
- 替代品的威脅
- 競爭公司之間的敵對關係
第 5 章市場細分（基於價值的市場規模 - 百萬美元）
- 按劑量
- 0.15 毫克
- 0.30 毫克
- 0.5毫克
- 按年齡段
- 0-6歲
- 6 至 12 歲
- 12 歲以上
- 最終用戶
- 醫院
- 診所
- 在家
- 按地區
- 北美
- 美國
- 加拿大
- 墨西哥
- 歐洲
- 德國
- 英國
- 法國
- 意大利
- 西班牙
- 其他歐洲地區
- 亞太地區
- 中國
- 日本
- 印度
- 澳大利亞
- 韓國
- 其他亞太地區
- 中東和非洲
- 海灣合作委員會
- 南非
- 其他中東地區
- 南美洲地區
- 巴西
- 阿根廷
- 其他南美洲
- 北美
第6章競爭格局
- 公司簡介
- 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 市場機會與今後動向
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
- 5.4.1 North 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
