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全球预灌封注射器市场 - 2023-2030 年

Global Prefilled Syringe Market - 2023-2030

出版日期: 2023年07月31日 | 出版商:

DataM Intelligence | 英文 195 Pages | 商品交期: 约2个工作天内

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简介目录

市场概述

全球预灌封注射器市场规模在 2022 年达到 64 亿美元，预计到 2030 年将达到 144 亿美元，2023-2030 年的复合年增长率为 10.9%。

预灌封注射器市场是制药和医疗保健行业中发展迅速的一个领域。这些注射器主要用于治疗各种慢性疾病，包括癌症、关节炎、糖尿病、过敏症和眼科疾病。与普通注射器相比，使用预灌封注射器给药既安全又方便。

预灌封注射器根据设计类型可分为两大类，包括单腔预灌封注射器和双腔预灌封注射器。双腔预充式注射器有两个分隔腔，两个腔内都装有预装药物。与标准预灌封注射器相比，双腔预灌封注射器的给药过程更为复杂。此外，慢性病发病率的上升、美国食品及药物管理局的批准、预灌封注射器临床试验的增加以及预灌封注射器技术的进步也是市场增长的主要驱动力。

市场动态

预灌封注射器的技术进步推动未来市场增长

由于各种技术进步，预灌封注射器市场出现了显著增长。许多主要企业通过推出新产品和服务在这些进步中发挥了重要作用。这些新产品可以提高慢性病患者的工作效率和疗效。

例如，希尔玛制药公司于 2022 年 10 月 24 日推出了预灌封注射器形式的氯化琥珀胆碱注射液。这种 100 毫克/5 毫升的预灌封注射器是经美国 FDA 批准的药物。氯化琥珀胆碱主要用于医院的全身麻醉，促进气管插管，也可用于手术过程中的放松。

预灌封注射器获得 FDA 批准的数量不断增加，有望推动全球市场的发展

预灌封注射器需要通过 FDA 的全面评估，以确保质量、可靠性和性能。来自临床试验、临床前研究和生产过程的数据都要经过仔细审查。一旦获得批准，这些产品就被认定为安全有效，符合所有监管要求，可用于其预期用途。

美国食品及药物管理局也一直在批准预灌封注射器作为组合产品，即药物或生物制品与给药装置包装在一起。这包括含有多种药物或疗法固定剂量组合的预灌封注射器。组合产品提供了便利，简化了治疗方案，提高了用药依从性。FDA 在评估这些组合产品的安全性和有效性方面发挥着至关重要的作用。

2023 年 3 月 3 日，Nexus 制药公司宣布其 25mg/5mL 和 50mg/10mL 单剂量预灌封注射器 Emerphed（硫酸麻黄碱注射液）已获得美国食品和药物管理局（FDA）批准。10毫升规格是首款也是唯一一款获得 FDA 批准的 10 毫升预灌封注射器。Nexus Pharmaceuticals EMERPHED（硫酸麻黄碱注射液）预灌封注射器以每盒十支单剂量注射器的包装形式立即供货。

2022 年 2 月 9 日，武田宣布美国食品和药物管理局（FDA）批准 Takhzyro 注射剂单剂量预灌封注射器（PFS）用于预防 12 岁及以上成人和儿童患者的遗传性血管性水肿发作。与目前的 Takhzyro 瓶装注射剂相比，PFS 即开即用，所需的配制步骤更少，同时还能减少耗材和浪费。因此，由于上述因素，市场有望在预测期内得到推动。

双腔预灌封注射器的复杂性预计将阻碍全球市场增长

双腔预充式注射器有两个分隔腔，两个腔内都装有预装药物。与标准预灌封注射器相比，双腔预灌封注射器的给药过程更为复杂。

例如，根据 Pharmaceuticalonline 的文章，使用双腔注射器的人在注射前需要更加谨慎，并采取更多的准备步骤。如果使用者在混合两个药室之前取下瓶盖，药物流失的几率就会很高。当使用者握住注射器稍向下远离身体时，也会造成药物流失。这是由于注射器内压力积聚造成的。

COVID-19 影响分析

COVID-19 大流行对全球预灌封注射器市场产生了重大影响。大流行期间，许多医疗系统不堪重负，非紧急医疗程序和检查被推迟或取消。这导致了慢性病诊断和患者治疗的延误。因此，一些慢性病病例被诊断出的时间较晚，可能会影响治疗效果。

此外，在大流行期间，研发工作的重点发生了转移，主要集中在开发 COVID-19 的疫苗和治疗方法上。这种资源和注意力的转移暂时影响了与 PFS 相关的研发活动的进展。

此外，为了最大限度地降低 COVID-19 传播的风险，医疗服务提供者对治疗方法进行了调整，如减少亲自出诊、增加远程医疗咨询和修改治疗时间表。因此，由于上述因素，预灌封注射器市场预计在预测期内将受到适度影响。

俄乌冲突分析

俄罗斯和乌克兰之间的冲突影响了多家预灌封注射器生产企业。冲突可能会扰乱供应链，影响预灌封注射器的生产和分销。俄罗斯和乌克兰都是制药业的重要参与者，其生产能力或运输路线的任何中断都可能导致预灌封注射器供应的延误或短缺。

在冲突期间，各国对某些医疗产品实施出口限制。冲突导致市场动态发生变化，因为公司可能会重新评估其供应链战略，寻找替代供应商或生产地点。这导致预灌封注射器市场的竞争格局发生变化，新的企业进入或现有企业扩大市场份额。

此外，冲突及其后果影响了受影响地区与预灌封注射器有关的数据收集和研究工作。这可能会影响最新流行病学数据的可用性，阻碍临床试验，并限制对受冲突影响地区预灌封注射器成果的了解。因此，考虑到上述因素，预灌封注射器市场受到俄罗斯和乌克兰冲突的影响不大。

Market Overview

Global Prefilled Syringe Market reached US$ 6.4 billion in 2022 and is expected to reach US$ 14.4 billion by 2030 growing with a CAGR of 10.9% during the forecast period 2023-2030.

One area of the pharmaceutical and healthcare industries that is expanding quickly is the prefilled syringe market. These syringes are primarily used to treat a variety of chronic illnesses including cancer, arthritis, diabetes, allergy, and ophthalmology. Prefilled syringes have also emerged as the most practical method of drug delivery in recent years. delivering medications with a prefilled syringe can be both safer and easier when compared to regular syringes.

Prefilled syringes are classified into two main categories based on the type of design which include single chamber PFS and dual chamber PFS. Dual chamber PFS has two partitioned chambers where both of the chambers are filled with pre-loaded drugs. Dual chamber PFS have more complex process of administering drugs when compared to the standard prefilled syringes. Moreover, the rising prevalence of chronic diseases, FDA approvals, increasing clinical trials on prefilled syringes, and technical advancements of PFS are the major growth drivers of the market.

Market Dynamics

Technical Advancement of the Prefilled Syringe is Boosting the Future Market Growth

Prefilled syringe market has witnessed significant growth due to various technological advancements. Many key players play a major role in these advancements by launching new products and services. These new products can rise the productivity and efficacy of patients who suffered from chronic illness.

For instance, on Oct 24 2022, Hilma Pharmaceuticals launched the Succinylcholine Chloride Injection which is in the prefilled syringe form. This 100mg/5ml PFS is the FDA approved drug. Succinylcholine Chloride is mainly used in hospitals for general anesthesia, facilitating tracheal intubation, and also used for relaxation during surgeries.

Rising FDA Approvals of Prefilled Syringe is Expected to Boost the Global Market

Prefilled syringes require a thorough assessment by the FDA to ensure quality, reliability, and performance. Data from clinical trials, preclinical studies, and manufacturing processes are carefully reviewed. Once approved, these products become recognized as safe and effective for their intended use, fulfilling all regulatory requirements.

The FDA has also been approving prefilled syringes as combination products, where drugs or biological products are packaged together with the delivery device. This includes prefilled syringes with fixed-dose combinations of multiple drugs or therapies. Combination products offer convenience, simplify treatment regimens, and improve medication adherence. The FDA plays a crucial role in evaluating the safety and effectiveness of these combination products.

On March 3, 2023, Nexus Pharmaceuticals, Inc. announced that it has received US Food and Drug Administration (FDA) approval for Emerphed (ephedrine sulfate injection) in 25mg/5mL and 50mg/10mL single-dose pre-filled syringes. The 10mL presentation is the first and only FDA approved ready to administer 10mL pre-filled syringe available. Nexus Pharmaceuticals EMERPHED (ephedrine sulfate injection) pre-filled syringe is available immediately in cartons of ten single-dose syringes

On Feb 9, 2022, Takeda announced the U.S. Food and Drug Administration (FDA) approval of the Takhzyro injection single-dose prefilled syringe (PFS) to prevent attacks of hereditary angioedema in adult and pediatric patients 12 years of age and older. The PFS is ready to use and requires fewer preparation steps than the current Takhzyro vial injection, while also reducing supplies and waste. Hence, owing to the above factors, the market is expected to boost over the forecast period.

Complexities related to Dual Chamber Prefilled Syringes are Expected to Hamper Global Market Growth

Dual chamber PFS has two partitioned chambers where both of the chambers are filled with pre-loaded drugs. Dual chamber PFS has more complex process of administering drugs when compared to the standard prefilled syringes.

For instance, According to Pharmaceuticalonline article, a person using dual chamber syringes needs to be more cautious and take more preparation steps before getting an injection. There is a high chance of losing drugs if the user removes the cap before mixing up the two drug chambers. It can also cause drug loss when the user holds the syringe slightly downward away from the body. This is caused due to the buildup of pressure inside the syringe.

COVID-19 Impact Analysis

The COVID-19 pandemic has had a significant impact on the global prefilled syringe market. During the height of the pandemic, many healthcare systems were overwhelmed, and non-urgent medical procedures and screenings were postponed or canceled. This led to delays in the diagnosis of chronic diseases and initiation of treatment for patients. As a result, some chronic disease cases were diagnosed at later stages, potentially affecting treatment outcomes.

Moreover, the focus of research and development efforts shifted during the pandemic, with a significant emphasis on developing vaccines and treatments for COVID-19. This diversion of resources and attention has temporarily impacted the progress of PFS-related research and development activities.

Also, to minimize the risk of COVID-19 transmission, healthcare providers implemented changes in treatment delivery, such as reducing in-person clinic visits, increasing telemedicine consultations, and modifying treatment schedules. Therefore, owing to the above factors, prefilled syringe market is expected to be moderately affected over the forecast period.

Russia-Ukraine Conflict Analysis

The conflict between Russia and Ukraine has impacted various prefilled syringe manufacturer companies. The conflict may disrupt supply chains, affecting the production and distribution of prefilled syringes. Both Russia and Ukraine are significant players in the pharmaceutical industry, and any disruption in their manufacturing capabilities or transportation routes could lead to delays or shortages in the supply of prefilled syringes.

During times of conflict, countries imposed export restrictions on certain medical goods. The conflict led to a shift in market dynamics, as companies may reassess their supply chain strategies and seek alternative suppliers or manufacturing locations. This resulted in changes in the competitive landscape of the prefilled syringe market, with new players entering or existing players expanding their market presence.

Furthermore, the conflict and its aftermath impact the data collection and research efforts related to prefilled syringes in the affected regions. This can impact the availability of up-to-date epidemiological data, hinder clinical trials, and limit the understanding of prefilled syringes outcomes in conflict-affected areas. Therefore, considering the above factors, the prefilled syringes market has been moderately affected by the conflict between Russia and Ukraine.

Segment Analysis

The global prefilled syringes market is segmented based on product type, material type, design, applications, distribution channels, and region.

Owing to the Increasing Prevalence of Chronic diseases, the Single Chamber PFS Segment Accounted for Approximately 54.5% of the Global Prefilled Syringe Market Share

For instance, on April 18, 2023, CSL Behring announced the U.S. Food and Drug Administration (FDA) approved a 50mL/10gm single chamber prefilled syringe for Hizentra. CSL Behring offers a full range of prefilled syringe sizes to meet the individual needs of people living with Primary Immunodeficiency (PI) or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Hizentra is the first and only immune globulin (Ig) available in a simple, convenient and ready-to-use prefilled syringe.

Additionally, on April 28, 2023, Otsuka Pharmaceutical Co., Ltd. and Lundbeck Pharmaceuticals LLC announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Abilify Asimtufii (aripiprazole). It is an injectable suspension for intramuscular use once every-two-months injection for the treatment of schizophrenia in adults or for maintenance monotherapy treatment of bipolar disorder in adults. Each dose is provided in a single-chamber prefilled syringe and is administered by a healthcare professional to appropriate patients via intramuscular injection in the gluteal muscle. Thus, owing to the above factors, the single-chamber prefilled syringe segment is expected to hold the largest market share over the forecast period.

Geographical Analysis

North America Accounted for Approximately 38.8% of the Market Share in 2022, Owing to the Increasing Technical Advancement and Prevalence of Chronic Diseases

North America, majorly the United States and Canada represents a substantial market for prefilled syringes. The region has a well-established healthcare infrastructure and a high demand for advanced drug delivery systems. The market size of prefilled syringes in North America is growing significantly due to factors such as the increasing prevalence of chronic diseases, the aging population, and technical advancements in prefilled syringes.

North America has stringent regulatory standards for medical devices, including prefilled syringes. The U.S. Food and Drug Administration and Health Canada enforce guidelines to ensure the safety, quality, and performance of prefilled syringes. Compliance with these regulatory requirements is essential for manufacturers to enter and thrive in the North American market.

For instance, on Sep 13, 2022 Becton, Dickinson, and Company, a leading global medical technology company introduced a next-generation BD Effivax glass prefillable syringe (PFS) that sets a new standard in performance for vaccine PFS with new and tightened specifications for processability, cosmetics, contamination and integrity. The new BD Effivax glass prefillable syringe has been designed in collaboration with leading pharmaceutical companies to meet the complex and evolving needs of vaccine manufacturing. Hence, owing to the above factors, the North American region is expected to hold the largest market share over the forecast period.

Competitive Landscape

The major global players in the market include: Gerresheimer AG, Sanofi, Terumo Corporation, B. Braun, Baxter International, West Pharmaceutical Services, Inc., Becton, Dickinson and Company, SCHOTT AG, Catalent Inc. and Cardinal Health Inc among others.

Why Purchase the Report?

To visualize the global prefilled syringe market segmentation based on the product type, material type, design, applications, distribution channels, and region, as well as understand key commercial assets and players.
Identify commercial opportunities by analyzing trends and co-development.
Excel data sheet with numerous data points of global prefilled syringe market-level with all segments.
PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
Product mapping available as Excel consisting of key products of all the major players.

The global prefilled syringe market report would provide approximately 69 tables, 70 figures, and 195 Pages.

Target Audience 2023

Manufacturers/ Buyers
Industry Investors/Investment Bankers
Research Professionals
Emerging Companies

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 Product Type
3.2. Snippet by Material Type
3.3. Snippet by Design
3.4. Snippet by Application
3.5. Snippet by Distribution Channels
3.6. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rising FDA Approvals of Prefilled Syringes
  - 4.1.1.2. Increasing Clinical Trials for Prefilled Syringes
- 4.1.2. Restraints
  - 4.1.2.1. Significant Challenges Possessed with the Prefilled Syringes
- 4.1.3. Opportunity
  - 4.1.3.1. Emerging Markets of Prefilled Syringes
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's 5 Forces Analysis
5.2. Supply Chain Analysis
5.3. Unmet Needs
5.4. Regulatory Analysis

6. COVID-19 Analysis

6.1. Analysis of COVID-19
- 6.1.1. Scenario Before COVID-19
- 6.1.2. Scenario During COVID-19
- 6.1.3. Scenario Post COVID-19
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During the Pandemic
6.5. Manufacturers' Strategic Initiatives
6.6. Conclusion

7. Russia-Ukraine War Analysis

8. By Product Type

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 8.1.2. Market Attractiveness Index, By Product Type
8.2. Needle Free PFS*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Needled PFS

9. By Material Type

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
- 9.1.2. Market Attractiveness Index, By Material Type
9.2. Glass Prefilled Syringes*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Plastic Prefilled Syringes

10. By Design

10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Design
10.1.2. Market Attractiveness Index, By Design

10.2. Single Chamber PFS
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Dual Chamber PFS

11. By Application

11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
11.1.2. Market Attractiveness Index, By Application

11.2. Diabetes
- 11.2.1. Introduction
- 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
11.3. Rheumatoid Arthritis
11.4. Ophthalmology
11.5. Anaphylaxis
11.6. Others

12. By Distribution Channels

12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
12.1.2. Market Attractiveness Index, By Distribution Channels

12.2. Hospitals
- 12.2.1. Introduction
- 12.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
12.3. Clinics
12.4. Ambulatory Centers

13. By Region

13.1. Introduction
- 13.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 13.1.2. Market Attractiveness Index, By Region
13.2. North America
- 13.2.1. Introduction
- 13.2.2. Key Region-Specific Dynamics
- 13.2.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 13.2.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Material Type
- 13.2.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Design
- 13.2.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 13.2.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channels
- 13.2.8. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 13.2.8.1. U.S.
  - 13.2.8.2. Canada
  - 13.2.8.3. Mexico
13.3. Europe
- 13.3.1. Introduction
- 13.3.2. Key Region-Specific Dynamics
- 13.3.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 13.3.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Material Type
- 13.3.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 13.3.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channels
- 13.3.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 13.3.7.1. Germany
  - 13.3.7.2. U.K.
  - 13.3.7.3. France
  - 13.3.7.4. Italy
  - 13.3.7.5. Spain
  - 13.3.7.6. Rest of Europe
13.4. South America
- 13.4.1. Introduction
- 13.4.2. Key Region-Specific Dynamics
- 13.4.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 13.4.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Material Type
- 13.4.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Design
- 13.4.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channels
- 13.4.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 13.4.7.1. Brazil
  - 13.4.7.2. Argentina
  - 13.4.7.3. Rest of South America
13.5. Asia Pacific
- 13.5.1. Introduction
- 13.5.2. Key Region-Specific Dynamics
- 13.5.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 13.5.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Material Type
- 13.5.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Design
- 13.5.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Country
  - 13.5.6.1. China
  - 13.5.6.2. India
  - 13.5.6.3. Japan
  - 13.5.6.4. Australia
  - 13.5.6.5. Rest of Asia Pacific
13.6. Middle East and Africa
- 13.6.1. Introduction
- 13.6.2. Key Region-Specific Dynamics
- 13.6.3. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Product Type
- 13.6.4. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Material Type
- 13.6.5. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Application
- 13.6.6. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Design
- 13.6.7. Market Size Analysis, and Y-o-Y Growth Analysis (%), By Distribution Channels

14. Competitive Landscape

14.1. Competitive Scenario
14.2. Product Benchmarking
14.3. Company Share Analysis
14.4. Key Developments and Strategies

15. Company Profiles

15.1. Gerresheimer AG*
- 15.1.1. Company Overview
- 15.1.2. Product Portfolio and Description
- 15.1.3. Financial Overview
- 15.1.4. Key Developments
15.2. Sanofi
15.3. Terumo Corporation
15.4. B. Braun
15.5. Baxter International
15.6. West Pharmaceutical Services, Inc.
15.7. Becton, Dickinson and Company
15.8. SCHOTT AG
15.9. Catalent Inc.
15.10. Cardinal Health Inc.

LIST NOT EXHAUSTIVE

16. Appendix

16.1. About Us and Services
16.2. Contact Us

02-2729-4219

+886-2-2729-4219

License/价格

全球预灌封注射器市场 - 2023-2030 年

Global Prefilled Syringe Market - 2023-2030

市场概述

市场动态

预灌封注射器的技术进步推动未来市场增长

预灌封注射器获得 FDA 批准的数量不断增加，有望推动全球市场的发展

双腔预灌封注射器的复杂性预计将阻碍全球市场增长

COVID-19 影响分析

俄乌冲突分析

目 录

第 1 章：研究方法与范围

第2章：定义和概述

第3章：执行摘要

第四章：动态

第 5 章：行业分析

第 6 章：COVID-19 分析

第 7 章 ：俄乌战争分析

第8章：按产品类型划分

第九章：按材料类型

第 10 章：按设计

第十一章：按应用分类

第十二章：按销售渠道划分

第 13 章 ：按地区

第 14 章：竞争格局

第 15 章 ：公司简介

第 16 章 ：附录