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市場調查報告書

商品編碼

1319135

全球預灌封注射器市場 - 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: 約2個工作天內

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簡介目錄

市場概述

全球預灌封注射器市場規模在2022 年達到64 億美元，預計到2030 年將達到144 億美元，2023-2030 年的年複合成長率為10.9%。

預灌封注射器市場是製藥和醫療保健行業中發展迅速的一個領域。這些注射器主要用於治療各種慢性疾病，包括癌症、關節炎、糖尿病、過敏症和眼科疾病。與普通注射器相比，使用預灌封注射器給藥既安全又方便。

預灌封注射器根據設計類型可分為兩大類，包括單腔預灌封注射器和雙腔預灌封注射器。雙腔預充式注射器有兩個分隔腔，兩個腔內都裝有預裝藥物。與標準預灌封注射器相比，雙腔預灌封注射器的給藥過程更為複雜。此外，慢性病發病率的上升、美國食品及藥物管理局的批准、預灌封注射器臨床試驗的增加以及預灌封注射器技術的進步也是市場成長的主要驅動力。

市場動態

預灌封注射器的技術進步推動未來市場成長

由於各種技術進步，預灌封注射器市場出現了顯著成長。許多主要企業通過推出新產品和服務在這些進步中發揮了重要作用。這些新產品可以提高慢性病患者的工作效率和療效。

例如，希爾瑪製藥公司於2022 年10 月24 日推出了預灌封注射器形式的氯化琥珀膽鹼注射液。這種100 毫克/5 毫升的預灌封注射器是經美國FDA 批准的藥物。氯化琥珀膽鹼主要用於醫院的全身麻醉，促進氣管插管，也可用於手術過程中的放鬆。

預灌封注射器獲得FDA 批准的數量不斷增加，有望推動全球市場的發展

預灌封注射器需要通過FDA 的全面評估，以確保品質、可靠性和性能。來自臨床試驗、臨床前研究和生產過程的數據都要經過仔細審查。一旦獲得批准，這些產品就被認定為安全有效，符合所有監管要求，可用於其預期用途。

美國食品及藥物管理局也一直在批准預灌封注射器作為組合產品，即藥物或生物製品與給藥裝置包裝在一起。這包括含有多種藥物或療法固定劑量組合的預灌封注射器。組合產品提供了便利，簡化了治療方案，提高了用藥依從性。 FDA 在評估這些組合產品的安全性和有效性方面發揮著至關重要的作用。

2023 年3 月3 日，Nexus 製藥公司宣布其25mg/5mL 和50mg/10mL 單劑量預灌封注射器Emerphed（硫酸麻黃鹼注射液）已獲得美國食品和藥物管理局（FDA）批准。 10毫升規格是首款也是唯一一款獲得FDA 批准的10 毫升預灌封注射器。 Nexus Pharmaceuticals EMERPHED（硫酸麻黃鹼注射液）預灌封注射器以每盒十支單劑量注射器的包裝形式立即供貨。

2022 年2 月9 日，武田宣布美國食品和藥物管理局（FDA）批准Takhzyro 注射劑單劑量預灌封注射器（PFS）用於預防12 歲及以上成人和兒童患者的遺傳性血管性水腫發作。與目前的Takhzyro 瓶裝注射劑相比，PFS 即開即用，所需的配製步驟更少，同時還能減少耗材和浪費。因此，由於上述因素，市場有望在預測期內得到推動。

雙腔預灌封注射器的複雜性預計將阻礙全球市場成長

雙腔預充式注射器有兩個分隔腔，兩個腔內都裝有預裝藥物。與標準預灌封注射器相比，雙腔預灌封注射器的給藥過程更為複雜。

例如，根據Pharmaceuticalonline 的文章，使用雙腔注射器的人在注射前需要更加謹慎，並採取更多的準備步驟。如果使用者在混合兩個藥室之前取下瓶蓋，藥物流失的機率就會很高。當使用者握住注射器稍向下遠離身體時，也會造成藥物流失。這是由於注射器內壓力積聚造成的。

COVID-19 影響分析

COVID-19 大流行對全球預灌封注射器市場產生了重大影響。大流行期間，許多醫療系統不堪重負，非緊急醫療程序和檢查被推遲或取消。這導致了慢性病診斷和患者治療的延誤。因此，一些慢性病病例被診斷出的時間較晚，可能會影響治療效果。

此外，在大流行期間，研發工作的重點發生了轉移，主要集中在開發COVID-19 的疫苗和治療方法上。這種資源和注意力的轉移暫時影響了與PFS 相關的研發活動的進展。

此外，為了最大限度地降低COVID-19 傳播的風險，醫療服務提供者對治療方法進行了調整，如減少親自出診、增加遠程醫療諮詢和修改治療時間表。因此，由於上述因素，預灌封注射器市場預計在預測期內將受到適度影響。

俄烏衝突分析

俄羅斯和烏克蘭之間的衝突影響了多家預灌封注射器生產企業。衝突可能會擾亂供應鏈，影響預灌封注射器的生產和分銷。俄羅斯和烏克蘭都是製藥業的重要參與者，其生產能力或運輸路線的任何中斷都可能導致預灌封注射器供應的延誤或短缺。

在衝突期間，各國對某些醫療產品實施出口限制。衝突導致市場動態發生變化，因為公司可能會重新評估其供應鏈戰略，尋找替代供應商或生產地點。這導致預灌封注射器市場的競爭格局發生變化，新的企業進入或現有企業擴大市場佔有率。

此外，衝突及其後果影響了受影響地區與預灌封注射器有關的數據收集和研究工作。這可能會影響最新流行病學數據的可用性，阻礙臨床試驗，並限制對受衝突影響地區預灌封注射器成果的了解。因此，考慮到上述因素，預灌封注射器市場受到俄羅斯和烏克蘭衝突的影響不大。

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