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市場調查報告書
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1575742

全球一次性組件市場 - 2024-2031

Global Single Use Assemblies Market - 2024-2031
出版日期: | 出版商: DataM Intelligence | 英文 186 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

概述

全球一次性組件市場將於 2023 年達到 42 億美元，預計到 2031 年將達到 98 億美元，2024-2031 年預測期間複合年成長率為 11.2%。

一次性組件是用於生物製藥和生物技術行業的預組裝流體管理解決方案。它們由管道、連接器、過濾器和儲存袋等組件組成，專為一次性使用而設計，可最大限度地降低污染風險、減少清潔和驗證要求並增強製程靈活性。它們可以節省成本、減少停機時間並提高營運效率，特別是在生物製劑生產、細胞和基因療法以及疫苗製造等領域，無菌至關重要。

市場動態：

驅動程式和限制

一次性組件進步的興起

全球一次性組件市場正在見證技術先進產品的開發激增，這些產品提供簡化的工作流程、便攜性和快速實施。這一趨勢催生了價格實惠、創新、整合且可立即實施的一次性組件，預計這些組件的需求將顯著成長，特別是在採用率較高的成熟市場。

例如，2023 年 4 月，默克宣布推出其 Ultimus 一次性工藝容器薄膜，旨在為生物加工液體應用的一次性組件提供極高的耐用性和防漏性。

袋子洩漏長期以來一直是生物製造商的頭號痛點，單次洩漏的成本從 45,000 歐元到 511,000 歐元不等。為了防止此類洩漏、磨損、撕裂和材料疲勞，Ultimus 薄膜採用專有的編織尼龍結構設計，可提供增強的袋子強度、改進的耐用性和彈性。

監管障礙

全球一次性組件市場面臨多項挑戰，包括高成本、處置問題、環境影響、監管障礙以及大規模營運或黏性流體製程的潛在限制。一次性技術的初始投資是巨大的，特別是對於小型生物製藥公司和新創公司而言。此外，對一次性塑膠的處置和環境影響的擔憂，以及與材料驗證、可萃取物和可浸出物測試相關的監管障礙，進一步限制了其廣泛採用。

目錄

第 1 章：方法與範圍

第 2 章：定義與概述

第 3 章：執行摘要

第 4 章：動力學

  • 影響因素
    • 促進要素
      • 一次性組件進步的興起
      • 生物製藥需求不斷成長
    • 限制
      • 監管障礙
    • 機會
    • 影響分析

第 5 章：產業分析

  • 波特五力分析
  • 供應鏈分析
  • 定價分析
  • 監管分析
  • 專利分析
  • 大環境分析
  • SWOT分析
  • DMI 意見

第 6 章：依產品類型

  • 袋子組件
  • 過濾組件
  • 瓶子組件
  • 混合系統
  • 其他

第 7 章：透過解決方案

  • 標準溶液
  • 客製化解決方案
  • 其他

第 8 章：按申請

  • 淨化過濾
  • 無菌轉移
  • 細胞培養和混合
  • 貯存
  • 取樣
  • 配方和填充完成

第 9 章：最終用戶

  • 製藥和生物製藥公司
  • 學術及研究機構
  • CRO 和 CMO
  • 其他

第 10 章：按地區

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 義大利
    • 西班牙
    • 歐洲其他地區
  • 南美洲
    • 巴西
    • 阿根廷
    • 南美洲其他地區
  • 亞太
    • 中國
    • 印度
    • 日本
    • 韓國
    • 亞太其他地區
  • 中東和非洲

第 11 章：競爭格局

  • 競爭場景
  • 市場定位/佔有率分析
  • 併購分析

第 12 章：公司簡介

  • Therma Fisher Scientific, Inc
    • 公司概況
    • 產品組合和描述
    • 財務概覽
    • 主要進展
  • Merck KgaA
  • Sartorius AG
  • Danahar Corporation
  • Avantor
  • Saint Gobain
  • Entegris
  • Parker Haniffn Corp
  • Intellitech, Inc
  • Antylia Scientific

第 13 章：附錄

簡介目錄
Product Code: BT2690

Overview

Global Single Use Assemblies Market reached US$ 4.2 billion in 2023 and is expected to reach US$ 9.8 billion by 2031, growing at a CAGR of 11.2% during the forecast period 2024-2031.

Single Use Assemblies are pre-assembled fluid management solutions used in biopharmaceutical and biotechnology industries. They consist of components like tubing, connectors, filters, and storage bags, designed for single use to minimize contamination risks, reduce cleaning and validation requirements, and enhance process flexibility. They offer cost savings, reduced downtime, and increased operational efficiency, especially in biologics production, cell and gene therapy, and vaccine manufacturing, where sterility is crucial.

Market Dynamics: Drivers & Restraints

Rise of advancements in single use assemblies

The global single-use assemblies market is witnessing a surge in the development of technologically advanced products, offering streamlined workflows, portability, and rapid implementation. This trend has led to the creation of affordable, innovative, integrated, and ready-to-implement single-use assemblies, which are expected to experience significant demand growth, particularly in mature markets with high adoption rates.

For instance, in April 2023, Merck has announced the launch of its Ultimus Single-Use Process Container Film, designed to provide extreme durability and leak resistance for single use assemblies used for bioprocessing liquid applications.

Bag leaks have long been a top pain point for biomanufacturers, with the cost of a single leak ranging from € 45,000 to € 511,000. To protect against such leaks, abrasions, tears, and material fatigue, Ultimus film is designed with a proprietary woven nylon structure and provides enhanced bag strength, improved durability, and resilience.

Regulatory hurdles

The global single use assemblies market faces several challenges, including high costs, disposal concerns, environmental impact, regulatory hurdles, and potential limitations in large-scale operations or viscous fluid processes. The initial investment in single-use technologies is substantial, especially for smaller biopharmaceutical companies and startups. Additionally, concerns about disposal and environmental impact of single-use plastics, as well as regulatory hurdles related to material validation, extractables, and leachables testing, further limit widespread adoption.

Segment Analysis

The global single use assemblies market is segmented based on product type, solution, application, end user and region.

The bag assemblies from the product type segment accounted for approximately 41.3% of the single use assemblies market share

The bag assemblies from the product type segment accounted for approximately 41.3%. Bag assemblies are crucial components in the global Single Use Assemblies Market, used for fluid storage, mixing, and transfer in bioprocessing applications. These pre-sterilized, disposable bags are available in various sizes and configurations to meet specific needs. They reduce cross-contamination risk and cleaning and validation efforts, making them essential in regulated industries like biopharmaceuticals. Their flexibility, ease of integration, and ability to scale from research to full production make them integral to single-use technologies, particularly in biologics and vaccine manufacturing.

Geographical Analysis

North America is estimated to hold about 38.4% of the total market share throughout the forecast period

North America is estimated to hold about 38.4% of the total market share throughout the forecast period due to growth in the biotechnology and pharmaceutical industries, advancement in products, and increasing incidence of diseases such as cancer coupled with investments and funding in drug discovery research.

For instance, in April 2024, Watson-Marlow Fluid Technology Solutions (WMFTS), a manufacturer of peristaltic pumps and associated fluid path technologies, announced the launch of WMArchitect, a range of flexible, single-use solutions for biopharmaceutical fluid management. The platform builds on predecessors such as puresu and asepticsu and is designed to streamline a biopharma company's process, safeguard product, and reduce regulatory burden.

Market Segmentation

By Product Type

  • Bag Assemblies
  • Filtration assemblies
  • Bottle Assemblies
  • Mixing systems
  • Others

By Solution

  • Standard Solution
  • Customized solution
  • Others

By Application

  • Purification and filtration
  • Aseptic transfer
  • Cell culture and mixing
  • Storage
  • Sampling
  • Formulation and fill finish

By End User

  • Pharmaceutical and Biopharmaceutical companies
  • Academic and research institutes
  • CROs and CMOs
  • Others

By Region

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Rest of Europe
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa

Competitive Landscape

The major global players in the market include Therma Fisher Scientific, Inc, Merck KgaA, Sartorius AG, Danahar Corporation, Avantor, Saint Gobain, Entegris, Parker Haniffn Corp, Intellitech, Inc, Antylia Scientific among others.

Key Developments

  • In August 2023, Trelleborg Healthcare and Medical launched the BioPharmaPro family of advanced products and services for fluid path single-use equipment to boost the development of advanced therapies.
  • In April 2023, Merck KGaA launched Ultimus, a SU process container film, to provide superior strength & leak resistance in single-use assemblies. In April 2022, Thermo Fisher Scientific developed a new SU manufacturing site in Utah, U.S. With this Utah facility, (part of the USD 650 Billion multi-year expansion plan), the company envisions providing bioprocessing solutions at even inland locations.

Why Purchase the Report?

  • To visualize the global single-use assemblies market segmentation based on product type, solution, application, end user, 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 the single-use assemblies 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 single use assemblies market report would provide approximately 64 tables, 61 figures and 186 pages.

Target Audience 2023

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

Table of Contents

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 Solution
  • 3.3. Snippet by Application
  • 3.4. Snippet by End User
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rise of advancements in single use assemblies
      • 4.1.1.2. Rising demand for biopharmaceuticals
    • 4.1.2. Restraints
      • 4.1.2.1. Regulatory Hurdles
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's Five Force Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Patent Analysis
  • 5.6. PESTLE Analysis
  • 5.7. SWOT Analysis
  • 5.8. DMI Opinion

6. By Product Type

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 6.1.2. Market Attractiveness Index, By Product Type
  • 6.2. Bag Assemblies*
    • 6.2.1. Introduction
  • 6.3. Filtration assemblies
  • 6.4. Bottle Assemblies
  • 6.5. Mixing systems
  • 6.6. Others

7. By Solution

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 7.1.2. Market Attractiveness Index, By Solution
  • 7.2. Standard Solution*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Customized solution
  • 7.4. Others

8. By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Purification and filtration*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Aseptic transfer
  • 8.4. Cell culture and mixing
  • 8.5. Storage
  • 8.6. Sampling
  • 8.7. Formulation and fill finish

9. By End User

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.1.2. Market Attractiveness Index, By End User
  • 9.2. Pharmaceutical and Biopharmaceutical companies*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Academic and research institutes
  • 9.4. CROs and CMOs
  • 9.5. Others

10. By Region

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.2.7.1. U.S.
      • 10.2.7.2. Canada
      • 10.2.7.3. Mexico
  • 10.3. Europe
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.3.7.1. Germany
      • 10.3.7.2. UK
      • 10.3.7.3. France
      • 10.3.7.4. Italy
      • 10.3.7.5. Spain
      • 10.3.7.6. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.4.7.1. Brazil
      • 10.4.7.2. Argentina
      • 10.4.7.3. Rest of South America
  • 10.5. Asia-Pacific
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.5.7.1. China
      • 10.5.7.2. India
      • 10.5.7.3. Japan
      • 10.5.7.4. South Korea
      • 10.5.7.5. Rest of Asia-Pacific
  • 10.6. Middle East and Africa
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

  • 11.1. Competitive Scenario
  • 11.2. Market Positioning/Share Analysis
  • 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

  • 12.1. Therma Fisher Scientific, Inc*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
  • 12.2. Merck KgaA
  • 12.3. Sartorius AG
  • 12.4. Danahar Corporation
  • 12.5. Avantor
  • 12.6. Saint Gobain
  • 12.7. Entegris
  • 12.8. Parker Haniffn Corp
  • 12.9. Intellitech, Inc
  • 12.10. Antylia Scientific

LIST NOT EXHAUSTIVE

13. Appendix

  • 13.1. About Us and Services
  • 13.2. Contact Us