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市场调查报告书
商品编码
1575742

全球一次性组件市场 - 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个工作天内

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简介目录

概述

全球一次性组件市场将于 2023 年达到 42 亿美元，预计到 2031 年将达到 98 亿美元，2024-2031 年预测期间复合年增长率为 11.2%。

一次性组件是用于生物製药和生物技术行业的预组装流体管理解决方案。它们由管道、连接器、过滤器和储存袋等组件组成，专为一次性使用而设计，可最大限度地降低污染风险、减少清洁和验证要求并增强製程灵活性。它们可以节省成本、减少停机时间并提高营运效率，特别是在生物製剂生产、细胞和基因疗法以及疫苗製造等领域，无菌至关重要。

市场动态：

驱动程式和限制

一次性组件进步的兴起

全球一次性组件市场正在见证技术先进产品的开发激增，这些产品提供简化的工作流程、便携性和快速实施。这一趋势催生了价格实惠、创新、整合且可立即实施的一次性组件，预计这些组件的需求将显着增长，特别是在采用率较高的成熟市场。

例如，2023 年 4 月，默克宣布推出其 Ultimus 一次性工艺容器薄膜，旨在为生物加工液体应用的一次性组件提供极高的耐用性和防漏性。

袋子洩漏长期以来一直是生物製造商的头号痛点，单次洩漏的成本从 45,000 欧元到 511,000 欧元不等。为了防止此类洩漏、磨损、撕裂和材料疲劳，Ultimus 薄膜采用专有的编织尼龙结构设计，可提供增强的袋子强度、改进的耐用性和弹性。

监管障碍

全球一次性组件市场面临多项挑战，包括高成本、处置问题、环境影响、监管障碍以及大规模营运或黏性流体製程的潜在限制。一次性技术的初始投资是巨大的，特别是对于小型生物製药公司和新创公司而言。此外，对一次性塑胶的处置和环境影响的担忧，以及与材料验证、可萃取物和可浸出物测试相关的监管障碍，进一步限制了其广泛采用。

目录

第 1 章：方法与范围

第 2 章：定义与概述

第 3 章：执行摘要

第 4 章：动力学

  • 影响因素
    • 司机
      • 一次性组件进步的兴起
      • 生物製药需求不断成长
    • 限制
      • 监管障碍
    • 机会
    • 影响分析

第 5 章：产业分析

  • 波特五力分析
  • 供应链分析
  • 定价分析
  • 监管分析
  • 专利分析
  • 大环境分析
  • SWOT分析
  • DMI 意见

第 6 章：依产品类型

  • 袋子组件
  • 过滤组件
  • 瓶子组件
  • 混合系统
  • 其他的

第 7 章：透过解决方案

  • 标准溶液
  • 客製化解决方案
  • 其他的

第 8 章：按申请

  • 净化过滤
  • 无菌转移
  • 细胞培养和混合
  • 贮存
  • 取样
  • 配方和填充完成

第 9 章：最终用户

  • 製药和生物製药公司
  • 学术及研究机构
  • CRO 和 CMO
  • 其他的

第 10 章：按地区

  • 北美洲
    • 我们
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 欧洲其他地区
  • 南美洲
    • 巴西
    • 阿根廷
    • 南美洲其他地区
  • 亚太
    • 中国
    • 印度
    • 日本
    • 韩国
    • 亚太其他地区
  • 中东和非洲

第 11 章：竞争格局

  • 竞争场景
  • 市场定位/份额分析
  • 併购分析

第 12 章：公司简介

  • Therma Fisher Scientific, Inc
    • 公司概况
    • 产品组合和描述
    • 财务概览
    • 主要进展
  • Merck KgaA
  • Sartorius AG
  • Danahar Corporation
  • Avantor
  • Saint Gobain
  • Entegris
  • Parker Haniffn Corp
  • Intellitech, Inc
  • Antylia Scientific

第 13 章：附录

简介目录
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