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市场调查报告书
商品编码
1702410

全球一次性组件市场 - 2025-2033

Global Single Use Assemblies Market - 2025-2033
出版日期: | 出版商: DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

2024 年全球一次性组件市场规模达到 37.2 亿美元，预计到 2033 年将达到 125.7 亿美元，在 2025-2033 年预测期内的复合年增长率为 14.3%。

一次性组件是一组根据客户需求组装的组件，例如管、袋和配件，通常用于生物製药製造中的流体传输、混合、过滤、容纳和最终填充。与传统不銹钢系统相比，一次性组件具有降低交叉污染风险、提高灵活性、加快转换速度、降低资本和营运成本以及减少环境影响等优势。

市场动态：

驾驶员和约束装置

生物製剂和生物相似药需求不断增长

对生物製剂和生物相似药日益增长的需求是推动生物製药製造中采用一次性组件 (SUA) 的主要因素。生物製剂是从活细胞中提取的复杂的大分子药物，用于治疗癌症、自体免疫疾病和罕见遗传疾病等疾病。生物相似药与生物製剂高度相似，但成本较低，有助于扩大患者获得救命治疗的机会。

慢性疾病（如癌症、糖尿病、自体免疫疾病）的盛行率不断上升，推动了对基于生物製剂的治疗的需求。一次性组件可实现更快、更有效率的生物生产，帮助公司扩大生产规模以满足需求。所有这些因素都要求全球一次性组件市场的发展。

鑑于製造生物製剂和生物相似药的复杂性、无菌需求和高成本，一次性技术比传统不銹钢系统越来越受到青睐，以提高效率、灵活性和成本效益。

例如，2024 年 4 月，SaniSure 推出了 Fill4Sure，这是一种客製化的一次性填充组件，旨在解决药品製造填充阶段的主要瓶颈。此次发布凸显了全球生物製药产业对先进一次性解决方案日益增长的需求。

复杂而严格的监管审批

复杂而严格的监管审批预计将成为一次性组件市场成长的重大障碍。 FDA（美国）、EMA（欧洲）和NMPA（中国）等监管机构对生物製药製造中使用的一次性系统实施严格的合规标准。

FDA 要求一次性系统符合良好生产规范 (GMP) 指南，该指南对生产中使用的材料、所涉及的流程和最终产品品质规定了严格的协议。欧洲药品管理局 (EMA) 也实施类似的 GMP 标准，确保生产的生物製药产品对人类是安全的。

作为中国的监管机构，国家药品监督管理局致力于确保药品的品质和合规性，包括对製造过程中使用的材料的生物相容性和无菌性的严格标准。

製造商必须进行彻底的验证测试，包括生物相容性、无菌保证以及可萃取物和可浸出物 (E&L) 测试，以满足这些监管要求。这些严格的流程可能会导致审批时间过长、营运成本增加以及产品发布延迟。因此，上述因素可能会限制全球一次性组件市场的潜在成长。

目录

第一章：市场介绍和范围

  • 报告目标
  • 报告范围和定义
  • 报告范围

第二章：高阶主管见解与关键要点

  • 市场亮点和战略要点
  • 主要趋势和未来预测
  • 按产品类型分类的程式码片段
  • 解决方案片段
  • 按应用程式截取的程式码片段
  • 最终用户的程式码片段
  • 按地区分类的片段

第三章：动态

  • 影响因素
    • 驱动程式
      • 生物製剂和生物相似药需求不断增长
      • 生物加工和製造领域的进步
    • 限制
      • 复杂而严格的监管审批
      • 一次性组件成本高昂
    • 机会
      • 新兴市场的扩张
    • 影响分析

第四章：战略洞察与产业展望

  • 市场领导者和先驱者
    • 新兴先锋和杰出参与者
    • 拥有最大销售品牌的成熟领导者
    • 拥有成熟产品的市场领导者
  • CXO 观点
  • 最新进展与突破
  • 案例研究/正在进行的研究
  • 监管和报销情况
    • 北美洲
    • 欧洲
    • 亚太地区
    • 拉丁美洲
    • 中东和非洲
  • 波特五力分析
  • 供应链分析
  • 专利分析
  • SWOT分析
  • 未满足的需求和差距
  • 市场进入和扩张的推荐策略
  • 情境分析：最佳情况、基本情况和最坏情况预测
  • 定价分析和价格动态
  • 关键意见领袖

第五章：一次性组件市场（依产品类型）

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

第六章：一次性组件市场（依解决方案）

  • 标准溶液
  • 客製化解决方案
  • 其他的

第七章：一次性组件市场（按应用）

  • 净化和过滤
  • 细胞培养和混合
  • 贮存
  • 取样
  • 配方和填充完成

第 8 章：一次性组件市场（以最终用户划分）

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

第九章：一次性组件市场，按区域市场分析和成长机会

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

第十章：竞争格局与市场定位

  • 竞争概况和主要市场参与者
  • 市占率分析与定位矩阵
  • 策略伙伴关係、併购
  • 产品组合和创新的关键发展
  • 公司基准化分析

第 11 章：公司简介

  • Thermo Fisher Scientific, Inc
    • 公司概况
    • 产品组合
      • 产品描述
      • 产品关键绩效指标 (KPI)
      • 历史和预测产品销售
      • 产品销售量
    • 财务概览
      • 公司收入
      • 地区收入份额
      • 收入预测
    • 关键进展
      • 併购
      • 关键产品开发活动
      • 监管部门批准等
    • SWOT分析
  • Merck KgaA
  • Sartorius AG
  • Saint-Gobain
  • Avantor
  • Entegris
  • Parker Haniffn Corp
  • Intellitech, Inc
  • AdvantaPure
  • BioPulse Solutions

第 12 章：假设与研究方法

  • 资料收集方法
  • 数据三角测量
  • 预测技术
  • 数据验证和确认

第 13 章：附录

简介目录
Product Code: MD2690

The global single-use assemblies market reached US$ 3.72 billion in 2024 and is expected to reach US$ 12.57 billion by 2033, growing at a CAGR of 14.3% during the forecast period of 2025-2033.

A single-use assembly is a set of components, such as tubing, bags, and fittings, assembled according to a customer's needs, commonly used in biopharmaceutical manufacturing for fluid transfer, mixing, filtration, containment, and final fill. Single-use assemblies offer advantages like reduced cross-contamination risk, increased flexibility, faster changeover, lower capital and operating costs, and reduced environmental impact compared to traditional stainless-steel systems.

Market Dynamics: Drivers & Restraints

Rising Demand for Biologics and Biosimilars

The growing demand for biologics and biosimilars is a major factor driving the adoption of single-use assemblies (SUA) in biopharmaceutical manufacturing. Biologics are complex, large-molecule drugs derived from living cells and are used to treat conditions like cancer, autoimmune diseases, and rare genetic disorders. Biosimilars are highly similar, lower-cost versions of biologics that help expand patient access to life-saving treatments.

The growing prevalence of chronic diseases (e.g., cancer, diabetes, autoimmune disorders) is fueling demand for biologics-based therapies. Single-use assemblies enable faster, more efficient bioproduction, helping companies scale up production to meet demand. All these factors demand the global single-use assemblies market.

Given the complexity, sterility requirements, and high costs associated with manufacturing biologics and biosimilars, single-use technologies are increasingly preferred over traditional stainless-steel systems to enhance efficiency, flexibility, and cost-effectiveness.

For instance, in April 2024, SaniSure introduced Fill4Sure, a custom single-use filling assembly designed to address major bottlenecks in the fill-finish stage of drug manufacturing. This launch highlights the growing demand for advanced single-use solutions in the global biopharmaceutical industry.

Complex and Stringent Regulatory Approvals

The complex and stringent regulatory approvals are expected to be a significant barrier to the growth of the single-use assemblies market. Regulatory authorities such as the FDA (U.S.), EMA (Europe), and NMPA (China) enforce strict compliance standards for single-use systems used in biopharmaceutical manufacturing.

The FDA requires that single-use systems meet Good Manufacturing Practice (GMP) guidelines, which specify strict protocols for the materials used in production, the processes involved, and the end-product quality. The European Medicines Agency (EMA) also imposes similar GMP standards, ensuring that the biopharmaceutical products manufactured are safe for human consumption.

As China's regulatory body, NMPA focuses on ensuring the quality and compliance of pharmaceutical products, which includes stringent standards for biocompatibility and sterility of materials used in manufacturing.

Manufacturers are required to carry out thorough validation tests, including biocompatibility, sterility assurance, and extractables & leachables (E&L) testing, to meet these regulatory requirements. These rigorous processes can lead to lengthy approval timelines, increased operational costs, and delays in product launches. Thus, the above factors could be limiting the global single-use assemblies market's potential growth.

Segment Analysis

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

Product Type:

The filtration assemblies segment in product type is expected to dominate the global single-use assemblies market with the highest market share

The filtration assemblies segment is driven by its widespread application in biopharmaceuticals, biotechnology, and research labs. These assemblies play a crucial role in sterile filtration, purification, and contamination control, making them indispensable in drug manufacturing and bioprocessing.

The increasing production of monoclonal antibodies, vaccines, and cell & gene therapies has fueled the demand for single-use filtration systems. Filtration assemblies ensure high sterility and reduced contamination risks, which is critical for biologics manufacturing.

Compared to traditional stainless-steel filtration systems, single-use assemblies reduce setup time, cleaning validation, and cross-contamination risks. They also lead to lower capital expenditure since they do not require extensive maintenance or sterilization. These factors have solidified the segment's position in the global single-use assemblies market.

Geographical Analysis

North America is expected to hold a significant position in the global single-use assemblies market with the highest market share

North America is expected to dominate the single-use assemblies market due to various significant factors. The growing prevalence of chronic diseases, cancer, and genetic disorders in North America fuels the demand for single-use assemblies. As more individuals are diagnosed with conditions such as diabetes, cancer, and hereditary diseases, there is a growing demand for single-use assemblies to help in early diagnosis, risk assessment, and personalized treatment planning. For instance, according to the report by the American Cancer Society in 2025, it is stated that approximately 1 in 8 women in the United States are diagnosed with breast cancer.

Being one of the common cancers among women, the need for single-use assemblies is expected to increase, which is expected to drive the single-use assemblies market. Genetic testing detects inherited genetic mutations for various cancers. Companies in the region are mainly focusing on developing advanced solutions for the diagnosis of genetic diseases to help in identifying the mutations in the genes and help in developing personalized medicine.

For instance, in March 2024, Nucleus Genomics, a next-generation single-use assemblies and analysis company, launched its DNA analysis product aimed at making the benefits of personalized medicine accessible to everyone. This product is designed to empower individuals with the knowledge of their genetic makeup, helping them make informed decisions about their health. Thus, various factors are contributing to the region's dominant position in the global single-use assemblies market.

Competitive Landscape

The major global players in the single-use assemblies market include Thermo Fisher Scientific, Inc., Merck KgaA, Sartorius AG, Saint-Gobain, Avantor, Entegris, Parker Hannifin Corp, Intellitech, Inc., AdvantaPure, and BioPulse Solutions, among others.

Key Developments

  • In September 2024, Merck launched a single-use reactor (SUR) specifically designed to enhance the manufacturing of antibody-drug conjugates (ADCs). ADCs are an innovative class of targeted cancer therapies that combine monoclonal antibodies (mAbs) with cytotoxic drugs, providing a highly targeted approach to treating cancer. This allows ADCs to precisely target cancer cells while minimizing damage to healthy cells, making them a promising treatment option for many types of cancer.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzed product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: This covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyze competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global single-use assemblies market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

Table of Contents

1. Market Introduction and Scope

  • 1.1. Objectives of the Report
  • 1.2. Report Coverage & Definitions
  • 1.3. Report Scope

2. Executive Insights and Key Takeaways

  • 2.1. Market Highlights and Strategic Takeaways
  • 2.2. Key Trends and Future Projections
  • 2.3. Snippet by Product Type
  • 2.4. Snippet by Solution
  • 2.5. Snippet by Application
  • 2.6. Snippet by End-User
  • 2.7. Snippet by Region

3. Dynamics

  • 3.1. Impacting Factors
    • 3.1.1. Drivers
      • 3.1.1.1. Rising Demand for Biologics and Biosimilars
      • 3.1.1.2. Advancements in Bioprocessing & Manufacturing
    • 3.1.2. Restraints
      • 3.1.2.1. Complex and Stringent Regulatory Approvals
      • 3.1.2.2. High Cost of Single-Use Components
    • 3.1.3. Opportunity
      • 3.1.3.1. Expansion in Emerging Markets
    • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

  • 4.1. Market Leaders and Pioneers
    • 4.1.1. Emerging Pioneers and Prominent Players
    • 4.1.2. Established leaders with the largest selling Brand
    • 4.1.3. Market leaders with established Product
  • 4.2. CXO Perspectives
  • 4.3. Latest Developments and Breakthroughs
  • 4.4. Case Studies/Ongoing Research
  • 4.5. Regulatory and Reimbursement Landscape
    • 4.5.1. North America
    • 4.5.2. Europe
    • 4.5.3. Asia Pacific
    • 4.5.4. Latin America
    • 4.5.5. Middle East & Africa
  • 4.6. Porter's Five Forces Analysis
  • 4.7. Supply Chain Analysis
  • 4.8. Patent Analysis
  • 4.9. SWOT Analysis
  • 4.10. Unmet Needs and Gaps
  • 4.11. Recommended Strategies for Market Entry and Expansion
  • 4.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 4.13. Pricing Analysis and Price Dynamics
  • 4.14. Key Opinion Leaders

5. Single Use Assemblies Market, By Product Type

  • 5.1. Introduction
    • 5.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 5.1.2. Market Attractiveness Index By Product Type
  • 5.2. Bag Assemblies*
    • 5.2.1. Introduction
    • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 5.3. Filtration Assemblies
  • 5.4. Bottle Assemblies
  • 5.5. Mixing Systems
  • 5.6. Others

6. Single-Use Assemblies Market, By Solution

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 6.1.2. Market Attractiveness Index By Solution
  • 6.2. Standard Solution*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Customized solution
  • 6.4. Others

7. Single Use Assemblies Market, By Application

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.1.2. Market Attractiveness Index By Application
  • 7.2. Purification and Filtration*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Cell culture and Mixing
  • 7.4. Storage
  • 7.5. Sampling
  • 7.6. Formulation and Fill Finish

8. Single Use Assemblies Market, By End-User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 8.1.2. Market Attractiveness Index, By End-User
  • 8.2. Pharmaceutical and Biopharmaceutical Companies*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Academic and Research Institutes
  • 8.4. CROs and CMOs
  • 8.5. Others

9. Single-Use Assemblies Market, By Regional Market Analysis and Growth Opportunities

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 9.1.2. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key Region-Specific Dynamics
    • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.2.7.1. U.S.
      • 9.2.7.2. Canada
  • 9.3. Europe
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.3.7.1. Germany
      • 9.3.7.2. U.K.
      • 9.3.7.3. France
      • 9.3.7.4. Spain
      • 9.3.7.5. Italy
      • 9.3.7.6. Rest of Europe
  • 9.4. Latin America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.4.7.1. Mexico
      • 9.4.7.2. Brazil
      • 9.4.7.3. Argentina
      • 9.4.7.4. Rest of Latin America
  • 9.5. Asia-Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.5.7.1. China
      • 9.5.7.2. India
      • 9.5.7.3. Japan
      • 9.5.7.4. South Korea
      • 9.5.7.5. Rest of Asia-Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Solution
    • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

10. Competitive Landscape and Market Positioning

  • 10.1. Competitive Overview and Key Market Players
  • 10.2. Market Share Analysis and Positioning Matrix
  • 10.3. Strategic Partnerships, Mergers & Acquisitions
  • 10.4. Key Developments in Product Portfolios and Innovations
  • 10.5. Company Benchmarking

11. Company Profiles

  • 11.1. Thermo Fisher Scientific, Inc*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio
      • 11.1.2.1. Product Description
      • 11.1.2.2. Product Key Performance Indicators (KPIs)
      • 11.1.2.3. Historic and Forecasted Product Sales
      • 11.1.2.4. Product Sales Volume
    • 11.1.3. Financial Overview
      • 11.1.3.1. Company Revenue
      • 11.1.3.2. Geographical Revenue Shares
      • 11.1.3.3. Revenue Forecasts
    • 11.1.4. Key Developments
      • 11.1.4.1. Mergers & Acquisitions
      • 11.1.4.2. Key Product Development Activities
      • 11.1.4.3. Regulatory Approvals, etc.
    • 11.1.5. SWOT Analysis
  • 11.2. Merck KgaA
  • 11.3. Sartorius AG
  • 11.4. Saint-Gobain
  • 11.5. Avantor
  • 11.6. Entegris
  • 11.7. Parker Haniffn Corp
  • 11.8. Intellitech, Inc
  • 11.9. AdvantaPure
  • 11.10. BioPulse Solutions

LIST NOT EXHAUSTIVE

12. Assumptions and Research Methodology

  • 12.1. Data Collection Methods
  • 12.2. Data Triangulation
  • 12.3. Forecasting Techniques
  • 12.4. Data Verification and Validation

13. Appendix

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