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市場調查報告書
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1702410

全球一次性組件市場 - 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個工作天內

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簡介目錄

2024 年全球一次性組件市場規模達到 37.2 億美元，預計到 2033 年將達到 125.7 億美元，在 2025-2033 年預測期內的複合年成長率為 14.3%。

一次性組件是一組根據客戶需求組裝的組件，例如管、袋和配件，通常用於生物製藥製造中的流體傳輸、混合、過濾、容納和最終填充。與傳統不銹鋼系統相比，一次性組件具有降低交叉污染風險、提高靈活性、加快轉換速度、降低資本和營運成本以及減少環境影響等優勢。

市場動態：

駕駛員和約束裝置

生物製劑和生物相似藥需求不斷成長

對生物製劑和生物相似藥日益成長的需求是推動生物製藥製造中採用一次性組件 (SUA) 的主要因素。生物製劑是從活細胞中提取的複雜的大分子藥物，用於治療癌症、自體免疫疾病和罕見遺傳疾病等疾病。生物相似藥與生物製劑高度相似，但成本較低，有助於擴大患者獲得救命治療的機會。

慢性疾病（如癌症、糖尿病、自體免疫疾病）的盛行率不斷上升，推動了對基於生物製劑的治療的需求。一次性組件可實現更快、更有效率的生物生產，幫助公司擴大生產規模以滿足需求。所有這些因素都要求全球一次性組件市場的發展。

鑑於製造生物製劑和生物相似藥的複雜性、無菌需求和高成本，一次性技術比傳統不銹鋼系統越來越受到青睞，以提高效率、靈活性和成本效益。

例如，2024 年 4 月，SaniSure 推出了 Fill4Sure，這是一種客製化的一次性填充組件，旨在解決藥品製造填充階段的主要瓶頸。此次發布凸顯了全球生物製藥產業對先進一次性解決方案日益成長的需求。

複雜而嚴格的法規核准

複雜而嚴格的法規核准預計將成為一次性組件市場成長的重大障礙。 FDA（美國）、EMA（歐洲）和NMPA（中國）等監管機構對生物製藥製造中使用的一次性系統實施嚴格的合規標準。

FDA 要求一次性系統符合良好生產規範 (GMP) 指南，該指南對生產中使用的材料、所涉及的流程和最終產品品質規定了嚴格的協議。歐洲藥品管理局 (EMA) 也實施類似的 GMP 標準，確保生產的生物製藥產品對人類是安全的。

作為中國的監管機構，國家藥品監督管理局致力於確保藥品的品質和合規性，包括對製造過程中使用的材料的生物相容性和無菌性的嚴格標準。

製造商必須進行徹底的驗證測試，包括生物相容性、無菌保證以及可萃取物和可浸出物 (E&L) 測試，以滿足這些監管要求。這些嚴格的流程可能會導致核准時間過長、營運成本增加以及產品發布延遲。因此，上述因素可能會限制全球一次性組件市場的潛在成長。

目錄

第1章：市場介紹和範圍

  • 報告目標
  • 報告範圍和定義
  • 報告範圍

第2章：高階主管見解與關鍵要點

  • 市場亮點和戰略要點
  • 主要趨勢和未來預測
  • 按產品類型分類的程式碼片段
  • 解決方案片段
  • 按應用程式截取的程式碼片段
  • 最終用戶的程式碼片段
  • 按地區分類

第3章：動態

  • 影響因素
    • 驅動程式
      • 生物製劑和生物相似藥需求不斷成長
      • 生物加工和製造領域的進步
    • 限制
      • 複雜而嚴格的法規核准
      • 一次性組件成本高昂
    • 機會
      • 新興市場的擴張
    • 影響分析

第4章：戰略洞察與產業展望

  • 市場領導者和先驅者
    • 新興先鋒和傑出參與者
    • 擁有最大銷售品牌的成熟領導者
    • 擁有成熟產品的市場領導者
  • CXO 觀點
  • 最新進展與突破
  • 案例研究/正在進行的研究
  • 監管和報銷情況
    • 北美洲
    • 歐洲
    • 亞太地區
    • 拉丁美洲
    • 中東和非洲
  • 波特五力分析
  • 供應鏈分析
  • 專利分析
  • SWOT分析
  • 未滿足的需求和差距
  • 市場進入和擴張的推薦策略
  • 情境分析：最佳情況、基本情況和最壞情況預測
  • 定價分析和價格動態
  • 關鍵意見領袖

第5章：一次性組件市場（依產品類型）

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

第6章：一次性組件市場（依解決方案）

  • 標準溶液
  • 客製化解決方案
  • 其他

第7章：一次性組件市場（按應用）

  • 淨化和過濾
  • 細胞培養和混合
  • 貯存
  • 取樣
  • 配方和填充完成

第 8 章：一次性組件市場（以最終用戶分類）

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

第9章：一次性組件市場，按區域市場分析和成長機會

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

第10章：競爭格局與市場定位

  • 競爭概況和主要市場參與者
  • 市佔率分析與定位矩陣
  • 策略夥伴關係、併購
  • 產品組合和創新的關鍵發展
  • 公司基準化分析

第 11 章：公司簡介

  • Thermo Fisher Scientific, Inc
    • 公司概況
    • 產品組合
      • 產品描述
      • 產品關鍵績效指標 (KPI)
      • 歷史和預測產品銷售
      • 產品銷售量
    • 財務概覽
      • 公司收入
      • 地區收入佔有率
      • 收入預測
    • 關鍵進展
      • 併購
      • 關鍵產品開發活動
      • 監管部門批准等
    • SWOT分析
  • Merck KgaA
  • Sartorius AG
  • Saint-Gobain
  • Avantor
  • Entegris
  • Parker Haniffn Corp
  • Intellitech, Inc
  • AdvantaPure
  • BioPulse Solutions

第 12 章：假設與研究方法

  • 資料收集方法
  • 數據三角測量
  • 預測技術
  • 數據驗證和確認

第 13 章：附錄

簡介目錄
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