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市場調査レポート
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1702410

シングルユースアセンブリーの世界市場 (2025-2033年)

Global Single Use Assemblies Market - 2025-2033

出版日
ページ情報
英文 176 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=143.57円
シングルユースアセンブリーの世界市場 (2025-2033年)
出版日: 2025年04月10日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

世界のシングルユースアセンブリーの市場規模は、2024年の37億2,000万米ドル米ドルから、予測期間中はCAGR 14.3%で推移し、2033年には125億7,000万米ドルに達すると予測されています。

シングルユースアセンブリーとは、顧客のニーズに応じて組み立てられたチューブ、バッグ、付属品などのコンポーネントのセットであり、生物製剤製造において流体の移送、混合、ろ過、封じ込め、最終充填に一般的に使用されます。シングルユースアセンブリーは、従来のステンレススチールシステムと比較して、交差汚染リスクの低減、柔軟性の向上、切り替えの迅速化、資本コストと運用コストの低減、環境への影響の低減などの利点を提供します。

市場力学：

生物製剤とバイオシミラーの需要増加

生物製剤とバイオシミラーの需要増加は、バイオ医薬品製造におけるシングルユースアセンブリーの採用を促進する主な要因です。生物製剤は生きた細胞に由来する複雑な高分子医薬品で、癌、自己免疫疾患、希少な遺伝性疾患などの治療に使用されます。バイオシミラー医薬品は、生物製剤の高度に類似した廉価版であり、救命治療への患者のアクセスを拡大するのに役立ちます。

癌、糖尿病、自己免疫疾患などの慢性疾患の蔓延は、生物製剤をベースとした治療への需要を促進しています。シングルユースアセンブリーは、より迅速で効率的なバイオ生産を可能にし、企業が需要に合わせて生産規模を拡大するのに役立ちます。これらすべての要因が、世界のシングルユースアセンブリー市場の需要となっています。

生物製剤やバイオシミラーの製造に伴う複雑さ、無菌性要件、高コストを考慮すると、効率性、柔軟性、費用対効果を高めるために、従来のステンレス製システムよりもシングルユース技術がますます好まれるようになっています。

当レポートでは、世界のシングルユースアセンブリーの市場を調査し、市場概要、市場成長への各種影響因子の分析、各種区分・地域/主要国別の詳細分析、主要企業のプロファイルなどをまとめています。

目次

第1章 調査手法・調査範囲

第2章 エグゼクティブインサイト・重要ポイント

  • 市場のハイライトと戦略的ポイント
  • 主な動向と将来の予測
  • 製品タイプ別概要
  • ソリューション別概要
  • 用途別概要
  • エンドユーザー別概要
  • 地域別概要

第3章 市場力学

  • 影響要因
    • 促進要因
    • 抑制要因
    • 機会
    • 影響分析

第4章 戦略的洞察と業界展望

  • 市場のリーダーとパイオニア
  • CXOによる見解
  • 最新の開発とブレークスルー
  • ケーススタディ/進行中の研究
  • 規制と償還の情勢
  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 特許分析
  • SWOT分析
  • アンメットニーズとギャップ
  • 市場参入と拡大のための推奨戦略
  • シナリオ分析：ベストケース、ベースケース、ワーストケースの予測
  • 価格分析と価格動向
  • キーオピニオンリーダー

第5章 シングルユースアセンブリー市場：製品タイプ別

  • バッグアセンブリー
  • ろ過アセンブリー
  • ボトルアセンブリー
  • 混合システム
  • その他

第6章 シングルユースアセンブリー市場：ソリューション別

  • 標準ソリューション
  • カスタマイズソリューション
  • その他

第7章 シングルユースアセンブリー市場：用途別

  • 精製・ろ過
  • 細胞培養・混合
  • 保管
  • サンプリング
  • 配合・充填仕上げ

第8章 シングルユースアセンブリー市場：エンドユーザー別

  • 製薬企業・生物製剤企業
  • 学術研究機関
  • CRO・CMO
  • その他

第9章 シングルユースアセンブリー市場：地域分析・成長機会

  • 北米
    • 米国
    • カナダ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他
  • ラテンアメリカ
    • メキシコ
    • ブラジル
    • アルゼンチン
    • その他
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他
  • 中東・アフリカ

第10章 競合情勢と市場ポジショニング

  • 競合状況の概要・主要企業
  • 市場シェア分析・ポジショニングマトリックス
  • 戦略的パートナーシップ・M&A
  • 製品ポートフォリオ・イノベーションにおける主な発展
  • 企業ベンチマーキング

第11章 企業プロファイル

  • Thermo Fisher Scientific, Inc
  • Merck KgaA
  • Sartorius AG
  • Saint-Gobain
  • Avantor
  • Entegris
  • Parker Haniffn Corp
  • Intellitech, Inc
  • AdvantaPure
  • BioPulse Solutions

第12章 仮定・調査手法

第13章 付録

目次
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