1. 方法論と範囲
1.1. 調査方法
1.2. 調査目的と調査範囲
2. 定義と概要
3. エグゼクティブ・サマリー
3.1. 製品タイプ別スニペット
3.2. ソリューション別スニペット
3.3. アプリケーション別スニペット
3.4. エンドユーザー別スニペット
3.5. 地域別スニペット
4. ダイナミクス
4.1. 影響要因
4.1.1. 推進要因
4.1.1.1. シングルユースアセンブリの進歩の台頭
4.1.1.2. バイオ医薬品需要の増加
4.1.2. 阻害要因
4.1.2.1. 規制上のハードル
4.1.2.2. XX
4.1.3. 機会
4.1.4. 影響分析
5. 産業分析
5.1. ポーターのファイブフォース分析
5.2. サプライチェーン分析
5.3. 価格分析
5.4. 規制分析
5.5. 特許分析
5.6. PESTLE分析
5.7. SWOT分析
5.8. DMI意見
6. 製品タイプ別
6.1. 製品紹介
6.1.1. 製品タイプ別市場規模分析および前年比成長率分析(%)
6.1.2. 市場魅力度指数（製品タイプ別
6.2. バッグアッセンブリー
6.2.1. 序論
6.3. ろ過アセンブリー
6.4. ボトルアセンブリ
6.5. 混合システム
6.6. その他
7. 溶液別
7.1. 導入
7.1.1. ソリューション別市場規模分析および前年比成長率分析（%） 7.1.2.
7.1.2. 市場魅力度指数（ソリューション別
7.2. 標準ソリューション
7.2.1. はじめに
7.2.2. 市場規模分析と前年比成長率分析(%)
7.3. カスタマイズソリューション
7.4. その他
8. アプリケーション別
8.1. 導入
8.1.1. 用途別市場規模分析および前年比成長率分析(%)
8.1.2. 市場魅力度指数、用途別
8.2. 精製・ろ過*市場
8.2.1. 序論
8.2.2. 市場規模分析と前年比成長率分析(%)
8.3. 無菌トランスファー
8.4. 細胞培養と混合
8.5. 保存
8.6. サンプリング
8.7. 処方と充填仕上げ
9. エンドユーザー別
9.1. はじめに
9.1.1. 市場規模分析および前年比成長率分析(%), エンドユーザー別
9.1.2. 市場魅力度指数、エンドユーザー別
9.2. 製薬・バイオ医薬品企業
9.2.1. はじめに
9.2.2. 市場規模分析と前年比成長率分析(%)
9.3. 学術・研究機関
9.4. CROおよびCMO
9.5. その他
10. 地域別
10.1. はじめに
10.1.1. 地域別市場規模分析および前年比成長率分析(%)
10.1.2. 市場魅力度指数、地域別
10.2. 北米
10.2.1. 序論
10.2.2. 主な地域別ダイナミクス
10.2.3. 市場規模分析および前年比成長率分析（%）, 製品タイプ別
10.2.4. 市場規模分析とYoY成長率分析（%）, ソリューション別
10.2.5. 市場規模分析および前年比成長率分析（%）, アプリケーション別
10.2.6. 市場規模分析および前年比成長率分析（%）, エンドユーザー別
10.2.7. 市場規模分析および前年比成長率分析(%)、国別
10.2.7.1. 米国
10.2.7.2. カナダ
10.2.7.3. メキシコ
10.3. ヨーロッパ
10.3.1. はじめに
10.3.2. 主な地域別ダイナミクス
10.3.3. 市場規模分析および前年比成長率分析（%）, 製品タイプ別
10.3.4. 市場規模分析とYoY成長率分析（%）, ソリューション別
10.3.5. 市場規模分析および前年比成長率分析（%）, アプリケーション別
10.3.6. 市場規模分析および前年比成長率分析（%）, エンドユーザー別
10.3.7. 市場規模分析および前年比成長率分析(%)、国別
10.3.7.1. ドイツ
10.3.7.2. イギリス
10.3.7.3. フランス
10.3.7.4. イタリア
10.3.7.5. スペイン
10.3.7.6. その他のヨーロッパ
10.4. 南米
10.4.1. はじめに
10.4.2. 地域別主要市場
10.4.3. 市場規模分析および前年比成長率分析（%）, 製品タイプ別
10.4.4. 市場規模分析とYoY成長率分析(%)、ソリューション別
10.4.5. 市場規模分析および前年比成長率分析（%）, アプリケーション別
10.4.6. 市場規模分析および前年比成長率分析 (%)、エンドユーザー別
10.4.7. 市場規模分析および前年比成長率分析(%)、国別
10.4.7.1. ブラジル
10.4.7.2. アルゼンチン
10.4.7.3. その他の南米諸国
10.5. アジア太平洋
10.5.1. 序論
10.5.2. 主な地域別ダイナミクス
10.5.3. 市場規模分析および前年比成長率分析（%）, 製品タイプ別
10.5.4. 市場規模分析とYoY成長率分析（%）, ソリューション別
10.5.5. 市場規模分析および前年比成長率分析（%）, アプリケーション別
10.5.6. 市場規模分析および前年比成長率分析（%）, エンドユーザー別
10.5.7. 市場規模分析および前年比成長率分析（%）, 国別
10.5.7.1. 中国
10.5.7.2. インド
10.5.7.3. 日本
10.5.7.4. 韓国
10.5.7.5. その他のアジア太平洋地域
10.6. 中東・アフリカ
10.6.1. 序論
10.6.2. 主な地域別ダイナミクス
10.6.3. 市場規模分析および前年比成長率分析（%）, 製品タイプ別
10.6.4. 市場規模分析とYoY成長率分析（%）, ソリューション別
10.6.5. 市場規模分析および前年比成長率分析（%）, アプリケーション別
10.6.6. 市場規模分析および前年比成長率分析（%）, エンドユーザー別
11. 競合情勢
11.1. 競争シナリオ
11.2. 市場ポジショニング／シェア分析
11.3. M&A分析
12. 企業プロフィール
12.1. Therma Fisher Scientific, Inc*
12.1.1. 会社概要
12.1.2. 製品ポートフォリオと内容
12.1.3. 財務概要
12.1.4. 主な展開
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
リストは網羅的ではありません
13. 付録
13.1. 会社概要とサービス
13.2. お問い合わせ

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

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
4.1.2.2. XX
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

❖ 世界のシングルユースアセンブリ市場に関するよくある質問(FAQ) ❖

・シングルユースアセンブリの世界市場規模は？
→DataM Intelligence社は2023年のシングルユースアセンブリの世界市場規模を42億米ドルと推定しています。

・シングルユースアセンブリの世界市場予測は？
→DataM Intelligence社は2031年のシングルユースアセンブリの世界市場規模を98億米ドルと予測しています。

・シングルユースアセンブリ市場の成長率は？
→DataM Intelligence社はシングルユースアセンブリの世界市場が2024年～2031年に年平均11.2%成長すると予測しています。

・世界のシングルユースアセンブリ市場における主要企業は？
→DataM Intelligence社は「Therma Fisher Scientific, Inc、Merck KgaA、Sartorius AG、Danahar Corporation、Avantor、Saint Gobain、Entegris、Parker Haniffn Corp、Intellitech, Inc、Antylia Scientificなど ...」をグローバルシングルユースアセンブリ市場の主要企業として認識しています。

※上記FAQの市場規模、市場予測、成長率、主要企業に関する情報は本レポートの概要を作成した時点での情報であり、納品レポートの情報と少し異なる場合があります。