市場調查報告書
商品編碼
1466468
全球一次性組裝市場:按產品、解決方案、應用和最終用途 - 預測 2024-2030 年Single Use Assemblies Market by Product (Bag Assemblies, Bottle Assemblies, Filtration Assemblies), Solution (Customized Solutions, Standard Solutions), Application, End User - Global Forecast 2024-2030 |
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預計2023年全球一次性組件市場規模為67億美元,預計2024年將達75.1億美元,2030年將達143.5億美元,複合年成長率為11.48%。
一次性組件 (SUA) 是生物製藥行業中使用的預組裝、無菌、一次性零件,可簡化製造流程、降低交叉污染風險並提高業務效率。該市場由各種產品組成,例如袋子、管組、過濾器、連接器和無菌輸送系統。該市場受到多種因素的推動,包括由於較低的資本支出和較低的清洗成本等經濟效益而在藥品製造中擴大採用一次性技術。此外,對生物製藥的需求不斷成長,導致製造商專注於透過採用一次性組裝解決方案來提高生產效率。然而,廢棄物處理、溶解/萃取性和多用途系統的廣泛可用性等監管問題正在降低一次性組件的全球市場滲透率。然而,人們越來越關注永續解決方案,例如開發環保材料和回收計劃,以解決與一次性組件相關的環境問題。此外,開發具有更好的機械性能、耐用性以及在不同溫度和壓力下的性能的先進材料正在提高一次性組件領域的效率和可靠性。
主要市場統計 | |
---|---|
基準年[2023] | 67億美元 |
預測年份 [2024] | 75.1億美元 |
預測年份 [2030] | 143.5億美元 |
複合年成長率(%) | 11.48% |
開發一次性過濾組件以降低產品交叉污染風險並縮短週轉時間
袋子組件由各種一次性袋子組成,設計用於生物製程應用中的流體管理、儲存和運輸。這些袋子由多層薄膜和材料製成,例如乙烯醋酸乙烯(EVA) 和聚乙烯薄膜結構。袋子材料的選擇通常取決於生物相容性要求、氣體阻隔性能、化學相容性和機械強度等因素。瓶組件與袋組件類似,但具有剛性結構,用於儲存和處理製造過程中涉及的各種液體成分。由聚對聚對苯二甲酸乙二酯(PET)、聚丙烯(PP)、聚碳酸酯(PC)等塑膠材料製成。瓶子組件的優點是易於操作,並且可以自訂以滿足特定的應用要求,例如液體分配系統或無菌通風過濾器。過濾組件透過使用具有規定孔徑的薄膜過濾器將污染物與目標分子分離,在精製過程中發揮關鍵作用。這些一次性過濾設備變得非常受歡迎,因為與傳統的不銹鋼系統相比,它們降低了交叉污染的風險。混合系統組件旨在滿足生物加工行業的各種混合要求。這些系統對於培養基製備、緩衝液交換和配製至關重要。
解決方案 標準解決方案為主流生產過程提供了易於使用且經濟高效的選擇。
客製化解決方案旨在滿足個別客戶和應用的具體要求。這些客製化產品採用特定的配置、材料和組件設計,可在獨特的製程環境中最佳化性能。客製化通常對於實現產品與現有設備的兼容性或解決與專業製造流程相關的獨特挑戰至關重要。客製化解決方案包括多種選項,包括客製化組件、客製化連接器和特定應用的管道材料。客製化一次性組件的主要優勢包括最佳化性能、降低風險以及與特定應用的品質標準和要求緊密結合,以簡化監管合規性。標準一次性組件的世界提供了適合各種生物製藥製造環境的核心功能。這些現成的選項包含符合常見監管標準的材料和組件,旨在滿足常見的行業要求。標準解決方案通常服務於更廣泛的細分市場,並為更專業的組件提供經濟高效且易於使用的替代方案。標準解決方案的子類別包括即用型過濾組件、一次性無菌袋和標準化管道套件。
應用全球對細胞培養和混合中的一次性組件的需求不斷增加,以促進疫苗開發
細胞培養和混合主要著重於在受控條件下培養細胞。一次性組件的世界正在發揮重要作用,因為一次性混合袋和反應器簡化了混合程序,並且無需大量清洗即可輕鬆更換。由於其優點,例如減少交叉污染的風險和提高擴大生產規模時的彈性等優點,單一組裝擴大在該領域得到應用。混合涉及在製造過程中組合不同的成分。填充和包裝應用涉及將無菌藥品無菌填充到最終容器(例如管瓶和注射器)中。透過採用一次性填充針和管子等SUA,可以顯著降低傳統可重複使用設備污染產品的風險,同時提高工作效率。一次性系統不需要清洗或滅菌步驟,最大限度地減少生產運作之間的停機時間。
過濾是生物製藥生產各階段的關鍵步驟,包括細胞培養收穫物的澄清、病毒去除和精製藥品的無菌過濾。使用一次性過濾膠囊和無菌一次性過濾模組等 SUA 可以降低交叉污染的風險,確保一致的產品質量,同時最大限度地減少清洗和消毒的停機時間。 SUA 提供的彈性使製造商能夠輕鬆擴展其過濾工藝,以滿足不斷變化的市場動態和生產需求。此外,SUA由於其優點,例如防止樣品之間的交叉污染、降低人事費用和簡化工作流程,在採樣領域越來越受歡迎。一次性採樣系統,例如無菌樣品袋,無需清洗和高壓釜,確保處理過程中的快速週轉時間。在儲存應用中,SUA 具有多種優勢。一次性儲物袋在容量變化方面具有高度的彈性,可以根據容量需求進行擴展或折疊。它還降低了污染風險,因為無需在使用之間進行清洗。
最終用戶:整合跨受託研究機構的一次性組裝世界,以加快處理和流程轉換時間
在學術研究實驗室中,一次性組件主要用於無菌液體轉移、樣品製備和細胞培養應用。這些機構喜歡一次性系統,因為它們交叉污染的風險較低,清洗需求較少,實驗之間的周轉時間較短。生物製藥和製藥公司正在利用一次性組件進行各種藥物開發和製造流程,包括上游細胞培養、下游精製、配製、填充和儲存。拋棄式系統是首選,因為它們可以最大限度地降低與產品污染相關的風險,同時透過減少工廠停機時間和人事費用來提高業務效率。參與外包藥物發現服務的 CRO 和 CMO 正在擁抱一次性組裝領域,用於藥物篩檢分析、化合物庫測試以及在 cGMP 條件下製造臨床試驗材料。一次性技術使這些組織能夠靈活地在不同的客戶需求和計劃之間快速切換,降低交叉污染的風險,並確保合規性。
區域洞察
在美洲,特別是在北美,生物技術和製藥行業的擴張在推動全球對一次性組件的需求方面發揮著重要作用。這種擴張是由於研發活動投資的增加、慢性病盛行率的增加以及人們對生物製藥益處的認知的提高。此外,促進安全和環境永續性的嚴格監管準則正促使製造商從傳統不銹鋼系統轉向一次性替代品。此外,在整個歐洲,歐洲生物製藥產業的快速發展正在顯著提升市場潛力,包括開發新的感測器和分析工具,以實現更好的一次性系統流程監測和控制。幾家大公司的存在,加上政府對研究計畫的大力支持,正在推動該地區更多地採用一次性技術。此外,印度和中國等新興市場透過擴大生物製造能力提供了巨大的成長機會。製造商也致力於透過採用更環保的生產方法來減少碳排放,包括引入一次性組件 World.FPNV。
FPNV定位矩陣
FPNV 定位矩陣對於評估一次性組件的全球市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對全球一次性組裝市場供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.全球一次性組裝市場的市場規模與預測為何?
2.在全球一次性組件市場的預測期間內,有哪些產品、細分市場、應用和領域需要考慮投資?
3. 全球一次性組裝市場的技術趨勢和法規結構是什麼?
4.全球一次性組裝市場主要供應商的市場佔有率為何?
5. 進入全球一次性組件市場的適當型態和策略手段是什麼?
[189 Pages Report] The Single Use Assemblies Market size was estimated at USD 6.70 billion in 2023 and expected to reach USD 7.51 billion in 2024, at a CAGR 11.48% to reach USD 14.35 billion by 2030.
Single use assemblies (SUA) are pre-assembled, sterilized, and disposable components utilized in the biopharmaceutical industry to streamline manufacturing processes, reduce cross-contamination risks, and improve operational efficiency. The market comprises various products such as bags, tubing sets, filters, connectors, and aseptic transfer systems. The market is driven by several factors, such as increased adoption of single-use technology in pharmaceutical manufacturing due to its economic benefits, such as reduced capital investment and lower cleaning costs. Additionally, increasing demand for biopharmaceuticals has led manufacturers to focus on improving production efficiency by adopting single-use assembly solutions. However, regulatory concerns due to waste disposal, leachable and extractable, and the vast availability of the multi-use system are lowering the penetration of the single use assemblies market. However, increasing focus on sustainable solutions, including the development of eco-friendly materials and recycling programs, address environmental concerns associated with single use assemblies. Furthermore, developing advanced materials with better mechanical properties, durability, and performance under varying temperatures or pressures has enhanced the efficiency and reliability of single use assemblies.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 6.70 billion |
Estimated Year [2024] | USD 7.51 billion |
Forecast Year [2030] | USD 14.35 billion |
CAGR (%) | 11.48% |
Product: Development of single use filtration assemblies in reducing cross-contamination risks and faster turnaround times
Bag assemblies consist of various single-use bags designed for fluid management, storage, and transportation in bioprocessing applications. These bags are made from multiple layers of films and materials, such as ethylene-vinyl acetate (EVA) or polyethylene-based film structures. The selection of bag material often depends on factors such as biocompatibility requirements, gas barrier properties, chemical compatibility, and mechanical strength. Bottle assemblies, similar to bag assemblies but with rigid structures, are used for storing and handling various liquid components involved in the manufacturing process. They are made from plastic materials such as polyethylene terephthalate (PET), polypropylene (PP), and polycarbonate (PC). Bottle assemblies offer advantages such as ease of handling and customization to accommodate specific application requirements, including liquid dispensing systems and sterile vent filters. Filtration assemblies play a crucial role in the purification process by separating contaminants from desired molecules using membrane filters with defined pore sizes. These single-use filtration devices have gained significant popularity due to their reduced risk of cross-contamination compared to traditional stainless-steel systems. Mixing system assemblies are designed to meet various mixing requirements within the bioprocess industry. These systems are vital for media preparation, buffer exchange, and drug product formulation.
Solution: Standard solutions offering accessible and cost-effective alternative for mainstream production processes
Customized solutions are tailored to meet the precise requirements of individual clients or applications. These bespoke products are designed with specific configurations, materials, and components that optimize performance in unique process environments. In many cases, customization is essential for achieving product compatibility with existing equipment or addressing distinctive challenges associated with specialized manufacturing processes. Customized solutions include various options, including custom-manufactured components, bespoke connectors, and application-specific tubing materials. Some key benefits of customized single use assemblies include optimized performance, reduced risk, and streamlining regulatory compliance by aligning more closely with application-specific quality standards and requirements. Standard single use assemblies offer a range of core features suitable for various biopharmaceutical production environments. These off-the-shelf options are designed with general industry requirements, incorporating materials and components that comply with common regulatory standards. Standard solutions typically cater to a broader market segment, offering cost-effective and readily available alternatives to more specialized assemblies. Subcategories within standard solutions encompass ready-to-use filtration assemblies, pre-sterilized disposable bags, and standardized tubing sets.
Application: Increasing demand for single use assemblies in cell culture & mixing to boost vaccine development
Cell culture & mixing primarily focuses on cultivating cells under controlled conditions. Single use assemblies play a key role by simplifying mixing procedures through disposable mixing bags or bioreactors that can be easily replaced without extensive cleaning procedures. Single assemblies are increasingly being used in this field due to their advantages, such as reduced risk of cross-contamination and increased flexibility in scaling up production. The mixing aspect involves combining different components during the manufacturing process. Fill-finish applications involve the aseptic filling of sterile drug products into their final containers, such as vials or syringes. Adopting SUA, such as disposable filling needles and tubing, significantly reduces the risk of product contamination from traditional reusable equipment while improving operational efficiency. Single-use systems minimize downtime between production runs since cleaning and sterilization procedures are eliminated.
Filtration is a critical step within various stages of biopharmaceutical manufacturing, including clarification of cell culture harvests, virus removal, and sterile filtration for purified drug products. Using SUA, such as single-use filter capsules and pre-sterilized disposable filter modules, ensures consistent product quality with reduced risk of cross-contamination and minimized downtime for cleaning and sanitization. The flexibility offered by SUA allows manufacturers to easily scale their filtration processes, catering to the changing market dynamics and production demands. Furthermore, SUA is gaining traction in the sampling domain due to benefits such as the prevention of cross-contamination between samples, reduced labor costs, and simplified workflows. Single-use sampling systems such as pre-sterilized sample bags eliminate the need for cleaning and autoclaving, ensuring rapid turnaround time during processing. In storage applications, SUA provides several advantages where disposable storage bags offer greater flexibility in terms of capacity variations and can be expanded or collapsed according to the volume requirements. They also reduce contamination risks by eliminating the need for cleaning between uses.
End User: Integrating single use assemblies across contract research organizations for quicker processing and process changeover time
In academic and research institutes, single use assemblies are primarily used for sterile fluid transfer, sample preparation, and cell culture applications. These organizations prefer disposable systems due to their lower risk of cross-contamination, reduced cleaning requirements, and shorter turnaround times between experiments. Biopharmaceutical and pharmaceutical companies utilize single use assemblies in various drug development and production processes, such as upstream cell culture, downstream purification, formulation, filling, and storage. The preference for disposable systems stems from their ability to minimize risks associated with product contamination while streamlining operational efficiency through reduced plant downtime and labor costs. CROs and CMOs involved in outsourced drug discovery services employ single use assemblies for drug screening assays or compound library testing as well as clinical trial material production under cGMP conditions. Single use technologies offer these organizations flexibility in accommodating different client requirements and rapid changeovers between projects, mitigating cross-contamination risks, and ensuring regulatory compliance.
Regional Insights
In the Americas region, especially North America, the expansion of the biotechnology and pharmaceutical industries is playing a major role in driving demand for single use assemblies. This expansion is attributed to rising investments in research & development activities, increasing prevalence of chronic diseases, and growing awareness about the benefits of biopharmaceuticals. Additionally, stringent regulatory guidelines promoting safety and environmental sustainability encourage manufacturers to switch from traditional stainless-steel systems to disposable alternatives. Furthermore, across Europe, the market potential is largely driven by rapid advancements in the European biopharmaceutical industry, such as developing new sensors and analytics tools enabling better process monitoring and control in single-use systems. The presence of several leading players, coupled with strong government support for research initiatives, has led to increased adoption of single-use technologies in this region. Moreover, emerging markets such as India and China offer immense growth opportunities due to their expanding bio-manufacturing capabilities. Manufacturers are also focusing on reducing their carbon footprint by adopting greener production methods, which include implementing single use assemblies.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Single Use Assemblies Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Single Use Assemblies Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Single Use Assemblies Market, highlighting leading vendors and their innovative profiles. These include 3M Company, Accuflow Systems, Inc., AdvantaPure by NewAge Industries, Inc., Ami Polymer Pvt. Ltd., Antylia Scientific, Avantor, Inc., avintos AG, BioProcess Engineering Services Limited, BioPulse Solutions Pvt. Ltd., Cellexus Limited, Cobetter Filtration Group, Colly Flowtech AB, Compagnie de Saint-Gobain S.A., Corning Incorporated, Danaher Corporation, Distek, Inc., Dover Corporation, DrM, Dr. Mueller AG, DuPont de Nemours, Inc., DWK Life Sciences GmbH, Entegris, Inc., Foxx Life Sciences, GE HealthCare Technologies Inc., Getinge AB, ILC Dover LP, Intellitech, Inc., Keofitt A/S, Liquidyne Process Technologies, Inc, Lonza Group Ltd., Meissner Corporation, Merck KGaA, Owen Mumford Limited, Parker-Hannifin Corporation, Pharsol Ltd., Purity One, Repligen Corporation, Romynox B.V., SaniSure Inc., Sartorius AG, Satake Multimix Corporation, Single Use Support GmbH, Thermo Fisher Scientific Inc., Trelleborg AB, and WHK BioSystems, LLC.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Single Use Assemblies Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Single Use Assemblies Market?
3. What are the technology trends and regulatory frameworks in the Single Use Assemblies Market?
4. What is the market share of the leading vendors in the Single Use Assemblies Market?
5. Which modes and strategic moves are suitable for entering the Single Use Assemblies Market?