市场调查报告书
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1466468
全球一次性组装市场:按产品、解决方案、应用和最终用途 - 预测 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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预计2023年全球一次性组件市场规模为67亿美元,预计2024年将达75.1亿美元,2030年将达143.5亿美元,复合年增长率为11.48%。
一次性组件 (SUA) 是生物製药行业中使用的预组装、无菌、一次性零件,可简化製造流程、降低交叉污染风险并提高业务效率。该市场由各种产品组成,例如袋子、管组、过滤器、连接器和无菌输送系统。该市场受到多种因素的推动,包括由于较低的资本支出和较低的清洗成本等经济效益而在药品製造中越来越多地采用一次性技术。此外,对生物製药的需求不断增长,导致製造商专注于透过采用一次性组装解决方案来提高生产效率。然而,废弃物处理、溶解/萃取性和多用途系统的广泛可用性等监管问题正在降低一次性组件的全球市场渗透率。然而,人们越来越关注永续解决方案,例如开发环保材料和回收计划,以解决与一次性组件相关的环境问题。此外,开发具有更好的机械性能、耐用性以及在不同温度和压力下的性能的先进材料正在提高一次性组件领域的效率和可靠性。
主要市场统计 | |
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基准年[2023] | 67亿美元 |
预测年份 [2024] | 75.1亿美元 |
预测年份 [2030] | 143.5亿美元 |
复合年增长率(%) | 11.48% |
开发一次性过滤组件以降低产品交叉污染风险并缩短週转时间
袋子组件由各种一次性袋子组成,设计用于生物製程应用中的流体管理、储存和运输。这些袋子由多层薄膜和材料製成,例如乙烯醋酸乙烯(EVA) 和聚乙烯薄膜结构。袋子材料的选择通常取决于生物相容性要求、气体阻隔性能、化学相容性和机械强度等因素。瓶组件与袋组件类似,但具有刚性结构,用于储存和处理製造过程中涉及的各种液体成分。由聚对聚对苯二甲酸乙二酯(PET)、聚丙烯(PP)、聚碳酸酯(PC)等塑胶材料製成。瓶子组件的优点是易于操作,并且可以自订以满足特定的应用要求,例如液体分配系统或无菌通风过滤器。过滤组件透过使用具有规定孔径的薄膜过滤器将污染物与目标分子分离,在精製过程中发挥关键作用。这些一次性过滤设备变得非常受欢迎,因为与传统的不銹钢系统相比,它们降低了交叉污染的风险。混合系统组件旨在满足生物加工行业的各种混合要求。这些系统对于培养基製备、缓衝液交换和配製至关重要。
解决方案 标准解决方案为主流生产过程提供了易于使用且经济高效的选择。
客製化解决方案旨在满足个别客户和应用的具体要求。这些客製化产品采用特定的配置、材料和组件设计,可在独特的製程环境中优化性能。客製化通常对于实现产品与现有设备的兼容性或解决与专业製造流程相关的独特挑战至关重要。客製化解决方案包括多种选项,包括客製化组件、客製化连接器和特定应用的管道材料。客製化一次性组件的主要优势包括优化性能、降低风险以及与特定应用的品质标准和要求紧密结合,以简化监管合规性。标准一次性组件的世界提供了适合各种生物製药製造环境的核心功能。这些现成的选项包含符合常见监管标准的材料和组件,旨在满足常见的行业要求。标准解决方案通常服务于更广泛的细分市场,并为更专业的组件提供经济高效且易于使用的替代方案。标准解决方案的子类别包括即用型过滤组件、一次性无菌袋和标准化管道套件。
应用全球对细胞培养和混合中的一次性组件的需求不断增加,以促进疫苗开发
细胞培养和混合主要着重于在受控条件下培养细胞。一次性组件的世界正在发挥重要作用,因为一次性混合袋和反应器简化了混合程序,并且无需大量清洗即可轻鬆更换。由于其优点,例如减少交叉污染的风险和提高扩大生产规模时的弹性等优点,单一组装越来越多地在该领域得到应用。混合涉及在製造过程中组合不同的成分。填充和包装应用涉及将无菌药品无菌填充到最终容器(例如管瓶和注射器)中。透过采用一次性填充针和管子等SUA,可以显着降低传统可重复使用设备污染产品的风险,同时提高工作效率。一次性系统不需要清洗或灭菌步骤,最大限度地减少生产运作之间的停机时间。
过滤是生物製药生产各阶段的关键步骤,包括细胞培养收穫物的澄清、病毒去除和精製药品的无菌过滤。使用一次性过滤胶囊和无菌一次性过滤模组等 SUA 可以降低交叉污染的风险,确保一致的产品质量,同时最大限度地减少清洗和消毒的停机时间。 SUA 提供的弹性使製造商能够轻鬆扩展其过滤工艺,以满足不断变化的市场动态和生产需求。此外,SUA由于其优点,例如防止样品之间的交叉污染、降低人事费用和简化工作流程,在采样领域越来越受欢迎。一次性采样系统,例如无菌样品袋,无需清洗和高压釜,确保处理过程中的快速週转时间。在储存应用中,SUA 具有多种优势。一次性储物袋在容量变化方面具有高度的弹性,可以根据容量需求进行扩展或折迭。它还降低了污染风险,因为无需在使用之间进行清洗。
最终用户:整合跨受託研究机构的一次性组装世界,以加快处理和流程转换时间
在学术研究实验室中,一次性组件主要用于无菌液体转移、样品製备和细胞培养应用。这些机构喜欢一次性系统,因为它们交叉污染的风险较低,清洗需求较少,实验之间的周转时间较短。生物製药和製药公司正在利用一次性组件进行各种药物开发和製造流程,包括上游细胞培养、下游精製、配製、填充和储存。抛弃式系统是首选,因为它们可以最大限度地降低与产品污染相关的风险,同时透过减少工厂停机时间和人事费用来提高业务效率。参与外包药物发现服务的 CRO 和 CMO 正在拥抱一次性组装领域,用于药物筛检分析、化合物库测试以及在 cGMP 条件下製造临床试验材料。一次性技术使这些组织能够灵活地在不同的客户需求和计划之间快速切换,降低交叉污染的风险,并确保合规性。
区域洞察
在美洲,特别是在北美,生物技术和製药行业的扩张在推动全球对一次性组件的需求方面发挥着重要作用。这种扩张是由于研发活动投资的增加、慢性病盛行率的增加以及人们对生物製药益处的认识的提高。此外,促进安全和环境永续性的严格监管准则正促使製造商从传统不銹钢系统转向一次性替代品。此外,在整个欧洲,欧洲生物製药产业的快速发展正在显着提升市场潜力,包括开发新的感测器和分析工具,以实现更好的一次性系统流程监测和控制。几家大公司的存在,加上政府对研究计画的大力支持,正在推动该地区更多地采用一次性技术。此外,印度和中国等新兴市场透过扩大生物製造能力提供了巨大的成长机会。製造商也致力于透过采用更环保的生产方法来减少碳排放,包括引入一次性组件 World.FPNV。
FPNV定位矩阵
FPNV 定位矩阵对于评估一次性组件的全球市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对全球一次性组装市场供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.全球一次性组装市场的市场规模与预测为何?
2.在全球一次性组件市场的预测期间内,有哪些产品、细分市场、应用和领域需要考虑投资?
3. 全球一次性组装市场的技术趋势和法规结构是什么?
4.全球一次性组装市场主要供应商的市场占有率为何?
5. 进入全球一次性组件市场的适当型态和策略手段是什么?
[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?