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全球一次性生物加工市场 2023-2030Global Single-Use Bioprocessing Market 2023-2030 |
全球一次性生物加工市场预计在预测期内(2023-2030)将以 10.9% 的CAGR成长。一次性生物加工技术广泛用于生物製药应用,包括过滤、混合、纯化、上游表达、储存和分离。一次性生物反应器的日益普及加上先进技术是支持全球市场成长的关键因素。一次性生物反应器的优点是它们为製造商提供了灵活性。停机的主要原因之一是在上游过程中准备生物反应器。一次性生物反应器大大减少了为后续批次准备生物反应器所花费的时间。因此,市场参与者也专注于引入大型一次性生物反应器生物加工解决方案,以进一步促进市场成长。例如,2021年2月,拥有开放取得生物製剂技术平台的全球公司药明生物宣布,其位于中国的MFG5原料药(DS)生产设施已成功启动GMP运营,产能为36,000L,部署了9台4,000 L一次性生物反应器。
全球一次性生物加工市场按产品、应用和最终用户进行细分。根据产品,市场细分为过滤组件、介质袋和容器、一次性生物反应器、一次性混合器和其他(一次性滤筒)。根据应用,市场细分为过滤、细胞培养、纯化和其他(混合)。此外,根据最终用户,市场细分为生物製药製造商、学术和临床研究机构及其他机构(CRO、CMO)。在这些应用中,由于先进的一次性过滤系统的发展不断增加,过滤子细分市场预计将占据相当大的市场份额。一次性过滤系统由许多完全一次性的组件组成,包括整个流体路径和过滤器。这样可以轻鬆快速地适应不断变化的要求 - 无论是需要不同的过滤孔径还是增加或减少填充量。
在这些产品中,介质袋和容器细分市场预计将在全球一次性生物加工市场中占据相当大的份额。该细分市场的成长归因于一次性生物加工技术的使用不断增加,该技术与传统不銹钢系统相比具有多种优势,包括减少清洁和验证时间、提高灵活性以及降低交叉污染的风险。各公司在不同一次性容器和组件在关键製程步骤(例如保护、填充和排水、冷冻和解冻、原料药的储存和运输)中的行为方面拥有丰富的专业知识,这些知识转化为一次性袋子。例如,2022 年 10 月,Single Use Support GmbH 正在扩大其产品组合,推出 IRIS 品牌的新型一次性生物工艺容器。该公司在生物製药流体管理领域提供可靠的製程解决方案,并继续追求与供应商无关的方法。
全球一次性生物加工市场根据地理位置进一步细分,包括北美(美国和加拿大)、欧洲(英国、义大利、西班牙、德国、法国和欧洲其他地区)、亚太地区(印度、中国) 、日本、韩国和亚洲其他地区)以及世界其他地区(中东和非洲以及拉丁美洲)。其中,亚太地区预计将在全球市场中占据显着份额,因为在基因疗法快速增长的推动下,采用一次性技术进行病毒载体和基因疗法生产的势头正在增强。主要市场参与者包括Foxx Life Sciences Pvt. Ltd.、Cesco Bioengineering Co. Ltd.、 PharmNXT 生物技术及其他
在所有地区中,北美地区预计在预测期内将以相当大的CAGR成长。区域成长归因于对一次性生物加工设备的需求增加,这也是由于越来越重视疫苗生产以帮助该地区的疾病预防措施所推动的。用于各种生物製药应用的一次性生物加工技术推动了市场的成长。一次性生物加工技术的采用受到其所提供的引人注目的优势的推动,包括降低交叉污染的风险、简化的转换流程和更快的周转时间。此外,聚合物材料的进步促进了一次性生物反应器的发展,其细胞培养性能与不銹钢反应器相当,进一步推动了市场扩张。此外,北美生物製程系统联盟(BPSA)的存在旨在推动一次性技术的采用,预计将进一步推动该地区一次性系统的销售。
此外,合约服务提供者对在北美发展基地的兴趣日益浓厚,加上 CMO 中采用一次性设备的趋势,成为本地和全球公司持续投资的催化剂。主要市场参与者包括 Agilitech Group、Avantor, Inc.、Corning Inc.、Entegris, Inc.、Pall Corp.、Thermo Fisher Scientific Inc. 等
Title: Global Single-Use Bioprocessing Market Size, Share & Trends Analysis Report by Product (Filtration Assemblies, Media Bags and Containers, Disposable Bioreactors, Disposable Mixers and Other), by Application (Filtration, Cell Culture, Purification and Other), and by End Users (Biopharmaceutical Manufacturers, Academic and Clinical Research Institutes and Other),Forecast Period (2023-2030).
The global single-use bioprocessing market is anticipated to grow at a CAGR of 10.9% during the Forecast Period (2023-2030). Single-use bioprocessing technology is used in a broad range of biopharmaceutical applications, including filtration, mixing, purification, upstream expression, storage, and separation. The growing adoption of single use bioreactor coupled with advance technology is the key factor supporting the growth of the market globally. The advantage of single-use bioreactors is the flexibility they allow manufacturers. One of the main culprits in downtime is preparing the bioreactor in the upstream process. Single-use bioreactors drastically decrease the time spent preparing the bioreactor for the subsequent batch. Hence, the market players are also focusing on introducing large single-use bioreactors bioprocessing solutions that further bolster the market growth. For instance, in February 2021, WuXi Biologics a global company with open-access biologics technology platforms, announced that its MFG5 Drug Substance (DS) manufacturing facility in China has successfully launched GMP operation, with a capacity of 36,000L, deploying nine 4,000L single-use bioreactors.
The global single-use bioprocessing market is segmented on the product, application, and end users. Based on the product, the market is sub-segmented into filtration assemblies, media bags and containers, disposable bioreactors, disposable mixers and others (disposable filter cartridges). Based on the application, the market is sub-segmented into filtration, cell culture, purification and other (mixing). Further, on the basis of end users, the market is sub-segmented into biopharmaceutical manufacturers, academic and clinical research institutes and others (CROs, CMOs). Among the applications, the filtration sub-segment is anticipated to hold a considerable share of the market owing to the rise in the development of advanced Single-use filtration systems are comprised of a number of fully disposable components, including the entire fluid pathway and filters. This allows for easy and quick adaptation to changing requirements - be it the need for different filter pore sizes or an increased or decreased filling volume.
Among the products, the media bags and containers sub-segment is expected to hold a considerable share of the global single-use bioprocessing market. The segmental growth is attributed to the growing uses of single-use bioprocessing technologies that offer several advantages over traditional stainless-steel systems, including reduced cleaning and validation time, increased flexibility, and reduced risk of cross-contamination. Various companies' extensive expertise in the behavior of different single-use containers and assemblies in critical process steps, such as protection, filling & draining, freezing & thawing, storage and shipping of drug substances, that translated into single-use bags. For instance, in October 2022, Single Use Support GmbH is expanding its product portfolio with new single-use bioprocess containers under the brand name IRIS. The company provide reliable process solutions in the field of biopharmaceutical fluid management, continuing to pursue its vendor-agnostic approach.
The global single-use bioprocessing market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America. Among these, Asia-Pacific is anticipated to hold a prominent share of the market across the globe, owing to the adoption of single-use technologies for viral vector and gene therapy production is gaining momentum, driven by the rapid growth of gene-based therapeutics. The key market players include Foxx Life Sciences Pvt. Ltd., Cesco Bioengineering Co. Ltd., PharmNXT Biotech and others
Among all regions, the North America regions is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to an increase in demand for single-use bioprocessing equipment is also driven by an increasing focus on vaccine production to aid in disease prevention measures in the region. single-use bioprocessing technologies for various biopharmaceutical applications have propelled the growth of the market. The adoption of single-use bioprocessing technologies is propelled by the compelling benefits they offer, including reduced risk of cross-contamination, streamlined changeover processes, and faster turnaround times. Additionally, advancements in polymer materials have led to the development of single-use bioreactors that offer cell culture performance at par with stainless steel reactors, further fueling market expansion. Moreover, the presence of the Bio-process System Alliance (BPSA) in North America, that aims at advancing the adoption of single-use technologies, is expected to further drive the sales of disposable systems in the region.
Furthermore, the increasing interest of contract service providers to develop their base in North America, coupled with the trend of implementation of disposables in CMOs, acts as a catalyst for continued investments by local as well as global companies. The key market players include Agilitech Group, Avantor, Inc., Corning Inc., Entegris, Inc., Pall Corp., Thermo Fisher Scientific Inc. and others
The major companies serving the single-use bioprocessing market include: Corning Inc., Eppendorf AG, Merck KGaA, Sartorius AG, Thermo Fisher Scientific Inc. and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance, in January 2020, 3i Group plc launched a single-use bioprocessing platform serving the biopharmaceutical sector with the acquisitions of Cellon, Silicone Altimex and TBL Performance Plastics. The company offer industry products, such as the PharmaTainerTM bottles and carboy product line, aSURE® fittings, Tri-Clamp® ends, Bio-EaseTM clamps, and a wide range of tubing solutions.