上游生物加工市场基于(关键地区、市场参与者、规模和份额)- 到 2030 年的预测

  • Report Code : TIPRE00006819
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 210
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[研究报告]上游生物加工市场价值预计将从2022年的9174.09百万美元增长到2030年的25,046.69百万美元。进一步预计上游生物加工市场2022年至2030年的复合年增长率将达到13.4%。
市场洞察和分析师观点:
上游生物加工是生物加工的第一阶段,包括细胞系开发、培养基开发和培养。推动上游生物加工市场增长的关键因素包括一次性生物反应器的商业化使用、生物制药制造的外包以及制药和生物技术行业的快速增长。然而,严格的监管框架阻碍了上游生物加工市场的增长。
增长驱动因素和限制:
由于一次性生物反应器 (SUB) 的坚固结构和高性能,许多制造商正在开发一次性生物反应器 (SUB),这对于生物制药的商业制造是必需的。与生物膜形成、搅拌机制、生物反应器设计和传感器系统等相关的技术的结合,增加了一次性反应器在实验室和生产规模的采用。一次性生物反应器用于制造下一代细胞和基因疗法,它们适用于连续生物加工。细胞培养工艺的进步现在能够开发出更高的滴度和细胞密度,这表明 SUB 的采用范围很大。一次性生物反应器的运行污染风险低,生产周转时间短,验证时间短。在过去几年中,一次性生物反应器在现代生物制药工艺中的使用有所增加,因为它们具有帮助提高灵活性、减少投资和限制运营成本的独特能力。此外,许多公司还开发了一次性生物反应器来生产各种治疗药物。 2021 年 3 月,Thermo Fischer Scientific 推出了容量为 3,000 L 和 5,000 L 的 HyPerforma DynaDrive 一次性生物反应器。 Sartorius AG 提供各种一次性生物反应器。该公司提供适用于 10-15 mL 微型生物反应器规模的 ambr 15 和适用于 50-2,000L 规模的 Biostat STR。随后,一次性生物反应器在上游生物加工中的使用不断增加。因此,用于生产治疗药物的一次性生物反应器的接受度不断提高,推动了上游生物加工市场的发展。
美国食品药品监督管理局和欧洲药品管理局 (EMA) 等监管机构始终严格监控药品制造商的运营。因此,这些企业必须遵守促进现行良好生产规范 (cGMP) 和良好实验室规范 (GLP) 的最新法规,以确保对制造工艺和设施的控制和监控。目前,FDA 的 CBER 法规并未提及一次性生物反应器。任何偏离本指南注册方案、要求和要求的行为都可能导致制造商或外包组织策划的临床试验终止。尽管与生物技术行业相关的严格法规刺激了对生物反应器的需求,但中国、印度和巴西等发展中国家缺乏明确的监管框架,阻碍了上游生物加工市场的整体增长。
分子从生物加工中获得的结果在临床试验中可能不会产生与实验室环境中相同的结果,这是与使用 SUB 相关的另一个重大问题。 SUB 的混合机制也可能导致难以遵守法规,从而限制了它们的使用。例如,在波浪式SUB中,混合原理仅限于摇摆运动,导致混合不均匀并产生错误。因此,生物制剂的安全性和有效性可能会引起SUBs应用的重大担忧。
趋势:
生物制药行业研发(R&D)投资的增加可能会给上游生物加工市场带来新趋势未来几年。 2020 年 3 月,Culture Biosciences 宣布在 A 轮投资中获得 1500 万美元(1340 万欧元)的资金,并得到了新老风险投资方的支持。据 Culture Biosciences 称,这笔资金已用于将生物反应器的容量提高三倍,以及开发更多基于云的软件监控和开发工具,用于生物制造研究和开发。该公司表示,这项投资将帮助科学家通过软件应用程序管理整个研发工作流程,从而支持生物制造研发的数字化。
随着研发投资持续激增,特别是在新型生物制剂、先进疗法和个性化医疗方面,同时强调优化上游生物加工技术和方法。这一趋势导致了创新生物反应器系统、细胞培养基配方和过程自动化解决方案的开发,以提高生物制药生产运营的效率、可扩展性和生产力。此外,对研发投资的关注有利于尖端生物加工平台的开发,以满足不断发展的生物制药领域,包括下一代治疗方式和生物仿制药。此外,将研发资金用于生物加工趋势,例如连续生物加工和过程监控的高级分析,预计将重塑上游生物加工的未来,推动最先进技术的采用,并为过程性能、质量、和监管合规性。
战略见解
报告细分和范围:
上游生物加工市场根据产品类型、工作流程、使用类型和模式进行细分。根据产品类型,市场分为生物反应器/发酵罐、细胞培养、过滤器、袋子和容器等。在工作流程方面,市场分为培养基制备、细胞培养和细胞分离。上游生物加工市场按用途分为一次性和多次用途。根据模式,上游生物加工市场分为内部和外包。从地域来看,上游生物加工市场分为北美(美国、加拿大和墨西哥)、欧洲(德国、法国、意大利、英国、俄罗斯和欧洲其他地区)、亚太地区(澳大利亚、中国、日本、印度、韩国和亚太其他地区)、中东和非洲(南非、沙特阿拉伯、阿联酋以及中东和非洲其他地区)以及南美洲和中美洲(巴西、阿根廷以及中南部和中美洲其他地区)美国)。
细分市场分析:
根据产品类型,到 2022 年,生物反应器/发酵罐细分市场将占据上游生物加工市场的最大份额。预计细胞培养细分市场将在 2022 年实现显着的复合年增长率2022–2030。生物反应器和发酵罐作为核心容器,细胞和微生物在其中生长,用于涉及生物衍生化合物的表达和生产的各种治疗和生物加工应用。这些系统经过精心设计,旨在为细胞生长提供最佳环境,并结合对温度、pH、溶解氧和搅拌等参数的精确控制。这些参数对于大规模生物加工操作中培养细胞和微生物至关重要。
上游生物加工市场,按产品类型 - 2022 年和 2030 年
根据工作流程,上游生物加工市场分为培养基制备、细胞培养、和细胞分离。细胞分离细分市场在 2022 年占据上游生物加工市场的最大份额。预计该细分市场从 2022 年至 2030 年将实现显着的复合年增长率。细胞分离是将蛋白质产品(细胞)从细胞中分离出来的初始阶段。文化。生物反应器中收集的产品的数量和质量在细胞培养的终止决策中发挥着关键作用。
根据使用类型,全球上游生物加工市场分为一次性和多次使用。到 2022 年,一次性细分市场将占据更大的市场份额。预计该细分市场的市场在 2022 年至 2030 年期间将以显着的复合年增长率增长。随着一次性技术的广泛采用,上游生物加工市场经历了一场变革。一次性系统,包括生物反应器、袋子和连接器,因其灵活性、成本效益和交叉污染风险降低而受到关注。这些一次性组件取代了传统的不锈钢设备,为生物生产提供了更灵活和可扩展的方法。一次性趋势加速了工艺开发,最大限度地减少了清洁和验证工作,并促进了生产运行之间的快速转换。
上游生物加工市场根据模式分为内部和外包。 2022年,内部细分市场占据了更大的市场份额。外包业务预计在 2022 年至 2030 年期间将录得更高的复合年增长率。随着生物制药公司寻求对其生产流程的更大控制,内部制造在上游生物加工市场中越来越受欢迎。建立内部上游生物加工设施使公司能够根据自己的需求定制流程,确保采用更加定制和高效的方法。该战略通常涉及对最先进的生物反应器、细胞培养系统和相关技术的投资。
区域分析:
上游生物加工市场按区域划分为北美、欧洲、亚洲太平洋、南美洲和中美洲、中东和非洲。 2022年,北美在全球上游生物加工市场中占据最大份额。据估计,2022-2030 年亚太地区的复合年增长率最高。
美国是最大的生物反应器市场 — 美国的一些市场参与者为制药和生物技术公司制造生物反应器。新生物反应器的推出、地域扩张战略以及市场参与者之间的合作伙伴关系促进了美国上游生物加工市场的增长。 2023 年 4 月,BioMADE 宣布了 5 个新项目,专注于解决美国生物工业制造中研究和采用生物反应器的差距。这些项目的资金承诺为 1050 万美元,涵盖工程、硬件开发和可扩展性,以解决与规模经济相关的困难。这些项目将专注于创新,引入施密特期货支持的先进生物反应器设计。 2023 年 4 月,Cytiva 推出了 X 平台生物反应器,以通过一次性产品简化上游生物加工操作。最初,生物反应器有 50 L 和 200 L 两种规格。 X-Platform生物反应器配备了Figurate自动化解决方案软件,它们可以通过人体工程学改进、生产能力和简化供应链操作来提高工艺效率。
生物制药行业的增长,主要得益于技术进步、灵活性的提高以及较低的运营成本也有利于美国上游生物加工市场。根据国际贸易管理局(ITA)的数据,美国是最大的生物制药市场,也是全球生物制药研发的领先者。据美国药物研究与制造商协会(PhRMA)统计,美国企业占全球药品研发工作量的近50%,并成功开发出许多拥有知识产权的新药。新生物制剂开发的不断增加,导致更多新分子实体(NME)获得监管机构的批准,为美国上游生物加工市场的增长创造了机会。据《化学与工程新闻》报道,美国食品药品监督管理局(FDA)在 2022 年、2021 年和 2020 年分别批准了约 37 个、50 个和 53 个新 NME。此外,美国制药和生物技术公司增加研发投资以改善临床试验结果并确保患者安全,有助于美国上游生物加工市场的增长。随着美国政府投资的增加,精准医疗的吸引力不断增强,这可能会在未来几年推动市场增长。
行业发展和未来机遇:
全球上游生物加工市场的知名参与者采取了不同的举措如下:
2023 年 12 月,默克收购了 Erbi Biosystems,这是一家总部位于马萨诸塞州的公司,该公司开发了“Breez”2 毫升微型生物反应器平台技术。此次收购增强了默克的上游治疗蛋白产品组合,使其能够迅速开发实验室规模的方案,用于可扩展的基于细胞的灌注生物反应器工艺,容量范围从 2 毫升到 2000 升。此外,它还为细胞疗法等尖端医疗器械应用的进一步研究和进步提供了机会。2023 年 10 月,Getinge AB 以 1.2 亿美元收购了 High Purity New England, Inc.。到 2024 年底,该公司将全面整合 High Purity New England, Inc。此次收购帮助 Getinge AB 获得了从药物发现、上下游加工、灌装到成品的全系列专有和分销产品。 2023 年 1 月,Sartorius 与 RoosterBio Inc. 合作,解决纯化挑战,并为基于外泌体的疗法建立可扩展的下游制造工艺。通过此次合作,Sartorius 和 RoosterBio 将为基于人间充质干细胞/基质细胞 (hMSC) 的外泌体生产平台提供一流的解决方案和专业知识,该平台可提供行业领先的产量、纯度和效力。2022 年 2 月,Thermo Fisher Scientific In 宣布扩大其生物加工业务。该公司已投资 4000 万美元在宾夕法尼亚州米勒斯堡建造和维护一次性技术制造工厂。此次扩建是 6.5 亿美元多年投资的一部分,旨在提高公司以灵活、可扩展和可靠的方式生产生物加工的能力。2021 年 3 月,Thermo Fisher Scientific Inc 推出了不同数量的 HyPerforma DynaDrive SUB,数量为 3,000 L 和 5,000 L 型号。 Thermo Fisher Scientific 最大的商用 SUB 是首款 5,000 L SUB,允许生物制药企业将一次性技术融入大规模生物工艺中,例如以极高细胞密度进行 cGMP 生产和灌注细胞培养。景观和主要公司:
Thermo Fisher Scientific Inc、Esco Micro Pte Ltd、Cellexus International Ltd、Sartorius AG、Danaher Corp、Getinge AB、Merck KGaA、Corning Inc、Entegris Inc 和 PBS Biotech Inc 都是运营中的知名参与者在上游生物加工市场。这些公司专注于新技术的开发和采用、现有产品的进步以及扩大其地域分布,以满足全球不断增长的消费者需求。
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

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Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

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Frequently Asked Questions


Which mode segment dominates the upstream bioprocessing market?

Based on mode, the upstream bioprocessing market is segmented into in-house and outsourced. In 2022, the in-house segment held a larger market share. The outsourced segment is expected to record a higher CAGR during 2022–2030.

Which usage type segment dominates the upstream bioprocessing market?

The global upstream bioprocessing market, based on usage type, is classified into single use and multiuse. The single use segment held a larger share of the market in 2022. The same segment is anticipated to record a significant CAGR in the upstream bioprocessing market during 2022–2030.

Which workflow segment dominates the upstream bioprocessing market?

Based on workflow, the upstream bioprocessing market is classified into media preparation, cell culture, and cell separation. The cell separation segment held the largest share of the upstream bioprocessing market in 2022. It is further anticipated to register a significant CAGR from 2022 to 2030.

What are the growth estimates for the upstream bioprocessing market till 2030?

The upstream bioprocessing market is expected to be valued at US$ 25,046.69 million in 2030.

Which product type segment dominates the upstream bioprocessing market?

The upstream bioprocessing market, based on product type, is segmented into bioreactors and fermenters, cell culture media, filters, bags and containers, and others. The bioreactors/fermenters segment held the largest share of the upstream bioprocessing market in 2022. Moreover, the cell culture segment is anticipated to register a significant CAGR during 2022–2030.

What was the estimated upstream bioprocessing market size in 2022?

The upstream bioprocessing market was valued at US$ 9,174.09 million in 2022.

Who are the major players in the upstream bioprocessing market?

The upstream bioprocessing market majorly consists of the players, including Thermo Fisher Scientific Inc, Esco Micro Pte Ltd, Cellexus International Ltd, Sartorius AG, Danaher Corp, Getinge AB, Merck KGaA, Corning Inc, Entegris Inc, and PBS Biotech Inc.

What is upstream bioprocessing?

Upstream bioprocessing is the first stage of the bioprocess. Upstream phase includes processes such as cell line development, media development and cultivation.

What factors drive the upstream bioprocessing market?

Factors such as the commercial use of single-use bioreactors, outsourcing of biopharmaceutical manufacturing, and rapid growth of pharmaceutical and biotechnology industries propel market growth.

The List of Companies - Upstream Bioprocessing Market 

  1. Thermo Fisher Scientific Inc         
  2. Esco Micro Pte Ltd          
  3. Cellexus International Ltd            
  4. Sartorius AG       
  5. Danaher Corp     
  6. Getinge AB         
  7. Merck KGaA       
  8. Corning Inc         
  9. Entegris Inc         
  10. PBS Biotech Inc

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