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市场调查报告书
商品编码
1722407
2025 年至 2033 年一次性生物反应器市场报告(按产品类型、类型、细胞类型、分子类型、最终用户和地区)Single-Use Bioreactors Market Report by Product Type, Type, Cell Type, Molecule Type, End User, and Region 2025-2033 |
2024 年全球一次性生物反应器市场规模达 39 亿美元。展望未来, IMARC Group预计到 2033 年市场规模将达到 124 亿美元,2025-2033 年期间的成长率 (CAGR) 为 13.1%。市场受到生物製药需求不断增长、产品提供的成本效益和可扩展性、一次性技术的重大发展、合约製造组织 (CMO) 中产品采用率不断提高、细胞和基因治疗生产中使用率不断提高的推动。
主要市场驱动因素:生物製药需求的不断增长、产品提供的成本效益和可扩展性以及一次性技术的重大发展是一些主要的市场驱动因素。
主要市场趋势:合约製造组织 (CMO) 中产品采用率的不断增长、细胞和基因治疗生产中利用率的不断提高以及生物反应器设计的重大进步是一次性生物反应器的一些主要市场趋势。
地理趋势:由于生物製药的使用量不断增加、生物加工技术的投资不断增加以及一次性系统比传统钢製生物反应器的优势不断增强,北美占据了市场主导地位。
竞争格局:ABEC Inc.、Cellexus、Celltainer Biotech BV、CESCO Bioengineering Co. Ltd.、Distek Inc.、Eppendorf SE、通用电气公司、Getinge AB、Merck KGaA、Pall Corporation(丹纳赫公司)、PBS Biotech Inc.、Sartorius AG 和赛默世尔?
挑战与机会:该行业面临的一些挑战包括高初始产品成本和对塑胶废物日益增长的担忧。然而,市场机会包括单一生物反应器设计的重大技术发展以及个人化医疗和小批量生产日益增长的需求。
生物製药的采用率不断上升
由于对多种疾病(包括糖尿病、癌症和自体免疫疾病等慢性疾病)的新型有效治疗方法的需求不断增加,生物製药产业正在快速成长。根据IMARC GROUP的数据,全球生物製药市场规模在2023年已达到3,005亿美元,预计到2032年将达到6,439亿美元,2024-2032年期间的复合年增长率为8.6%。疫苗、单株抗体、重组蛋白等生物製药都是利用活细胞生产的,需要高度专业的生产环境。一次性生物反应器 (SUB) 因其成本效益高、灵活性强且交叉污染风险低而被广泛采用。它们可以加快产品开发和生产时间,从而使生物製药公司能够快速满足这些需求并为患者开发新的治疗方法。
生物加工技术投资不断增加
随着生物加工技术寻求提高生产能力和营运效率,对生物加工技术的投资也不断增加。根据IMARC GROUP发布的报告,全球生物製程技术市场规模在2023年已达292亿美元,预计到2032年将达到533亿美元,2024-2032年期间的复合年增长率为6.93%。一次性生物反应器能够透过提供多种优势来组织生物加工工作流程,例如减少资本支出、最大限度地减少清洁和验证要求以及在扩大或缩小生产量方面具有更好的灵活性。主要参与者正在大力投资一次性技术,以最大限度地提高生产流程、最大限度地减少停机时间并实现成本效益。
有利的监管支持和政府政策
监管机构和政府机构透过制定持久的指导方针和框架来确保产品的安全性、有效性和质量,在改变生物製药製造格局方面发挥重要作用。近年来,监管界越来越认识到一次性生物反应器(SUB)的好处。美国食品药物管理局 (FDA) 和欧洲药品管理局 (EMA) 等监管机构一直支持一次性技术,因为它们能够降低污染风险并提高流程效率。这种监管支持为 SUB 的采用提供了有利的环境,鼓励生物製药公司投资这些系统。
The global single-use bioreactors market size reached USD 3.9 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 12.4 Billion by 2033, exhibiting a growth rate (CAGR) of 13.1% during 2025-2033. The market is propelled by the increasing demand for biopharmaceuticals, cost-efficiency and scalability offered by the product, significant developments in single-use technology, increasing product adoption in contract manufacturing organizations (CMOs), rising usage in cell and gene therapy production.
Major Market Drivers: Increasing demand for biopharmaceuticals, cost-efficiency and scalability offered by the product, and significant developments in single-use technology are some of the major market drivers.
Key Market Trends: Growing product adoption in contract manufacturing organizations (CMOs), increasing utilization in cell and gene therapy productions, and significant advancements in bioreactor design are some single-use bioreactors key market trends.
Geographical Trends: North America dominates the market on account of the increasing usage of biopharmaceuticals, rising investment in bioprocessing technologies, and growing benefits of single-use systems more than conventional-steel bioreactors.
Competitive Landscape: ABEC Inc., Cellexus, Celltainer Biotech B.V., CESCO Bioengineering Co. Ltd., Distek Inc., Eppendorf SE, General Electric Company, Getinge AB, Merck KGaA, Pall Corporation (Danaher Corporation), PBS Biotech Inc., Sartorius AG and Thermo Fisher Scientific Inc., are among some of the key players in the single-use bioreactors industry.
Challenges and Opportunities: Some of the challenges of the industry include high initial product costs and increasing concerns about plastic waste. Whereas, opportunities of the market include the significant technological developments in single-bioreactor designs and the rising demand for personalized medicine and small-batch production.
Rising Adoption of Biopharmaceuticals
The biopharmaceutical industry is rapidly growing on account of the increasing demand for new and effective treatments for numerous diseases, including chronic diseases, such as diabetes, cancer, and autoimmune disorders. According to the IMARC GROUP, the global biopharmaceuticals market has reached US$ 300.5 Billion in 2023, and is expected to reach US$ 643.9 Billion by 2032, exhibiting a CAGR of 8.6% during 2024-2032. Biopharmaceuticals which possess vaccines, monoclonal antibodies, and recombinant proteins, are produced using living cells, which need highly specialized production environments. Single-use bioreactors (SUBs) are highly adopted on account of their cost-efficiency, flexibility, and reduced risk of cross-contamination. They allow quicker product development and production times, thus enabling biopharmaceutical companies to rapidly cater to these demands and develop new therapies for patients.
Rising Investment in Bioprocessing Technologies
The rising investment in bioprocessing technologies is increasing as they seek to improve their production capabilities and enhance operational efficiencies. As per a report published by the IMARC GROUP, the global bioprocess technology market has reached US$ 29.2 Billion in 2023, and is expected to reach US$ 53.3 Billion by 2032, exhibiting a CAGR of 6.93% during 2024-2032. Single-use bioreactors are able to organize the bioprocessing workflow by offering a wide variety of benefits such as reduced capital expenditure, minimized cleaning and validation requirements, and better flexibility in scaling up or down production volumes. Key players are extensively investing in single-use technologies to maximize their production processes, minimize downtime, and achieve cost-efficiency.
Favorable Regulatory Support and Favorable Government Policies
Regulatory agencies and government bodies play a major role in evolving the landscape of biopharmaceutical manufacturing by enduring guidelines and frameworks that guarantee product safety, efficacy, and quality. In recent years, there has been a growing recognition of the benefits of single-use bioreactors (SUBs) within the regulatory community. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have been supportive of single-use technologies due to their ability to reduce contamination risks and improve process efficiencies. This regulatory support has provided a conducive environment for the adoption of SUBs, encouraging biopharmaceutical companies to invest in these systems.
Single-use bioreactor systems accounts for the majority of the market share
The single-use bioreactors market report has provided a detailed breakup and analysis of the market based on the product type. This includes single-use bioreactor systems, media bags, filtration assemblies, and others. According to the report, single-use bioreactor systems represented the largest segment.
Single-use bioreactor systems dominate the market on account of the numerous benefits offered by them. These are meant for single time usage, which eliminates the need of the vigorous cleaning and sterilization procedure that stainless-steel bioreactors need. This in turn minimizes the downtime between production runs, improves operational efficiency, and reduces the risk of cross-contamination, which is vital in biopharmaceutical production.
Stirred tank bioreactors holds the largest share in the industry
Stirred tank bioreactors hold maximum number of single-use bioreactors market share on account of their efficiency, scalability, and versatility in a wide variety of bioprocessing applications. These bioreactors are built to offer optimized mixing and aeration conditions, which are vital for maintaining uniform cell culture environments and achieving high cell densities and product results. This type of single-use bioreactors is appropriate for both microbial and mammalian cell cultures, thereby making it a preferred choice for creating a wide variety of biopharmaceutical products, such as vaccines, monoclonal antibodies, and recombinant proteins.
Mammalian cell represents the leading market segment
Mammalian cells hold the largest market share due to several critical factors. Initially, mammalian cells are critical for producing complex biopharmaceuticals such as monoclonal antibodies, recombinant proteins, and vaccines. These therapeutic agents need mammalian cells for their post-translational modifications, which are crucial for their functional and structural integrity. Unlike microbial or yeast cells, mammalian cells can perform glycosylation and other modifications that are vital for the efficacy and safety of biopharmaceutical products. Mammalian cells possess the ability to produce human-like glycosylation patterns which further makes them irreplaceable for the development of biologics that need to mimic natural human proteins closely.
Vaccines exhibits a clear dominance in the market
Vaccines represent the largest segment due to several compelling factors, such as the rising global demand for vaccines, driven by the continuous upsurge of infectious diseases and the need for rapid and effective immunization strategies. The COVID-19 pandemic is a notable instance that has underlined the importance of vaccines, promoting unprecedented investments in vaccine research, development, and production. Single-use bioreactors have become indispensable in this context because of their flexibility, scalability, and ability to support quick production cycles, which are critical for meeting urgent vaccine demands.
Pharmaceutical and biopharmaceutical companies are the primary end users of single-use bioreactors. These organizations leverage single-use systems for the production of a wide range of therapeutics, including monoclonal antibodies, recombinant proteins, and, notably, vaccines.
Contract Research Organizations (CROs) are significant users of single-use bioreactors, offering outsourced research services to pharmaceutical and biopharmaceutical companies. CROs utilize these systems to conduct various stages of drug development, including preclinical and clinical research.
Academic and research institutes play a crucial role in the innovation and development of new bioprocessing technologies. These institutions use single-use bioreactors for experimental and educational purposes, focusing on the research and development of new drugs, vaccines, and therapeutic proteins.
North America leads the market, accounting for the largest single-use bioreactors market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America is the largest segment in the single-use bioreactors market by region due to several key factors. The region is home to a robust biopharmaceutical industry with significant investment in research and development. The presence of major pharmaceutical and biotechnology companies, coupled with a strong focus on innovation and advanced manufacturing technologies, drives the demand for single-use bioreactors. Additionally, North America benefits from well-established regulatory frameworks and government support for biopharmaceutical production, particularly in response to public health challenges such as the COVID-19 pandemic.
The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the single use bioreactors industry include ABEC Inc., Cellexus, Celltainer Biotech B.V., CESCO Bioengineering Co. Ltd., Distek Inc., Eppendorf SE, General Electric Company, Getinge AB, Merck KGaA, Pall Corporation (Danaher Corporation), PBS Biotech Inc., Sartorius AG and Thermo Fisher Scientific Inc.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
Key players in the single-use bioreactors industry have undertaken several strategic efforts to drive market growth and innovation. Companies such as Thermo Fisher Scientific, Sartorius Stedim Biotech, and GE Healthcare are at the forefront of these initiatives. One major area of focus has been the continuous enhancement of product portfolios through research and development. These companies invest heavily in developing new and improved bioreactor designs that offer greater efficiency, scalability, and ease of use. Innovations such as automated control systems, improved sensors, and better materials for bioreactor components are some of the advancements being pursued.
Figure 98 Middle East and Africa: Single-use Bioreactor Market: Sales Value (in Million USD), 2019 & 2024