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市場調查報告書
商品編碼
1722407
2025 年至 2033 年一次性生物反應器市場報告(按產品類型、類型、細胞類型、分子類型、最終用戶和地區)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應器市場規模達 39 億美元。展望未來, IMARC Group預計到 2033 年市場規模將達到 124 億美元,2025-2033 年期間的成長率 (CAGR) 為 13.1%。市場受到生物製藥需求不斷成長、產品提供的成本效益和可擴展性、一次性技術的重大發展、合約製造組織 (CMO) 中產品採用率不斷提高、細胞和基因治療生產中使用率不斷提高的推動。
主要市場促進因素:生物製藥需求的不斷成長、產品提供的成本效益和可擴展性以及一次性技術的重大發展是一些主要的市場促進因素。
主要市場趨勢:合約製造組織 (CMO) 中產品採用率的不斷成長、細胞和基因治療生產中利用率的不斷提高以及生物反應器設計的重大進步是一次性生物反應器的一些主要市場趨勢。
地理趨勢:由於生物製藥的使用量不斷增加、生物加工技術的投資不斷增加以及一次性系統比傳統鋼製生物反應器的優勢不斷增強,北美佔據了市場主導地位。
競爭格局:ABEC Inc.、Cellexus、Celltainer Biotech BV、CESCO Bioengineering Co. Ltd.、Distek Inc.、Eppendorf SE、通用電氣公司、Getinge AB、Merck KGaA、Pall Corporation(丹納赫公司)、PBS Biotech Inc.、Sartorius AG 和賽默世爾?
挑戰與機會:該行業面臨的一些挑戰包括高初始產品成本和對塑膠廢物日益成長的擔憂。然而,市場機會包括單一生物反應器設計的重大技術發展以及個人化醫療和小批量生產日益成長的需求。
生物製藥的採用率不斷上升
由於對多種疾病(包括糖尿病、癌症和自體免疫疾病等慢性疾病)的新型有效治療方法的需求不斷增加,生物製藥產業正在快速成長。根據IMARC GROUP的數據,全球生物製藥市場規模在2023年已達到3,005億美元,預計到2032年將達到6,439億美元,2024-2032年期間的複合年成長率為8.6%。疫苗、單株抗體、重組蛋白等生物製藥都是利用活細胞生產的,需要高度專業的生產環境。一次性生物反應器 (SUB) 因其成本效益高、靈活性強且交叉污染風險低而被廣泛採用。它們可以加快產品開發和生產時間,從而使生物製藥公司能夠快速滿足這些需求並為患者開發新的治療方法。
生物加工技術投資不斷增加
隨著生物加工技術尋求提高生產能力和營運效率,對生物加工技術的投資也不斷增加。根據IMARC GROUP發布的報告,全球生物製程技術市場規模在2023年已達292億美元,預計到2032年將達到533億美元,2024-2032年期間的複合年成長率為6.93%。一次性生物反應器能夠透過提供多種優勢來組織生物加工工作流程,例如減少資本支出、最大限度地減少清潔和驗證要求以及在擴大或縮小生產量方面具有更好的靈活性。主要參與者正在大力投資一次性技術,以最大限度地提高生產流程、最大限度地減少停機時間並實現成本效益。
有利的監管支持和政府政策
監管機構和政府機構透過制定持久的指導方針和框架來確保產品的安全性、有效性和質量,在改變生物製藥製造格局方面發揮重要作用。近年來,監管界越來越認知到一次性生物反應器(SUB)的好處。美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構一直支持一次性技術,因為它們能夠降低污染風險並提高流程效率。這種監管支持為 SUB 的採用提供了有利的環境,鼓勵生物製藥公司投資這些系統。
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