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市场调查报告书
商品编码
1663327
一次性生物反应器 - 市场洞察、竞争格局、2032年市场预测Single-use Bioreactors - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
2024年全球一次性生物反应器市场规模价值为 30.9217亿美元,预计到2032年将达到 103.1591亿美元,预测期内(2025-2032年)的年复合成长率为 16.33%。
一次性生物反应器的市场动态
生物製药产业对一次性技术的快速应用推动全球一次性生物反应器市场的显着成长。这一趋势的主要驱动因素是成本效益、降低污染风险和提高製造灵活性等。与传统的不銹钢系统相比,一次性生物反应器所需的资本投资较少,并且不需要大量的清洁或验证,这可以显着节省成本。这些优势对于缺乏资源开发大规模基础设施的小型生物技术公司和合约製造组织(CMO)尤其有价值。
例如,西班牙 CDMO mAbxience 于2023年 4月在其莱昂工厂安装了 ABEC 的4,000L 一次性生物反应器,以提高生产效率,同时最大限度地降低营运成本。同样,WuXi Biologics在其无锡工厂安装了多个 4,000L 一次性生物反应器,标誌着业界向更安全、更合规和可扩展的製造解决方案转变。
由于一次性生物反应器是一次性的,因此批次之间交叉污染的风险大大降低。在生产疫苗和单株抗体等敏感生物製剂时,这是一个非常重要的优势,因为即使是最小的污染也会导致安全问题和经济损失。
预计这些因素将在2025-2032年预测期内推动全球一次性生物反应器市场的发展。然而,一次性系统产生的越来越多的塑胶垃圾带来了环境问题,并可能对市场成长构成小小的挑战。
北美预计将主导整个一次性生物反应器市场
预计到2024年北美将占据全球一次性生物反应器市场的最大占有率。该地区的主导地位归功于其成熟的生物製药行业,其中Pfizer、Moderna 和Amgen等大公司在先进生物加工技术的采用方面处于领先地位。人们对生物製剂、细胞和基因疗法以及个人化医疗的日益关注,进一步推动了这些领域对灵活製造解决方案的需求,而一次性生物反应器在其中具有显着的优势。
FDA 等机构的监管支持鼓励创新,主要製造商和研究机构的存在加速了产品开发。此外,对生物技术基础设施的投资不断增加以及临床试验的扩大也推动了对可扩展、经济高效的生产解决方案的需求。
一次性技术在北美的快速应用是由于这些系统提供的灵活性、可扩展性和营运效率。生物製药公司依靠一次性生物反应器来实现快速生产设置、无缝批次转移和最小污染风险,这对于在严格监管的环境中维持产品安全和品质非常重要。与需要大量清洁和消毒的传统不銹钢系统不同,一次性生物反应器可减少停机时间和营运成本,因此对合约製造组织(CMO)和小型生物技术公司特别有吸引力。
随着临床试验和生物製剂製造转向更小的批量和连续处理,一次性系统的多功能性使公司能够快速适应不断变化的生产需求。美国市场的成长将进一步受到新产品创新的推动。例如,美国公司Agilitech于2021年10月推出了Agilitech生物反应器控制器。此控制器最多可管理两个容量从 30L 到 2,000L 的一次性生物反应器。
考虑到所有这些因素,预计北美一次性生物反应器市场在预测期内将实现健康成长。
本报告研究了全球一次性生物反应器市场,并提供了有关市场规模和预测、过去三年的产品/技术发展、市场主要参与者和可用机会的资讯。
Single-use Bioreactors Market by Capacity (<=10 L, 11-100 L, 101-500 L, 501-1,500 L, and Above 1,500 L), Product (System and Accessories), Type (Stirred Tank Bioreactors, Wave-Induced Bioreactors, Bubble-Column Bioreactors, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rapid adoption of single-use technologies by the industries, minimal risk of contamination between batches, and growing product development activities across the globe.
The single-use bioreactors market was valued at USD 3,092.17 million in 2024, growing at a CAGR of 16.33% during the forecast period from 2025 to 2032 to reach USD 10,315.91 million by 2032. The rapid adoption of single-use technologies, especially in biopharmaceutical manufacturing, is driven by their flexibility and efficiency, allowing quick setup for various processes to meet the growing demand for diverse bioproducts. The minimal risk of contamination between batches enhances product safety and quality, crucial in regulated environments, while also reducing cleaning and validation costs. Additionally, increased product development activities in biologics and personalized medicine require innovative manufacturing solutions for smaller batch sizes and rapid production adjustments. Collectively, these factors are expected to drive the market for single-use bioreactors, establishing them as a preferred choice in modern biomanufacturing during the forecast period from 2025 to 2032.
Single-use Bioreactors Market Dynamics:
The rapid adoption of single-use technologies in the biopharmaceutical industry is driving significant growth in the global single-use bioreactor market. This trend is fueled by key advantages such as cost efficiency, reduced contamination risk, and enhanced manufacturing flexibility. Compared to traditional stainless-steel systems, single-use bioreactors require lower capital investment and eliminate the need for extensive cleaning and validation, resulting in substantial cost savings. These benefits are particularly valuable for small biotech companies and contract manufacturing organizations (CMOs) with limited resources for large-scale infrastructure.
For example, in April 2023, Spanish CDMO mAbxience installed a 4,000 L single-use bioreactor from ABEC at its Leon facility to improve production efficiency while minimizing operational costs. Similarly, WuXi Biologics implemented multiple 4,000 L single-use bioreactors at its Wuxi facility, underscoring the industry's shift toward safer, more compliant, and scalable manufacturing solutions.
The disposable nature of single-use bioreactors significantly reduces the risk of cross-contamination between batches a critical advantage in producing sensitive biologics such as vaccines and monoclonal antibodies, where even minor contamination can lead to safety concerns and financial losses.
These factors are projected to propel the global single-use bioreactor market during the 2025-2032 forecast period. However, the increased plastic waste generated by disposable systems raises environmental concerns, which may pose a minor challenge to market growth.
Single-use Bioreactors Market Segment Analysis:
Single-use Bioreactors Market by Capacity (<=10 L, 11-100 L, 101-500 L, 501-1,500 L, and Above 1,500 L), Product (System and Accessories), Type (Stirred Tank Bioreactors, Wave-Induced Bioreactors, Bubble-Column Bioreactors, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the capacity segment of the single-use bioreactors market, bioreactors exceeding 1,500 liters are projected to capture a significant revenue share in 2024. The growing adoption of these large-capacity systems is significantly driving the market, enabling biopharmaceutical manufacturers to scale up production efficiently while benefiting from the core advantages of single-use technologies reduced contamination risk, minimized cleaning and validation requirements, and faster turnaround times.
Leading industry players like Lonza and Sartorius have made notable strides in developing large-volume single-use bioreactors to streamline the production of biologics, including monoclonal antibodies and vaccines. For example, in June 2024, WuXi Biologics, a global Contract Research, Development, and Manufacturing Organization (CRDMO), successfully installed three 5,000 L single-use bioreactors at its Hangzhou facility, enhancing large-scale drug substance manufacturing capabilities.
The integration of high-capacity single-use bioreactors into existing manufacturing workflows reduces the need for extensive infrastructure modifications typically associated with traditional stainless-steel systems. This operational flexibility is vital for companies aiming to optimize production without incurring significant capital expenditures. As biopharmaceutical manufacturers increasingly focus on process intensification and adopt continuous manufacturing practices, larger single-use bioreactors offer the scalability needed to achieve higher yields within shorter production cycles.
These factors of scalability, operational efficiency, and improved product quality are propelling the growth of the above 1,500 L capacity segment, thereby contributing to the overall expansion of the global single-use bioreactors market.
North America is expected to dominate the overall single-use bioreactors market:
North America is projected to hold the largest share of the global single-use bioreactors market in 2024. The region's dominance is driven by its well-established biopharmaceutical sector, with key players such as Pfizer, Moderna, and Amgen leading the adoption of advanced bioprocessing technologies. The growing focus on biologics, cell and gene therapies, and personalized medicine further fuels the demand for flexible manufacturing solutions in an area where single-use bioreactors offer significant advantages.
Regulatory support from agencies like the FDA encourages innovation, while the presence of leading manufacturers and research institutions accelerates product development. Additionally, increasing investments in biotechnology infrastructure and the expanding number of clinical trials heighten the need for scalable, cost-effective production solutions.
The surge in single-use technology adoption across North America stems from the flexibility, scalability, and operational efficiency these systems provide. Biopharmaceutical companies are leveraging single-use bioreactors for faster production setup, seamless batch transitions, and minimal contamination risk crucial for maintaining product safety and quality in highly regulated environments. Unlike traditional stainless-steel systems that require extensive cleaning and sterilization, single-use bioreactors reduce downtime and operational costs, making them particularly attractive to contract manufacturing organizations (CMOs) and smaller biotech firms.
As clinical trials and biologics manufacturing increasingly shift toward smaller batch sizes and continuous processing, the versatility of single-use systems enables companies to adapt swiftly to evolving production demands. The market's growth in the U.S. is further bolstered by new product innovations. For example, in October 2021, Agilitech a U.S.-based company launched the Agilitech bioreactor controller, capable of managing up to two single-use bioreactors with capacities ranging from 30 L to 2,000 L. Its flexible design ensures compatibility with various single-use bioreactor brands, reflecting industry-wide efforts to enhance manufacturing agility.
Collectively, these factors are expected to drive robust growth in the North American single-use bioreactors market over the forecast period.
Single-use Bioreactors Market Key Players:
Some of the key market players operating in the single-use bioreactors market include Getinge AB, Agilitech, WuXi Biologics, mAbxience, Eppendorf AG, Sartorius AG, Cytiva Life Sciences, Merck KGaA, Bionet, OmniBRx Biotechnologies, Thermo Fisher Scientific Inc., Pall Corporation, Distek, Inc., AGC Biologics, Celltainer, Applikon Biotechnology, Biolinx Labsystems, Sartorius Stedim Biotech, Solaris Biotech, Synthecon, and others.
Recent Developmental Activities in the Single-use Bioreactors Market:
Key Takeaways from the Single-use Bioreactors Market Report Study
Target Audience Who Can be Benefited from this Single-use Bioreactors Market Report Study
Frequently Asked Questions for the Single-use Bioreactors Market: