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市場調查報告書
商品編碼
1663327
一次性生物反應器 - 市場洞察、競爭格局、2032年市場預測Single-use Bioreactors - Market Insights, Competitive Landscape, and Market Forecast - 2032 |
2024年全球一次性生物反應器市場規模價值為 30.9217億美元,預計到2032年將達到 103.1591億美元,預測期內(2025-2032年)的年複合成長率為 16.33%。
一次性生物反應器的市場動態
生物製藥產業對一次性技術的快速應用推動全球一次性生物反應器市場的顯著成長。這一趨勢的主要驅動因素是成本效益、降低污染風險和提高製造靈活性等。與傳統的不銹鋼系統相比,一次性生物反應器所需的資本投資較少,並且不需要大量的清潔或驗證,這可以顯著節省成本。這些優勢對於缺乏資源開發大規模基礎設施的小型生物技術公司和合約製造組織(CMO)尤其有價值。
例如,西班牙 CDMO mAbxience 於2023年 4月在其萊昂工廠安裝了 ABEC 的4,000L 一次性生物反應器,以提高生產效率,同時最大限度地降低營運成本。同樣,WuXi Biologics在其無錫工廠安裝了多個 4,000L 一次性生物反應器,標誌著業界向更安全、更合規和可擴展的製造解決方案轉變。
由於一次性生物反應器是一次性的,因此批次之間交叉污染的風險大大降低。在生產疫苗和單株抗體等敏感生物製劑時,這是一個非常重要的優勢,因為即使是最小的污染也會導致安全問題和經濟損失。
預計這些因素將在2025-2032年預測期內推動全球一次性生物反應器市場的發展。然而,一次性系統產生的越來越多的塑膠垃圾帶來了環境問題,並可能對市場成長構成小小的挑戰。
北美預計將主導整個一次性生物反應器市場
預計到2024年北美將佔據全球一次性生物反應器市場的最大佔有率。該地區的主導地位歸功於其成熟的生物製藥行業,其中Pfizer、Moderna 和Amgen等大公司在先進生物加工技術的採用方面處於領先地位。人們對生物製劑、細胞和基因療法以及個人化醫療的日益關注,進一步推動了這些領域對靈活製造解決方案的需求,而一次性生物反應器在其中具有顯著的優勢。
FDA 等機構的監管支持鼓勵創新,主要製造商和研究機構的存在加速了產品開發。此外,對生物技術基礎設施的投資不斷增加以及臨床試驗的擴大也推動了對可擴展、經濟高效的生產解決方案的需求。
一次性技術在北美的快速應用是由於這些系統提供的靈活性、可擴展性和營運效率。生物製藥公司依靠一次性生物反應器來實現快速生產設置、無縫批次轉移和最小污染風險,這對於在嚴格監管的環境中維持產品安全和品質非常重要。與需要大量清潔和消毒的傳統不銹鋼系統不同,一次性生物反應器可減少停機時間和營運成本,因此對合約製造組織(CMO)和小型生物技術公司特別有吸引力。
隨著臨床試驗和生物製劑製造轉向更小的批量和連續處理,一次性系統的多功能性使公司能夠快速適應不斷變化的生產需求。美國市場的成長將進一步受到新產品創新的推動。例如,美國公司Agilitech於2021年10月推出了Agilitech生物反應器控制器。此控制器最多可管理兩個容量從 30L 到 2,000L 的一次性生物反應器。
考慮到所有這些因素,預計北美一次性生物反應器市場在預測期內將實現健康成長。
本報告研究了全球一次性生物反應器市場,並提供了有關市場規模和預測、過去三年的產品/技術發展、市場主要參與者和可用機會的資訊。
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: