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市場調査レポート
商品コード
1718953
単回使用バイオリアクター市場:製品別、モジュールタイプ別、細胞タイプ別、用途別、エンドユーザー別、地域別、機会、予測、2018年~2032年Single-use Bioreactors Market Assessment, By Product, By Type of Module, By Cell Type, By Application, By End-user, By Region, Opportunities and Forecast, 2018-2032F |
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カスタマイズ可能
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単回使用バイオリアクター市場:製品別、モジュールタイプ別、細胞タイプ別、用途別、エンドユーザー別、地域別、機会、予測、2018年~2032年 |
出版日: 2025年05月05日
発行: Market Xcel - Markets and Data
ページ情報: 英文 404 Pages
納期: 3~5営業日
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世界の単回使用バイオリアクターの市場規模は、予測期間の2025年~2032年に18.37%のCAGRで拡大し、2024年の42億2,572万米ドルから2032年には160億2,594万米ドルに成長すると予測されています。単回使用バイオリアクター市場はヘルスケア産業の重要な一部であり、ヘルスケア市場で大きな市場規模を占めています。汚染リスクの低減、技術の進歩、新興企業や中小企業での採用の増加、従来のバイオリアクターに対する優位性などの要因が市場成長の原動力となっています。ディスポーザブルバイオリアクター市場は、バイオ医薬品企業が医薬品開発・製造の柔軟性、スピード、効率を向上させるために単回使用バイオリアクターシステムを導入するケースが増えており、急速に変化しています。これらの滅菌済みのディスポーザブルバッグやコンポーネントベースのシステムは、従来のステンレス製バイオリアクターに比べて、交差汚染のリスクが低い、洗浄やバリデーションの工程が不要、設置やメンテナンスのコストが低いなど、いくつかの利点があり、小規模なバイオテクノロジー企業、受託製造機関、個別化医薬品のバイオ治療薬やバイオシミラーメーカーに非常に適しています。生物製剤、ワクチン、細胞・遺伝子治療薬の開発により、スケーラブルでモジュール化されたバイオプロセス技術への需要が高まっており、単回使用バイオリアクターは製品開発サイクルの迅速化と厳格な規制要求へのコンプライアンスの簡素化を促進しています。技術の進歩により、これらのシステムの信頼性、安全性、材料の品質が向上している一方、継続的な技術革新により、抽出物、溶出物、バッチ間の性能の一貫性に関する懸念が満たされています。このような利点がある一方で、ステンレス鋼製システムに比べて製造の初期コストが高いこと、サプライヤー間で標準化を進める必要があること、組み立て時や操作時の無菌性保証が複雑であることなどの課題が、市場の足かせとなっています。
バイオプロセス分野における単回使用バイオリアクター市場は、バイオ医薬品およびバイオテクノロジーの様々な用途に使用される単回使用バイオリアクターシステムの設計、製造、展開に特化しています。これらのシステムは、発酵、タンパク質発現、細胞増殖などの細胞培養活動に効果的で手頃なソリューションを提供することで、従来のステンレス製バイオリアクターの需要を削減しています。バイオ製薬会社は、パンデミックにオンラインで対応する汎用性の高い技術を使用し、SARS-CoV-2ウイルスに対するワクチンの迅速な大量製造の必要性を高めました。単回使用システムは、コロナウイルスと、速いペースでの大規模ワクチン製造の必要性により、大きな需要を目の当たりにしました。これが、パンデミック後の単回使用バイオリアクター市場の拡大につながっています。
2025年3月、英国政府のUK InnovateスキームとCentre for Process Innovation Limitedが245万米ドルの予算で共同開発した「Project Nexus」には、Photocentric Ltd、Sartorius AG、シェフィールド大学が参加しました。このプロジェクトの目標は、バイオリアクターなどの単回使用バイオプロセス技術用の持続可能なバイオベース材料の創出です。高度な3Dプリンティングを取り入れ、生体適合性樹脂を利用することで、プラスチック廃棄物を削減し、リサイクル性を高め、循環型経済コンセプトをサポートします。このプロジェクトは、ネットゼロの野望とともに、新素材と持続可能なアプローチを通じてバイオプロセスを変革することを目指しています。このプロジェクトは、気候変動と環境を取り巻く懸念の高まりの中で、バイオ医薬品市場の成長と環境意識のバランスを取りながら、バイオ加工に取り組む方法のパラダイムを転換するものです。
当レポートでは、世界の単回使用バイオリアクター市場について調査し、市場の概要とともに、モジュールタイプ別、細胞タイプ別、用途別、エンドユーザー別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。
Global single-use bioreactors market is projected to witness a CAGR of 18.37% during the forecast period 2025-2032, growing from USD 4,225.72 million in 2024 to USD 16,025.94 million in 2032. The single-use bioreactors market is an important part of the healthcare industry, accounting for a significant market size in the healthcare market. Factors such as reduced risk of contamination, technological advancements, increased adoption among startups and SMEs (small and medium-sized enterprises), and advantages over traditional bioreactors drive the market growth. The disposable bioreactor market is fast-changing as biopharmaceutical companies more and more implement disposable bioreactor systems to improve flexibility, speed, and efficiency in drug development and manufacture. These pre-sterilized, disposable bag and component-based systems pose several advantages over conventional stainless-steel bioreactors, such as lower risk of cross-contamination, removal of cleaning and validation processes, and lower installation and maintenance costs, making them highly suitable for small biotech companies, contract manufacturing organizations, and biotherapeutic and biosimilar manufacturers of personalized medicines. The growth in biologics, vaccines, and cell and gene therapies is driving demand for scalable and modular bioprocessing technologies, with single-use bioreactors facilitating quicker product development cycles and simpler compliance with rigorous regulatory demands. Advances in technology have enhanced the reliability, safety, and material quality of these systems, while continued innovation is meeting extractables, leachable, and batch-to-batch performance consistency concerns. In spite of these advantages, the market is hampered by such challenges as the greater initial cost of production compared to stainless steel systems, the necessity for more standardization among suppliers, and complexities in sterility assurance during assembly and operation.
The market for single-use bioreactors in the bioprocessing sector is dedicated to the design, production, and deployment of single-use bioreactor systems for a range of biopharmaceutical and biotechnology uses. These systems reduce the demand for conventional stainless-steel bioreactors by offering effective and affordable solutions for cell culture activities including fermentation, protein expression, and cell growth. Biopharmaceutical firms used versatile technology that brought online response to the pandemic, increasing the requirement for quick mass manufacturing of vaccines against the SARS-CoV-2 virus. Single-use systems witnessed huge demand due to coronavirus and the need for large-scale vaccine manufacturing at a fast pace. This led to the expansion of the single-use bioreactors market post pandemic.
In March 2025, "Project Nexus," a collaboration between the UK government's UK Innovate scheme and the Centre for Process Innovation Limited with a budget of USD 2.45 million, included Photocentric Ltd, Sartorius AG and Sheffield University. The project's goal is the creation of sustainable bio-based materials for single use bioprocessing technologies such as bioreactors. It incorporates advanced 3D printing and utilizes biocompatible resins to reduce plastic waste, enhance recyclability, and support circular economic concepts. The project aims to transform bioprocessing through novel materials and sustainable approaches alongside net-zero ambitions. It shifts the paradigm of how bioprocessing is approached within the context of increasing concerns surrounding climate change and the environment, balancing the growth of the biopharmaceutical market with environmental consciousness.
Single-use Bioreactors Offer Clinical Advantages Over Traditional Bioreactors
When compared to stainless steel bioreactors (SSBs), single-use bioreactors (SUBs) have been demonstrated to significantly reduce water consumption and facility energy use. Disposing of single-use parts, however, presents issues with waste production and possible environmental effects. Single-use bioreactors require less maintenance, have quick setup periods, and are simpler to customize in terms of reactor size and configuration as they provide greater flexibility. In research and development applications, where process development is continuous, and production quantities are low, single-use bioreactors can be useful. Additionally, SUBs have shown themselves to be significantly more helpful in facilities that produce many products and in situations where process flexibility is crucial in terms of quantities and product needs. For example, in March 2025, ABEC launched the Advanced Therapy Bioreactor (ATB), a revolutionary single-use bioreactor for Advanced Therapy Medicinal Products (ATMPs). Imitating the human circulatory system, it employs hollow fiber membranes for localized delivery of nutrients and waste removal to support maximum growth. The ATB provides smooth scalability (0.2L to 10L) and closed-system automated operation. It showed high cell viabilities and cell densities for T-cells, CD34+ stem cells, HEK293, and CHO cells. This technology overcomes limitations in advanced therapy manufacturing, which speeds up clinical and commercial timelines while ensuring uniform cell culture conditions on all scales.
Avoiding Risk of Cross-Contamination and Improving Compliance Facilitate the Market Growth
The market for single-use bioreactors continues to grow because bioreactors can be used to reduce cross-contamination events when applied in multi-product biologic manufacturing systems. Stainless steel equipment requires thorough cleaning and sterilization procedures that involve significant labor in terms of worker time and subject the process to human errors, which may introduce contaminating substances to the system. One of the examples pointing out this benefit is the application of BioBLU Single-Use Bioreactors by Eppendorf with sealed magnetic drives to avoid microbial contamination and becoming pre-sterilized and thus eliminating cleaning validation entirely. This technology is extensively used across the biopharmaceutical market, enabling the companies to achieve streamlined operations along with high quality products and regulations. Consequently, the increasing demand for single-use systems is transforming manufacturing processes. For instance, In July 2024, Avantor, Inc. launched two new high-performance reagents for gene therapy manufacturing, J.T. Baker Cell Lysis Solution and J.T. Baker Endonuclease. These reagents will improve the process efficiency and reduce the contamination risk.
Technological Advancements to Advance the Global Single-use Bioreactors Market
Recent substantial technological improvements have led to an increased utilization of single-use bioreactors in biopharmaceutical production. Manufacturers are coming up with new ideas to enhance single-use bioreactor film technologies, designs, stirring motors, and sensor systems. Single-use bioreactors are more effective and efficient for developing cell cultures on a large scale due to such advancements. Improved sensor systems for better process monitoring, control, and improvements in the materials and designs of bioreactor bags can promote cell growth and productivity, including other significant advancements. The AMBR 250 modular, a novel benchtop small bioreactor system for parallel fermentation or cell culture, was launched by Sartorius Stedim Biotech. This system gives bioprocess scientists access to advanced benchtop bioreactor technology for process research by combining a special single-use bioreactor vessel with a flexible system architecture. For instance, in September 2023, Getinge launched the AppliFlex ST GMP, a next-generation single-i bioreactor system that allows bioprocesses to easily move from research in the laboratory to clinical manufacturing. The system is specifically suited for cell and gene therapy processes and mRNA manufacturing, providing scalability and Good Manufacturing Practice (GMP) compliance. In another instance, on March 31, 2025, ABEC, Inc. introduced the Advanced Therapy Bioreactor (ATB), a groundbreaking single-use bioreactor for Advanced Therapy Medicinal Products (ATMPs). Mimicking the human circulatory system, it uses hollow fiber membranes for localized nutrient delivery and waste removal, ensuring optimal cell growth. The ATB offers seamless scalability (0.2L to 10L) and automated, closed-system operation. It demonstrated high cell densities and viabilities for T-cells, CD34+ stem cells, HEK293, and CHO cells. This innovation addresses challenges in advanced therapy manufacturing, accelerating clinical and commercial timelines while maintaining consistent cell culture conditions across all scales.
Single-use Bioreactor Systems to Dominate Market
In 2024, the single-use bioreactor systems segment accounts for the highest market share in the global single-use bioreactors market. Systems for single-use bioreactors are frequently used in biopharmaceutical manufacturing procedures when a high product yield is necessary. Single-use bioreactors' adaptability, affordability, and high capacity for mass production would spur consumer demand and propel the industry's rapid expansion. The need for faster discovery and increased production of novel bio-therapeutics, such as vaccines, antibodies, enzymes, and hormones, and a rise in the product quantities that these bioreactors can generate are expected to drive the growth of market. Over the forecast period, the category will rise due to major manufacturers' increased focus on providing small-scale bioreactors.
In June 2024, WuXi Biologics Cayman Inc, a CRDMO, announced that its pharmaceutical manufacturing plant in Hangzhou had installed three sets of 5,000L single-use bioreactors in the second drug substance line. The facility's overall capacity will rise from 8,000L to 23,000L due to the recently installed bioreactors, substantially enhancing the company's manufacturing capabilities for clients throughout the world.
North America Leads the Single Use Bioreactor Market
North America is the biggest player in the single-use bioreactor market worldwide, thanks to the widespread presence of prominent biopharmaceutical firms, strong uptake of next-generation bioprocessing technology, and a highly developed regulatory regime. The United States dominates the region with large investments in biologics, biosimilars, and manufacturing of cell and gene therapies. The increasing activity of CDMOs and biopharma growth in Canada and Mexico is further driving market expansion. Further, positive government policies, growth in R&D spending, and the swift movement towards flexible and scalable single-use manufacturing solidify North America's global market dominance. For instance, in November 2024, Avantor, Inc. inaugurated its new Bridgewater Innovation Center in New Jersey, United States. This state-of-the-art facility tackles critical challenges in life science, biopharma, and advanced technological sectors. The center focuses on scientific collaboration, material innovation, and process optimization to accelerate drug development and manufacturing.
Asia-Pacific is Expected to Grow at the Fastest Pace in the Forecast Period
The single-use bioreactor market in Asia-Pacific is anticipated to grow at a high CAGR due to generic medicine manufacturers and recent biosimilar industry players based in the region. It faces commercial pressure to quickly scale up production utilizing disposable technology at reduced prices. Growing population and changing disease patterns are driving the demand for biopharmaceuticals and vaccines throughout Asia. Local companies have opted for single-use solutions to expedite facility construction and accelerate their services in the market.
In the second half of 2024, Syngene International Ltd, a global contract research, development, and manufacturing organization (CRDMO), will begin clinical and commercial supply of its recently renovated biologics facility (Unit 3) in Bangalore, India, to clients in the United States and Europe. With two production chambers and five 2KL single-use bioreactors each, the machines have a production capacity of 20KL.
Future Market Scenario (2025-2032F)
The biopharmaceutical manufacturing sector is rapidly adopting single-use bioreactors as they are better than traditional systems in numerous ways. Advantages include faster turnaround times between production runs, reduced risk of cross-contamination, and lower capital investment.
Single-use bioreactors are predominantly employed in the manufacturing of biopharmaceuticals. However, their usage extends to other areas such as the food and beverage industry, agriculture, and environmental science sector.
More sustainable practices are being supported by single-use bioreactors such as sustainability, which is increasingly becoming an urgent challenge in biomanufacturing. These practices will reduce waste generation, save energy expenses through reducing water and chemical usage and eliminating cleaning and sterilization requirements.
Continuous technological advancements are expected to enhance the performance and reliability of single-use bioreactors in the future. New technologies that can become part of single-use bioreactors include advanced sensors for real-time monitoring, integration of artificial intelligence (AI), machine learning (ML), 3D printing, and IoT devices.
Key Players Landscape and Outlook
Several medical device companies and biotech companies are flourishing in the single-use bioreactors market by planning and adopting new strategies. They are complying with new strategic initiatives for antimicrobial susceptibility testing devices to increase their market presence. New agreements, contracts, acquisitions mergers, investments, and partnerships are major ways through which they try to achieve higher market share.
In August 2023, Repligen XCell ATF upstream intensification technology was incorporated into Sartorius Stedim Biotech Inc's Biostat STR bioreactor as part of an integrated bioreactor system. A completely compatible embedded XCell ATF hardware and software module that offers predefined advanced control recipes with integrated Process Analytical Technology (PAT) is now included in the Biostat STR. A single point of control for 50 L-2000 L upstream intensification processes, developed by the integration of the XCell Controller hardware and software into the Biobrain automation platform, allowing clients to make greater use of their facility space with a smaller equipment footprint.
In September 2024, Getinge AB completed the acquisition of Paragonix Technologies, Inc., a leading organ transport products and services company. This strategic move strengthens Getinge's position in the organ preservation and transportation market, leveraging Paragonix's innovative technologies and expanding global healthcare solutions.
In June 2024, Aragen Bioscience, Inc. successfully validated Getinge AB's SUPR bioreactor (Single-Use Production Reactor) for large-scale recombinant antibody production. The study demonstrated the SUPR system's exceptional performance in generating high-quality recombinant antibodies.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.