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市場調査レポート
商品コード
1722407
シングルユースバイオリアクター市場レポート:製品タイプ、タイプ、細胞タイプ、分子タイプ、エンドユーザー、地域別、2025年~2033年Single-Use Bioreactors Market Report by Product Type, Type, Cell Type, Molecule Type, End User, and Region 2025-2033 |
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シングルユースバイオリアクター市場レポート:製品タイプ、タイプ、細胞タイプ、分子タイプ、エンドユーザー、地域別、2025年~2033年 |
出版日: 2025年05月01日
発行: IMARC
ページ情報: 英文 149 Pages
納期: 2~3営業日
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世界のシングルユースバイオリアクターの市場規模は2024年に39億米ドルに達しました。今後、IMARC Groupは、同市場が2033年までに124億米ドルに達し、2025年から2033年にかけて13.1%の成長率(CAGR)を示すと予測しています。同市場は、バイオ医薬品需要の増加、同製品が提供するコスト効率と拡張性、シングルユース技術の大幅な市場開拓、製造受託機関(CMO)における同製品の採用増加、細胞治療および遺伝子治療生産における使用量の増加などによって推進されています。
主な市場促進要因:バイオ医薬品需要の増加、製品が提供するコスト効率と拡張性、シングルユース技術の著しい発展などが主な市場促進要因として挙げられます。
主な市場動向:受託製造機関(CMO)における製品採用の増加、細胞治療および遺伝子治療製造における利用の増加、バイオリアクター設計の大幅な進歩などがシングルユースバイオリアクターの主要市場動向です。
地理的動向:バイオ医薬品の使用量の増加、バイオプロセス技術への投資の増加、従来のスチール製バイオリアクターよりもシングルユースシステムの利点が高まっていることから、北米が市場を独占しています。
競合情勢: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、Thermo Fisher Scientific Inc.などがシングルユースバイオリアクター業界の主要プレーヤーです。
課題と機会:業界の課題としては、製品の初期コストの高さやプラスチック廃棄物に対する懸念の高まりなどが挙げられます。一方、市場開拓の機会としては、シングルバイオリアクター設計の大幅な技術開拓、個別化医療や少量生産の需要の高まりなどが挙げられます。
バイオ医薬品の採用拡大
バイオ医薬品業界は、糖尿病、がん、自己免疫疾患などの慢性疾患を含む数多くの疾患に対する新規かつ効果的な治療に対する需要の高まりにより、急速に成長しています。IMARC GROUPによると、世界のバイオ医薬品市場は2023年に3,005億米ドルに達し、2032年には6,439億米ドルに達すると予想され、2024-2032年のCAGRは8.6%です。ワクチン、モノクローナル抗体、組換えタンパク質を有するバイオ医薬品は、生きた細胞を用いて生産されるため、高度に専門化された生産環境が必要とされます。シングルユースバイオリアクター(SUB)は、そのコスト効率、柔軟性、交差汚染のリスクの低減を理由に、非常に多く採用されています。SUBは迅速な製品開発と生産時間を可能にするため、バイオ製薬企業はこうした需要に迅速に対応し、患者のための新しい治療法を開発することができます。
バイオプロセス技術への投資の増加
バイオプロセス技術への投資が増加しているのは、生産能力を向上させ、業務効率を高めようとしているためです。IMARC GROUPが発表したレポートによると、世界のバイオプロセス技術市場は2023年に292億米ドルに達し、2032年には533億米ドルに達すると予測され、2024年から2032年のCAGRは6.93%です。シングルユースバイオリアクターは、資本支出の削減、洗浄およびバリデーション要件の最小化、生産量の増減における柔軟性の向上など、さまざまな利点を提供することにより、バイオプロセスのワークフローを整理することができます。主要企業は、生産プロセスを最大化し、ダウンタイムを最小化し、コスト効率を達成するため、シングルユース技術に幅広く投資しています。
有利な規制支援と有利な政府政策
規制当局や政府機関は、製品の安全性、有効性、品質を保証するガイドラインや枠組みを永続させることで、バイオ医薬品製造の情勢を進化させる上で大きな役割を果たしています。近年、規制当局の間でもシングルユースバイオリアクター(SUB)の利点が認識されつつあります。米国食品医薬品局(FDA)や欧州医薬品庁(EMA)などの規制機関は、汚染リスクを低減し、プロセス効率を向上させるシングルユース技術を支持してきました。このような規制当局の支援は、SUBの採用に好都合な環境を提供し、バイオ医薬品企業にこれらのシステムへの投資を促しています。
Figure 98 Middle East and Africa: Single-use Bioreactor Market: Sales Value (in Million USD), 2019 & 2024
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.