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시장보고서
상품코드
1722407
일회용 바이오리액터 시장 보고서 : 제품 유형, 유형, 세포 유형, 분자 유형, 최종사용자, 지역별(2025-2033년)Single-Use Bioreactors Market Report by Product Type, Type, Cell Type, Molecule Type, End User, and Region 2025-2033 |
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세계 일회용 바이오리액터 시장 규모는 2024년 39억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 124억 달러에 달하고, 2025-2033년 13.1%의 연평균 성장률(CAGR)을 보일 것으로 전망하고 있습니다. 이 시장은 바이오의약품 수요 증가, 비용 효율성과 확장성, 일회용 기술 시장 개척, 위탁생산(CMO)에서의 제품 채택 증가, 세포치료제 및 유전자치료제 생산에 대한 사용량 증가 등에 힘입어 성장세를 보이고 있습니다.
주요 시장 성장 촉진요인 : 바이오 의약품 수요 증가, 제품이 제공하는 비용 효율성과 확장성, 일회용 기술의 눈부신 발전 등이 주요 시장 성장 촉진요인으로 꼽힙니다.
주요 시장 동향 : 위탁생산기관(CMO)의 제품 채택 증가, 세포치료제 및 유전자치료제 생산에 대한 활용 증가, 바이오리액터 설계의 획기적인 발전 등이 일회용 바이오리액터의 주요 시장 동향으로 꼽힙니다.
지리적 동향 : 바이오 의약품 사용량 증가, 바이오프로세스 기술에 대한 투자 증가, 기존 스틸 바이오리액터에 비해 일회용 시스템의 장점으로 인해 북미가 시장을 주도하고 있습니다.
ABEC Inc., Cellexus, Celltainer Biotech B.V., CESCO Bioengineering Co.Ltd., Distek Inc. Merck KGaA, Pall Corporation(Danaher Corporation), PBS Biotech Inc., Sartorius AG, Thermo Fisher Scientific Inc. 등이 일회용 바이오리액터 산업의 주요 업체입니다.
과제와 기회: 업계의 과제로는 높은 제품 초기 비용과 플라스틱 폐기물에 대한 우려 증가를 꼽을 수 있습니다. 반면, 시장 개척의 기회로는 단일 바이오리액터 설계의 획기적인 기술 개발, 개인 맞춤형 의료 및 소량 생산에 대한 수요 증가 등을 꼽을 수 있습니다.
바이오의약품 채용 확대
IMARC GROUP에 따르면, 바이오의약품 산업은 당뇨병, 암, 자가면역질환 등 만성질환을 포함한 수많은 질병에 대한 새롭고 효과적인 치료법에 대한 수요가 증가함에 따라 빠르게 성장하고 있으며, 2023년에는 3,005억 달러에 달하고 2032년에는 6,439억 달러에 이를 것으로 예측됩니다. 는 6,439억 달러에 달할 것으로 예상되며, 2024-2032년 CAGR은 8.6%를 보일 것으로 예측됩니다. 백신, 단클론 항체, 재조합 단백질을 가진 바이오 의약품은 살아있는 세포를 이용하여 생산되기 때문에 고도로 전문화된 생산 환경이 필요합니다. 일회용 바이오리액터(SUB)는 비용 효율성, 유연성, 교차 오염의 위험 감소 등의 이유로 많이 사용되고 있으며, SUB는 빠른 제품 개발 및 생산 시간을 가능하게 함으로써 바이오 제약사가 이러한 수요에 빠르게 대응하고 환자를 위한 새로운 치료법을 개발할 수 있도록 도와줍니다. 할 수 있습니다.
바이오프로세스 기술에 대한 투자 증가
IMARC GROUP이 발표한 보고서에 따르면, 세계 바이오프로세스 기술 시장은 2023년 292억 달러, 2032년 533억 달러에 달할 것으로 예상되며, 2024년부터 2032년까지 연평균 6.93%의 성장률을 보일 것으로 예측됩니다. 2024년부터 2032년까지 연평균 복합 성장률(CAGR)은 6.93%입니다. 일회용 바이오리액터는 자본 지출 감소, 세척 및 검증 요구 사항 최소화, 생산량 증가 및 감소에 대한 유연성 향상 등 다양한 이점을 제공하여 바이오프로세스의 워크플로우를 정리할 수 있습니다. 주요 기업들은 생산 공정을 극대화하고, 다운타임을 최소화하며, 비용 효율성을 달성하기 위해 일회용 기술에 광범위하게 투자하고 있습니다.
유리한 규제 지원과 유리한 정부 정책
규제 당국과 정부 기관은 제품의 안전성, 유효성, 품질을 보장하는 가이드라인과 프레임워크를 지속함으로써 바이오의약품 제조 환경을 발전시키는 데 큰 역할을 하고 있습니다. 최근 규제 당국도 일회용 바이오리액터(SUB)의 이점을 인식하고 있습니다. 미국 식품의약국(FDA)과 유럽의약품청(EMA)과 같은 규제 기관은 오염 위험을 줄이고 공정 효율을 향상시키는 일회용 기술을 지지하고 있습니다. 이러한 규제 당국의 지원은 SUB의 도입에 유리한 환경을 제공하고, 바이오제약 기업들이 이러한 시스템에 투자하도록 장려하고 있습니다.
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.