Global Single Use Bioreactors Market Overview

Global Single Use Bioreactors Market size was valued at USD 4,154.08 Million in 2023 and is poised to grow from USD 4,926.74 Million in 2024 to USD 19,285.79 Million by 2032, growing at a CAGR of 18.6 % in the forecast period (2024-2032).

The Global Single-Use Bioreactors (SUBs) Market has emerged as the most prominent component in the biotechnology and biopharmaceutical industries, transforming the bioprocessing environment by virtue of its novel cost-saving mechanisms. Single-use bioreactors are disposable units and not the traditional stainless-steel bioreactors, dedicated primarily to cell cultures, microorganisms, or any other biological entity. These bioreactors are also held in high esteem for their ability to lower the risk of contamination, decrease downtime, and reduce capital and operating expenses, and are thus particularly useful in flexible and small-scale production processes. By using pre-sterilized disposable bags, these bioreactors eliminate the need for extensive cleaning and sterilization, allowing faster turnaround times and increased productivity.

Growing application of single-use bioreactors is driven by the growing need for biologics like monoclonal antibodies, vaccines, and cell and gene therapies. Scalability and flexibility of SUBs are well-suited to the industry's shift towards personalized medicine and low batch sizes. The systems are critical to shortening development times, particularly in early-phase drug development and clinical trials, where speed and efficiency are paramount.

Technological innovation also has sped adoption of SUBs, with innovation focused on increasing mixing efficiency, scalability, and monitoring. Fixes for scalability capacity and leachable and extractables problems improve single-use systems' reliability on a broader platform of applications. Automation and sensor integration into single-use systems further enhance process control and monitoring to reduce variability in quality and errors due to human intervention.

Environmental considerations have also taken centre stage, with the industry looking into sustainable methods of curbing plastic waste arising from single-use systems. Recycling efforts and developing biodegradable products are on the rise, highlighting the conscientiousness of stakeholders to achieve a balance between operational efficiency and environmental responsibility.

Single-use bioreactors market is also characterized by stiff competition between the established players and new entrants, which in turn fuels cost reduction and innovation. Manufacturers-user joint ventures have played a vital role in guiding product development as well as overcoming specific industry requirements. The shared strategy makes the SUBs adaptive and multi-functional to suit ever-changing market demands.

Market Drivers

Growing Demand for Biologics, Including Monoclonal Antibodies and Cell Therapies

• Single-use bioreactors are becoming more and more popular due to the growing need for biologics such cell treatments and monoclonal antibodies. With their very successful, specialized treatments for a variety of illnesses, including cancer, autoimmune diseases, and genetic disorders, biologics have revolutionized modern medicine. This revolution is led by monoclonal antibodies, which target certain antigens. Cell treatments, such as CAR-T cells, have the potential to revolutionize personalized medicine by enabling customized treatment for each patient.
• This increasing demand for biologics created the demand for flexible, productive, and scalable manufacturing platforms that are the advantage of SUBs. Single-use bioreactors differ from conventional stainless-steel equipment in that they provide for quicker setup, reduced risk of contamination, and quicker batch turnover, all key to the ability to meet the demanding schedules for the manufacture of biologics. In addition, SUBs suit the small-to-medium-volume production commonly demanded by clinical trials and personalized drugs of smaller batch quantities but high precision and quality. As the growing global biologics pipeline is complemented with more treatments attaining regulatory clearance, reliance on SUBs should grow, which will become an industry standard in biopharmaceutical manufacturing going forward.

Key Findings:

• In November 2023, the University of Sydney Infectious Diseases Institute (Sydney ID) and Bharat Biotech signed a Memorandum of Understanding (MoU) to work on vaccine research programs and enhance relationships between industry and academia.
• In August 2023, National Institute of Science Communication and Policy Research (NIScPR), which is a part of CSIR, released a special issue of Indian Journal of Biochemistry and Biophysics (IJBB) on Biological Electron Microscopy and Nanobiotechnology.

Cost-Efficiency and Reduced Operational Complexity in Bioprocessing

• Single-use bioreactors (SUBs) in bioprocessing are becoming popular day by day because they are cost-effective and convenient. The high capital investment required in conventional stainless-steel bioreactor systems, much of which consists of huge amounts of piping, cleaning, and sterilizing facilities, contributes to both capital and operational expense. SUBs, however, are pre-sterilized disposable devices that save considerable labour, time, and water usage by avoiding such cleaning and sterilizing procedures. Such a simplified process reduces total cost and saves dead time between cycles of production to enable higher production.
• It is easier to work with SUBs because they are built in a flexible and user-friendly manner. This implies that they can be easily installed and can expand according to requirements. Businesses can readily adapt to fluctuations in production requirements, like varying batch sizes or product type changes, without significant changes to infrastructure. Additionally, there is less requirement for elaborate checks and approvals that are typically required with reusable systems, so operations become even easier.

Market Opportunities

Expansion in Emerging Markets with Increasing Biologics Production

• The growth in single-use bioreactors (SUBs) in emerging regions is being supported by the increase in the manufacturing of biologics in such markets. Most nations in Asia, Latin America, and the Middle East are experiencing a huge investment in the production of biopharmaceuticals, powered by growing health demands, increases in the spread of chronic ailments, and heavy emphasis on autarky in drug production. Emerging markets are also becoming hubs of choice for contract manufacturing organizations (CMOs) because they are cost-competitive and possess skilled labour pools, further propelling the need for scalable and efficient bioprocessing technologies such as SUBs.
• SUBs are especially attractive in these markets due to their relatively lower upfront capital investment in comparison to conventional stainless-steel equipment. This is because the cost-effectiveness of SUBs enables manufacturers to open or expand a facility faster, fulfilling the increased demand for biologics at minimal operational costs. The ability of SUBs to accommodate small batch sizes and fast product changeovers also resonates with production requirements in the emerging markets, where diverse therapeutic needs need to be fulfilled in quick succession.

Market Restraining Factors

Limited Suitability for Certain High-Stress Bioprocessing Applications

• Single-use bioreactors (SUBs) have their drawbacks in being suitable for some high-stress bioprocessing applications, and this will constrain their application in some instances. High-stress processes, such as those requiring severe agitation, harsh temperature environments, or extensive process durations, can strain the structural integrity and resilience of single-use materials. SUBs tend to employ polymer-based construction, which, while low-cost and accommodating, may not be as well-suited to withstand the mechanical and chemical stresses inherent in such high-demand uses as stainless-steel systems. As an example, in large-scale production involving intensive mixing or aeration, material fatigue or failure may become an issue. Certain high-shear regimes or severe chemical reagents used in some bioprocessing processes can cause degradation of single-use bioreactor liners with possibilities for product contamination or process disruption. These limitations make stainless-steel bioreactors of conventional design the best fit for such uses due to their strength and ability to withstand a broader spectrum of process conditions.

Segmentation Analysis

The market scope is segmented because of by Product Scope, by Type, by Type of Cell, by Molecule Type, by Application, by End-use, by Usage Type.

By Product Scope

• Single-use bioreactor systems
• Up to 10L
• 11-100L
• 101-500L
• 501-1500L
• Above 1500L
• Single-use media bags
• 2D Bags
• 3D Bags
• Others
• Single-use Filtration Assemblies
• Other Products

Among the product scope segments in the single-use bioreactors (SUBs) industry, single-use bioreactor systems with capacities between 101-500L have had a stronghold in the market. The dominance of this segment has been due to its flexibility and universal applicability in biopharmaceutical production. These mid-scale bioreactor systems balance scalability and ease of operation optimally, hence making them particularly appropriate for clinical as well as commercial production stages. Their scale is appropriately designed to make biologics like monoclonal antibodies, vaccines, and cell therapies that tend to be produced at medium batch sizes these systems efficiently manage.

The 101-500L range is also widely used by small to mid-sized biopharmaceutical firms and contract manufacturing organizations (CMOs), who account for the majority of the market. These organizations value cost savings and flexibility highly, and mid-range SUBs offer the perfect solution by keeping capital investment low and ensuring rapid process setup and scale-up. Furthermore, this capacity range is also important in the production of clinical trials, where replicable but smaller batches are critical to meet regulatory requirements and time factors.

By Type

• Stirred-tank SUBs
• Wave-induced SUBs
• Bubble-column SUBs
• Other SUBs

Among the single-use bioreactors (SUBs) market product segments, the stirred-tank SUBs have been in the leading position as they are scalable, versatile, and most commonly used in the industry within biopharmaceutical manufacturing. Stirred-tank SUBs are most similar to conventional stainless steel stirred-tanks and are the standard for manufacturers looking to move to single-use systems. Their engineering enables efficient mixing, gas exchange, and temperature control, required to a range of cell culture and microbial fermentations. Their bioprocessing applicability enables stirred-tank SUBs to treat a range of applications, such as monoclonal antibody production, vaccine production, and cell therapy development.

Another vital driver of their dominance is scalability. Stirred-tank SUBs range from the few litters, which are handy for R&D, to several thousand litters in size, ensuring simple scaling of R&D levels to commercial scale-up. Their scalability caters to the range of needs for the biopharmaceutical industry, from individualized medicine manufactured on a small scale to scaled-up biologics production.

By Type of Cell

• Mammalian Cells
• Bacterial Cells
• Yeast Cells
• Other Cells

By Molecule Type

• Monoclonal Antibodies
• Vaccines
• Gene Modified Cells
• Stem Cells
• Other Molecules

By Application

• Research and Development (R&D) or Process Development
• Bioproduction

By End-use

• Pharmaceutical & Biopharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutes

By Usage Type

• Lab-scale Production
• Pilot-scale Production
• Large-scale Production

Regional Snapshots

By region, Insights into the markets in North America, Europe, Asia-Pacific, Latin America and MEA are provided by the study. North America has led the single-use bioreactors (SUBs) market because of its highly established biopharmaceutical sector, strong infrastructure, and significant research and development spending. It possesses the world-class biopharmaceutical firms and contract manufacturing organizations (CMOs) that heavily employ SUBs in the manufacture of biologics, such as monoclonal antibodies, vaccines, and cell therapies. The overwhelming presence of these players coupled with aggressive uptake of advanced technologies has cemented North America's leadership position as a market. The region's encouragement of good regulatory environments, generous government spending on healthcare and biopharmaceutical research, and focus on personalized medicine have driven the demand for cost-effective and adaptable manufacturing platforms like SUBs.

On the other hand, Asia-Pacific will be the region with the fastest growth rate in the market of SUBs. The sector of biopharmaceutical is rapidly growing in countries such as China, India, South Korea, and Japan. The public and private organizations of the region are making enormous investments in creating domestic manufacturing infrastructure in order to lower import dependency and cater to increasing healthcare needs. Asia-Pacific's low-cost manufacturing environment and highly skilled labour force also make it an attractive site for CMOs, supporting the trend towards embracing SUBs. Furthermore, the increasing prevalence of chronic diseases, a widening interest in biosimilars and generics, and the rising wave of precision medicine are creating significant opportunities for bioprocessing technologies in this region.

List of Companies Profiled

• Sartorius Stedim Biotech
• Thermo Fisher Scientific
• Danaher
• Merck KgaA
• Celltainer Biotech BV
• Getinge AB
• Eppendorf AG
• Cellexus
• PBS Biotech Inc.
• Distek Inc.
• ABEC
• Able Corporation & Biott Corporation
• G&G Technologies Inc.
• Solida Biotech GmbH
• Satake Chemical Equipment Mfg., Ltd.
• Stobbe Pharma GmbH
• bbi-biotech GmbH

Key Industry Developments

• Getinge AB launched the 50-liter and 250-liter Single-Use Production Reactor (SUPR) systems in March 2024.
• Merck KGaA launched the Ultimus single-use process container film during April 2023. It aims to provide superior durability and resistance to leakage for single-use assemblies used in liquid bioprocessing applications.

Report Coverage

The report will cover the qualitative and quantitative data on the Global Single Use Bioreactors Market. The qualitative data includes latest trends, market players analysis, market drivers, market opportunity, and many others. Also, the report quantitative data includes market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations:

Global Single-Use Bioreactors Market Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Single-Use Bioreactors market and is expected to expand at a CAGR of xx% during the forecast period. This growth can be attributed to the growing adoption of Single-Use Bioreactors. The market in APAC is expected to witness significant growth and is expected to register a CAGR of xx% over upcoming years, because of the presence of key Single-Use Bioreactors companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Single-Use Bioreactors Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language.

Single-Use Bioreactors Market Report is also available for below Regions and Country Please Ask for that

North America

• U.S
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions

• How much the global Single-Use Bioreactors Market valued?
• Which region has the largest share in 20214 for the global Single-Use Bioreactors Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of Single-Use Bioreactors Market

• Historic year: 2019- 2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Billion

Single-Use Bioreactors Market Trends: Market key trends which include Increased Competition and Continuous Innovations Trends: