Single Use Bioreactors Market (3rd Edition) - Distribution by Type of Bioreactor, Scale of Operation, Type of Cell Culture, Type of Biologics Synthesized, Application Area, End-users, and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

Single Use Bioreactors Market Overview

The global single use bioreactors market is estimated to be worth USD 1.3 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of ~17% during the forecast period. Over the past few years, biopharmaceuticals have gained significant attention owing to their therapeutic efficacy. In fact, in the past two decades, over 170 biologics have received the USFDA approval, while over 10,000 biologics are currently under different stages of development. It is a well-known fact that the commercial and clinical scale manufacturing of these complex biomolecules requires highly specialized bioprocessing equipment. Conventionally, stainless steel bioreactors were the preferred choice for biologics manufacturing; however, to fulfill the need for high quality antibodies, cell therapies, gene therapies and other bio-therapeutics, a gradual shift towards the use of a single use bioreactor has been observed.

A single-use bioreactor, also known as disposable bioreactor, employs single use bioreactor bags instead of stainless steel culture vessel for the manufacturing of various biologics. Single-use bioreactors offer various advantages over conventional bioreactors; these include cost efficiency (~40%), shorter production timeline (~35%), reduction in energy and water consumption (45%-50%), better product yield and low risk of contamination. Owing to the aforementioned benefits, various stakeholders have adopted disposable bioreactors for the manufacturing of biologics. Moreover, many single use bioreactor manufacturers are focusing on incorporating a variety of advanced features, including provisions for alerts / alarms, electronic process logs, built-in system process control sensors, touch screens, remote monitoring features, and advanced safety provisions in their proprietary offerings. In order to address the growing demand for biologics, such companies are working towards manufacturing more efficient single use bioreactors for global markets and thereby, supporting the adoption of single use technology. The global market for single use bioreactors is anticipated to witness substantial growth during the forecast period.

Key Market Insights

The Single Use Bioreactors Market (3rd Edition) - Distribution by Type of Bioreactor (Stirred Tank, Pneumatically Mixed, Rocker / Rotating, Wave-Induced, Paddle Sleeve, Fixed-Bed, Hollow Fibre, Diffusion, and Orbitally Shaken), Scale of Operation (Lab, Clinical and Commercial), Type of Cell Culture (Mammalian, Insect, Microbial, Viral, Plant and Bacterial), Type of Biologics Synthesized (Vaccine, Monoclonal Antibody, Recombinant Protein, Stem Cell, Cell Therapy, and Gene Therapy), Application Area (Cancer Research, Stem Cell Research, Tissue Engineering / Regenerative Medicine, Drug Discovery / Toxicity Testing and Others), End-users (Biopharmaceutical / Pharmaceutical Industries, Academic / Research Institutes), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunities associated with this industry, for the given forecast period. The market research report highlights the efforts of several stakeholders engaged in this emerging and rapidly evolving segment of the biopharmaceutical industry. Key takeaways from the study of single-use bioreactor market are briefly discussed below.

Rising Interest in Large Scale Disposable Bioreactors for Single use Bioprocessing 

Several breakthroughs in the biotechnology industry, over the last few years, have provided a considerable boost to the overall growth of biopharmaceutical industry. However, in 2022, owing to the increasingly stringent regulatory guidelines related to biomanufacturing process, the new drug approvals declined by around 25%. Hence, the growing demand for quality products has encouraged biologic manufacturers to adopt single-use bioreactor, a more advanced and long-term solution. These disposable bioreactors are cost effective and have the capability to provide operational flexibility as compared to the conventional technologies. In April 2023, mAbxience, a Spanish CDMO installed a 4000 L single-use bioreactor manufactured by ABEC, at its Leon facility. Earlier, in 2018, WuXi Biologics had also installed these 4,000 L bioreactors for large scale single use bioprocessing at their Wuxi city manufacturing facility. It is worth mentioning that ABEC, Henan Lanphan, and Thermo Fisher Scientific are amongst the key players that have launched the largest single-use bioreactors with capacity of more than 4,000 L.

The ongoing technological advancements focused on the development of improved versions of biosensors and single use bioreactor bags are likely to encourage the biopharmaceutical companies to adopt disposable bioreactor for bioprocessing, representing a lucrative opportunity for companies engaged in this growing market.

Current Single use Bioreactors Market Landscape

The single-use bioreactor market features a mix of large, mid-sized and small companies that have the required expertise to provide various types of single use bioreactors for the production of biologics. At present, more than 260 single-use bioreactors have been developed by over 60 industry stakeholders to enable the manufacturing of biologics. It is worth highlighting that majority of the single use bioreactors (~60%) offered by various manufacturers are stirred tank bioreactors. This can be attributed to the fact that stirred tank bioreactors are less likely to cause damage to the cell cultures, as these bioreactors possess optimal blade diameters and agitation speed. It is worth highlighting that constant evolution of disposable bioreactors is likely to support the development of novel and more efficacious biologics, in turn, contributing to the substantial growth of single use bioreactor market, during the forecast period.

Key Advantages Associated with Single use Bioreactors Used for the Production of Wide Variety of Biopharmaceuticals

Single use bioreactors offer various advantages over conventional stainless steel bioreactors. These advantages include ~50% reduction in total energy and water consumption and ~40% cost saving by elimination of cleaning and sterilization processes after every batch production. Apart from the aforementioned benefits, use of single-use bioreactors also lowers the risk of cross-contamination, making these disposable bioreactors more user-friendly and efficient. Further, these systems are portable and have a smaller footprint as compared to the conventional systems, which reduces the total space required for installation. Owing to the aforementioned benefits associated with single use bioreactors, we believe that there is significant growth opportunity for the companies engaged in this industry during the forecast period.

Key Challenges Associated with the Adoption of Single use Bioreactors

One of the key challenges faced by single use bioreactor manufacturers is the reluctance of industry players to adopt these novel systems. This can be attributed to the expenses that they are likely to incur while switching to a new technology. Although, disposable bioreactors have gained significant popularity in the recent past owing to their advantages, they still pose a reasonable risk of contamination from extractables and leachables. Single use bioreactors are developed using plastic materials that can release organic or inorganic chemicals into liquid pharmaceutical products under high temperature and pressure. Potentially, these chemicals can jeopardize the safety of drug products and well-being of the patient. Further, insufficient supply of raw materials, single use components and assemblies can be another roadblock in this industry. While disposable bioreactor manufacturers are striving to tackle these challenges through innovation in design and manufacturing methods, the current inability of single use bioreactors to operate at volume greater than 6,000 L for large scale production, remains another pressing concern.

Single use Bioreactor Market Size: Stirred Tank Single-Use Bioreactor Segment holds the Largest Market Share

The global single use bioreactors market is likely to be worth around USD 1.3 billion in 2023. Driven by the rising demand for novel biopharmaceuticals, high adoption rates of precision medicine, along with advancement in bioprocessing technologies, the single use bioreactor market is anticipated to grow at a CAGR of 17%, during the forecast period 2023-2035. Currently, the global market for single-use bioreactors is dominated by companies providing stirred tank bioreactors. The single-use stirred tank bioreactor segment captures 80% of the market share and it is likely to grow at a CAGR of 14% during the forecast period.

Additionally, in terms of type of cell culture, the mammalian cell cultures are anticipated to hold more than 40% share of the single use bioreactor market. It is worth mentioning that over 80% of the disposable bioreactors are suitable for processing mammalian cell cultures.

North America and Europe to Compete for the Largest Share of Single use Bioreactors Market

Overall, the companies based / headquartered in North America and Europe capture 75% share of the current market. Companies, such as ABEC, Eppendorf, Merck Millipore, PBS Biotech and Thermo Fisher Scientific offer a wide range of single use bioreactors. These companies have in-house single use bioreactor portfolio, with different types of bioreactors, such as stirred tank bioreactor, wave / induced bioreactor and pneumatically mixed bioreactor. Furthermore, Asia Pacific region is witnessing huge growth in biopharmaceutical market, with a number of CMOs setting up new facilities or announcing expansions in countries such as Singapore and Korea. In May 2023, Merck KgaA announced its plan to build a bioprocessing center in Daejeon City, Korea. Further, several companies, including WuXi Biologics have invested for biopharmaceutical manufacturing in Singapore. Moreover, a number of manufacturing facilities are being set up in Asia Pacific region, to meet the growing local demand for biologics from the consumers as well as the demand from small biopharmaceutical startups, which are likely to drive the market for single use bioreactors over the coming years.

Bioreactor manufacturers are continuously putting efforts to improve their product portfolio in order to address the challenges related to biomanufacturing by delivering innovative disposable bioreactors to the pharmaceutical industry. Given the ongoing efforts of stakeholders, we believe that the single use bioreactor market is poised to witness significant growth over the forecast period.

Partnership Activity in Single-use Bioreactor Market

In recent years, several partnerships have been established by industry stakeholders, in order to consolidate their presence in this field and enhance their capabilities and product portfolio to meet the growing demand for biotherapeutics. In fact, the partnership activity in this domain grew at a CAGR of ~15% over the past five years. Interestingly, most of the agreements were supply and technology integration agreements. The domain also witnessed a significant number of mergers and acquisitions during the past five years, indicating the growing interest of stakeholders in this industry.

In January 2023, Thermo Fisher Scientific entered into a manufacturing agreement with ASLAN Pharmaceuticals for the manufacturing of eblasakimab for phase III clinical studies. Sartorius Stedim Biotech has signed several deals in the past few years to provide innovative single use systems to various biomanufacturers with an aim to support biologics manufacturing. Given the trends in this market, we believe that such deals are likely to drive the single use bioreactors market during the forecast period.

Key Emerging Trends in the Single use Bioreactor Market

Stakeholders engaged in this industry are identifying new ways to enhance efficiency and reduce turnaround time. This has led to various technological advancements in this field, which include alerts / alarms, built-in system process control sensors, electronic process logs, remote monitoring features, touch screens, and advanced safety provisions, that have demonstrated increase in efficiency and quality of the process. Further, the integration of controllers and automated systems is another advancement that allows to keep the process parameters within the desired and acceptable limits, but also make the necessary adjustments, while minimizing the risks of human errors. It is worth mentioning that the single use bioreactors market is also witnessing the adoption of bioprocessing 4.0 solutions that leverages machine learning (ML) and artificial intelligence (AI) for real-time process monitoring. Such advancements are anticipated to result into better yields, reduced waste, and development of higher quality biologics. The ongoing efforts in the field of single use technologies will support the growth of the single use bioreactors market over the forecast period.

Leading Companies Engaged in Single Use Bioreactors Market

Examples of key companies engaged in this industry include (which have also been captured in this report) Applikon Biotechnology, Biolinx Labsystems, Celartia, Cell Culture Company, Cellexus, Cercell, CESCO Bioengineering, Cytiva, Eppendorf, Merck Millipore, Pall Corporation, PBS Biotech, PerfuseCell, ProlifeCell, Sartorius Stedim Biotech, Solaris Biotech, Synthecon and Thermo Fisher Scientific. This market report includes an easily searchable excel database of the single use bioreactor manufacturers worldwide.

Scope of the Report

The market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments.

The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this industry, across different regions. Amongst other elements, the research report includes:

• An executive summary of the insights captured during our research, offering a high-level view on the current state of the single use bioreactors market and its likely evolution in the mid-long term.
• A general introduction to single use bioreactors, highlighting key technology specifications and offering details related to some of the current and future trends in this industry. It also includes a comparative summary of conventional stainless steel bioreactor and single use bioreactor. The chapter features insights related to prevalent regulatory standards, existing challenges and elaborates on the various advantages of single use bioreactors.
• A detailed assessment of various single-use bioreactors that are either commercialized or under development. It includes detailed analysis of the overall market landscape of single use bioreactors based several relevant parameters, such as type of bioreactor (diffusion, fixed bed bioreactor, hollow fibers, pneumatically mixed, rotating bioreactor, stirred tank bioreactor, and wave induced / rocking bioreactors), scale of operation (lab, clinical and commercial), typical working volume, stirrer speed, weight of the bioreactor, advanced display / control features (alarm system, build-in system, electronic-log, remote monitoring and touch screen), mode of operation (batch, fed-batch and continuous), type of culture (2D culture and 3D culture), type of cell culture (insect, mammalian, microbial, plant, viral and others), type of biologic synthesized (cell therapies, gene therapies, monoclonal antibodies, recombinant proteins, stem cells, vaccines and others), end-users (academic, CRO, CMO and pharmaceutical / biopharmaceutical). In addition, the chapter presents the overall market landscape of companies developing single-use bioreactors, including information on their year of establishment, company size, and location of headquarters.
• A contemporary market trend analysis, featuring a hybrid chart representation of companies engaged in this industry based on their company size and location of headquarters, a stacked bar chart representation of company size and type of single use bioreactor, a stacked bar chart representation of type of single use bioreactor and mode of operation, a heat map representation analyzing the data on the basis of the type of single use bioreactor and type of biologic synthesized, a heat map representation analyzing the data on the basis of the scale of operation, type of cell culture and type of biologic synthesized, and a world map representation highlighting the regional distribution of companies engaged in single use bioreactors market, based on the location of their headquarters.
• An insightful four-dimensional bubble chart representation, highlighting the competitiveness of single use bioreactor manufacturers, taking into consideration the supplier strength (based on expertise of the manufacturer), product portfolio diversity and portfolio strength.
• Tabulated profiles of key companies based in North America, Europe, Asia-Pacific and Rest of the World (shortlisted based on a proprietary criterion) engaged in developing single use bioreactors. Each company profile features a brief overview of the company, along with its financial information (if available), product portfolio, recent developments and an informed future outlook.
• An analysis of the recent partnerships and collaborations related to single use bioreactors, which have been established during period 2007 and 2023 (till January), based on several parameters, such as year of agreement, type of partnership (mergers / acquisitions, product / technology integration agreements, product distribution agreements, product / technology development agreements, service alliances, supply agreements, supply / distribution agreements and others), focus area (capacity expansion, geographical expansion, incorporation of automation solutions, product portfolio expansion, product development / testing, process optimization / improvement, research and development, supply of product and others), type of partner (industry and non-industry), type of biologic synthesized (antibodies, cell lines, cell therapies, gene therapies, plasmid DNA, proteins, vaccines, viral vectors and others), type of bioreactor involved (pneumatically mixed, rotating bioreactor, stirred tank bioreactor, wave induced / rocking bioreactor and others), location of facility, expanded bioreactor capacity and most active players. It also provides the regional distribution of the companies involved in these agreements.
• A detailed product competitiveness analysis of single use bioreactors, taking into consideration several relevant parameters, such as the supplier strength (based on company’s overall experience) and product competitiveness (calculated using status of development, scale of operation, type of cell culture, type of biologics synthesized, mode of operation, working volume and weight). In order to make relevant comparisons, we segregated the aforementioned products into peer groups based on the type of bioreactor (stirred tank bioreactors, fixed-bed bioreactors, wave induced / rocking bioreactors and other bioreactors).
• An opinion on the relative popularity of the respective brands of key industry stakeholders (companies offering single-use bioreactors), based on prevalent trends. The primary purpose of this analysis is to develop an understanding on how the brands of companies are currently perceived / positioned in different market segments, relative to their competitors, based on several relevant parameters, such as portfolio strength (based on number of products), portfolio diversity (working volume, stirrer speed, weight, type of biologics synthesized and type of cell culture), years of experience, number of patents and number of partnerships. In addition, the framework can assist companies in determining improvement areas by identifying gaps within their existing capabilities, as well as recognize ways to gain competitive advantage in the mid to long term. 
• An overview of the various patents that have been filed / granted for single use bioreactors. Additionally, it features a detailed analysis of these patents, highlighting the prevalent trends related to the type of patent, publication year, application year, patent jurisdiction, focus area, Cooperative Patent Classification (CPC) symbols and type of applicant. Further, the chapter highlights the leading industry and non-industry players (in terms of number of patents filed / granted). In addition, it includes an informed patent benchmarking analysis, along with an analysis of the relative valuation of patents filed / granted for single use bioreactors based on parameters, such as patent age, region in which the patent was filed / granted and number of citations.
• A case study on the key technological innovations, such as built-in system control sensors, advanced alarm systems, electronic-log records, touch screens, real-time tracking, remote monitoring and advanced mixing technologies, that have been introduced in the single use bioreactors industry. It also highlights the ongoing progression of automation in single use bioreactor for better bioprocess development. 
• A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall single use bioreactors industry.
• A case study on the market landscape of bioprocess controllers and automation systems, providing information on scale of operation (laboratory, clinical, and commercial), key features (scalability / ease to use, visual data display, remote accessibility, built-in system control sensors, expansive I/O compatibility and provisions for alarms / alerts), compatibility with bioreactor system (stirred tank (glass), single-use bioreactor, stirred tank (steel), fermenter, rocking motion), type of bioprocess (batch, fed-batch and perfusion), and type of process controlled (cell cultivation and microbial fermentation). In addition, the chapter presents details of companies involved in the development of bioprocess control software, upstream and downstream controllers, including information on their respective year of establishment, company size, and location of headquarters.

One of the key objectives of the market report was to estimate the current opportunity and the future growth potential of the global single use bioreactor market over the forecast period. We have provided an informed estimate on the likely evolution of the market for the period 2023-2035. Our year-wise projections of the current and forecasted market have been further segmented based on relevant parameters, such as type of bioreactor (stirred tank, pneumatically mixed, rocker / rotating, wave-induced, paddle sleeve, fixed-bed, hollow fiber, diffusion, and orbitally shaken), scale of operation (lab, clinical and commercial), type of cell culture (mammalian, insect, microbial, viral, plant and bacterial), type of biologic synthesized (vaccine, monoclonal antibody, recombinant protein, stem cell, cell therapy, and gene therapy), application area (cancer research, stem cell research, tissue engineering / regenerative medicine, drug discovery / toxicity testing and others), end-users (biopharmaceutical / pharmaceutical industries, academic / research institutes), and key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain.

The research report features detailed transcripts of interviews held with the following individuals:

• Shane Kilpatrick (Founder and Chief Executive Officer, Membio)
• Justin Cesmat (Manager, Bioprocessing, Distek)
• Bradley Maykow (Quality and Products Manager, Refine Technology)
• Per Stobbe (Chief Executive Officer, CerCell)
• Torsten Due Bryld (Global Director of Sales Support, CelVivo)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is a single use bioreactor?

Answer: Single use bioreactors are those bioreactors that use disposable bags instead of reusable stainless steel cultural vessels.

Question 2: What is the market size of single use bioreactors?

Answer: The global single use bioreactor market is anticipated to be worth around USD 1.3 billion in 2023.

Question 3: What are the factors driving the single use bioreactors market?

Answer: Advancements in bioprocessing technologies and rise in demand for novel biopharmaceuticals are the key factors driving the global single use bioreactors market.

Question 4: Who are the key players in single use bioreactors market?

Answer: Presently, more than 60 companies are engaged in single use bioreactors market, worldwide. Examples of top players engaged in this industry (full list available in the report) include Applikon Biotechnology, Biolinx Labsystems, Celartia, Cell Culture Company , Cellexus, Cercell, CESCO Bioengineering, Cytiva, Eppendorf, Merck Millipore, Pall Corporation, PBS Biotech, PerfuseCell, ProlifeCell, Sartorius Stedim Biotech, Solaris Biotech, Synthecon and Thermo Fisher Scientific.

Question 5: Which region has the largest share in single use bioreactors market?

Answer: North America and Europe captures around 75% of the current single use bioreactors market, followed by Asia-Pacific.

Question 6: Which type of single use bioreactor has the largest share in the global single use bioreactor market?

Answer: Currently, the global single use bioreactor market is dominated by the companies providing stirred tank single use bioreactors. The stirred tank bioreactor market captures 80% market share and it is likely to grow at a CAGR of 14%, during the forecast period.

Question 7: Which are the leading market segments in global single use bioreactor market, in terms of type of biologic synthesized?

Answer: Our estimates suggest that monoclonal antibodies capture more than 25% share in the overall global single use bioreactor market.

Question 8: What is the growth rate of single use bioreactors market?

Answer: The global single use bioreactor market is projected to grow at a CAGR of ~17% during the forecast period.