Market Overview

Global Single Use Bioprocessing Market size was valued at USD 28.54 Billion in 2023 and is poised to grow from USD 33.35 Billion in 2024 to USD 115.82 Billion by 2032, growing at a CAGR of 16.8 % in the forecast period (2024-2032).

The global single-use bioprocessing market has witnessed phenomenal growth over the last few years with increasing demand for biologics and the need for cost-effective and efficient manufacturing processes in the pharmaceutical and biotechnology industries. Single-use bioprocessing or disposable bioprocessing refers to the utilization of disposable products such as bioreactors, filters, and tubing in the manufacture of biopharmaceutical products. This strategy reduces expensive cleaning and sterilization of reusable equipment, reduces the risk of contamination as well as process inefficiency in general.

One of the biggest reasons that the market is expanding is the increasing focus on biologics such as monoclonal antibodies, vaccines, and gene therapies that need to be produced by highly sophisticated manufacturing techniques. Stainless steel biomanufacturing is time-consuming, expensive, and needs to be serviced often. Single-use systems, however, have several benefits such as flexibility, scalability, reduced capital cost, and a shorter time to market. The throwaway character of the systems provides for quick changeover from batch to batch with minimal down time and maximum total output.

Single-use bioprocessing systems provide continuous manufacturing, a more significant role in management of bulk supply needs of biologics. As the pharma sector continues to seek accelerated new drug development, scalable with cost-effective manufacturing processes with flexibilities are in huge demand. Single-use bioprocessing systems are found to be the optimum solution in managing such in terms of scaling up or down with adaptability to manufacturing without having to make any considerable infrastructural alterations.

The other market driver is the increased demand for customized medicine. As patient-specific therapy and treatment have increased popularity, the demand for production systems to facilitate customized manufacturing processes and small batch production is increasing. Single-use bioprocessing technologies are capable of addressing such demands because they are flexible and adaptable to various forms of biologic manufacturing, from commercial scale to clinical trials.

Technological innovations in more control and automation of the manufacturing process, such as process efficiency improvement in bioreactors, sensors, and monitoring devices, contribute to the market. The innovations increase the process's performance, reduce risk, and improve overall process reliability in the manufacturing process. Furthermore, combinations of digitalization and data analysis with single-use bioprocessing systems enable more efficient process monitoring and decision-making, resulting in improved biomanufacturing outcomes.

Key Findings:

• To boost pharmaceutical production capacity in the Asia-Pacific region, CDMO AGC Biologics made an expansion plan in January 2024 to increase its mRNA, cell therapy, and mammalian cell culture facilities in Japan. This development aims to address the world's need for biologics and advanced therapeutic drugs.

Market Drivers

Cost-Effectiveness and Reduced Capital Investment

• Cost savings and lower capital investment are two of the strongest benefits of single-use bioprocessing systems. Conventional biomanufacturing processes tend to be based on stainless-steel equipment, which demands high initial capital investment, as well as continuous costs for cleaning, maintenance, and sterilization. Utilizing disposable components such as bioreactors, filters, and tubing, single-use systems, however, significantly reduced the need for extensive facility and infrastructure overhauls. Time and resources are saved as these disposable components eliminate the necessity for complex and costly cleaning protocols between runs.
• Single-use bioprocessing systems compared to biomanufacturing plants are less capital-intensive because they are more scalable and adaptable. Producers can forgo these expenses, as opposed to the conventional bioprocessing that in most cases calls for costly investment in stainless-steel reactors or specialized cleaning devices. Single-use systems, however, can simply scale up or down depending on the production needs without investing in new equipment.
• This cost-effectiveness is especially beneficial in biologics and customized drug development and production, where the demand can be variable and small batches are typical. Single-use bioprocessing systems therefore maximize resource utilization, reduce operating expenses, and increase overall profitability while enabling manufacturers to respond to the needs of a fast-changing biopharmaceutical market.

Key Findings:

• Merck KGaA launched Ultimus, a single-use process container film to enhance the strength and leak resistance of single-use assemblies, in April 2023.
• Cytiva launched the X-platform bioreactors in April 2023, which streamline upstream bioprocessing processes for monoclonal antibody (mAb) production, cell and gene therapy, and protein-based medicines.

Enhanced Flexibility and Scalability in Production

• Single-use bioprocessing systems share one of the principal advantages of being more flexible and scalable. It is costly and time-consuming to reconfigure the large-scale fixed hardware of conventional biomanufacturing operations to accommodate diversified production cycles. Single-use systems are easier to be changed, though, since they use hardware that is easily disposable for each new manufacture cycle. This enables companies to react to changes in market demand, product development, or clinical trial specifications with minimum lost time and without having to invest in massive infrastructure developments.
• Scalability is another aspect of single-use bioprocessing that is highly important. The manufacturers are able to scale up or scale down as required without the need to invest in new technology or central redesign of existing systems. It is particularly valuable in the instance of biologic production, where batch sizes would differ, and customized care, where small batch production could be necessary.
• Single-use technology also enables continuous manufacturing, which adds efficiency along with maintaining the cost savings during production through de-skilled processing. The versatility and scalability that are offered with single-use technology enable the producer of biopharmaceutical drugs to easily cater to demand fluctuation, to shut down and restart production rapidly, and reduce overall investment.

Market Opportunities

Integration of Artificial Intelligence and Automation in Bioprocessing

• Artificial intelligence (AI) and automation are revolutionizing bioprocessing in biomanufacturing at the core level by demanding unprecedented degrees of efficiency, precision, and productivity. AI machines can filter through reams of data generated in each step of the manufacturing process, making it possible for real-time monitoring and optimization of the bioprocess. With machine learning algorithms forecasting possible problems and optimizing vital parameters like temperature, pH, and oxygen, biologics manufacture can be assured with improved process control, including improved yields, lower variability, and higher quality of the end product.
• These advantages are complemented by automation, which streamlines processes that were earlier man-labour and time-consuming. Repetitive tasks such as material handling, cleaning, and equipment maintenance are best served by automated systems with minimal human intervention. In the process, the need for human intervention is minimized, and a more consistent and reliable manufacturing process is ensured. In addition, biomanufacturing operations are readily scalable at whim with automation, and there is no challenge in switching between continuous and batch operation as required.
• With the synergy of automation and AI, biopharmaceutical companies can propel process reliability, reduce operating expenses, and accelerate the time-to-market for new therapies. This potent synergy not only enables efficiency but also enables the increase in demand for biologics and customized drugs, creating a new benchmark for the future of bioprocessing.

Market Restraining Factors

Environmental Concerns Related to Waste Disposal

• Single-use bioprocessing systems are known to offer important advantages such as cost-effectiveness and efficiency but they also pose serious environmental issues with regard to waste disposal. They produce massive quantities of disposable parts such as bioreactors, tubing, filters, and bags made mainly of plastics. Recycling these components is not easy as they become contaminated by intricate bioprocess residues like proteins and chemicals so most of the waste ends up in landfills.
• As the usage of single-use systems grows, the environmental implication of this disposal of waste further intensifies. Biopharmaceutical companies face pressure to make their operations more sustainable by venturing into strategies for managing their waste through recycling or reusing disposable parts, although such choices are currently restricted. In addition, regulatory authorities and stakeholders call for more environmentally friendly manufacturing operations, prompting the development of cleaner solutions that lessen the environmental contribution of their operations.
• To respond, manufacturers are working to develop substitute materials, improve waste management strategies, and adopt more environmentally friendly production operations. Equally, striking the right balance between the operational benefits of single-use systems and their environmental drawbacks will be essential to long-term sustainability of the bioprocessing industry.

Segmentation Analysis

The market scope is segmented because of by Product, by Application, by Workflow, by End User.

• By Product

Based on the Product of the market is segmented into Filtration Assemblies, Disposable Bioreactors, Disposable Mixers, Media Bags & Containers, Others.

Among the global single-use bioprocessing market products, Filtration Assemblies are presently leading due to several reasons. Filtration Assemblies play a critical role in the purification and separation step during biomanufacturing for the removal of impurities, sterility maintenance, and product quality assurance. The increasing use of disposable systems in biopharmaceutical production has led to additional needs for cost-increasing and scalable filtration technologies needed to optimize downstream processing of biologics like monoclonal antibodies and vaccines. Filtration Assemblies are providing ease of use, lower risk of cross-contamination, and lower operating cost and therefore they are of immense interest to manufacturers who desire to simplify processes

As the focus has grown on cost reduction, reduced downtime, and greater productivity, so too has single-use technology usage. With a need to adapt to changing production requirements, filtration systems represent a quick and versatile solution. In addition, the industry can be dominated owing to the prevalence of continuous processes of manufacturing based primarily on effective filtering to facilitate high volumes of biologics. In the single-use bioprocessing market, Filtration Assemblies has been the market leader by meeting the needs of the biopharmaceutical market that demands more responsive manufacturing solutions and faster time-to-market with excellent product quality.

• By Application

Based on the Application of the market is segmented into Filtration, Purification, Cell Culture, Others.

Among various application segments of the global single-use bioprocessing market, cell culture is the biggest segment, and it is leading due to a variety of factors. Cell culture is a crucial step in the production of biologics such as monoclonal antibodies, vaccines, and cell-based therapies. As biologics are growing in demand, so are the demands for efficient, scalable, and flexible cell culture processes. Single-use bioprocessing systems, i.e., disposable bioreactors and culture bags, are a significant benefit in this respect. They eliminate the requirement for costly and time-consuming cleaning and sterilization procedures of the conventional stainless-steel systems, thus making cell culture processes faster and cost-effective.

The single-use systems' flexibility and scalability also contribute to making the cell culture segment the leader. With single-use equipment, manufacturers can increase or decrease production, subject to the variable batch sizes that are required by clinical trials and commercial manufacture. The same flexibility is also necessary in the new trend of personalized medicine and small-batch manufacture, whereby individualized treatments and small patient groups require tailor-made manufacturing solutions.

• 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 currently leads the globe single-use bioprocessing industry by virtue largely of the pharmaceutical and biotechnology sectors' depth and maturity, both of which are also lead drivers of biologic demand. The United States is especially well-suited to host biopharmaceutical companies and research institutions among the world's largest, all of which increasingly rely on single-use bioprocessing technologies as a means to achieve maximum effectiveness at reduced costs. The region has an advanced healthcare infrastructure, significant investments in innovation related to biotechnology, and an open regulatory platform favourable to biologic development and manufacturing. Besides, the increasing need for customized medicine and sophisticated treatments like gene and cell therapies has fuelled the use of flexible, scalable, and cost-efficient single-use bioprocessing equipment.

On the other hand, the Asia-Pacific market is forecast to be the fastest-growing market for single-use bioprocessing technologies. This is influenced by several factors, including increased healthcare investments, high-rate industrialization, and increasing pharmaceutical and biotechnology sectors in countries like China, India, and Japan. These countries are heavily investing in the biopharmaceutical industry to meet growing domestic demand for biosimilars and biologics and become key players in the supply chain across the world. The region's focus on improving healthcare infrastructure, combined with increasing adoption of biopharmaceuticals, makes the Asia-Pacific region a hub for new biomanufacturing technologies, including single-use systems. Their cost-effectiveness and scalability are most appropriate for the region's emphasis on efficiency, which is driving the swift growth of the market in Asia-Pacific.

List of Companies Profiled

• Sartorius AG
• Danaher
• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Avantor, Inc.
• Eppendorf SE
• Corning Incorporated
• Lonza
• PBS Biotech, Inc.
• Meissner Filtration Products, Inc.

Key Industry Developments

• The AppliFlex ST GMP single-use bioreactor was launched by Getinge in September 2023. The device provides an integrated cGMP manufacturing solution for mRNA manufacturing as well as cell and gene therapies, and it is available in different sizes.

Report Coverage

The report will cover the qualitative and quantitative data on the Global Single Use Bioprocessing 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 Bioprocessing Market Regional Analysis

North America accounted for the highest xx% market share in terms of revenue in the Single-Use Bioprocessing 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 Bioprocessing. 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 Bioprocessing companies in economies such as Japan and China.

The objective of the report is to present comprehensive analysis of Global Single-Use Bioprocessing 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 Bioprocessing 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 12 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 Reasons to Purchase

• To gain insightful analyses of the Single-Use Bioprocessing market and have comprehensive understanding of the global market and its commercial landscape.
• Assess the production processes, major issues, and solutions to mitigate the development risk.
• To understand the most affecting driving and restraining forces in the market and its impact in the global market.
• Learn about the Single-Use Bioprocessing market strategies that are being adopted by leading respective organizations.
• To understand the future outlook and prospects for the Single-Use Bioprocessing market. Besides the standard structure reports, we also provide custom research according to specific requirements.

Research Scope of Single-Use Bioprocessing Market

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

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