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The single-use bioprocessing system market size is forecast to increase by USD 15.32 billion at a CAGR of 19.38% between 2023 and 2028. The market is experiencing significant growth due to the high demand for biopharmaceuticals to treat various diseases. The upstream bioprocessing segment, which involves the production of raw materials and cells, is a key driver for the market. Downstream bioprocessing, which involves the purification and formulation of the final product, is also witnessing advancements and automation, leading to increased efficiency and productivity. However, validation issues while selecting suppliers and integrators pose a challenge to the market. Ensuring the quality and reliability of these systems is crucial to maintain regulatory compliance and ensure patient safety. Overall, the market is expected to continue its growth trajectory, driven by technological advancements and the increasing demand for biopharmaceuticals.
The single-use bioprocessing systems market in the biopharmaceutical industry is witnessing significant growth due to the increasing demand for biologics, monoclonal antibodies, vaccines, and recombinant proteins. Biopharmaceutical companies are increasingly adopting single-use technologies, such as disposables and carbon dioxide (CO2) systems, for clinical and preclinical applications. Single-use bioprocessing equipment, including stainless steel reactors and automation systems, are being replaced with single-use facilities to reduce contamination risks and improve efficiency. The pre-commercial market for single-use bioprocessing systems is growing rapidly, with biologics and monoclonal antibodies being the major applications. The market is driven by the advantages of single-use technologies, such as reduced downtime, ease of use, and cost savings.
Furthermore, the trend toward automation in commercial biopharmaceutical manufacturing is also driving the growth of the single-use bioprocessing systems market. High-volume pharmaceuticals, regenerative medicine, and clinical scales are other emerging applications for single-use bioprocessing systems. The bioprocessing industry is expected to continue to adopt single-use technologies to improve productivity and reduce costs.
The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.
The mab production segment is estimated to witness significant growth during the forecast period. Single-use bioprocessing systems have gained significant traction among mAb producers as they establish end-to-end production capabilities. Trelleborg Healthcare and other suppliers offer a range of Single-use Technology (SUT) solutions, including tubing, filters, medical connectors, and transfer systems, which enable efficient compliance with Good Manufacturing Practices (GMP) and facilitate the rapid production of mAbs in continuous batches without compromising product quality and purity. The growing competition for new indications and the approval of new mAbs necessitates low-cost and flexible production capabilities. As a result, mAb manufacturers are increasingly deploying single-use technologies in purification operations, which heavily rely on single-use filters. Moreover, wave bioreactors and disposable stirred-tank bioreactors are finding considerable adoption in upstream and downstream processing.
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The MAb production segment was valued at USD 1.93 billion in 2018 and showed a gradual increase during the forecast period.
North America is estimated to contribute 37% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.
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The market is witnessing significant growth, with Trelleborg Healthcare and other key players providing innovative solutions in the form of tubing, filters, connectors, and transfer systems for single-use bioreactors. Single-use technology (SUT) has gained prominence in the biologics sector due to its advantages, such as eliminating the need for cleaning and sterilization of equipment between batches, reducing downtime, and lowering costs. North America is the leading region in this market, with the US and Canada at the forefront, due to the increasing adoption of single-use bioprocessing systems by pharmaceutical companies for higher productivity and cost savings. The region's dominance is further bolstered by the presence of prominent companies, including Danaher Corp.
Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The high demand for biopharmaceuticals to treat various diseases is the key driver of the market. Biopharmaceuticals, derived from various biological sources, encompass a wide range of therapeutic products including vaccines, monoclonal antibodies, recombinant proteins, regenerative medicine, and cell and gene therapies. These biologics are extracted from living cells or tissues and have gained significant attention due to their ability to cure a broad spectrum of diseases, expedite recovery processes, and exhibit fewer side effects compared to conventional pharmaceuticals.
Furthermore, single-use bioprocessing systems and equipment play a crucial role in the production of these biopharmaceuticals, particularly those manufactured using mammalian cells. Single-use technologies have gained traction in recent years due to their advantages such as reduced production costs, improved product quality, and ease of use. The demand for these biopharmaceuticals, particularly monoclonal antibodies and recombinant proteins, is expected to continue growing, driven by the increasing number of clinical trials and regulatory approvals for these products. Regenerative medicine, another area of significant growth in biopharmaceuticals, is expected to revolutionize the treatment of chronic diseases by replacing or regenerating damaged or diseased cells, tissues, or organs using stem cells.
The growing product advancements and automation is the upcoming trend in the market. The market is witnessing significant growth due to the increasing demand for advanced products in the biopharmaceutical industry. Single-use bioreactors, a key component of these systems, are being integrated with industrial automation platforms, including single-use sensors, probes, and processing software. This automation enhances the productivity of production lines by eliminating the need for additional manpower and optimizing the process through real-time monitoring and automated control.
Furthermore, single-use technologies are gaining popularity in the production of monoclonal antibodies, vaccines, recombinant proteins, and regenerative medicine. Clinical trials also benefit from these systems due to their ease of use and cost-effectiveness. Overall, the market is poised for continued growth as it addresses the need for cost control and high productivity in the biopharmaceutical industry.
The validation issues while selecting suppliers and integrators is a key challenge affecting the market growth. Single-use bioprocessing systems have gained significant traction in the biopharmaceutical industry due to their advantages in producing biologics such as monoclonal antibodies, vaccines, recombinant proteins, and components for regenerative medicine. Single-use technologies, including single-use bioprocessing equipment, play a crucial role in this process.
Furthermore, the components of these systems, which include clamps, filters, connectors, cable ties, ports, and bags, must adhere to stringent validation requirements before the final assembly. System integrators and market companies must ensure the reliability and quality of these components to meet the demands of the industry. However, the absence of a standardized approach, inconsistencies among suppliers, and insufficient understanding of end-user requirements pose challenges in validating these components. The lack of uniformity and standardization can lead to inconsistencies in production, making it challenging to measure performance and quality accurately.
The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
3M Co.: The company offers single use bioprocessing system such as 3M Zeta Plus BC Series Filter Capsule with SP Series Media, 3M LifeASSURE PSN Series Filter Cartridge and 3M LifeASSURE PLA Series Filter Capsule.
The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market in the biopharmaceutical industry has witnessed significant growth due to the increasing demand for biologics, monoclonal antibodies, vaccines, and recombinant proteins. Single-use bioprocessing systems have gained popularity in the production of high-volume pharmaceuticals due to their advantages such as reduced contamination risk, easier cleaning, and shorter turnaround times. These systems consist of disposable equipment, including tubing, filters, connectors, transfer systems, and single-use bioreactors. The bioprocessing industry's shift towards automation, big data analytics, and workflow optimization has further boosted the adoption of single-use technologies. Upstream bioprocessing involves fermentation, while downstream bioprocessing includes filtration assembles and purification processes.
Furthermore, single-use facilities have become increasingly common in clinical scales, customized medicine, and biomanufacturing. Single-use bioprocessing systems are essential in the production of biologics for chronic illnesses and conditions. These systems simplify the manufacturing process by eliminating the need for cleaning and sterilizing stainless steel reactors. However, concerns regarding extractables from disposable components remain a challenge for the market's growth. Carbon dioxide (CO2) handling, disposables, and automation are key trends in the single-use bioprocessing market. The market is expected to continue growing due to the increasing demand for patient health-focused solutions and the need for efficient, cost-effective manufacturing processes.
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Market Scope |
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Report Coverage |
Details |
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Page number |
210 |
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Base year |
2023 |
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Historic period |
2018-2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 19.38% |
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Market growth 2024-2028 |
USD 15.32 billion |
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Market structure |
Fragmented |
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YoY growth 2023-2024(%) |
17.13 |
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Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
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Performing market contribution |
North America at 37% |
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Key countries |
US, Germany, France, China, and Japan |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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Key companies profiled |
3M Co., ABEC Inc., Adolf Kuhner AG, Advanced Microdevices Pvt. Ltd., Avantor Inc, Celltainer, Compagnie de Saint Gobain, Corning Inc., Danaher Corp., Eppendorf SE, GE Healthcare Technologies Inc., Getinge AB, Meissner Filtration Products Inc., Merck KGaA, Parker Hannifin Corp., PBS Biotech Inc., Sartorius AG, SENTINEL PROCESS SYSTEMS INC., Solaris Biotechnology Srl, Thermo Fisher Scientific Inc., Cytiva, and Entegris Inc. |
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Market dynamics |
Parent market analysis, market growth inducers and obstacles, market forecast, fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the forecast period |
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Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
We can help! Our analysts can customize this market research report to meet your requirements. Get in touch
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Application
7 Market Segmentation by Product
8 Market Segmentation by End-user
9 Customer Landscape
10 Geographic Landscape
11 Drivers, Challenges, and Trends
12 Vendor Landscape
13 Vendor Analysis
14 Appendix
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