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The global single-use bioprocessing system market size is estimated to grow by USD 15.32 billion, at a CAGR of 19.38% between 2023 and 2028.
The integration of real-time monitoring and control technology is revolutionizing bioprocessing operations worldwide. By providing enhanced visibility into critical process parameters, these technologies enable data-driven decision-making in real time, resulting in heightened productivity, efficiency, and product quality. Sensors in single-use bioreactors continuously monitor vital metrics like temperature, pH levels, and agitation speed, with data routed to a central control system for analysis and adjustment. This approach facilitates preventive maintenance and troubleshooting through predictive analytics, minimizing downtime and enhancing overall process reliability. As a result, real-time monitoring and control technologies are driving efficiency gains and quality improvements across bioprocessing operations, fueling market growth.
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The market caters to the growing demand for biologics production, leveraging innovative technologies like HyPerforma single use bioreactors and disposables. These solutions offer advantages in higher use for commercial-scale manufacturing, especially for high-volume pharmaceuticals, in both pre-commercial and commercial-scale settings. With a focus on carbon dioxide (CO2) reduction and flexibility, they are increasingly preferred over traditional fixed stainless steel systems, particularly in single-use facilities operating at clinical scales. Further, biopharmaceutical commercials play a crucial role in shaping the pre-commercial market landscape, influencing stakeholders and generating awareness about upcoming treatments and therapies in the industry.
The market share by the mAb production segment will be significant during the forecast period. mAb producers are increasingly embracing single-use bioprocessing systems for end-to-end production capabilities, ensuring compliance with GMP and rapid mAb production without compromising quality. Pressure to adopt low-cost technologies for new indications fuels the deployment of single-use purification operations, including filters and bioreactors.
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The mAb production segment was valued at USD 1.93 billion in 2018. Further, these systems offer benefits like reduced cross-contamination and preparation time between batches. However, challenges exist in scaling up single-use systems for large-scale production, leading to the use of multiple 2,000 L bioreactors in tandem, as seen in Amgen Inc.'s Singapore facility, driving growth in the mAb segment and the global single-use bioprocessing market.
Bags and mixers are integral to the formulation and preparation of media, buffers, and viral inactivation processes for biotechnology and pharmaceutical companies. Vendors focus on high-quality raw materials to ensure chemical compatibility. End-users prioritize sterile conditions and regulatory compliance, driving vendors to adhere to GMP standards and ISO certifications. Single-use mixers offer advantages like reduced contamination and downtime compared to stainless steel mixers, with vendors offering customizable options to meet specific production needs. Automation and sensor integration further enhance product offerings, fostering adoption among end-users and driving single-use bioprocessing system market growth.
Bioreactors and fermenters utilize disposable bags and polymeric linings for culturing mammalian cells, offering flexibility and ease of use. Market vendors provide various types of bioreactors, including rocking motion-based and stirred integrated models. Innovative square-shaped bioreactors are gaining popularity for enhanced mixing and simplified cleaning. Compliance with GMP standards drives the launch of new bioreactors, boosting adoption among regulated industries like pharmaceuticals and biotechnology. Single-use fermenters meet the demand for efficient microbial fermentation in producing high-value protein therapeutics, driving market growth.
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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 will shape the market during the forecast period. North America leads the market, with the US and Canada as key players. The region's pharmaceutical sector drives adoption, aiming for cost reduction and productivity enhancement.
Further, major market players like Danaher Corp., Entegris Inc., Eppendorf SE., and Thermo Fisher Inc. further bolster market availability. Regulatory authorities encourage strategic enhancements in therapeutic approvals, fostering commercial entry of monoclonal antibody-based drugs. This trend will propel the North American market during the forecast period.
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. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
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.
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 is witnessing robust growth driven by the rising demand for biopharmaceuticals, including monoclonal antibodies and vaccines, as well as recombinant proteins. Biopharmaceutical companies are increasingly adopting single-use bioprocessing equipment provided by specialized single-use manufacturers. These systems find extensive applications in regenerative medicine, cell and gene therapies, and emerging mRNA and DNA technologies. With advantages such as flexibility, reduced contamination risk, and cost-effectiveness, SUT (Single-use technology) is gaining traction over traditional stainless steel reactors. The market encompasses various offerings like liquid single-use bioprocessing bags and HyPerforma single-use bioreactors tailored for clinical and preclinical as well as pre-commercial and commercial-scale manufacturing in the bioprocessing industry. Our researchers analyzed the market research and growth data with 2023 as the base year, along with the key market growth analysis, trends, and challenges. A holistic analysis of drivers, trends, and challenges will help companies refine their marketing strategies to gain a competitive advantage.
Increasing use to minimize the risk of contamination is the key factor driving the market. Some of the major concerns faced by bio manufacturers during production processes are related to the contamination risks involved and the significant expenditure incurred on preventing such risks. Bioprocessing activities are also exposed to various kinds of risks, such as microbial contamination, cross-contamination, and biologic contamination. Moreover, end-users such as pharmaceutical companies and biotechnology companies operate in a highly regulated market.
Additionally, regulatory authorities such as the US FDA, EMA, and China Food and Drug Administration (CFDA) largely focus on the maintenance of quality and purity standards in the end products as well as in the operational processes by defining stringent guidelines. Thus, the use of pre-sterilized flow paths in every new production batch eliminates the chances of contamination. This helps end-users to establish continuous production batches, thereby increasing productivity, ensuring product integrity and safety, and reducing the time-to-market. Such factors are expected to drive market growth during the forecast period.
The need for scalability in biopharmaceutical manufacturing is one of the primary market trends shaping the growth. Traditional stainless steel bioprocessing facilities necessitate large initial investments in infrastructure and equipment, as well as ample area for installation and operation. Single-use bioprocessing systems, on the other hand, are a more cost-effective option since they eliminate the need for costly cleaning, validation, and maintenance that comes with reusable equipment. Furthermore, single-use systems require less physical space, allowing for more efficient use of manufacturing facilities and allowing businesses to increase production capacity without extensive facility upgrades.
Furthermore, the implementation of single-use technologies allows biopharmaceutical businesses to streamline their operations, speed time-to-market for new medicines, and respond swiftly to changing market demands, resulting in cost savings and increased industry competitiveness. As a result, the trend toward lower capital expenditures and facility footprints is projected to continue to shape the global biopharmaceutical production landscape. Such factors are expected to drive market growth during the forecast period.
Issues related to extractable and leachable is the major challenges that affect market growth. Concerns over contamination in single-use bioprocessing systems, stemming from the use of plastics and additives that may interact with drugs and chemicals, are widespread among pharmaceutical and biotechnology companies. Leachables and extractables pose significant risks, potentially impacting product safety and efficacy. Regulatory bodies like the US FDA mandate safety demonstrations for materials used in production systems and drug delivery devices.
Consequently, failure to comply can result in product approval challenges. Despite efforts by market vendors to select safe polymeric materials, ensuring biological compatibility remains a challenge. Testing standards such as USP <661> and USP <87> are crucial, as material failure can lead to significant losses in time and resources. Contamination concerns, particularly from leachables and extractables, pose a significant obstacle to market growth during the forecast period.
The market 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 market growth and forecasting report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Customer Landscape
The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028.
The market is revolutionizing biomanufacturing with technologically advanced products and solutions from industry leaders like Trelleborg Healthcare. These systems encompass various components such as tubing, connectors, and transfer systems, optimizing workflow in upstream and downstream bioprocessing. With big data analytics, manufacturers enhance efficiency and ensure patient health by addressing chronic illnesses & conditions.
Furthermore, the adoption of disposable technologies and disposable bioreactors is on the rise, catering to the growing demand for commercial biopharmaceutical manufacturing and customized medicine while mitigating risks associated with extractables and leachables. Further, the market is experiencing a surge due to its pivotal role in bioprocesses and clinical trials. With a focus on upstream bioprocessing, these systems offer disposable technology adoption for enhanced efficiency. Key components like apparatus & plants and filtration assemblies streamline operations, providing simple & peripheral elements for work equipment. This sector's growth underscores its importance in modern biopharmaceutical manufacturing and bioprocessing.
Market Scope |
|
Report Coverage |
Details |
Page number |
210 |
Base year |
2023 |
Historic period |
2018-2022 |
Market forecasting period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 19.38% |
Market Growth 2024-2028 |
USD 15.32 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
17.13 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 37% |
Key countries |
US, Germany, France, China, and Japan |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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. |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and market condition analysis for the forecast period. |
Customization purview |
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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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