Global Single-use Bioprocessing Material Market Growth, Share, Size, Trends and Forecast (2025 - 2031)
By Product;
Plastic, Silicone, and Others.By End User;
Biopharmaceutical Manufacturers, Life Science R&D & Academic Institutes, and Contract Research Organizations (CROs) & Manufacturers (CMOs).By Geography;
North America, Europe, Asia Pacific, Middle East and Africa and Latin America - Report Timeline (2021 - 2031).Introduction
Global Single-use Bioprocessing Material Market (USD Million), 2021 - 2031
In the year 2024, the Global Single-use Bioprocessing Material Market was valued at USD 13,262.26 million. The size of this market is expected to increase to USD 39,258.74 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 16.8%.
The global single-use bioprocessing material market has experienced significant growth due to its critical role in the biopharmaceutical industry. Single-use bioprocessing systems, which are disposable and designed for one-time use, offer several advantages over traditional stainless steel systems, including reduced risk of contamination, lower capital investment, and greater flexibility. These benefits are particularly valuable in the production of biologics, vaccines, and personalized medicines, where stringent sterility and rapid scalability are essential. As a result, the demand for single-use bioprocessing materials such as bioreactors, bags, tubing, and filters has surged, driving market expansion.
Technological advancements and innovation have been key drivers in the adoption of single-use systems. Improvements in material science have led to the development of robust, high-performance polymers that can withstand various bioprocessing conditions. Additionally, the integration of automation and process control technologies has enhanced the efficiency and reliability of single-use systems. These advancements not only increase the appeal of single-use systems for large-scale biomanufacturing but also support their use in research and development settings, where agility and cost-effectiveness are paramount. Consequently, the market is witnessing increased investment from both established biopharma companies and emerging biotech firms.
Regional market dynamics reflect the global nature of the biopharmaceutical industry, with significant growth observed in North America, Europe, and Asia-Pacific. North America, driven by the presence of leading biopharmaceutical companies and a robust regulatory framework, remains a dominant market. Europe follows closely, benefiting from strong governmental support and a well-established healthcare infrastructure. Meanwhile, the Asia-Pacific region is rapidly emerging as a key player, fueled by growing investments in biotechnology, favorable government policies, and an expanding healthcare sector. The interplay of these regional markets contributes to the overall growth and diversification of the global single-use bioprocessing material market.
Global Single-use Bioprocessing Material Market Recent Developments
- October 2022: PharmNXT Biotech launched its first integrated manufacturing unit in Pune to provide single-use bioprocessing solutions. With this launch, the facility addresses the challenges to biologics manufacturing in India.
- October 2022: Single Use Support GmbH, an Austrian solution provider, expanded its product portfolio with new single-use bioprocess containers under the brand name IRIS. This expansion assists the company in the robust storage and shipping of drug substances with IRIS single-use bags in RoSS Shell.
Segment Analysis
The global single-use bioprocessing material market can be segmented based on product type, application, and end-user. In terms of product type, the market includes bioreactors, bags, tubing, filters, mixers, connectors, and assemblies. Bioreactors and bags represent the largest segments due to their extensive use in upstream and downstream bioprocessing. Single-use bioreactors, in particular, are highly sought after for their efficiency in cell culture and fermentation processes. Filters and tubing are also critical, ensuring sterility and integrity in fluid management. These segments benefit from continuous innovation aimed at improving material compatibility and performance.
Application-wise, the market is divided into monoclonal antibody production, vaccine production, gene therapy, cell therapy, and others. Monoclonal antibody production constitutes a significant share due to the high demand for these therapeutics in treating various diseases, including cancer and autoimmune disorders. Vaccine production is another vital segment, underscored by the recent global emphasis on vaccine development and manufacturing, particularly highlighted during the COVID-19 pandemic. Gene and cell therapy applications are rapidly growing segments, driven by advancements in personalized medicine and regenerative therapies. The unique requirements of these applications, such as precise control and sterility, make single-use systems an ideal choice.
In terms of end-users, the market is categorized into pharmaceutical and biotechnology companies, contract research organizations (CROs), and academic and research institutes. Pharmaceutical and biotechnology companies are the primary end-users, leveraging single-use systems to streamline production, reduce costs, and maintain flexibility. CROs are increasingly adopting these technologies to offer more efficient and scalable services to their clients. Academic and research institutes also represent a growing segment, utilizing single-use bioprocessing materials for a wide range of research applications, including drug discovery and development. The diverse needs and adoption rates across these end-user categories drive the overall expansion and innovation within the single-use bioprocessing material market.
Global Single-use Bioprocessing Material Segment Analysis
In this report, the Global Single-use Bioprocessing Material Market has been segmented by Product, End User, and Geography.
Global Single-use Bioprocessing Material Market, Segmentation by Product
The Global Single-use Bioprocessing Material Market has been segmented by Product into Plastic, Silicone, and Others.
Plastic materials dominate the market due to their versatility, cost-effectiveness, and suitability for a wide range of bioprocessing applications. High-performance polymers such as polyethylene, polypropylene, and polyvinyl chloride are commonly used in manufacturing bioreactors, bags, tubing, and filters. These plastics offer excellent biocompatibility, chemical resistance, and ease of disposal, making them the preferred choice for single-use systems. Advances in plastic technology have further enhanced their durability and performance, addressing concerns related to leachables and extractables, thereby boosting their adoption in critical bioprocessing applications.
Silicone is another significant material in the single-use bioprocessing market, valued for its exceptional flexibility, durability, and inertness. Silicone is often used in applications where a high degree of flexibility and resilience is required, such as in tubing, gaskets, and seals. Its excellent thermal stability and resistance to a wide range of chemicals make it ideal for maintaining the integrity of bioprocesses under varying conditions. Additionally, silicone’s biocompatibility ensures it does not adversely affect the biological products being processed. However, its higher cost compared to plastics can limit its use to specific, high-demand applications where its unique properties provide critical benefits.
Materials like glass and stainless steel components that may still find use in hybrid systems, where a combination of single-use and traditional reusable components is implemented. This segment is relatively small but significant in applications requiring specialized properties such as enhanced mechanical strength or specific chemical resistance that plastics and silicone cannot provide alone. These materials are often used in conjunction with single-use components to create tailored solutions for complex bioprocessing needs. As bioprocessing technologies evolve, there is ongoing research and development aimed at finding new materials that can offer improved performance, sustainability, and cost-efficiency, potentially expanding this segment in the future.
Global Single-use Bioprocessing Material Market, Segmentation by End User
The Global Single-use Bioprocessing Material Market has been segmented by End User into Biopharmaceutical Manufacturers, Life Science R&D & Academic Institutes, and Contract Research Organizations (CROs) & Manufacturers (CMOs).
Biopharmaceutical manufacturers constitute the largest end-user segment. These companies leverage single-use technologies to enhance the efficiency, flexibility, and cost-effectiveness of their production processes. Single-use systems help biopharmaceutical manufacturers rapidly scale up production, reduce contamination risks, and simplify regulatory compliance, which is particularly crucial in the production of biologics, vaccines, and personalized medicine. The ability to quickly switch between production batches without extensive cleaning procedures makes single-use systems invaluable in this highly competitive and fast-paced industry.
Life science R&D and academic institutes represent another significant segment within the single-use bioprocessing market. These institutions utilize single-use materials for a variety of research applications, including drug discovery, development, and preclinical testing. The flexibility and lower initial investment associated with single-use systems make them ideal for experimental setups and pilot studies where multiple small-scale processes are run in parallel. Academic researchers benefit from the ability to conduct high-throughput screening and other complex procedures without the need for costly and time-consuming equipment sterilization. The adaptability and ease of use of single-use systems support innovation and accelerate the pace of scientific discovery in these settings.
Contract research organizations (CROs) and contract manufacturing organizations (CMOs) are key players in the single-use bioprocessing market, providing specialized services to biopharmaceutical companies. CROs utilize single-use technologies to offer flexible, scalable, and efficient research services, helping clients advance their drug development pipelines more rapidly and cost-effectively. CMOs, on the other hand, employ single-use systems to streamline manufacturing processes, reduce turnaround times, and accommodate varying production scales. The ability to quickly adapt to different client needs and product specifications makes single-use systems highly attractive to CROs and CMOs. As outsourcing trends continue to grow in the biopharmaceutical industry, the demand for single-use bioprocessing materials within this segment is expected to increase significantly, driving further market expansion.
Global Single-use Bioprocessing Material Market, Segmentation by Geography
In this report, the Global Single-use Bioprocessing Material Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.
Global Single-use Bioprocessing Material Market Share (%), by Geographical Region, 2024
North America holds the largest market share, accounting for approximately 40% of the global market. This dominance is attributed to the presence of numerous leading biopharmaceutical companies, advanced healthcare infrastructure, and robust investment in biotechnology research and development. The United States, in particular, has a well-established biopharma industry and favorable regulatory policies that encourage innovation and the adoption of single-use technologies. Additionally, the region benefits from a strong network of contract research and manufacturing organizations (CROs and CMOs), further driving the demand for single-use bioprocessing materials.
Europe follows North America, comprising around 30% of the global market share. The region's strong market position is supported by significant governmental support for the biotechnology sector, a well-developed healthcare system, and a high concentration of biopharmaceutical firms. Countries such as Germany, the United Kingdom, and France are key contributors, with substantial investments in bioprocessing technologies and a focus on high-quality production standards. European regulatory agencies also support the use of single-use systems, recognizing their benefits in maintaining sterility and reducing cross-contamination risks. Collaborative research initiatives and public-private partnerships in Europe further enhance the adoption and growth of single-use bioprocessing materials.
The Asia-Pacific region is rapidly emerging as a significant player in the single-use bioprocessing material market, capturing around 20% of the market share. This growth is driven by increasing investments in biotechnology and pharmaceutical industries, particularly in countries like China, India, and South Korea. The region benefits from favorable government policies aimed at boosting domestic biopharmaceutical production, as well as a growing emphasis on improving healthcare infrastructure. The cost advantages and scalability offered by single-use systems are particularly appealing in this region, where the demand for biologics and vaccines is rising. As more biopharmaceutical companies and research institutions in Asia-Pacific adopt single-use technologies, the region's market share is expected to continue growing, contributing significantly to the global market dynamics.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Single-use Bioprocessing Material Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers
- Cost-Effectiveness Of Single-Use Systems
- Advancements In Bioprocessing Technologies
- Flexibility And Scalability In Manufacturing
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Reduction In Risk Of Cross-Contamination - The adoption of single-use bioprocessing materials significantly reduces the risk of cross-contamination in biopharmaceutical manufacturing. Traditional stainless steel systems require extensive cleaning and sterilization between production batches to prevent cross-contamination, which can be time-consuming and costly. Single-use systems, however, are designed for one-time use and can be easily disposed of after each batch, eliminating the need for rigorous cleaning processes. This not only enhances the sterility and integrity of the production environment but also ensures that there is no residual contamination from previous batches, thereby maintaining high product quality and safety.
Single-use bioprocessing materials provide a closed system environment that further mitigates the risk of contamination. These systems often include pre-assembled and pre-sterilized components, such as bags, tubing, and connectors, which minimize the exposure of the bioprocessing materials to external contaminants. By using disposable elements, the potential for human error during cleaning and assembly is significantly reduced, contributing to a more controlled and contamination-free manufacturing process. This is particularly crucial in the production of biopharmaceuticals, where even the slightest contamination can compromise the efficacy and safety of the final product.
The reduction in cross-contamination risk afforded by single-use systems also translates into economic and operational benefits for biopharmaceutical manufacturers. The need for fewer cleaning validations and shorter turnaround times between production batches can lead to increased operational efficiency and cost savings. Additionally, the ability to quickly and easily switch between different products without extensive cleaning reduces downtime and enhances the flexibility of the manufacturing process. As the biopharmaceutical industry continues to grow and evolve, the adoption of single-use bioprocessing materials is likely to become increasingly prevalent, driven by their ability to ensure product safety, improve operational efficiency, and reduce contamination risks.
Restraints
- Limited Availability Of High-Quality Materials
- Environmental Concerns Related To Waste Disposal
- Regulatory Challenges And Compliance Issues
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Supply Chain Disruptions - Supply chain disruptions pose a significant challenge to the single-use bioprocessing material market. These disruptions can arise from various factors, including geopolitical tensions, natural disasters, and logistical issues, which can impede the timely delivery of essential materials and components. In the highly specialized field of biopharmaceutical manufacturing, any delay in the supply chain can halt production processes, potentially leading to financial losses and shortages of critical medicines. The reliance on a few key suppliers for high-quality single-use components further exacerbates the vulnerability of the supply chain to disruptions.
COVID-19 pandemic has highlighted the fragility of global supply chains, particularly for the biopharmaceutical industry. The surge in demand for vaccines and therapeutics strained the existing supply chains, causing shortages and delays in the availability of single-use bioprocessing materials. Manufacturers had to navigate complexities such as restricted transportation, limited workforce availability, and the increased cost of raw materials. These challenges underscored the need for more resilient and diversified supply chains to ensure the continuous and reliable production of biopharmaceuticals.
To mitigate the impact of supply chain disruptions, companies in the single-use bioprocessing material market are exploring various strategies. Diversification of suppliers is one approach, reducing dependence on single sources and spreading risk. Additionally, some manufacturers are increasing their inventory levels and establishing local production facilities to minimize the impact of global disruptions. Advances in digital supply chain management and predictive analytics are also being leveraged to enhance visibility and responsiveness, allowing companies to anticipate and address potential disruptions more effectively. By adopting these measures, the biopharmaceutical industry aims to build more robust supply chains that can withstand future challenges and ensure the uninterrupted availability of vital single-use bioprocessing materials.
Opportunities
- Development Of Sustainable Materials
- Integration Of Automation And Digitalization
- Growth In Personalized Medicine
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Collaborations And Strategic Partnerships - Collaborations and strategic partnerships play a pivotal role in the growth and innovation of the single-use bioprocessing material market. By joining forces, companies can leverage each other's strengths, share resources, and accelerate the development and commercialization of new technologies. For instance, partnerships between bioprocessing material manufacturers and biopharmaceutical companies can lead to the co-development of customized solutions that meet specific production needs, enhancing efficiency and product quality. These collaborations often result in faster time-to-market for new products, benefiting both parties and the broader healthcare industry.
Strategic partnerships also facilitate knowledge and technology transfer, which is crucial in a rapidly evolving field like bioprocessing. Companies with complementary expertise can collaborate to overcome technical challenges, optimize processes, and innovate more effectively than they could individually. For example, a material science company might partner with a bioprocessing equipment manufacturer to create advanced single-use systems with improved performance characteristics. Such partnerships can lead to the development of next-generation bioprocessing materials that offer greater scalability, sterility, and cost-effectiveness, driving the market forward.
Collaborations and strategic partnerships can help companies navigate regulatory landscapes and expand their global reach. By partnering with local firms or those with established regulatory expertise, companies can better understand and comply with regional regulations, facilitating smoother market entry and expansion. These alliances can also provide access to new markets and customer bases, enhancing competitive advantage and market presence. In an industry where innovation and speed are critical, strategic partnerships are indispensable for staying ahead of the curve and meeting the growing demands of the biopharmaceutical sector.
Competitive Landscape Analysis
Key players in Global Single-use Bioprocessing Material Market include :
- 3M company
- Applikon Biotechnology
- Cesco Bioengineering Co. Ltd
- Danaher Corporation
- Eppendorf AG
- General Electric Company
- Merck KGaA
- PBS Biotech
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Product
- Market Snapshot, By End User
- Market Snapshot, By Region
- Global Single-use Bioprocessing Material Market Dynamics
- Drivers, Restraints and Opportunities
- Drivers
- Cost-Effectiveness Of Single-Use Systems
- Advancements In Bioprocessing Technologies
- Flexibility And Scalability In Manufacturing
- Reduction In Risk Of Cross-Contamination
- Restraints
- Limited Availability Of High-Quality Materials
- Environmental Concerns Related To Waste Disposal
- Regulatory Challenges And Compliance Issues
- Supply Chain Disruptions
- Opportunities
- Development Of Sustainable Materials
- Integration Of Automation And Digitalization
- Growth In Personalized Medicine
- Collaborations And Strategic Partnerships
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
- Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Single-use Bioprocessing Material Market, By Product, 2021 - 2031 (USD Million)
- Plastic
- Silicone
- Other
- Global Single-use Bioprocessing Material Market, By End User, 2021 - 2031 (USD Million)
- Biopharmaceutical Manufacturers
- Life Science R&D & Academic Institutes
- Contract Research Organizations (CROs) & Manufacturers (CMOs)
- Global Single-use Bioprocessing Material Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Single-use Bioprocessing Material Market, By Product, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- 3M company
- Applikon Biotechnology
- Cesco Bioengineering Co. Ltd
- Danaher Corporation
- Eppendorf AG
- General Electric Company
- Merck KGaA
- PBS Biotech
- Company Profiles
- Analyst Views
- Future Outlook of the Market