Bioprocess Bags & Containers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (Upstream Processes, Downstream Processes, Process Development, Others), By Product Type (2D Bioprocess Bags and Containers, 3D Bioprocess Bags and Containers), By End User (Pharmaceutical and Biopharmaceutical Companies, Academic and Research Institutes, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.76 Billion
CAGR (2026-2031)	13.67%
Fastest Growing Segment	Upstream Process
Largest Market	North America
Market Size (2031)	USD 8.11 Billion

Market Overview

The Global Bioprocess Bags & Containers Market will grow from USD 3.76 Billion in 2025 to USD 8.11 Billion by 2031 at a 13.67% CAGR. Bioprocess bags and containers are specialized disposable or semi-durable vessels engineered for the secure handling, storage, and transport of sterile liquids, media, and buffers throughout biopharmaceutical manufacturing workflows. These containment solutions are increasingly favored over traditional stainless steel alternatives due to their ability to eliminate cleaning validation requirements and significantly reduce turnaround times between production batches. The primary driver propelling this market is the robust global demand for biologics and vaccines which necessitates flexible and scalable manufacturing capacities. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, the research-based pharmaceutical industry invested an estimated 55,000 million euros in research and development in Europe which underscores the substantial capital flowing into development pipelines that rely heavily on these fluid management technologies.

Despite the upward trajectory, the market faces a significant challenge regarding the environmental impact and sustainability of plastic waste generated by disposable consumables. As production scales to meet global healthcare needs, the industry must address the complex disposal and recycling of multi-layer polymer films used in these bags. Failure to implement effective circular economy strategies could lead to strict regulatory pressures and increased disposal costs which may impede the broader adoption of disposable bioprocessing systems in the long term.

Key Market Drivers

The accelerated adoption of single-use bioprocessing technologies is fundamentally reshaping the market as manufacturers prioritize operational cost efficiency and manufacturing flexibility. Unlike traditional stainless steel systems, single-use bags and containers significantly lower capital expenditure by removing the need for complex clean-in-place and steam-in-place infrastructure. This shift allows for rapid facility turnover and decreased risk of cross-contamination, which is critical for multiproduct facilities aiming to maximize uptime. The industry commitment to this flexible technology is evident in recent large-scale capital projects designed to integrate these consumables. According to Fujifilm Diosynth Biotechnologies, April 2024, in the 'Fujifilm Announces 1.2 Billion USD Investment' press release, the organization committed an additional 1.2 billion USD to expand its large-scale cell culture manufacturing network, a move directly supporting flexible production modalities that rely on disposable containment solutions.

The surging global demand for biologics and biosimilars serves as a critical external force expanding the volume of required fluid management consumables. As the pharmaceutical industry pivots from small-molecule drugs to large-molecule therapies, the need for sterile, secure, and scalable liquid handling solutions throughout the upstream and downstream processes has intensified. Regulatory bodies are validating this trend through steady approval rates for complex new therapies. According to the U.S. Food and Drug Administration, January 2024, in the 'New Drug Therapy Approvals 2023' report, the center officially approved 17 new biologics license applications, highlighting the commercialization of complex therapeutics that require specialized containment. To meet this rising consumption, manufacturing partners are scaling operations. According to Samsung Biologics, in 2024, the company recorded an annual revenue of 3.69 trillion KRW for the previous fiscal year, reflecting the immense service demand that directly correlates with the increased utilization of bioprocess containers.

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Key Market Challenges

The environmental sustainability of plastic waste generated by disposable consumables constitutes a significant impediment to the growth of the Global Bioprocess Bags & Containers Market. As biopharmaceutical production scales, the volume of non-recyclable, multi-layer polymer waste creates substantial compliance and financial liabilities for manufacturers. This issue directly hampers market expansion because companies striving for corporate sustainability targets may limit their reliance on single-use systems to avoid the reputational risks and regulatory penalties associated with increasing their environmental footprint. Consequently, the complex logistics of managing end-of-life disposables elevate the total cost of ownership, counteracting the efficiency benefits that typically drive the adoption of these technologies.

According to the Bio-Process Systems Alliance, in 2024, industry data highlighted that biopharmaceutical manufacturing-related plastic waste is projected to reach approximately 11,700 metric tons annually by 2028. This escalating volume places immense pressure on existing waste management infrastructures. With strict environmental mandates looming, the current inability to effectively recycle these bio-contaminated films forces manufacturers to depend on costly incineration or specialized landfilling. This financial burden acts as a direct restraint on the market, discouraging the replacement of traditional stainless steel equipment with disposable alternatives in cost-sensitive manufacturing workflows.

Key Market Trends

The rising utilization of bags in cell and gene therapy (CGT) workflows is a critical trend diverging from the volume-driven demands of traditional biologics. Unlike monoclonal antibodies that require large-scale bioreactors, autologous and allogeneic therapies necessitate smaller, closed-system 2D and 3D bioprocess containers to manage patient-specific batches and prevent cross-contamination during cryogenic storage and transport. This shift forces manufacturers to develop specialized film technologies that maintain integrity at ultra-low temperatures while ensuring sterility for high-value, low-volume payloads. The momentum in this sector is quantified by the capital flowing into the field to support these complex modalities. According to the Alliance for Regenerative Medicine, January 2025, in the 'State of the Industry Briefing', investment in the cell and gene therapy sector rose by 30 percent, signaling a robust expansion in clinical pipelines that directly depend on these advanced containment solutions.

Concurrently, the market is witnessing a significant expansion of single-use solutions into downstream processing, moving beyond simple buffer storage to complex purification and fill-finish operations. Historically, disposable bags were predominantly used in upstream media preparation; however, the need for end-to-end continuous manufacturing is driving the adoption of single-use assemblies for chromatography, viral inactivation, and final formulation steps. This transition reduces the operational footprint and eliminates the cleaning validation bottlenecks associated with stainless steel piping in purification suites. This strategic move toward fully integrated disposable lines is evident in major pharmaceutical infrastructure commitments. According to Novartis, April 2025, in the 'Novartis plans to expand its US-based manufacturing and R&D footprint' press release, the organization committed a 23 billion USD investment over five years to establish end-to-end manufacturing capabilities, including for siRNA technologies that heavily utilize these downstream single-use fluid paths.

Segmental Insights

The Upstream Process segment represents the fastest-growing category in the Global Bioprocess Bags & Containers Market, primarily due to the increasing reliance on single-use technologies for cell culture and media preparation. Biopharmaceutical manufacturers prioritize these disposable solutions to mitigate cross-contamination risks and eliminate time-consuming cleaning validation procedures. This operational shift aligns with stringent safety guidelines from regulatory bodies like the U.S. Food and Drug Administration, which emphasize rigorous contamination control in drug manufacturing. Consequently, the demand for sterile containment during the initial stages of biologics production drives the rapid expansion of this segment.

Regional Insights

North America maintains a leading position in the global bioprocess bags and containers market, primarily driven by the extensive presence of major biopharmaceutical manufacturers in the United States. The region benefits from substantial investment in research and development activities focused on biologics and vaccine production. Additionally, the rapid adoption of single-use technologies is supported by rigorous safety frameworks established by the U.S. Food and Drug Administration. This regulatory environment encourages the use of disposable containment solutions to ensure sterility and operational efficiency, securing the region's dominance in this sector.

Recent Developments

• In August 2025, Meissner announced the launch of its Rotary Impeller Mixing Solutions (RMS) portfolio, a new product line engineered to enhance the performance and reliability of biocontainer mixing. These assemblies are manufactured using the company's proprietary TepoFlex polyethylene multi-layer film, which ensures a low extractables profile and high process purity for critical bioprocessing applications. The new mixing assemblies were designed to offer drop-in compatibility with industry-standard tanks and drive units, allowing biomanufacturers to upgrade their capabilities without workflow disruptions. This launch emphasizes the company's focus on vertically integrated manufacturing to provide supply chain resilience and consistent quality control for the market.
• In June 2025, Sartorius Stedim Biotech celebrated the completion of a major capacity expansion at its headquarters in Aubagne, France, to meet the rising demand for fluid management technologies. The project involved a significant investment to double the site's cleanroom space and install automated, digitized production lines specifically for 2D and 3D single-use bags. These advanced manufacturing capabilities are intended to increase productivity and reliability for cell culture, storage, and shipping applications. The company also integrated a high-bay warehouse with autonomous logistics systems to accelerate the handling of raw materials, ensuring a robust supply chain for its global biopharmaceutical clients.
• In July 2024, Thermo Fisher Scientific introduced a new line of single-use bioprocess containers derived from plant-based materials to help the biopharmaceutical industry reduce its environmental impact. These biobased films, which received International Sustainability and Carbon Certification (ISCC) PLUS, allow customers to lower carbon emissions associated with plastic resin without requiring the validation of new materials. The President of Single-Use Technologies at Thermo Fisher Scientific stated that these films enable manufacturers to improve sustainability while maintaining productivity. The new containers are designed to be incorporated into both upstream and downstream systems, offering a circular economy approach to bioprocessing consumables.
• In April 2024, SaniSure launched Fill4Sure, a new custom single-use filling assembly designed to address critical challenges in the drug product filling process. This innovative solution features extremely clean, low-particulate 2D surge bags and utilizes silicone overmolding to enhance durability during operations. The system was engineered to support biopharmaceutical manufacturers in securing their supply chains and expanding capacity by improving efficiency and repeatability. According to the Global Product Line Manager at SaniSure, the assembly allows for effortless scaling and includes high-performance tubing to ensure accuracy, ultimately helping to expedite the delivery of drugs to the market while minimizing contamination risks.

Key Market Players

• Meissner Filtration Products, Inc.
• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Saint-Gobain
• Corning Incorporated
• Entegris
• PROAnalytics, LLC
• CellBios Healthcare and Lifesciences Pvt Ltd.

By Application	By Product Type	By End User	By Region
Upstream Processes Downstream Processes Process Development Others	2D Bioprocess Bags and Containers 3D Bioprocess Bags and Containers	Pharmaceutical and Biopharmaceutical Companies Academic and Research Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Bioprocess Bags & Containers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Bioprocess Bags & Containers Market, By Application:

• Upstream Processes
• Downstream Processes
• Process Development
• Others

• Bioprocess Bags & Containers Market, By Product Type:

• 2D Bioprocess Bags and Containers
• 3D Bioprocess Bags and Containers

• Bioprocess Bags & Containers Market, By End User:

• Pharmaceutical and Biopharmaceutical Companies
• Academic and Research Institutes
• Others

• Bioprocess Bags & Containers Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE