PUBLISHER: TechSci Research | PRODUCT CODE: 1953556
PUBLISHER: TechSci Research | PRODUCT CODE: 1953556
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The Global Bioprocess Bags & Containers Market is projected to expand significantly, rising from USD 3.76 Billion in 2025 to USD 8.11 Billion by 2031, representing a compound annual growth rate of 13.67%. These disposable or semi-durable vessels are designed for the safe handling and transport of sterile fluids within biopharmaceutical workflows, offering a distinct advantage over traditional stainless steel options by eliminating cleaning validation needs and shortening production turnaround times. A key factor driving this growth is the intense global demand for biologics and vaccines, which requires adaptable and scalable manufacturing capabilities. As noted by the European Federation of Pharmaceutical Industries and Associations in 2024, the research-based pharmaceutical sector invested approximately 55,000 million euros in R&D across Europe, highlighting the massive capital supporting development pipelines that depend on these fluid management solutions.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 3.76 Billion |
| Market Size 2031 | USD 8.11 Billion |
| CAGR 2026-2031 | 13.67% |
| Fastest Growing Segment | Upstream Process |
| Largest Market | North America |
Despite this positive outlook, the market encounters a substantial obstacle regarding the environmental sustainability of plastic waste produced by disposable consumables. As production volumes increase to address global health demands, the industry faces the difficult task of managing the disposal and recycling of the complex multi-layer polymer films utilized in these containers. If effective circular economy strategies are not adopted, the sector may face stringent regulatory measures and rising disposal costs, which could ultimately hinder the widespread long-term adoption of disposable bioprocessing systems.
Market Driver
The rapid shift toward single-use bioprocessing technologies is fundamentally reshaping the market as manufacturers prioritize cost efficiency and operational flexibility. By replacing traditional stainless steel infrastructure, single-use bags and containers reduce capital expenditures by eliminating the need for elaborate clean-in-place and steam-in-place systems. This transition enables faster facility turnover and minimizes cross-contamination risks, a crucial benefit for multiproduct facilities seeking to maximize operational uptime. This commitment to flexible technology is reflected in major capital projects, such as Fujifilm Diosynth Biotechnologies' April 2024 announcement of an additional 1.2 billion USD investment to expand its large-scale cell culture network, directly bolstering flexible production methods reliant on disposable containment.
Additionally, the escalating global demand for biologics and biosimilars acts as a pivotal external force driving the volume of fluid management consumables. As the industry moves from small-molecule drugs to large-molecule therapies, the necessity for secure, scalable, and sterile liquid handling throughout upstream and downstream processes has intensified. Regulatory approvals underscore this trend; the U.S. Food and Drug Administration's 'New Drug Therapy Approvals 2023' report, released in January 2024, noted the approval of 17 new biologics license applications, emphasizing the commercialization of complex therapeutics requiring specialized containment. To accommodate this demand, partners like Samsung Biologics are scaling operations, reporting 3.69 trillion KRW in annual revenue in 2024, a figure that correlates with the heightened usage of bioprocess containers.
Market Challenge
The environmental sustainability of plastic waste from disposable consumables represents a major barrier to the growth of the Global Bioprocess Bags & Containers Market. As biopharmaceutical production scales, the accumulation of non-recyclable, multi-layer polymer waste generates significant financial and compliance liabilities for manufacturers. This challenge directly restricts market expansion because companies aiming to meet corporate sustainability goals may curtail their use of single-use systems to mitigate reputational risks and regulatory penalties linked to an increased environmental footprint. Consequently, the complicated logistics involved in managing end-of-life disposables increase the total cost of ownership, potentially negating the efficiency gains that usually encourage the adoption of these technologies.
Industry data provided by the Bio-Process Systems Alliance in 2024 indicates that plastic waste related to biopharmaceutical manufacturing is expected to reach nearly 11,700 metric tons annually by 2028. This growing volume exerts tremendous strain on existing waste management infrastructures. With strict environmental mandates approaching, the current inability to effectively recycle these bio-contaminated films compels manufacturers to rely on expensive incineration or specialized landfilling options. This financial strain acts as a restraint on the market, deterring the transition from traditional stainless steel equipment to disposable alternatives in cost-sensitive manufacturing environments.
Market Trends
A significant trend is the increasing use of bags in cell and gene therapy (CGT) workflows, which diverges from the volume-centric demands of traditional biologics. In contrast to monoclonal antibodies produced in large-scale bioreactors, autologous and allogeneic therapies require smaller, closed-system 2D and 3D bioprocess containers to handle patient-specific batches and ensure safety during cryogenic storage and transport. This requirement compels manufacturers to innovate specialized film technologies that retain integrity at ultra-low temperatures while preserving sterility for high-value, low-volume products. The growth in this area is highlighted by the Alliance for Regenerative Medicine's January 2025 'State of the Industry Briefing', which reported a 30 percent increase in sector investment, indicating strong pipeline expansion dependent on these advanced containment solutions.
Simultaneously, the market is witnessing a significant expansion of single-use solutions into downstream processing, extending beyond basic buffer storage to include complex purification and fill-finish tasks. While disposable bags were traditionally used for upstream media preparation, the push for end-to-end continuous manufacturing is fostering the adoption of single-use assemblies for chromatography, viral inactivation, and final formulation. This shift minimizes the operational footprint and removes cleaning validation bottlenecks associated with stainless steel piping. Major pharmaceutical companies are validating this move toward integrated disposable lines; for instance, Novartis announced in April 2025 a 23 billion USD investment over five years to build end-to-end manufacturing capabilities, including siRNA technologies that rely heavily on downstream single-use fluid pathways.
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:
Company Profiles: Detailed analysis of the major companies present in the Global Bioprocess Bags & Containers Market.
Global Bioprocess Bags & Containers Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: