Global Single-Use Bioprocessing Bag Films Market Assessment, By Film Material Type [Polyethylene, EVA Films, EVOH-Based Multilayer Films, Others], By Layer Structure [Single-Layer Films, Multi-Layer Films], By Capacity [Small (≤ 5L), Medium (5–50L), Large (50–500L), Very large (500L–2000L+)], By End-User [Biopharmaceutical Companies, CROs & CDMOs, Others], By Region, Opportunities and Forecast, 2018-2032F

Global Single-Use Bioprocessing Bag Films Market is projected to witness a CAGR of 12.90% during the forecast period 2025-2032, growing from USD 20.37 billion in 2024 to USD 53.77 billion in 2032. The market is expanding as these technologies align with the operational and regulatory requirements of future biologics manufacturing. The key factors contributing to market growth include the rapid production of complex biologics, for instance, monoclonal antibodies, cell and gene therapies, which require the provision of sterile and low-risk handling environments.  

The use of single-use bag films enables closed, disposable systems that significantly reduce cleaning and sterilization cycles, thereby minimizing cross-contamination risk, shortening changeover times, and improving overall facility efficiency and flexibility. Advancements in materials and construction, particularly polyethylene-based and multilayer films, have enhanced the chemical resistance, mechanical integrity, and barrier properties of single-use bags, making them suitable for a broader range of process fluids and storage conditions.

Contract manufacturers and biopharmaceutical companies are key beneficiaries and adopters of these technologies, as they enable faster scale-up, lower capital expenditure, and simplified facility design.

Regulatory requirements emphasize contamination control and documentation for sterility, which is also a crucial factor for disposable components that ease validation. Mature supply chains, better availability of quality films, and supplier collaborations with CDMOs facilitate the market uptake by lowering the barriers.

For instance, in July 2024, Thermo Fisher Scientific launched biobased films for single-use bioprocessed containers. This enabled biopharmaceutical manufacturers to cut their carbon emissions while also adhering to performance requirements and ongoing material innovation.

Report Attributes	Details
Base Year	2024
Forecast Period	2025-2032F
Historical Period	2018-2023
Projected Growth Rate	CAGR of 12.90% between 2025 and 2032
Revenue Forecast in 2032	USD 53.77 billion

Rapid Expansion of Biologics and Advanced Therapy Manufacturing is Driving Market Growth

Rapid​‍​‌‍​‍‌​‍​‌‍​‍‌ expansion of biologics and advanced therapy manufacturing is one of the main reasons for the increase in demand for single-use bioprocessing bag films. These therapies need production environments that are highly controlled, flexible, and free from contamination. Biologics like monoclonal antibodies, recombinant proteins, vaccines, and cell and gene therapies comprise sensitive living systems and complex media which are easily contaminated. Single-use bioprocessing bag films allow closed-system processing for media preparation, buffer storage, cell culture, mixing, and transport, thus considerably lowering the chances of microbial and cross-batch contamination. In addition, advanced therapies, especially cell and gene therapies, are usually made in smaller batches with frequent changeovers and unpredictable production volumes. With single-use bag films, manufacturers can eliminate cleaning and sterilization between batches, allowing rapid process changeovers and scalable production without extensive downtime. The availability of such a feature is very significant for clinical-stage products and personalized therapies, where the time to market and process adaptability are of utmost importance.

In addition, the shift toward modular and decentralized manufacturing facilities for advanced therapies aligns well with disposable systems, which reduce capital investment in fixed stainless-steel infrastructure. There is also the aspect of continual improvements in polyethylene-based and multi-layer film structures, which have contributed to the enhancement of the chemical compatibility, mechanical strength, and barrier performance of the materials, thus single-use bags have become suitable for biologics workflows that are complex to a higher degree. As the pipelines of biologics spread worldwide, the use of single-use bioprocessing bag films is increasingly becoming a necessity.

For instance, in March 2025, ABEC introduced its Advanced Therapy Bioreactor (ATB), a new single-use platform specifically aimed at scalable cell therapy manufacturing. This indicates that demand for flexible, contamination-controlled systems is rising alongside the growth of advanced therapy pipelines.

Increasing Outsourcing to Contract Manufacturing Organizations (CMOs) and CROs Propels Market Expansion

One​‍​‌‍​‍‌​‍​‌‍​‍‌ of the major reasons leading to the increased demand for single-use bioprocessing bag films is the ever-increasing trend of outsourcing activities to Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs). These organizations operate under highly flexible, multi-client manufacturing models. CMOs and CROs are running different biologics programs simultaneously at various stages, like early-stage clinical batches, scaled-up production for commercials, etc. Single use bag films enable rapid changeovers between clients and products by eliminating cleaning validation, reducing production downtime, and minimising the risk of cross contamination, which are critical advantages in shared manufacturing environments.

Moreover, outsourced manufacturing requires rapid project initiation and capacity that can be scaled up or down to meet changing client timelines. Single-use bioprocessing bags enable CMOs and CROs to modify their facility layouts and process volumes swiftly without heavy capital investment in a fixed stainless-steel system. Such flexibility finds its value particularly in biologics, vaccines, and cell and gene therapies, where production volumes and process parameters are subject to frequent changes.

For instance, in March 2025, Syngene International acquired a biologics manufacturing facility in Baltimore, Maryland, boosting its single‑use bioreactor capacity to 50,000 L to meet growing client outsourcing needs for biologics development and production. This expansion reflects increased reliance on contract manufacturers and the associated demand for single‑use consumables like bag films to support flexible, multi‑client operations.

Multi-layer films are leading the Global Single-Use Bioprocessing Bag Films Market Share

Multi-layer​‍​‌‍​‍‌​‍​‌‍​‍‌ films account for most of the single-use bioprocessing bag films market volume, as they provide better functional performance than single-layer ones, and thus are more suitable for the strict demands of biologics manufacturing. By co-extruding several polymer layers, these films essentially combine the mechanical strength, chemical resistance, and barrier properties of various materials into one structure. For example, polyethylene provides flexibility, toughness, and impact resistance, while Ethylene Vinyl Alcohol (EVOH) and nylon layers contribute oxygen barrier performance and mechanical strength, helping to preserve media integrity and support aseptic processing in single-use bioprocessing applications.

In addition, the multilayer design allows materials to be tailored to specific process requirements, such as high-temperature resistance, compatibility with buffers and solvents, and resistance to leachables and extractables. In this way, multi-layer films can be used for any capacity range, from small clinical batches to large-scale production, thus being able to support applications such as media storage, mixing, and cell culture.

Additionally, multilayer films enhance operational reliability by reducing the risk of tears, punctures, and leaks during transport and handling, making them critical components of closed, disposable bioprocessing systems. The reduction of waste and the uninterrupted operation due to their longevity are the main factors that ensure product quality ​‍​‌‍​‍‌​‍​‌‍​‍‌consistency.

For instance, in May 2025, Qosina announced a strategic partnership with Sealed Air to distribute the NEXCEL BIO1250 co‑extruded bioprocessing bag film, a high‑performance multi‑layer polyethylene/EVOH structure engineered for single‑use systems. The film combines multiple barrier layers that significantly limit oxygen transmission and maintain chemical resistance, while also exhibiting strong durability, low extractables, and compatibility with aseptic connectors and tubing in bioprocessing applications.

North America is Dominating the Global Single-Use Bioprocessing Bag Films Market Share

North​‍​‌‍​‍‌​‍​‌‍​‍‌ America holds a major lead in the single-use bioprocessing bag films market. This is attributed to a combination of factors, including a highly integrated biopharmaceutical infrastructure, rapid adoption of single-use technologies, and a robust pipeline of biologics and advanced therapies. As such, the area is home to a large number of top-tier biopharmaceutical companies, CMOs, and CROs, all of which are turning to single-use systems as a means of upgrading their operational efficiency, cutting down contamination risks, and, most importantly, speeding up the time-to-market of complex biologics like monoclonal antibodies, vaccines, and cell and gene therapies.

The U.S. and Canada are well equipped with modular, versatile manufacturing plants that have been the focus of their investments. These favor the use of disposable technologies over traditional stainless-steel infrastructure. Single-use bioprocessing bag films, particularly those made from multilayer polyethylene-based materials, enable rapid changeovers, scalable production, and simplified validation. All these features align with the region’s emphasis on speed, regulatory compliance, and innovation.

Additionally, regulatory frameworks established by the Food and Drug Administration and similar agencies emphasize sterility, contamination control, and process traceability. These factors play a key role in driving increased adoption of single-use consumables.

For instance, in April 2025, Amgen announced a USD 900 million expansion of its biotech manufacturing facility in Ohio, aimed at increasing production capacity and reinforcing the region’s position as a hub for biologics manufacturing and related single-use technologies.

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Impact of U.S. Tariffs on the Global Single-Use Bioprocessing Bag Films Market

• Tariff Exposure for Single-Use Bioprocessing Bag Films
  • Under current U.S. trade policy, certain polymer films and multi-layer bioprocessing consumables may face additional ad valorem duties ranging from 10% to 25%, depending on classification and origin.
  • These tariffs can increase the landed cost of imported single-use bag films, impacting CMOs, CROs, and biopharmaceutical companies in the U.S. that rely on cost-effective disposable consumables for manufacturing biologics and advanced therapies.
• Reduced Competitiveness & Risk of Reconfigured Supply Chains
  • Higher import tariffs could reduce the price competitiveness of foreign-made single-use films in the U.S., encouraging manufacturers to explore alternative suppliers in North America or regions with preferential trade agreements.

Report Scope

“Global Single-Use Bioprocessing Bag Films Market Assessment, Opportunities and Forecast, 2018-2032F”, is a comprehensive report by Markets and Data, providing in-depth analysis and qualitative and quantitative assessment of the current state of the global single-use bioprocessing bag films market, industry dynamics, and challenges. The report includes market size, segmental shares, growth trends, opportunities, and forecast between 2025 and 2032. Additionally, the report profiles the leading players in the industry, mentioning their respective market share, business models, competitive intelligence, etc.

Report Attribute	Details
Segments Covered	Film Material Type, Layer Structure, Capacity, End-User
Regions Covered	North America, Europe, Asia-Pacific, South America, Middle East and Africa
Key Companies Profile	Merck KGaA, Corning Incorporated, KIEFEL GmbH, Shanghai Duoning Biotechnology Co., Ltd., Aran Biotech Ltd., Thermo Fisher Scientific Inc., Sartorius AG, Danaher Corporation, Meissner Filtration Products, Inc., CellBios Healthcare and Lifesciences Pvt Ltd.
Customization Scope	15% free report customization with purchase
Pricing and Purchase Options	Avail the customized purchase options to fulfill your precise research needs
Delivery Format	PDF and Excel through email (subject to the license purchased)

In the report, global single-use bioprocessing bag films market has been segmented into the following categories: 

• By Film Material Type
  • Polyethylene
  • EVA Films
  • EVOH-Based Multilayer Films
  • Others
• By Layer Structure
  • Single-Layer Films
  • Multi-Layer Films
• By Capacity
  • Small (≤ 5L)
  • Medium (5–50L)
  • Large (50–500L)
  • Very large (500L–2000L+)
• By End-User
  • Biopharmaceutical Companies
  • CROs & CDMOs
  • Others
• By Region
  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa

Key Players Landscape and Outlook

The global single-use bioprocessing bag films market landscape is defined by increasing adoption of disposable bioprocessing systems, technological innovations in multi-layer and high-barrier films, and growing demand from biologics, cell and gene therapy manufacturers. Leading players, including global suppliers and regional distributors, are focusing on advanced film materials (polyethylene, EVOH, and multilayer composites), enhanced mechanical strength, chemical compatibility, and regulatory-compliant solutions to meet the stringent requirements of biopharmaceutical production. The market outlook remains positive, supported by expanding biologics pipelines, the growth of contract manufacturing organizations (CMOs), and the increasing adoption of modular and flexible manufacturing facilities across North America, Europe, and Asia-Pacific.

Manufacturers are prioritizing multi-layer film structures, improved barrier properties, and scalable bag designs to support a wide range of capacities from small-scale clinical batches to large commercial production. Integration of automation, sensor technologies, and compatibility with aseptic connectors is strengthening the competitive positioning of key players. Strategic collaborations with CDMOs and biopharmaceutical companies, as well as investments in domestic and regional production, are enhancing supply reliability and process efficiency.

For instance, in August 2025, Meissner launched its new Rotary Impeller Mixing Solutions (RMS) portfolio, which incorporates proprietary TepoFlex polyethylene multi‑layer film designed for enhanced performance, low extractables, and high purity in critical bioprocessing applications. This product line demonstrates that established suppliers are innovating at the film-material level to enhance functionality and reliability in single-use systems, particularly for mixing and fluid-handling applications where operational robustness and chemical compatibility are critical.

Key Players Operating in the Global Single-Use Bioprocessing Bag Films Market are:

• Merck KGaA
• Corning Incorporated
• KIEFEL GmbH
• Shanghai Duoning Biotechnology Co., Ltd.
• Aran Biotech Ltd.
• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Meissner Filtration Products, Inc.
• CellBios Healthcare and Lifesciences Pvt Ltd.

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