Bioprocess Bags Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Type (2D Bioprocess Bags, 3D Bioprocess Bags, Other Bags & Accessories), By Workflow (Upstream Process, Downstream Process, Process Development), by End User (Pharmaceutical & Biopharmaceutical Companies, CMOs & CROs, Academic & Research Institutes), by region, and Competition

Market Overview

Global Bioprocess Bags Market has valued at USD 2.78 billion in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 13.23% through 2028. Bioprocess bags, also known as single-use bioprocess bags or disposable bioprocess bags, are specialized containers used in biopharmaceutical and bioprocessing industries to facilitate the production and processing of biologics and pharmaceuticals, particularly in the fields of cell culture, fermentation, and other related applications. These bags are designed to meet the stringent quality and regulatory requirements of the biopharmaceutical industry.  Bioprocess bags are primarily used to contain, store, and transport liquids and materials involved in biopharmaceutical manufacturing and bioprocessing. Bioprocess bags are typically made from specialized materials that are chosen for their strength, flexibility, and compatibility with bioprocessing fluids and chemicals. These materials must meet stringent quality and regulatory standards to ensure product safety and integrity. In response to growing environmental concerns, some bioprocess bags are designed with eco-friendly materials, such as biodegradable or recyclable options, to reduce their environmental impact.

The growing demand for biopharmaceuticals, including monoclonal antibodies, gene therapies, and vaccines, is a major driver. Bioprocess bags are essential to produce these advanced therapies. The adoption of single use bioprocessing systems, including bioprocess bags, is increasing due to their cost-effectiveness, flexibility, and reduced risk of contamination. Bioprocess bags offer scalability from small-scale research and development to large-scale production, providing the flexibility required to meet varying market demands. Single-use systems, including bioprocess bags, reduce the need for time-consuming and costly cleaning and sterilization processes associated with traditional stainless-steel equipment. Innovations in bioprocess bag design and materials have improved their performance, sterility, and compatibility with various bioprocessing systems. Manufacturers offering customization options for bioprocess bags enable companies to tailor the bags to their specific needs further driving demand.

Key Market Drivers

Technological Advancements

Technological advancements in bioprocess bags have contributed to the evolution and improvement of these critical components in biopharmaceutical manufacturing and bioprocessing. These innovations aim to enhance performance, sterility, ease of use, and the overall efficiency of bioprocess operations. Manufacturers have developed novel materials for bioprocess bags that offer improved strength, flexibility, and resistance to various chemicals. These materials are designed to ensure the bags' integrity throughout the production process. Enhanced aseptic manufacturing processes and improved closures and connectors help maintain the sterility of bioprocess bags, reducing the risk of contamination during production. Some bioprocess bags now feature baffle systems, which are internal structures that promote better mixing and oxygen transfer during cell culture and fermentation processes. This improves the homogeneity of the culture and enhances yield. Technological advancements have allowed for better scalability of bioprocess bags, facilitating the transition from small-scale research and development to large-scale manufacturing without significant process changes. Bioprocess bags with integrated sensors can provide real-time data on critical process parameters like temperature, pH, and dissolved oxygen. This data helps operators monitor and control the process more effectively. Smart bioprocess bags can communicate with control systems and software, allowing for automated process monitoring and control. This helps optimize process parameters in real time. Advanced bag designs incorporate improved mixing technologies, such as rocking or wave-induced motion, to enhance cell culture and fermentation performance.

Advances in tubing and connectors have made it easier to integrate bioprocess bags with other bioprocessing equipment, reducing the risk of leaks and contamination. Some manufacturers offer customizable bioprocess bags, allowing companies to design bags tailored to their specific processes and equipment, including the incorporation of unique ports and tubing configurations. Innovations in connectors and clamps have made it easier to assemble and disassemble bioprocess bags, facilitating quick and secure connections and disconnections. Some bioprocess bags are now designed with biodegradable or eco-friendly materials to reduce their environmental impact. Bioprocess bags with built-in filtration systems can help remove impurities, viruses, or bacteria during production, streamlining downstream processing. Special bag designs with enhanced flow characteristics are developed for applications that require high flow rates. This factor will help in the development of the Global Bioprocess Bags Market.

Rise in Biopharmaceuticals

 Bioprocess bags are essential components in the production of biopharmaceuticals, and the growing demand for these advanced therapeutic products has a direct impact on the market for bioprocess bags. The development and production of biopharmaceuticals, including monoclonal antibodies, vaccines, gene therapies, and cell-based therapies, require bioprocessing operations. Bioprocess bags are used in various stages of production, from cell culture and fermentation to downstream processing. As biopharmaceutical products progress from research and development to commercial production, the need for scalability becomes critical. Bioprocess bags allow companies to efficiently scale up their production processes to meet growing market demands. The biopharmaceutical industry places a high emphasis on product quality and safety. Bioprocess bags, being single-use and sterile, help minimize the risk of contamination, ensuring that the final product meets regulatory and quality standards. Bioprocess bags offer flexibility in terms of manufacturing operations. Companies can quickly adapt to changes in product demand and production schedules, making them well-suited for the dynamic nature of biopharmaceutical production.

Bioprocess bags reduce the need for extensive cleaning and validation procedures associated with traditional stainless-steel equipment. This not only saves time but also reduces operating costs. During global health emergencies, such as pandemics, there is a heightened need for the rapid development and production of vaccines. Bioprocess bags have played a crucial role in expediting vaccine production in response to such events. Bioprocess bag manufacturers often offer customization options, allowing companies to design bags that meet the specific requirements of their processes and equipment. Compatibility with various bioprocessing systems is another key advantage. The biopharmaceutical industry is increasingly dominated by biologics, which are complex molecules that require specialized production processes. Bioprocess bags are well-suited for these processes and have become an integral part of biologics manufacturing. Bioprocess bags are designed to meet stringent regulatory requirements, ensuring that products meet the necessary safety and quality standards. This factor will pace up the demand of the Global Bioprocess Bags Market.

Growing Environmental Concerns

Bioprocess bags made from biodegradable materials can address concerns about plastic waste. These bags break down naturally over time, reducing their environmental impact. Some bioprocess bags are designed to be recyclable, making it easier for companies to responsibly dispose of or recycle the bags after use, reducing waste. Environmentally conscious companies may seek bioprocess bags with reduced plastic content, which can contribute to a reduction in overall plastic consumption. Many biopharmaceutical companies have set sustainability goals and are looking to align their operations with these objectives. Using environmentally friendly bioprocess bags is one way to meet these goals. As environmental regulations become more stringent, companies may choose bioprocess bags designed with sustainability in mind to comply with these regulations. Companies that prioritize environmentally responsible practices can enhance their image and reputation among customers, investors, and stakeholders who value sustainability. In some cases, the use of eco-friendly bioprocess bags may lead to cost savings through reduced waste disposal and recycling expenses. Some bioprocess bag manufacturers obtain environmental certifications that verify the eco-friendliness of their products, making them attractive to environmentally conscious customers. Increased consumer and stakeholder demand for sustainable practices and products can drive companies to adopt more environmentally friendly bioprocess bags. This factor will accelerate the demand of the Global Bioprocess Bags Market.

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Key Market Challenges

Raw Material Costs

Bioprocess bags require materials that meet rigorous quality and sterility requirements. These materials are often more expensive than standard plastics, contributing to the overall cost of production. Bioprocess bags must comply with strict regulatory standards, particularly in the biopharmaceutical industry. Ensuring materials meet these standards can require additional quality control measures and may involve higher costs. Bioprocess bags are often customized to meet the specific requirements of individual companies and processes. Customization can lead to variations in material requirements, making it challenging to manage costs efficiently. As environmental concerns grow, some companies may seek eco-friendly materials for bioprocess bags. While these materials may have a lower environmental impact, they can sometimes be more expensive than traditional materials. Raw material costs can be subject to market fluctuations, which can impact the overall production cost of bioprocess bags. Disruptions in the supply chain, such as those experienced during global events like the COVID-19 pandemic, can lead to shortages and price increases for certain materials. Manufacturers may invest in research and development to improve bioprocess bag materials, which can lead to increased costs associated with developing and producing these advanced materials. Ensuring consistent quality and performance of materials in bioprocess bags may require stringent quality control processes, adding to the overall production cost.

Supply Chain Disruptions

Disruptions in the supply chain can lead to shortages of critical materials, such as specialized plastics and films used in bioprocess bags. Material scarcity can result in increased costs and delayed production. When supply chain disruptions affect the delivery of components or materials, it can lead to delays in bioprocess bag manufacturing. This can impact the ability to meet customer demand and project timelines. As supply chain disruptions disrupt the availability of materials and components, prices may increase due to scarcity and increased demand. This can result in higher production costs for bioprocess bag manufacturers. Maintaining consistent material quality and performance may be challenging during supply chain disruptions, as manufacturers may need to adapt to the use of alternative materials or suppliers. Companies may need to maintain larger inventories to mitigate the impact of potential supply chain disruptions, tying up capital and increasing storage costs. Supply chain disruptions can result in delays in delivering bioprocess bags to customers. This can affect the operational efficiency of biopharmaceutical and bioprocessing companies relying on these products. Companies operating in the Global Bioprocess Bags Market may face increased competition for scarce materials, potentially driving up costs and affecting profitability. Supply chain disruptions can make it challenging for companies to engage in long-term planning and investment, as they must adapt to a more uncertain environment.

Key Market Trends

Bioprocess Bag Customization

 Biopharmaceutical companies have unique processes and equipment setups. Customized bioprocess bags can be designed to seamlessly integrate with existing systems, optimizing the overall production process. Bioprocess bag manufacturers offer customization options to ensure compatibility with a wide range of bioprocessing equipment, such as bioreactors, mixers, and connectors. This compatibility is essential for efficient and successful operations. Customization allows companies to specify the bag size, configuration, and ports that best suit their processes. This level of tailoring ensures that the bags are an exact fit for the application. Some biopharmaceutical processes are unique and require specialized equipment and containers. Customized bioprocess bags can accommodate these distinctive requirements.

Companies can choose the materials that best align with their product and process needs, considering factors like material strength, flexibility, and sterility. Customized bags can incorporate quality control features specific to a company's processes, such as integrated sensors for real-time monitoring of critical parameters. Companies focused on sustainability may request custom bioprocess bags made from eco-friendly materials or with reduced plastic content. Customization can address specific regulatory requirements and standards relevant to a particular application, ensuring that the bags meet compliance standards. By tailoring bioprocess bags to their exact needs, companies can improve process efficiency and reduce waste. This can lead to cost savings and higher overall productivity. Customization allows companies to differentiate their products and processes in the market. It can be a competitive advantage and may attract customers who seek tailored solutions.

Segmental Insights

Type Insights

In 2022, the Global Bioprocess Bags Market largest share was held by 2D bioprocess bag segment and is predicted to continue expanding over the coming years. 2D bioprocess bags are often more cost-effective than their 3D counterparts. This cost advantage is appealing to biopharmaceutical companies looking to manage expenses in their manufacturing processes. 2D bioprocess bags are compatible with a wide range of bioreactor systems and other equipment commonly used in upstream and downstream bioprocessing. Their compatibility makes them a versatile choice for various applications. The design of 2D bioprocess bags is straightforward, which simplifies their handling and integration into existing bioprocessing systems. This simplicity can save time during setup and operation. Like 3D bags, 2D bioprocess bags are designed to maintain a sterile environment, crucial for biopharmaceutical manufacturing to ensure product quality and safety. 2D bioprocess bags are available in a range of sizes, allowing for scalability in bioprocessing operations. They can be used in both small-scale research and development (R&D) projects and large-scale industrial production. Single-use systems, including 2D bioprocess bags, help minimize the risk of cross-contamination, as they are disposed of after use, reducing the need for extensive cleaning and sterilization processes.

Workflow Insights

In 2022, the Global Bioprocess Bags Market largest share was held by upstream process segment and is predicted to continue expanding over the coming years.  Upstream processes in bioprocessing involve the cultivation of cells, microorganisms, and the initial stages of product formation. These processes are fundamental to the production of biopharmaceuticals, vaccines, and other biologics. Bioprocess bags play a crucial role in these early stages, such as cell culture and fermentation, by providing a sterile and controlled environment. The adoption of single-use technologies, including bioprocess bags, has gained significant traction in the biopharmaceutical industry. Upstream processes often involve the use of bioreactors and other equipment, and the use of single-use bioprocess bags simplifies operations, reduces cleaning and validation efforts, and minimizes the risk of cross-contamination. Upstream processes need to be adaptable to varying production scales, from small research and development (R&D) settings to large-scale manufacturing. Bioprocess bags offer scalability, allowing companies to easily transition from laboratory-scale operations to full-scale production while maintaining process consistency. Ensuring product quality and safety is paramount in biopharmaceutical manufacturing. Bioprocess bags are designed to be sterile and minimize the risk of contamination, providing a reliable solution for maintaining the integrity of the upstream process.

End-User Insights

In 2022, the Global Bioprocess Bags Market largest share was held by pharmaceutical & biopharmaceutical companies’ segment in the forecast period and is predicted to continue expanding over the coming years.  Pharmaceutical and biopharmaceutical companies are among the most significant consumers of bioprocess bags due to their extensive involvement in the production of biopharmaceuticals, vaccines, and other pharmaceutical products. These companies often require large volumes of bioprocess bags to support their manufacturing processes. The biopharmaceutical sector relies heavily on bioprocess bags for various stages of production, including cell culture, fermentation, and downstream processing. Bioprocess bags provide a sterile and single-use solution for handling critical processes in biopharmaceutical manufacturing. The pharmaceutical and biopharmaceutical industries are subject to stringent regulatory requirements, including those related to product quality and safety. Bioprocess bags are designed to meet these regulatory standards, making them a preferred choice for companies seeking compliance. Consistency and quality control are paramount in pharmaceutical and biopharmaceutical manufacturing. Bioprocess bags help ensure the integrity and sterility of the manufacturing process, reducing the risk of contamination and ensuring product quality.

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Regional Insights

The North America region dominates the Global Bioprocess Bags Market in 2022. North America, particularly the United States, is a global hub for the biopharmaceutical industry. It is home to a significant number of biopharmaceutical companies, research institutions, and pharmaceutical manufacturing facilities. The high concentration of biopharmaceutical activities in the region drives the demand for bioprocess bags, which are essential components of bioprocessing. North America is at the forefront of biopharmaceutical research and innovation. The region has a strong focus on developing cutting-edge biopharmaceutical products, including vaccines, monoclonal antibodies, and gene therapies. These advanced therapies often require specialized bioprocessing solutions, contributing to the demand for bioprocess bags. The region has well-established and stringent regulatory frameworks for pharmaceutical and biopharmaceutical products. Compliance with these regulations necessitates the use of high-quality, reliable, and validated single-use systems, including bioprocess bags. North America generally allocates significant resources to healthcare and pharmaceutical research. Government funding, private investment, and academic collaborations support the growth of the biopharmaceutical sector, leading to a higher demand for bioprocess bags.

Recent Developments

• In March 2022, ILC Dover LP, a company known for its innovative single-use solutions in the biotherapeutics and pharmaceutical processing industry, has announced the launch of liquid single-use bioprocessing bags. These new products are the initial offerings in a series of upcoming solutions designed for handling and supplying sterile liquids within the biotherapeutics market. This strategic expansion is a part of ILC Dover's comprehensive range of solutions that cover the entire spectrum of biotherapeutic and pharmaceutical manufacturing processes. Their offerings include products for powder containment and handling, sterile liquid management, and pre-filled bags for both liquid and powder substances. ILC Dover manufactures these high-quality single-use bioprocessing bags in Frederica, DE, with plans to leverage its expanding cGMP global network to support its clients and collaborators on a global scale. The company maintains manufacturing facilities dedicated to serving its pharmaceutical and biotherapeutic clients in key locations such as Frederica, DE, Durham, NC, Stockport, UK, Rossens, Switzerland, and Blarney, Ireland.
• In July 2021, Pall Corporation, a renowned global expert in filtration, separation, and purification, has disclosed an exciting development—a fresh contract valued at over $7 million with Exothera S.A., a comprehensive contract development and manufacturing organization (CDMO). This newly established contract with Pall will set up a suspension-based manufacturing platform capable of handling volumes of up to 2000 liters. The platform will leverage various technologies, including the utilization of Allegro STR single-use bioreactors. This advanced installation is designed to facilitate the production of a diverse range of viral vectors, primarily intended for gene therapies and viral vector-based vaccines.

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.

Report Scope:

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

• Bioprocess Bags Market, By Type:

o   2D Bioprocess Bags

o   3D Bioprocess Bags

o   Other Bags & Accessories

• Bioprocess Bags Market, By Workflow:

o   Upstream Process

o   Downstream Process

o   Process Development

• Bioprocess Bags Market, By End-User:

o   Pharmaceutical & Biopharmaceutical Companies

o   CMOs & CROs

o   Academic & Research Institutes

• Bioprocess Bags Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Bioprocess Bags Market.

Available Customizations:

Global Bioprocess Bags Market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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