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January 2025
The global bioprocess bags market size is calculated at USD 4.07 billion in 2024, grew to USD 4.74 billion in 2025, and is projected to reach around USD 18.65 billion by 2034. The market is expanding at a CAGR of 16.44% between 2025 and 2034. The burgeoning biotechnology sector, growing demand for biologics, and technological advancements drive the market.
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Bioprocess bags are single-use, flexible, and customizable solutions to handle liquids safely within a bioprocess environment. They are made of multilayer film, offering biocompatibility, chemical compatibility, barrier, and strength properties. They are used in every aspect of the field, from small-scale research to full-scale production. Bioprocess bags are designed and manufactured in different sizes and shapes using different materials depending on the requirements. They are most widely used to collect, feed, harvest, store, and transport various preparations, including media and buffer preparations, cell culture, and cell and gene therapy products. They are also available for cryopreservation, which offers flexible storage at liquid nitrogen temperatures.
The burgeoning biotechnology sector leading to increased manufacturing of biologicals contributes to market growth. The rising incidences and prevalence of acute and chronic disorders facilitate growing research and development activities driving the market. The need for sterile storage throughout the drug manufacturing process positively influences the market. Integrating advanced technology in manufacturing bioprocess bags introduces automation in the entire process.
Artificial intelligence (AI) has been found to play a vital role in the biotechnology sector, improving the overall outcome. AI introduces automation in the manufacturing of bioprocess bags. This leads to faster and more flexible production of single-use bioprocess bags with different sizes and shapes, leading to less downtime and high-quality products. Automation limits human intervention, reducing manual errors. It can lead to more efficient and accurate manufacturing, resulting in reproducibility. AI can also optimize the overall manufacturing and labor costs. AI can also offer sustainable manufacturing, diminishing material wastage. Furthermore, AI can streamline the supply chain process of bioprocess bags. AI can predict the demand for bioprocess bags, track inventory levels, and analyze performance metrics. Hence, AI possesses immense applications in the manufacturing and distribution of bioprocess bags.
Growing Demand for Biopharmaceuticals
The growing demand for biopharmaceuticals such as vaccines, monoclonal antibodies, hormones, antibody-drug conjugates, and recombinant blood cells or plasma factors boosts the bioprocess bags market. The demand is increasing due to the rising incidences of chronic disorders and changing consumer preferences for personal wellness. They offer superior advantages over conventional drugs, such as targeted action, fewer side effects, and high specificity and activity. The growing research and development activities to develop novel biopharmaceuticals also support market growth. The new biopharmaceutical approval by several regulatory agencies contributes positively to the market growth. As of October 2023, the U.S. Food and Drug Administration approved 15 novel antibody-drug conjugates. Hence, the demand for biopharmaceuticals continues to rise owing to the huge potential for further dynamic growth.
Environmental Sustainability and Supply Chain Disruption
The bioprocess bags market faces formidable challenges, such as environmental sustainability and supply chain disruption. The use of single-use plastics such as polyethylene and polypropylene poses a significant threat to the environment. They are non-biodegradable and responsible for greenhouse gas emissions. Several government bodies have banned the use of such plastics, resulting in reduced demand for bioprocess bags.
In addition, the rising bioprocessing activities globally lead to supply chain disruption of the bioprocess bags. The COVID-19 post-pandemic era has faced significant challenges in the supply chain disruption of products related to pharmaceuticals and biotechnology. This negatively impacts a company’s reputation and loss of consumer interest.
Customized Solutions
The future of the bioprocess bags market is promising, driven by the offering of customized bioprocess bags. Numerous manufacturers provide customized solutions to researchers and drug manufacturers depending on their needs. Different materials and their combinations are used to provide extra resistance to a wide range of chemicals. The different sizes, shapes, and volumes are customized based on purpose. The use of advanced technologies facilitates customized bioprocess bags. The custom bag assemblies allow for user-specified tubing materials and connection types, including a range of sterile connectors from all major manufacturers. Bags are designed for various applications such as buffer & media storage, seed train, bulk & intermediate storage, sampling, waste collection, separation, purification, cold storage & transportation, and surge bags for final fill applications.
By type, the 2D bioprocess bags segment held a dominant presence in the bioprocess bags market in 2024. 2D bioprocess bags are designed to integrate seamlessly with the entire bioprocessing process, from media prep to cell culture or ultrafiltration to final fill. They are used for the containment of sterile media, cell cultures, sera, buffers, and reagents. They are widely preferred due to their easy scalability, flexibility, and cost-effectiveness. They are also environmentally beneficial. 2D bags are generally used for smaller volumes, usually less than 50L. They are usually flat-surfaced, hence favor easy handling and transportation without affecting the liquid. The advancements in technology and the growing demand for customized bags potentiate the segment’s growth.
By type, the 3D bioprocess bags segment is anticipated to grow with the highest CAGR in the market during the studied years. 3D bioprocess bags offer the same advantages as that of 2D bags. However, they are preferred for larger volumes, usually 50L to 3000L. 3D bioprocess bags are available in different shapes, such as cube, conical, or cylindrical. They are formed by sealing multiple films together. They offer full flexibility for the liquid substance transfer workflow. The increasing large-scale manufacturing of biopharmaceuticals globally boosts the segment’s growth.
By workflow, the upstream process segment held the largest share in the global bioprocess bags market in 2024. The upstream process is the initial stage in bioprocessing, from cell line development and cultivation to culture expansion of the cells through harvest. It describes the bacterial cell growth for microbial fermentation or the growth of cell culture-based protein products for mammalian cell culture. Bioprocess bags are used in upstream processing to cultivate and prepare cells or microorganisms for further biomanufacturing, preventing contamination and maintaining sterility.
By workflow, the downstream process segment is expected to grow at the fastest rate in the market during the forecast period. Downstream processing refers to the manufacture of purified final products, including antibiotics, hormones, and enzymes. It is a part of the bioprocess where the cell mass from the upstream is processed to meet purity and quality requirements. Bioprocess bags are primarily used in downstream processing to store and transport products during purification. Additionally, they are also used in the final formulation and filling of formulated products.
By end-user, the pharmaceutical & biopharmaceutical companies segment led the global bioprocess bags market in 2024. The segmental growth is attributed to suitable capital investment, increasing collaborations & acquisitions, and state-of-the-art research and development facilities. The favorable regulatory frameworks govern the launch of new products.
By end-user, the CMOs & CROs segment is projected to expand rapidly in the market in the coming years. The increasing number of contract manufacturing organizations (CMOs) and contract research organizations (CROs) globally and the rising demand for manufacturing and research on a contract basis promote the segment’s growth. CMOs and CROs help companies to reduce costs, improve efficiency, and focus on their core competency. They possess specialized equipment and trained professionals to develop the desired biopharmaceuticals.
North America hold the major share of 36% in the bioprocess bags market in 2023. The presence of key players and technological advancements drive the market. The increasing number of new product launches boosts the market. The U.S. FDA approved a total of 37 biologicals and biosimilars in the first and second quarter of 2024. The increasing investments and public-private collaborations also contribute to the market growth. According to the International Trade Administration, the U.S. is one of the largest markets for biopharmaceuticals globally. In 2023, the U.S. biopharmaceutical firms spent about $96 billion on R&D, accounting for over 20% of total sales. The Canadian Government invested $15 million over three years to expand Northern RNA’s biomanufacturing capacity for manufacturing mRNA vaccines and therapies.
Asia-Pacific is anticipated to grow at the fastest rate in the bioprocess bags market during the forecast period. The increasing investments & collaborations, growing research and development activities, and suitable manufacturing facilities drive the market. The Chinese government has released several guidelines and initiatives to support innovations related to biopharmaceuticals in China. The Government also provides funding for manufacturing and performing research on biologicals. The Indian Government invested approximately Rs. 25,813 crores for the pharmaceutical sector. In July 2024, the Japanese Government laid out a five-year roadmap for boosting drug development in the country by fiscal 2028. The increasing number of pharmaceutical and biopharmaceutical startups in the region also propels market growth.
Charles Ruban, President and CEO of Verdot, commented on collaborating with BioLink that the latter has a strong reputation within the field of bioprocessing, and its commitment to excellence and its strong market presence make it a perfect partner for our innovative bioprocessing technologies. He also added that the main aim of the collaboration was to empower biopharmaceutical companies in China with advanced solutions, driving efficiency and quality, particularly for large-scale and commercial production.
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