Press release
Bioprocess Bags Market is Expected to Progress at a CAGR of 16.90% to Reach US$ 20.5 Billion by 2035
The global bioprocess bags market is anticipated to expand significantly, growing from USD 4.3 billion in 2025 to USD 20.5 billion by 2035, at a robust CAGR of 16.90%. This growth is fueled by the rising adoption of single-use technologies in biopharmaceutical manufacturing, the increasing production of biologics, and the industry-wide shift toward flexible and modular manufacturing facilities.Additional momentum comes from the expansion of contract development and manufacturing organizations (CDMOs) and a growing emphasis on cost-effective, contamination-free processing solutions. North America currently dominates the market in terms of revenue, owing to a strong biopharma infrastructure and early technology adoption. However, the Asia Pacific region is witnessing the fastest growth, driven by rapid investments in biotechnology and the establishment of new production hubs.
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Market Drivers
1. Surge in Biologics and Advanced Therapies
The pipeline for biologics, monoclonal antibodies, vaccines, cell and gene therapies is swelling. These highly specialized products require aseptic production environments and flexible batch sizes-making single‐use bioprocess bags a necessity for controlling costs and contamination.
2. Single‐Use and Modular Manufacturing Trends
Manufacturers are favoring single‐use bag systems for their ability to reduce capital expenditure and enable rapid facility changeovers. The result-shorter timelines, heightened efficiency, and lower water/energy usage compared to fixed stainless‐steel infrastructures.
3. CDMO Expansion
The boom in contract development and manufacturing (CDMO) services is accelerating demand for scalable, contamination‐free solutions. Bag systems allow CDMOs to quickly adapt to multiple clients and product types without costly cleaning and validation efforts.
4. Cost‐Efficiency & Reduced Contamination Risk
Fact.MR notes that bioprocess bags eliminate leak points and drastically reduce contamination hazards, while simplifying operational workflows-making them ideal for research, clinical, and commercial‐scale production
Regional Trends of the Bioprocess Bags Market
North America stands as the dominant region in the bioprocess bags market, backed by a robust biopharmaceutical ecosystem, mature regulatory infrastructure, and widespread acceptance of single-use technologies. The United States leads the region, owing to continuous investments in biologics research and development, a dense network of contract development and manufacturing organizations (CDMOs), and strong regulatory support from bodies like the FDA for disposable and flexible manufacturing platforms. The region's strategic focus on advanced therapies, including cell and gene therapies, and efforts toward process intensification are key factors sustaining demand for bioprocess bags.
Europe closely follows, with countries like Germany, Switzerland, and the United Kingdom leading the adoption of single-use systems. The region benefits from a clear emphasis on Good Manufacturing Practices (GMP), automation, and sustainable bioproduction. Supportive regulatory policies, along with EU-funded initiatives focused on biosimilars, vaccine development, and gene therapy manufacturing, are fostering a rapid transition from traditional stainless-steel equipment to more agile, disposable technologies across European biomanufacturing facilities.
Competitive Analysis
The bioprocess bags market is highly competitive, shaped by a blend of global powerhouses and specialized innovators. Key players include Corning Incorporated, Charter Medical Ltd., Danaher Corporation, Entegris Inc., Merck, Rim Bio Inc., Saint-Gobain, Sartorius AG, and Thermo Fisher Scientific. These companies are at the forefront of developing advanced materials, innovative bag designs, and sensor-integrated solutions tailored to the evolving needs of biopharmaceutical manufacturing.
To maintain a competitive edge, market leaders are actively pursuing strategic partnerships, capacity expansions, and acquisitions. Companies like Sartorius and Thermo Fisher have significantly invested in scaling their single-use technology production facilities, enhancing their ability to serve global demand efficiently. Danaher and Merck continue to expand their portfolios by acquiring niche technology providers and increasing their R&D capabilities.
As biomanufacturing becomes more complex and specialized, there is growing emphasis on product performance, compliance with global regulatory standards, and sustainability. End-users are demanding customizable, scalable solutions for biologics, vaccines, and emerging cell and gene therapies-driving innovation in design, materials, and integrated process controls.
Recent Development
In 2023, Sartorius Stedim Biotech completed a landmark €2.4 billion acquisition of Polyplus, strengthening its position in viral vector and transfection reagent technologies, which are critical components in cell and gene therapy manufacturing. This move highlights the industry's growing convergence between bioprocess bag systems and advanced therapeutic production capabilities.
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Segmentation of the Bioprocess Bags Market
By Type :
2D
3D
By Capacity :
Small
Medium
Large
Extra Large
By Application :
Buffer & Media Storage
Cell Culture
Cell Separation & Harvest
Chromatography Feed & Collection
Ultrafiltration & Diafiltration
Intermediate & Final Product Hold
Others
By End-use Industry :
Biotechnology
Pharmaceuticals
By Region :
North America
Latin America
Europe
East Asia
South Asia & Oceania
Middle East & Africa
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