PUBLISHER: Grand View Research | PRODUCT CODE: 1609960
PUBLISHER: Grand View Research | PRODUCT CODE: 1609960
The global bioprocess bags market size is expected to reach USD 10.21 billion by 2030, registering a CAGR of 16.40% from 2025 to 2030, according to a new report by Grand View Research, Inc. One of the primary drivers of growth in this market is the growing trend towards personalized medicine, the rising focus on sustainability in the pharmaceutical industry, and the increasing adoption of single-use bioprocessing technologies.
The market is driven by a growing number of biologics and an increase in research and development activities by biopharmaceutical companies and academic institutions. There is an increasing trend towards modular manufacturing in the biopharmaceutical industry, wherein manufacturing processes are scaled down into smaller, more flexible units. Bioprocess bags play a crucial role in this trend as they enable the production of smaller batches, reducing waste and increasing efficiency.
Advancement in bioprocess technology has played a significant role in the growth of the market. A major advancement in bioprocess technology is the use of single-use bioreactors, which are designed to be used along with bioprocess bags. These bioreactors are small, more flexible, and easier to use than traditional stainless-steel bioreactors. These offer several benefits, including reduced risk of contamination, increased efficiency, and lower cost.
For instance, in March 2020, Sartorius AG partnered with CanSino Biologics Inc. and the Institute of Bioengineering at the Academy of Military Medical Sciences in China to develop the first vaccine candidate against SARS-CoV-2. During the clinical trials of this vaccine, Sartorius' BIOSTAT STR single-use bioreactor system was used for the upstream preparation of the recombinant vaccine. The bioreactor system includes an updated BioPAT toolbox for process monitoring and Flexsafe STR integrated single-use bioprocess bags.
Another key advancement is the development of cell and gene therapies, which requires specialized materials and equipment, such as bioprocess bags, to produce and deliver the therapies to patients. For instance, in December 2022, Food and Drug Administration (FDA) approved 27 cell and gene therapies (CGTs). The number is expected to grow in the coming years as there are over 1,500 ongoing clinical trials for cell and gene therapies registered with ClinicalTrials.gov.
Cell and gene therapies require specialized manufacturing processes, which often involve the use of single-use technologies such as bioprocess bags. These therapies require the use of sterile and controlled environments to produce therapeutic products, and bioprocess bags provide an ideal solution for the storage and transfer of the materials used in the manufacturing process. The growth of the cell and gene therapy market is expected to drive demand for bioprocess bags in the coming years.
However, the potential for leachable and extractable (L&E) compounds to migrate from the bag material into the bioprocess fluid is one of the major concerns related to the market. L&E compounds can be derived from various sources, including bag material, processing aids, and other components used during bag manufacturing. This has increased regulatory concerns about L&E compounds in relation to bioprocess bags. This has led to increased scrutiny and testing requirements for manufacturers, to ensure the safety and efficacy of bioprocess products for patients.