The global bioprocess bags market size is expected to reach USD 10.21 billion by 2030, expanding at a CAGR of 17.14% from 2023 to 2030. 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.
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.
Bioprocess Bags Market Report Highlights
- Based on type. The 2D bioprocess bags segment dominated the market with a share of over 55% in 2022. The market is expected to dominate due to the increasing demand for cost-effective and scalable bioprocessing solutions in the pharmaceutical industry
- By workflow. The upstream process held the largest market share of 43.45% in 2022. The use of bioprocess bags in upstream processes is driven by several factors, including flexibility, reduced contamination risk, efficiency, cost-effectiveness, and sustainability
- The CMO and CRO segment is expected to continue growing lucratively with a CAGR of 18.16% over the forecast period, as the demand for outsourced manufacturing and research services is increasing in the biopharmaceutical industry
- North America dominated the global market with a 35.27% share in 2022, due to the increasing demand for biologics and biosimilars, and the trend toward flexible and modular manufacturing
- Asia Pacific is anticipated to register the fastest CAGR of 20.04% during the forecast period. This is due tothe increasing adoption of bioprocessing technologies and the growth of the biopharmaceutical industry in the region
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Market Variables, Trends, & Scope
Chapter 4. Bioprocess Bags Market: Type Business Analysis
Chapter 5. Bioprocess Bags Market: Workflow Business Analysis
Chapter 6. Bioprocess Bags Market: End-Use Business Analysis
Chapter 7. Bioprocess Bags Market: Regional Business Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Thermo Fisher Scientific Inc.
- Sartorius AG
- Danaher Corporation
- Merck KGaA
- Saint Gobain
- Corning Incorporated
- Entegris
- Meissner Filtration Products, Inc.
- PROAnalytics, LLC
- CellBios Healthcare And Lifesciences Pvt Ltd.
Methodology
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Table Information
Report Attribute | Details |
---|---|
No. of Pages | 180 |
Published | April 2023 |
Forecast Period | 2022 - 2030 |
Estimated Market Value ( USD | $ 2.81 Billion |
Forecasted Market Value ( USD | $ 10.21 Billion |
Compound Annual Growth Rate | 17.1% |
Regions Covered | Global |
No. of Companies Mentioned | 10 |