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. 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.
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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 held the highest market share of over 46.28% in 2024. This is due to the increasing demand for biopharmaceuticals and cell therapies.
- By workflow, the upstream process segment held the highest market share of 43.76% in 2024. Bioprocessing bags are widely used in upstream processes for cell culture, media preparation, and fermentation. These bags provide a sterile and controlled environment for cell growth and are designed to optimize cell growth and productivity.
- The pharmaceutical & biopharmaceutical companies segment held the highest market share of 45.98% in 2024. The strategic activities adopted key market such as expansion, new product launch, merger & acquisition, and collaboration offer lucrative opportunities.
- North America bioprocess bags market dominated the global market with a share of 35.65% in 2024. The increasing demand for biopharmaceuticals is expected to drive the growth of the bioprocess bags market in the region.
- The Asia Pacific bioprocess bags market is estimated to be the fastest-growing region with CAGR due to the growing population, with increasing healthcare needs. As a result, there is a growing demand for biopharmaceuticals in the region, which is driving the growth of the bioprocess bags market.
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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 user Business Analysis
Chapter 7. Bioprocess Bags Market: Regional Estimates & Trend Analysis by Workflow, Product, End User
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 | 120 |
Published | November 2024 |
Forecast Period | 2024 - 2030 |
Estimated Market Value ( USD | $ 4.03 Billion |
Forecasted Market Value ( USD | $ 10.21 Billion |
Compound Annual Growth Rate | 16.4% |
Regions Covered | Global |
No. of Companies Mentioned | 10 |