Single-use Bioreactors Market Poised for a Remarkable Growth Rate of 20% by 2029.

Posted by Prathamesh on December 12th, 2024

Single-use bioreactors use the disposable bag as a substitute for a culture vessel made of stainless steel or glass. It is widely used by pharmaceutical companies for cell harvesting, media & buffer preparation, filtration, purification, and virus inactivation.

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Due to their Ability to Enhance Flexibility, Reduce Investment & Limit Operational Costs, Single-use Bioreactors Have Become Established in Modern Biopharmaceutical Processes

Enhanced flexibility is one of the biggest benefits of single-use bioreactors. There is a growing trend towards multi-drug facilities, which warrants the production of different drugs using the same facility with minimum time & cost and top-notch quality. In such scenarios, one of the key manufacturing challenges is line clearance and validation of cleaning to ensure there is no carry-over from earlier batches. Downtime limits the number of batches produced in a given period.

Single-use bioreactors significantly reduce the time spent preparing the bioreactor for the subsequent batch. A line changeover with a stainless-steel bioreactor can take ~6 to 10 hours and three weeks for a full product changeover while by using single-use bioreactors it is likely to take 2 hours for line changeover. If the manufacturing line is composed of all single-use components such as bags, filters, and connectors, the total time for product changeover can be 48 hours. Single-use bioreactors possess the capability to reduce downtime from two to three weeks to 48 hours, which in turn can significantly impact a company's output.

Some of the other key advantages of using single-use bioreactors are:

•         Elimination of validation issues as no cleaning process is required
•         Lowers the risk of cross-contamination
•         Reduces operating costs and capital investments (including space, labour requirements, and utilities)
•         Single-use bags are scalable and can be adjusted to different volumes
•         Simple installation

Potential Time Savings for Highly Trained Personnel Another Key Benefit of Single-use Bioreactors

Generally, drug development research, process development, and scale-up activities are performed by highly qualified and trained personnel. These individuals are involved in every stage of a study from early-stage research through to benchtop manufacturing. With stainless steel or glass benchtop bioreactors, individual components need to be cleaned, assembled, leak-tested, sterilized, and cooled before every trial batch is taken. However, the use of single-use bioreactors almost eliminates these steps, which allows scientists more time to focus on their developmental studies.

Technological Advancements & Customer-Centric Approach – A Key Factor Bolstering the Demand of Single-use Bioreactors

Commercially available single-use bioreactors are robust and provide the high performance necessary for commercial manufacturing of biopharmaceuticals. Significant advancements in bioreactor design, film technologies, stirring mechanisms, and sensor systems have contributed to the increasing adoption of single-use bioreactors from the lab to the production scale.

To cater to the changing needs of the customers such as next-generation cell- and gene-therapies and continuous bioprocessing, suppliers of single-use bioreactors often work closely with its customers, which in turn is expected to fuel the demand for single-use bioreactors.

“The uptake of single-use bioreactors is mainly driven by the activity of the different regions regarding the development of new disease treatments and biosimilars. In addition, existing production capacity comes into play and company strategies regarding the manufacture of clinical material. As the USA is indeed leading in the field of developing innovative treatments, we see a strong uptake of single-use bioreactors, but Europe and Asia are not far behind.”

- CEO, Leading Manufacturer of Single-use Bioreactors, United States

Introduction of Large-Scale Single-use Bioreactors Set to Drive the Market

Traditionally, single-use bioreactors were restricted in size due to pressure challenges from the increased weight of the liquid medium in larger volume bags with 2,000 L being the upper limit. Therefore, if bio manufacturers required larger volumes, they had to run several systems in unison or opt for stainless-steel tanks.

However, in the last few years, considering strong demand from pharmaceutical companies and contract development and manufacturing organizations (CDMOs), several single-use bioreactor manufacturers have launched large-scale single-use bioreactors which are expected to fuel the market growth in the coming years.

Aligned with this trend,

•        In March 2023, Getinge is expanding its bioreactor line with the Single-Use Production Reactor (SUPR) system, available initially in 50-litre and 250-litre sizes, to help expedite the delivery of life-saving medicines and improve quality of life
•        In March 2021, Thermo Fisher launched 3,000 L and 5,000 L HyPerforma DynaDrive single-use bioreactors. It is touted as a next-level innovation in single-use bioreactors with unmatched design, scalability, and performance. The system provides improved performance and scalability to larger volumes and is suitable for fed-batch and perfusion processes

Competitive Landscape Analysis

Some of the key players operating in the market are Sartorius Stedim Biotech, Thermo Fisher Scientific, Danaher Corporation, Merck KGaA, Celltainer Biotech BV, Getinge AB, Eppendorf AG, Cellexus, PBS Biotech Inc., ABEC, Able Corporation & Biott Corporation, G&G Technologies Inc., Solida Biotech GmbH, and Satake Chemical Equipment Mfg among others.  

Organic and Inorganic Growth Strategies Adopted by Players to Establish Their Foothold in the Market

Players operating in this market are adopting both organic and inorganic growth strategies such as collaborations, acquisitions, and new product launches to garner market share. For instance,

•        In August 2023, Sartorius and Repligen Corporation have launched an integrated bioreactor system combining Sartorius’ Biostat STR® and Repligen’ s XCell® ATF technology, featuring a single direct control interface to simplify upstream process intensification and optimize facility equipment and maintenance requirements for biopharmaceutical manufacturers
•        In March 2022, Cellexus has partnered with Verder Liquids to supply pumps for controlling pH balance in their CellMaker Plus and Low Flow bioreactor systems, enabling manual or automated injection of acids or alkali into the bioreactor bag
•        In July 2021, Cytiva and Pall Corporation announced a .5 billion investment over two years to expand manufacturing capacity for life sciences products at 13 sites, addressing the growing demand for biotechnology solutions

The market is expected to gain further momentum in the coming years due to technological advancements, rising R&D investments, new product launches, and aggressive organic and inorganic growth strategies followed by the players.