Single-Use Bioreactors: A Leading Paradigm for Commercial Manufacturing of Biopharmaceutical Products

The Global Single-use Bioreactors Market pegged at US$ 2.8 billion (2020) is expected to witness a precipitous growth rate of ~21% from 2021 to 2031.

Rising adoption of single-use bioreactors among biopharmaceutical companies owing to its benefits, growing biologics market, rising demand for biosimilars and bulk quantities of antibodies, technological advancements such as the launch of large scale single-use bioreactors, growing prominence of hybrid systems, and potential application of sensors, big data & machine learning (ML) are some of the pivotal factors propelling the growth of the single-use bioreactors market. However, issues related to leachables and extractables are likely to hinder the growth of the market to a certain extent.

Clairvoyance Research conducted an in-depth market analysis study of the global single-use bioreactors market. The study comprehensively analyzes the market from different perspectives and provides granular insights on hot revenue pockets, headwinds & tailwinds impacting the market, quantitative (market size & forecasts), and qualitative analysis on different segments, key strategies, and competitive landscape.

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Exploration of Hybrid Systems Expected to Drive the Global Single-Use Bioreactors Market

Over the past decade, the growing demand for biosimilars and bulk quantities of antibodies has pushed drug makers to become more creative and implement strategies to enhance their productivity & to bring affordable therapies to the market quickly and cost-effectively. Biopharmaceutical companies are moving away from traditional stainless-steel bioreactors and have started to explore new technologies such as disposable bioprocessing equipment for commercial manufacturing. A single-use bioreactor is a bag composed of a multilayer polymer film, with various connection ports with tubing, agitator, and systems for gas inlet and outlet. The cells are cultured inside these bags, and bags are disposed of after processing. This allows the elimination of all the post-production processes related to cleaning and sterilization, which in turn reduces capital investment, accelerates turnaround time, and maximizes operational efficiency with better-managed risks. It also allows manufacturers to quickly switch their portfolios in response to market needs and enhances their ability to manufacture over a wider range of production scales.

Various manufacturers are adopting a hybrid bioprocessing approach i.e., using a combination of single-use and reusable bioreactors in the production line to enjoy the advantages of both technologies. The hybrid system may not provide the same benefits as a fully equipped single-use facility, but it allows to build familiarity & confidence in single-use systems while maintaining production capacity. For certain processes, manufacturers are building a stainless-steel plant along with some single-use systems to make the process more efficient and cost-effective.

Incorporation of Machine Learning Based on Big Data in Bioprocessing - A Push Towards Pharma 4.0

Technological advancements have played a crucial role in the launch of new single-use bioprocessing consumables. One of the areas of rapid development involves the potential application of sensors, big data, and machine learning (ML) to bioreactor performance modeling. Various prominent players are introducing technologies such as single-use sensors & mixers to differentiate themselves from their competitors and for making single-use bioprocessing safer, easier, and more efficient than before. Single-use sensor technologies such as pH, dissolved oxygen, and carbon dioxide sensors based on fluorescence technology have become established standards for single-use bioreactors that provide a means to measure physio-chemical attributes. Whereas, other sensors technology such as capacitance, determination of viable cell mass, glucose, and lactate concentrations are also gaining acceptance. The real-time data provided by sensors and incorporation of machine learning based on big data provides a path for developing algorithms and analytical models that can predict and improve process parameters to yield high-quality products consistently.

"Machine learning models based on the ability to leverage larger datasets have enabled automated data-driven models of bioreactor performance and offer the potential to help determine fitted parameters in first-principles models of bioreactor performance"

-  Chief Technical Officer, Leading Manufacturer of Single-use Bioreactors, USA

Impact of Leachables & Extractables from Single-use Bioreactors on Cell Culture Performance - An Area of Concern

Drug companies are highly motivated to use single-use solutions at a commercial scale and the final drug manufacturing stages owing to their benefits. Singe-use bioreactors are rapidly replacing conventional bioreactors. Singe-use bioreactors are equipped with a disposable plastic bag instead of a stainless-steel culture vessel. Drugmakers are facing several quality issues, regulatory issues, and a lack of interoperability with the use of single-use bioreactors, which is expected to restrain the growth of the market. Leachables & extractables are compounds that migrate from the contact material under normal usage and/or storage conditions. The use of organic solvents and intermediate chemicals in plastic manufacturing possesses concerns over leachables & extractables that could contaminate the buffers, media, and product intermediates after prolonged storage in single-use bags. As the cell culture solution is a complex mixture of numerous compounds dissolved at high concentrations, the direct leachable assessment for single-use bioreactors is difficult. Furthermore, the lack of defined leachable & extractable standards for disposable products may pose regulatory challenges.

Snapshot - Competitive Landscape

The single-use bioreactors market is marked by the presence of prominent players such as Merck KGaA, Thermo Fisher Scientific, Getinge AB, Pall Corporation, Sartorius AG, Solida Biotech GmBH, Stobbe Pharma GmbH, ABEC, G&G TECHNOLOGIES, INC., and Satake Chemical Equipment Mfg., Ltd. Other players operating in the market are CESCO BIOENGINEERING CO., LTD, PBS Biotech, Inc., Cellexus, Distek, Inc., OmniBRx, New Horizon Biotechnology, Inc, GPC Bio, Aptus Bioreactors, among others.

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