Global Single-Use Bioreactors Market is valued at $3.39 bn and is poised to witness a Consistent Growth Rate of 20% in the next 5 years (2021) : Sartorius Stedim Biotech, Thermo Fisher Scientific, Danaher, Merck KGaA, ABEC, Cellexus

The Global Single-use Bioreactors Market valued at ~$3.39 billion (2021) is set to witness a healthy growth rate of 20% in the next 5 years. Technological advancements such as the launch of large-scale single-use bioreactors, increased demand from pharmaceutical companies, CROs & CDMOs, growing biologics market, increasing biopharmaceutical R&D, and benefits of single-use bioreactors are some of the key factors driving the Global Single-use Bioreactors Market.

Single-use bioreactors are bioreactors that 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.

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.

Major Advantages of using Single-Use Bioreactors are as follows:

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.

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.

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Technological Advancements & Customer-Centric Approach – A Major Factor Enhancing 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 market.

“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

Competitive Landscape Analysis : Key Business Players

Some of the Leading players operating in the Single-use Bioreactors market are Sartorius Stedim Biotech, Thermo Fisher Scientific, Danaher Corporation, and Merck KGaA.

Other Players Operating in the Single-use Bioreactors Market are as follows:

ABEC
Cellexus
Celltainer Biotech BV
Distek Inc.
G&G Technologies Inc.
GPC Bio, among others

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

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 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 Single-use Bioreactors market growth in the coming years.

Aligned with this trend in March 2021, Thermo Fisher launched 3,000 L and 5,000 L HyPerforma DynaDrive single-use bioreactors. It is touted as next-level innovation in single-use bioreactors market 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.

Sources: Medi-Tech Insights Analysis, Interviews, Company Websites

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Ruta Halde
Medi-Tech Insights
Tel No: +32 498 86 80 79
Email: info@meditechinsights.com
Website: https://meditechinsights.com/

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services in the areas of market assessments, due diligence, competitive intelligence, market sizing and forecasting, pricing analysis & go-to-market strategy.

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