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Single-use bioprocessing systems gain more momentum

Our Bureau, Mumbai
Thursday, November 24, 2022, 08:00 Hrs  [IST]

With the biopharmaceutical segment expected to register a steady growth, single-use bioprocessing systems have received a lot of attention as a result of pharmaceutical corporations increased usage of disposable technology. The technology is mostly employed upstream (bioreactors, media preparation, and buffer preparation) and downstream (fluid route transfer for filtering, chromatography, virus clearing, and other phases of biologics manufacturing), according to a report.

The global single use bioprocessing market is highly consolidated due to the presence of a large number of companies across this industry.

The single-use bio-reactors segment is expected to register significant market revenue growth. Most major consequence has been introduction of single-use bioreactors as an alternative to cleanable and re-usable systems. Single-use bioreactors have increased manufacturing flexibility, enhanced sterility assurance, reduced capital investment, and facilitated start-up of additional facilities.

The single-use bioprocessing market size which was US$ 17.10 billion in 2021, is expected to register a revenue CAGR of 17.2 per cent, according to the latest analysis by Emergen Research. Growing adoption of single-use technology is a key factor driving growth of the market.

Single-use systems not only require less maintenance and installation but also use less energy. In certain volume ranges, single-use systems can be stacked and or movable, reducing the spacing effect.

These systems also require space for manipulation, transportation, and trash removal and their footprint is substantially lower than that of fixed systems. It is feasible to move equipment out of the way to manipulate it. Although it may appear that discarding plastic bags is wasteful, this is not always the case when compared to older equipment, which requires washing and sterilizing between batches. According to recent studies, single-use technology emits 25-50 per cent less carbon dioxide than stainless steel.

However, certain risks and challenges involved with single-use bioprocessing equipment and products are expected to hamper revenue growth of the market. Implementation of such criteria in scale-up and production scale processes is critical for success of developmental trials to optimize process conditions for manufacturing.

Availability of single-use bioreactors that can translate those precise conditions to huge fermentation volumes is a major barrier, volume capacity is limited (not over 2,000 L), and questions about quality of finished product after large-scale production persist. With single-use bioreactors, scaling down is also a potential impediment.

The filtration segment is expected to grow considerably owing to increasing use of single-use bioprocessing technologies in filtering, which are efficient even at a large scale. It is used for reducing bioburden, polishing biomolecules and ultrafiltration.

The adoption rate and demand for single-use equipment have significantly increased in the past few years. This is due to the commercial advantages including cost and time-saving advantages associated with it, thereby driving the market.

The growing adoption of the equipment by in-house as well as contract biomanufacturers has spurred the investment flow in this space. Also, the market is witnessing notable advancements in various product portfolios such as stirring systems, bioreactor designs, disposable probes and sensors, and film technologies, thereby leading to strong revenue growth. Furthermore, the implementation of big data and machine-learning technologies exhibits great potential in advancing single-use-based biomanufacturing processes.

Several manufactures have begun shifting towards automation to ease the process and reduce cost margin. Besides, considering the improved efficiency of disposables in accelerating the biopharmaceuticals production, end-users are undertaking various initiatives to convert their bioprocessing unit into a single-use unit. This is anticipated to create lucrative opportunities for the operating technology and product supplier in the market during the forecast period.

Global markets
North America is the leading single-use bioprocessing market owing to the increased spending on healthcare, technological development in bioprocessing, and growing importance of life science research. Growing adoption of disposable systems and increased energy efficiency coupled with the minimal risk of product cross-contamination are the beneficial factors associated with the use of single-use bioprocessing products. Further, the introduction of automation, big data technology, and artificial intelligence in the single-use system has been gaining rapid traction in North America.

These latest technologies in the manufacturing units are expected to boost production and helps the manufacturers to achieve cost-efficiency and reduce wastages. The presence of a large number of big and small contract manufacturing organizations in the region are increasingly using the single-use bioprocessing technology due to its low cost and improved output. The increased economic activity of these contract manufacturers will significantly drive the growth of the single-use bioprocessing market in North America.

Asia Pacific is characterized by growing production of biosimilars, cell therapy, vaccines, and various other types of biopharmaceutical products. Moreover, China is the second largest biopharmaceutical market just after the US. China’s economic policies to attract FDIs for setting up manufacturing plants for biopharmaceutical products is exponentially fostering the demand for single-use bioprocessing technology. India, Japan, and South Korea are leading players in the Asia Pacific region.

Single-use bioprocessing probes and sensors
Single-use bioprocessing probes and sensors are effective alternatives to traditional biopharmaceutical development and manufacturing methods. They are well-positioned to support the growing interest in the product’s implementation of continuous bioprocessing, according to a study.

Conventional bioreactors and fermenters are made up of stainless steel or glass. In contrast, the vessels for single-use bioreactors and single-use fermenters are disposable plastic bags installed into outer metal containers. The increasing adoption of single-use technologies in the biopharmaceutical industry for biologics, vaccines, and cell therapy production indicates that such technology has moved far beyond its novelty stage.

The rise of bioprocessing in biopharmaceutical manufacturing, combined with the advantages of single-use systems, is driving up demand for single-use bioprocessing probes and sensors with a track record of long-term performance. The challenges for single-use technology in bioprocessing include the time for a sensor when the bioprocess has a long duration and whether the materials are durable enough to be exposed to process fluids for a more extended period.

The rising popularity of single-use bioreactors and fermenters because of its increasing demand in the development of therapeutics has drawn several vital stakeholders’ attention to the single-use bioprocessing probes and sensors market. The bioreactors and fermenters meet the need of the biopharmaceutical industry for lower costs, increased efficiency, and overall greater flexibility. This is because single-use equipment can be pre-sterilized by the supplier before use, and there is the potential to eliminate classified environments from the manufacturing process. In addition, the reduced risk of cross-contamination helps companies avoid costly downtime and material waste.

Expanding the use of single-use bioreactors and fermenters has fuelled the growth of the single-use bioprocessing probes and sensors market. There will be substantial growth in the utilization of single-use bioprocessing probes and sensors by 2023, with a 214.29 per cent increase in revenue from 2018.

The global single-use bioprocessing market is moderately competitive and offers significant growth opportunities for vendors. Thermo Fisher Scientific, Sartorius, Danaher, and Merck are some of the key companies dominating the market, the study adds.

Technological advancements
To cater to the growing demand for single-use probes and sensors, vendors focus more on developing advanced single-use probes and sensors to meet the current requirements. As a result, several companies are engaged in focusing on developing improved single-use sensors.

For instance, Emerson Electric’s Rosemount 550 Ph single-use sensor and connector offers storage, installation, gamma sterilization, and standardization in moist conditions. The non-invasive single-use probes and sensors reduce the risk of cross-contamination as the sensors are read out contactless via an optical fibre. SONOTEC offers an ultrasonic clamp-on flow meter, i.e., SONOFLOW CO.55, which is non-invasive and does the contamination-free flow metering on flexible tubes.

Other vendors such as PreSens Precision Sensing and High Purity New England have recently started offering non-invasive probes and sensors. Smart single-use probes and sensors, consisting of memory devices with gamma stability to record calibration data and carry sensor-specific information, have emerged, with applications in growth media preparation, bioreactor maintenance, cell culture harvest, buffer preparation, and tangential flow filtration.

The Covid impact
The outbreak of the Covid-19 pandemic has led to a boost in demand for single-use bioprocessing probes and sensors. The demand for Covid-19 vaccine, cell and gene therapies, and monoclonal antibody manufacturing is likely to influence the market because most biopharmaceutical companies rely on advanced technologies such as single-use systems to develop therapeutic agents.

The vaccine segment has shown the highest CAGR of 16.99 per cent, which is expected to be because of the increasing demand for vaccine development in several therapeutic areas, mainly during the Covid pandemic.

Wide acceptance among CMOs
The wide acceptance of single-use bioreactors among CMOs is increasing the demand for single-use probes and sensors in recent years because CMOs prefer higher flexibility manufacturing with the aim of time and cost savings. It is estimated that about 60 per cent of CMOs are currently using single-use probes and sensors for their single-use bioreactors to produce biologics. Thus, increasing the growth and manufacturing of biopharmaceuticals is boosting the demand for single-use probes and sensors.

CMOs play an important role in biopharma companies and help create a valuable investment.


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