SUS Preferred over Conventional Stainless Steel Systems
Despite being a relatively new technology, single use technology has gained ubiquity in the biopharma sector. Single-use systems (SUS) are gaining wider preference over stainless steel systems in the biotechnology and pharmaceutical markets. Disposable systems are now making the leap from clinical- to commercial-scale bio-manufacturing. Vaccine manufacturers were the early adopters of single use technology as there is no cleaning and no cross-contamination involved. More than 90% of biopharma facilities use at least some single use components and the market for single-use bioprocessing is estimated to reach ~US$ 6 Bn by 2026. The single-use equipment constitutes pre-sterilised disposable bags, tubing, fittings, and connectors. Bioreactor volumes up to 2,000 litre for single use cell culture process are also available.
Flexibility and Cost Competitiveness Make Single-use Systems an Attractive Prospect for Biopharma Manufacturers
In a single-use set up, changing the bag sizes is relatively easy instead of buying, and installing a new stainless steel vessel. Cleaning of the conventional stainless steel vessel is another cumbersome job. Sanitisation of stainless steel vessels is both a time- and cost-intensive activity. Process development, validation, operator training, and then utility consumption only make it more complex and time-consuming. Using plastic disposable technology makes more sense both time-wise and economically. Another strong driver for the single-use bioprocessing technology adoption is the availability of the 2,000 liter bioreactor. Earlier, drugs were produced in a standard batch size of 10,000 liters. However, with the advent of personalised medicines, the batch sizes for many products have reduced to 2,000 liters or even less – hitting the sweet spot for single use. As novel technologies like cell and gene therapies are making their ways, single-use bioprocessing will be deployed from the start, in clinical, process development, and commercial manufacturing suites, pushing the growth prospects of the global single-use bioprocessing market.
Environmental Sustainability and Safety Remain Paramount with Growing Ubiquity of Single Use
Stainless steel bioreactors need huge amounts of water, energy, and cleaning products unlike single-use bioprocessing systems, which makes the latter a sustainable alternative over the former. One of the case studies reveals that swapping to single use has enabled a manufacturer to achieve annual savings of a whopping 1 Mn liters of water, nearly 28,812 kwh electrical power, and over 20 MT of CO2 from their carbon footprint.
However, the seemingly conservative biopharmaceutical industry is still reluctant to give up control of critical process technology. Validation is another major issue as companies raise concerns regarding chemicals released from the polymers in single use products might contaminate the drug. Thus, supply chain security is a critical issue for pharmaceutical manufacturers. Despite all these challenging factors, the adoption of single use has spread to all corners of the globe, worldwide, including some of the relatively less developed markets of South America, the Middle East, Asia, and Africa.
Upstream Workflow a Dominant Segment
The upstream workflow segment dominated the single-use bioprocessing market and accounted for more than half of the global market revenue in 2020. Single-use systems are commonly available for upstream processes (such as cell-culture seeding, and media preparation) vis-à-vis downstream processing. However, rapid technological advancements in the implementation of single-use systems in downstream processing, viz. filtration devices, pumps, and heat exchangers is fueling the segment growth further.
North America Key Revenue Generator; Prolific Growth of Market in Asia Pacific
North America captured ~1/3rd of the global single-use bioprocessing market revenue in 2020 as the region houses a large number of contract manufacturers involved in the implementation of disposables in their workflows. Also, heavy R&D spending by large-scale biopharmaceutical companies contributed to the dominance of the region in the global market. Moreover, patent expiry of several biologics is driving further the North American single-use bioprocessing market. The market in Asia Pacific are growing rapidly as compared to their western counterparts largely on the back of increasing government initiatives in the area, and improving R&D infrastructure, and investments. With pharmaceutical manufacturing powerhouses - China and India, this region is anticipated to register the fastest CAGR during the forecast period.
Key Companies Preparing for Post-COVID-19 Demand Surge
The anticipation of the need for vaccinating billions of people against COVID-19 has resulted in soaring demand for bioprocessing equipment in recent quarters. Avantor is investing to boost single-use bioprocessing equipment production capacity. Wuxi Biologics, and Chine CDMO kick-started facility employing nine 4,000 litre single-use bioreactors in early 2021. Earlier in 2020, Danaher bought GE Healthcare’s biopharma business for US$ 20 Bn to consolidate its strong industry position. Besides, Thermo Fisher Scientific, Inc., Merck KGaA, Sartorius AG, Pall Corporation, Eppendorf AG, Rentschler Biopharma SE, Lonza, Meissner Filtration Products, Inc., JM BioConnect, Boehringer Ingelheim GmbH, Danaher Corporation, Avantor Inc., and Kuhner AG are some of the most prominent players actively participating in global single-use bioprocessing market landscape.