Global Single-use Bioprocessing Market - Market Size & Forecast To 2032

Global Single-use Bioprocessing Market - Market Size & Forecast To 2032

The global single-use bioprocessing market is estimated to be worth of USD 23.61 Billion in 2023 and is growing at a CAGR of 15.45% during the forecast period from 2023 to 2032. Single-use bioprocessing (SUB) describes the use of active consumables, conduits, and containers that only come into touch with process fluids once before being discarded. In its most basic form, SUB substitutes plastic for glass or stainless steel. SUB emerged in earnest during the late 1990s, when biotech businesses began utilizing polymeric containers for low-risk biomanufacturing processes such as buffer preparation and storage, realizing the ubiquitous usage of plastic packaging for blood products and medications. Bioprocess bags were created by companies to replace glass or bigger stainless-steel containers, and this led to the development of industries for aseptic connections, valves, and tubing.

Tubing and filters, which are now virtually invariably of the single-use sort, are really the single-use goods that have seen the most success and the biggest market penetration. In stainless steel facilities, plastic tubing is also always utilized, although almost all filters nowadays are single-use and have no recycling possibilities. The key to SUB's success and its potential for growth as a manufacturing technology is its near-elimination of non-value-added tasks, such as packing chromatography columns, but more specifically the labor-intensive, expensive, time-consuming, and strictly regulated cleaning and cleaning validation of fixed-tank bioreactors and feed lines. Equipment that is used once and then destroyed eliminates product cross-contamination and significantly reduces disease concerns. The economics of use-and-throw vs use, clean, validate, and reuse have been thoroughly established for single-use bioreactors and are now generally recognized. Additionally, the emergence of multi-product facilities, contract manufacturing, and outsourced product development has produced a setting where speed and flexibility, which are challenging to achieve with fixed-tank equipment, are highly valued.

The increased demand for biopharmaceuticals in recent years has fueled the adoption of single-use bioprocessing technology, as has a rise in funding for the development of biologics such as monoclonal antibodies, vaccines, recombinant proteins, and others. The adoption of single-use systems in the bioprocessing industry has also been aided by advantages related to their usage, such as a notable decrease in operating costs and the amount of time and money needed to build new facilities. The company's single-use assembly processes as well as other product portfolios were intended to be improved by this expansion. Furthermore, with a growing emphasis on the research of regenerative medicine, such as cell and gene treatments, higher clinical trial success, and a faster pace of regulatory approvals, demand for commercialization of these products is projected to expand in the near future. Additionally, in order to sustain their highly dynamic and regularly changing product portfolios, CMOs are using single-use systems due to the rising outsourcing activities in the biopharmaceutical manufacturing industry.

Based on product, the market is segregated into bioreactors, tangential-flow filtration devices, depth filters, disposable filter cartridges, media bags & containers, mixing systems, tubing assemblies, sampling systems, and others.

Among these, the tubing assemblies and sampling systems are expected to held a notable share in the market due to ongoing product advancements and the growing importance of bioprocessing activities in the entire manufacturing process. The tubing assemblies and sampling systems subsegment was dominated by tubing, filters, connectors, and transfer systems since most single-use vendors offer tubing and connections in a format that is compatible with single- use bags, bioreactors, or other single-use bioprocessing equipment.

On the basis of application, the market is divided into monoclonal antibody production, vaccine production, plant cell cultivation, patient specific cell therapies, and others.

Among these, the monoclonal antibody production subsegment is predicted to held a significant share in the market owing to the significant increase in product demand for mAbs, efforts were made to simultaneously enhance production capacity by building large bulk manufacturing facilities and making modifications to cell culture procedures to boost product titers. The improvement in titers has also resulted in a significant decrease in manufacturing costs, which may become a relatively modest proportion of sales price for future products marketed at or around present levels.

Based on Method, the market is categorized into

Among these the filtration subsegment is predicted to held a significant share in the market. Due to its effective filtering even at large scales, single-use bioprocessing systems are becoming more and more popular in filtration. It is utilized for ultrafiltration, biomolecular polishing, and the removal of bioburden.

On the basis of end user, the market is segregated into biopharmaceutical manufacturers, life science R&D companies & academic research institutes, and contract research organizations & manufacturers.

Among these, the biopharmaceutical manufacturers subsegment is anticipated to held a notable share in the market. The significant growth of the market has been attributed to the rise in contract manufacturing and research services as well as an increase in the commercial success of biologics in recent years. In bioprocessing operations, CROs and CMOs can provide a number of advantages, including scalability, flexibility, a reduction in the need for internal infrastructure, and specialized supply channels. These benefits are encouraging the use of contract services and are projected to have a favourable impact on the expansion of the sector in the near future.

Based on workflow, the market is segregated into upstream bioprocessing, fermentation, downstream bioprocessing.

Among these, the upstream bioprocessing subsegment is expected to held a sizeable share in the market owing to the ongoing improvements and advances in upstream bioprocessing technology. For instance, cutting-edge technologies like the Ambr 15 micro-bioreactor system from Sartorius AG offer automated experimental setup and sampling in addition to high-throughput upstream process development, efficient cell culture processing, and medium & feed optimization. These options are expected to accelerate segment growth and shorten the time required for upstream bioprocessing processes.

Based on region, the Single-use Bioprocessing market has been segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South America. In 2022, the Europe accounted for the significant share xx.xx% in the global Single-use Bioprocessing Market. This region was valued at USD xx.xx million in 2022, and it is projected to grow at a CAGR of xx.xx% during the forecast period, reaching USD xx.xx million by 2032.

North America region is anticipated to held a significant share in the market. This is due to the presence of a well- established pharmaceutical and biomanufacturing business in the region, as well as a high level of R&D activity. Similar to this, the need for single-use bioprocessing equipment is fueled by a growing emphasis on vaccine manufacturing to support local efforts at disease prevention. Additionally, the Bio-process System Alliance (BPSApresence)'s in North America, which promotes the use of single-use technology, is anticipated to significantly boost the region's disposable system sales.

Asia-Pacific region is also expected to held a notable share in the market. Multiple investments from numerous international corporations have been made in the region's expanding bioprocessing sector. These investments help the important businesses establish a presence in the region and seize unexplored opportunities. Additionally, the trend of using disposables in CMOs combined with the growing demand of contract service providers to expand their base in Asia Pacific serves as a motivator for ongoing investments by both domestic and international businesses.