SINGLE-USE BIOPROCESSING INDUSTRY INSIGHTS
The global single-use bioprocessing market size was valued at USD 4.8 billion in 2020 and is expected to reach USD 12 billion in 2026, growing at a CAGR of 17% during the forecast period. The outbreak of the COVID-19 pandemic has boosted the demand for single-use bioprocessing technology.
The ongoing robust R&D activities and clinical studies on the Covid-19 vaccine encourage many stakeholders to use SUB technology. Modalities such as covid-19 vaccine requirement, cell and gene therapies, and monoclonal antibodies are likely to influence the single-use bioprocessing market growth. The majority of biomanufacturing companies rely on advanced technology such as single-use systems to develop the vaccine.
Single-use technology is primarily used in pre-commercial development activities, production phases, and small biotech manufacturing. Single-use solutions have already supplanted a significant portion of traditional biopharmaceutical manufacturing practices, and this trend is expected to increase in the coming years. The biopharmaceutical industry's shift from traditional stainless-steel bioprocessing equipment to single-use ones is majorly influenced by proven economic and operational benefits of single-use bioprocessing technology. The market is likely to observe significant growth as single-use technology is increasing in downstream bioprocessing.
- SUB market is expected to observe an incremental growth of over USD 4 billion on account of high safety profile and flexibility in pre-commercial production processes.
- Vaccines are likely to grow at the fastest CAGR during the forecast period due to the shift from traditional vaccine production to SUB-based manufacturing.
- Monoclonal bodies are projected to reach a revenue share of approx. $5 billion by 2026 due to the adoption of SUB in manufacturing increases potential feasibility, cost-effectiveness, and reduced staff overheads.
- Contract manufacturing organizations (CMO) are likely to grow at the fastest CAGR of over 17% during 2020–2026 because of the high adoption of SUBs by CMOs for biopharmaceuticals manufacturing.
- The cell culture segment is expected to witness an incremental growth of over $2 billion by 2026 due to tremendous advances in human and cell cultures.
- The U.S. single-use bioprocessing market is expected to grow at a CAGR of approx. 17% during 2020-2026.
GLOBAL SINGLE-USE BIOPROCESSING MARKET SEGMENTATION
This research report includes a detailed segmentation by
INSIGHTS BY PRODUCT
Single-use bioprocessing products observe growth due to advances in equipment, higher scalability, and the increased application in the biopharmaceutical industry. Bioreactors and fermenters cover significant shares among SUB. The use of bioreactors and fermenters is growing for the development of biosimilars & biologics. The availability of single-use chromatography systems is considered a solution for single-use downstream bioprocessing. The use of membrane formats, scaling technologies, ion exchange technology, and polymeric column constructions are shifting end-users toward SUBs in downstream processes. Chromatography systems combined with tangential flow filtrations provide the highest productivity in downstream separation and purification steps.
Simple & peripheral elements accounted for over 45% single-use bioprocessing market share. The recurring use of tubing and filling, connectors, bags, sampling devices, probes and sensors, bottle assemblies, and manifolds is responsible for these devices' growth. Connectors, filling and tubing, and filters occupy a significant portion of the market share. Single-use connectors and tubing are prioritized for advanced aseptic processing, enabling reliability, flexibility, and cost-efficiency. Biopharmaceutical and pharmaceutical industries are currently relying on single-use solutions for the upstream process. However, with recent advances and increased SUB penetration, end-users are likely to use single-use technologies for commercial purposes. As this equipment is single-use in nature, the sales of simple and peripheral devices are rapidly increasing, thereby increasing their revenue shares.
INSIGHTS BY APPLICATION
The increased application of monoclonal antibodies (mABs) to diagnose and treat autoimmune disorders, cancer, and sexually transmitted infections (STIs) is boosting the single-use bioprocessing market growth. The production of mABs via single-use bioreactors reduces the operating cost and offers more flexibility than traditional stainless steel equipment. Also, the use of SUB in mABs manufacturing increases capacity, productivity, and flexibility. The utilization of SUBs in vaccine manufacturing is catching pace and is considered the smart method, especially during pandemics. They have become an ideal choice among manufacturers as they can be manufactured quickly and do not require validation, and have a reduced risk of contamination. Furthermore, single-use systems help enhance flexibility in small and large vaccine manufacturing and produce multiple products in a single suite.
Vaccine manufacturing via SUB has shifted to a large scale due to the increasing demand for high capacities. With the outbreak of the covid-19 pandemic, single-use technology has emerged as a critical factor for the rapid production of the COVID-19 vaccine in a short time. In addition to covid-19 vaccine production, single-use technology is finding application in the manufacturing of other vaccines such as influenza, thereby influencing the market growth.
INSIGHTS BY END-USER
Biopharmaceutical manufacturers occupy a significant share of the market, with single-use systems witnessing adoption in pre-commercial production processes. Several biopharmaceutical manufacturers have started to explore these solutions in commercial manufacturing. However, their potential benefits are significant, particularly for small-volume manufacturing in modular facilities. With the advent of single-use bioprocessing, the bioprocessing industry's dynamics have changed, enabling companies to develop new biologics with higher flexibility and low upfront costs. As technology has become increasingly popular, many companies are becoming interested in the widespread adoption of single-use bioprocessing.
In 2020, contract manufacturing organizations (CMO) accounted for over 34% share in the single-use bioprocessing market. Currently, over 10% of bioprocessing worldwide - about 1.7 million liters rely on single-use systems. It is expected that single-use covers 25–30% of the bioprocessing market in the future. CMOs use more SUB than biopharmaceutical developers as they offer quick switching over process lines and increased flexibility. Moreover, CMOs implementing SUB are likely to save on operating costs, capital investments, and floor space & process lines.
INSIGHTS BY METHOD
Advances in the cell culture process and biopharmaceutical manufacturing are leading to the development of innovative single-use technology. Single-use bioreactors are increasingly used for animal and human cell production processes. SUBs in mammalian cell culture result in high flexibility, reduced cost, and enhanced product productivity. They are increasingly being used for small-batch, large-batch volumes, clinical trials, and process development.
Filtration contributes to over 30% shares of the market. The application of disposable products is increasing from downstream sterilization and purification to upstream depth filtration and clarification. Single-use systems are used in membrane absorption and viral clearance. Single-use depth filters are applied to clarify cell culture streams in the first step of the downstream process. The increased demand for advanced filtration techniques is growing with growing challenges in the downstream bioprocessing and improvements in the biomass concentration during biologics manufacturing.
INSIGHTS BY GEOGRAPHY
North America and Europe constitute over 75% of the market share; however, the APAC region is expected to grow at the fastest CAGR of over 19% during 2020-2026. The increasing spending on biopharmaceutical research activities in the US and Canada, large-scale manufacturing facilities, and the growing demand for single-use technology contribute to the region's growth.
Similarly, in Europe, the increasing adoption of disposable bioprocessing, increasing biopharmaceutical manufacturing, and growing chronic diseases across Europe are significant drivers influencing the market growth. However, the APAC region is poised for growth. It is likely to grow at the fastest CAGR during the forecast period because of the growth in the R&D infrastructure, increase in the awareness of disposables, expiry of blockbuster biologics, favorable government initiatives, and increased demand for biologics.
INSIGHTS BY VENDORS
Thermo Fisher Scientific, Sartorius Stedim Biotech, Merck KGaA, Danaher Corporation, and Avantor are the key vendors operating in the global single-use bioprocessing market. The key players are increasing their focus on mergers and acquisitions in the past few years. With the sudden onset of the COVID-19 pandemic, vendors target vaccine developers and offer customized and flexible SUB technology. Acquisitions of emerging/small, specialized single-use suppliers, product portfolio development, expansion in regional markets, and strengthening of global distribution networks are the major strategies adopted by vendors in the market.
The global single-use bioprocessing market research report includes in-depth coverage of the industry analysis with revenue and forecast insights for the following segments:
- Single-use Bioprocessing Equipment
- Simple & Peripheral Devices
- Monoclonal Antibodies (mABs)
- Cell Therapies
- Biopharmaceutical Manufacturers
- Contract Manufacturing Organizations (CMOs)
- R&D Companies & Research Institutes
- Storage & Transport
- Cell Culture
- North America
- South Korea
- Latin America
- Middle East & Africa
- Saudi Arabia
- South Africa