Global Single-Use Bioprocessing Market - 2022-2029

Global Single-Use Bioprocessing Market - 2022-2029

Market Overview

Single-use Bioprocessing Market size was valued US$ 7.62 billion in 2021 and is estimated to reach US$ 25.40 billion by 2029, growing at a CAGR of 18.93% during the forecast period (2022-2029).

Single-use bioprocessing systems are bioprocessing equipment that is used once and disposed of. Single-use bioprocessing systems are made up of plastic components that can be sterilized and sealed by using gamma irradiation. Single-use bioprocessing systems are used for mixing, filtration, purification, upstream expression, storage, and separation of biopharmaceutical products. The market is dominated by the availability of several single-use bioprocessing systems such as bioreactors & fermenters, mixers, bags, bioprocess containers, and filtration.

Market Dynamics

The market is driven by the increasing demand for single-use bioprocessing systems with the growing penetration of biopharmaceuticals. Single-use bioprocessing systems have several advantages, such as high energy efficiency, low water usage, less floor space requirement, and very low or no risk of product cross-contamination. Single-use bioprocessing systems are faster to implement.

Growing demand for biopharmaceuticals drives the growth of single-use bioprocessing market

According to the UN Ageing Population Highlights, an estimated 727 million people in the global population will be 65 and older in 2020, by 2050, this figure is expected to double to 1.5 billion. The elderly population is more prone to chronic conditions and diseases, so demand for biopharmaceuticals is expected to rise as the senior population grows in major markets. Companies increasingly prefer single-use bioprocessing systems to meet the growing demand for biopharmaceuticals because they increase process efficiency and reduce costs associated with complicated steps such as cleaning, sterilization, and maintenance of steel-based bioreactor systems. Filtration, mixing, purification, upstream expression, storage, and separation are all biopharmaceutical applications that use single-use bioprocessing technology.

In January 2019, Sartorius Stedim Biotech launched the Biostat RM TX with Flexsafe RM TX for producing consistent quality cellular products. Biostat RM TX is a single-use bioreactor, a new wave hybrid system developed specifically for closed, automated expansion of consistent quality cell products such as ex vivo cellular immunotherapies. It combines single-use Flexsafe bag technology with the company’s expertise in biopharmaceutical automation. Biostat RM TX is designed for scale-out expansion of cells, including patient-specific T cells, and is a closed system comprising an automated control unit and up to two rocking platforms to gently agitate single-use Flexsafe RM TX bags.

The problem associated with waste disposal is likely to hamper the growth of the single-use bioprocessing market

Biopharmaceutical firms are increasingly adopting single-use bioprocessing Products due to the numerous benefits associated with them, including cost savings, faster process development time, and lower capital investments. However, there are still serious concerns about the disposal of solid waste materials generated by this alternative technology. Recycling is not an option for such products because separating the components into homogeneous parts requires significant effort. As a result, most single-use systems and their parts are unsuitable for recycling. These factors are hampering the growth of the market in the forecast period.

Industry Analysis

The global single-use bioprocessing market provides in-depth analysis of the market based on various industry factors such as porter’s five forces, regulatory analysis, supply chain analysis and pricing analysis.

Segment Analysis

Disposable/ single-use bioreactor segment is expected to hold the largest market share in global single-use bioprocessing market

The single-use bioprocessing market is segmented based on product as media bags and containers, filtration assemblies, disposable/single-use bioreactors, disposable mixers, and others. The disposable/single-use bioreactors segment accounts for a significant market share in 2019. The disposable/single-use bioreactors comprised of the disposable bag instead of a culture vessel. Disposable/single-use bioreactors that are ideal for mammalian cell culture depend on high cell density or microcarrier-based processes. Single-use bioreactors reduce the cleaning and sterilization demands. These bioreactors are effective for enhancing biological and process safety. The market is dominated by the availability of several disposable/single-use bioreactors. For instance, Sartorius’s single-use bioreactors i.e., Ambr15 to BiostatSTR 2,000 L have been developed to ensure easy scale-up and scale-down. It is combined with unprecedented high performance even at a large scale. These bioreactors make the products perfectly suitable to serve all the current and future needs from process development to commercial production phases. Several companies are expanding their manufacturing facilities with the use of disposable/single-use bioreactors. For instance, MilliporeSigma had expanded its single-use cGMP facility with the addition of the Mobius 2,000 L single-use bioreactor, enabling the company to provide upstream development and manufacturing services using its equipment through its Provantage End-to-End Services offering

Further, the single-use bioprocessing market is also classified based on the end-users as biopharmaceutical manufacturers, life science R&D companies, academic research institutes, contract research organizations & manufacturers, and others. The contract research organizations & manufacturers segment accounts for the highest market share. Contract research organizations & manufacturers are focusing on installing single-use bioprocessing products at their manufacturing facilities. Contract research organizations & manufacturers are installing single-use bioprocessing equipment including bioreactors at a large scale for in-house biomanufacturing. Contract research organizations & manufacturers are using single-use blood bags, transfer sets, T-flasks, and pipettes for cell therapy-based clinical research.

Geographical Analysis

North America region holds the largest market share in the global single-use bioprocessing market

By region, the single-use bioprocessing market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the single-use bioprocessing market due to the higher adoption of single-use bioprocessing systems for the production of vaccines, monoclonal antibiotics, cell therapies, and other therapies. The single-use bioprocessing systems are manufactured by using high-grade polymer materials and plastic composites that provide enhanced integral strength. Several manufacturers are using single-use bioprocessing systems as the use of these systems reduced the overall operational costs and provides continuity in biomanufacturing. There is a presence of large-scale biopharmaceutical manufacturing facilities. The market is witnessing technological advancement including automation, big data, and machine learning (ML) solutions in bioprocessing. These technological advancements are useful for predicting errors and improving accuracy during medical procedures.

Europe single-use bioprocessing market acquired the second position followed by North America in the global market with a prominent share of the market. Significant factors are probable the growth of the market owing to rising R&D initiatives, and huge production capabilities. In the Europe region, the United Kingdom is majorly controlling the market and estimated constant growth over the forecast period. Germany and France are projected to develop prominent growth in the Single-use Bioprocessing Market over the forecast period.

The Asia-Pacific is expected to witness positive market growth over the forecasted period. There is growing usage of single-use bioprocessing systems as these bioprocessing systems have made the drug manufacturing process faster, simpler, and cheaper. The use of single-use bioprocessing systems increases the productivity of the manufacturing of the products. There is a presence of several companies developing single-use bioprocessing systems. Several public and private players are raising their investment in the development of single-use bioprocessing systems.

Competitive Landscape

The single-use bioprocessing market is highly competitive with the presence of several international and local market players. Product diversification, technological advancement, revenue generation, and opportunities intensify the market competition. 3M Company, Applikon Biotechnology, Cesco Bioengineering Co., Danaher Corporation, General Electric Company, Merck KGaA, PBS Biotech Inc., and Thermo Fisher Scientific Inc. are the leading Market players with significant market share.

Companies are using novel product launches, capacity utilization, technology advancement, new product development, and market expansion strategies for holding their position in the market. For instance, in Jul 2021, Sartorius acquired German firm Xell, including it to subgroup Sartorius Stedim Biotech. This will lead to expanding its business of media and feed supplement for cell cultures. Xell also extends Sartorius analytical products and services for characterizing and quantifying media and its components and for optimizing the composition of media.

In Jan 2019, Boehringer Ingelheim expanded its commercial biologics manufacturing site in China. The expansion covered the incorporation of a bioreactor with all required infrastructure and utility to support the GMP operations of 2x 2.000 L single-use bioreactor manufacturing lines.

For instance, in Mar 2019, Sartorius Stedim Biotech (SSB), a leading supplier in the biopharmaceutical industry entered into a collaboration with Novasep in the area of chromatography and single-use bioprocessing. Novasep provides various products and services to the life science industry, based on specialized technologies. Novasep’s established BioSC platform and SSB’s single-use technology would form the basis for the development of innovative chromatography systems.

In Feb 2019, Pall Biotech entered into a collaboration with Artesyn Biosolutions, a company specializing in single-use components and fluid management technologies. The agreement would encompass a co-development partnership, delivering complete solutions from clinical to commercial-scale for single-use automated bioprocessing systems. These systems would accelerate product development and time to market through a fully industrialized and standard platform for cGMP manufacturing of biotech and biological products. This collaboration expands Pall Biotech's Allegro single-use solution portfolio from upstream through downstream, and to final filling. This collaboration would provide industrial and modular single-use bioprocess solutions, resulting in robust fluid management.

Key Companies to Watch

Thermo Fisher Scientific Inc.:

Overview: Thermo Fisher is an American company that supplies variety of scientific or analytical instruments, lab reagents & consumables, and some scientific software services. It was founded in 1956 and headquartered in Waltham, Massachusetts, U.S.

Product Portfolio:

Thermo Scientific HyPerforma DynaDrive Single-Use Bioreactor: It is a single-use bioreactor that is better in performance and scalability for larger volumes. It is suitable for perfusion and fed batch processes.

Key Developments: In Oct 2021, Thermo Fisher Scientific announced about assuming operational responsibility for Lengnau, Switzerland their latest site for biologics manufacturing. It will have a flexible bioproduction technology including single use bioreactor and stainless steel bioreactors.

The global single-use bioprocessing market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.