一次性使用 (單回使用) 生物處理的全球市場:2020年∼2027年
Global Single-use Bioprocessing Market - 2020-2027
一次性使用生物處理系統，是只使用一次便廢棄的生物處理系統。系統使用伽馬射線照射可殺菌及密封塑膠零組件構成。隨著生物醫藥品的越來越普及，一次性使用 (單回使用) 生物處理系統的需求增加，促進市場。
本報告提供全球一次性使用 (單回使用) 生物處理市場相關調查分析，產業分析，各市場區隔的市場分析，競爭情形，主要企業等相關的系統性資訊。
Single-use bioprocessing systems are the bioprocessing equipment that are used for once and disposed. Single-use bioprocessing systems are made up of the plastic components that can be sterilized and sealed by using the 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 the several single-use bioprocessing systems such as bioreactors & fermenters, mixers, bags, bioprocess containers, filtration devices, tubing, sampling systems, connectors & clamps, and probes & sensors. The single-use bioprocessing market valued USD XX million in 2018 and it is expected to grow at a CAGR of XX% to reach USD XX million by 2026.
The market is driven by the increasing demand for the single-use bioprocessing systems with the growing penetration of the biopharmaceuticals. Single-use bioprocessing systems are widely used for the production of the biopharmaceutical products such as vaccines, monoclonal antibodies (mAbs), personalized medicine, and others. 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.
There is increase in the launch of the single-use bioprocessing systems. For instance, in September 2019, ABEC had launched a single-use bioreactor system with a working volume of 6,000 L three times that of industry's standard upper limit.
In January 2019, Sartorius Stedim Biotech had 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 mixed 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 of an automated control unit and a up to two rocking platforms to gently agitate single-use Flexsafe RM TX bags.
The market is witnessing the technological advancement for the development of the single-use bioprocessing systems. For instance, in February 2019, Applikon Biotechnology B.V. had launched the single-use AppliFlex ST lab-scale bioreactor as a significant extension to its range of innovative bioreactor systems. AppliFlex ST is a fully customizable and scalable stirred tank single-use bioreactor that uses 3D printing technology to provide a head plate that is uniquely configured to each individual process, including custom impeller design, and different sample port connections. The 3D printing production technology had allowed the multiple options such as designed on demand impellers in Helical, Hydrofoil, Marine or Rushton formats. It provides the complete reproducibility between the different customized bioreactors, providing exact identical conditions between runs.
However, the extractability and leachability issues regarding disposable components like plastic bags is hindering the market growth. Environmental and economic concerns with the usage of the single-use bioprocessing systems could have a negative impact on the market.
The single-use bioprocessing market is segmented based on the product as the media bags and containers, filtration assemblies, disposable/single-use bioreactors, disposable mixers, and others. The disposable/single-use bioreactors segment accounts for the significant market share of XX% 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 depending on the high cell-density or microcarrier-based processes. Single-use bioreactors reduce the cleaning and sterilization demands. These bioreactors are effective for enhancing the biological and process safety. The market is dominated by the availability of the 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 and straightforward scale-up and scale-down. It is combined with the unprecedented high performance even at 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 the 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 own equipment through its Provantage End-to-End Services offering
Further, the single-use bioprocessing market is also classified based on the end users as the 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 of XX% in 2019. Contract research organizations & manufacturers are focusing on installing the single-use bioprocessing products at their manufacturing facilities. Contract research organizations & manufacturers are installing the single use bioprocessing equipment including bioreactors at large scale for in house biomanufacturing. Contract research organizations & manufacturers are using the single-use blood bags, transfer sets, T-flasks, and pipettes for cell therapy-based clinical research.
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 the single-use bioprocessing systems for production of the vaccines, monoclonal antibiotics, cell therapies, and other therapies. The single-use bioprocessing systems are manufactured by using the high-grade polymer materials and plastic composites that provide the enhanced integral strength. Several manufacturers are using the single-use bioprocessing systems as the use of these systems reduced the overall operational costs and provide the continuity in biomanufacturing. There is presence of the large-scale biopharmaceutical manufacturing facilities. The market is witnessing the technological advancement including the automation, big data and machine learning (ML) solutions in bioprocessing. These technological advancements are useful for predicting errors and improving accuracy during medical procedures.
The Asia-Pacific is expected to witness the positive market growth over the forecasted period. There is growing usage of the single-use bioprocessing systems as these bioprocessing systems have make the drug manufacturing process a faster, simpler and cheaper. The use of the single-use bioprocessing systems increase the productivity of the manufacturing the products. There is presence of the several companies developing the single-use bioprocessing systems. Several public and private players are raising the investment for the development of the single-use bioprocessing systems.
The Single-use Bioprocessing market is highly competitive with the presence of several international and local market players. The 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 January 2019, Sartorius launched BIOSTAT RM TX single-use bioreactor for closed and automated expansion of various cellular therapies
In January 2019, Boehringer Ingelheim expanded its commercial biologics manufacturing site in China. The expansion covered 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.
In March 2012, Thermo Fisher Scientific Inc had launched the Thermo Scientific HyPerforma Single-Use Bioreactor TK, an integrated system that combines the company's proven single-use bioreactor technology with a robust controller platform that enhances functionality and greatly reduces setup times before each production run. The new HyPerforma S.U.B. TK is available in either 50 L or 250 L sizes, both incorporating Thermo Scientific S.U.B. vessels with PC and Delta V controller systems from Finesse LLC. This enables the use of the HyPerforma S.U.B. TK systems in both process development and cGMP production.
Several companies are entering into the mergers, collaborations, agreement, and licensing activities for increasing their market penetration. For instance, in March 2019, Sartorius Stedim Biotech (SSB), a leading supplier for the biopharmaceutical industry had entered into the collaboration with the 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 February 2019, Pall Biotech had entered into the collaboration with the 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 the 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 the industrial and modular single-use bioprocess solutions, resulting in robust fluid management.
Visualize the composition of the single-use bioprocessing market products in terms of product, application, and end-users highlighting the critical commercial assets and players.
Identify commercial opportunities in the single-use bioprocessing market by analyzing trends and co-development deals.
Excel data sheet with thousands of data points of global single-use bioprocessing market-level 4/5 segmentation.
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