Within the field of cell culture as applied to bio-pharmaceutical processes there exists a need to separate cells from the media in which they are grown. There are several process variations currently in use which include batch, repeat batch, and perfusion. The product may be a molecular species that the cell excretes into the media, a molecular species that remains within the cell, or it may be the cell itself. In all cases the product must eventually be separated from other process components before final purification and product formulation and the present invention is directed to that separation in large-scale systems. Methods currently in common use for this purpose include continuous and semi-continuous centrifugation, tangential flow filtration (TFF), and depth filtration. The centrifuges for batch and repeat batch processes at production scale are complex systems that require clean-in-place (CIP) and steam-in-place (SIP) technology to provide an aseptic environment to prevent contamination by microorganisms.
There is now a desire in the industry to use pre-sterilized, single-use centrifuges for some large, production-scale operations, but the mere geometric scale-up of the existing smaller designs has not been successful beyond a processing rate of 1-2 liter/min. Technical limitations inherent in the smaller existing designs preclude a direct geometric scale-up approach. For example, simple geometric scale-up of small-scale designs leads to stress levels that are unsustainable by the materials of construction typically used in single-use designs. While pre-sterilized, single-use components are currently used for media storage, mix tanks, holding tanks, and bioreactors, e.g. up to about 2000-liter capacity, there are no production-size centrifuges available that employ pre-sterilized components that can be used to process such large cell culture batches. Currently, the largest semi-continuous centrifuge commercially available is only capable of processing at a maximum hydraulic rate of about 2 liters per minute (ppm), which limits its use to batch sizes of a maximum of only about 250 liters or perfusion processes
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Global Single-Use Centrifuge System Market -Competitive Insights
February 12, 2024, Multiply Labs and Thermo Fisher Scientific expand partnerships to automate cell expansion and separation in cell therapy manufacturing. Merger acquisitions and strategic partnerships of companies increase the growth of the market.
Some of the Global Single-Use Centrifuge System Market Includes-
- Beckman Coulter, Inc. (Danaher Corporation)
- Sartorius AG
- Becton
- Dickinson and Company
- Merck KGaA
- Thermo Fisher Scientific, Inc.
- Alfa Laval
- Pneumatic Scale Angelus
- GEA Group Aktiengesellschaft.
Global Single-Use Centrifuge System Market – Growth Drivers
The demand for single-use centrifuge systems is expected to increase due to the rising need for novel cell and gene therapies to treat various blood disorders like anemia and hemophilia, as well as common blood cancers such as leukemia, lymphoma, and myeloma. This demand is further driven by increased research and development in cellular therapies for B-cell leukemia and lymphoma. The prevalence of nonmalignant and inherited blood disorders is projected to rise in regions like North America, leading to market growth. The use of advanced centrifugation technology in blood processing applications and high-throughput biopharmaceutical manufacturing processes, particularly in bioengineered vaccine production, is also contributing to market expansion. Hospitals, diagnostic laboratories, and biopharmaceutical manufacturing processes are key areas where the demand for centrifuge solutions is expected to be significant. The rise in usage of centrifugation technology in high-throughput biopharmaceutical manufacturing processes, especially in bioengineered vaccine manufacturing, is likely to boost the market.
Global Single-Use Centrifuge System Market -Restraints
Single-use centrifuge systems offer numerous benefits in bioprocessing, including reduced cross-contamination risk, minimal cleaning validation requirements, and enhanced operational flexibility. However, they also face technical limitations that limit their widespread adoption and scalability. Processing rate constraints are a significant restraint, as existing designs are optimized for small to moderate volumes, making scaling up challenging due to rotor design, motor power, and structural integrity. Geometric scaling is another challenge, as single-use systems face limitations in material strength, rotor dynamics, and operational efficiency, restricting their scalability for high-volume bioprocessing applications. Operational efficiency concerns also contribute to the restraint in the single-use centrifuge system market, as they may exhibit lower processing efficiencies compared to traditional centrifuges. Factors such as material compatibility, rotor design limitations, and speed constraints can impact the overall efficiency of single-use centrifuge systems, affecting their suitability for certain high-throughput applications. Addressing these technical limitations presents an opportunity for innovation and advancement in single-use centrifuge systems, with research and development efforts focusing on rotor design, material strength, motor power optimization, and overcoming scalability challenges.
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Global Single-Use Centrifuge System Market -Opportunities
The increasing demand for centrifuges in developing countries presents a significant opportunity for market expansion and industry development. As these nations experience rapid industrialization and economic growth, there is a growing need for advanced technologies to optimize industrial processes. Centrifuges offer efficient liquid-solid separation solutions in sectors like energy, pharmaceuticals, and wastewater treatment. Adopting centrifuges can lead to improved resource recovery, reduced waste disposal costs, and enhanced operational efficiency. The opportunity lies in tailoring centrifuge technologies to suit the specific needs and infrastructure of developing economies. Strategic market penetration and collaborations with local industries can further accelerate the growth of centrifuges, creating a mutually beneficial scenario.
Global Single-Use Centrifuge System Market-Geographical Insights
North America was the leading region in the global single-use centrifuge system market in 2020, with the U.S. being the dominant player due to factors like advanced products, an aging population, and many manufacturers. In the future, Asia Pacific is expected to increase its market share. This growth will be driven by new product launches, partnerships, and expansions by local companies in countries like China and India. In Europe, advancement in technology enhances the opportunities for the market.
Global Single-Use Centrifuge System Market– key development
- On January 24, 2023, Alfa Laval developed new biofuel-ready separators for the marine industry to effectively clean biofuels like HVO (hydrotreated vegetable oil) and FAME (fatty acid methyl ester) and prevent performance issues and expensive engine wear.
- On May 11, 2023, GEA Group AG will invest around EUR 50 million in the modernization of its German centrifuge production facilities in Niederahr (Rhineland-Palatinate) and Oelde (North Rhine-Westphalia) by the end of 2024. By investing in sustainable production, digitalization, and automation, GEA is targeting further growth in its key markets, including the food, beverage, and pharmaceutical industries.