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Market Overview

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The North America and Europe single-use bioprocessing market is expected to witness significant growth, with a projected increase from USD 6.22 billion in 2022 to USD 15.14 billion by 2028, at a compound annual growth rate (CAGR) of 15.82% during the forecast period.

Single-use bioprocessing technology plays a crucial role in the development of disposable equipment used for manufacturing biopharmaceutical products. While the initial phase of the pandemic had a negative impact on the market due to disruptions in manufacturing processes and limited demand and supply of drugs, single-use technology has emerged as a leading solution in pre-commercial manufacturing stages, including preclinical and clinical scales. The demand for effective drugs and vaccines, driven by the COVID-19 pandemic, has led to an increased adoption of single-use bioprocessing systems by biopharmaceutical companies. These systems offer advantages such as reduced contamination risk and minimized sterilization requirements between batches. Notably, single-use technologies are also instrumental in drug discovery efforts related to COVID-19, particularly in research involving novel approaches like mRNA and DNA technologies. As a result, the single-use bioprocessing market has been significantly impacted by the ongoing pandemic.

Several factors are driving the market growth. These include faster implementation and decreased risk of product cross-contamination, rising demand for biopharmaceuticals, lower costs, and reduced environmental impact associated with single-use bioprocessing technologies. The increasing prevalence of chronic diseases and the growing need for effective drugs have fueled the demand for biopharmaceuticals, consequently driving the adoption of single-use technologies. For example, in 2021, the Food and Drug Administration approved 14 biologics for treating various chronic diseases. This trend is expected to boost biopharmaceutical manufacturing and the utilization of single-use bioprocessing technologies in the coming years.

Furthermore, single-use technologies and systems enable biopharmaceutical manufacturers to mitigate contamination risks and eliminate the need for sterilization between batches, thus improving overall efficiency. Companies are actively developing new single-use systems for both upstream and downstream processing in biopharmaceutical production. The market expansion is also attributed to the low water usage, high energy efficiency, small footprint, and reduced risk of contamination associated with these products. The adoption of big data-based machine learning in single-use systems enhances product yield, maximizes productivity and efficiency in the manufacturing process, and has become a mainstream strategy for many biopharmaceutical manufacturers.

Additionally, increasing company activities and the implementation of various business strategies such as collaborations, partnerships, and product launches have contributed to market growth. For instance, Qosina entered into a distribution agreement with Nordson MEDICAL in May 2021 to support Single-Use Bioprocess Integrators and Medical Device Manufacturers.

However, challenges related to leachables and extractables are expected to hinder market growth during the forecast period.

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Market Segmentation

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The market is segmented based on various factors, including product, application, end-user, and geography.

Segmentation by Product
Filtration Assemblies
Media Bags and Containers
Disposable/Single-use Bioreactors
Disposable Mixers
Other Products

Segmentation by Application
Filtration
Cell Culture
Purification
Other Applications

Segmentation by End-User
Biopharmaceutical Manufacturers
Academic and Clinical Research Institutes
Other End Users

Segmentation by Geography
North America
Europe
Single-Use Filtration Assemblies are disposable filtration devices specifically designed for single use in a variety of liquid filtration applications. These assemblies typically consist of a filter housing, filter media, and connectors for integration into fluid systems. They are commonly used in industries such as biopharmaceuticals to filter liquids, including biological fluids, in order to remove contaminants and impurities before use or further processing. Single-use filtration assemblies offer numerous advantages compared to traditional reusable filtration systems, including reduced cleaning and validation requirements, improved process consistency, and increased safety and ease of use.

The Filtration segment holds the majority share in the single-use bioprocessing market, reaching USD 2,632 million in 2022. It is expected to witness a compound annual growth rate (CAGR) of 16.81% over the forecast period. Single-use bioprocessing filtration involves the use of disposable filtration devices to filter biopharmaceutical liquids. These filters are typically made from polymers or synthetic materials and are designed for one-time use, offering efficiency and cost-effectiveness while reducing the risk of contamination. Single-use filtration is widely utilized in the production of biopharmaceuticals, vaccines, and cell therapies, replacing traditional stainless-steel filtration systems. The filters can be tailored for various applications, such as clarification, sterilization, or virus removal, to meet the specific needs of bioprocessing operations. The market is expected to be driven by increasing research studies and product launches.

Among the end users, the Biopharmaceutical Manufacturers segment dominates the market, with a valuation of USD 4,157 million in 2022. It is projected to experience a CAGR of 16.32% over the forecast period. This segment is anticipated to witness substantial growth in the single-use bioprocessing market due to factors such as the growing adoption of single-use technologies and systems. These advancements offer advantages such as reduced initial investment and research and development costs, lower labor and material expenses, and easy disposability compared to conventional bioprocessing methods. Additionally, the demand for biologics and increasing company activities contributes to the growth of this segment.

The United States is expected to hold the highest market share in the single-use bioprocessing market due to the rising implementation of single-use systems and increased research and development activities in the biopharmaceutical sector. The country has a well-established biopharmaceutical industry, with a wide availability of single-use assemblies provided by regional market leaders. Furthermore, there is a growing focus on acquisitions in biologics and biosimilar manufacturing, contributing to the region’s significant market share.

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Competitive Landscape

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The market for single-use bioprocessing exhibits a moderate level of competition and is characterized by the presence of several prominent players. This report profiles key companies operating in this market, including Sartorius AG, Thermo Fisher Scientific, Danaher Corporation (Cytiva), Eppendorf AG, Merck KGaA, 3M, CESCO Bioengineering Co. Ltd, PBS Biotech Inc., ABEC Inc., HIGH PURITY NEW ENGLAND, Distek Inc., and Solida Biotech GmbH.

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Recent Industry Developments

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In April 2022, High Purity New England (HPNE) announced the launch of a new manufacturing facility, representing a USD 10 million investment. This facility will serve as the company’s specialized manufacturing and distribution center, significantly expanding their capacity to produce single-use solutions.

In March 2022, Central Research Laboratories (CRL) introduced a new product line called Single-Use Beta Bags. These beta bags are essential components used in various applications, including the transfer of ready-to-use components and waste-handling processes within the Life Science product manufacturing sector.

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Key Questions Answered

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What is the duration of the study period for this market?
What is the growth rate of the Single-use Bioprocessing Market?
Which region exhibits the highest growth rate in the Single-use Bioprocessing Market?
Which region holds the largest share in the Single-use Bioprocessing Market?
Who are the major players in the Single-use Bioprocessing Market?