Single-use Assemblies Market worth $6.3 billion by 2026 – Rapid implementation and low risk of cross-contamination

The Research Report on “Single-use Assemblies Market by Product (Bag Assembly, Filtration Assembly, Bottle Assembly, Mixing Assembly), Application (Filtration, Storage), Solution (Standard, Customized), End User (Pharmaceutical, Biopharma, CMOs, CROs) – Global Forecast to 2026“, is projected to reach USD 6.3 billion by 2026 from USD 2.2 billion in 2021, at a CAGR of 23.3% during the forecast period.

Growth Driver: Rapid implementation and low risk of cross-contamination;

A single-use solution has numerous advantages over traditional bioprocessing technologies, due to which the adoption of single-use assemblies is growing continuously. These include the faster implementation of single-use assembly components in the bioprocess cycle and a lower risk of cross-contamination. Single-use assemblies are ergonomically designed to hold integrated single-use flow paths for faster set-up and reduced space requirements. The product design is aimed to reduce the amount of time and cost related to preparation, set-up, testing, validation, and documentation. In addition, with the elimination of the Clean-In-Place (CIP) and Sterilization-In-Place (SIP) steps, the project lead time for the implementation of single-use production plants is reduced by at least eight months as compared to stainless-steel reactors and reusable assemblies. Owing to such advantages, single-use solutions enable faster batch turnaround and product change-over.

Product cross-contamination is a major concern in the biomanufacturing industry. The potential for cross-contamination occurs when the same process equipment is used repeatedly in the process cycle. Unwanted protein contamination, for example, may reduce production yields by requiring additional purification steps, or in the worst possible case, proteins that co-purify may result in potentially fatal treatments. Since the product flow path is discarded and replaced after each batch, the risk of product cross-contamination between batches is virtually eliminated with the use of single-use assembly components. Single-use component manufacturers also typically make and assemble products in cleanrooms to ensure that their products do not introduce harmful particulates and endotoxins into a bioprocess. Such advantages are driving the adoption of single-use assemblies among end users in the biopharmaceutical & pharmaceutical industries.

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Industry Segmentation In Detailed:

The biopharmaceutical & pharmaceutical companies segment accounted for the largest share of the end user segment in the single-use assemblies market in 2020.

On the basis of end users, segmented into biopharmaceutical & pharmaceutical companies, contract research & manufacturing organizations (CROs & CMOs), and academic & research institutes. In 2020, the biopharmaceutical & pharmaceutical companies segment accounted for the largest share of the single-use assemblies market. The demand for biopharmaceuticals among the geriatric population is increasing as the elderly are more prone to diseases/disorders, which are treated using biologics. This has resulted in the increased focus of biopharmaceutical companies on developing affordable biologics at lower costs. As single-use assemblies have wide applications in each stage of the production cycle, their adoption is increasing with the growth in the production of biologics and biosimilars.

The standard solutions segment accounted for the largest share of the solutions segment in the single-use assemblies market in 2020. 

Based on solution, segmented into standard solutions and customized solutions. In 2020, the standard solutions segment accounted for the largest share of the single-use assemblies market. The adoption of standard solutions is high in the pharmaceutical & biopharmaceutical industries due to the advantages these solutions offer, such as manufacturing process efficiency with reduced capital costs, improved flexibility with the use of pre-qualified components for building assemblies, reduced implementation time, and more flexibility with production planning.

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Leading Key Players and Analysis:

Prominent players operating in the single-use assemblies market are Thermo Fisher Scientific, Inc. (US), Sartorius Stedim Biotech (France), Danaher Corporation (US), Merck KGaA (Germany), Avantor, Inc. (US), and Saint-Gobain (France).

Thermo Fisher Scientific is one of the leading players in the market. The company offers a range of single-use assemblies for downstream, upstream, and fill-finish stages of bioprocessing. The company’s BioProcess containers and transfer assemblies are single-use flexible container systems for critical liquid handling applications in biopharmaceutical & biomanufacturing operations. In the last few years, the company has majorly focused on expanding its bioproduction capabilities and market presence. In 2020, it saw significant growth in its Life Sciences segment, driven by the demand for diagnostic testing for COVID-19; the demand for bioproduction products, including single-use assemblies, saw a significant surge.

Geographical Analysis in Detailed:

The Asia Pacific region is the fastest-growing region of the single-use assemblies market in 2020.

In 2020, North America accounted for the largest share of the single-use assemblies market. The large share of the North American market can be attributed to its well-established biopharmaceutical industry, wide availability of single-use assemblies offered by market leaders in the region, and increased production of biologics and biosimilars in the region.

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