According to the new market research report “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″, published by MarketsandMarkets™, 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.

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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The growth of the market can primarily be attributed to the major advantages of single-use technologies as compared to traditional stainless-steel assemblies, such as rapid implementation and the low risk of cross-contamination. The increasing biopharmaceutical RD expenditure and growing biologics market are also driving the market growth.

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.

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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 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.

Geographically; In 2020, the Asia Pacific region accounted for the fasted growing region of the Single use Assemblies Market. This can be attributed to the growing biopharmaceutical market and biopharmaceutical manufacturing capabilities in Asian countries, rising life science research activities, increasing investments by pharmaceutical biotechnology companies, and the growth of the contract RD sector.

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).

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