Single-use Assemblies Market Size, Share & Trends Analysis Report By Product (Bag Assemblies, Filtration Assemblies), By Application (Filtration, Storage), By Solution (Customized, Standard), And Segment Forecasts, 2023 - 2030

Report Overview

The global single-use assemblies market size was valued at USD 10,232.8 million in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 18.60% from 2023 to 2030. Single-use assemblies are preassembled plastic fluid paths and self-contained products. They are built by a combination of various standard components and are usually ready-to-use and gamma irradiated to ensure sterility. The broadly used industrial products include sampling bottles, filters, tubings, check valves, clamps, sterile connectors, fittings, and seals. The growing biologics market, continuous technological innovations in bioprocessing, increasing biopharmaceutical R&D and widespread adoption of single-use assemblies by various CMOs are expected to boost the industry growth during the forecast period.

However, regulatory concerns due to leachable and extractable, waste disposal, and the vast availability of the multi-use system can hinder the single-use assemblies market penetration to a certain extent. COVID-19 has augmented an already rapidly rising demand for single-use assemblies as the disposable assemblies’ technology allows for the speedy production and development of therapies and vaccines and improves accuracy and time. For instance, Aramus single-use bag assembly developed by Entegris, Inc. was used for storing COVID-19 vaccines as the vaccines need extremely low temperatures to preserve. With low leachable and extractable and an extensive operating-temperature variety, the patented single-use bags were ideal for cold chain storage and collection.

The growing prevalence of cancer and infectious diseases is increasing the production of effective novel biologics options for the diagnosis and treatment of cancer. The increasing number of cancer cases is aiding in the development of novel biologics options. Furthermore, a rise in the cases of infectious diseases, such as lower respiratory infections and Human Immunodeficiency Virus (HIV), in recent years due to climate change, changing land-use patterns, and rapid urbanization are expected to aid in the industry growth. For instance, according to the WHO, lower respiratory infections ranked fourth place in causing deaths globally. In addition, in 2020, according to UNAIDS, there were approximately 38.4 million cases of HIV across the globe.

Thus, infectious diseases require effective diagnosis and treatment options, such as biologics, which, in turn, is expected to boost industry growth. Furthermore, novel developments in vaccines for various infectious diseases are expected to contribute to industry growth. For instance, in January 2022, Moderna launched a new clinical trial for an HIV vaccine that utilizes mRNA technology similar to that found in the company’s COVID-19 mRNA vaccine. This vaccine is aimed at the production of antibodies that can neutralize HIV particles and such attempts highlight the use of recently developed technologies in the biologics space. Similarly, emerging infectious diseases with the potential to develop into future pandemics are leading to collaborative efforts for the development of new vaccine alternatives.

For instance, in August 2022, Lytic Solutions, which offers various molecular biology tools for research use, signed an agreement with NightHawk Biosciences to support NightHawk’s vaccine development efforts toward a new subunit monkeypox vaccine. Hence, such technological developments and collaborative efforts can significantly drive the adoption of single-use assemblies for the production of newly developed vaccines in the near future. The single-use assemblies aid in the cost reduction associated with complex steps, such as the maintenance of steel-based bioreactors and accessories, cleaning, and sterilization. This cost reduction by the application of single-use assemblies significantly helps in reducing the R&D costs and initial investments involved in the production of biologics.

Moreover, the adoption of single-use assemblies helps in increasing productivity in the manufacturing process by decreasing the complexity of automation and eliminating the need for changeover validation or cleaning between consecutive operations. The single-use assemblies have observed more traction in the biologics manufacturing industry where they are being used at multiple stages, namely in the upstream process, media & buffer preparation, downstream process, and process-intermediate storage. By outsourcing, the leading companies can target new product development and rely on the CMO for meeting the clinical as well as commercial manufacturing needs. As a pipeline product moves from phase trials to a fully developed commercial manufacturing stage, the corresponding single-use technology development can happen concurrently at the CMO to speed up the market penetration of the product.

Product Insights

The filtration assemblies segment held the highest share of 29.22% of the overall revenue in 2022. Increased regulatory prospects and the need to diminish the risk of contamination have promoted the use of filtration assemblies for bulk and final fill operations. Single-use filtration assemblies are a flexible and efficient alternative to stainless-steel systems as they eradicate sterilization steps and the related validation protocols. The bag assemblies segment is expected to grow at the fastest CAGR of 19.8% from 2023 to 2030. In the biopharmaceutical industry, single-use bag assemblies of various sizes & shapes are used for many different applications, such as cell cultivation, formulation, sampling bag, buffer medium, and feed-process among others.

Moreover, the extended application of single-use bag assemblies throughout the biomanufacturing processes has further resulted in its use in drug substance transportation. Single-use bag assemblies allow rapid assembly and configuration of an extensive range of sterile, fluid-processing circuits. These bags also provide an attractive option for shipping and bulk freezing. Furthermore, advantages, such as less maintenance cost & capital investment and lower shipping costs due to less weight and no need for validation or cleaning, will further drive the adoption of bag assemblies.

The bag assemblies segment is further divided into 2D and 3D bag assemblies. 2D bag assemblies held the largest share owing to factors, such as advancements in technology. For instance, The Aramus single-use 2D bags are made of a high-quality, gamma-stable fluoropolymer, offering greater compatibility, higher purity, and enhanced safety for final products and critical process fluids. The Aramus single-use 2D bags are made with novel single-layer technology and offer the broadest operational temperature range, making them more robust in cold applications (to -85°C [-121°F] or lower) without destructively affecting the film.

Application Insights

The filtration segment dominated the industry in 2022 and accounted for a revenue share of 28.70% of the overall revenue. The implementation of single-use assemblies for filtration is rapidly increasing owing to their benefits infiltration. SUTs save not only expense and time, but also 90% of integrity testing, 90% of sterile connections, and up to 90% tubing time. Single-use flirtation systems also save process time as it is ready to use, unlike conventional filtration systems. The commercial success of biopharmaceuticals will require multiple manufacturing facilities to meet the increasing market demand. Biopharmaceutical manufacturers are integrating single-use facilities for faster product turnaround time and to house multiple product manufacturing processes in the same manufacturing area. The growing demand for single-use applications in the biopharmaceutical market has led the key players of this industry to expand their single-use production facilities globally.

The cell culture & mixing segment is expected to register the fastest CAGR of 20.33% from 2023 to 2030. The growth is mainly driven by the rising demand for biopharmaceuticals, favorable governmental policies, and increasing investment in R&D. Moreover, augmented demand for mammalian cell lines in upstream bioprocessing is further driving the industry. Currently, biopharmaceutical companies and researchers are progressively using cell culture techniques to develop vaccines for a broad range of diseases including rubella, polio, smallpox, chickenpox, and hepatitis. Furthermore, the increasing prevalence of infectious diseases such as COVID-19 and chronic diseases globally will provide a strong impetus to the growth of the market during the study period.

Solution Insights

On the basis of solutions, the global industry has been categorized into customized solutions and standard solutions. The customized solutions segment dominated the global industry in 2022 and accounted for the largest share of 71.47% of the overall revenue. With a single order, pharmaceutical companies, labs, and other end-users can effortlessly integrate the systems into their process, coupled with streamlining production, and reducing the hassle of sterilizing and cleaning. Moreover, the majority of the players offer customized solutions as per the needs of the users. For instance, Mobius single-use assemblies manufactured by MilliporeSigma provide flexible, customized single-use solutions to fast-track pharmaceutical manufacturing and drug development.

Manufacturers who provide custom solutions to end users offer valuable insight into producing systems, which address supply chain constraints, component incompatibility, and fit-for-purpose requirements while at the same time helping the customers to safeguard that the system evolves to meet the forthcoming needs. Major market players, such as Sartorius AG, Thermo Fisher Scientific, Inc, Merck, and Danaher, have been continuously advancing technologies for these single-use systems and providing a wide variety of custom products to meet the growing demand. Furthermore, the ongoing developments and expansion of product portfolios have driven the bioprocessing industry to integrate these customized products into the biomanufacturing processes.

End-use Insights

The biopharmaceutical & pharmaceutical companies segment dominated the global industry in 2022 and accounted for the highest share of more than 45.61% of the overall revenue. The growth of the current manufacturing facilities for biopharmaceuticals drives the demand for single-use assemblies. For instance, in June 2022 Alexion invested USD 70 million in novel drug production warehousing facilities and equipment to enhance Alexion’s manufacturing in Ireland. The expansion aims to expand the biologics drug substance portfolio. Similarly, in May 2022 Upperton Pharma Solutions announced an investment of USD 16 million in the facility expansion that can significantly aid in the increase in R&D space and a 10-fold increase in GMP manufacturing space.

CROs & CMOs segment is expected to grow at the fastest CAGR of 19.57% during the forecast period. In recent years, CMOs have been integrating single-use assemblies into most or all their bioprocess. CMOs broadly uses single-use assemblies for quicker processing and process changeover time. The short turnaround time and flexibility between process runs and various client projects allowed by single-use equipment can enhance the CMO efficiency, which, in turn, aids in the reduction of the overall costs. In addition, the growing number of CMO facilities are essentially fully single-use. CMOs adoption of single-use technology can save on campaign and facility costs, which supports in reduction of operating costs and capital investments.

Regional Insights

North America dominated the regional market with a share of 36.45% in 2022. This major share can be attributed to the growth in the biotechnology and pharmaceutical industries, advancement in products, and increasing incidence of diseases such as cancer coupled with investments and funding in drug discovery research. For instance, in August 2022 Thermo Fisher Scientific Inc., opened its single-use technology manufacturing site in Greater Nashville. The 400,000-square-foot USD 105 million facilities allow the company to meet the increasing demand for the bioprocessing materials required to produce breakthrough therapies and vaccines for cancer and other diseases.

This site is part of the company’s USD 650 million multi-year investment to develop its bioprocessing production capabilities. Asia Pacific is estimated to register the fastest CAGR of 21.64% from 2023 to 2030 owing to the strategic developments from key players. For instance, in 2021, Sartorius made extensive investments in China and Beijing, where additional cleanroom space was created to produce bags and single-use filters. Moreover, in September 2021, Cytiva announced to build of a disposable manufacturing facility in South Korea with an investment of USD 52.5 million. This expansion is aimed to deliver single-use bags to the bioprocessing industry, which are used in COVID-19 vaccine production.

Key Companies & Market Share Insights

Key players are adopting various organic and inorganic strategies, such as partnerships, mergers & acquisitions, geographical expansion, and strategic collaborations, to expand their market presence. For instance, in April 2022, Thermo Fisher Scientific developed a new single-use manufacturing site in Utah, U.S. With this Utah facility, (part of the USD 650 million multi-year expansion plan), the company envisions providing bioprocessing solutions at even inland locations. Some of the key players in the global single-use assemblies market include:

• Thermo Fisher Scientific

• Sartorius AG

• Danaher Corp.

• Merck KGaA

• Avantor

• Lonza

• Saint-Gobain

• Corning Inc.

• Entegris

• KUHNER AG

Single-use Assemblies Market Report Scope

Global Single-use Assemblies Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global single-use assemblies market report based on product, application, solution, end-use, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Bag Assemblies

  • 2D bag assemblies

  • 3D bag assemblies

  • Filtration Assemblies

  • Bottle Assemblies

  • Tubing Assemblies

  • Other Products

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Filtration

  • Cell Culture & Mixing

  • Storage

  • Sampling

  • Fill-finish Applications

  • Other Applications

• Solution Outlook (Revenue, USD Million, 2018 - 2030)

  • Customized Solutions

  • Standard Solutions

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Biopharmaceutical & Pharmaceutical Companies

  • CROs & CMOs

  • Academic & Research Institutes

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • China

    • Japan

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE