Single-use Assemblies Market (By Product: Bag Assemblies, Filtration Assemblies; By Application: Filtration, Storage; By Solution: Customized, Standard) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2022-2030

Published Date : Sep 2022 | No. of Pages : 150+ Pages | Category : Healthcare

The global single-use assemblies market size was estimated at around USD 8.51 billion in 2021 and it is projected to hit around USD 49.16 billion by 2030, growing at a CAGR of 21.52% from 2022 to 2030.

Single-use Assemblies Market Size 2021 to 2030

Report Highlights

  • The filtration assemblies segment held the highest share of more than 29.04% of the overall revenue in 2021. 
  • The filtration segment dominated the industry in 2021 and accounted for a revenue share of more than 28.77% of the overall revenue. 
  • The customized solutions segment dominated the global industry in 2021 and accounted for the maximum share of 71.63% of the overall revenue. 
  • The biopharmaceutical & pharmaceutical companies segment dominated the global industry in 2021 and accounted for the highest share of more than 45.6% of the overall revenue. 
  • North America dominated the regional market with a share of 36.8% in 2021.  

Life science companies are eager to avoid the cost and time of cleaning needed with stainless steel. The augmented expansion of the international biotech industries has offered a growth environment, in which novel, disposable technologies are becoming more significant. As pharmaceutical companies, distributors, CDMOs, and manufacturers converge around the benefits of single-use assemblies, the industry will grow at a faster pace during the forecast period. From therapies for rare diseases to cancer research, the impact of single-use technology in accelerating cutting-edge research into these conditions is set to grow, thereby propelling industry growth.

In addition, the growing biologics market will further offer lucrative opportunities during the study period. Eradicating the risk of contamination is the major challenge faced by biopharmaceutical manufacturers, which currently involves high-level monitoring of critical manufacturing solutions. Single-use assemblies support manufacturers in overcoming this difficulty by eliminating or reducing the necessity for sterilization between the batches, thereby filtering the operational capability. SUTs are considered one of the important areas of growth among biomanufacturing companies, as several biopharmaceutical companies are venturing into disposable assembly offerings for the production of all sorts of biopharmaceuticals.

Moreover, SUTs are now being heavily adopted for the clinical manufacturing of biopharmaceuticals and have become more conventional within commercial manufacturing facilities. SUTs permit biologics manufacturers to reduce the facilities' footprint by almost 20% due to the need for utilities, which generate steam, water, and clean-in-place solutions. Furthermore, as per the research by BioProcess International, the engineers estimated that the capital expenditure for the single-use facility is 25-45% less than for a facility established on stainless-steel equipment. Similarly, they also estimated that single-use facilities need half the energy and water during operations and can be built in 18 months. Whereas the stainless-steel facility takes three years. Owing to such advantages, the adoption of single-use assemblies is increasing, thereby driving industry growth.

In recent years, CMOs have been integrating single-use assemblies into most or all their bioprocess. CMOs broadly use single-use assemblies for quicker processing and process changeover time. The quick turnaround time and flexibility between process runs and various client projects allowed by single-use assemblies 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 helps reduce the operating costs and capital investments. Furthermore, single-use assemblies in CMOs decrease the complexity and reduces lead times in upstream processes.

They also enhance the quality of products by preventing cross-contamination in downstream processes, especially for processes handling potent or toxic materials, such as antibody-drug conjugates and viral vectors. Moreover, stringent regulatory requirements in the manufacturing systems also endorse the adoption of single-use assemblies in CMOs.COVID-19 has augmented an already rapidly rising demand for single-use assemblies as the SUTs allow for the speedy production and development of therapies and vaccines and improve accuracy and time. For instance, Aramus single-use bag assembly developed by Entegris, Inc. was used for the storage of 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.

In addition, key manufacturers are also accelerating investment projects or increasing their capital expenditures. For instance, Pall Corp., invested USD 114 million to upsurge its single-use output. These investments comprise additional manufacturing capacity at 6 current manufacturing facilities in the United States and Europe. Moreover, MilliporeSigma, Thermo Fisher, and Cytiva have also augmented growth plans to support the industry’s backlog. For instance, in March 2021 Merck announced the addition of a single-use assembly production unit at its Life Science Center in Molsheim, France. The investment of USD 26.25 million will accelerate the European expansion plans of the company for single-use products critical to manufacturing vaccines and lifesaving therapies. On the other hand, regulatory concerns due to leachable and extractable might hamper the growth of disposable assemblies in the forecast period.

Leachable and extractable are set of undesired impurities in the product stream, these are compounds that can move into the product from manufacturing systems, packaging containers, or other product-contact systems. Extractable is extracted from the contact materials under extreme conditions, such as treatment with a harsh solvent or elevated temperature conditions. Leachable compounds, on the other hand, are those that are leached into the final product from contact materials during normal or real-time storage conditions. North America dominated the global industry in 2021 due to the growth in the biotechnology and pharmaceutical industries, advancement in SUT products, and increasing incidence of diseases, such as cancer coupled with increasing investments and funding in drug discovery research. Asia Pacific is expected to grow at a considerable CAGR over the forecast years owing to the strategic activities by key players coupled with funding by the government for biopharmaceutical R&D.

Scope of The Report

Report Coverage Details
Market Size in 2021 USD 8.51 billion  
Revenue Forecast by 2030 USD 49.16 billion 
Growth rate from 2022 to 2030 CAGR of 21.52%
Base Year 2021
Forecast Period 2022 to 2030
Segmentation Product, application, solution, end-use, region
Companies Covered

Thermo Fisher Scientific; Sartorius AG; Danaher Corp.; Merck KGaA; Avantor; Lonza; Saint-Gobain; Corning Inc.; Entegris; KUHNER AG

 

Product Insights

The filtration assemblies segment held the highest share of more than 29.04% of the overall revenue in 2021. 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 from 2022 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 2021 and accounted for a revenue share of more than 28.77% 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 from 2022 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 2021 and accounted for the maximum share of 71.63% 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 2021 and accounted for the highest share of more than 45.6% 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 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 36.8% in 2021. 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 Pacificis estimated to register the fastest CAGRfrom 2022 to 2030 owing to the strategic activities of 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 Players

  • Thermo Fisher Scientific
  • Sartorius AG
  • Danaher Corp.
  • Merck KGaA
  • Avantor
  • Lonza
  • Saint-Gobain
  • Corning Inc.
  • Entegris
  • KUHNER AG

Market Segmentation

  • By Product Outlook
    • Bag Assemblies
      • 2D bag assemblies
      • 3D bag assemblies
    • Filtration Assemblies
    • Bottle Assemblies
    • Tubing Assemblies
    • Other Products
  • By Application Outlook
    • Filtration
    • Cell Culture & Mixing
    • Storage
    • Sampling
    • Fill-finish Applications
    • Other Applications
  • By Solution Outlook
    • Customized Solutions
    • Standard Solutions
  • By End-user Outlook
    • Biopharmaceutical & Pharmaceutical Companies
    • CROs & CMOs
    • Academic & Research Institutes
  • By Regional Outlook
    • 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

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