Global Single-use Assemblies Market Research Report Information By Product (Filtration Assemblies, Bag Assemblies, Mixing System Assemblies, Bottle Assemblies and Other Products), By Solution (Customized Solutions and Standard Solutions), By Application (Filtration & Purification, Cell Culture & Mixing, Formulation & Fill-Finish, Storage, Sampling and Other Applications), By End User (Pharmaceutical & Biopharmaceutical Companies, Academic & Research Institutes and Contract Research Organizations & Contract Manufacturing Organizations) And B

Single-use Assemblies Market Overview

The Single-use Assemblies Market was valued at USD 2.6 billion in 2022. The Single-use Assemblies market industry is projected to grow from USD 3.09 billion in 2023 to USD 12.3 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 18.90% during the forecast period (2024 - 2032). The growing advancement in single-use assemblies technology and reduced risk of cross-contamination are the primary market drivers propelling the market's expansion.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Single-use Assemblies Market Trends

Growing demand for pharmaceutical and biopharmaceutical companies is driving the market growth

Single-use assemblies and consumables, such as aseptic bottle transfers, single-use manifolds and bespoke tube kits, are widely used by biopharmaceutical and pharmaceutical companies to expedite the upstream process. Pharmaceutical and biopharmaceutical companies now invest a significant portion of their budgets in research and development. The growing use of single-use assemblies in the production of biopharmaceuticals is anticipated to boost the market CAGR growth even more. Single-use assemblies are now crucial for biopharma processing research, scale-up and commercial biomanufacturing, according to a paper published in Wiley Online Library. As a result, it is anticipated that the growing acceptance of single-use assemblies in biopharmaceutical and pharmaceutical research will propel segment expansion.

Furthermore, the expansion of services by major industry players is anticipated to propel market expansion. For example, in September 2022, Merck invested over EUR 130 million in Molsheim, France, bolstering its capacity to manufacture single-use assemblies for producing COVID-19 vaccines and other life-saving treatments. Due to the growing use of single-use assemblies by pharmaceutical and biopharmaceutical businesses in developed countries, such activities are anticipated to propel segment expansion. In addition, it is anticipated that rising healthcare spending per capita across countries will make novel medications more widely available. Because of the growing demand for medications, corporations are investing more in their research and development. Therefore, the necessity for single-use assembly is growing among biopharmaceutical and pharmaceutical organizations.

Moreover, single-use (SU) assemblies are self-contained, preassembled plastic fluid pathways. They are typically assembled from various standard parts, gamma-irradiated to guarantee sterility and ready for use. Sterilized connectors, fittings, clamps, tubings, filters, sampling bottles, clamps and seals are widely used industrial items. The industry is anticipated to increase faster over the projected period because of ongoing technological advancements in bioprocessing, rising biopharmaceutical R&D and the widespread usage of single-use assemblies by CMOs. Automation, real-time monitoring and data analytics are a few examples of Industry 4.0 technologies that are increasingly combined with single-use assemblies to improve process efficiency, control and product quality while decreasing human error and variability. Thus, driving the Single-use Assemblies market revenue.

Single-use Assemblies Market Segment Insights

Single-use Assemblies Product Insights

Based on Product, the  Single-use Assemblies market segmentation includes filtration assemblies, bag assemblies, mixing system assemblies, bottle assemblies and other products. In 2023, the filtration assemblies segment dominated the market. Filtration assemblies are increasingly being used in bulk and final fill operations due to increased regulatory prospects and the need to reduce the risk of contamination. Because they do away with sterilizing procedures and the associated validation standards, single-use filtration assemblies provide a versatile and effective substitute for stainless-steel systems.

The bag assemblies category is anticipated to be the fastest growing. Single-use bag assemblies come in a variety of sizes and shapes. They are utilized in various biopharmaceutical applications, including cell culture, formulation, buffer medium, feed-processing and sampling bags.

Single-use Assemblies Solution Insights

Based on Solution, the  Single-use Assemblies market segmentation includes customized solutions and standard solutions. In 2023, the customized solutions category generated the most income. Pharmaceutical firms, labs and other end users can quickly and easily incorporate the systems into their workflow with just one order, streamlining production and lessening the difficulty of cleaning and sterilizing. Most players provide consumers with personalized solutions based on their needs. MilliporeSigma's Mobius single-use assemblies offer adaptable, personalized solutions that expedite pharmaceutical production and drug discovery.

The single-use assemblies’ standard solutions segment market is anticipated to grow fastest during the forecast period. Standard solutions reduce the risk of performance variability and provide constant quality and dependability in the production of biopharmaceuticals because they are usually evaluated and qualified by the manufacturer.

Figure 1:  Single-use Assemblies Market, by Solution, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Single-use Assemblies Application Insights

Based on application, the  Single-use Assemblies market segmentation includes filtration & purification, Cell Culture & Mixing, formulation & fill-finish, storage, sampling and other applications. The filtration & purification category leads the market. The use of single-use assemblies is being driven by technological advancements in bioprocessing, such as continuous manufacturing, high-throughput screening and perfusion techniques, which call for effective filtering and purifying solutions.

The single-use assemblies market’s Cell Culture & Mixing segment is anticipated to grow fastest during the projection period. The primary factors propelling the rise are the escalating need for biopharmaceuticals, pro-business policies and growing R&D expenditures. Further propelling the sector is the increased need for mammalian cell lines in upstream bioprocessing. Biopharmaceutical companies and researchers are currently employing cell culture techniques to produce vaccines for various diseases, such as hepatitis, smallpox, chickenpox, polio, rubella and others.

Single-use Assemblies End User Insights

Based on end users, the Single-use Assemblies market segmentation includes pharmaceutical & biopharmaceutical companies, academic & research institutes and contract research organizations & contract manufacturing organizations. The pharmaceutical & biopharmaceutical companies category leads the market. Because single-use biorefinery technologies are more economical, trustworthy and efficient, over 80% of pharmaceutical companies have adopted them. The company's growth has been propelled by contract makers' notable and increasing use of single-use or disposable items. In the near future, the market is also expected to grow due to the growing demand for single-use biorefinery systems across a range of biorefinery solutions.

The contract research organizations & contract manufacturing organizations segment of the single-use assemblies market is predicted to develop quickly over the projected period. Most CMOs' bioprocesses now include SUT, which has been integrated in recent years. To expedite processing and reduce process changeover time, CMOs frequently employ single-use assemblies. Single-use equipment can improve the CMO's productivity, which helps lower overall costs by allowing for quick turnaround times and flexibility between process runs and different client projects. Furthermore, a rising percentage of CMO facilities are for one-time use only. When single-use technology is used by CMOs, campaign and facility expenditures can be reduced, which helps to lower operating and capital expenditure costs.

Single-use Assemblies Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific and the Rest of the World. The North American Single-use Assemblies market will dominate this market. Owing to the rise of the biotechnology and pharmaceutical sectors, product improvements, rising rates of diseases like cancer and funding and investment in drug discovery research are all responsible for a significant portion. For instance, Thermo Fisher Scientific Inc. opened its manufacturing site for single-use technology in Greater Nashville in August 2022. With the USD 105 million, 400,000-square-foot facilities, the company can handle the growing demand for bioprocessing materials needed to develop novel cancer and other disease-fighting treatments and vaccines.

Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea and Brazil.

Figure 2:  SINGLE-USE ASSEMBLIES MARKET SHARE BY REGION 2023 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe's Single-use Assemblies market accounts for the second-largest market share because Europe is leading the way in the adoption of cutting-edge treatments like gene and cell therapies. Because of their scalability and versatility, single-use assemblies are an appealing alternative for these novel treatments, frequently calling for flexible manufacturing methods. Further, the German Single-use Assemblies market held the largest market share and the UK Single-use Assemblies market was the fastest-growing market in the European region.

The Asia-Pacific Single-use Assemblies Market is expected to grow at the fastest CAGR from 2024 to 2032 because of the major players' strategic actions. To make bags and single-use filters, Sartorius increased its cleanroom area in Beijing, China, by a significant amount in 2021. With a USD 52.5 million investment, Cytiva announced in September 2021 that it would construct a disposable manufacturing facility in South Korea. This expansion aims to supply single-use bags to the bioprocessing sector, which uses them to produce the COVID-19 vaccine. Moreover, China’s Single-use Assemblies market held the largest market share and the Indian Single-use Assemblies market was the fastest-growing market in the Asia-Pacific region.

Single-use Assemblies Key Market Players & Competitive Insights

The single-use assemblies market will continue to grow due to major companies in the industry making significant R&D investments to extend their product ranges. Significant market developments include new Product releases, contractual agreements, mergers and acquisitions, greater investments and cooperation with other organizations. Market participants also engage in various strategic actions to broaden their  footprint. The Single-use Assemblies sector must provide affordable Products & Services to grow and thrive in a more cutthroat and dynamic market.

One of the main strategies manufacturers use in the worldwide single-use assemblies market is local manufacturing, which expands the market sector and helps customers by lowering operating costs. Some of the biggest medical benefits in recent years have come from the Single-use Assemblies sector. Major players in the Single-use Assemblies market, including Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Avantor, Inc. (US), Sartorius AG (Germany), Danaher (US), Repligen Corporation (US), Corning Incorporated (US), Entegris (US), Parker Hannifin Corp. (US), Saint-Gobain (France), NewAge Industries (US), Romynox (Netherlands), Antylia Scientific (US), Lonza (Switzerland), Keofitt A/S (Denmark), Intellitech, Inc. (US), SaniSure (US), Meissner Filtration Products, Inc. (US) and others, are attempting to increase market demand by investing in research and development operations.

Thermo Fisher Scientific Inc. (Thermo Fisher) supplies tools for medicine, analytical equipment, consumables and reagents, software and services for handling difficult analytical problems in clinical, research and diagnostic labs. It provides answers for synthetic biology, flow cytometry and cellular biology. Products from the company include technologies for molecular biology, genetic sequencing, electron microscopy, protein analysis and mass spectrometry. Serving the environmental, industrial quality and process control sectors, government organizations, academic and research institutions, pharmaceutical and biotech firms and clinical diagnostic labs. In October 2021, Thermo Fisher Scientific launched the HyPeak chromatographic building, a single-use chromatographic system designed for bioprocessing. The new outcome was engineered to interact with the Emerson DeltaV automated network, enabling technology transfer installation and buffering utilization for downstream operations to boost yield.

Sartorius AG (Sartorius) produces and supplies equipment for process and laboratory technology. The company offers a range of scientific tools, including pipettes, lab water purification systems, scales and weight sets. It offers bioprocessing technologies for productive biological drug and vaccine production. The company also provides a wide range of solutions for the storage and transportation of intermediate and final biological products and items for purification, separation and concentration. It provides services to the food and beverage, biotechnology, pharmaceutical and chemical sectors and many research and educational facilities and laboratories in Germany and other nations. The chromatography division of Novasep (France) was acquired by Sartorius Stedim Biotech (France) in February 2022. Smaller biomolecules are the primary target of the chromatography systems in the acquired portfolio.

Key Companies in the Single-use Assemblies market include

• Thermo Fisher Scientific Inc. (US)


• Merck KGaA (Germany)


• Avantor, Inc. (US)


• Sartorius AG (Germany)


• Danaher (US)


• Repligen Corporation (US)


• Corning Incorporated (US)


• Entegris (US)


• Parker Hannifin Corp. (US)


• Saint-Gobain (France)


• NewAge Industries (US)


• Romynox (Netherlands)


• Antylia Scientific (US)


• Lonza (Switzerland)


• Keofitt A/S (Denmark)


• Intellitech, Inc. (US)


• SaniSure (US)


• Meissner Filtration Products, Inc. (US)

Single-use Assemblies Industry Developments

April 2023: Ultimus is an SU process container film that Merck KGaA introduced to offer better strength and resistance to leaks in single-use assemblies.

September 2022: Thermo Fisher Scientific Inc. introduced the Thermo Scientific DynaSpin Single-Use Centrifuge system during the Bioprocess International conference in Boston, Massachusetts. The system aims to offer the best single-use option for large-scale cell culture harvesting.

Single-use Assemblies Market Segmentation

Single-use Assemblies Product Outlook

• Filtration Assemblies


• Bag Assemblies


• Mixing System Assemblies


• Bottle Assemblies


• Other Products

Single-use Assemblies Solution Outlook

• Customized Solutions


• Standard Solutions

Single-use Assemblies Application Outlook

• Filtration & Purification


• Cell Culture & Mixing


• Formulation & Fill-Finish


• Storage


• Sampling


• Other Applications

Single-use Assemblies End User Outlook

• Pharmaceutical & Biopharmaceutical Companies


• Academic & Research Institutes


• Contract Research Organizations & Contract Manufacturing Organizations

Single-use Assemblies Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  

• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  

• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America