Single Use Assemblies Market

Single Use Assemblies Market Overview

The global single use assemblies market, valued at USD 13.61 billion in 2024, is projected to reach USD 16.61 billion in 2025 and USD 81.53 billion by 2035, representing a CAGR of 17.2% during the forecast period.

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Single-use assemblies refer to the disposable or pre-assembled solutions that are widely used in biopharmaceutical manufacturing. With a rapid shift towards biologics and standardized drug safety guidelines, single use assemblies offer a hygienic approach to filter final products, fluid transfer and other processes. Furthermore, single use assemblies eliminate the requirement of bioprocessors and drug manufacturing units cleaning and sterilization after every use, which further reduces overall manufacturing time and reduces the risk of contamination.

Additionally, the growing prevalence of chronic conditions and infectious diseases globally has put significant burden on pharmaceutical industries to develop advanced biologics-based drugs and fast pace the drug development. Single-use assemblies in such instance help to streamline the workflow and improve overall efficiency of drug development, which further increases its adoption across pharmaceutical industry. Furthermore, the growing shift towards single use bioprocessing technologies to maintain a sterile and continuous drug development flow has further bolstered the demand for single use assemblies.

With the rising shift towards single use assemblies, several industrial players are taking active initiatives to expand their product portfolio and develop innovative single use products and technologies for biopharmaceutical industry. For instance, in February 2025, Recipharm (global leader of contract development and manufacturing organization) announced the new modular sterile filling system which is specifically tailored for bioprocess development with single use capabilities in mind to offer flexibility for clinical development and small-batch product.

Additionally, in November 2024, Freudenberg announced the commitment to launch new products including single use assemblies & ASTC UV-Shielding Tubing for Indian customers at CPhl & PMEC India 2024. Considering the ongoing initiatives by industrial players and heightened demand for single use assemblies, we believe that the single use assemblies market will remain investible and grow steadily during the forecast period.

Single Use Assemblies Market Segmentation Insights

The market report provides comprehensive information on industrial players who are currently active across various segments of the industry as mentioned in the table below.

Single Use Assemblies Market: Report Attributes / Market Segmentation

Key Report Attributes	Details
Historical Trend	Since 2020
Forecast Period	Till 2035
Market Size 2025	USD 16.61 billion
Market Size 2035	USD 81.53 billion
CAGR (Till 2035)	17.2%
Type of Product	Bag Assemblies (2D Bag Assemblies and 3D Bag Assemblies) Filtration Assemblies Bottle Assemblies Tubing Assemblies Other Products
Application Area	Filtration Cell Culture & Mixing Storage Sampling Fill-Finish Applications Other Applications
Type of Modality	Monoclonal Antibodies Vaccines Cell and Gene Therapies
Type of Solution	Customized Solutions Standard Solutions
End User	Biopharmaceutical & Pharmaceutical Companies CROs & CMOs Academic & Research Institutes
Geographical Regions	North America (US, Canada and Mexico) Europe (France, Germany, Italy, Spain, UK and Rest of Europe) Asia-Pacific (China, India, Japan, South Korea, and Rest of Asia-Pacific) Middle East and North Africa (Egypt, Saudi Arabia and United Arab Emirates) Latin America (Argentina and Brazil)
Key Companies Profiled	Antylia Scientific Avantor Dover Entegris Flexbiosys Fujimori Kogyo Meissner Filtration Products Newage Industries Pall Parker-Hannifin Repligen Romynox Sartorius Stedim Biotech Saint-Gobain Thermo Fisher Scientific (A complete list of companies captured is available in the report)
PowerPoint Presentation (Complimentary)	Available
Customization Scope	15% Free Customization
Excel Data Packs (Complimentary)	Available

One of the key objectives of the single use assemblies market report was to estimate the current size, opportunity, and the market growth potential, over the forecast period, till 2035. We have provided informed estimates on the likely evolution of the market for the forecast period.

The global single use assemblies market analysis report also features the likely distribution of the current and forecasted opportunity within the market across various segments, such as type of product (bag assemblies (2D bag assemblies and 3D bag assemblies), filtration assemblies, bottle assemblies, tubing assemblies and other products), application area (filtration, cell culture & mixing, storage, sampling, fill-finish applications and other applications), type of modality (monoclonal antibodies, vaccines, and cell and gene therapies), type of solution (customized solutions and standard solutions), end user (biopharmaceutical & pharmaceutical companies, CROs & CMOs and academic & research institutes), geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America) and leading players.

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. The financial figures mentioned in this market report are in USD, unless otherwise specified.

Single Use Assemblies Market Share

Market Share by Type of Product

Based on the type of product, the global market is segmented into bag assemblies (2D bag assemblies and 3D bag assemblies), filtration assemblies, bottle assemblies, tubing assemblies and other products. According to our single use assemblies market report, presently single use filtration assemblies market segment holds the highest share (29%) of the market. This can be attributed to the increasing usage of single use filtration systems in biopharmaceutical industry due to numerous benefits. Notably, single use filtration assemblies eliminate the requirement of sterilization of filters and are extremely flexible to use with wide range of biomanufacturing technologies, which further enhance the drug development process and shorten the time for commercialization.

However, the bag assemblies segment is expected to register the highest CAGR during the forecast period. Bag assemblies such as 2D and 3D bag assemblies are extensively used for a broad range of applications, such as sampling the bag, cell cultivation, feed-process and other biomanufacturing processes specifically for fluid processing circuits.

Market Share by Application Area

The global market is distributed across different application areas, such as filtration, cell culture & mixing, storage, sampling, fill-finish applications and other applications. According to our single use assemblies market forecast, presently filtration (27%) accounts for the highest share of the market. This dominance is due to the rapid surge in the demand for single use / disposable filtration to overcome the risk of contamination during biological manufacturing. Furthermore, single use filtration offer faster turnaround times which further enhance the manufacturing of drugs.

However, in the long run, cell culture & mixing segment is expected to grow at a higher CAGR during the forecast period. This unprecedented growth is primarily due to the rising demand for the safe single use systems for streamlining manufacturing operations. Further, single use systems are pre-sterilized, eliminating the requirement of cleaning and sterilization.

Market Share by Type of Modality

Based on the type of modality, the global market is bifurcated into monoclonal antibodies, vaccines, and cell and gene therapies. According to our market report, presently monoclonal antibodies segment accounts for the highest share of the single use assemblies market. This dominance is due to the growing usage of monoclonal antibodies for the treatment of a wide range of diseases including cancer. Additionally, single use technologies / single use assemblies reduce the time of material shifting procedures and validation of process, which further contributed to the widespread adoption of these assemblies for manufacturing monoclonal antibodies-based therapies.

However, it is worth mentioning that cell and gene therapies segment register the fastest CAGR during the forecast period. This is likely to be the result of rising shifting towards single use bioprocessing technology to lower down the cost, eliminating the sterilization requirement and improving overall manufacturing efficiency.

Market Share by Type of Solution

This segment highlights the distribution of global market for single use assemblies across customized solutions and standard solutions. According to our projection, customized solutions segment accounts for the highest single use assemblies market share (72%). This can be attributed to the increasing demand for custom made single use assemblies to meet with unique requirement of biopharmaceutical industrial players for fluid transfer, filtration, mixing and other crucial processes. Driven by the growing preferences for custom-made solutions, this segment is likely to maintain its dominance and is projected to grow at a higher CAGR during the forecast period.

Market Share by End User

Based on the end user, the global market is segmented into biopharmaceutical & pharmaceutical companies, CROs & CMOs and academic & research institutes. Among these, the biopharmaceutical & pharmaceutical companies’ segment is dominating the single use assemblies market with a share of 42% and this trend is likely to remain unchanged during the forecast period. This can be attributed to the rising adoption of single use assemblies to maintain sterile conditions during bioprocessing manufacturing and streamline workflow.

However, it is worth mentioning that based on single use assemblies market analysis for CROs and CMOs this segment is anticipated to register a higher CAGR during the forecast period. This lucrative growth is due to the extensive adoption of single use technologies in bioprocessing units by CROs and CMOs for shorter turnaround times and high flexibility.

Market Share by Geographical Region

Based on the geographical region, the global market is distributed across North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. According to our single use assemblies market analysis, presently North America is dominating the market with a share of 37%. The growing incidence of chronic conditions in this region has necessitated the demand for advanced biologics which further underscore the requirement of single use assemblies for streamlining biomanufacturing. Additionally, the growing adoption of single use technologies by biopharmaceutical companies established in this region and technological innovations are contributing to the highest share of this region.

In Asis-Pacific, the market is expected to be driven at a higher CAGR during the forecast period. This is potentially due to the growing focus on adopting disposable assemblies to maintain sterile biomanufacturing conditions and active initiatives by industrial players to develop more single use technologies for biologics productions.

Single Use Assemblies Market Dynamic Insights

The “Single Use Assemblies Market Analysis Report: Industry Trends and Global Forecasts, till 2035” market report features an extensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics, and future opportunities for single use assemblies industrial players. The market research report lays emphasis on the single use assemblies products that are being developed. Key takeaways of the market report are briefly discussed below.

Single Use Assemblies Market Competitive Landscape

Currently, the market landscape for single use assemblies seems highly competitive, witnessing the presence of several small, mid-sized and large players. Majority of the industrial players, such as Avantor, Dover, and Thermo Fisher Scientific are focusing on technological innovations and designing single use assemblies. For instance, in October 2024, Avantor announced an expansion of partnership with the National Institute for Bioprocessing Research and Training. The partnership aims to address the challenges in biopharma manufacturing by providing a complete suite of aseptic fluid handling equipment, including Masterflex® pump systems and supporting single use systems.

As market leaders continue to expand their single use assemblies’ products and innovate new technologies, the market will remain competitive throughout the projected period.

Single Use Assemblies Market Drivers: Increasing Focus on Biopharmaceuticals and Adoption of Single Use Biomanufacturing Technologies

Single use assembles are gaining momentum driven by the rising shift towards biopharmaceuticals to treat wide range of diseases and adoption of single use biomanufacturing processes. Notably, single use bioprocessing systems offer several significances, such as pre-sterilized assembles, quick integration, contamination free manufacturing and workflow efficiency. Driven by the significances, the biopharmaceutical industry is adopting single use assemblies to accelerate drug production, which is anticipated to be a kye driver of the market. Additionally, the risk of cross contamination during material transfer is likely to foster the demand for single use assemblies for filtration, material transfer and cultivation.

Single Use Assemblies Market Challenges: Supply Chain Vulnerability and High Waste Generation

Despite high demand, several factors that are impacting market growth include supply chain vulnerability and higher waste generation. It is worth mentioning that single use assemblies are designed for one-time use. It generates huge amounts of waste material which can be challenging to dispose, thereby raising environmental concern. Additionally, the leachable and extractable from the single use material can contaminate the biopharmaceutical products. Furthermore, the adoption of single use bioprocessing assemblies requires consistent supply of raw materials and supplies, which significantly disrupts the supply chain due to high demand.

Single Use Assemblies Market Trends: Rising Focus on Custom Solutions, Technological Advancements and Scalability

The market for single use assemblies is likely to witness upward trajectory driven by the rising demand for customized solutions, and technological innovations. It is worth mentioning that biologics, such as monoclonal antibodies, cell therapies, gene therapies and therapeutic proteins require unique manufacturing conditions. Hence, biopharmaceutical industries require customized single use assemblies to meet the manufacturing requirement while ensuring complete contamination free environment.

Additionally, industrial players are consistently focusing on innovating single use products, such as material compatibility to reduce leachable and extractables. In addition, the industrial players are aiming to integrate AI technologies and advanced biosensors to enhance process control, which further offer lucrative opportunities to industrial players for innovations in this field.

Single Use Assemblies Market Size Analysis

The global single use assemblies market is currently valued at USD 16.61 billion and is expected to reach USD 81.53 billion, representing a CAGR of 17.2% during the forecast period. Currently, the industrial players are taking strategic initiatives for product portfolio expansion and technological advancements. For instance, in June 2024, Thermo Fisher Scientific has introduced bio-based films build on existing Aegis™ and CX film for its single use technology bioprocessing containers to reduce greenhouse gas emission.

Leading Companies in Single Use Assemblies Market

Examples of key players engaged in this domain (which have also been captured in this report) include Antylia Scientific, Avantor, Dover, Entegris, Flexbiosys, Fujimori Kogyo, Meissner Filtration Products, Newage Industries, Pall, Parker-Hannifin, Repligen, Romynox, Sartorius Stedim Biotech, Saint-Gobain and Thermo Fisher Scientific. This market report includes an easily searchable excel database of all the companies focusing on the development of single use assemblies solutions.

Single Use Assemblies Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this domain across different segments. Amongst other elements, the market report includes:

• A preface providing an introduction to the full report, single use assemblies market, 2020-2024 (Historical Trends), and Future Forecast till 2035 (Forecasted Estimates).
• An outline of the systematic research methodology adopted to conduct the study on the single use assemblies industry, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure the accuracy and reliability of our findings.
• An overview of economic factors that impact the overall single use assemblies market analysis, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the insights captured during our research. It offers a high-level view of the current state of the single use assemblies market and its evolution in the mid-and long-term.
• A detailed assessment of the single use assemblies market landscape is based on several relevant parameters, including years of experience, company size, headquarters location, and ownership structure.
• Elaborated profiles of prominent players engaged in offering single use assemblies solutions, featuring information on their year of establishment, location of headquarters, company size, company mission, company footprint, management team, contact details, financial information, operating business segments, single use assemblies portfolio, recent developments, and an informed future outlook.
• A discussion on affiliated trends, key drivers, and challenges under a SWOT framework, which is likely to impact the industry's evolution, along with a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall single use assemblies industry.
• A market impact analysis features a discussion on the factors that can impact the growth of the single use assemblies market.
• A detailed estimate of the current market size and the future growth potential of the single use assemblies market over the next decade. Based on multiple parameters, we have provided an informed estimate of the market's evolution during the forecast period till 2035. The report also features the likely distribution of the current and forecasted opportunities within the single use assemblies industry. Further, in order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.
• Detailed projections of the current and future single use assemblies market across various types of products, including bag assemblies (2D bag assemblies and 3D bag assemblies), filtration assemblies, bottle assemblies, tubing assemblies and other products.
• Detailed projections of the current and future single use assemblies market size across various types of application area, including filtration, cell culture & mixing, storage, sampling, fill-finish applications and other applications.
• Detailed projections of the current and future single use assemblies market share across various types of modalities, including monoclonal antibodies, vaccines, and cell and gene therapies.
• Detailed projections of the current and future single use assemblies industry across various types of solution, including customized solutions and standard solutions.
• Detailed projections of the current and future single use assemblies market forecast across various types of end user, including biopharmaceutical & pharmaceutical companies, CROs & CMOs and academic & research institutes.
• Detailed projections of the current and future market for single use assemblies across various key geographical regions, such as North America (US, Canada and Mexico), Europe (France, Germany, Italy, Spain, UK and Rest of Europe), Asia-Pacific (China, India, Japan, South Korea, and Rest of the Asia-Pacific), Middle East and North Africa (Egypt, Saudi Arabia and UAE), and Latin America (Argentina and Brazil).

Recent Developments in Single Use Assemblies Market

Several recent developments have taken place in the field of single use assemblies. We have outlined some of these recent initiatives below.

• In March 2025, Shah Brothers has expanded its manufacturing footprint with three new state-of-the-art buildings totaling 87,220 sq. ft in Vadodara, significantly boosting India's single-use assembly production capacity to deliver next-generation, customized solutions for the biopharma industry.
• In September 2024, MilliporeSigma launched the Mobius ADC Reactor, the first scalable single-use reactor specifically designed to accelerate and improve efficiency in antibody drug conjugate (ADC) manufacturing, marking a significant advancement in the Single Use Assemblies domain.
• In May 2024, Asahi Kasei Medical announced the completion of third assembly plant for Planova™ virus removal filters and equipment that will be used in the manufacturing of biotherapeutic products, such as plasma derivates, biopharmaceutical CDMO operations and biopharmaceuticals in Nobeoka, Miyazak, Japan.
• In April 2024, SaniSure launched Fill4Sure (a custom designed single use filling assembly) to accelerate drugs supply to market and build efficiency, security and repeatability within drug product filling.