Market Overview:

The Single-Use Assemblies Market size was valued at around 12.66 Billion in 2023 and is expected to reach a value of USD 61.04 Billion by 2032, at a CAGR of 19.1% over the forecast period (2024–2032) according to a new report by Intellectual Market Insights Research. 

Single-use, (SU) assemblies are defined by Aorn as the following; pre-assembled plastic fluid path, Self-contained product. They consist of a number of standard parts which are combined jointly, and usually the final product is ready for use and often it is gamma-irradiated to make it sterile. Popular products used in industries are sampling bottles, filter, tubing, check valves, clamp, sterile connectors, fittings, and seals. The increased market demand of biologics, the constant development of new technologies in bioprocessing, the increasing biopharmaceutical research and development, as well as the widespread use of single-use assemblies by multiple CMOs are expected to contribute to the industry’s growth within the specified period.

The legal constraints related to leachable and extractable waste disposal and also the sheer ubiquity of the multiple use system constitute some of the restraints that may somewhat limit the market access. The development of Covid-19 has accelerated an already fast-growing demand for disposable assemblies as the disposable assemblies’ technology used in rapid development of therapies and vaccines and enhance precision, speed. An example of a single-use bag assembly is the Aramus system that was produced by Entegris, Inc; COVID-19 vaccines require special storage conditions given that the vaccines require low temperatures. Largely, the patented disposable bags had low leachable and extractable and a great variety in operating-temperature which made them suitable for cold chain storage and collection.

The high incidence of cancer and infectious diseases is used to rise the demand for novel biologics for diagnosis of cancer and also, potential treatment. They include climate change, changing land-use patterns and rapid urbanization which increases the rate of infection diseases like the lower respiratory infections and HIV which have recently increased thus helping the industry to grow. For instance, based on the WHO classification, lower respiratory tract infections occupied the four ranked causes of deaths internationally. In fact, by June 2014 as pointed out by UNAIDS, there were estimated to about 38 million. charged 4 million cases of HIV infection across the globe in the year 2020.

People can get easily infected with these diseases, so proper diagnosis, treatment, including the use of patent-protected biologics, will drive the industry’s progress. In addition, new innovations in vaccines on different communicable diseases are believed to boost the industry. For example, in January this year, Moderna began a new phase of the clinical trial for a HIV vaccine that uses the mRNA technology applied in its vaccine against Covid-19. This vaccine is meant to produce antibodies that may effectively neutralise HIV particles and the above attempts depict the application of emerging technologies in the biologics segment.

The same is true for new viral diseases, which have threats of future pandemics and consequently, rationally call for collective endeavors in the development of new substitutes for vaccines. For example, in August 2022, Lytic Solutions, which provided multiple molecular biology products for research purpose, entered into a collaboration with NightHawk Biosciences in order to advance NightHawk’s vaccine plan in a new subunit monkeypox vaccine. Thus, the published technological advancements and cooperation with the related industries can potentially help to promote the implementation of SU assemblies for manufacturing new types of vaccines in the close future.

Market Drivers:

Increased Demand for Biopharmaceuticals

• There are several factors that have a direct influence in the single-use assemblies market and the most predominant being the growing need for biopharmaceuticals all over the world. Vaccines, monoclonal antibodies, cell and gene therapies constituting the biopharmaceuticals’ subsector are rising in popularity because of their ability to cure multiple diseases, from cancer to autoimmune disorders and rare genetic diseases. Products manufactured in the biopharmaceutical industry need to have single-use assemblies or a high degree of sterility, the particularities of which necessitate flexible production processes. These assemblies minimize contamination and consequently incorporate fast cycle times which are essential for sale deployment due to the increasing market volatility.
• In addition, the COVID-19 pandemic underlined the necessity of fast development and manufacturing of biopharmaceuticals, which stimulated the progress of single-use technologies. Since single-use systems are useful in bettering the quality of the end product and eliminating contamination issues, their application has been gradually adopted by the biopharmaceutical enterprises This is one of the primary factors that will contribute toward the increased growth of assembly systems.

Technological Advancements in Single-Use Assemblies

• The continuous growth in single-use assemblies is contributed with the help of Technology and growth in this point is also another factor for the market growth. Advancements in material science and engineering of single use technologies have produced improved more durable, dependable, and multipurpose units. Such developments comprise of the type of the material being used such as advanced polymers that can withstand chemical content and are more durable compared to earlier materials. Also, the device integration like sensor and automation into single-use system offers the advanced system of controls during the manufacturing processes. These innovations allow efficiency of information accumulation and processing in time, controlling of product homogeneity and meeting primarily legal requirements. In addition, the technology in the design and manufacturing of single-use assemblies has been improved to incorporate elements that are friendly for the users and adapt to the operations of different biopharmaceutical applications. As these technologies advance even further they are likely to continue propelling the use of single-use systems, thus improving their attractiveness and functionality in the biopharmaceutical manufacturing environment.

Market Opportunity:

Expansion in Emerging Markets

• Among all the discussed emerging markets, the expansion in the single-use assemblies market can be viewed as one of the greatest opportunities for the global market. The biopharmaceutical industries in the Asia-Pacific, Latin American, and Middle Eastern regions are expanding fast due to the growing demand for healthcare products, ancillary policies from the governments, and surging interest in biotechnology. These regions present a great market opportunity for single-use assemblies since the pharmaceutical industries’ capacity in the regions is rapidly developing and paying more attention to embracing more innovations. The above-discussed advantage such as economy, versatility, and reduced contamination make single-use system approach suitable to follow the fast-growing emerging markets’ infrastructure development.
• Also, the enhancement in chronic diseases and the urgency for effective therapeutic options in these areas also foster the consumption of biopharmaceuticals, thus promoting the usage of single-use assemblies. Thus by identifying the opportunities and investment for growth in emerging markets the manufacturers of single-use systems can develop a favorable ground for business and sustained action leading to an overall growth of the market.

Adoption of Innovative Dispensing Systems and Application Techniques

• Buyers of the Manufacturers of Single-Use Assemblies Market are investing in new dispensing technologies and applying methods to ease workflows dependent on high construction outputs and improved safety measures. These include pneumatic or battery operated caulking machines and adhesive dispensers that allow the precise delivery of adhesive and minimize waste.
• Also, equipment and technologies have been developed where high nozzle designing, spray, and dispensing equipment which result in excellent finishing and bonding in large surface areas and complicated structures. Also, the IoT sensors and the intelligent monitoring systems are incorporated in the management of adhesives in the project to enhance adhesive use through tracking the quantity, quality and net maintenance which is essential in providing quality construction projects. The enhancement of dispensing systems and application methods enhances productivity, cuts down the employment costs, and minimizes material losses and thus advances the Single-Use Assemblies Market.

Market Restraining Factors:

High Initial Setup Costs

• While there are several advantages that comes with single-use assemblies, one major disadvantage of using hot-melt adhesives is that they have low bonding strength under conditions such as high Although single use assembly have many benefits, its major drawback is that it comes with very high initial costs. Evaluating the effectiveness of single-use systems involves considerable expenditures on procuring new equipments and shifting from stainless-steel based equipments to disposable technologies. Such costs may be even more challenging for small and mid-sized especially those in the biopharmaceutical industries due to scarce sources of funding.
• However, validation and qualification of such single-use systems, to conform to the existing regulatory standards can again add to the expenses. This paper identified that adopting single-use assemblies may in the long run lower the cost of cleaning and sterilization hence recommended for adoption though the initial costs may be too expensive for the firms. Also, single-use technologies are non-standardized, this can create compatibility problems, which leads to additional investments into their integration. Therefore, such high startup costs continue to present a major challenge which is why the single-use systems uptake rate has not been as fast in the biopharmaceutical manufacturing industry.

Report Coverage:

The report will cover the qualitative and quantitative data on the global Single-Use Assemblies Market. The qualitative data includes latest trends, Market players analysis, Market drivers, Market opportunity, and many others. Also, the report quantitative data includes Market size for every region, country, and segments according to your requirements. We can also provide customize report in every industry vertical.

Report Scope and Segmentations:

List of Companies Profiled:

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

Key Industry Developments:

• In February 2022, Sartorius Stedim Biotech, a French based company bought chromatography division of Novasep also a France based company. In the chromatography portfolio obtained, more systems are for the smaller biomolecules as a general classification of the chromatography systems.
• In August 2022, Thermo Fisher Scientific launched a new single-use technology centre in Memphis, Tennessee: the centre covers 400 000 sq ft of the area. In time, it rose to become the world’s largest SUT site for the company as more facility branches were established.

Segmentation Analysis:

The Market scope is segmented because of by Product, by Solution, by Application, By End User.

By Product

Based on the Product of the Market is segmented into Bag, Filtration, Bottle, Mixing Assemblies.

Filtration assemblies held the highest market share of around 31.25% in 2023. The enhancement in the number of regulations to be fulfilled and the requirement to reduce the chances of contamination have led to the adoption of filtration assemblies in cases of both bulk as well as final fill. Single pass filtration assemblies are easily separable and can be applied instead of stainless-steel systems eliminating sterilization steps and corresponding validation procedures. Among the type of bag assemblies, this segment is expected to grow at the highest CAGR of 20%. 02% from 2024 to 2030 for ‘Other’. Single bag assemblies in the biopharmaceutical industry are of different types and sizes as well as shapes and the multiple uses of single-use bag assemblies are cell cultivation formulation, sampling bag, situated in a buffer food-process medium, feed-process among the others.

By Solution

Based on the Solution of the Market is segmented into Standard, Customized.

The Customized segment dominated the industry in 2023 and accounted for a revenue share of 75.32%. SUTs result in not only cost and time, but also 90 % of integrity testing, sterile connections, and tubing. It eliminates process time since the filtration systems are ready to use as compared to other filtration systems. The increase in market demand for biopharmaceuticals will necessitate, several production plants hence high returns. The use of single-use systems is increasing in the production of biopharmaceuticals and other products to allow fast product change-overs and manufacturing/production of distinct products in different areas throughout the same building/structure.

By Application

Based on the Application of the Market is segmented into Filtration, Cell Culture, Storage, Sampling, Fill-finish.

The filtration segment dominated the industry in 2023 and accounted for a revenue share of 29.81%. Thus, using the systems, one can easily purchase the related products for pharmaceutical manufacturers, laboratories and other end consumers, combined with facilitating the production, minimizing the time spent on sterility and cleanliness of equipment. Most players provide individualized products based on the unique characteristics of the consumers. Single-use assemblies produced by MilliporeSigma company under the brand name Mobius are fully customizable and ready to use that enables preparedness of quick launch of the manufacturing and development processes in the pharmaceutical industries.

By End Use

Based on the End Use of the Market is segmented into Biopharmaceutical & pharmaceutical companies, CROS & CMOS.

Biopharmaceutical & pharmaceutical companies dominated the industry in 2023 and accounted for the highest share of 46.52%. Prospects in the advancement of the existing bio-manufacturing capacity for biopharmaceuticals explain instances that propel the application of single-use assemblies. For example, Alexion in June 2022 allocated USD 70 million in new drug production warehousing, and equipment to improve Alexion’s manufacturing, specific to Ireland. As it will be viewed further the expansion has for a goal the optimization of the biologics drug substance offer. Likewise, in May 2022 Upperton Pharma Solutions provided a plan of USD 16 million to enhance the facility Ramification might benefit the growth of the research and development area and GMP manufacturing area by ten folds.

Regional Snapshots

By region, Insights into the Market in North America, Europe, Asia-Pacific, and the rest of the world are provided by the study. North America dominated the market with a share of 38.22% in 2023. The contribution of the major share could be due to the developing industries such as the biotechnology and pharmaceutical industries, developing products, and due to the elevated prevalence rate of diseases like cancer besides investment and funding of drug discovery research. For instance, in August 2022 Thermo Fisher Scientific Inc. was officiated to the single-use technology manufacturing site in Greater Nashville. The 400,000 sq ft USD 105m new facilities enable the company to accommodate the rising demand for the bioprocessing materials needed to develop new therapies as well as cancer and other diseases’ vaccines.

This site is within the framework of the company’s USD 650 million long-term investment in the expansion of bioprocessing production capacity. The Asia Pacific is expected to have the highest growth rate from 2024 to 2030 due to plans executed by top stakeholders in the market. In the past year, major investments were made to expand operations in China and Beijing in particular because new cleanrooms were established for the creation of bags and single-use filters. Cytiva disclosed in September 2021 on forming a disposable manufacturing hub in South Korea which require an investment of up to USD 52m. 5 million. This expansion is being intended to provide single-use bags to the bioprocessing industry that deals with COVID-19 vaccines.

Global Single-Use Assemblies Market Regional Analysis:

The objective of the report is to present comprehensive analysis of Global Single-Use Assemblies Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. 

North America

• U.S.
• Canada

Europe

• Switzerland
• Belgium
• Germany
• France
• U.K.
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Rest of Europe

Asia-Pacific

• India
• Australia
• Philippines
• Singapore
• South Korea
• Japan
• China
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Argentina
• Peru
• Colombia
• Brazil
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Points Covered in the Report:

• The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc.
• The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 5 years data history and forecast.
• The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail.
• Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements.
• The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

Key Questions:

• How much the global Single-Use Assemblies Market valued?
• Which region has the largest share in 2024 for the global Single-Use Assemblies Market?
• What are the driving factors for the market?
• Which is the leading segment in the global market?
• What are the major players in the market?

Research Scope of Single-Use Assemblies Market:

• Historic year: 2019- 2022
• Base year: 2023
• Forecast: 2024 to 2032
• Representation of Market revenue in USD Million