PUBLISHER: Market Xcel - Markets and Data | PRODUCT CODE: 1718952
PUBLISHER: Market Xcel - Markets and Data | PRODUCT CODE: 1718952
Global single-use assemblies market is projected to witness a CAGR of 16.56% during the forecast period 2025-2032F, growing from USD 4,311.00 million in 2024 to USD 14,733.11 million in 2032F. The market's growth is augmented by the rapid growth of the pharmaceutical and biopharmaceutical sectors, increasing investments towards biologics, the introduction of novel products and technologies, growing efforts to expedite the drug development process, and the increasing prevalence of infectious diseases. The single-use assemblies market is growing strongly due to the growing use of preassembled fluid path systems, disposable in nature, in biopharmaceutical production and life sciences. Assemblies-including tubing, bags, filters, and connectors-have great benefits in terms of better sterility, lowered cross-contamination risk, and avoided cleaning and validation processes, which result in improved operation efficiency and cost savings. The increased demand for the manufacture of biologics such as monoclonal antibodies, vaccines, and cell and gene therapies has escalated the need for scalable and flexible solutions to manufacture these products, and single-use assemblies are addressing that need. Technologies have enhanced reliability, safety, and regulatory support for the product, and market players are incorporating sustainable materials as they focus on reducing the environmental impact related to disposables. Regulatory bodies are favorable owing to the assemblies' capacity to ensure high sterility standards, which further aids in market uptake. Notwithstanding these encouraging trends, the market has challenges such as environmental concern, supply chain complexities, non-standardization, and the requirement for specialized experts.
Rising efforts by companies to expedite drugs to market are among the major global single-use assembly market trends. In April 2024, SaniSure Limited launched Fill4Sure, a custom single-use filling assembly to increase drug product filling processes' repeatability, safety, and efficiency. Features such as high-performance tubing, silicone over-molding, low-particulate 2D surge bags, adhesive and oil-free OEM, and custom-designed needles ensure product purity by minimizing contamination risks. These advanced features also streamline bioprocessing and biomanufacturing processes, aiding the manufacturer in securing supply chains and expanding their capacity. Such cost-efficient and tailor-made efficiencies aid in effortless scaling up to meet the industry's evolving requirements.
Increasing investments in biologics are also expected to aid the market's growth. In January 2024, AbbVie Inc. announced an investment of USD 223 million to expand their Singapore biologics manufacturing facility. The expansion is expected to conclude in 2026 and add 24,000 liters of biologics drug-substance capacity and 100 new jobs. This investment is expected to aid the expansion of the company's manufacturing network globally and support its oncology and immunology pipeline. Additionally, single-use assemblies are used in various stages in the biologics manufacturing sector, including process-intermediate storage, media and buffer preparation, downstream processing, and upstream processing.
Increasing Research and Development Activities Boost Market Demand
The rise in infectious and chronic disease cases in various regions across the globe is propelling the requirement for vaccines, which require single-use assemblies. Due to this, the investments in the production of vaccines are increasing as they aid in reducing the detrimental effects associated with infectious diseases, eradicate major viruses and pathogens, such as smallpox, and decrease child mortality rates. Various government agencies such as the National Institute of Health (NIH), philanthropic foundations and supranational bodies, including the Bill and Melinda Gates Foundation and the European Commission, are also financing vaccine research and development activities. According to estimates from the World Health Organization (WHO), vaccines worth USD 141 million, approximately 16 million doses, were supplied in 2021. These factors boost the demand for single-use assemblies as they offer cost efficiency due to reduced cleaning and downtime and minimize the risk of product loss due to contamination. Another example of growing research and development scenario is reflected by the deal done in January 2025, in which Sartorius extended its collaboration with McMaster University by opening a new bioprocessing automation lab at the university's Faculty of Engineering in Hamilton, Ontario. This state-of-the-art, 1600-square-foot facility aims to advance research and development in biomanufacturing.
Rising Demand for Biopharmaceuticals Propels Demand for Single-Use Assemblies
As the biopharmaceutical sector continues to grow, especially with the rising trend of chronic illnesses like cancer and diabetes and the growth of biologics and biosimilars, there is a growing demand for effective and adaptable manufacturing solutions. According to the American Cancer Society, an estimated 2,041,910 new cases of cancer will be diagnosed in the United States in 2025. Single-use assemblies provide a number of benefits, such as minimized risk of cross-contamination, decreased operational costs, and easier cleaning procedures. These assemblies allow biopharmaceutical firms to automate production and respond to shifting market needs in a timely manner without the extensive cleaning and validation necessary for conventional systems. The flexibility to quickly set up manufacturing arrangements with single-use technologies improves operating efficiency, thus making them more appealing to many biopharmaceutical and pharmaceutical firms.
Surging Demand for Biosimilars and Biologics Supports the Market Growth
The surging demand for biologics and biosimilars is propelling the use of single-use systems in the biopharmaceutical sector. For example, in 2024, 46 biosimilars were approved in Europe and the U.S., reflecting the speedy growth in this industry. With increasing competition for new indications and the introduction of new biosimilars, manufacturers are under increasing pressure to reduce the cost of production. Single-use technology, in addition to continuous upstream processes, have become cost-reducing alternatives, allowing manufacturers to ramp up biomass production as well as increasing overall product yield. This increased uptake of biologics, driven by advances in personalized medicine and demand for more potent medicines, has increased the requirement for quicker and cost-effective production processes. Single-use systems fulfill these requirements by providing higher turn-around, minimizing cleaning and maintenance costs to compensate for marketplace demands. Growing investments into biologics are supporting market growth. AbbVie Inc. announced in January 2024 an investment of USD 223 million to enhance their Singaporean biologics manufacturing plant. The expansion will finish in 2026 and is slated to bring additional 24,000 liters of biologics drug-substance capacity and 100 new employees. This investment is anticipated to contribute to the company's manufacturing footprint expansion worldwide and help its oncology and immunology pipeline. Moreover, single-use assemblies find applications in different stages within the biologics manufacturing industry, such as process-intermediate storage, media and buffer preparation, downstream processing, and upstream processing.
New Product Launches Support Market Growth
Rising efforts to develop novel products that aid in streamlining workflow while allowing for rapid implementation are one of the major factors bolstering the global single-use assemblies market growth. Cytiva introduced Supor Prime filters on June 26, 2024, to enhance high-concentration biologics filtration. Supor Prime is intended for drug developers and improves yields, minimizes blockages, and reduces filtration losses, meeting the growing demand for subcutaneous drugs. The filters accommodate high throughput for feeds up to 220 grams per liter and 30 centipoise viscosity, scaling from clinical to commercial manufacture. Being a green solution, Supor Prime eliminates the use of plastic, cleaning requirements, fluid usage for priming, and CO2 release through enhanced recovery of the product and reduction in upstream manufacturing needs.
Such developments are expected to propel the global single-use assemblies market demand as they allow companies to provide comprehensive solutions tailored to the customer's unique requirements. They also allow for the availability of technologically advanced products and ready-to-implement, affordable, and innovative solutions, thus positively influencing the market's growth.
North America Accounts for Significant Market Share
The market growth in North America is supported by the expansion of the pharmaceutical sector, increasing prevalence of infectious and chronic diseases, and rising emphasis on drug discovery research. Single-use assemblies find applications in patient delivery systems, cell cultivation, lab and drug discovery, and downstream and upstream bioprocessing. The increasing awareness about the various advantages associated with using single-use assemblies as opposed to their counterparts is also supporting the expansion of the market in North America. Traditionally, process equipment is made of stainless steel, among other metals, and has high maintenance and upfront costs.
The rapid growth of the biotechnology industry in the United States is also expected to offer lucrative growth opportunities to the market as single-use assemblies find applications in various biotechnology domains, such as cell and gene therapy. According to estimates from the Council of State Bioscience Associations (CSBA) and Biotechnology Innovation Organization (BIO), the bioscience industry in the United States was valued at USD 2.9 trillion in 2021.
Pharmaceutical and Biopharmaceutical Companies Hold Significant Market Share
The rapid expansion of the pharmaceutical and biopharmaceutical sectors, owing to the increasing prevalence of various chronic and infectious diseases, supports the segment's growth. The increasing investments by major companies in developing new facilities to combat this growing threat bolstered the market's demand. Single-use assemblies reduce the risk of cross-batch and cross-product contamination and provide a smaller manufacturing footprint. Various sterile sectors, including pharmaceutical and biopharmaceutical sectors, have shifted to single-use assemblies and technologies at some time for a few applications, if not all, over the past few years as they aid in improving facility adaptability and flexibility and increase product integrity.
In February 2024, Thermo Fisher Scientific Inc. announced the opening of its new sterile drug facility in Singapore to ensure the delivery of new vaccines and medicines to the Asia Pacific market. The facility has been established with assistance from the Singapore Economic Development Board (EDB) and is in alignment with the efforts of the government to prepare for health emergencies that can emerge in the future. The increasing development of such facilities is expected to propel the requirement for single-use assemblies in the coming years, owing to their various advantages.
Future Market Scenario (2025-2032F)
According to the global single-use assemblies market analysis, the expansion of the pharmaceutical sector, coupled with increasing investments in research and development activities, is expected to bolster the market's demand in the coming years. Features such as reduced environmental impact, faster turnaround and changeover times, high flexibility, and reduced risk of product loss and cross-contamination are expected to propel the utilization of single-use assemblies in the coming years. Continuous efforts of key market players to enhance leak resistance and strength of single-use assemblies are also expected to provide lucrative growth opportunities to the market. Increasing market activity from prominent industry players also secures the robust future growth of market, for instance, in January 2025, Cytiva partnered with Cellular Origins to integrate Cytiva's automated Sefia platform with Cellular Origins' robotics system, Constellation. This collaboration aims to scale cell and gene therapy manufacturing while preserving established processes.
Key Players Landscape and Outlook
New launches by the key market players are bolstering the global single-use assemblies market size. In April 2023, Merck & Co., Inc. launched Ultimus films to provide leak resistance and superior strength in single-use assemblies used in bioprocessing liquid applications. The film is designed using a proprietary woven nylon structure to provide protection against fatigue, tears, leaks, and abrasion, as well as improved resilience and durability and enhanced bag strength. Incorporating woven nylon also provides ease of handling, conformity, and flexibility, which are essential for single-use processing. Such developments are expected to offer lucrative growth opportunities to the market in the coming years as they provide durable and stronger solutions to end-users while minimizing disruptions and increasing operational efficiency.
Watson-Marlow Fluid Technology Solutions (WMFTS) launched a new range of single-use solutions, WMArchitect, in April 2024, aimed at streamlining fluid management in biopharmaceutical manufacturing. The new offering consists of both off-the-shelf and custom single-use assemblies, easing the validation burden and allowing smooth integration into a range of bioprocessing processes. With its open architecture solution, WMArchitect offers flexible system compatibility while ensuring robust regulatory compliance. The answer meets industry priorities, including mitigating cross-contamination risks and inefficiencies of operation, with high-quality ready-to-use assemblies. WMArchitect further optimizes process development by encompassing end-to-end fluid handling applications from upstream processing to finished fill-finish.
In February 2025, Thermo Fisher Scientific Inc. collaborated with the NIH to integrate the Thermo Scientific HyPerforma Enhanced Single-Use Fermentor (eS.U.F.) into vaccine manufacturing processes. This partnership aims to enhance vaccine production efficiency by utilizing single-use technology. In another deal in the same month, Thermo Fisher announced plans to acquire Solventum's Purification and Filtration Business for approximately USD 4.1 billion. This acquisition is expected to complement Thermo Fisher's bioproduction capabilities, particularly in the bioprocessing market.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work