Single-Use Assemblies Market Assessment, By Product [Filtration Assemblies, Bottle Assemblies, Bag Assemblies, Tubing Assemblies, Mixing System Assemblies, Others], By Solution [Customized Solutions, Standard Solutions], By Application [Filtration and Pur

Single-Use Assemblies Market Assessment, By Product [Filtration Assemblies, Bottle Assemblies, Bag Assemblies, Tubing Assemblies, Mixing System Assemblies, Others], By Solution [Customized Solutions, Standard Solutions], By Application [Filtration and Purification, Storage, Cell Culture and Mixing, Formulation and Fill-finish Applications, Sampling, Others], By End-user [Biopharmaceutical and Pharmaceutical Companies, Academic and Research Institutes, CROs and CMOs], By Region, Opportunities and Forecast, 2017-2031F

Global single-use assemblies market is projected to witness a CAGR of 16.73% during the forecast period 2024-2031F, growing from USD 3.69 billion in 2023 to USD 12.72 billion in 2031F. 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.

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 billion, approximately 16 billion 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.

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. In March 2022, Dover Corporation launched its liquid single-use bioprocessing bags for handling sterile liquids. The company is also expanding its powder (pre-filled and non-pre-filled) and sterile liquid offerings. Their supply reputation, global footprint, and quality ensure that they can meet the customers' evolving requirements at scale and speed.

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 (2024-2031F)

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.

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.