GLOBAL SINGLE USE ASSEMBLIES MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

Global single-use assemblies market is expected to reach US$ 34.73 Bn by 2030, from US$ 11.03 Bn in 2023, exhibiting a CAGR of 17.8% during the forecast period.

Single-use assemblies, also known as disposables, are pre-assembled sterile products that are intended for single-use application in biopharmaceutical manufacturing. There are mainly two types of single-use assemblies - single-use bioreactors and single-use mixers.

Global Single Use Assemblies Market- Regional Insights

• North America is expected to be the largest market for single-use assemblies during the forecast period, accounting for over 35.7% of the market share in 2023. North America currently dominates the global single-use assemblies market owing to strong presence of pharmaceutical and biotechnology industries in the region. Countries like the U.S. and Canada have some of the largest pharmaceutical companies in the world with robust research and development infrastructure. These companies have been early adopters of single-use assemblies as these help to reduce infrastructure and equipment costs significantly. Additionally, favorable regulatory environment in the region promotes the use of technologies that enhance efficiency and flexibility of bio manufacturing operations, thus, boosting demand for single-use
• Asia Pacific is expected to be the second-largest market for single-use assemblies, accounting for over 25.2% of the market share in 2023. The Asia Pacific region is poised to be the fastest growing market for single-use assemblies over the next five years. Rapid expansion of domestic biopharmaceutical industries in countries like China, India, Japan and South Korea is the major factor accelerating market growth. These countries currently contribute over 60% of the global biologics production. Rising incomes have led to increased healthcare spending, providing impetus to development of local biosimilars industry. Presence of skilled workforce at competitive costs is attracting biopharma investments into the region from multinationals seeking to expand manufacturing capabilities. As local companies ramp up their capabilities to cater to domestic as well as international markets, adoption rates of single-use technologies is expected to surge considerably. Moreover, Asia Pacific governments are offering incentives to promote healthcare innovations and establish world-class biomanufacturing hubs, which will strengthen the regional supply chain network and further augment market opportunities.
• Europe is expected to be the fastest-growing market for single-use assemblies, with a share of 19% during the forecast period. The growth of the market in Europe is attributed to increasing product launch by market players in the region.

Figure 1. Global Single-use Assemblies Market Share (%), By Region, 2023

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Analyst View: The global single-use assemblies market is positioned for strong growth over the next five years. Growing biopharmaceutical industry reliance on single-use technologies to improve efficiency and reduce costs will continue boosting widespread adoption of single-use pipework, bags, and other assemblies. North America currently dominates due to its large biopharma industry and acceptance of new technologies. However, Asia Pacific is expected to be the fastest growing region, fueled by expanding biologics production in China, India, and other Asian countries. Stringent regulatory norms in the region will also propel market growth.

Global Single-use Assemblies Market- Drivers

• Increasing Demand for Disposable Systems: The biopharmaceutical industry has been seeing a gradual shift towards the use of single-use assemblies as these offer significant economic advantages over traditional stainless steel-based equipment. Using single-use assemblies reduces the costs associated with cleaning, sterilization and validation of multi-use equipment. Cleanup and sterilization of stainless steel bioreactors and transfer lines after every production run require considerable labor, water, steam and chemical costs. This makes the overall production process quite expensive. The use of pre-sterilized single-use bags eliminates the need for such extensive cleaning and validation steps between batches. It allows manufacturers to rapidly change the production process or product with fewer process interruptions. This significantly improves facility utilization and overall equipment effectiveness.

Single-use assemblies are designed for one-time use and are disposed after the production run. This approach saves bio manufacturers from the recurring costs of cleaning and sterilizing the same equipment for multiple uses. It is estimated that using disposable equipment can reduce cleaning validation costs by as much as 70-80% when compared to traditional production systems. The cost savings from lower cleaning and sterilization requirements with single-use bioprocessing have made it an economically viable option even for large-scale manufacturing. Advances in single-use technology such as larger bag volumes and connector designs have further increased the scope of single-use assemblies in industrial bio manufacturing. Their cost-effectiveness is a major driver accelerating the adoption of these assemblies by biopharmaceutical companies.

• Increasing Levels of Outsourcing: The expansion of the worldwide single-use assemblies market is also propelled by the growing trend of bioproduction activities being outsourced to contract development and manufacturing organizations (CDMOs).CDMOs help drug developers and smaller biotech firms focus on their core competencies of R&D and clinical trials while outsourcing capital-intensive bulk manufacturing. These contract manufacturers extensively use disposable assemblies to improve production flexibility and enable multi-product manufacturing in their facilities. With stringent regulatory oversight and quality requirements, it is imperative for CDMOs to minimize the risks of cross-contamination. This has increased their reliance on single-use technologies that reduce cleaning, maintenance and validation costs compared to conventional stainless-steel equipment.

Furthermore, single-use assemblies allow CDMOs to quickly configure and reconfigure their manufacturing suites based on changing production demands from clients. This helps them to efficiently utilize plant capacity and shorten turnaround times. The use of modular pre-assembled single-use systems by CDMOs also lowers installation and commissioning costs of new production lines. All these advantages have driven greater adoption of disposable assemblies at large scale contract manufacturing facilities. The outsourcing trend is expected to steadily grow as more pharmaceutical firms focus on their core drug discovery and commercialization activities, thereby positively impacting demand for single-use assemblies

• Flexibility and reduced process development time: Another important driver for the demand of single-use assemblies is the agility and flexibility these provide to bio manufacturers. Using these disposable assemblies allows companies to rapidly change the manufacturing process and shift production between different products. Theseeliminate many issues related to carryover contamination that is often problematic in traditional stainless steel systems. This feature enables operators to switch promptly between different drug productions without the need for extensive and expensive equipment cleaning and validation processes. This level of operational agility is highly appreciated in the biopharmaceutical sector, where the efficient and timely manufacturing of drugs is essential.

Adopting a single-use platform significantly reduces the development timeline and resources required to scale-up a manufacturing process. Without the need for capital-intensive equipment purchases, qualification and validation, single-use based facilities can be rapidly set up at a much lower cost. Manufacturers can test multiple assembly configurations, media and process parameters concurrently in separate single-use suites instead of running them sequentially on the same stainless steel equipment. This speeds up process development and optimization leading to faster availability of bio therapeutics. Single-use assemblies empower manufacturers to quickly respond to changing business needs and facilitate faster commercialization of important drugs. Their flexibility in swiftly adapting production capacity gives biopharmaceutical companies an important competitive edge.

Global Single-use Assemblies Market- Opportunities

• Technological advances in single-use assemblies: Technological advances in single-use assemblies offer a great opportunity in the global market. Single-use technologies enable the production of biopharmaceuticals in a more cost-effective and sustainable manner. With advancements in material sciences, manufacturing techniques, and process control strategies, single-use assemblies are becoming more robust and reliable for complex bio production needs.

Some of the key emerging technologies include modular and customizable single-use systems, advanced sensors for real-time monitoring of processes, and integrated digital solutions for data connectivity. Modular production equipment built using assemblies that can be customized based on manufacturing requirements provide more flexibility compared to conventional stainless-steel facilities. For example, pre-assembled modular production skids save significant construction time at client facilities. Advanced sensor technologies allow process parameters like pH, temperature, pressure to be continuously monitored and controlled remotely. This helps to improve process understanding, consistency between batches, and early detection of deviations. Integrating such sensors with digital platforms also helps companies to better track and analyze manufacturing data across projects and sites.

• Adoption of modular facilities: Adoption of modular facilities is poised to provide significant opportunities in the global single-use assemblies market. With rising demands for flexibility and reduced construction timelines in biopharmaceutical manufacturing, modular facilities are rapidly gaining traction. Their pre-fabricated and standardized design allows for swift assembly and validation at the target site, helping companies speed up production starts and facility expanded capacity.

Modular facilities rely extensively on single-use assemblies to components like bulk containers, tubing, mixers, filters and others. Their use eliminates the need for costly and complex stainless steel pipework and vessels, further improving flexibility. Modular facilities can be quickly reconfigured or relocated as production needs change, which would not be feasible with conventional brick-and-mortar structures. This inherent quality makes them well-suited for multiproduct facilities with varying production cycles. According to the World Health Organization 2022 report, the effects of an aging global population will lead to a substantial increase in the demand for biologics and pharmaceuticals in the coming years. As biopharmaceutical companies seek to rapidly scale drug substance manufacturing capacity and adapt to changing market conditions, adoption of modular facilities is likely to grow significantly.

Global Single-use Assemblies Market- Trends

• Advancements towards pre-sterilized and ready-to-use assemblies: The biopharmaceutical industry has seen significant advancements in the development of pre-sterilized and ready-to-use single-use assemblies over the past few years. This trend is having a notable impact on the global single-use assemblies market. Previously, assembling single-use systems was labor intensive and required sterilization by end users. Recent innovations have focused on delivering complete assemblies to customers in a sterilized format, ready for seamless integration. These advancements fulfill an unmet need within bioprocessing as these help eliminate steps from the workflow and minimize the chances of contamination.

Leading manufacturers are now offering entire modular assemblies made of inter connectable single-use components like tubes, bags, and filters that are terminally sterilized and validated by the manufacturer. For example, Sartorius Stedm Biotech, a leading partner of the biopharma industry, offers its single-use Flex Factory platform that provides pre-assembled modular components for upstream and downstream processing. According to the company's 2021 annual report, sales of its pre-assembled systems increased by 18% in 2021 as compared to 2020. As more drug developers choose to outsource manufacturing to contract development and manufacturing organizations, there is even greater demand for turnkey, compliance-ready solutions.

Global Single-use Assemblies Market - Restraints

• High costs associated with single-use assemblies: High costs associated with single-use assemblies are significantly restraining the growth of the global single-use assemblies market. The production and procurement costs of single-use components and assemblies are considerably higher compared to their reusable counterparts. This is primarily due to the expenses involved in manufacturing single-use products with high-quality materials that can withstand stringent sterilization procedures and avoid contamination during their intended short operational lifecycle. Moreover, the costs associated with validations, cleaning, and waste treatment or disposal of single-use parts add to the overall financial burden on end users.

The high initial investment required for setting up single-use production lines and facilities by biopharmaceutical manufacturers is also slowing the adoption rate. Significant capital is needed for purchasing assemblies, installation of required equipment such as plastic welding machines, assembly robots, and sterile manufacturing suites. Additionally, frequent production line clearances and changeovers further inflate the operational costs. These substantial expenses pose serious budgetary challenges, especially for small and medium-sized biopharmaceutical companies with limited financial resources. As a result, some drug developers prefer conventional stainless-steel based reusable equipment over single-use technologies for large-scale commercial production.

• Lack of standardized manufacturing processes: The lack of standardized manufacturing processes is one of the key factors restraining the growth of the global single-use assemblies market. When there are no standardized processes, each manufacturer has to develop their own unique process flows, specifications, and protocols. This leads to inconsistencies in quality, specifications and performance of the single-use products coming from different sources. Establishing standardized manufacturing techniques would help ensure harmonization and quality control across different manufacturers. This becomes especially important since these assemblies are single-use and meant for critical bio manufacturing applications. Any variability or quality issues can directly impact the end products like biologics which are meant for human use.

Having a diverse range of non-standardized manufacturing procedures also increases the compliance burden and operational costs for bio manufacturers. They have to validate and qualify every new vendor and product individually due to differences in manufacturing and quality standards. This leads to longer approval cycles and delays in setting up new production lines or making vendor changes. It also prevents the feasible and timely scale-up of manufacturing during periods of high demand like the ongoing COVID pandemic. With standardized manufacturing under a harmonized framework, the changes and additions of new contract manufacturing partners could be done more efficiently and swiftly to meet any unexpected rise in market requirements.

Figure 2. Global Single-use Assemblies Market Share (%), By Product, 2023

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Global Single-use Assemblies Market- Recent Developments

Product Launch

• On April 24, 2023, Merck, a leading science and technology company, announced the launch of its Ultimus Single-Use Process Container Film that is designed to provide extreme durability and leak resistance for single use assemblies used for bioprocessing liquid applications. Bag leaks have consistently been a significant concern for biomanufacturers, with the financial impact of a single leak estimated to be anywhere between US$ 49,369 and US$ 5,606,131. To protect against such leaks, abrasions, tears, and material fatigue, Ultimus film is designed with a proprietary woven nylon structure and provides enhanced bag strength, improved durability, and resilience.
• In September 2022, Thermo Fisher Scientific Inc., the world leader in serving science, launched the Thermo Scientific DynaSpin Single-Use Centrifuge system at the BioProcess International annual conference in Boston, U.S. The system is specifically designed to provide an optimal single-use solution for large-scale cell culture harvesting. The DynaSpin system improves and streamlines harvesting for cell culture separation in single-use bioprocesses by reducing the number of depth filtration cartridges required to complete the harvest process. The DynaSpin solution delivers equivalent or improved product yield as compared to traditional harvest systems while enabling operational efficiency, cost savings and sustainable practices in the production of biologics.

Business Development Activities by the Market Players

• In October 2022, Single Use Support, a provider of fluid management solutions, announced expansion of its product portfolio with new single-use bioprocess containers under the brand name IRIS. The company leveraged its know-how to provide reliable process solutions in biopharmaceutical fluid management, continuing to pursue its vendor-agnostic approach.
• In June 2021, Avantor, a biotechnology company, acquired RIM Bio, a China-based manufacturer of single-use bioprocess bags and assemblies for biopharmaceutical production. This acquisition, will further help Avantor access RIM's Changzhou, China, facility, making it Avantor's one of the first single-use production units in Africa, the Middle East, and Asia (AMEA) region.

Top companies in Global Single-use Assemblies Market

• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Sartorius AG
• Danaher (Pall Corporation)
• Avantor, Inc
• Lonza
• Saint-Gobain
• Corning Incorporated
• Entegris
• KUHNER AG.
• Parker Hannifin Corporation
• Ami Polymer
• HIGH PURITY NEW ENGLAND
• Liquidyne Process Technologies, Inc.
• ESI Ultrapure

Definition: Single-use assemblies are pre-designed or customized configurations of disposable components used in the bio-manufacturing industry to manage fluid transfer and processing steps. These assemblies are typically made of plastic and can include a variety of components such as tubing, connectors, filters, bags, bottles, and sensors. These are supplied sterile and ready to use, which minimizes the risk of contamination and eliminates the need for complex cleaning and sterilization processes required for reusable equipment. The use of single-use assemblies brings several advantages such as:

• Reduced risk of cross-contamination
• Lowered cleaning and validation costs
• Greater flexibility in manufacturing
• Scalable production capabilities
• Faster turnaround time for the production setup

Single-use assemblies are commonly implemented in pharmaceutical and biotechnological production processes, including manufacturing of vaccines, monoclonal antibodies, cell therapies, and other biologics. The increased adoption of single-use technologies is driven by the need for more efficient, flexible, and cost-effective production methods in the life sciences industry.