Single-Use Assemblies Market

Market Overview

The global single-use assemblies market size was valued at USD 13.4 billion in 2023 and is projected to reach USD 66.5 billion by 2032, registering a CAGR of 19.4% during the forecast period (2024-2032). The growing necessity in the pharmaceutical industry is a significant factor in the growth of the single-use assembly market.

Single-use systems (SUS), or disposable systems, are commonly employed in the biopharmaceutical and biotechnology industries. They are intended to make the production and processing of biopharmaceutical products such as vaccines, monoclonal antibodies, and other biologics easier. These assemblies often comprise single-use bags, tubing, connectors, filters, and other components, allowing hygienic and efficient fluid handling without cleaning and sterilizing between batches.

Rapid and simple deployment, a reduced danger of cross-contamination, increased R&D expenditure by biopharmaceutical companies, and a burgeoning biologics industry are factors driving market expansion. The use of single-use assemblies in the global biopharmaceutical industry has grown over time due to their benefits, such as reduced cross-contamination risks, more accessible cleaning procedures, and tailored solutions. This helps to speed drug research and manufacture. Biopharmaceutical businesses' increased R&D spending contributes considerably to the single-use assemblies market share.

Highlights

• Filtration Assemblies dominate the market by product.
• Filtration contributes significantly to the market by application.
• Customized Solutions generate the highest revenue share by solutions.
• Biopharmaceutical and Pharmaceutical Companies are the major end-users of the market.

Market Dynamics

Global Single-Use Assemblies Market Drivers

Rising Adoption in Biopharmaceuticals

The biopharmaceutical industry is rapidly expanding, driven by the development of new biologics, vaccines, and cell therapies. Single-use assemblies allow these items to be produced more quickly and efficiently, making them indispensable in this market. The global biopharmaceutical market is expanding rapidly. Biopharmaceuticals account for roughly 20% of the global medicines industry. Monoclonal antibodies (mAbs) are one of the most significant segments in the biopharmaceutical market. They treat various conditions, including Cancer, autoimmune disorders, and infectious diseases. The production of mAbs requires complex bioprocessing steps, where single-use assemblies provide significant benefits. As of December 31, 2023, the FDA had approved 173 therapeutic mAbs (excluding two diagnostic mAb). Pharmaceuticals are chemotherapeutic medications, including vaccines, allergens, and cell therapies. Cancer patients can also benefit from it. The demand for single-use bioprocessing equipment is increasing dramatically as biopharmaceuticals proliferate. 

Furthermore, many biopharmaceutical products, including mAbs, require regulatory approval from the US Food and Drug Administration and the European Medicines Agency. Single-use technologies are widely recognized and have received regulatory approval, making them critical to the manufacturing processes for these items. As a result, the biopharmaceutical industry's growth and the use of single-use assemblies may have accelerated since then.

In addition, the ability of biopharmaceutical products to treat previously incurable conditions has paved the way for introducing novel drugs to the market. For example, in September 2022, the Center for Biologics Evaluation and Research (CBER) approved Bluebird Bio, Inc.'s SKYSONA (elivaldogene autotemcel), which is intended to slow the progression of neurologic dysfunction in boys aged 4 to 17 with early, active cerebral adrenoleukodystrophy (CALD). Single-use assemblies allow biopharmaceutical manufacturers to quickly adapt to changing demands and scale up or down production as needed. This is critical given the variable demand seen in mAbs production.

Global Single-Use Assemblies Market Restraints

Environmental Concerns

Single-use assemblies, primarily made of plastics, raise environmental concerns because they generate plastic waste. While they save water and energy compared to traditional stainless-steel systems, the accumulation of plastic waste is a significant concern for sustainability-minded stakeholders. According to an Earth Action report, the global production of short-life plastic is expected to reach 159 million tonnes by 2023. This volume could exceed the global capacity for plastic management without leakage. The report also predicts that 43% of all plastic waste will be mismanaged at the end of its life, resulting in over 68.5 million tonnes of short-life plastics polluting the environment.

Furthermore, regulatory bodies in various regions enforce stricter plastic use and waste management rules. For example, the European Union has implemented directives such as the Single-Use Plastics Directive, which aims to reduce the environmental impact of specific plastic products.

On the other hand, single-use bioreactors are designed to be used and discarded only once. As a result, single-use methods may be less cost-effective for large-scale biomanufacturing because disposal costs can add up over time. In such cases, traditional stainless-steel systems, with their reusability, may be more cost-effective.

Global Single-Use Assemblies Market Opportunity

Technological Advancement

Advances in materials, designs, and integration capabilities drive innovation in single-use assemblies, opening up new applications in the biopharmaceutical industry. Continuous refinement of design features such as connectors, tubing, and bioreactor chambers improves the functionality and usability of single-use assemblies. User-friendly designs allow for quick assembly, disassembly, and manipulation during bioprocessing operations, increasing efficiency and lowering the risk of errors.

Furthermore, single-use assemblies are increasingly designed for seamless integration into existing biomanufacturing workflows, enabling modular and customizable solutions tailored to specific production needs. Integration with automation and control systems makes bioprocessing operations more flexible and scalable.

Additionally, biopulse provides "ready-to-use" and "pre-sterile" customized single-use assemblies manufactured in-house in our certified cleanrooms in India. With their Open Architecture approach, single-use assemblies can be tailored to the specific requirements of a given process or application. For example, the End User can choose different materials, sizes, and configurations for their bags, filters, and tubing based on their needs. This level of customization can increase process efficiency and product quality while lowering waste.

Regional Analysis

The global single-use assemblies market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global single-use assemblies market shareholder and is estimated to grow at a CAGR of 19.1% over the forecast period. This significant stake can be attributed to the rise of the biotechnology and pharmaceutical sectors, product advancement, and the rising incidence of diseases such as Cancer, as well as investments and funding in drug discovery research. For example, Thermo Fisher Scientific Inc. inaugurated its single-use technology production site in Greater Nashville in August 2022. The 400,000-square-foot USD 105 million facilities enable the company to fulfill the growing demand for bioprocessing materials needed to develop breakthrough cancer treatments and vaccines.

Additionally, according to the International Trade Administration (ITA), which the United States Department of Commerce runs to encourage and support foreign investment in the country, the United States has the world's largest biopharmaceutical market, accounting for nearly one-third of global sales, and it leads the world in biopharmaceutical research and development. The United States has one of the best domestic conditions in the world for pharmaceutical research and commercialization, with low market barriers. Further, In 2023, the biopharmaceutical industry saw numerous mergers and acquisitions, including Pfizer and Seagen, Bristol Myers Squibb and Karuna Therapeutics, and Merck and Prometheus Biosciences. The advanced pharmaceutical and biopharmaceutical sectors encourage sales of single-use assemblies and a favorable domestic climate.

Similarly, in June 2023, the Canadian government invested more than USD 2.1 billion in 36 national projects related to biomanufacturing, vaccines, and therapeutics. Thus, such investment in biomanufacturing is likely to create a high demand for single-use assemblies in the region, as single-use technologies can reduce or eliminate the need for expensive stainless-steel equipment and the associated installation and cleaning expenses, thereby fueling regional market growth over the forecast period.

Thus, due to the factors above, such as rising demand for single-use assemblies, increased investments in the biopharmaceutical sector, and several strategic initiatives launched by industry participants, market growth in North America is expected to accelerate during the study period.

Europe is anticipated to exhibit a CAGR of 19.5% over the forecast period. Germany is expected to lead the European single-use assembly market during the projection period. Biological therapeutic choices have a more significant influence on the single-use assemblies market in this country than pharmacological therapeutic options. As a result, the German biopharmaceutical contract manufacturing sector is experiencing increased demand, improving single-use assembly sales. More biopharmaceutical research and clinical trials are being undertaken to save costs and focus on outsourcing most research tasks.

Furthermore, European nations have demonstrated a significant commitment to sustainability. The potential for single-use assemblies to lessen the environmental impact of bioprocessing has been identified. European biopharmaceutical businesses are investing in these technologies to meet sustainability objectives. For example, in May 2023, Getinge announced an agreement to purchase the entire stock of Purity New England, Inc. Purity New England Inc. is the market leader in single-use technologies for bioprocessing.

Asia-Pacific is expected to have the quickest CAGR due to strategic advances by critical companies. Sartorius, for example, made significant investments in China and Beijing in 2021, where additional cleanroom space was developed to make bags and single-use filters. According to China's National Medicines and Pharmaceutical Administration (NMPA), 87 novel drugs were approved in 2023, with targeted drugs accounting for 67.8% of the total (59 drugs). Cytiva stated in September 2021 that it will invest USD 52.5 million in constructing a disposable manufacturing facility in South Korea. This expansion aims to provide single-use bags to the bioprocessing industry, which are utilized to manufacture COVID-19 vaccines.

Consequently, several pharmaceutical and biopharmaceutical companies plan to develop their single-use production facilities in rising markets such as China, India, and South Korea to make these countries a hub for outsourcing bioprocesses.

Segmental Analysis

The global single-use assembly market is segmented based on product, applications, solutions, end-users, and region.

The market is further segmented by product into Bag Assemblies, Filtration Assemblies, Bottle Assemblies, and tubing Assemblies.

Filtration Assemblies account for the largest share of the market. Filtration assemblies are single-use filters and associated components used in the pharmaceutical and biotechnology industries to purify and sterilize bioprocess fluids. In 2022, the filtering assemblies segment accounted for 30% of total revenue. Increased regulatory opportunities and the desire to reduce contamination risk have pushed the usage of filtration assemblies in bulk and final fill operations. Since they eliminate sterilizing processes, and the associated validation protocols, single-use filtration assemblies provide a versatile and efficient alternative to stainless-steel systems.

Bag assemblies comprise single-use bags of biocompatible materials for storing, transporting, and handling liquids and powders in various bioprocessing applications.

The market can be bifurcated by application into Filtration, Cell Culture and mixing, Storage, Sampling, and Fill-finish Applications.

Filtration is the most common application in the market. Single-use assemblies filter bioprocess fluids to eliminate contaminants, particles, and microbes in filtration applications. This procedure is critical for ensuring the final biopharmaceutical product's purity and sterility. In 2022, the filtration segment dominated the industry with a revenue share of 29% of total revenue. Due to their advantages of infiltration, using single-use filtration assemblies is fast expanding. SUTs save not just money and time but also 90 percent integrity testing, 90 percent sterile connections, and up to 90 percent tubing time. Unlike traditional filtering systems, single-use flirtation systems save process time because they are ready to use. Several manufacturing facilities will be required to address the growing market demand for biopharmaceuticals.

Cell culture and mixing applications include cultivating and propagating cells in bioreactors using single-use assemblies. Mixing is necessary for uniform growth and the distribution of nutrients and gasses. Single-use cell culture and mixing assemblies enable versatile and scalable procedures, allowing for efficient cell growth and bioprocess optimization.

Based on solutions, the market is divided into Customized, Standard.

Customized solutions are a significant contributor to the market. Customized single-use solutions are assemblies manufactured to satisfy a specific customer's needs, application, or process. These solutions are frequently developed with the end user or manufacturer to address unique issues or optimize a particular bioprocessing operation. In 2022, the customized solutions segment dominated the global industry, accounting for 75% of overall sales. Pharmaceutical businesses, labs, and other end-users can easily integrate the devices into their processes, speeding production and minimizing the trouble of sterilizing and cleaning with a single order.

Standard single-use solutions are pre-designed and off-the-shelf assemblies for various typical bioprocessing applications. These solutions are intended to fulfill the needs of a wide range of customers and are often easy to get and deploy without requiring substantial modification.

Based on end-users, the market is sub-segmented into Biopharmaceutical and Pharmaceutical Companies, CROs and CMOs, and Academic and Research Institutes.

Biopharmaceutical and pharmaceutical Companies are the primary end-users of the market. Established biopharmaceutical and pharmaceutical firms involved in the research, development, production, and commercialization of pharmaceutical goods such as biologics, vaccines, and traditional pharmaceuticals are included in this section. Single-use assemblies are used by biopharmaceutical and pharmaceutical businesses at many stages of product research and manufacture, including cell culture, fermentation, purification, and fill-finish procedures.

CROs and CMOs provide biopharmaceutical and pharmaceutical companies with outsourced services such as research, development, clinical trials, and contract manufacturing of biopharmaceutical products.

Recent Developments

• June 2024- Thermo Fisher Scientific will open a new GMP-certified ultra-cold facility in the EU to accelerate advanced therapy development.
• May 2024- Sartorius and NVIDIA collaborated to advance drug discovery and manufacturing through AI.
• April 2024- Watson-Marlow Fluid Technology Solutions introduced new single-use solutions for fluid management.