Single-use Assemblies Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

Single-Use Assemblies Market Analysis

The Single-Use Assemblies Market size is estimated at USD 3.41 billion in 2025, and is expected to reach USD 7.15 billion by 2030, at a CAGR of 15.96% during the forecast period (2025-2030).

The single-use assemblies industry is experiencing a significant transformation driven by technological advancements and sustainability initiatives. According to industry data, single-use systems deliver remarkable operational efficiencies, including a 46% reduction in water and energy consumption, a 35% improvement in CO2 emissions due to reduced facility emissions, and a 40% lower initial investment cost compared to traditional systems. This shift towards sustainable manufacturing practices has prompted major industry players to invest heavily in expanding their production capabilities and developing innovative solutions. The integration of advanced materials and manufacturing processes has enhanced the durability and reliability of single-use assemblies, making them increasingly attractive for biopharmaceutical manufacturing operations.

The industry landscape is witnessing substantial investments in manufacturing infrastructure and technology development. In September 2022, Merck KGaA demonstrated its commitment to the sector by investing EUR 130 million to enhance single-use technology capabilities at its Molsheim, France facility, while in February 2023, Foxx Life Sciences invested USD 2.5 million in India to expand pharmaceutical single-use technology capabilities. These investments reflect the industry's response to growing demand and the need for enhanced production capabilities. The expansion of manufacturing facilities has been accompanied by technological innovations aimed at addressing key challenges in bioprocessing applications.

Product innovation and development continue to drive market evolution, with manufacturers focusing on addressing critical challenges such as durability and leak resistance. In April 2023, Merck launched its Ultimus single-use Process Container Film, specifically designed to provide enhanced durability and leak resistance for bioprocessing applications. Similarly, Cytiva introduced X-platform bioreactors to streamline single-use upstream bioprocessing operations, demonstrating the industry's commitment to improving operational efficiency and process optimization. These innovations reflect the industry's response to end-user demands for more reliable and efficient single-use solutions.

The market is experiencing a shift towards integrated solutions and comprehensive bioprocessing platforms. Manufacturers are increasingly focusing on developing complete single-use solutions that encompass multiple aspects of bioprocessing, from upstream to downstream operations. This trend is evidenced by recent strategic collaborations and acquisitions aimed at expanding product portfolios and technological capabilities. The industry has also witnessed increased attention to quality control and regulatory compliance, with manufacturers investing in advanced testing and validation procedures to ensure product reliability and safety. This evolution towards integrated solutions is reshaping the competitive landscape and driving innovation across the industry.

Single-use Assemblies Market Trends

Rapid Implementation and Low Risk of Cross-Contamination

Single-use assemblies have revolutionized biopharmaceutical manufacturing by offering significant advantages over traditional stainless-steel systems. These assemblies consist of disposable components such as bags, tubing, connectors, and filters that are used once and then discarded, eliminating the need for extensive cleaning and sterilization procedures between manufacturing runs. This rapid implementation capability allows manufacturers to respond swiftly to changing market demands and production schedules, significantly reducing setup times and operational complexity. For instance, in April 2023, Cytiva launched X-platform bioreactors to streamline single-use systems upstream bioprocessing operations, demonstrating how these systems can boost process efficiency through enhanced production capability and streamlined supply chain operations.

The risk of cross-contamination poses a significant challenge in biopharmaceutical manufacturing, where even minimal impurities can compromise product quality and safety. Single-use assemblies effectively address this concern by providing a fresh, sterile environment for each production batch. For example, in March 2022, Cellexus International launched a single-use mixing system airlift bioreactor that helps scientists grow delicate cell cultures efficiently and cost-effectively. The Cell Maker creates bubbles that filter through the mixture, providing gentle mixing action for fragile cell cultures while maintaining sterility. This innovation not only enhances product purity but also simplifies regulatory compliance by reducing the need for extensive cleaning validation studies, making it an attractive solution for manufacturers focused on product quality and operational efficiency.

Increasing R&D Investment by Biopharmaceutical Companies

The biopharmaceutical industry is experiencing unprecedented levels of research and development investment, driving the adoption of single-use technology. These investments are primarily focused on developing innovative therapies and optimizing manufacturing processes to meet growing market demands. For instance, in February 2023, Foxx Life Sciences announced plans to invest USD 2.5 million in Telangana, India, to expand capabilities in pharmaceutical single-use technology for drug manufacturing. Similarly, in September 2022, Merck KGaA invested 130 million euros in expanding its manufacturing arm MilliporeSigma's single-use systems capabilities at its facility in Molsheim, France, marking the largest investment in the site's 50-year history.

The surge in R&D investments has led to significant facility expansions and technological advancements in single-use technologies. In April 2024, Aptar Pharma announced a major capacity expansion plan at its Congers, New York site, significantly expanding the manufacturing capacity of its proprietary systems through the addition of molds and assembly lines in cleanroom manufacturing settings. Additionally, in January 2024, AbbVie Inc. invested USD 223 million to expand its Singapore manufacturing facility, adding new biologics manufacturing capacity and creating over 100 jobs. These investments demonstrate the industry's commitment to advancing single-use technologies and improving manufacturing capabilities to meet the growing demand for innovative biological therapies.

Growing Biologics Market

The biologics market has experienced substantial growth, driven by the increasing prevalence of chronic diseases and rising demand for personalized medicine. According to April 2024 data from the European Commission's EUROCAT, genetic anomalies were witnessed in 20.26 cases per 10,000 births in 2022, compared to 19.6 cases per 10,000 births in 2017 in Europe. This growing disease burden has led to increased development of biological therapies, which require sophisticated manufacturing processes that benefit from bioprocess container technologies. The Australian Institute of Health and Welfare reports that 4,500 (or 1.7%) of Australian babies are born with congenital disabilities each year, further highlighting the need for advanced biological treatments.

The expansion of biologics manufacturing facilities worldwide reflects the market's growth trajectory. In March 2024, Merck KGaA invested more than EUR 300 million into a new bioprocessing production center in Daejeon, South Korea, to support biopharmaceutical companies in process development, clinical research, and commercial manufacturing of biologics. Similarly, in January 2024, GSK announced plans to invest over USD 250 million in constructing new facilities and assembly lines in its United Kingdom sites by 2025. These investments demonstrate the industry's commitment to expanding biologics production capacity and the concurrent adoption of single-use filtration assemblies, which offer the flexibility and efficiency needed for modern biological drug manufacturing.

Segment Analysis: By Product Type

Filtration Assemblies Segment in Single-Use Assemblies Market

Filtration assemblies dominate the single-use assemblies market, commanding approximately 33% of the total market share in 2024. This significant market position is attributed to the segment's crucial role in ensuring the safety and quality of biotechnology and pharmaceutical products through various filtration systems like surface filtration, depth filtration, and ultra-filtration. The segment's leadership is further strengthened by the growing demand for reliable and efficient downstream bioprocessing applications such as sterile filtration, clarification, and virus removal. Major companies are actively expanding their single-use filtration assembly portfolios, as evidenced by TeraPore Technologies' launch of the IsoBlock VF product line for parvovirus removal from biopharmaceuticals in December 2023, demonstrating the segment's continued innovation and market dominance.

Bag Assemblies Segment in Single-Use Assemblies Market

The single-use bag assemblies segment is projected to experience the highest growth rate of approximately 17% during the forecast period 2024-2029. This exceptional growth is driven by the increasing adoption of continuous bioprocessing as an alternative to batch processing in the biopharmaceutical industry. The segment's growth is further accelerated by recent technological advancements, such as Xheme Inc.'s launch of the Xheme Multifunctional Additive (XMA) for bioprocess container films in July 2023, which demonstrated significant improvements in cell viability and proliferation. Additionally, Merck's introduction of the Ultimus Single-Use Process Container Film in April 2023, designed for extreme durability and leak resistance, exemplifies the ongoing innovation in this segment, making it increasingly attractive for bioprocessing applications.

Remaining Segments in Single-Use Assemblies Market by Product Type

The bottle assemblies and single-use mixing system assemblies segments complete the market landscape, each serving distinct but crucial functions in the biopharmaceutical manufacturing process. Bottle assemblies are essential for fluid transfer in various life science manufacturing and research laboratory settings, offering secured fluid transmission and storage capabilities. The mixing system assemblies segment focuses on efficient mixing of pharmaceutical ingredients and preparation of process solutions, providing advantages such as reduced validation and operating costs. Both segments continue to evolve with technological advancements and increasing adoption of single-use technologies in bioprocessing applications, contributing to the overall market growth.

Segment Analysis: By Application

Filtration Segment in Single-Use Assemblies Market

The filtration segment dominates the single-use assemblies market, commanding approximately 26% of the total market share in 2024. This significant market position is primarily driven by the growing production of biopharmaceuticals and increased investments in manufacturing and downstream processing. The segment's prominence is further reinforced by the critical role of single-use filtration in ensuring product quality and safety throughout the bioprocessing workflow. Single-use filtration assemblies have become increasingly essential in biopharmaceutical manufacturing due to their ability to minimize cross-contamination risks, reduce cleaning validation requirements, and provide enhanced operational flexibility. The segment's growth is also supported by continuous innovations in filter materials and designs, enabling more efficient and cost-effective bioprocessing solutions.

Cell Culture and Mixing Segment in Single-Use Assemblies Market

The cell culture and mixing segment is projected to experience the highest growth rate of approximately 17% during the forecast period 2024-2029. This exceptional growth is driven by the increasing development of biopharmaceuticals, including monoclonal antibodies, vaccines, and cell therapies. The segment's rapid expansion is supported by technological advancements in single-use technologies that favor healthy cell growth and improve operational efficiency. The adoption of single-use systems in cell culture applications has been particularly strong due to their ability to reduce contamination risks, decrease turnaround times, and provide greater flexibility in manufacturing processes. Recent innovations in mixing technologies and the launch of advanced products supporting cell culture processes have further accelerated the segment's growth trajectory.

Remaining Segments in Single-Use Assemblies Market by Application

The single-use assemblies market encompasses several other significant application segments, including storage, sampling, fill-finish applications, and other specialized applications such as aseptic transfer and fluid management. The storage segment plays a crucial role in maintaining product integrity throughout the bioprocessing workflow, while sampling applications ensure quality control and process monitoring. Fill-finish applications have gained importance due to the growing demand for sterile drug products and the need for contamination-free packaging solutions. The remaining specialized applications segment addresses specific needs in aseptic transfer and fluid management, contributing to the overall efficiency and safety of bioprocessing operations. Each of these segments continues to evolve with technological advancements and increasing adoption of single-use technologies in biopharmaceutical manufacturing.

Segment Analysis: By End-User

Biopharmaceutical and Pharmaceutical Companies Segment in Single-Use Assemblies Market

The biopharmaceutical and pharmaceutical companies segment dominates the single-use assemblies market, commanding approximately 56% of the market share in 2024. This significant market position is primarily driven by the increasing adoption of single-use technologies in biopharmaceutical manufacturing processes. The segment's growth is further bolstered by major pharmaceutical companies expanding their manufacturing facilities and increasingly incorporating single-use systems to enhance operational efficiency and reduce cross-contamination risks. For instance, in April 2024, Aptar Pharma announced a capacity expansion plan in North America at its Aptar Congers, New York site, significantly expanding the manufacturing capacity of its proprietary systems. Similarly, in January 2024, AbbVie Inc invested USD 223 million to expand its Singapore's Tuas Biomedical Park manufacturing facility, incorporating single-use technologies. These developments, coupled with the growing demand for biologics and the need for flexible manufacturing solutions, continue to strengthen the segment's market leadership.

Contract Research and Manufacturing Organizations Segment in Single-Use Assemblies Market

The Contract Research and Manufacturing Organizations (CROs/CMOs) segment is projected to exhibit the fastest growth rate of approximately 17% during the forecast period 2024-2029. This accelerated growth is attributed to the increasing outsourcing of biopharmaceutical manufacturing activities to CROs and CMOs, who are rapidly adopting single-use technologies to enhance operational efficiency and flexibility. The segment's expansion is evidenced by recent developments such as National Resilience Inc's February 2024 announcement to expand its clinical and commercial drug product manufacturing capabilities, aiming to provide over 200 million units to its partners by 2025. Additionally, in August 2023, Cellares raised USD 255 million in Series C funding to expand and launch an integrated development and manufacturing organization Smart Factory for cell therapy manufacturing. These strategic expansions and investments in single-use technologies by CROs and CMOs are driving the segment's rapid growth trajectory.

Remaining Segments in End-User Market

The academic and research institutes segment, while smaller in market share, plays a crucial role in advancing single-use assembly technologies through research and development activities. This segment is characterized by its focus on innovative applications and testing of single-use technologies in various research settings. Academic and research institutes contribute significantly to the validation and optimization of single-use assembly systems, particularly in areas such as cell culture, bioprocessing, and novel therapeutic development. Their work often leads to improvements in single-use technology design and applications, benefiting the entire industry. The segment's activities are supported by various research grants and collaborations with industry partners, enabling them to conduct cutting-edge research using single-use technologies while maintaining cost-effectiveness and experimental flexibility.

Single-Use Assemblies Market Geography Segment Analysis

Single-Use Assemblies Market in North America

North America represents a dominant force in the single-use assemblies market, driven by its well-established biopharmaceutical sector and extensive research infrastructure. The region benefits from the presence of major market players, advanced healthcare systems, and significant investments in biotechnology research and development. The United States, Canada, and Mexico collectively contribute to the region's market leadership, with each country demonstrating unique strengths in terms of manufacturing capabilities, research initiatives, and adoption of single-use technologies in bioprocessing applications.

Single-Use Assemblies Market in the United States

The United States maintains its position as the largest market for single-use assemblies in North America, commanding approximately 89% of the regional market share in 2024. The country's dominance is attributed to its robust biopharmaceutical infrastructure, presence of leading industry players, and widespread availability of various single-use assembly products for bioprocessing. The market is further strengthened by substantial government investments in biomanufacturing initiatives, strategic facility expansions by key players, and increasing adoption of single-use technologies across research institutions and pharmaceutical companies. The country's commitment to advancing biotechnology and bioprocessing capabilities has created a favorable environment for market growth, supported by stringent regulatory frameworks and continuous technological innovations.

Single-Use Assemblies Market in Canada

Canada emerges as the fastest-growing market in North America, with a projected growth rate of approximately 17% from 2024 to 2029. The country's remarkable growth is driven by increasing expenditure in biopharmaceutical research and development, growing government initiatives, and rising single-use assembly product developments. The Canadian market benefits from significant government investments in the biomanufacturing sector, with focused efforts on strengthening domestic pandemic response capabilities and life science innovation. The presence of key market players and their strategic activities, such as market expansions and facility developments, further contribute to the market's rapid growth. Canadian authorities have demonstrated a strong commitment to the biomanufacturing and pharmaceutical sectors, implementing various initiatives to meet the rising demand for medicines and biologics.

Single-Use Assemblies Market in Europe

Europe represents a significant market for single-use assemblies, characterized by its strong focus on biotechnology research, advanced manufacturing capabilities, and robust regulatory framework. The region's market is driven by increasing investments in biopharmaceutical research and development, growing adoption of single-use technologies, and the presence of major industry players. Germany, the United Kingdom, France, Italy, and Spain form the key markets within Europe, each contributing significantly to the region's growth through various initiatives and developments in the biopharmaceutical sector.

Single-Use Assemblies Market in Germany

Germany stands as the largest market for single-use assemblies in Europe, holding approximately 21% of the regional market share in 2024. The country's leadership position is supported by its strong pharmaceutical and biotechnology infrastructure, significant research and development activities, and high demand for single-use technologies. German manufacturers have demonstrated particular strength in implementing advanced manufacturing processes, with numerous companies investing in expanding their production facilities and adopting innovative single-use solutions. The country's market is further bolstered by substantial research and development expenditure in the pharmaceutical sector and strategic initiatives by key industry players.

Single-Use Assemblies Market in France

France emerges as the fastest-growing market in Europe, with a projected growth rate of approximately 17% from 2024 to 2029. The country's impressive growth trajectory is driven by increasing research and development expenditure, rising government support in biomanufacturing, and further biologics and biosimilars manufacturing activities. French authorities have demonstrated a strong commitment to life science research and development, particularly during recent years, leading the sector to proliferate significantly. The country's market benefits from strategic expansions by key players and significant investments in manufacturing facilities, particularly in the development of single-use technologies for bioprocessing applications.

Single-Use Assemblies Market in Asia-Pacific

The Asia-Pacific region represents a rapidly evolving market for single-use assemblies, characterized by increasing investments in biotechnology, growing adoption of advanced manufacturing technologies, and expanding healthcare infrastructure. The region encompasses key markets including China, Japan, India, Australia, and South Korea, each contributing uniquely to the market's development through various initiatives and investments in the biopharmaceutical sector. The market is driven by rising demand for biopharmaceuticals, increasing research and development activities, and a growing focus on cost-effective manufacturing solutions, including the use of bioprocess containers.

Single-Use Assemblies Market in China

China maintains its position as the largest market for single-use assemblies in the Asia-Pacific region. The country's dominance is attributed to its rapidly growing biopharmaceutical sector, increasing research and development investments, and strong government support for innovative drug development. Chinese authorities have implemented various initiatives to encourage biopharmaceutical enterprises in research and development activities, while also focusing on expanding manufacturing capabilities through strategic collaborations and facility expansions. The market benefits from the growing prominence of contract manufacturing organizations and continuous advancements in single-use technologies.

Single-Use Assemblies Market in India

India emerges as the fastest-growing market in the Asia-Pacific region. The country's remarkable growth is driven by increasing investments in biopharmaceutical companies for developing novel therapies, rising research studies about single-use technologies, and growing strategic initiatives by key players. The Indian market has witnessed significant developments in manufacturing facilities and increasing adoption of single-use technologies across biopharmaceutical companies. The country's focus on strengthening its global presence in biologics and biosimilars, coupled with building capabilities regarding quality and faster go-to-market strategies, has created a favorable environment for market growth.

Single-Use Assemblies Market in Middle East & Africa

The Middle East & Africa region demonstrates growing potential in the single-use assemblies market, driven by increasing investments in biotechnology and healthcare infrastructure. The region encompasses various markets including GCC countries and South Africa, with each area showing distinct development patterns and adoption rates of single-use technologies. Within this region, GCC emerges as the largest market, benefiting from robust healthcare infrastructure and significant investments in biopharmaceutical manufacturing, while South Africa shows the fastest growth potential, supported by increasing research activities and development of biomanufacturing capabilities.

Single-Use Assemblies Market in South America

The South American market for single-use assemblies demonstrates significant growth potential, characterized by increasing investments in biotechnology research and manufacturing capabilities. The region, primarily led by Brazil and Argentina, shows growing adoption of single-use technologies across various applications in the biopharmaceutical sector. Brazil emerges as the largest market in the region, supported by substantial investments in research and development and expanding manufacturing facilities, while Argentina shows promising growth potential through increasing research activities and strategic initiatives in the biotechnology sector.