Single-use Assemblies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Bag Assemblies (2D bag assemblies, 3D bag assemblies), Filtration Assemblies, Bottle Assemblies, Tubing Assemblies, Others), By Application (Filtration, Storage, Cell Culture & Mixing, Sampling, Fill-finish Applications, Others), By End user (Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs, Academic & Research Institutes), By Region and Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 3.57 Billion
CAGR (2026-2031)	5.85%
Fastest Growing Segment	Filtration Assemblies
Largest Market	North America
Market Size (2031)	USD 5.02 Billion

Market Overview

The Global Single-use Assemblies Market will grow from USD 3.57 Billion in 2025 to USD 5.02 Billion by 2031 at a 5.85% CAGR. Global Single-use Assemblies consist of distinct pre-sterilized plastic components such as tubing, manifolds, and connectors integrated into a unified system for biopharmaceutical fluid management. The market is primarily propelled by the critical necessity to eliminate cross-contamination risks between batches and the operational requirement for flexible manufacturing lines that significantly reduce changeover times and capital expenditure. According to the Bio-Process Systems Alliance, in 2024, concerns regarding supply chain security for these technologies decreased by 14%, reflecting a strengthening logistics framework that further supports industry adoption.

Despite this expansion, the industry faces a significant challenge regarding the environmental impact of increasing plastic waste generated by these disposable products. The disposal of non-biodegradable materials necessitates complex waste management strategies to align with global sustainability goals, which could potentially impede the rate of market application in environmentally stringent regions.

Key Market Drivers

Surging Global Demand for Biopharmaceuticals and Biologics is the primary engine propelling the adoption of single-use assemblies. As the pharmaceutical industry accelerates the production of monoclonal antibodies, vaccines, and cell therapies, manufacturers are increasingly relying on disposable technologies to ensure supply chain continuity and handle high-volume processing requirements. The transition from clinical to commercial-scale manufacturing necessitates robust fluid management systems that can be deployed rapidly without the bottlenecks associated with fixed infrastructure. This trend is evidenced by recent financial performance in the sector; according to Sartorius, October 2025, in the '9M 2025 Earnings Release', the company's Bioprocess Solutions Division recorded a sales revenue increase of 9.9 percent in constant currencies, a growth explicitly driven by the strong performance of consumables used in biopharmaceutical manufacturing. To support this expanding market requirement, industry leaders are heavily capitalizing on capacity expansion; according to Sartorius, in 2025, investments in global research and production infrastructure amounted to 305 million euros, highlighting the sector's commitment to meeting future demand.

Minimization of Water and Energy Consumption in Bioprocessing has also emerged as a decisive factor influencing market uptake, as companies align operational strategies with stringent environmental goals. By replacing traditional stainless steel equipment with single-use assemblies, facilities can eliminate energy-intensive steam-in-place (SIP) and clean-in-place (CIP) cycles, thereby significantly lowering their utility footprint and water usage. This operational shift is not merely a regulatory compliance measure but a core strategic objective for the industry. According to Cytiva, September 2024, in the 'Single-use and sustainability' article, sustainability is now ranked as the number one priority for 62% of biopharma companies over the next five years. This prioritization is driving a widespread replacement of permanent piping and reusable vessels with disposable alternatives, ensuring that manufacturing efficiency does not come at the cost of environmental responsibility.

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Key Market Challenges

The substantial environmental footprint associated with the disposal of plastic waste constitutes a critical challenge impeding the broader expansion of the Global Single-use Assemblies Market. Unlike traditional stainless-steel systems that are cleaned and reused, single-use assemblies are designed for one-time application, leading to a continuous generation of solid bio-hazardous waste. This reliance on disposable multi-layer polymers creates a direct conflict with the stringent sustainability mandates and net-zero goals increasingly adopted by biopharmaceutical manufacturers and regulatory bodies. Consequently, in regions with rigorous environmental protection laws, the operational complexity and high costs associated with incinerating or managing this non-recyclable waste discourage the full-scale replacement of conventional equipment.

The magnitude of this issue is underscored by recent industry projections regarding waste accumulation. According to the Bio-Process Systems Alliance, in 2024, it was reported that biopharmaceutical manufacturing-related plastic waste is estimated to rise significantly to reach 11,700 metric tons per year by 2028. This projected increase highlights the severity of the waste management burden, effectively forcing companies to weigh the operational flexibility of single-use technologies against their escalating ecological impact. As a result, the difficulty in aligning these disposable products with circular economy principles continues to act as a substantial retarding force on market penetration.

Key Market Trends

The Expansion of Regionalized Manufacturing and Supply Chain Hubs is reshaping the single-use landscape as biopharmaceutical companies increasingly decentralize production to mitigate geopolitical risks and ensure local supply security. This strategic shift involves the construction of "cookie-cutter" manufacturing facilities in key regional markets, utilizing single-use assemblies to replicate standardized processes without the heavy infrastructure required for traditional stainless-steel plants. This trend is directly supported by financial performance in the sector; according to WuXi Biologics, March 2025, in the '2024 Annual Results', the company reported a 13.1% year-over-year increase in non-COVID revenue, a growth explicitly attributed to the successful ramp-up of its expanded manufacturing sites in Europe and other regions.

Concurrently, the Development of Specialized Assemblies for Cell and Gene Therapies is gaining momentum, driven by the unique stringency requirements of advanced therapeutic modalities. Unlike standard biologics, cell and gene therapies often require assemblies that can withstand cryopreservation temperatures and minimize particulate contamination to strictly protect small-volume patient batches. However, the industry faces a capability gap in this area; according to Cytiva, October 2025, in the 'Global Biopharma Index 2025', more than 25% of biopharma executives reported that their current supply chains are not equipped to support advanced modalities such as cell and gene therapies, highlighting an urgent market need for purpose-built disposable components.

Segmental Insights

The Filtration Assemblies segment is recognized as the fastest-growing category within the Global Single-use Assemblies Market. This rapid expansion is primarily driven by the critical necessity to mitigate cross-contamination risks during biopharmaceutical manufacturing processes. Producers are widely adopting disposable filtration units to comply with stringent sterility mandates enforced by regulatory bodies such as the US Food and Drug Administration. Furthermore, the ability to bypass complex cleaning and validation procedures required for reusable equipment significantly enhances operational efficiency, thereby fueling the consistent demand for these single-use filtration solutions in the production of biologics and vaccines.

Regional Insights

North America holds the leading position in the global single-use assemblies market, driven by a well-established biopharmaceutical manufacturing infrastructure. The region benefits from a high concentration of major pharmaceutical companies and substantial investments in research and development. Furthermore, regulatory agencies such as the U.S. Food and Drug Administration support the adoption of disposable technologies to mitigate cross-contamination risks and accelerate the time-to-market for biologics. This favorable regulatory environment, combined with increasing demand for efficient production methods, solidifies North America as the primary market for single-use assemblies.

Recent Developments

• In March 2025, Cytiva expanded its Xcellerex single-use bioreactor portfolio by introducing new 500-liter and 2,000-liter X-platform systems. These additions were designed to facilitate the scalable manufacturing of advanced therapeutics, allowing a seamless transition from smaller pilot scales to commercial production. The new bioreactors featured enhanced sensor technologies, including infrared-based foam detection for automated process control and improved ergonomic designs for safer filter and bag management. This launch aimed to increase operational efficiency and production capacity for biopharmaceutical developers, supporting the rapid delivery of next-generation medicines to the market while minimizing the risks associated with scaling up complex biological processes.
• In October 2024, Avantor announced an expanded collaboration with the National Institute for Bioprocessing Research and Training (NIBRT) to address critical efficiency challenges in biopharmaceutical manufacturing. The partnership focused on optimizing downstream processing workflows, particularly for monoclonal antibodies, by integrating the company’s advanced single-use fluid handling technologies and chromatography solutions. Through this agreement, the company committed to providing state-of-the-art equipment and specialized training programs at the institute's facility. This initiative aimed to upskill the biopharma workforce and demonstrate how single-use assemblies can resolve bottlenecks in drug production, ultimately supporting the industry's need for higher yields and more flexible manufacturing operations.
• In September 2024, MilliporeSigma launched the Mobius ADC Reactor, a breakthrough single-use system specifically engineered for the manufacturing of antibody-drug conjugates. This innovative reactor was designed to address the unique challenges of linking toxic payloads to antibodies, a process that traditionally required complex cleaning of stainless steel equipment. By utilizing single-use technology, the system eliminated the need for hazardous cleaning validation and significantly reduced the risk of cross-contamination between batches. The company reported that this new solution could increase manufacturing efficiency by approximately 70% compared to traditional methods, thereby accelerating the production timeline for these potent therapeutic agents.
• In April 2024, SaniSure launched Fill4Sure, a customized single-use filling assembly designed to streamline the critical fill-finish stage of drug manufacturing. This new product line featured a sterile, pre-assembled fluid path that included low-particulate 2D surge bags and silicone overmolded connections to ensure high durability and integrity. The system was engineered to mitigate contamination risks and eliminate the cleaning steps associated with traditional stainless steel needles and tubing. By offering a ready-to-use solution, the company aimed to help biopharmaceutical manufacturers reduce operational costs, enhance process security, and accelerate the time-to-market for high-value injectable drugs.

Key Market Players

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation
• Merck KGaA
• Avantor, Inc.
• Parker Hannifin Corp.
• Repligen Corporation
• Corning Incorporated
• Meissner Filtration Products, Inc.
• Dover Corporation
• TSE Industries, Inc.
• Fujimori Kogyo Co., Ltd.

By Product	By Application	By End user	By Region
Bag Assemblies (2D bag assemblies, 3D bag assemblies) Filtration Assemblies Bottle Assemblies Tubing Assemblies Others	Filtration Storage Cell Culture & Mixing Sampling Fill-finish Applications Others	Biopharmaceutical & Pharmaceutical Companies CROs & CMOs Academic & Research Institutes	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Single-use Assemblies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Single-use Assemblies Market, By Product:

• Bag Assemblies (2D bag assemblies, 3D bag assemblies)
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Others

• Single-use Assemblies Market, By Application:

• Filtration
• Storage
• Cell Culture & Mixing
• Sampling
• Fill-finish Applications
• Others

• Single-use Assemblies Market, By End user:

• Biopharmaceutical & Pharmaceutical Companies
• CROs & CMOs
• Academic & Research Institutes

• Single-use Assemblies Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE