Single Use Assemblies Market

Market Definition

The market involves the production and sale of pre-assembled, disposable fluid management systems used primarily in biopharmaceutical and biotechnology processes. These systems streamline sterile manufacturing by eliminating the need for cleaning and sterilization. 

Commonly used in vaccine production, cell therapy, and drug development, they enhance process efficiency, reduce contamination risk, and support flexible manufacturing operations. The report outlines the primary drivers of market growth, along with an in-depth analysis of emerging trends and evolving regulatory frameworks shaping the industry's trajectory.

Single Use Assemblies Market Overview

The global single use assemblies market size was valued at USD 12.65 billion in 2024 and is projected to grow from USD 14.41 billion in 2025 to USD 40.80 billion by 2032, exhibiting a CAGR of 16.03% during the forecast period. 

The market is driven by the rising vaccine production and growing use of automation, which depends on single-use systems to enable faster, scalable manufacturing while minimizing contamination risks. Automation enhances precision, real-time monitoring, and regulatory compliance, supporting efficient, sterile bioproduction aligned with evolving industry demands.

Major companies operating in the single use assemblies industry are Thermo Fisher Scientific Inc., Sartorius AG, Merck KGaA, Avantor, Inc., Repligen Corporation, Corning Incorporated, Entegris, Lonza, ZACROS Corporation, NewAge Industries, Spirax Group, Cobetter, Nupore Filtration Systems, Intellitech Inc., and SaniSure.

The market is growing due to rising demand for contamination control in sterile manufacturing. These disposable systems eliminate risks associated with reusable equipment by reducing human contact and preventing product carryover. Their use in automated and modular setups enhances sterility, regulatory compliance, and product safety. 

As a result, they are essential in high-purity biopharmaceutical production, offering a reliable and efficient alternative to traditional systems while supporting stringent hygiene and quality standards in critical processing environments.

• In March 2025, Mycenax and Sartorius formed a strategic partnership to deliver integrated biopharmaceutical manufacturing solutions. Combining Mycenax’s flexible CDMO expertise with Sartorius’s CHO cell line platform, the alliance offers end-to-end services from cell line development to GMP production and sterile filling. This collaboration enhances global service capabilities, accelerates protein drug development, and strengthens market access in the biopharmaceutical sector.

Key Highlights:

1. The single use assemblies market size was recorded at USD 12.65 billion in 2024.
2. The market is projected to grow at a CAGR of 16.03% from 2025 to 2032.
3. North America held a market share of 37.44% in 2024, with a valuation of USD 4.74 billion.
4. The filtration assemblies segment garnered USD 4.88 billion in revenue in 2024.
5. The filtration segment is expected to reach USD 15.69 billion by 2032.
6. The contract research organizations & contract manufacturing organizations segment is anticipated to witness the fastest CAGR of 17.91% during the forecast period.
7. Asia Pacific is anticipated to grow at a CAGR of 16.94% during the forecast period.

Market Driver

Growing Adoption of Single-Use Technologies in Vaccine

The market is driven by the growing adoption of single-use technologies in vaccine production, which has accelerated due to the need for rapid response during global health crises. These technologies enable faster manufacturing cycles, reduce contamination risks, and eliminate extensive cleaning processes. 

Their flexibility supports scaling production up or down efficiently, meeting fluctuating demand. As vaccine complexity increases, single-use systems provide streamlined, cost-effective solutions that enhance process reliability and compliance with stringent regulatory standards.

• In August 2024, Pfizer Inc. and BioNTech SE received Food and Drug Administration (FDA) approval of their Omicron KP.2-adapted 2024-2025 COVID-19 vaccine for individuals of age 12 and older, with emergency use authorization for ages 6 months to 11 years. The vaccine will be administered as a single dose for 5 years and older and it relies on advanced single-use assemblies to ensure sterile, efficient manufacturing and rapid distribution.

Market Challenge

Concerns over Plastic Waste and Environmental Sustainability

The single use assemblies market faces a significant challenge from concerns over plastic waste and environmental sustainability. These assemblies are primarily made of plastic and designed for one-time use, leading to large volumes of biomedical waste. As environmental regulations tighten and sustainability becomes a priority, manufacturers face pressure to reduce the ecological impact of their products.

To address this, companies are developing recyclable and biodegradable materials and investing in waste-to-energy solutions. Key players are also designing single-use components with lower material use and improved lifecycle analysis to reduce environmental footprint while maintaining safety and efficiency in biopharmaceutical production.

Market Trend

Increasing Use of Automation in Single-Use Systems

A key trend in the market is the increased automation in system integration, reflecting the shift toward high-efficiency pharmaceutical manufacturing. Automated single-use systems reduce human intervention, enhance precision, and support consistent sterile operations in controlled environments. 

This aligns with the growing adoption of robotic fill-finish lines and cleanroom technologies. Automation also supports real-time monitoring, improves batch traceability, and streamlines regulatory compliance, making it integral to next-generation bioproduction strategies focused on speed, safety, and scalability.

• In June 2024, Particle Measuring Systems and Pharma Integration launched the BioCapt Single-Use AutoM Microbial Impactor, designed for automated microbial air monitoring in robotic pharmaceutical manufacturing. Its magnetic seal ensures contamination control, eliminates manual handling, and integrates easily into existing lines. It is fully disposable and compliant with ISO 14698-1.

Single Use Assemblies Market Report Snapshot

Segmentation	Details
By Product Type	Bag Assemblies, Filtration Assemblies, Bottle Assemblies, Tubing Assemblies, Others
By Application	Filtration, Cell Culture & Mixing, Storage, Sampling, Others
By End-user	Biopharmaceutical & Pharmaceutical Companies, Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs), Academic & Research Institutes
By Region	North America: U.S., Canada, Mexico
	Europe: France, UK, Spain, Germany, Italy, Russia, Rest of Europe
	Asia-Pacific: China, Japan, India, Australia, ASEAN, South Korea, Rest of Asia-Pacific
	Middle East & Africa: Turkey, U.A.E., Saudi Arabia, South Africa, Rest of Middle East & Africa
	South America: Brazil, Argentina, Rest of South America

Market Segmentation:

• By Product Type (Bag Assemblies, Filtration Assemblies, Bottle Assemblies, Tubing Assemblies, and Others): The filtration assemblies segment earned USD 4.88 billion in 2024 due to the rising demand for high-purity filtration solutions in biologics manufacturing and stringent regulatory requirements for contamination control.
• By Application (Filtration, Cell Culture & Mixing, Storage, and Sampling): The filtration segment held 38.31% of the market in 2024, due to its critical role in ensuring product sterility and purity across various stages of biopharmaceutical manufacturing.
• By End-user (Biopharmaceutical & Pharmaceutical Companies, Contract Research Organizations (CROs) & Contract Manufacturing Organizations (CMOs), Academic & Research Institutes): The biopharmaceutical & pharmaceutical companies segment is projected to reach USD 18.98 billion by 2032, due to increasing adoption of single-use technologies to accelerate drug development, enhance manufacturing flexibility, and reduce operational costs.

Single Use Assemblies Market Regional Analysis

Based on region, the global market has been classified into North America, Europe, Asia Pacific, Middle East & Africa, and South America.

North America single use assemblies market share stood at around 37.44% in 2024 in the global market, with a valuation of USD 4.74 billion. North America leads the market due to its advanced biopharmaceutical infrastructure and focus on scalable bioprocessing. 

This supports efficient progression from research to commercial production. Growing investment in flexible, sustainable manufacturing technologies further drives market growth. 

The region also benefits from a strong network of contract development and manufacturing organizations (CDMOs), which enhances its ability to meet diverse industry needs. These factors collectively reinforce North America's central role in driving the adoption of single-use systems across biopharmaceutical applications.

• In April 2025, Thermo Fisher Scientific introduced the 5L DynaDrive Single-Use Bioreactor, offering scalable bioprocessing from 1 to 5,000 liters. Designed for biopharma, CDMOs, and biotech firms, it claims to boost productivity by 27% over glass systems. Featuring consistent design and film across all scales, it enhances efficiency, supports rapid development, and streamlines commercialization while improving sustainability through biobased film and retention devices.

Asia Pacific is poised for significant growth at a CAGR of 16.94% over the forecast period. A key factor driving the growth of the single use assemblies industry in Asia Pacific is the increasing establishment of local biopharmaceutical manufacturing facilities to reduce dependence on imports and strengthen domestic supply chains. 

Governments across the region are actively supporting initiatives to boost pharmaceutical self-sufficiency, leading to rising investments in modern, contamination-free production technologies. 

This shift is encouraging the widespread adoption of single-use assemblies, which offer greater efficiency, faster turnaround, and improved sterility meeting the growing demand for high-quality biopharmaceutical products across diverse regional markets.

Regulatory Frameworks

• In the U.S., single-use assemblies used in biopharmaceutical manufacturing are regulated primarily by the Food and Drug Administration (FDA). The FDA ensures these products meet safety, quality, and sterility standards under its guidelines for medical devices and drug manufacturing.
• In India, the Central Drugs Standard Control Organization (CDSCO), operating under the Indian Ministry of Health and Family Welfare, regulates single-use assemblies. These devices are classified as medical devices under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. CDSCO oversees their manufacture, import, sale, and distribution, ensuring compliance with safety, efficacy, and quality standards.
• In Europe, single-use assemblies are regulated under the Medical Devices Regulation (MDR) by the European Medicines Agency (EMA) and notified bodies. These authorities ensure compliance with safety, quality, and performance standards for medical devices used in biopharmaceutical manufacturing.

Competitive Landscape

Key players in the single use assemblies market are employing strategies such as mergers and acquisitions, strategic partnerships, and product launches to strengthen their market positions. Market players are actively aiming to expand product portfolios, enhance technological capabilities, and increase geographic reach. Companies are also investing in advanced single-use solutions to meet evolving industry demands.

• In April 2024, SaniSure introduced Fill4Sure, a customizable single-use filling assembly aimed at improving efficiency, scalability, and process security in drug fill-finish operations. It offers features like low-particulate surge bags, silicone overmolding, high-performance tubing, and contamination-resistant needles, Fill4Sure addresses key manufacturing challenges while supporting streamlined bioprocessing, capacity expansion, and enhanced supply chain stability.

List of Key Companies in Single Use Assemblies Market:

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Merck KGaA
• Avantor, Inc.
• Repligen Corporation
• Corning Incorporated
• Entegris
• Lonza
• ZACROS Corporation
• NewAge Industries
• Spirax Group
• Cobetter
• Nupore Filtration Systems
• Intellitech Inc.
• SaniSure

Recent Developments (Product Launch)

• In September 2024, Merck launched the Mobius Antibody-Drug Conjugate (ADC ) Reactor, the first scalable single-use mixer tailored for antibody-drug conjugate (ADC) manufacturing. Leveraging Ultimus Film for superior leak resistance, it claims to improve efficiency by 70% over traditional methods. This innovation addresses chemical compatibility challenges in ADC production, offering faster turnaround, reduced contamination risk, and enhanced operational flexibility for biopharmaceutical manufacturers.
• In August 2024, Freudenberg Medical expanded its biopharma portfolio with custom single-use assemblies, including y-connector manifolds, tubing, and bottle cap assemblies for critical fluid transfer in lab and cGMP processes. These assemblies ensure leak prevention and flow consistency.
• In April 2023, Merck introduced Ultimus Single-Use Process Container Film that offers high durability and leak resistance in bioprocessing applications. Featuring a proprietary woven nylon structure, the film claims to offer 10 times greater abrasion resistance, 2.8 times higher tensile strength, and double the puncture resistance compared to standard films.