Towards Healthcare
Single-Use Assemblies Market Leads by 16.15% CAGR till 2034

Single-Use Assemblies Market 2025 Insights Bag Assemblies, Biotech Demand Driving Billion-Dollar Growth

Market insights predict the global single-use assemblies industry will increase from USD 13.25 billion in 2024 to USD 58.44 billion by 2034, achieving a CAGR of 16.15%. The market is growing rapidly due to increasing biopharmaceutical production and the need for contamination-free, cost-efficient processing. Technological advancement and regulatory support are further accelerating global adoption.

Category: Life Sciences Insight Code: 5905 Format: PDF / PPT / Excel

The global single-use assemblies market size is calculated at USD 13.25 billion in 2024, grow to USD 15.39 billion in 2025, and is projected to reach around USD 58.44 billion by 2034. The market is expanding at a CAGR of 16.15% between 2025 and 2034.

Single-Use Assemblies Market Size 2024 - 2034

The single-use assemblies market is experiencing strong global growth, driven by rising biopharmaceutical and vaccine production, which demand sterile, flexible, and cost-effective processing solutions. These assemblies reduce contamination risks, enhance operational efficiency, and support faster turnaround in manufacturing. Technological advancements, along with supportive regulatory frameworks and increasing adoption in emerging markets, are further fueling market expansion across research labs, contract manufacturers, and pharmaceutical companies.

Key Takeaways

  • Single-use assemblies market to cross USD 13.25 billion in 2024.
  • Market projected at USD 58.44 billion by 2034.
  • CAGR of 16.15% expected in between 2025 to 2034.
  • North America dominated the single-use assemblies market revenue shares of approximately 44% in 2024.
  • Asia Pacific is expected to grow at the fastest CAGR in the market during the forecast period.
  • By solution type, the standard assemblies segment dominated the market with a revenue share of approximately 57%.
  • By solution type, the custom assemblies segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By product type, the bag assemblies segment led the market with the largest revenue share of approximately 28% in 2024.
  • By application, the filtration segment held the highest single-use assemblies market share of approximately 32% in 2024.
  • By application, the fill-finish segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By end user, the biopharmaceutical & biotech companies segment held the highest revenue shares of approximately 48% in 2024.
  • By end user, the contract manufacturing organizations (CMOs) segment is expected to grow at the fastest CAGR in the market during the forecast period.
  • By processing stage, the upstream processing segment dominated the market with the major revenue share of approximately 52% in 2024.
  • By processing stage, the fill & finish operations segment is expected to grow at the fastest CAGR in the market during the forecast period.

Key Metrics and Overview

Metric Details
Market Size in 2025 USD 15.39 Billion
Projected Market Size in 2034 USD 58.44 Billion
CAGR (2025 - 2034) 16.15%
Leading Region North America share by 44%
Market Segmentation By Solution Type, By Product Type, By Application, By End User, By Bioprocessing Stage, By Region
Top Key Players Sartorius AG, Thermo Fisher Scientific, Merck KGaA (MilliporeSigma), Danaher Corporation (Cytiva), Saint-Gobain Life Sciences, Avantor, Inc., Pall Corporation, Entegris, Inc., Repligen Corporation, Meissner Filtration Products, Parker Hannifin Corporation, EWPS (formerly Colder Products Company - CPC), KBI Biopharma, Eppendorf AG, ILC Dover LP, FlexBiosys Inc., Gore & Associates, ZETA GmbH, ABEC, Inc., Asahi Kasei Medical Co., Ltd.

How is the Single-Use Assemblies Market Evolving?

The Market refers to the market for pre-assembled, sterile fluid path systems designed for biopharmaceutical and biologics manufacturing processes. These assemblies integrate components such as tubing, connectors, clamps, filters, and sensors into ready-to-use systems that eliminate the need for cleaning, sterilization, and validation between batches. Single-use assemblies offer benefits such as reduced cross-contamination risk, faster turnaround time, improved operational flexibility, and lower operational costs.

As biologics and cell & gene therapies expand, demand for these disposable solutions continues to surge across upstream and downstream bioprocessing workflows. The single-use assemblies market is evolving rapidly, driven by increasing adoption in biologics and vaccines manufacturing. Innovation like integrated sensors, modular plug-and-play systems, and analytics-enabled disposables is enhancing flexibility, reducing contamination risk, and improving process efficiency.

  • In January 2025, Pall Corporation launched a new modular 3D bag system equipped with in-line sterile connectors, specifically developed to support upstream media preparation and large-scale filtration processes in biopharmaceutical manufacturing. (Source - Pall)
  • In April 2024, SaniSure launched Fill4Sure, a tailored single-use filling system designed to improve drug product filling by boosting safety, efficiency, and consistency, while also helping to speed up time-to-market for pharmaceutical products. (Source - Sanisure)

How Can AI Affect the Single-Use Assemblies Market?

AI can significantly impact the market by enhancing process optimization, predictive maintenance, and quality control. Through data analytics and machine learning, AI enables real-time monitoring of manufacturing workflows, reducing downtime and minimizing contamination risks. It also supports smarter supply chain management and accelerates innovation in design and production, making single-use systems more efficient, reliable, and adaptable to the evolving needs of biopharmaceutical manufacturing.

Market Dynamics

Driver

Rising Demand for Biopharmaceuticals and Vaccines

The surge in demand for biopharmaceuticals and vaccines is driving the adoption of single-use assemblies, as they offer flexible, sterile, and scalable solutions ideal for biologics production. These systems minimize contamination risks, reduce downtime, and eliminate the need for extensive cleaning, making them highly efficient for high-throughput manufacturing. With biologics becoming a central focus in modern medicine, single-use technologies are increasingly preferred for their ability to streamline production and meet growing global healthcare needs.

For Instance,

  • In April 2024, Aptar Pharma revealed plans to expand its manufacturing capabilities at its Congers, New York facility, including augmented cleanrooms and new assembly lines for its proprietary single-use systems like bag-on-valve technology. This expansion is aimed at supporting higher volumes and accelerating the production of biologics, exemplifying the industry's increasing reliance on disposable, modular assemblies for efficient scale-up.  (Source - Pharmaceutical Technology)

Restraint

Limited Reusability and Environmental Concerns Due to Plastic Waste

The disposable nature of single-use assemblies contributes to increasing plastic waste, which raises sustainability challenges and attracts environmental scrutiny. As industries and regulators push for eco-friendly manufacturing practices, concerns over waste management and the limited recyclability of medical-grade plastic make adoption more complex. This growing environmental pressure can hinder the market's expansion, especially in regions with strict waste disposal regulations and sustainability goals.

Opportunity

Expansion for Personalized Medicine and Cell & Gene Therapies

The growing focus on personalized medicine and cell and gene therapies presents a significant opportunity for the single-use assemblies market. These therapies require flexible, small-batch, and contamination-free manufacturing processes, which single-use systems are well-suited to provide. Their modular design, ease of customization, and reduced cross-contamination risk make them ideal for producing individualized treatments. As demand for precision therapies rises, the need for scalable and adaptable manufacturing solutions will further drive the adoption of single-use technologies.

For Instance, 

  • In March 2024, Syngene International unveiled its upgraded Unit 3 biologics facility in India, scheduled to begin operations in the second half of 2024. The expansion includes two production suites equipped with five 2 KL single-use bioreactors (totaling 20 KL capacity) and high-speed vialfilling lines capable of handling up to one million vials per day, demonstrating significant investment in single-use infrastructure for advanced therapy manufacture.  (Source - Contract Pharma)

Segmental Insights

How will the Standard Assemblies Segment Dominate the Single-Use Assemblies Market in 2024?

In 2024, the standard assemblies segment led the market due to their widespread availability, lower cost, and ease of integration into existing bioprocess workflows. These ready-made solutions are preferred for routine operations, reducing setup time and ensuring consistency across batches. Their reliability and shorter lead times make them ideal for large-scale biopharmaceutical manufacturing, especially where speed and cost-efficiency are critical, contributing to their dominant share in the global market.

The custom assemblies segment is expected to see the fastest growth as biopharma companies increasingly seek specialized solutions to match unique manufacturing requirements. These assemblies allow greater flexibility in system design, making them ideal for complex and small-batch production, such as in cell and gene therapies. As the industry shifts towards more personalized and high-value treatments, demand for tailored single-use systems that ensure precision and process compatibility continues to accelerate, driving the market expansion.

For Instance,

  • In March 2024, MilliporeSigma’s Mobius single-use assemblies were highlighted for offering flexible and customizable solutions that help speed up pharmaceutical manufacturing and drug development. These systems are designed to meet specific process requirements, enhancing efficiency and adaptability. (Source - Merck)

Why Did the Bag Assemblies Segment Dominate the Market in 2024?

The bag assemblies segment dominated the single-use assemblies market in 2024 because of its growing application in fluid handling, storage, and transfer across biopharmaceutical production. These systems are favored for their adaptability, space-saving design, and ability to maintain sterile conditions throughout processing. As demand for efficient and contamination-free manufacturing solutions increased, bag assemblies became the preferred choice for both small-and large-scale operations, driving their strong market performance during the year.

How Does the Filtration Segment Dominate the Single-Use Assemblies Market?

The filtration segment led the market in 2024, driven by its vital function in maintaining product safety and quality during bioprocessing. With biologics and vaccines requiring strict microbial control, filtration systems became essential for removing impurities throughout production. Single-use filtration setups are preferred for their ease of integration, reduced cleaning needs, and enhanced efficiency, making them a top choice across upstream and downstream processes in pharmaceutical manufacturing.

The fill-finish segment is projected to witness the fastest growth in the single-use assemblies market as pharmaceutical manufacturing shifts towards more efficient and sterile solutions for final drug packing. Single-use systems offer enhanced flexibility, reduced risk of cross-contamination, and faster changeovers, which are essential for handling sensitive biologics and small-batch production. Their ability to simplify compliance and support rapid scale-up makes them increasingly favored in modern aseptic processing environments.

How will the Biopharmaceutical & Biotech Companies Segment Dominate the Market in 2024?

The biopharmaceutical & biotech companies segment led the single-use assemblies market in 2024 as these organizations increasingly embraced single-use assemblies to streamline complex biologics production and reduce turnaround times. Their need for adaptable, sterile systems to support high-throughput workflows, especially in the development of advanced therapies, boosted adoption. With a growing focus on innovation, speed to market, and minimizing cross-contamination risks, these companies played a major role in driving revenue within the single-use assemblies space.

For Instance,

  • In January 2024, AbbVie Inc. announced a USD 223 million investment to expand its manufacturing site at Singapore's Tuas Biomedical Park, integrating advanced single-use systems. This expansion reflects the rising demand for biologics and the industry's shift toward more flexible and efficient production methods, further reinforcing the strong position of this segment in the global market. (Source - Abbvie)

The contract manufacturing organizations (CMOs) segment is projected to grow rapidly as more pharmaceutical companies rely on external partners to meet rising production demands and shorten time-to-market. Single-use assemblies offer CMOs the flexibility to manage diverse projects efficiently while minimizing downtime and contamination risks with the increasing downtime and contamination risks. With the increasing need for adaptable, small-batch manufacturing, especially in biologics and advanced therapies, CMOs are expanding their use of single-use systems to remain competitive and meet client expectations.

For Instance,

  • In August 2023, Cellares raised $255 million in Series C funding to develop its Smart Factory for cell therapy manufacturing. This reflects the growing trend of CMOs and CROs investing in single-use technologies to boost efficiency, flexibility, and scalability. (Source - Cellares)

Why Did the Upstream Processing Segment Dominate the Single-Use Assemblies Market in 2024?

The upstream processing segment led the market in 2024, driven by its vital role in initial biomanufacturing activities like cell growth and media handling. These stages demand sterile, flexible systems that reduce the risk of contamination and support rapid production cycles. With growing biologics output and the shift toward disposable technologies, single-use solutions became the preferred choice for upstream workflows, contributing significantly to the market dominance.

The fill & finish operations segment is projected to grow at the fastest CAGR in the single-use assemblies market due to increasing demand for sterile, flexible, and efficient final drug packing solutions. Single-use systems reduce the risk of contamination, lower cleaning validation requirements, and support quick batch changeovers, key advantages for aseptic processing. As biologics and personalized therapies require high precision and safety in final dosing, manufacturers are increasingly adopting single-use technologies to streamline fill & finish operations and meet regulatory standards.

Regional Insights

Single-Use Assemblies Market Share, By Region, 2024 (%)

How is North America Contributing to the Expansion of the Single-Use Assemblies Market?

North America dominated the market share by 44% in 2024, due to the strong presence of biopharmaceutical companies, increased adoption of advanced technologies, and robust investments in biologics and vaccine production. The region benefits from well-established healthcare infrastructure, favorable regulatory support, and a growing focus on personalized medicine. Additionally, the rising demand for flexible manufacturing processes and the need to reduce contamination risks further propelled the use of single-use systems across bioprocessing facilities in North America.

The U.S. Single-Use Assemblies Market Trends

The U.S. market is expanding due to the increasing demand for biologics, growing investments in biopharmaceutical R&D, and the need for cost-effective, flexible manufacturing solutions. The country’s strong regulatory framework, presence of key market players, and advancements in vaccine and cell therapy production also contribute to market growth. Additionally, the shift toward disposable technologies to reduce contamination risks and downtime is further driving adoption.

For Instance,

  • In 2023, key mergers in the biopharmaceutical industry and the growth of advanced pharma sectors, supported by a favorable domestic environment, significantly boosted the demand for single-use assemblies. (Source - Pharma Live)

The Canada Single-Use Assemblies Market Trends

Canada's market is increasing due to rising demand for efficient and contamination-free bioprocessing solutions. Growing investments in biologics manufacturing, supportive government initiatives, and expanding biopharmaceutical infrastructure are key drivers. The presence of skilled professionals and collaborations with global players are also enhancing market development. Additionally, the shift toward single-use technologies for flexible and scalable production processes is accelerating adoption across Canadian biotech and pharmaceutical sectors.

For Instance,

  • In June 2023, the Canadian government allocated over USD 2.1 billion to 36 biomanufacturing, vaccine, and therapeutic projects. This substantial investment is expected to boost the demand for single-use assemblies, as these systems offer a cost-effective alternative to traditional stainless-steel equipment by minimizing installation and cleaning needs, ultimately supporting market growth in the region over the coming years. (Source - Government of Canada)

How is Asia Pacific approaching the Single-Use Assemblies Market in 2024?

Asia-Pacific is anticipated to grow at the fastest pace in the market due to the rapid expansion of the biopharmaceutical sector, increasing government support, and rising investments in healthcare infrastructure. Countries like China, India, and South Korea are enhancing their manufacturing capabilities and adopting advanced bioprocessing technologies. Additionally, the growing demand for vaccines, biosimilars, and personalized therapies, along with a surge in clinical research activities, is driving the adoption of single-use systems in the region.

For Instance,

  • In February 2025, Thermo Fisher Scientific announced it would expand its bioproduction facility in Singapore to enhance the supply of pre-assembled single-use systems. This move aims to better serve the growing needs of clients across the Asia-Pacific region and strengthen the company’s regional manufacturing capabilities. (Source - Thermo Fisher)

The China Single-Use Assemblies Market Trends

China’s market is growing due to a booming biopharmaceutical sector supported by strong government incentives and rising R&D investments. The nation is expanding manufacturing capacity with global partnerships and domestic suppliers for bags, tubing, and connectors, reducing lead times and lowering costs. Furthermore, increased demand for biologics, biosimilars, and advanced manufacturing, alongside regulatory alignment with cGMP standards, drives the adoption of flexible, contamination-resistant disposable systems across China.

The India Single-Use Assemblies Market Trends

India’s market is expanding due to the increasing focus on domestic biologics and vaccine production, along with rising partnerships between local and global biopharma companies. The government's supportive initiatives, like Make in India and investments in biomanufacturing infrastructure, have accelerated adoption. Additionally, the need for scalable, cost-effective, and contamination-free production technologies is pushing pharmaceutical companies and contract manufacturers to shift toward single-use systems across their production processes.

How is Europe Accelerating the Single-Use Assemblies Market?

Europe is accelerating its market through a combination of industry investments, regulatory backing, and innovation in biomanufacturing. Governments are funding biotech infrastructure and biosimilars R&D, prompting major biopharma players and CDMOs to adopt modular single-use technologies. Advanced automation, materials innovations, and integration of process analytics support continuous and hybrid bioprocessing. Sustainability mandates such as EU eco-design directives and water-saving targets further encourage adoption, while expansion of new biomanufacturing hubs in Germany, the UK, and Switzerland bolsters regional uptake.

For Instance,

  • In May 2023, Getinge revealed its plan to acquire all shares of Purity New England, Inc., a leading provider of single-use bioprocessing technologies. This move strengthens Getinge’s position in the single-use assemblies market and expands its presence in the biopharmaceutical sector. (Source - Getinge)

The UK Single-Use Assemblies Market Trends

In 2023, the UK market generated approximately USD 575.8 million, driven by strong demand in filtration and rapid growth in cell culture and mixing applications. The country accounted for about 4.8% of the global market. With expanding biopharmaceutical manufacturing, rising adoption of flexible production systems, and strong government and private investments, the UK is expected to register the highest growth rate in Europe through 2030.

The Germany Single-Use Assemblies Market Trends

Germany’s market is rising due to its dominant pharmaceutical and biotechnology infrastructure, extensive R&D investments, and strong presence of global and domestic players like Merck KGaA and Sartorius AG. Leading CDMOs are expanding capacity using disposable systems to meet growing demand for biologics and biosimilars, ensure compliance with EUGMP standards, and streamline production flexibility and contamination control.

Top Companies in the Single-Use Assemblies Market

Life Science Microscopes Market Companies

  • Sartorius AG
  • Thermo Fisher Scientific
  • Merck KGaA (MilliporeSigma)
  • Danaher Corporation (Cytiva)
  • Saint-Gobain Life Sciences
  • Avantor, Inc.
  • Pall Corporation
  • Entegris, Inc.
  • Repligen Corporation
  • Meissner Filtration Products
  • Parker Hannifin Corporation
  • EWPS (formerly Colder Products Company - CPC)
  • KBI Biopharma
  • Eppendorf AG
  • ILC Dover LP
  • FlexBiosys Inc.
  • Gore & Associates
  • ZETA GmbH
  • ABEC, Inc.
  • Asahi Kasei Medical Co., Ltd.

Latest Announcement by Industry Leaders

In April 2024, SaniSure, a global leader in single-use bioprocessing solutions, recently introduced Fill4Sure, a customizable single-use filling system aimed at improving efficiency, consistency, and speed in drug product filling. Designed to tackle key industry challenges like high costs and slow production, Fill4Sure offers clean 2D surge bags, durable silicone overmolding, precision tubing, and contamination-free needles. Dr. Alex Van Hagen emphasized that Fill4Sure reflects their innovative approach and dedication to supporting customers through personalized, consultative design partnerships. (Source - Contract Pharma)

Recent Developments in the Single-Use Assemblies Market

  • In December 2024, Saint-Gobain Life Sciences entered into a strategic collaboration with a prominent European contract manufacturing organization to design and implement comprehensive disposable assembly systems across the facility, aiming to enhance production efficiency and flexibility. (Source - Saint Gobain)
  • In June 2024, Thermo Fisher Scientific announced plans to launch a new GMP-certified ultra-cold storage facility in the European Union. This facility is intended to support the rapid development of advanced therapies by providing specialized storage conditions and ensuring compliance with regulatory standards. (Source - Businesswire)

Segments Covered in the Report

By Solution Type

  • Standard Assemblies
  • Custom Assemblies

By Product Type

  • Bag Assemblies
  • Filtration Assemblies
  • Bottle Assemblies
  • Mixing System Assemblies
  • Tubing Assemblies
  • Sampling Assemblies
  • Others (Manifold assemblies, sensor-integrated assemblies)

By Application

  • Filtration
  • Cell Culture & Mixing
  • Storage
  • Sampling
  • Fill-Finish 
  • Fluid Transfer

By End User

  • Biopharmaceutical & Biotech Companies
  • Contract Manufacturing Organizations (CMOs) Academic & Clinical
  • Research Institutes
  • Contract Research Organizations (CROs)

By Bioprocessing Stage

  • Upstream Processing
  • Downstream Processing
  • Fill & Finish Operations

By Region 

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Last Updated: 28 July 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Deepa Pandey is a focused and detail-oriented market research professional with growing expertise in the healthcare sector, delivering high-quality insights across therapeutic areas, diagnostics, biotechnology and healthcare services.

Learn more about Deepa Pandey

Aditi Shivarkar, with over 14 years of experience in consumer goods, leads research at Towards Consumer Goods, ensuring precise, actionable insights on trends, consumer preferences, and sustainable packaging for businesses.

Learn more about Aditi Shivarkar

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FAQ's

The single-use assemblies market is projected to reach USD 58.44 billion by 2034, growing at a CAGR of 16.15% from 2024 to 2034.

North America is currently leading the healthcare cybersecurity market due to the strong presence of biopharmaceutical companies, increased adoption of advanced technologies, and robust investments in biologics and vaccine production.

The single-use assemblies market includes six segments by product type, by solution, by application, by end user, by bioprocessing stage, and by region.

Key trends include the growth due to increasing biopharmaceutical production and the need for contamination-free, cost-efficient processing.

By eliminating cleaning validation and reducing downtime between batches, they streamline operations and enable quicker turnaround, especially in multi-product facilities.

India Brand Equity Foundation, Food and Drug Administration, U.S. Environmental Protection Agency, European Medicines Agency, and National Medical Products Administration.