SINGLE USE ASSEMBLIES MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025-2032)

Global Single Use Assemblies Market Size and Share Analysis - 2025 to 2032

Global single-use assemblies market is expected to reach USD 51.56 Bn by 2032, from USD 16.19 Bn in 2025, exhibiting a CAGR of 18% during the forecast period.

Key Takeaways

• By Product, the Bag Assemblies segment is projected to dominate the global single-use assemblies’ market in 2025, accounting for an estimated 32.2% share.
• By Region, North America is expected to remain the largest market for single-use assemblies in 2025, holding over 35.7% of the global market share.
• By Region, the Asia Pacific region is forecasted to be the second-largest and fastest-growing market, with a projected 25.2% share in 2025.
• By Region, Europe is anticipated to be one of the fastest-growing markets, capturing approximately 19.0% of the market share in 2025.

Market Overview

Global Single Use Assemblies Market growth is propelled by increasing adoption of biopharmaceuticals, rising demand for flexible and cost-effective manufacturing, and stringent regulatory standards emphasizing contamination control. For example, single use bioreactors have gained traction due to faster setup times and reduced cross-contamination risks compared to traditional systems.

Single-use assemblies, also known as disposables, are pre-assembled sterile products that are intended for single-use application in biopharmaceutical manufacturing. There are mainly two types of single-use assemblies - single-use bioreactors and single-use mixers.

Current Events and Its Impacts on the Single Use Assemblies Market

Uncover macros and micros vetted on 75+ parameters: Get instant access to report

Segmental Insights 

To learn more about this report, Download Free Sample

Global Single Use Assemblies Market Insights, By Product

In terms of product, bag assemblies are expected to dominate the global single-use assemblies market in 2025, contributing an estimated 32.2% share of the total market value of USD 16.19 billion. This significant market share is driven by the widespread use of bag assemblies in biopharmaceutical manufacturing for fluid storage, mixing, and transfer applications.

Bag assemblies offer advantages such as contamination control, ease of use, and flexibility, making them essential components in disposable bioprocessing systems. Their compatibility with single-use bioreactors and filtration units further boosts demand. Additionally, ongoing innovations aimed at enhancing durability and scalability are expanding their application scope.

As the biopharma industry continues to prioritize cost-efficiency and contamination-free production, other product segments like filtration, tubing, and bottle assemblies are also witnessing steady growth, supporting the overall expansion of the single-use assemblies market.

Regional Insights 

To learn more about this report, Download Free Sample

North America Single-Use Assemblies Market Analysis and Trends

North America is expected to remain the largest market for single-use assemblies in 2025, holding over 35.7% of the global share. The region benefits from a strong pharmaceutical and biotechnology presence, led by the U.S. and Canada’s world-class R&D infrastructure. Early adoption of single-use assemblies by leading pharma companies has significantly reduced infrastructure costs and enhanced manufacturing flexibility. Supportive regulatory environments encourage technologies that improve bio-manufacturing efficiency, propelling further market growth.

Asia Pacific Single-Use Assemblies Market Analysis and Trends

Asia Pacific is projected to be the second-largest and fastest-growing market for single-use assemblies in 2025, accounting for over 25.2% of the global market share. Rapid expansion of biopharmaceutical industries in China, India, Japan, and South Korea is driving this growth, as these countries contribute more than 60% of global biologics production.

Rising disposable incomes and healthcare spending, combined with a skilled yet cost-competitive workforce, are attracting multinational investments to expand regional manufacturing capabilities. Government incentives aimed at promoting healthcare innovation and establishing advanced biomanufacturing hubs further bolster the market, enhancing supply chain networks and adoption of single-use technologies.

Europe Single-Use Assemblies Market Analysis and Trends

Europe is anticipated to be the fastest-growing region in the single-use assemblies market, with a 19% share in 2025. Growth is primarily driven by increased product launches and innovations from regional market players. Strong focus on biopharmaceutical advancements and adoption of single-use technologies for scalable and contamination-free manufacturing are key contributors to Europe’s expanding market footprint.

Global Single-use Assemblies Market- Drivers

• Increasing Demand for Disposable Systems

The biopharmaceutical industry has been seeing a gradual shift towards the use of single-use assemblies as these offer significant economic advantages over traditional stainless steel-based equipment. Using single-use assemblies reduces the costs associated with cleaning, sterilization and validation of multi-use equipment. Cleanup and sterilization services of stainless-steel bioreactors and transfer lines after every production run require considerable labor, water, steam and chemical costs.

Running a biotech plant, the old way can get quite pricey, because every piece of equipment must be scrubbed, tested, and logged after each batch. Switching to pre-sterilized, single-use bags cuts out most of that exhausting clean-room choreography. Manufacturers can swap from one product to the next almost on the spot and with far fewer delays. That speed boosts overall equipment effectiveness and keeps the facility busy for longer stretches.

Single-use kits are meant for a single run and then sent to the shredder, so nothing sits around waiting to be cleaned. By using them, companies dodge repeat bills for cleaning tanks, pipes, and filters over and over again. Industry estimates say the upfront use-cost can trim cleaning-validation expenses by 70 to 80 percent when measured against the traditional model. Because of those savings, single-use processing looks smart even when the final output runs into hundreds of thousands of doses.

Newer innovations-large bags, user-friendly connectors, and tougher materials-have stretched the single-use footprint into almost every corner of industrial biology. Cost and convenience together are pushing more biopharma firms to embrace these disposable assemblies at an accelerating pace.

• Increasing Levels of Outsourcing

The global market for single-use production sets keeps growing because more biopharma work is handed to contract development and manufacturing organizations, or CDMOs. By sending bulky, expensive production tasks to these partners, drug sponsors and smaller biotechs can stay focused on research and early trials.

CDMOs, in turn, lean heavily on disposable kits so they can switch between products on the same line without long waits. Yet because regulators watch every step, these facilities must limit any chance of cross-contamination. That need pushes them toward single-use gear, which cuts the time, money, and paperwork tied to scrubbing and re-validating stainless-steel tanks.

Disposable sets also snap into place fast, letting CDMOs rearrange their cleanrooms whenever a client changes an order. The result is tighter schedules and better use of floor space. On top of that, pre-assembled, modular systems trim the costs of setting up and starting a new line. Taken together, these perks explain why large contract plants are embracing single-use tech more than ever. As the outsourcing momentum keeps building, pharmaceutical companies are likely to lean on CDMO partners even more, driving demand further upward.

• Flexibility and reduced process development time

Another important driver for the demand of single-use assemblies is the agility and flexibility these provide to bio manufacturers. Using these disposable assemblies allows companies to rapidly change the manufacturing process and shift production between different products. These eliminate many issues related to carryover contamination that is often problematic in traditional stainless-steel systems.

This feature enables operators to switch promptly between different drug productions without the need for extensive and expensive equipment cleaning and validation processes. This level of operational agility is highly appreciated in the biopharmaceutical sector, where the efficient and timely manufacturing of drugs is essential.

Adopting a single-use platform significantly reduces the development timeline and resources required to scale-up a manufacturing process. Without the need for capital-intensive equipment purchases, qualification and validation, single-use based facilities can be rapidly set up at a much lower cost. Manufacturers can test multiple assembly configurations, media and process parameters concurrently in separate single-use suites instead of running them sequentially on the same stainless-steel equipment.

This speeds up process development and optimization leading to faster availability of bio therapeutics. Single-use assemblies empower manufacturers to quickly respond to changing business needs and facilitate faster commercialization of important drugs. Their flexibility in swiftly adapting production capacity gives biopharmaceutical companies an important competitive edge.

Global Single-use Assemblies Market- Opportunities

• Technological advances in single-use assemblies

Technological advances in single-use assemblies offer a great opportunity in the global market. Single-use technologies enable the production of biopharmaceuticals in a more cost-effective and sustainable manner. With advancements in material sciences, manufacturing techniques, and process control strategies, single-use assemblies are becoming more robust and reliable for complex bio production needs.

Some of the key emerging technologies include modular and customizable single-use systems, advanced sensors for real-time monitoring of processes, and integrated digital solutions for data connectivity. Modular production equipment built using assemblies that can be customized based on manufacturing requirements provide more flexibility compared to conventional stainless-steel facilities.

For example, pre-assembled modular production skids save significant construction time at client facilities. Advanced sensor technologies allow process parameters like pH, temperature, pressure to be continuously monitored and controlled remotely. This helps to improve process understanding, consistency between batches, and early detection of deviations. Integrating such sensors with digital platforms also helps companies to better track and analyze manufacturing data across projects and sites.

• Adoption of modular facilities

Adoption of modular facilities is poised to provide significant opportunities in the global single-use assemblies market. With rising demands for flexibility and reduced construction timelines in biopharmaceutical manufacturing, modular facilities are rapidly gaining traction. Their pre-fabricated and standardized design allows for swift assembly and validation at the target site, helping companies speed up production starts and facility expanded capacity.

Modular facilities rely extensively on single-use assemblies to components like bulk containers, tubing, mixers, filters and others. Their use eliminates the need for costly and complex stainless steel pipework and vessels, further improving flexibility. Modular facilities can be quickly reconfigured or relocated as production needs change, which would not be feasible with conventional brick-and-mortar structures.

This inherent quality makes them well-suited for multiproduct facilities with varying production cycles. According to the World Health Organization 2022 report, the effects of an aging global population will lead to a substantial increase in the demand for biologics and pharmaceuticals in the coming years. As biopharmaceutical companies seek to rapidly scale drug substance manufacturing capacity and adapt to changing market conditions, adoption of modular facilities is likely to grow significantly.

Global Single-use Assemblies Market- Trends

• Advancements towards pre-sterilized and ready-to-use assemblies

The biopharmaceutical industry has seen significant advancements in the development of pre-sterilized and ready-to-use single-use assemblies over the past few years. This trend is having a notable impact on the global single-use assembly’s market. Previously, assembling single-use systems was labor intensive and required sterilization by end users.

Recent innovations have focused on delivering complete assemblies to customers in a sterilized format, ready for seamless integration. These advancements fulfill an unmet need within bioprocessing as these helps eliminate steps from the workflow and minimize the chances of contamination.

Leading manufacturers are now offering entire modular assemblies made of inter connectable single-use components like tubes, bags, and filters that are terminally sterilized and validated by the manufacturer. For example, Sartorius Stedm Biotech, a leading partner of the biopharma industry, offers its single-use Flex Factory platform that provides pre-assembled modular components for upstream and downstream processing.

Market Report Scope

Single Use Assemblies Market Report Coverage

Analyst View

• The global single-use assemblies market is positioned for strong growth over the next five years. Growing biopharmaceutical industry reliance on single-use technologies to improve efficiency and reduce costs will continue boosting widespread adoption of single-use pipework, bags, and other assemblies.
• North America currently dominates due to its large biopharma industry and acceptance of new technologies.
• However, Asia Pacific is expected to be the fastest growing region, fueled by expanding biologics production in China, India, and other Asian countries. Stringent regulatory norms in the region will also propel market growth.

Global Single-use Assemblies Market- Recent Developments

• In April 2023, Merck, a leading science and technology company, launched Ultimus Single-Use Process Container Film that is designed to provide extreme durability and leak resistance for single use assemblies used for bioprocessing liquid applications.
• In September 2022, Thermo Fisher Scientific Inc., the world leader in serving science, launched the Thermo Scientific DynaSpin Single-Use Centrifuge system at the BioProcess International annual conference in Boston, U.S. The system is specifically designed to provide an optimal single-use solution for large-scale cell culture harvesting.

Top companies in Global Single-use Assemblies Market

• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Sartorius AG
• Danaher (Pall Corporation)
• Avantor, Inc
• Lonza
• Saint-Gobain
• Corning Incorporated
• Entegris
• KUHNER AG.
• Parker Hannifin Corporation
• Ami Polymer
• HIGH PURITY NEW ENGLAND
• Liquidyne Process Technologies, Inc.
• ESI Ultrapure

Market Segmentation

• Global Single Use Assemblies Market, By Product
• Bag Assemblies
• 2D bag assemblies
• 3D bag assemblies
• Filtration Assemblies
• Bottle Assemblies
• Tubing Assemblies
• Others
• Global Single Use Assemblies Market, By Application
• Filtration
• Cell Culture & Mixing
• Storage
• Sampling
• Fill-finish
• Others
• Global Single Use Assemblies Market, By Solution
• Customized
• Standard
• Global Single Use Assemblies Market, By End User
• Biopharmaceutical Companies
• CROs
• CMOs
• Others
• Global Single Use Assemblies Market, By Region
• North America
• U.S.
• Canada
• Latin America
• Brazil
• Argentina
• Mexico
• Rest of Latin America
• Europe
• Germany
• U.K.
• Spain
• France
• Italy
• Russia
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East
• GCC Countries
• Israel
• Rest of Middle East
• Africa
• South Africa
• North Africa
• Central Africa
• Global Single-use Assemblies Market, Key Players
• Thermo Fisher Scientific, Inc.
• Merck KGaA
• Sartorius AG
• Danaher (Pall Corporation)
• Avantor, Inc
• Lonza
• Saint-Gobain
• Corning Incorporated
• Entegris
• KUHNER AG.
• Parker Hannifin Corporation
• Ami Polymer
• HIGH PURITY NEW ENGLAND
• Liquidyne Process Technologies, Inc.
• ESI Ultrapure

Sources

Primary Research Interviews

• Key Opinion Leaders (KOLs)
• Industry Experts
• Manufacturers
• Suppliers
• Others

Databases

• Factiva
• Bloomberg
• MarketLine
• Others

Magazines

• Pharmaceutical Technology
• BioPharm International
• Genetic Engineering & Biotechnology News (GEN)
• BioProcess International
• Others

Journals

• Journal of Bioprocessing & Biotechniques
• Biotechnology Progress
• Biotechnology and Bioengineering
• Others

Newspapers

• The Wall Street Journal
• The New York Times
• Financial Times
• The Washington Post
• Others

Associations

• Parenteral Drug Association (PDA)
• International Society for Pharmaceutical Engineering (ISPE)
• Biotechnology Innovation Organization (BIO)
• Bioprocess Systems Alliance (BPSA)
• Others

Public Domain Sources

• World Health Organization (WHO)
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• National Institutes of Health (NIH)
• Others

Proprietary Elements

• CMI Data Analytics Tool
• Proprietary CMI Existing Repository of information for last 8 years