Single-Use Systems Market Analysis | 2025-2031

Market Insights

“The single-use systems market size was US$ 6.0 billion in 2024 and is likely to grow at a robust CAGR of 15.1% in the long run to reach US$ 15.8 billion in 2031.”

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Market Dynamics

Introduction

Single-use systems for bioprocess solutions refer to the use of disposable, or single-use, components in the manufacturing and processing of biopharmaceuticals. Single-use technologies offer several advantages in terms of flexibility, cost-effectiveness, and reduced risk of cross-contamination. These solutions allow for more flexible and scalable manufacturing processes. As a result, biopharmaceutical companies can easily adjust their production capabilities based on demand without the need for extensive facility modifications.

The systems are particularly beneficial in early-stage R&D and clinical trials, where scalability, speed, and containment are critical. With the rising demand for biologics, including monoclonal antibodies, cell and gene therapies, and vaccines, single-use systems are becoming an essential enabler of innovation and agility in the biopharmaceutical industry.

The COVID-19 pandemic accelerated the adoption of single-use technologies as companies sought scalable, flexible, and rapid-deployment manufacturing platforms to meet urgent global demand. The market also benefits from sustainability initiatives, with vendors developing recyclable or lower-waste SUS products, and from digitization and automation, which improve process control, traceability, and compliance.

Market Drivers:

Key drivers of the single-use systems market include the growing demand for biologics, such as monoclonal antibodies, vaccines, and cell & gene therapies; faster time-to-market enabled by reduced setup and validation times; and cost-effectiveness due to lower capital and operational expenses. The market is further propelled by reduced risk of cross-contamination, increasing adoption by CDMOs and small biotech firms, expanding regulatory support for single-use technologies, and the scalability and flexibility these systems offer from clinical to commercial-scale production.

Recent Market JVs & Acquisitions:

A considerable number of strategic alliances, including M&As, JVs, etc., have been performed over the past few years:

• In July 2023, Sartorius AG completed the acquisition of the French company Polyplus, a leading provider of innovative technologies for cell and gene therapies.
• In January 2020, Getinge acquired Applikon Biotechnology B.V. from Applikon Biotechnology Holding B.V., strengthening its capabilities in delivering efficient, safe, and contamination-free research and production solutions for the biopharmaceutical sector.
• In March 2020, Danaher Corporation completed the acquisition of the GE biopharma business.

Recent Product Development: 

• In April 2023, Merck KGaA announced the launch of its Ultimus single-use process container film, designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications.
• In January 2020, Getinge acquired Applikon Biotechnology B.V. from Applikon Biotechnology Holding B.V., strengthening its capabilities in delivering efficient, safe, and contamination-free research and production solutions for the biopharmaceutical sector.
• In March 2020, Thermo Fisher Scientific Inc. invested over US$ 475 million to enhance biologics development, manufacturing, and cell and gene therapy capabilities at its St. Louis site in Missouri. In addition, the site completed its expansion, doubling its single-use production capacity for biological drug substance development and commercial manufacturing.

Segment Analysis

By Product Type

“Media bags and containers are likely to be the dominant product category during the forecast period.”

The market is segmented into media bags and containers, bioreactors, tangential-flow filtration devices, depth filters, disposable fiber cartridges, mixing systems, tubing assemblies, sampling systems, and other products. Media bags and containers have the got the majority market share of single-use biopharmaceutical manufacturing due to their flexibility, scalability, and cost-effectiveness, eliminating the need for cleaning and validation between batches while reducing the risk of cross-contamination.

By Method Type

“Filtration is anticipated to remain the dominant category of the market during the forecast period.”

The market is segmented into filtration, cell culture, purification, mixing, and storage. Filtration is a fundamental and widely used step in biopharmaceutical processing for separating impurities and particulate matter from the desired product. It is crucial method for achieving high product purity. Its efficiency, ease of scale-up, and strict regulatory compliance also favor filtration as a unit operation in drug manufacturing, especially in biologics and vaccines.

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By Application Type

“Monoclonal antibody production is expected to remain the dominant category of the market in the coming years.”

The market is segmented into monoclonal antibody production, vaccine production, plant cell cultivation, patient-specific cell therapies, and other applications. Monoclonal antibody production plays a crucial role in treating various diseases, including cancer and autoimmune disorders, driving high demand for their production. Its dominance is further boosted by its high demand, large-scale manufacturing needs, and compatibility with flexible, contamination-free single-use technologies.

By End-User Type

“Biopharmaceutical manufacturers are expected to remain the biggest demand generator of the market during the forecast period.”

The single-use systems market is segmented into biopharmaceutical manufacturers, life science R&D companies & academic research, and contract research organizations & manufacturers. Biopharmaceutical manufacturers dominated the market owing to the increased flexibility, scalability, cost-efficiency, and reduced contamination risks offered by single-use technologies, that completely align with the dynamic nature of biopharmaceutical production.

Regional Analysis

“North America is anticipated to be the dominant region in the single-use systems market during the forecast period.”

In terms of region the market is segmented into North America, Europe, Asia-Pacific, and Rest of the World. Advanced biopharmaceutical industry, strong regulatory support (FDA), high R&D expenditures, and rapid innovation and use of new technologies in biopharmaceutical production are key factors driving the dominance of North America in the market. Additionally, supportive biotech companies and cost-effective, flexible manufacturing demands also enhance North America's regional dominance in this market.

China is likely to witness the fastest growth in the coming years owing to the significant growth this region, driving by factors, such as rising healthcare expenditure and the active presence of the major companies, such as Danaher Corporation, Merck KGaA, Sartorius AG, and Thermo Fischer Scientific, Inc., in the region.

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Key Players

The market for single-use systems is very competitive and highly consolidated, with the leading players capturing the lion’s market share. The major players compete in some of the governing factors, including price, service offerings, regional presence, etc. The following are the key players in the single-use systems market.

Here is the list of the Top Players (Based on Dominance)

• Sartorius AG
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• Merck KGaA

Note: The above list does not necessarily include all the top players in the market.

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Report Features

This report provides market intelligence most comprehensively. The report structure has been kept so that it offers maximum business value. It provides critical insights into market dynamics and will enable strategic decision-making for existing market players as well as those willing to enter the market. The following are the key features of the report:

• Market structure: Overview, industry life cycle analysis, supply chain analysis.
• Market environment analysis: Growth drivers and constraints, Porter’s five forces analysis, SWOT analysis.
• Market trend and forecast analysis.
• Market segment trend and forecast.
• Competitive landscape and dynamics: Market share, Service portfolio, New Product Launches, etc.
• COVID-19 impact and its recovery curve
• Attractive market segments and associated growth opportunities.
• Emerging trends.
• Strategic growth opportunities for the existing and new players.
• Key success factors.

The single-use systems market is segmented into the following categories. 

By Product Type

• Media Bags and Containers 
• Bioreactors 
• Tangential-Flow Filtration Devices 
• Depth Filters 
• Disposable Fiber Cartridges 
• Mixing Systems 
• Tubing Assemblies 
• Sampling Systems 
• Other Products 

By Method Type

• Filtration 
• Cell Culture 
• Purification 
• Mixing 
• Storage 

By Application Type

• Monoclonal Antibody Production 
• Vaccine Production 
• Plant Cell Cultivation
• Patient Specific Cell Therapies 
• Other Applications 

By End-User Type

• Biopharmaceutical Manufacturers 
• Life Science R&D Companies & Academic Research 
• Contract Research Organizations & Manufacturers 

By Region  

• North America (Country Analysis: The USA, Canada, and Mexico)
• Europe (Country Analysis: Germany, France, The UK, Spain, Italy, Turkey, and the Rest of Europe)
• Asia-Pacific (Country Analysis: China, Japan, India, Australia, and the Rest of Asia-Pacific)
• Rest of the World (Country Analysis: Brazil, Argentina, South Africa, and Others)

Research Methodology

• This strategic assessment report from Stratview Research provides a comprehensive analysis that reflects today’s single-use systems market realities and future market possibilities for the forecast period.
• The report segments and analyzes the market in the most detailed manner to provide a panoramic view of the market.
• The vital data/information provided in the report can play a crucial role for market participants and investors in identifying the low-hanging fruit available in the market and formulating growth strategies to expedite their growth process.
• This report offers high-quality insights and is the outcome of a detailed research methodology comprising extensive secondary research, rigorous primary interviews with industry stakeholders, and validation and triangulation with Stratview Research’s internal database and statistical tools.
• More than 1,000 authenticated secondary sources, such as company annual reports, fact books, press releases, journals, investor presentations, white papers, patents, and articles, have been leveraged to gather the data.
• We conducted more than 15 detailed primary interviews with market players across the value chain in all four regions and industry experts to obtain both qualitative and quantitative insights.

Report Customization Options

With this detailed report, Stratview Research offers one of the following free customization options to our respected clients:

Company Profiling

• Detailed profiling of additional market players (up to three players)
• SWOT analysis of key players (up to three players)

Competitive Benchmarking

• Benchmarking of key players on the following parameters: Service portfolio, geographical reach, regional presence, and strategic alliances

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