Single-Use Assemblies Market Research Report By Application (Biopharmaceutical Manufacturing, Vaccination, Cell Culture, Tissue Engineering), By Component Type (Bag Systems, Filters, Connectors, Tubing), By Material Type (Polyethylene, Polypropylene, Polyvinyl Chloride, Thermoplastic Elastomers), By End User (Pharmaceutical Companies, Contract Manufacturing Organizations, Research Laboratories) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

Single-Use Assemblies Market Overview

As per MRFR analysis, the Single-Use Assemblies Market Size was estimated at 7.52 (USD Billion) in 2023. The Single-Use Assemblies Market Industry is expected to grow from 8.03 (USD Billion) in 2024 to 16.4 (USD Billion) by 2035. The Single-Use Assemblies Market CAGR (growth rate) is expected to be around 6.71% during the forecast period (2025 - 2035).

Key Single-Use Assemblies Market Trends Highlighted

The Global Single-Use Assemblies Market is witnessing a significant shift towards increased adoption of single-use technologies across various industries, notably in the biopharmaceutical and healthcare sectors. This trend is driven by the need for reduced contamination risk, lower operational costs, and greater flexibility in production processes. Many pharmaceutical companies are increasingly favoring single-use assemblies due to their ability to streamline manufacturing workflows and minimize cleaning validation requirements. Furthermore, the ongoing shift towards personalized medicine and smaller batch production is creating a demand for innovative single-use solutions that can adapt to specific therapeutic needs.
Global marketing possibilities are expanding as the European Union and the United States regulatory bodies encourage the further use of single use technologies and their compliant and safe use for various applications. The growth of biotechnology and the development of other manufacturing technologies provide great opportunities for a supplier to customize and provide solutions that address the increasing number of applications. The eco concern sustains single use technologies design innovation trends, further driving the advancement of more biodegradable and environmentally friendly strategies of single use assemblies. These changes result from the growing demand to comply with legislation that aims to minimize plastic waste.

The emphasis on achieving higher efficiency and speed in the production cycles is further pushing the evolution of single-use systems, allowing for rapid scalability and easier integration in existing facilities. Overall, the Global Single-Use Assemblies Market is evolving dynamically, influenced by technological advancements, market demands, and regulatory landscapes.

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Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

Single-Use Assemblies Market Drivers

Increasing Demand for Biopharmaceuticals

The demand for biopharmaceuticals is rapidly increasing on a global scale, driving a significant need for the Global Single-Use Assemblies Market Industry. According to the Biopharmaceutical Section of the American Pharmaceutical Association, biopharmaceuticals account for approximately 40% of the currently marketed drugs and this figure is set to grow as the industry is shifting towards personalized medicine. This growth is reflected in the substantial investments from major organizations such as Pfizer and Roche, who are focusing on R for biopharmaceutical products.
These companies are witnessing a year-on-year increase in their biopharmaceutical revenues, reinforcing the necessity for adaptable and cost-effective manufacturing solutions like single-use assemblies. The growing biopharmaceutical market, which is expected to exceed USD 500 billion by 2025, further elevates the demand for single-use technologies to streamline production processes and reduce contamination risks.

Regulatory Support for Single-Use Technologies

Global regulatory bodies are increasingly endorsing single-use technologies due to their advantages in ensuring product safety and compliance. The U.S. Food and Drug Administration (FDA) has recognized single-use systems as part of Good Manufacturing Practices (GMP), promoting their usage across pharmaceutical manufacturing. In Europe, the European Medicines Agency (EMA) has also released guidelines supporting the adoption of single-use technologies, confirming that these systems help reduce the risks of cross-contamination in manufacturing processes.
According to the FDA, over 70% of new drug approvals in the past year have employed single-use technologies in their production processes, validating the positive regulatory climate for the Global Single-Use Assemblies Market Industry.

Shift Toward Cost-Effective Manufacturing Solutions

The demand for cost-effective manufacturing solutions is a significant driver of growth in the Global Single-Use Assemblies Market Industry. A report by the Healthcare Plastics Recycling Council indicates that single-use assemblies can reduce production costs by up to 30% due to their disposable nature, which alleviates the need for extensive cleaning and sterilization processes. This cost efficiency has led major organizations like Amgen and Johnson Johnson to adopt single-use technologies, which have helped these companies improve their operational efficiency while maintaining product quality.
As manufacturers continue to seek ways to minimize overhead costs in a competitive market, the shift towards single-use systems is anticipated to gain further traction, contributing positively to market growth.

Single-Use Assemblies Market Segment Insights

Single-Use Assemblies Market Application Insights

The Global Single-Use Assemblies Market, specifically focusing on the Application segment, is poised for substantial growth and significant contributions to various sectors, notably in the realms of Biopharmaceutical Manufacturing, Vaccination, Cell Culture, and Tissue Engineering. In 2024, the Biopharmaceutical Manufacturing application reached a valuation of 3.2 USD Billion, which illustrates its critical role in the production of biologics and drugs, enabling efficient manufacturing processes while also maintaining the quality and safety of the products. Furthermore, this application dominates the sector, showcasing a majority holding in the overall market alongside growing demand for customized therapies and biologics.

Similarly, the Vaccination application reached a valuation of 2.0 USD Billion in the same year. The importance of this sector has been particularly highlighted with the global focus on vaccine development and distribution, especially in the wake of health crises. As populations become more health-conscious and global vaccination efforts intensify, the significance of Single-Use Assemblies in this application cannot be overstated.

In the realm of Cell Culture, the application was valued at 1.8 USD Billion in 2024, underscoring its relevance in fields such as regenerative medicine and genetic research. This application is crucial for researchers and companies aiming to study cell behavior and development effectively, making it an essential component of biological research and development. Finally, Tissue Engineering, which had a market value of 1.03 USD Billion in 2024, contributed to the ambitious development of bioengineered tissues and organs, reflecting increasing advancements in this field.

The landscape of the Global Single-Use Assemblies Market is enhanced by opportunities driven by innovations, regulatory support promoting single-use technologies, and an escalating demand for environmentally friendly manufacturing solutions. The growth in these applications is further fueled by ongoing Research and Development efforts aimed at enhancing production efficiency and reducing contamination risks. However, challenges such as the need for sustainable materials and cost management remain pertinent hurdles that industry players must address to maintain competitive positions. Overall, the Application segment of the Global Single-Use Assemblies Market indicates strong potential for development, underpinned by its significant segmentation that caters to dynamic industries focused on biopharmaceuticals, vaccines, cellular therapies, and tissue innovations.

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Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

Single-Use Assemblies Market Component Type Insights

The Global Single-Use Assemblies Market is projected to witness robust growth, with a valuation reaching 8.03 USD Billion in 2024. Within this expansive market, the Component Type segment played a crucial role, encompassing various critical elements such as Bag Systems, Filters, Connectors, and Tubing. Each of these components serves specific functions essential for maintaining efficiency in biologics manufacturing and pharmaceuticals. Bag Systems, for instance, provide secure storage solutions for liquids, while Filters are vital for ensuring the sterility of processes.
Connectors aid in seamless operation across various systems, enhancing productivity, and Tubing is integral for fluid transfer, making it invaluable in maintaining product integrity. The significant reliance on these components highlights their importance in streamlining operations in the Global Single-Use Assemblies Market industry. As innovations and regulatory requirements evolve, the market growth will be driven by the increasing need for efficient, flexible, and disposable solutions that these components provide, addressing the challenges faced by traditional systems.
The market continues to adapt, presenting opportunities for advancements and expanded applications.

Single-Use Assemblies Market Material Type Insights

The Global Single-Use Assemblies Market, particularly regarding Material Type, witnessed notable growth, with its valuation that reached 8.03 billion USD by 2024. Among various materials, Polyethylene and Polypropylene are emerging as leading players due to their versatility and cost-effectiveness, making them ideal for single-use applications in healthcare and food industries. Polyvinyl Chloride, though traditionally used, faces challenges due to environmental concerns, yet it remains significant in specific applications due to its favorable properties.
Thermoplastic Elastomers are gaining traction for their flexibility and durability, catering to the evolving demands for innovative and sustainable solutions. The Global Single-Use Assemblies Market segmentation is pivotal, as these materials address distinct regulatory and customer preferences globally, driving market growth and encouraging advancements in production techniques to enhance performance while minimizing environmental footprints. As trends toward sustainability continue to grow, manufacturers are likely to focus on developing biodegradable options, further influencing the dynamics of the Global Single-Use Assemblies Market.

Single-Use Assemblies Market End User Insights

The Global Single-Use Assemblies Market exhibits significant growth across its End User segment, which comprises Pharmaceutical Companies, Contract Manufacturing Organizations, and Research Laboratories. In 2024, the market achieved a valuation of 8.03 USD Billion, showcasing the increasing preference for single-use technologies in various applications. Pharmaceutical Companies are seeing an uptrend in demand due to the efficiency and reduced contamination risk associated with single-use assemblies. Similarly, Contract Manufacturing Organizations benefit from the flexibility and cost-effectiveness these solutions provide, enabling them to cater to diverse client needs.
Research Laboratories, on the other hand, are utilizing single-use assemblies to streamline processes and enhance productivity while minimizing the need for extensive cleaning protocols. The collective growth of these sectors is propelled by trends such as increased biopharmaceutical production and the push for automated, scalable solutions. However, challenges such as the variability in material quality and sustainability concerns could impact market dynamics. Nonetheless, the Global Single-Use Assemblies Market continues to present numerous opportunities for innovation and expansion within the industry, as seen in the projected growth reaching 16.4 USD Billion by 2035.

Single-Use Assemblies Market Regional Insights

The Regional segment of the Global Single-Use Assemblies Market is pivotal, with significant market values expected in 2024. North America led this segment, valued at 2.6 USD Billion, and projected to grow to 5.41 USD Billion by 2035, supported by a robust biopharmaceutical sector prioritizing flexibility and efficiency in manufacturing. Europe followed closely, with a valuation of 2.1 USD Billion in 2024 and anticipated growth to 4.47 USD Billion by 2035, driven by stringent regulatory standards and increased adoption of single-use technologies in medication production.
The Asia-Pacific (APAC) region is also noteworthy, with a starting value of 2.0 USD Billion in 2024, forecasted to reach 4.0 USD Billion in 2035. The region's dominance arises from increasing investments in healthcare infrastructure and a growing demand for biologics. South America and the Middle East and Africa (MEA) held smaller market shares, valued at 0.75 USD Billion and 0.58 USD Billion in 2024, respectively, but show promising growth potential as these regions modernize their healthcare facilities and integrate single-use assemblies for improved efficiency.
The market trends show a growing preference for single-use systems across these regions, addressing challenges related to contamination and production costs while presenting opportunities for innovation and expansion in the healthcare industry.

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Source: Primary Research, Secondary Research, MRFR Database and Analyst Review

Single-Use Assemblies Market Key Players and Competitive Insights:

The Global Single-Use Assemblies Market is characterized by its rapid growth and innovation, driven by the increasing demand for biopharmaceutical manufacturing and the trend towards cost-effective, flexible production methods. Single-use assemblies have become essential in various applications, particularly in bioprocessing and pharmaceutical manufacturing, owing to their ability to reduce contamination risks, minimize cleaning costs, and enhance operational efficiency. The competitive landscape of this market reveals a mix of established players and emerging companies, all vying for a larger share by enhancing their product portfolios and investing in advanced technologies. As the industry continues to evolve, companies are focusing on strategic partnerships, collaborations, and mergers to strengthen their market position and expand their geographical reach, thereby shaping a dynamic competitive environment.
Lonza plays a significant role in the Global Single-Use Assemblies Market with a strong presence and notable strengths that set it apart from competitors. The company has established itself as a leader with its extensive experience in biopharmaceutical manufacturing. Lonza's commitment to innovation is reflected in its development of high-quality single-use systems designed to meet the diverse needs of its clients. With a strong focus on regulatory compliance and customer support, Lonza has built a reputation for reliability and expertise in the market. The company’s robust global footprint enables it to cater to a wide range of clients across different regions, thus reinforcing its competitive advantage in providing cutting-edge solutions tailored to the specific needs of the bioprocessing landscape.
Repligen Corporation also plays a crucial role in the Global Single-Use Assemblies Market, offering a broad range of products and services tailored for biopharmaceutical manufacturing. The company’s focus on high-quality filtration, chromatographic resins, and single-use components positions it favorably among key players in the market. Repligen has effectively expanded its market presence through strategic mergers and acquisitions, acquiring complementary technologies that enhance its product offerings and broaden its capabilities. This growth strategy not only strengthens its market position but also enables the company to provide comprehensive solutions that meet evolving customer demands. With a commitment to innovation and quality, Repligen Corporation continues to enhance its competitive strengths and foster long-term relationships with its global clientele in the ever-evolving single-use assembly sector.

Key Companies in the Single-Use Assemblies Market Include:

• Lonza


• Repligen Corporation


• BD


• Thermo Fisher Scientific


• Merck KGaA


• GE Healthcare


• Danaher Corporation


• Kimatru


• Pall Corporation


• Eppendorf AG


• Fujifilm Diosynth Biotechnologies


• Mylan


• BioRad Laboratories


• West Pharmaceutical Services


• Sartorius

Single-Use Assemblies Market Industry Developments

The Global Single-Use Assemblies Market continues to evolve with significant recent developments. In September 2023, Lonza announced the expansion of its manufacturing capabilities for single-use technologies, aiming to enhance flexibility and scalability in biopharmaceutical production. Meanwhile, Repligen Corporation secured a partnership with GE Healthcare to develop novel single-use solutions, reinforcing their commitment to innovation in bioprocessing. In August 2023, BD completed the acquisition of a leading single-use medical device company, further strengthening its product portfolio. 

Additionally, Thermo Fisher Scientific has reported a surge in demand for single-use bioprocessing systems as biopharma companies transition towards more efficient manufacturing techniques. Notably, Merck KGaA has unveiled new single-use assemblies designed to accelerate drug development processes. The impact of these developments has been substantial, leading to improved market valuation for companies like Sartorius and Pall Corporation, both of which have witnessed increased investments and expanded market presence. Over the past few years, the overall growth in the single-use assemblies sector aligns with the growing trend towards cost-effective and flexible manufacturing solutions in the biopharmaceutical industry, confirming the sector's resilience and potential for further advancements.

Single-Use Assemblies Market Segmentation Insights

Single-Use Assemblies Market Application Outlook

• Biopharmaceutical Manufacturing


• Vaccination


• Cell Culture


• Tissue Engineering

Single-Use Assemblies Market Component Type Outlook

• Bag Systems


• Filters


• Connectors


• Tubing

Single-Use Assemblies Market Material Type Outlook

• Polyethylene


• Polypropylene


• Polyvinyl Chloride


• Thermoplastic Elastomers

Single-Use Assemblies Market End User Outlook

• Pharmaceutical Companies


• Contract Manufacturing Organizations


• Research Laboratories

Single-Use Assemblies Market Regional Outlook

• North America


• Europe


• South America


• Asia Pacific


• Middle East and Africa

Report Attribute/Metric	Details
Market Size 2023	7.52 (USD Billion)
Market Size 2024	8.03 (USD Billion)
Market Size 2035	16.4 (USD Billion)
Compound Annual Growth Rate (CAGR)	6.71% (2025 - 2035)
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Base Year	2024
Market Forecast Period	2025 - 2035
Historical Data	2019 - 2024
Market Forecast Units	USD Billion
Key Companies Profiled	Lonza, Repligen Corporation, BD, Thermo Fisher Scientific, Merck KGaA, GE Healthcare, Danaher Corporation, Kimatru, Pall Corporation, Eppendorf AG, Fujifilm Diosynth Biotechnologies, Mylan, BioRad Laboratories, West Pharmaceutical Services, Sartorius
Segments Covered	Application, Component Type, Material Type, End User, Regional
Key Market Opportunities	Rising demand for biopharmaceuticals, Increasing adoption in clinical trials, Enhanced focus on cost-effective solutions, Growth in personalized medicine, Technological advancements in manufacturing processes
Key Market Dynamics	Cost efficiency, Increased regulatory compliance, Growing biopharmaceutical industry, Enhanced operational flexibility, Rising demand for sterile products
Countries Covered	North America, Europe, APAC, South America, MEA