Single-Use Technologies for the Biologic Market Size, Share, Growth, and Industry Analysis, By Types (Membrane Adsorber, Bioreactors, Disposable Mixing Systems, Tangential Flow Filtration, Tubing and Connectors, Depth Filtration, Buffer Containers, Waste Containers) , Applications (Monoclonal Antibodies, Vaccines, Gene Therapy, Recombinant Proteins, Blood Derivatives) and Regional Insights and Forecast to 2033

Single-Use Technologies for the Biologic Market Size

The Single-Use Technologies market for biologics was valued at USD 5.287 billion in 2024 and is expected to grow to USD 5.81 billion in 2025, reaching approximately USD 12.365 billion by 2033. This expansion reflects a compound annual growth rate (CAGR) of 9.9% over the forecast period from 2025 to 2033.

The US Single-Use Technologies for the Biologic Market region is projected to experience strong growth, driven by rising demand for biopharmaceuticals, advancements in disposable bioprocessing systems, and increasing investments in biotechnology research. The adoption of single-use technologies is accelerating due to their cost-effectiveness, operational efficiency, and reduced risk of cross-contamination, making them a preferred choice for biopharmaceutical manufacturers.

Single-use technologies are transforming the biologic market by replacing traditional stainless-steel systems with disposable solutions. These innovations eliminate cleaning and sterilization processes, reducing cross-contamination risks while enhancing operational efficiency. The increasing demand for monoclonal antibodies, vaccines, and gene therapies is driving widespread adoption. Additionally, the flexibility of single-use bioprocessing systems accelerates production timelines, making them ideal for biopharmaceutical manufacturing. The global market is expanding due to the rising preference for cost-effective and scalable solutions. Biotech firms are investing heavily in single-use bioreactors, filters, tubing, and bags, positioning these technologies as the backbone of modern biologic production.

Single-Use Technologies for the Biologic Market Trends

The biologic market is witnessing a surge in the adoption of single-use technologies due to their cost-effectiveness, flexibility, and sterility benefits. The rapid growth of biologics, including cell and gene therapies, has created a demand for scalable and disposable bioprocessing solutions. Single-use bioreactors, media bags, and filtration systems are now widely used across biopharmaceutical facilities, significantly reducing downtime and contamination risks.

Biotech companies are shifting toward single-use components to accelerate production while minimizing capital investment. Over 80% of new biopharmaceutical manufacturing facilities are incorporating single-use technology, highlighting its increasing preference over traditional stainless-steel systems. The demand for disposable bioreactors has surged, with adoption rates exceeding 65% in commercial biologic production.

The rise in personalized medicine and small-batch biologic production has fueled demand for single-use technologies. The Asia-Pacific region is emerging as a key market due to increased biopharmaceutical investments and regulatory support. Additionally, sustainability initiatives are influencing the development of recyclable and biodegradable single-use materials to address environmental concerns.

With rising global demand, continuous technological advancements, and increasing investments in bioprocessing, single-use technologies are set to dominate the biologic manufacturing landscape, driving efficiency and innovation in the industry.

Market Dynamics

The biologic market is undergoing a significant transformation with the adoption of single-use technologies. These disposable systems are replacing traditional stainless-steel equipment, providing greater flexibility and efficiency in biopharmaceutical manufacturing. The shift towards single-use bioreactors, filtration systems, and disposable mixing assemblies has streamlined production processes, reducing contamination risks and decreasing turnaround times. Single-use systems are particularly beneficial for producing monoclonal antibodies, vaccines, and gene therapies, where sterility and speed are critical. Additionally, these technologies require lower capital investment and minimize operational costs associated with cleaning and sterilization. As the industry evolves, single-use technologies are becoming an essential component in the global biologic manufacturing landscape.

DRIVER

"Rising Demand for Personalized Medicines"

The increasing demand for personalized medicines is a key driver for the adoption of single-use technologies in the biologic market. Personalized treatments, including gene therapies and cell-based therapies, now account for a substantial portion of new pharmaceutical innovations. Single-use systems provide the flexibility required for small-batch production, ensuring efficient manufacturing of customized treatments. The ability to quickly adapt processes for different therapies without cross-contamination risks enhances their appeal. These systems also help reduce time-to-market and lower costs associated with cleaning and validation procedures. As personalized medicine continues to gain traction, the reliance on single-use technologies will grow, further driving market expansion.

RESTRAINT

"Regulatory Complexities"

Despite the benefits, regulatory complexities pose a significant restraint on the adoption of single-use technologies. The biopharmaceutical industry is subject to strict regulations, which vary across different regions. Manufacturers face challenges in ensuring that single-use components meet all compliance requirements, leading to potential delays and increased costs. A considerable percentage of product development delays are attributed to regulatory hurdles associated with new technologies. Additionally, the lack of standardized guidelines for single-use systems creates difficulties in global adoption. Companies must navigate diverse regulatory landscapes, which can be a barrier, especially for smaller firms with limited resources.

OPPORTUNITY

"Expansion in Emerging Markets"

Emerging markets, particularly in Asia-Pacific and Latin America, present significant growth opportunities for single-use technologies. The rapid expansion of the biopharmaceutical industry in these regions is fueled by increased healthcare investments and rising demand for biologics. Single-use systems provide an attractive solution for companies seeking cost-effective and flexible manufacturing capabilities. These technologies reduce capital expenditure, allowing faster facility setup and efficient production scaling. Additionally, shorter implementation times and reduced operational complexities make single-use technologies an ideal choice for emerging market manufacturers. As biopharmaceutical investments in these regions continue to rise, the adoption of single-use systems is expected to grow significantly.

CHALLENGE

"High Upfront Costs"

A major challenge in the widespread adoption of single-use technologies is the high initial investment required. The upfront costs of implementing single-use systems can be substantial, representing a significant portion of overall production budgets. While these technologies offer long-term savings by eliminating cleaning and sterilization expenses, the initial financial burden can deter small and medium-sized enterprises. Additionally, concerns about the scalability of single-use systems for large-scale production further contribute to industry hesitation. The ongoing costs of consumables, such as disposable bags and tubing, add to the financial challenge. Addressing these cost barriers will be crucial in expanding the adoption of single-use technologies across the biologic market.

Segmentation Analysis

The single-use technologies market in biologics is categorized by various types and applications, each playing a crucial role in biopharmaceutical manufacturing.

By Type

• Membrane Adsorbers: These are utilized for efficient purification processes, capturing impurities during downstream processing. Their integration into single-use systems enhances process efficiency and product purity.
• Bioreactors: Single-use bioreactors have become essential in biopharmaceutical production, offering flexibility and reducing contamination risks. They are particularly favored for their scalability and cost-effectiveness in various production scales.
• Disposable Mixing Systems: These systems facilitate the preparation of solutions and buffers, ensuring sterility and reducing cross-contamination. Their disposable nature eliminates the need for cleaning, streamlining the production process.
• Tangential Flow Filtration: This technique is employed for concentration and diafiltration processes in biologics manufacturing. Single-use tangential flow filtration systems offer advantages in terms of reduced cleaning requirements and faster turnaround times.
• Tubing and Connectors: Essential components in single-use assemblies, tubing and connectors ensure sterile fluid transfer within bioprocessing systems. Their design and material compatibility are critical for maintaining product integrity.
• Depth Filtration: Used for clarifying cell culture fluids, single-use depth filters effectively remove particulates and cell debris, contributing to higher product yields and quality.
• Buffer Containers: Single-use buffer containers provide a sterile solution for storing and transporting buffers and media, reducing contamination risks and simplifying logistics in biomanufacturing.
• Waste Containers: Designed for the safe disposal of bioprocessing waste, single-use waste containers help maintain a sterile environment and comply with regulatory standards.

By Application

• Monoclonal Antibodies: The production of monoclonal antibodies has significantly benefited from single-use technologies, which offer flexibility and reduce contamination risks, leading to more efficient manufacturing processes.
• Vaccines: Single-use systems have streamlined vaccine production by enabling rapid changeovers and reducing downtime, which is crucial during pandemic responses and for seasonal vaccine manufacturing.
• Gene Therapy: In gene therapy, maintaining sterility is paramount. Single-use technologies provide closed systems that minimize contamination risks, thereby enhancing the safety and efficacy of gene therapies.
• Recombinant Proteins: The manufacturing of recombinant proteins has adopted single-use technologies to increase process efficiency and reduce costs associated with cleaning and validation of traditional equipment.
• Blood Derivatives: Processing blood derivatives requires stringent sterility. Single-use systems offer sterile and efficient solutions, ensuring product safety and compliance with regulatory standards.

Regional Outlook

The global adoption of single-use technologies in the biologic market varies across regions, influenced by factors such as technological advancements, healthcare infrastructure, and investment levels.

North America

North America leads in the implementation of single-use technologies within the biologic sector. The region's well-established biopharmaceutical industry and substantial investment in research and development have accelerated the adoption of these systems. A significant number of biomanufacturing facilities in the United States have integrated single-use bioreactors and disposable filtration systems to enhance production efficiency and reduce contamination risks. The presence of key industry players further bolsters the market's growth in this region.

Europe

Europe represents a significant market for single-use technologies in biologics, driven by stringent regulatory standards and a focus on sustainable manufacturing practices. Countries such as Germany, France, and the United Kingdom have seen increased adoption of disposable systems in biopharmaceutical production. The European market emphasizes reducing environmental impact, and single-use technologies contribute by minimizing water and energy consumption associated with traditional cleaning processes.

Asia-Pacific

The Asia-Pacific region is experiencing rapid growth in the adoption of single-use technologies, propelled by expanding biopharmaceutical industries in countries like China, India, and South Korea. Government initiatives supporting biotechnology advancements and increasing investments in healthcare infrastructure have facilitated this trend. The flexibility and cost-effectiveness of single-use systems are particularly appealing to emerging markets aiming to establish or scale up biologic manufacturing capabilities efficiently.

Middle East & Africa

In the Middle East and Africa, the adoption of single-use technologies in the biologic market is in the nascent stages but shows promising potential. Growing healthcare investments and efforts to develop local biopharmaceutical production are driving interest in disposable systems. Countries in the Gulf Cooperation Council (GCC) are investing in biotechnology sectors, recognizing the benefits of single-use technologies in establishing efficient and contamination-free manufacturing processes.

LIST OF KEY SINGLE-USE TECHNOLOGIES FOR THE BIOLOGIC MARKET COMPANIES PROFILED

• Thermo Fisher Scientific
• Applikon Biotechnology
• GE Healthcare
• Pall
• BioPure Technology
• Sartorius
• Novasep
• W. L. Gore and Associates
• EMD Millipore
• DowDuPont

Two Top Companies with Highest Market Share

• Thermo Fisher Scientific and Sartorius AG dominate with the highest market shares. Thermo Fisher Scientific holds approximately 28% of the market, driven by its comprehensive range of single-use solutions, including bioreactors, fluid management systems, and filtration technologies. The company’s global presence and continuous innovation in disposable bioprocessing systems solidify its leadership position.
• Sartorius AG follows closely with a 22% market share, known for its advanced single-use bioreactors and filtration systems. Sartorius' strong foothold in biopharmaceutical manufacturing and strategic acquisitions contribute significantly to its growth in this sector.

Investment Analysis and Opportunities

The single-use technologies market for biologics is attracting significant investment due to its advantages in cost efficiency, flexibility, and contamination control. In 2023, investments in single-use systems grew by over 35%, reflecting increasing adoption by biopharmaceutical companies. Governments and private investors are focusing on expanding biomanufacturing capabilities, particularly in North America, Europe, and Asia-Pacific. Over 50% of recent investments in bioprocessing infrastructure have been allocated to single-use technologies, signaling a shift from traditional stainless-steel systems. The rising demand for biologics, including monoclonal antibodies, gene therapies, and vaccines, is expected to further drive investments in advanced single-use solutions.

Emerging economies in Asia-Pacific are becoming hotspots for investment, with countries like China and India receiving 40% of new biopharma funding. Additionally, innovations such as automation in single-use bioreactors and the development of sustainable single-use products are attracting investor interest. Companies are increasingly investing in research collaborations, with over 60% of major biopharmaceutical firms partnering with single-use technology providers to enhance efficiency and scalability. The investment landscape is poised for continued expansion as biopharma companies prioritize single-use systems to streamline production and reduce operational costs.

New Product Development

Companies are continuously launching advanced single-use technologies to enhance efficiency and meet the growing demand for biologics. In 2023, over 45% of newly introduced bioprocessing products were single-use solutions, reflecting a strong market focus on disposable systems. The latest innovations include high-performance single-use bioreactors with 30% improved mixing efficiency and enhanced scalability for both small- and large-scale production.

Filtration systems have also advanced, with newly developed single-use membrane filters demonstrating 25% higher retention capacity, optimizing downstream processing. Companies are prioritizing real-time monitoring in biomanufacturing, leading to the development of single-use sensors with 50% increased accuracy, improving quality control and process efficiency. Sustainability is another key trend, with major firms introducing single-use products made from biodegradable materials, aiming to reduce plastic waste by 20% compared to traditional single-use plastics.

Additionally, the modular design of new single-use systems enables 40% faster integration into existing biomanufacturing facilities. These innovations cater to the evolving needs of biopharmaceutical companies, particularly in the production of gene therapies, cell therapies, and vaccines. As technological advancements continue, the adoption of next-generation single-use technologies is expected to rise significantly.

Recent Developments by Manufacturers in Single-Use Technologies (2023 & 2025)

• Thermo Fisher Scientific Expansion (2023) – Thermo Fisher invested $1.2 billion to expand its single-use bioprocessing production facilities, increasing global manufacturing capacity by 35%.

• Sartorius AG's Advanced Bioreactors (2023) – Sartorius launched a new line of single-use bioreactors featuring 30% faster processing times and 20% lower energy consumption.

• Danaher Corporation Acquisition (2023) – Danaher acquired a leading single-use technology provider, increasing its market share by 5% and expanding its disposable bioprocessing portfolio.

• Merck KGaA Sustainability Initiative (2025) – Merck KGaA announced a commitment to reducing single-use plastic waste by 50% by developing eco-friendly disposable systems.

• GE Healthcare's Smart Sensors (2025) – GE Healthcare introduced AI-powered single-use sensors with 60% improved real-time monitoring capabilities, enhancing biomanufacturing process control.

Report Coverage 

The report provides an in-depth analysis of the single-use technologies market for biologics, covering market segmentation by type, application, and region. The study includes detailed insights into key product categories such as single-use bioreactors, filtration systems, and disposable mixing solutions, highlighting their adoption trends and impact on biopharmaceutical manufacturing.

Market share distribution indicates that single-use bioreactors account for 40% of total market adoption, followed by filtration systems at 25%. The application analysis covers the use of single-use technologies in monoclonal antibodies, vaccines, gene therapy, and recombinant proteins, with monoclonal antibodies leading at 45% market penetration.

The regional outlook highlights North America as the dominant market, contributing 42% of global demand, followed by Europe at 30% and Asia-Pacific at 20%. The report also covers key drivers such as the increasing demand for biologics, cost benefits of single-use systems, and advancements in automation. Additionally, it examines challenges like waste management concerns and regulatory compliance issues.

The competitive landscape includes detailed profiling of major industry players, their product innovations, and strategic expansions. The report also identifies emerging trends, such as the integration of AI in single-use technologies and the development of environmentally sustainable disposable systems. With comprehensive market insights, the report serves as a valuable resource for stakeholders seeking to understand the evolving dynamics of the single-use technologies sector in biologics.