Global Single-use Bioprocessing Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In September 2023, Getinge launched a single-use bioreactor named the AppliFlex ST GMP. The new product is available in different sizes and provides a comprehensive cGMP manufacturing solution for mRNA production and cell and gene therapies.

• In April 2023, Merck KGaA launched Ultimus, a single-use process container film, to provide superior strength & leak resistance for single-use assemblies.

The Global Single-use Bioprocessing Market is segmented by product, workflow, application, and end-use, reflecting the broad and growing adoption of single-use technologies in the biopharmaceutical industry.

By product, the market includes bioreactors, disposable bags, filters, sensors, connectors, tubing, and other consumables. Bioreactors are a key component in single-use bioprocessing systems, allowing for cell culture and fermentation processes to occur in a controlled environment. Disposable bags are used for storing, mixing, and transporting media and cell cultures, while filters ensure that the media is free from contaminants. Sensors and connectors are essential for monitoring and controlling variables such as temperature, pH, and oxygen levels, ensuring optimal conditions for the biological processes. Other consumables like tubing, valves, and seals play critical roles in ensuring the smooth transfer of materials throughout the bioprocess.

In terms of workflow, the market is divided into upstream processing, downstream processing, and final product packaging. Upstream processing refers to the steps involved in cultivating cells, such as cell culture, fermentation, and media preparation, where single-use bioreactors and disposable bags are commonly used. Downstream processing focuses on the recovery and purification of the bioproduct, including filtration and chromatography. Finally, single-use technologies are also employed in final product packaging, ensuring that the end product remains sterile and contamination-free during storage and distribution.

The application segment includes monoclonal antibody production, vaccine production, gene therapy, and other biologics. Single-use bioprocessing is widely used in the production of monoclonal antibodies, as it offers flexibility, cost-efficiency, and scalability for large-scale manufacturing. Vaccine production benefits from single-use systems by reducing the risk of cross-contamination between batches. In gene therapy, single-use technologies facilitate the production of viral vectors, ensuring consistent quality and minimizing the risk of contamination. Other biologics, such as enzymes and hormones, also rely on single-use systems for efficient production.

By end-use, the market includes biopharmaceutical companies, contract development and manufacturing organizations (CDMOs), academic and research institutions, and hospitals. Biopharmaceutical companies are the largest end-users, utilizing single-use bioprocessing for large-scale manufacturing of biologics. CDMOs offer outsourcing services to other companies, making them a significant player in the market. Academic and research institutions use single-use systems for process development and small-scale production. Hospitals and clinical labs also adopt single-use technologies for research purposes and clinical trials, benefiting from the flexibility and efficiency that these systems provide.

Overall, the single-use bioprocessing market is driven by its advantages of flexibility, cost-effectiveness, and scalability, contributing to its rapid adoption across various applications in the biopharmaceutical industry.

Global Single-use Bioprocessing Segment Analysis

In this report, the Global Single-use Bioprocessing Market has been segmented by Product, Workflow, Application, End Use and Geography.

Global Single-use Bioprocessing Market, Segmentation by Product

The Global Single-use Bioprocessing Market has been segmented by Product into Filtration Assemblies, Disposable Bioreactors, Disposable Mixers, Media Bags and Containers, and Others.
Filtration assemblies are essential components in single-use bioprocessing systems. These assemblies are used for various purposes, including sterilization, separation, and purification of liquids in biopharmaceutical manufacturing. They ensure that the final product is free from contaminants and particles. Filtration assemblies come in different configurations, including depth filters, membrane filters, and tangential flow filtration units, depending on the specific needs of the bioprocess.

Disposable bioreactors are widely used for cell culture and fermentation processes in single-use systems. These bioreactors provide a controlled environment for the growth of cells, allowing for the production of biologics like monoclonal antibodies and vaccines. The advantages of disposable bioreactors include their cost-effectiveness, ease of use, and reduced risk of cross-contamination, which makes them particularly suitable for small to medium-scale production runs.

Disposable mixers are used in the mixing of media, cell cultures, and other substances during bioprocessing. They help maintain homogeneity and ensure the optimal conditions for cell growth and production. Single-use disposable mixers are designed to be easy to clean and replace, minimizing the risk of contamination between batches.

Media bags and containers are essential for storing and transporting media, buffers, and other liquids used in the bioprocessing workflow. These bags and containers are made from materials that prevent contamination and ensure the safety of the biological products being produced. They are widely used in both upstream and downstream bioprocessing.

Other products in the segment include tubing, connectors, sensors, and valves, all of which are used to transport materials and monitor critical parameters such as pH, temperature, and oxygen levels during the bioprocessing stages. These products contribute to the overall efficiency and automation of single-use bioprocessing systems.

Global Single-use Bioprocessing Market, Segmentation Workflow

The Global Single-use Bioprocessing Market has been segmented by Workflow into Upstream, Fermentation and Downstream.

The upstream segment encompasses processes involved in cell culture, including cell expansion, media preparation, and inoculum development. Single-use bioreactors and disposable bags are extensively used in upstream workflows due to their flexibility, scalability, and cost-effectiveness. These technologies enable biomanufacturers to rapidly adapt to changing production needs, reduce the risk of contamination, and lower operational costs associated with cleaning and validation.

In the fermentation stage, single-use bioprocessing technologies play a critical role in microbial fermentation and cell culture processes. Single-use bioreactors, mixing systems, and filtration units are commonly employed to facilitate efficient nutrient delivery, oxygenation, and agitation, thereby optimizing cell growth and product yield. The adoption of single-use fermentation technologies is driven by their ability to streamline operations, minimize cross-contamination risks, and accelerate time-to-market for biopharmaceutical products.

Downstream processing involves the purification and isolation of biopharmaceutical products from the fermentation broth or cell culture supernatant. Single-use chromatography columns, filtration systems, and disposable tubing assemblies are widely utilized in downstream workflows to achieve high product purity and yield while reducing the need for cleaning and validation. These single-use solutions offer greater flexibility, process consistency, and cost-efficiency compared to traditional stainless-steel equipment, making them increasingly preferred by biopharmaceutical manufacturers.

Global Single-use Bioprocessing Market, Segmentation by Application

The Global Single-use Bioprocessing Market has been segmented by Application into Filtration, Purification, Cell Culture, and Others.

Filtration is a key application in single-use bioprocessing, used for separating particles, impurities, and contaminants from liquids during the biomanufacturing process. Filtration technologies, such as depth filtration, membrane filtration, and tangential flow filtration, are commonly used to ensure the sterility and purity of biological products. These systems are designed to meet strict regulatory standards, making them essential in producing high-quality biologics, vaccines, and other pharmaceuticals.

Purification is another crucial application in single-use bioprocessing, focusing on the recovery and purification of biomolecules like proteins, antibodies, and enzymes. During this stage, techniques such as chromatography, filtration, and centrifugation are used to isolate the desired product from complex mixtures. Single-use systems in purification allow for flexibility, scalability, and reduced risk of cross-contamination, making them ideal for both small-scale and large-scale production. The use of disposable equipment in this stage also reduces the need for cleaning and validation, resulting in cost savings and faster turnaround times.

Cell culture is a core application in single-use bioprocessing, where cells are grown in controlled environments to produce therapeutic proteins, vaccines, and other biologics. Disposable bioreactors, media bags, and mixers are commonly used in cell culture applications to facilitate the growth and maintenance of cells. The use of single-use systems in cell culture processes offers advantages such as reduced contamination risks, lower operating costs, and the flexibility to scale up or down depending on production needs.

Other applications in the market include virus production, gene therapy, and diagnostics. These applications leverage the flexibility and sterility of single-use technologies to support the development and production of innovative biopharmaceuticals. Single-use bioprocessing systems are integral to these specialized applications due to their ability to meet specific production requirements while maintaining high levels of efficiency and safety.

Global Single-use Bioprocessing Market, Segmentation by End Use

The Global Single-use Bioprocessing Market has been segmented by End Use into Biopharmaceutical Manufacturer, Academic & Clinical Research Institutes and Others.

Biopharmaceutical manufacturers represent a major end-use segment within the single-use bioprocessing market. These manufacturers rely on single-use technologies to streamline their production processes, enhance flexibility, and reduce operational costs. The shift towards single-use bioprocessing systems among biopharmaceutical companies is primarily driven by the need for efficient and scalable manufacturing solutions to meet the growing demand for biologics and biosimilars.

Another significant end-use segment is academic and clinical research institutes. These institutions play a crucial role in advancing scientific knowledge and developing new therapies. Single-use bioprocessing technologies offer several advantages to academic and research settings, including simplified workflow, reduced risk of cross-contamination, and lower capital investment compared to traditional stainless-steel systems. As a result, academic and clinical research institutes are increasingly adopting single-use bioprocessing solutions to support their research activities.

The market includes other end-use sectors such as contract manufacturing organizations (CMOs), contract research organizations (CROs), and biotechnology startups. These entities often require flexible and cost-effective manufacturing solutions to support their varied production needs. Single-use bioprocessing technologies provide them with the agility to scale production capacity quickly, accommodate varying batch sizes, and minimize the risk of product cross-contamination.

Global Single-use Bioprocessing Market, Segmentation by Geography

In this report, the Global Single-use Bioprocessing Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Single-use Bioprocessing Market Share (%), by Geographical Region, 2024

North America holds a substantial share in the global single-use bioprocessing market, primarily due to the presence of a well-established biopharmaceutical industry and a high level of adoption of advanced bioprocessing technologies. Additionally, favorable regulatory policies and increasing investments in research and development activities further contribute to market growth in this region.

Europe is another prominent market for single-use bioprocessing solutions, driven by a strong biotechnology sector and growing demand for biopharmaceutical products. Countries like Germany, the UK, and France are witnessing significant investments in bioprocessing technologies, leading to the expansion of the market. Moreover, collaborations between academic institutions, research organizations, and industry players are fostering innovation and driving market growth.

The Asia Pacific region is emerging as a lucrative market for single-use bioprocessing, propelled by rapid industrialization, increasing healthcare expenditure, and rising investments in biotechnology and pharmaceutical sectors. Countries such as China, India, and Japan are witnessing a surge in demand for bioprocessing technologies, driven by the growing need for affordable healthcare solutions and the presence of a large patient pool.

The Middle East and Africa, along with Latin America, are also experiencing steady growth in the single-use bioprocessing market. Factors such as government initiatives to promote the biopharmaceutical industry, expanding healthcare infrastructure, and rising investments in research and development activities are contributing to market expansion in these regions.

This report provides an in depth analysis of various factors that impact the dynamics of Global Single-use Bioprocessing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers

• Biopharmaceutical industry growth
• Cost-effectiveness
• Technological advancements
• Regulatory support

• Increasing demand for vaccines: The global single-use bioprocessing market is experiencing significant growth, primarily driven by the increasing demand for vaccines. With the ongoing COVID-19 pandemic and the need for rapid vaccine development and manufacturing, the biopharmaceutical industry has turned to single-use bioprocessing technologies to streamline production processes. These technologies offer advantages such as reduced risk of cross-contamination, shorter setup times, and increased flexibility, making them ideal for the fast-paced production of vaccines. Additionally, single-use bioprocessing systems help manufacturers scale up production quickly to meet the high demand for vaccines worldwide. As a result, the market for single-use bioprocessing equipment and consumables is expected to continue expanding as biopharmaceutical companies invest in infrastructure to enhance their manufacturing capabilities.

  The increasing prevalence of infectious diseases and the rising awareness of the importance of vaccination programs in preventing their spread are driving the demand for vaccines globally. Governments, healthcare organizations, and pharmaceutical companies are collaborating to develop and distribute vaccines to combat diseases such as influenza, measles, hepatitis, and human papillomavirus (HPV), among others. Single-use bioprocessing technologies play a crucial role in this endeavor by enabling efficient and cost-effective vaccine production. As the global population continues to grow, along with the need for immunization against both existing and emerging infectious diseases, the demand for vaccines is expected to rise further, driving the growth of the single-use bioprocessing market. In essence, the synergy between the demand for vaccines and the adoption of single-use bioprocessing technologies underscores the pivotal role these technologies play in meeting the world's healthcare needs.

Restraints

• Environmental concerns
• Quality concerns
• Lack of standardization
• Material compatibility issues

• Limited scalability: The global single-use bioprocessing market has witnessed significant growth in recent years, driven by its advantages such as reduced contamination risks, lower operational costs, and faster turnaround times. However, one of the key challenges faced by this market is limited scalability. While single-use bioprocessing systems excel in small to medium-scale production, they encounter limitations when it comes to large-scale manufacturing. Scaling up single-use systems to meet the demands of large-scale production often proves to be complex and costly.

  The scalability issue extends beyond the physical infrastructure to include concerns regarding process consistency, reliability, and regulatory compliance. Ensuring consistent product quality and maintaining regulatory compliance become more challenging as the scale increases. As a result, some biopharmaceutical companies may hesitate to fully adopt single-use bioprocessing technologies for large-scale production, opting instead for traditional stainless-steel systems or hybrid approaches that combine single-use and stainless-steel components. Addressing the scalability limitations through technological advancements and regulatory frameworks will be crucial for the continued growth and adoption of single-use bioprocessing in the global biopharmaceutical industry.

Opportunities

• Emerging markets expansion
• Customization options
• Adoption in cell therapy
• Continuous manufacturing adoption

• Contract manufacturing services demand: The global single-use bioprocessing market has witnessed substantial growth in recent years, primarily driven by the increasing adoption of single-use technologies across the biopharmaceutical industry. These technologies offer several advantages, including reduced risk of cross-contamination, lower operational costs, and enhanced flexibility in manufacturing processes. As biopharmaceutical companies strive to expedite production processes while maintaining stringent quality standards, the demand for single-use bioprocessing solutions continues to rise.

  In parallel, there has been a notable surge in demand for contract manufacturing services within the biopharmaceutical sector. Biopharmaceutical companies are increasingly outsourcing manufacturing activities to contract development and manufacturing organizations (CDMOs) to leverage their expertise, infrastructure, and scalability. This trend is fueled by factors such as the complexity of biopharmaceutical manufacturing processes, the need for specialized facilities and equipment, and the desire to focus on core competencies. CDMOs offer a range of services, including process development, manufacturing, and analytical testing, enabling biopharmaceutical companies to accelerate product development timelines and mitigate risks associated with in-house manufacturing. As the biopharmaceutical industry continues to expand and diversify, the demand for contract manufacturing services is expected to remain robust, driving further growth in the global single-use bioprocessing market.

Key players in Global Single-use Bioprocessing Market include:

• General Electric Company (GE healthcare)
• Eppendorf AG
• Corning Incorporated
• Thermo Fisher Scientific, Inc.
• Sartorius AG
• Merck KGaA
• LONZA
• Boehringer Ingelheim GmbH
• Danaher Corporation
• MEISSNER FILTRATION PRODUCTS, INC

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis