• In September 2023, Getinge introduced the AppliFlex ST GMP, a next-generation single-use bioreactor designed to support cGMP-compliant manufacturing processes. Available in multiple sizes, this flexible solution is tailored to meet the evolving needs of mRNA production as well as cell and gene therapy workflows. The launch underscores Getinge’s commitment to advancing scalable, disposable bioprocessing technologies, enabling biopharmaceutical manufacturers to streamline operations, maintain regulatory compliance, and accelerate time to market for advanced therapies.

• In April 2023, Merck KGaA introduced Ultimus, an advanced single-use process container film engineered to deliver enhanced strength and leak resistance for single-use bioprocessing assemblies. Designed to meet the rigorous demands of biopharmaceutical manufacturing, Ultimus offers a robust solution that ensures product integrity while supporting operational efficiency. The launch reflects Merck’s ongoing commitment to innovation in disposable bioprocessing technologies, helping manufacturers optimize reliability and reduce contamination risks in critical workflows.

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

Single-use Bioprocessing Market, Segmentation by Product

The Single-use Bioprocessing Market has been segmented by Product into Filtration Assemblies, Disposable Bioreactors, Disposable Mixers, Media Bags and Containers, and Others.

Filtration Assemblies
Filtration assemblies are fundamental to many stages of the bioprocessing workflow. They assist in the purification and separation of various biological materials, ensuring high-quality end products. Filtration technology represents approximately 25% of the global market. This sector's growth is closely tied to the increasing demand for biologics, personalized medicines, and efficient pharmaceutical production processes.

Disposable Bioreactors
Disposable bioreactors are transforming biopharmaceutical production by providing an efficient and scalable solution for cell culture and fermentation processes. These bioreactors are cost-effective, flexible, and easy to scale, making them a preferred choice in the production of vaccines and biologics. With around 30% of the global market share, disposable bioreactors are anticipated to experience strong growth in the coming years as the demand for large-scale manufacturing solutions increases.

Disposable Mixers
Disposable mixers are essential tools for preparing media and ensuring the uniform mixing of components in bioprocessing. This segment holds a market share of approximately 20% and is expected to continue expanding due to their ease of use and the growing trend toward single-use technologies. Their popularity is further fueled by the industry's demand for efficient, sterile, and cost-effective solutions.

Media Bags and Containers
The media bags and containers segment represents an essential component in the storage and transportation of bioprocessing materials. These products account for about 15% of the market share. As biopharmaceutical manufacturers increasingly adopt single-use technologies, the demand for media bags and containers for the storage of cell cultures, media, and other components is expected to surge, leading to continued market growth.

Single-use Bioprocessing Market, Segmentation Workflow

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

Upstream
The upstream segment is responsible for early-stage bioprocessing, including the growth of cells and the preparation of media. This stage is critical to producing the raw biological materials needed for the creation of biopharmaceuticals. With an estimated 40% share of the overall market, upstream processes are expected to continue expanding due to the increasing need for biologics, vaccines, and other therapeutic products. The trend toward flexible, single-use systems is driving this growth by improving operational efficiency and minimizing the risk of contamination.

Fermentation
Fermentation plays a key role in the production of therapeutic proteins, biologic drugs, and enzymes. This segment contributes about 30% of the global market share. As the demand for biologics grows, so does the need for more scalable and cost-efficient fermentation solutions. Single-use bioreactors and other disposable systems are gaining traction for their ability to offer flexibility and reduced downtime, further accelerating growth in this segment.

Downstream
Downstream processing is essential for the final purification and preparation of biopharmaceutical products. This phase includes critical steps like protein purification, filtration, and formulation before the product is finalized. The downstream segment makes up approximately 30% of the single-use bioprocessing market. With the increasing demand for high-quality biologics, including cell and gene therapies, downstream processes are expected to experience continued growth as manufacturers seek efficient and cost-effective ways to meet regulatory standards and consumer needs.

Single-use Bioprocessing Market, Segmentation by Application

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

Filtration
Filtration is one of the most vital applications in the bioprocessing market. It plays a significant role in removing contaminants, such as bacteria, endotoxins, and viruses, from biological products. The filtration application accounts for approximately 30% of the market share. With increasing demand for biologic drugs, stricter quality control regulations, and larger-scale production needs, the demand for efficient filtration systems is expected to grow steadily.

Purification
Purification is another critical application within the single-use bioprocessing market. It involves the removal of impurities and contaminants during the manufacturing process to ensure that the final products meet strict regulatory standards. The purification segment represents around 35% of the market share. As personalized medicine and biologics become more prominent, there is a growing need for advanced purification technologies to ensure the safety and effectiveness of the products.

Cell Culture
Cell culture is a cornerstone of biopharmaceutical production, particularly for the production of vaccines, monoclonal antibodies, and other biologics. The cell culture segment holds about 25% of the total market share. With the increasing demand for biologic drugs, there is a growing emphasis on improving cell culture techniques using disposable technologies to enhance efficiency and scalability in biomanufacturing.

Single-use Bioprocessing Market, Segmentation by End Use

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

Biopharmaceutical Manufacturer - CMOs & CROs and In-house Biomanufacturer
The biopharmaceutical manufacturer segment, which includes Contract Manufacturing Organizations (CMOs), Contract Research Organizations (CROs), and in-house biomanufacturers, is a major player in the single-use bioprocessing market. This segment contributes approximately 45% to the total market share. The rise in demand for biologic drugs and vaccines, along with the growing trend of outsourcing manufacturing and research, is driving significant growth. CMOs and CROs are increasingly adopting single-use technologies for their ability to enhance production flexibility, reduce contamination risks, and streamline manufacturing processes.

Academic & Clinical Research Institutes
Academic and clinical research institutes are vital to the development of new therapies, biologics, and vaccines. This segment represents about 25% of the single-use bioprocessing market. The increasing focus on research and development in biotechnology and pharmaceuticals, combined with the demand for more efficient and cost-effective processes, has led to the wider adoption of single-use bioprocessing technologies. These technologies allow for greater scalability and improved outcomes in laboratory and clinical research settings.

Single-use Bioprocessing Market, Segmentation by Geography

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

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

North America
North America leads the global market, holding approximately 40% of the market share. The region’s dominance is driven by its well-established pharmaceutical industry, high healthcare expenditure, and technological advancements in biomanufacturing. The increasing need for biologic drugs and vaccines, combined with the adoption of single-use bioprocessing technologies to improve efficiency, is fueling the growth of the market in this region.

Europe
Europe accounts for about 30% of the single-use bioprocessing market. The region’s growth is propelled by strong pharmaceutical and biotechnology sectors, as well as a favorable regulatory framework. With an emphasis on research and development, Europe continues to be a hub for innovation in the biomanufacturing industry, encouraging the use of single-use technologies to streamline production processes.

Asia Pacific
Asia Pacific holds around 20% of the global market share and is witnessing rapid growth in the biopharmaceutical and biotechnology industries. Countries such as China, India, and Japan are major contributors to this growth, driven by increasing demand for biologics and rising investments in healthcare infrastructure. The adoption of single-use bioprocessing technologies is expected to accelerate as regulatory support and healthcare systems continue to improve.

Middle East and Africa & Latin America
The Middle East and Africa (MEA) and Latin America regions together account for about 10% of the single-use bioprocessing market. While smaller in market share, these regions are poised for significant growth. This growth is fueled by improving healthcare infrastructure, increased biomanufacturing investments, and the rising need for cost-effective bioprocessing solutions in these regions.

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

Drivers, Restraints and Opportunity Analysis

Drivers:

• Surging expansion in biopharma sector
• Reduced costs drive adoption
• Innovations fueling bioprocessing evolution
• Favorable regulations boosting market growth

• Rising global vaccine production needs - The market for single-use bioprocessing is experiencing robust growth, driven primarily by the escalating demand for vaccines. Amid the ongoing COVID-19 pandemic, there has been a critical need for rapid vaccine development and manufacturing. Biopharmaceutical companies are increasingly turning to single-use bioprocessing technologies to streamline production processes. These technologies offer several advantages, including reduced risk of cross-contamination, shorter setup times, and enhanced flexibility. Such characteristics make them particularly suitable for the swift production of vaccines.

  Single-use bioprocessing systems are pivotal in enabling efficient and cost-effective vaccine production. They empower manufacturers to scale up production swiftly to meet the soaring global demand for vaccines. This technology's ability to adapt quickly to changing production needs is crucial in the biopharmaceutical industry's efforts to combat infectious diseases.

  The increasing prevalence of infectious diseases and growing awareness of vaccination's role in disease prevention are key drivers of vaccine demand globally. Governments, healthcare organizations, and pharmaceutical companies are collaborating extensively to develop and distribute vaccines targeting diseases like influenza, measles, hepatitis, and human papillomavirus (HPV). As the global population expands, so does the imperative for immunization against both existing and emerging infectious diseases. The synergy between the rising demand for vaccines and the adoption of single-use bioprocessing technologies underscores the pivotal role these technologies play in addressing global healthcare needs. As the biopharmaceutical industry continues to invest in enhancing manufacturing capabilities, the market for single-use bioprocessing equipment and consumables is expected to expand further.

Restraints

• Rising worries over plastic waste
• Inconsistencies in product quality
• Absence of unified industry standards
• Challenges in component material compatibility

• Constraints in large-scale implementation - The single-use bioprocessing market has seen significant growth in recent years, largely driven by its advantages, such as reduced contamination risks, lower operational costs, and faster turnaround times. Despite these benefits, a major challenge faced by the market is its limited scalability. While single-use bioprocessing systems are well-suited for small to medium-scale production, they encounter significant hurdles when it comes to scaling up for large-scale manufacturing. The process of expanding single-use systems to meet the demands of large-scale production often proves complex and costly.

  The scalability challenge goes beyond just physical infrastructure. It also includes concerns related to process consistency, reliability, and meeting regulatory compliance standards. As the scale of production increases, maintaining consistent product quality and ensuring compliance with regulatory requirements become more difficult. This complexity may lead some biopharmaceutical companies to hesitate in fully adopting single-use bioprocessing technologies for large-scale production. Instead, they may opt for traditional stainless-steel systems or hybrid approaches that combine single-use and stainless-steel components. To overcome these scalability limitations, technological advancements and robust regulatory frameworks will be critical. Developing solutions that enhance the scalability of single-use bioprocessing systems will be essential for their continued growth and widespread adoption in the biopharmaceutical industry.

Opportunities

• Growth opportunities in emerging regions
• Tailored solutions gaining industry traction
• Rising use in cell-based therapies
• Shift toward continuous production models

• Growing reliance on outsourced production - The single-use bioprocessing market has experienced substantial growth in recent years, driven largely by the increasing adoption of single-use technologies in the biopharmaceutical industry. These technologies offer a range of benefits, such as reducing the risk of cross-contamination, lowering operational costs, and enhancing manufacturing flexibility. As biopharmaceutical companies strive to streamline production processes while adhering to strict quality standards, the demand for single-use bioprocessing solutions continues to rise.

  There has been a significant surge in demand for contract manufacturing services within the biopharmaceutical sector. More biopharmaceutical companies are turning to contract development and manufacturing organizations (CDMOs) to take advantage of their specialized expertise, infrastructure, and scalability. This trend is driven by factors such as the increasing complexity of biopharmaceutical manufacturing processes, the necessity for specialized facilities and equipment, and the desire to focus on core business areas. CDMOs offer a comprehensive range of services, including process development, manufacturing, and analytical testing, which helps biopharmaceutical companies accelerate product development timelines while minimizing risks associated with in-house manufacturing.

  As the biopharmaceutical industry continues to grow and diversify, the demand for contract manufacturing services is expected to remain strong, further fueling growth in the single-use bioprocessing market. The synergy between the increasing need for efficient manufacturing solutions and the rise of contract manufacturing is expected to drive continued market expansion.

Key players in 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
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis