Analyzing Top 15 Companies Driving Growth in Single-Use Bioreactor Market in 2025
The biopharmaceutical industry is rapidly evolving, and single-use bioreactors (SUBs) are playing a critical role in transforming bioprocessing. Unlike traditional stainless-steel bioreactors, which require extensive cleaning and sterilization, SUBs utilize disposable plastic components, reducing contamination risks and operational costs. These flexible systems have gained widespread adoption in drug development, cell culture, and vaccine production due to their efficiency, scalability, and cost-effectiveness. With the increasing demand for biologics, monoclonal antibodies, and gene therapies, single-use bioreactors have become indispensable in modern biomanufacturing.
Leading companies are continuously innovating to enhance SUB technology, making bioprocessing more sustainable and adaptable. This blog explores the benefits, challenges, and key players driving the single-use bioreactor industry.
What Are Single-Use Bioreactors?
Single-use bioreactors are bioprocessing systems designed with disposable plastic bags instead of traditional stainless-steel vessels. These bags are pre-sterilized and replaceable after each production cycle, eliminating the need for cleaning and reducing contamination risks.
Following is a list of key components of SUBs.
- Bioreactor Bag
It is made of multi-layered plastic films with oxygen and carbon dioxide permeability.
- Agitation System
Stirred-tank, wave-mixed, or rocking-motion mechanisms for efficient cell culture.
- Sensors and Control Systems
Integrated pH, dissolved oxygen, temperature, and CO? sensors for process monitoring.
- Tubing and Connectors
Sterile and disposable components for media transfer and sampling.
Types of Single-Use Bioreactors
The following are the main types of single-use bioreactors.
- Stirred-Tank Single-Use Bioreactors
These are the most common types of SUBs employed globally. It mimics traditional stainless-steel bioreactors with impellers for mixing.
- Wave-Mixed Single-Use Bioreactors
Wave-mixed SUBs use a rocking motion to agitate cells, which is ideal for shear-sensitive cultures gently.
- Bubble Column and Air-Lift SUBs
Bubble column and air-lift SUBs utilize gas bubbles for mixing and aeration, reducing mechanical stress.
Advantages of Single-Use Bioreactors
- Reduced Cleaning and Validation Costs: The primary benefit of single-use bioreactors is that they are disposable, eliminating the need for extensive cleaning and sterilization (CIP/SIP) processes, which significantly cuts down on labor costs, water usage, and associated validation requirements.
- Faster Turnaround Time
By eliminating cleaning steps, single-use bioreactors allow for quicker transitions between batches, resulting in shorter production cycles and faster time to market.
- Increased Flexibility
Single-use systems can be easily scaled up or down to accommodate different production volumes by simply choosing a different size bag, allowing for flexibility in the research and development phases.
- Lower Risk of Cross-Contamination
Since each bioreactor is used only once, the risk of cross-contamination between different cell lines or products is significantly reduced.
Top Companies Influencing Single-Use Bioreactors Market
- Thermo Fisher Scientific
Thermo Fisher Scientific was formed in 2006 when Thermo Electron and Fisher Scientific merged. Thermo Fisher Scientific is a public company that provides scientific instrumentation, software services, reagents, and consumables. Thermo Fisher offers HyPerforma™ single-use bioreactors, widely used in biopharmaceutical manufacturing. Their systems support scalability from process development to commercial production.
Sartorius AG is the parent company of the Sartorius Group. Sartorius AG is a German company that was founded in 1870 in Göttingen, Germany. The company's headquarters are still located in Göttingen. Sartorius’ Biostat STR and Biostat RM bioreactors are known for their advanced automation and integration capabilities, making them popular for cell culture applications.
- Danaher Corporation (Pall and Cytiva)
Danaher Corporation is a global conglomerate that designs, manufactures, and sells medical, industrial, and commercial products and services. It is headquartered in Washington, D.C., and was founded in 1946 in New York City. Pall’s Allegro and Cytiva’s Xcellerex bioreactors are leading choices for single-use bioprocessing, offering flexibility in upstream processing.
- Eppendorf AG
Eppendorf AG is a private company that manufactures and supplies laboratory equipment and consumables. It was established in 1945 and headquartered in Hamburg, Germany. Eppendorf’s BioBLU single-use vessels are designed for microbial and cell culture applications, supporting various bioprocesses.
Merck KGaA (MilliporeSigma) is the world's oldest operating chemical and pharmaceutical company. It was founded in 1668, and its headquarters are presently located in Darmstadt, Germany. Merck’s Mobius single-use bioreactors provide scalable solutions for cell culture and protein production with robust control systems.
Challenges in Single-Use Bioreactors Market
Single-use bioreactors, while offering advantages like faster turnaround times and reduced cleaning validation, face significant challenges that are discussed below.
Leachables and Extractables (L/E)
Plastic materials used in single-use bags can leach chemicals into the cell culture media, potentially affecting product quality and safety and requiring rigorous testing and validation to ensure acceptable levels of L/E.
Scaling Up Limitations
While single-use bioreactors can be scaled up, reaching very large volumes for high-volume production can be challenging due to limitations in bag size and material properties.
Validation Complexity
Single-use systems often involve multiple components from different suppliers, making validation more intricate as each component needs to be assessed for quality and compatibility.
Sustainability Issues
The significant amount of plastic waste generated by single-use bioreactors poses a significant concern regarding environmental sustainability, requiring better recycling or disposal methods. This is one of the biggest challenges being faced in the market.
Regulatory Hurdles
Regulatory organizations might impose strict standards for validating single-use systems, increasing the challenges of creating and applying new technologies in single-use bioreactors.
What Does Future Holds?
The growing adoption of biologics, gene therapies, and personalized medicine is driving demand for flexible, cost-effective bioreactors. The future of single-use bioreactors looks very promising and is expected to expand further due to their advantages in flexibility, cost-effectiveness, and reduced turnaround times compared to traditional stainless-steel systems, particularly in the biopharmaceutical industry. Key trends in the market include advancements in scale-up capabilities, integration of advanced sensors for real-time monitoring, and increasing adoption by smaller companies and contract manufacturers, driving further market expansion. As technology advances, SUBs will continue to evolve, offering better scalability, automation, and sustainability. With continued innovation from leading biopharma companies, the future of bioprocessing is set to be more efficient, adaptive, and environmentally responsible.
Conclusion
Single-use bioreactors are revolutionizing the biopharmaceutical industry by offering a faster, more cost-effective, and flexible alternative to traditional stainless-steel systems. Despite facing several challenges, such as plastic waste and scalability, innovations in automation, sustainability, and hybrid systems are addressing these concerns. The leading companies are driving advancements in SUB technology, making bioprocessing more efficient and accessible.
As the demand for biologics continues to rise, single-use bioreactors will remain at the forefront of modern biomanufacturing, shaping the future of drug production and cell-based therapies.
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