Single-use systems (SUS) have revolutionized biopharmaceutical manufacturing, with single-use bioreactors (SUBs) leading the charge in recent decades. However, while the adoption of SUBs has plateaued, other forms of single-use technology (SUT) are gaining momentum. The landscape is evolving rapidly, driven by technological innovations, market demands, and the urgent needs highlighted by recent global events like the COVID-19 pandemic.
Historical Adoption and Evolution of Single-Use Systems
The transition from traditional stainless-steel bioprocessing equipment to single-use systems began gradually but has seen accelerated growth, especially in the early 2000s. The shift was significantly aided by technological advancements in sterile connectors and tube welders, which enabled seamless and sterile integration of SUS components. Furthermore, the introduction of disposable rocking-bag bioreactors provided a pivotal moment for the adoption of single-use technologies.
These early innovations set the stage for more extensive use of SUBs, enhancing efficiency and reducing the time required for setup and sterilization processes. The COVID-19 pandemic further drove the adoption of SUS, as manufacturers needed flexible, rapid, and scalable solutions to meet unprecedented demands. This period highlighted the critical advantages of SUS in terms of adaptability and speed, making them indispensable in emergency response scenarios. As a result, the adoption rate of single-use systems, including SUBs, saw a significant increase, reaching 87% in 2024 according to BioPlan’s 21st Annual Report and Survey.
Current Trends and Market Penetration
Despite the explosive growth in the use of single-use bioreactors during the pandemic, the adoption rate has now plateaued. As of 2024, usage rates for SUBs in biomanufacturing facilities have remained relatively stable, hovering around 85-87%, with growth rates slowing to between 1.6% and 3.5%. This plateau suggests that while the technology has become a staple in biomanufacturing, its widespread adoption has reached a mature stage.
However, this does not signal a decline; instead, it indicates that the market for SUBs is now more established, with future growth likely to be driven by incremental improvements and innovations rather than rapid adoption. While the momentum for SUBs may have leveled off, other single-use technologies continue to gain traction. Systems such as disposable sensors, chromatography systems, and tangential flow filtration (TFF) systems are witnessing increased adoption as they offer similar benefits in terms of efficiency, cost savings, and reduced risk of contamination.
Advantages of Single-Use Systems
The continued preference for SUS can be attributed to several key benefits. First, SUS provide fast bioprocessing options, significantly reducing setup times and expediting production cycles. This is crucial in the biopharmaceutical industry, where time-to-market can be a significant competitive advantage.
Cost savings are another significant benefit. By eliminating the need for extensive cleaning and validation processes, SUS reduce labor and material costs, contributing to overall cost efficiency. Additionally, the flexibility and scalability of these systems allow for easy adjustments in production volume, making them suitable for both pilot projects and large-scale manufacturing.
SUS also minimize the risk of contamination, as disposable components are used only once, reducing the potential for cross-contamination. This is particularly important in the production of high-stakes biopharmaceuticals where purity is paramount. Lastly, facilities utilizing SUS generally require less space and investment, allowing for quicker changeovers and improved operational efficiency.
Challenges to Overcome
Despite their many advantages, SUS are not without challenges. One primary concern is the high cost associated with disposable systems, which continues to be a significant point of contention among industry professionals. More than two-thirds of industry respondents emphasize the need for cost reduction to make SUS more economically feasible.
Environmental impact due to increased waste from disposable systems is another critical issue. The biopharmaceutical industry is under pressure to find sustainable solutions to mitigate the negative environmental effects of plastic waste generated by SUS. Efforts towards recycling programs and the development of biodegradable materials are underway, but these solutions need to be scaled and standardized to make a significant impact.
In addition to cost and environmental challenges, maintaining regulatory compliance with evolving standards is a constant hurdle. As the technology advances, ensuring that all components meet stringent industry regulations remains a pressing concern.
Innovations and Future Directions
Continuous technological advancements are essential to address the current challenges and drive future growth in the SUS sector. Innovations in single-use purification systems are becoming increasingly important, offering more efficient and integrated processes for biomanufacturing.
Moreover, the integration of digital monitoring technologies with SUS promises greater process control and optimization. Real-time data acquisition and analysis can improve manufacturing efficiency and product quality, supporting the overall advancement of biopharmaceutical production technologies. Digital monitoring technologies also provide enhanced traceability, which is critical for regulatory compliance and quality assurance. As these technologies evolve, they will enable more precise control over bioprocessing conditions, leading to higher yield and better product consistency.
Emerging Trend: Modular Bioprocessing Units
Single-use systems (SUS) have significantly transformed biopharmaceutical manufacturing, particularly with the rise of single-use bioreactors (SUBs) over the past few decades. These SUBs have been instrumental in making production more flexible and cost-effective, but their adoption has now hit a plateau. Nonetheless, this doesn’t mean the era of single-use technology (SUT) is waning; quite the opposite, in fact. Other types of SUT are gaining significant traction in the industry.
This shift is being propelled by a blend of technological innovation, evolving market demands, and the pressing needs underscored by recent global crises, such as the COVID-19 pandemic. The pandemic, in particular, has highlighted the necessity for rapid, scalable, and adaptable manufacturing solutions in the biopharmaceutical sector. This urgent global need has acted as a catalyst, pushing for more widespread implementation of various single-use technologies beyond just bioreactors.
These advancements are not merely evolutionary but represent a significant leap in how biopharmaceutical products are developed and manufactured. The inherent flexibility and reduced risk of contamination associated with SUS make them invaluable in today’s fast-paced medical landscape. As the industry continues to navigate through these changes, one can expect even more innovative single-use solutions to emerge, further enhancing the efficiency and responsiveness of biopharmaceutical manufacturing.
