The Singular Rise of Single-Use Technologies

When plastic pollution is known to be a significant global problem, it might seem paradoxical that single-use (plastic, disposable) biopharmaceutical technology use is on the rise. However, the improved efficiencies, flexibility, lower costs, reduced contamination risks and faster production times achieved with single-use technologies are driving the uptake of these apparatus, and it is widely argued that concerns over their environmental sustainability might not be as straightforward as they seem.

With increased adoption among startups and SMEs, as well as heavy investment from leading multinationals like Eli Lilly and Merck, the trend for single-use technologies is remarkable. Here, we look at some of the pros and cons of single-use equipment in biopharma, and we ask the question – could the future of biopharma be disposable?

What are single use technologies?

Single-use technologies have been commercially available for about 30 years, since companies like HyClone Laboratories (a cell culture media provider) pioneered sterile "bio bags” for media packaging in the late 1990s. However, the range and type of available disposable technologies has since expanded, now covering upscale bioprocessing to final formulation and filling. Single-use bags, connectors and tubing are commonly found within facilities that have adopted single-use technologies.

However, when most people refer to single-use technologies in biopharma, they are usually referring to single-use bioreactors. These apparatus saw relatively modest uptake until the COVID-19 pandemic. The subsequent and sudden high demand for vaccines is seen by many as the factor that drove the proportion of commercial-scale single-use bioreactors to grow from 32.5% in 2019 to 43% in 2022. However, even now, the uptake of disposable apparatus is continuing to grow, driven by increased global demand for biologics and vaccines. In fact, more than half of all commercial-scale bioreactors are now single-use.

Why the uptake?

Single-use bioreactors offer a speed and flexibility that stainless steel just can’t match. Facilities using them also have a much lower up-front capital investment and a shorter construction period as they reduce the time needed for building, cleaning and general maintenance. For example, if contamination occurs, downtime can be minimized as only the affected unit in a single-use set-up needs to be replaced, with limited loss of product or time. The same applies to any parts of a system that might need to be upgraded. As a result, one study suggests that after 10 years of active use, single-use bioreactors can reduce capital costs by 40–50%, time-to-build by 30%, and ongoing operating costs by 20–30% [1].

However, the global move towards single-use technologies is about more than just cost and process efficiencies. Over and above these advantages, it is argued that they are simply better suited to the demands placed on the modern biopharmaceutical company. In particular, single-use bioreactors are thought to support flexible manufacturing, while enabling efficient and rapid adjustment of production schedules and volumes.

For example, stainless steel bioreactors typically have volumes of 10,000 Liters or more, but this can actually lead to over-capacity, when a 2,000 Liter bioreactor can produce enough protein over a year to meet the needs of more than 50% of currently-marketed biologics. For on-demand production, personalized medicines for smaller patient groups, and for facilities simply needing to achieve flexibility in order to manage capacity utilization, the traditional stainless-steel set-up is no longer always the best solution. This is a main driver for biopharma companies to switch to smaller, more flexible single-use bioreactors.

Conversely, for situations requiring very large volumes (single-use bioreactors tend to be limited by pressure challenges to around 6,000 Liters), scaling out, which involves using multiple bioreactors parallel, can be implemented flexibly to increase production capacity. For example, a recent article in Contract Pharma [2] explained that WuXi Biologics’ facility in Ireland houses four 4,000L SUBs, enabling the company to ‘scale out’ its biomanufacturing at 4,000L, 8,000L, 12,000L and 16,000L, for different stages, scales and products. 

What are the downsides?

Despite lower up-front costs and capital investment, single-use bioreactors are associated with higher ongoing consumable costs due to their disposability. Consideration needs to be given to those costs, versus the cost and process efficiencies described above.

Another common concern with single-use bioreactors is the possibility of leachables and extractables from the plastics used in their construction, and the need for standardization and robust validation. In fact, numerous industry groups and organizations have worked to find practical solutions to these issues in recent years, including the standardization of extractables/leachables and integrity testing, particulate control, product characteristics or specifications to increase interoperability between components produced by different suppliers, and rigorous change management procedures to ensure that single-use equipment consistently meets specifications for every application [3]. As a result of these efforts, many issues have been addressed.

It is also worth noting that, while great for advanced products manufactured using biotechnology methods (e.g. monoclonal antibodies, gene therapies), single-use bioreactors are not suited to microbial fermentation. This is because of their inability to handle high metabolic demands, leading to poor oxygen transfer, inadequate heat removal, and difficulty in achieving sufficient mixing.

Sustainability

Despite the ‘single-use’ red flag, in fact numerous experts claim that single-use bioreactors can have a better sustainability profile than stainless-steel systems. In particular, single-use bioreactors have been demonstrated to significantly reduce water consumption and energy use. This is due to the requirements for sanitization and cleanliness in biological drug manufacture, which place an extreme environmental burden on the traditional stainless-steel facility. Sanitization and cleaning are chemical, water and energy intensive. As a result, multiple studies have shown that single-use bioreactors can significantly reduce the overall carbon footprint of bioprocessing by consuming less energy, water and cleaning chemicals [4].

Disposing of single-use parts, however, presents significant issues with waste production and possible environmental effects. The main negative impact of single-use bioreactors is definitely a result of their plastic content. Echoing the current global focus on reducing single-use plastics, this is the most common argument against their use. It has been reported that about 880 kg of solid waste per batch may be generated [4], but material recycling is challenging due to GMP regulations. Waste that comes into contact with pharmaceutical liquids must follow specialized disposal protocols, making recycling difficult. This is the focus of some interesting research, which could have implications for pharma’s sustainability in general.

In March 2025, Project Nexus, an Innovate UK-funded initiative focused on developing sustainable, 3D-printed single-use bioreactors using bio-based materials, was initiated. This collaboration, involving companies like Sartorius and Metamorphic, and academic institutions including the University of Sheffield and Imperial College London, aims to reduce the environmental impact of biopharmaceutical manufacturing by using additive manufacturing to create more sustainable and circular bioprocessing equipment. The project is leveraging expertise in digital design, automation, and material innovation to pioneer this advanced manufacturing approach for bioreactors at scale.  The project's goal is the creation of sustainable bio-based materials for single use bioreactors (and other single use bioprocessing technologies). Project Nexus aims to transform bioprocessing through novel materials and sustainable approaches alongside net-zero ambitions. If successful, the project could have a huge impact on achieving a circular economy in biopharma, even when using single-use technologies.

What’s next?

The single-use bioreactor market is a rapidly-evolving one, with a remarkable rate of expansion. Global market analysts Markets & Data predict that the worldwide single-use bioreactors market will grow at a CAGR of 18.37% over the next seven years, quadrupling in value from around US$4 million in 2024 to over US$16 million in 2032. The rapid expansion of the single-use bioreactor market is complemented by strong growth in biologics, vaccines, and cell and gene therapies, all of which are driving demand for scalable and modular bioprocessing technologies, with single-use bioreactors facilitating quicker, more flexible, and less expensive product development cycles.

As more and more companies adopt single-use bioreactor systems to improve flexibility, speed and efficiency in drug development and manufacture, these pre-sterilized, disposable systems are increasingly recognized for the advantages they offer. From a lower risk of cross-contamination and removal of cleaning and validation processes, to lower installation and maintenance costs, these systems are highly suitable for small biotech companies, contract manufacturing organizations, and manufacturers of biotherapeutic and biosimilar medicines. Further technological advances, such advanced sensors for real-time monitoring, integration of artificial intelligence (AI) and IoT devices are also expected to further enhance the performance and reliability of single-use bioreactors in the future.

So, is the future disposable? For certain sectors of biopharma, it certainly looks that way!

Single-use bioreactors' flexibility, efficiency, affordability and surprisingly acceptable sustainability credentials (which should hopefully improve further with initiatives like Project Nexus) are driving demand and uptake. There can be little doubt that single-use bioreactors will dominate their field for the foreseeable future.

References

1.      Hernandez R. Top trends in biopharmaceutical manufacturing: 2015. Pharmaceut Tech 2015;39.

2.      Chen C. Addressing industry challenges with single-use technologies. Contract Pharma, June 3, 2026.

3.      Walker N. Single-use technology integral to advancing biomanufacturing. Contract Pharma, March 9, 2016.

4.      Sinclair A et al. The environmental impact of disposable technologies. BioPharm Int 2008; 201-9.

About the Author

Sarah Harding, PhD

Sarah Harding worked as a medical writer and consultant in the pharmaceutical industry for 15 years, for the last 10 years of which she owned and ran her own medical communications agency that provided a range of services to blue-chip Pharma companies. She subsequently began a new career in publishing as Editor of Speciality Chemicals Magazine, and then Editorial Director at Chemicals Knowledge. She now focusses on providing independent writing and consultancy services to the pharmaceutical and speciality chemicals industry