Single-use Bioprocessing: A Rapidly Growing Frontier in Biomanufacturing

The global biopharmaceutical industry is undergoing a major transformation with the rise ofsingle-use bioprocessing technologies. These systems, which utilize disposable components such as bioreactors, mixers, and storage containers, are significantly reshaping production processes across the sector.

According to FutureWise analysis, the market for single-use bioprocessing was valued at US$ 11.95 billion in 2023 and is projected to reach US$ 53.9 billion by 2031, growing at a remarkable CAGR of 20.70%. This explosive growth reflects a broad industry shift toward greater flexibility, efficiency, and innovation.

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Key Growth Drivers

Several factors are propelling the adoption of single-use systems:

• Cost-effectiveness: Disposable technologies eliminate the need for costly cleaning and sterilization, reducing operational expenses.

• Reduced Risk of Contamination: Single-use components minimize cross-contamination risks, a critical factor in biopharmaceutical manufacturing.

• Faster Production Timelines: Streamlined setup and turnaround times enable quicker scale-up and adaptation to new therapies, especially important in pandemic responses and personalized medicine.

Applications Expanding Across Therapies

Single-use bioprocessing is now a backbone for many advanced therapies:

• Vaccines: Single-use systems were instrumental in the rapid development and production of COVID-19 vaccines.

• Monoclonal Antibodies: These therapies, vital for treating cancer and autoimmune diseases, are increasingly manufactured using disposable technologies.

• Cell and Gene Therapies: The highly specialized, small-batch nature of these treatments makes them ideal candidates for single-use solutions.

Challenges to Watch

Despite the benefits, the market faces certain hurdles:

• Environmental Concerns: The reliance on disposable plastics has sparked sustainability discussions, pushing manufacturers to seek recyclable or biodegradable materials.

• Scalability: While single-use systems are highly effective at small and medium scales, scaling up to meet large-volume commercial demands remains a technical challenge.

Regional Insights

The North American and European markets currently lead in adoption, driven by the presence of major biopharmaceutical companies and supportive regulatory frameworks. However, Asia-Pacific is rapidly catching up, fueled by growing investments in biotechnology research and infrastructure.

Leading Players

Several major corporations are driving innovation and competition in the single-use bioprocessing space, including:

• Thermo Fisher Scientific

• Sartorius AG

• Danaher Corporation

• Merck KGaA

These companies are investing heavily in expanding their single-use product portfolios and supporting services, indicating a strong and sustained market momentum.

Future Outlook

As biologics, personalized medicine, and regenerative therapies continue to gain prominence, the demand for agile, cost-efficient manufacturing solutions like single-use bioprocessing will only intensify. Coupled with innovations in materials science and automation, the market is poised for robust, sustainable growth over the next decade.