The Single-use Bioprocessing Market is entering a transformative growth phase, fueled by the rapid expansion of biopharmaceutical manufacturing, rising demand for flexible production systems, and heightened focus on contamination control. Valued at USD 7.62 billion in 2021, the market is projected to reach USD 25.40 billion by 2031, growing at an impressive CAGR of 18.93% during the forecast period (2024–2031).

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This market is evolving rapidly with the increasing adoption of single-use bioprocessing systems such as bioreactors, fermenters, mixers, filtration units, bags, and containers. These disposable systems, primarily made of sterilizable plastic components, support critical processes like upstream expression, purification, storage, and separation of biopharmaceutical products. As global biomanufacturing shifts toward agile, cost-effective, and contamination-free solutions, single-use technologies are being embraced by both established pharma giants and emerging biotech firms—especially in alignment with trends seen in the United States and Asia, where scalable, single-use systems are driving next-gen biologics production.

Key Market Drivers

1. Rise in Biologics and Personalized Medicine:
The growth of monoclonal antibodies, gene therapy, and personalized medicine has created a strong need for scalable, contamination-free, and faster bioprocessing methods. Single-use systems (SUS) offer agility and ease of implementation, making them ideal for such advanced therapies.

2. Cost Efficiency and Operational Flexibility:
Unlike traditional stainless-steel systems, SUS eliminate the need for cleaning and sterilization, significantly reducing downtime and water/chemical usage. This makes them highly attractive for small-to-mid-sized biotech firms and contract manufacturing organizations (CMOs).

3. Pandemic Preparedness and Vaccine Development:
COVID-19 and subsequent global health threats highlighted the urgent need for rapid-response manufacturing capabilities. Single-use systems enabled fast-tracked vaccine production and played a pivotal role in scaling mRNA technologies.

4. Regulatory and Environmental Incentives:
The U.S. FDA and EMA support the adoption of single-use bioreactors and modular facilities, facilitating market expansion. Meanwhile, vendors are innovating biodegradable materials to tackle concerns over plastic waste and sustainability.

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Market Segmentation Snapshot

• By Product Type: The market is segmented into bioreactors, mixers, bags, tubes & connectors, sampling systems, and others. Bioreactors and mixing systems account for the largest share due to their central role in upstream processing.
• By Workflow: Upstream processing dominates the market share, given the high usage of SUS in cell culture and fermentation.
• By End-User: Biopharmaceutical companies hold the majority share, followed by CMOs and academic research institutes.

Regional Insights

United States:
The U.S. remains the largest and most mature market, fueled by robust biopharma R&D, government funding, and large-scale manufacturing investments. In 2024, the U.S. government announced a new initiative to strengthen domestic biologics production, allocating over USD 2 billion toward advanced manufacturing platforms—predominantly single-use facilities. Leading companies like Thermo Fisher Scientific, Danaher Corporation, and Sartorius Stedim Biotech are expanding their manufacturing capacities across North America.

Japan:
Japan’s biopharma industry is rapidly integrating single-use systems as part of its strategic vision for regenerative medicine and mRNA vaccine production. In 2024, the Japanese Ministry of Health, Labour and Welfare (MHLW) introduced incentives for companies transitioning from conventional systems to disposable solutions. Furthermore, leading Japanese firms such as Asahi Kasei and Nipro Corporation are increasing R&D spending on sustainable single-use materials to enhance product lifecycle management.

Europe and Asia-Pacific:
Germany, the UK, and Switzerland continue to be innovation hubs, while emerging economies in the Asia-Pacific region, such as China, South Korea, and India, are rapidly adopting SUS to scale biologics and biosimilars production.

Latest Industry Trends

• AI Integration in Bioprocess Monitoring:
  Vendors are now embedding AI and data analytics into SUS platforms to allow predictive maintenance, batch tracking, and process optimization.
• Modular Biomanufacturing Units:
  Companies are investing in mobile, modular units using SUS to cater to outbreak hotspots and rural regions, enhancing supply chain agility.
• Green Bioprocessing Innovations:
  Environmental concerns are driving innovations in recyclable polymers and closed-loop systems to minimize single-use plastic waste.
• M&A Activity on the Rise:
  The market is witnessing increased mergers and acquisitions. For example, in Q1 2025, Repligen Corporation announced the acquisition of a European tubing and bagging system manufacturer to strengthen its product portfolio.

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Competitive Landscape

The market is highly competitive and fragmented, with major players focusing on product innovation, capacity expansion, and strategic partnerships. Notable players include:

• Thermo Fisher Scientific Inc.
• Sartorius AG
• Danaher Corporation (Cytiva and Pall)
• Merck KGaA
• Eppendorf AG
• Parker Hannifin Corp.
• Avantor, Inc.
• Corning Incorporated
• PBS Biotech, Inc.
• Saint-Gobain Performance Plastics

These companies are investing in next-generation single-use assemblies, automation, and flexible manufacturing to meet evolving industry demands.

Growth Opportunities

1. CMO & CDMO Expansion: As pharmaceutical outsourcing grows, CMOs are increasingly deploying SUS to reduce turnaround time and manage multiple client processes efficiently.
2. Biosimilar Production: The patent cliff for blockbuster biologics has opened lucrative opportunities for biosimilars, where SUS offers a cost-effective pathway to scale.
3. Emerging Markets Penetration: Expansion in Latin America, Southeast Asia, and Africa presents a significant untapped opportunity, supported by international funding agencies.
4. Regenerative Medicine and Cell Therapy: As cell therapy and tissue engineering progress, single-use bioreactors and closed systems will be pivotal in clinical and commercial scale-up.

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Conclusion

The global single-use bioprocessing market is on the cusp of a revolution, catalyzed by innovation in biologics, operational efficiency, and a growing preference for flexible, scalable manufacturing. The United States and Japan stand at the forefront of this transformation, while global demand signals a sustained, long-term market boom. As regulatory and environmental concerns are addressed through innovation, single-use technologies are poised to become the new standard in biopharmaceutical manufacturing.