Single-Use Bioprocessing Market to Reach US$ 25.40B by 2031 | CAGR 18.93% | North America Leads with 38% Share | Key Players: Thermo Fisher Scientific, 3M, Applikon Biotechnology, Danaher, Merck KGaA

Leander, Texas and Tokyo, Japan - Jan.28.2026
Single-use Bioprocessing Market size was valued US$ 7.62 billion in 2021 and is estimated to reach US$ 25.40 billion by 2031, growing at a CAGR of 18.93% during the forecast period (2024-2031).

The single-use bioprocessing market is growing as biopharmaceutical manufacturers seek flexible, cost-effective, and contamination-resistant production solutions. Single-use systems, including disposable bioreactors, tubing, and filtration units, reduce cleaning requirements and accelerate production timelines. Advancements in materials, scalability, and integrated process monitoring are improving efficiency and reliability. Rising demand for biologics, vaccines, and personalized therapies is driving strong adoption of single-use bioprocessing technologies worldwide.

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Single-Use Bioprocessing: Competitive Intelligence
Thermo Fisher Scientific Inc., 3M Company, Applikon Biotechnology, Danaher Corporation, Merck KGaA, General Electric Company, PBS Biotech Inc., Sartorius, Boehringer Ingelheim, and NovoSep

The global single-use bioprocessing market is witnessing rapid growth as biopharmaceutical companies increasingly adopt disposable technologies to improve manufacturing flexibility, reduce contamination risks, and accelerate time-to-market for biologics and cell & gene therapies. Leading players including Thermo Fisher Scientific Inc., 3M Company, Applikon Biotechnology, Danaher Corporation, Merck KGaA, General Electric Company, PBS Biotech Inc., Sartorius, Boehringer Ingelheim, and NovoSep are driving innovation in single-use bioreactors, filtration systems, mixers, tubing assemblies, and integrated process solutions. These companies enable efficient, scalable, and cost-effective production of complex biologics while addressing industry challenges related to sterility, cross-contamination, and process optimization.

Competitive differentiation in this market is increasingly driven by technological innovation, system integration, and end-to-end process support. Thermo Fisher Scientific, Danaher Corporation, and Sartorius offer comprehensive single-use platforms with modular designs that allow seamless scale-up and adaptability across upstream and downstream processes. 3M Company and Merck KGaA focus on advanced filtration, fluid management, and membrane technologies that enhance process yield and consistency. Applikon Biotechnology and PBS Biotech contribute specialized bioreactor solutions optimized for cell culture performance, while Boehringer Ingelheim and NovoSep provide application-specific services and support for biopharmaceutical manufacturers. General Electric leverages its engineering expertise to deliver robust single-use systems and automation solutions. Collectively, these companies are shaping the single-use bioprocessing market by combining innovation, reliability, and flexibility to meet the evolving demands of modern biomanufacturing.

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United States: Recent Industry Developments
✅ In January 2026, Thermo Fisher Scientific and Sartorius expanded single-use bioreactor platforms for monoclonal antibody production. The systems improve scalability. They reduce cross-contamination risks.

✅ In November 2025, GE Healthcare invested $150 million in next-generation single-use technologies for vaccine manufacturing. The investment accelerates flexible biomanufacturing. It supports rapid response to global health demands.

✅ In September 2025, Merck launched AI-enabled monitoring and control tools for single-use bioprocesses. The platform improves process consistency. It reduces batch failures.

✅ In July 2025, Cytiva introduced pre-assembled single-use kits for upstream and downstream processing. The solution improves operational efficiency. It minimizes cleaning and validation requirements.

Japan: Recent Industry Developments
✅ In January 2026, Fujifilm Diosynth Biotechnologies and Takeda expanded single-use biomanufacturing capabilities for complex biologics. The systems enhance process flexibility. They support faster product development timelines.

✅ In October 2025, Ajinomoto Bio-Pharma Services invested ¥12 billion in advanced disposable bioprocessing platforms. The investment improves production reliability. It strengthens high-mix, low-volume manufacturing.

✅ In August 2025, Asahi Kasei launched modular single-use systems for integrated upstream and downstream bioprocessing. The platform improves workflow efficiency. It reduces facility footprint.

✅ In June 2025, Chugai Pharmaceutical implemented automated single-use monitoring solutions for real-time quality control. The technology improves regulatory compliance. It reduces operational risks.

Segment Covered in the Single-Use Bioprocessing Market
By Product
The market is segmented into Single-Use Bioreactors 45%, Single-Use Bags & Assemblies 25%, Filtration & Tubing Systems 15%, Sensors & Probes 10%, and Others 5%. Single-use bioreactors dominate due to their flexibility, scalability, and reduced risk of cross-contamination, making them ideal for both clinical and commercial production. Single-use bags and assemblies are widely adopted for fluid transfer and storage in upstream and downstream processes. Filtration and tubing systems are essential for ensuring sterility and process efficiency, while sensors and probes are gaining traction to provide real-time monitoring and process control in biomanufacturing.

By Application
Based on application, the market is categorized into Monoclonal Antibodies Production 35%, Vaccines Manufacturing 25%, Cell & Gene Therapy 20%, Recombinant Proteins 15%, and Others 5%. Monoclonal antibody production leads due to high demand in oncology, autoimmune, and infectious disease treatments. Vaccine manufacturing is rapidly growing, fueled by pandemic preparedness, government initiatives, and global immunization programs. Cell and gene therapy applications are expanding due to advancements in personalized medicine, while recombinant proteins continue to benefit from increased adoption of single-use technologies for faster and safer production.

By End User
The end-user segment includes Biopharmaceutical Companies 60%, Contract Manufacturing Organizations (CMOs) 25%, Academic & Research Institutes 10%, and Others 5%. Biopharmaceutical companies dominate as they leverage single-use technologies for flexible and cost-effective production, especially for small-batch and high-value biologics. CMOs are expanding their adoption to meet client demands for faster turnaround and reduced capital investment. Academic and research institutes utilize single-use systems for experimental research, process development, and pilot-scale manufacturing, while the remaining segment includes government and non-profit biomanufacturing facilities exploring innovative biologic production methods.

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Regional Analysis
North America - 38% Share
North America leads with around 38% share, driven by the presence of leading biopharmaceutical companies, advanced manufacturing infrastructure, and strong R&D investments in the U.S. and Canada. The adoption of single-use technologies in upstream and downstream processes enhances flexibility, reduces contamination risks, and shortens production timelines. High demand for monoclonal antibodies, vaccines, and cell therapies further supports market growth.

Europe - 26% Share
Europe holds approximately 26% share, supported by well-established pharmaceutical and biotech ecosystems in Germany, the U.K., and Switzerland. Single-use systems are increasingly adopted to improve process efficiency and meet stringent regulatory standards. Government initiatives promoting biopharmaceutical innovation and collaborations between contract development & manufacturing organizations (CDMOs) and biotech firms boost regional adoption.

Asia Pacific - 23% Share
Asia Pacific accounts for about 23% share, driven by rapid expansion of the biopharmaceutical industry in China, India, Japan, and South Korea. Rising biologics production, increasing outsourcing to CDMOs, and investments in flexible manufacturing facilities accelerate adoption. The growing need for cost-effective, scalable solutions for vaccines and biosimilars further strengthens regional growth.

Latin America - 7% Share
Latin America represents around 7% share, with Brazil, Mexico, and Argentina gradually adopting single-use bioprocessing solutions. The focus is on expanding biologics manufacturing and improving production efficiency. However, limited infrastructure and high initial costs restrict widespread implementation, though collaborations with global technology providers are helping adoption.

Middle East & Africa - 6% Share
Middle East & Africa captures approximately 6% share, driven by emerging biopharmaceutical initiatives and investments in flexible manufacturing facilities in countries such as UAE, Saudi Arabia, and South Africa. Single-use systems are gaining traction for vaccine production and specialty biologics, but adoption remains limited due to infrastructure constraints and technical expertise gaps.

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