The Single Use Bioprocessing Market refers to biomanufacturing systems and components designed for one-time use, replacing traditional stainless-steel equipment in pharmaceutical and biotechnology production. These systems include disposable bioreactors, tubing, filters, bags, sensors, and other process components that are discarded after a single production run.

In 2025, the single use bioprocessing market was valued at USD 20.32 Billion. Driven by the increasing adoption of flexible, cost-effective, and contamination-resistant manufacturing solutions, the market is expected to grow at a CAGR of 14.50% from 2026 to 2035, reaching USD 78.70 Billion by 2035. The rapid expansion of biologics, vaccines, cell and gene therapies, and biosimilars is accelerating demand across the globe.

Why Is the Single Use Bioprocessing Market Growing So Rapidly?

One of the most frequently searched questions around the single use bioprocessing market is why manufacturers are moving away from traditional stainless-steel systems. The answer lies in efficiency, flexibility, and speed.

Single use systems significantly reduce cleaning, sterilization, and validation requirements, allowing faster changeovers between batches. This is especially critical in multiproduct facilities and contract manufacturing environments. Additionally, lower capital expenditure and reduced risk of cross-contamination make single use bioprocessing highly attractive for both large biopharmaceutical companies and emerging biotech firms.

How Does Single Use Bioprocessing Work in Biopharmaceutical Manufacturing?

Single use bioprocessing involves disposable components that come pre-sterilized and ready to use. These components are integrated into upstream and downstream workflows, from cell culture and fermentation to filtration, chromatography, and final filling.

After production, the systems are safely disposed of, eliminating the need for extensive cleaning-in-place (CIP) and sterilization-in-place (SIP) processes. This approach not only saves time but also reduces water, energy, and chemical usage, aligning with sustainability goals.

What Are the Key Drivers Fueling the Single Use Bioprocessing Market?

The most important driver is the rapid growth of biologics and advanced therapies. Monoclonal antibodies, vaccines, recombinant proteins, and cell and gene therapies require flexible manufacturing platforms, which single use systems provide.

Another major driver is the rise of CMOs and CROs, which rely on adaptable infrastructure to serve multiple clients efficiently. Additionally, the need for rapid scale-up during health emergencies, such as pandemics, has highlighted the advantages of single use bioprocessing.

What Are the Main Product Segments in the Single Use Bioprocessing Market?

By product, the single use bioprocessing market is segmented into simple and peripheral elements, apparatus and plants, and work equipment.

Simple and peripheral elements include tubing, filters, connectors, transfer systems, bags, sampling systems, probes, and sensors. These components form the backbone of disposable bioprocess workflows and account for a significant share due to their high replacement frequency.

Why Are Single Use Bioreactors and Apparatus Gaining Popularity?

Apparatus and plants such as single use bioreactors, mixing systems, storage and filling systems, filtration systems, chromatography systems, and pumps are witnessing strong adoption. Single use bioreactors, in particular, are widely used in upstream processing for cell culture and fermentation.

Manufacturers prefer these systems because they allow rapid scale-up, minimize downtime, and reduce the risk of batch failure. Their modular nature also supports continuous bioprocessing, which is becoming increasingly important in modern biomanufacturing.

What Role Does Work Equipment Play in Market Growth?

Work equipment, including cell culture systems, syringes, and other disposable tools, supports day-to-day laboratory and production activities. These products are especially important in research and clinical manufacturing, where flexibility and sterility are paramount.

The growing number of clinical trials and early-stage biologics development programs is driving consistent demand for disposable work equipment.

How Is the Single Use Bioprocessing Market Segmented by Workflow?

Based on workflow, the market is divided into upstream bioprocessing, fermentation, and downstream bioprocessing.

Upstream bioprocessing dominates the market due to extensive use of single use bioreactors, bags, and cell culture systems. These tools are essential for growing cells and producing biologic substances.

Downstream bioprocessing is also growing rapidly, with increasing adoption of single use filtration and chromatography systems for purification and concentration. Fermentation processes benefit from disposable components that reduce contamination risks and improve operational efficiency.

Why Is Downstream Bioprocessing a Fast-Growing Segment?

Many users search why downstream single use technologies are gaining momentum. The answer lies in advancements in disposable chromatography membranes, filters, and mixing systems that now offer performance comparable to traditional systems.

As biologics become more complex, manufacturers are investing in flexible downstream solutions that can adapt to different molecules without extensive reconfiguration.

Who Are the Key End Users of Single Use Bioprocessing Systems?

By end user, the single use bioprocessing market is segmented into biopharmaceutical manufacturers, CMOs and CROs, in-house manufacturers, and academic and clinical research institutes.

Biopharmaceutical manufacturers represent the largest share due to high-volume production of biologics and vaccines. CMOs and CROs are among the fastest-growing segments, driven by outsourcing trends and the need for multiproduct manufacturing capabilities.

Academic and clinical research institutes also contribute significantly, particularly in early-stage research and pilot-scale production.

How Is the Single Use Bioprocessing Market Performing Regionally?

North America leads the single use bioprocessing market, supported by a strong biopharmaceutical industry, high R&D spending, and early adoption of advanced manufacturing technologies.

Europe follows closely, driven by regulatory support for biologics production, sustainability initiatives, and a growing number of biotech startups.

The Asia Pacific region is expected to witness the fastest growth during the forecast period. Expanding biomanufacturing capacity, government investments, and increasing presence of global CMOs are fueling adoption across countries such as China, India, and South Korea.

Latin America and the Middle East and Africa are emerging markets, with gradual improvements in biopharmaceutical infrastructure and increasing focus on local manufacturing.

Which Companies Are Leading the Single Use Bioprocessing Market?

The market is highly competitive, with leading players focusing on product innovation, portfolio expansion, and strategic collaborations. Key companies include:

• Thermo Fisher Scientific Inc.

• Sartorius AG

• Merck KGaA

• Danaher Corporation

• Eppendorf AG

• VWR International, LLC

• Corning Incorporated

• Entegris, Inc.

• Saint-Gobain Life Sciences

• Rentschler Biopharma SE

These companies are investing in advanced materials, integrated single use platforms, and digital bioprocessing solutions to gain a competitive edge.

What Challenges Does the Single Use Bioprocessing Market Face?

Despite strong growth, the market faces challenges such as concerns over extractables and leachables, waste management, and supply chain constraints for disposable components.

Environmental impact is another consideration, prompting manufacturers to develop recyclable and bio-based materials. Regulatory scrutiny around material safety and process validation also requires continuous innovation and compliance.

What Is the Future Outlook of the Single Use Bioprocessing Market?

The future of the single use bioprocessing market is highly promising. Advancements in material science, automation, and continuous manufacturing are expected to further expand the capabilities of disposable systems.

As biologics pipelines grow and manufacturing becomes more decentralized and flexible, single use bioprocessing will remain a cornerstone of modern biomanufacturing through 2035 and beyond.

FAQs

What is the Single Use Bioprocessing Market?

The Single Use Bioprocessing Market includes disposable systems and components used in biopharmaceutical manufacturing to replace traditional stainless-steel equipment.

How large is the Single Use Bioprocessing Market globally?

The market was valued at USD 20.32 Billion in 2025 and is projected to reach USD 78.70 Billion by 2035, growing at a CAGR of 14.50%.

Which products dominate the market?

Single use bioreactors, tubing, filters, bags, and chromatography systems are among the most widely used products.

Who are the major end users of single use bioprocessing systems?

Biopharmaceutical manufacturers and CMOs/CROs are the primary end users due to their need for flexible and scalable production.

Which region is expected to grow the fastest?

Asia Pacific is expected to experience the fastest growth due to expanding biomanufacturing capacity and increasing investment in biologics.