Single-Use Bioreactors Market to Reach USD 9.12 Billion by 2033 | CAGR 8.8% | North America Leads with 30% Share | Key Players: Thermo Fisher Scientific, Sartorius, ABEC, Merck KGaA

Market Overview

The global single-use bioreactors market reached US$ 4.30 billion in 2023, rising to US$ 4.64 billion in 2024, and is projected to grow to US$ 9.12 billion by 2033, reflecting a CAGR of 8.8% during the forecast period 2025-2033. The market's growth is driven by the increasing demand for biologics, vaccines, and advanced cell and gene therapies, as well as the expanding number of contract development and manufacturing organizations (CDMOs) and biopharmaceutical R&D facilities. The adoption of single-use bioreactors is further accelerated by the need for flexible, scalable, and contamination-free production processes across laboratories, pilot plants, and commercial-scale manufacturing facilities.

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Technological innovations, such as integrated sensors, automated control systems, and larger-volume disposable reactors, are enhancing process efficiency, reproducibility, and product safety. The shift toward modular and flexible manufacturing, combined with the urgency to rapidly scale production for emerging therapies, has further strengthened the preference for single-use bioreactor systems. Additionally, sustainability trends, including recyclable or low-waste disposable materials, are opening new avenues for innovation. With ongoing product improvements, the rise in biologics production, and the expansion of global biopharma infrastructure, the single-use bioreactors market is poised to become an essential component of modern biomanufacturing.

Recent Developments:

✅ January 2026: In the United States, biopharmaceutical manufacturers increased adoption of advanced viral inactivation technologies such as solvent/detergent treatment, low-pH inactivation, and UV-based methods to enhance safety in plasma-derived products, monoclonal antibodies, and cell & gene therapies.

✅ January 2026: In Europe, regulatory emphasis on viral safety validation strengthened demand for integrated viral inactivation steps within biologics manufacturing workflows, particularly for vaccines and recombinant protein therapeutics.

✅ January 2026: In Japan, pharmaceutical companies expanded the use of single-use systems incorporating validated viral inactivation processes to improve manufacturing flexibility and contamination control.

✅ December 2025: In the United States, growth in plasma fractionation and contract manufacturing activities drove investments in scalable viral inactivation solutions aligned with FDA and global regulatory standards.

✅ December 2025: In Asia-Pacific, expanding biologics and biosimilars production capacity supported wider implementation of robust viral clearance and inactivation strategies across upstream and downstream processing.

✅ November 2025: In Europe, increasing production of blood products and advanced therapies accelerated adoption of automated viral inactivation equipment to improve consistency and compliance.

Mergers & Acquisitions:

✅ January 2026: In the United States, a life sciences technology provider acquired a viral inactivation and pathogen reduction technology firm to expand its bioprocessing safety portfolio.

✅ December 2025: In Europe, a bioprocess solutions company completed the acquisition of a viral clearance validation specialist to strengthen regulatory support services for biologics manufacturers.

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Key Players:
ABEC | Thermo Fisher Scientific | Sartorius | Merck KGaA | Cytiva | PBS Biotech | Eppendorf | Getinge

Key Highlights with Market Share:

• ABEC - Holds a 12% share, specializing in single-use bioreactor bags, mixers, and integrated bioprocess solutions for flexible biologics manufacturing.

• Thermo Fisher Scientific - Holds a 15% share, offering DynaDrive and HyPerforma single-use bioreactor systems with advanced process monitoring and scalability.

• Merck KGaA - Holds a 10% share, delivering single-use bioreactors, filtration systems, and solutions for viral inactivation and downstream processing.

• PBS Biotech - Holds a 7% share, specializing in photobioreactor and single-use bioreactor platforms for cell culture and microbial fermentation.

• Eppendorf - Holds a 6% share, providing bioreactor systems and automation solutions for laboratory and pilot-scale single-use applications.

• Getinge - Holds a 5% share, offering integrated single-use technologies including mixers, bags, and bioreactor accessories for GMP-compliant production.

Market Segmentation:

By product, single-use bioreactor systems dominate with approximately 45% of the market, driven by their flexibility, scalability, and contamination-free production capabilities. Single-use media bags hold around 20%, supporting streamlined upstream processes. Single-use filtration assemblies account for roughly 15%, enabling efficient separation and downstream processing, while other products make up the remaining 20%, including mixers, connectors, and accessories for integrated bioprocessing.

By type, stirred tank single-use bioreactors lead the segment with about 40% share, favored for their versatility and ease of scale-up. Wave-induced single-use bioreactors follow with 30%, valued for gentle mixing and low shear for sensitive cell cultures. Bubble column single-use bioreactors hold approximately 20%, primarily for microbial fermentation and small-scale applications, while other specialized reactor types account for 10%.

By molecule type, monoclonal antibodies (mAbs) dominate with 35% share, reflecting the rapid growth of therapeutic antibodies. Vaccines account for 25%, supported by global immunization programs and emerging infectious disease responses. Stem cells and gene-modified cells together hold around 20%, reflecting the expansion of advanced cell and gene therapies, while other molecules make up the remaining 20%.

By cell type, mammalian cells represent the largest share at 40%, widely used in biologics and vaccine production. Bacterial cells contribute 25%, primarily for recombinant protein expression. Yeast cells hold about 20%, used in industrial fermentation and protein production, while other cells account for 15%, including insect and plant cell lines.

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Regional Insights:

North America leads the single-use bioreactors market with approximately 30% share, driven by the presence of major biopharmaceutical companies, advanced R&D infrastructure, and early adoption of single-use technologies in biologics and vaccine production.

Europe holds around 25% of the market, supported by regulatory emphasis on flexible, scalable manufacturing, increasing contract development and manufacturing organization (CDMO) activity, and growing demand for advanced cell and gene therapies.

Asia-Pacific contributes about 28%, fueled by expanding biopharma manufacturing capacity, rising government initiatives in biologics production, and increasing adoption of single-use systems in emerging economies such as China, Japan, and India.

Latin America accounts for roughly 10%, driven by the growth of regional biopharmaceutical infrastructure and vaccine manufacturing.

Market Dynamics:

Drivers:

A major driver of the single-use bioreactors (SUB) market is the growing demand for biologics. As biopharmaceutical companies increasingly develop complex therapies such as monoclonal antibodies (mAbs), vaccines, and advanced cell and gene therapies, they require production systems that are flexible, scalable, and safe. Single-use bioreactors meet these needs by reducing cross-contamination risk, enabling rapid scale-up, and avoiding the high capital and maintenance costs associated with traditional stainless-steel systems. SUBs, including large-scale 5,000 L systems, bridge the gap between lab-scale and commercial-scale production, allowing companies to adjust production based on fluctuating demand without major infrastructure changes. Contract development and manufacturing organizations (CDMOs) are increasingly adopting SUBs to support both emerging biotech firms and large pharmaceutical companies. Stirred-tank configurations remain particularly popular, accounting for over 50% of recent SUB deals, reflecting their strong alignment with commercial biologics production. Overall, the surge in biologics is fueling rapid adoption of single-use bioreactors due to their speed, flexibility, and cost-effectiveness.

On the other hand, a key restraint is the risk of extractables and leachables. Materials used in disposable bioreactors such as plastic films, tubing, and connectors can release chemical compounds into the cell culture, potentially affecting product quality, safety, and regulatory compliance, especially for sensitive biologics like monoclonal antibodies or cell therapies. Manufacturers must rigorously validate and control for these leachables, which can increase development costs and slow adoption, particularly at commercial scale. This challenge remains a critical consideration for biopharmaceutical companies evaluating SUB implementation.

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