Single Use Bioreactors Market Strengthened by Rapid Vaccine Development Needs

[nikitapawar]

The global single-use bioreactors market has emerged as one of the fastest-growing segments in the bioprocessing and biomanufacturing industry. Valued at USD 3,284.8 million in 2023, the market is estimated to reach USD 3,805.8 million in 2024 and further expand to USD 10,688.0 million by 2031, exhibiting a strong CAGR of 15.89% during the forecast period (2024–2031). The rapid adoption of single-use systems in the production of biologics, vaccines, and cell-based therapies is significantly propelling market growth.

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Market Overview

Single-use bioreactors (SUBs) are disposable systems used for cultivating cells or microorganisms in a controlled environment. Unlike traditional stainless-steel bioreactors, these systems utilize pre-sterilized, single-use plastic bags, eliminating the need for cleaning and sterilization between runs. The growing demand for flexible, scalable, and cost-efficient biomanufacturing solutions has led to widespread adoption of SUBs across the pharmaceutical and biotechnology sectors.

The rise in biopharmaceutical production, cell and gene therapy research, and the development of monoclonal antibodies (mAbs) are key drivers of market expansion. Additionally, the COVID-19 pandemic further accelerated the demand for single-use technologies as companies sought rapid vaccine and therapeutic development capabilities with minimal risk of cross-contamination.

Market Dynamics
Key Growth Drivers

Rising Biologics Demand: The increasing prevalence of chronic diseases such as cancer, autoimmune disorders, and infectious diseases has boosted the global demand for biologics. Single-use bioreactors provide rapid turnaround and high production efficiency, meeting the evolving needs of biopharma companies.

Cost Efficiency and Flexibility: SUBs offer reduced capital investment, lower operating costs, and faster changeover times compared to traditional stainless-steel systems. These advantages make them ideal for small to mid-scale production and multiproduct facilities.

Growing Adoption in CMOs and CDMOs: Contract manufacturing and development organizations are increasingly implementing single-use technologies to offer flexible manufacturing capacities for multiple clients, driving market penetration.

Advancements in Bioprocessing Technology: Innovations in film materials, mixing systems, and process monitoring sensors have improved the scalability and reliability of single-use bioreactors, enhancing their adoption in commercial-scale manufacturing.

Restraints

Limited Scalability for Large-Volume Production: Although SUBs are efficient for small and mid-scale production, their scalability is limited beyond a certain volume (typically 2,000 liters), which restricts adoption in large-scale biologic manufacturing.

Environmental Concerns: The use of disposable plastic components in single-use systems poses sustainability challenges. Increasing environmental awareness and waste disposal regulations may impact the market in the long term.

Opportunities

Growing Demand for Personalized Medicine: The rapid rise of personalized therapies and cell-based treatments is fueling the need for flexible and efficient production systems, creating new opportunities for single-use bioreactor manufacturers.

Expansion in Emerging Markets: The growth of biopharmaceutical infrastructure in regions such as Asia-Pacific and Latin America presents significant opportunities for market players to expand their footprint.

Market Segmentation
By Product

Single-use Bioreactor Systems:
This segment dominates the market due to the increasing deployment of complete bioreactor systems for upstream processing. The ease of use, scalability, and reduced downtime contribute to their widespread adoption.

Single-use Assemblies:
These include connectors, tubing, and sensors that form integral parts of bioreactor systems. The need for reliable and sterile connections in bioprocess workflows supports segment growth.

Single-use Media Bags:
These pre-sterilized bags are used for storing and transferring culture media, buffers, and reagents. They offer high flexibility and help minimize contamination risks.

Others:
Includes disposable filters, sampling systems, and auxiliary components that support the overall bioprocessing workflow.

By Type

Stirred-Tank Single-Use Bioreactors (SUBs):
Representing the largest share, stirred-tank SUBs are widely used for mammalian cell culture due to their efficient mixing and oxygen transfer capabilities. They are suitable for both research and commercial-scale production.

Wave-Induced SUBs:
These systems utilize rocking motion for gentle mixing, making them ideal for shear-sensitive cell lines such as stem cells and insect cells.

Others:
Includes fixed-bed and hybrid systems that combine reusable and single-use components for specific applications.

By Cell Type

Mammalian Cells:
Dominating the market, mammalian cells are extensively used for the production of therapeutic proteins and monoclonal antibodies. SUBs provide optimal growth conditions for these cell types.

Insect Cells:
Gaining traction for vaccine and recombinant protein production.

Bacterial and Yeast Cells:
Used in microbial fermentation for enzymes and biosimilars production.

By Molecule Type

Monoclonal Antibodies (mAbs):
This segment holds the largest share, driven by the increasing number of mAb-based therapeutics in the pipeline.

Vaccines:
Rapid vaccine production capabilities using SUBs contributed to their demand during the COVID-19 pandemic and continue to support market expansion.

Recombinant Proteins and Cell Therapies:
The emergence of personalized cell-based therapies and gene-modified products creates strong growth potential for this segment.

By Application

Research and Development (R&D):
Widely adopted in research settings due to their flexibility and low maintenance.

Process Development and Production:
Growing use in pilot-scale and full-scale biopharmaceutical production facilities to reduce costs and increase operational efficiency.

By End User

Pharmaceutical and Biotechnology Companies:
This segment dominates the market, accounting for the majority of single-use bioreactor installations.

Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs):
Increasing outsourcing of biologics production to CMOs/CDMOs is boosting the demand for SUBs.

Academic and Research Institutes:
Growing adoption in academic labs for small-scale culture and bioprocess studies.

Regional Analysis
North America

North America leads the global market owing to the strong presence of biopharmaceutical companies, high adoption of advanced bioprocessing technologies, and significant investments in biologics manufacturing infrastructure. The U.S. dominates the regional market due to the growing emphasis on monoclonal antibody production and cell therapy development.

Europe

Europe holds a substantial share of the market, driven by the presence of leading pharmaceutical firms and favorable regulatory support for biologics production. Countries such as Germany, the U.K., and Switzerland are major contributors to the regional growth.

Asia-Pacific

Asia-Pacific is projected to register the fastest growth during the forecast period. Increasing government initiatives to promote biotechnology research, rising biologics manufacturing capacity in China and India, and expanding biopharma outsourcing trends are driving market growth in this region.