Global Single-use Bioreactors Market Size, Trend & Opportunity Analysis Report, by Product Type (Single-use, Reusable), Cell (Mammalian, Bacterial, Yeast), and Forecast, 2025–2035

Market Definition and Introduction

The worldwide single-use bioreactor market was valued at USD 11.63 billion in 2024, and it is forecasted to reach USD 39.67 billion by 2035, thereby growing at a CAGR of 11.80% during the forecast period (2025-2035). In the face of increasing global requirements for vaccines, monoclonal antibodies, and cell and gene therapeutics, biopharmaceutical manufacturers have escalated their scale-up productions to meet these demands, whereby the single-use bioreactor (SUB) adoption represents a rapid and paradigm-changing shift for bioprocessing. These disposable systems save users from time-consuming activities associated with cleaning and sterilizing, thus giving speed, flexibility, and cost-effectiveness to upstream processes.

Transitioning from traditional stainless-steel bioreactors to single-use formats is not just an evolution of functionality but is a strategic repositioning. This enables facilities to work in a multiproduct environment with reduced cross-contamination risk and faster changeover, shortening time to market further. The modular and scalable nature of SUBs adds batch-size flexibility, thus becoming a necessity for small-volume, high-value biologics, particularly in cell therapy and personalized medicine manufacturing. Increasing pressure to deliver safe and effective biologics faster is generating unprecedented momentum for single-use platforms.

In addition, SUBs are becoming central to the design of next-generation biopharma facilities with the rise of decentralized biomanufacturing and increased demand for mobile, GMP-compliant production suites. Firms are introducing advanced automation, AI-enabled process analytics, and digital twins into SUB platforms to enhance yields and guarantee reproducibility. As regulators start to relax restrictions for single-use systems and innovation in sustainable bioplastics gathers steam, the market finds itself in the midst of accelerated innovation and worldwide expansion, driven both by necessity and opportunity.

Recent Developments in the Industry

Sartorius AG Launches a Scalable Bioreactor System for Cell and Gene Therapy Manufacturing

In April 2024, Sartorius AG announced the launch of the BIOSTAT STR® Generation 4 system, a new kind of single-use bioreactor platform dedicated to viral vector and cell therapy production with all the modern bells and whistles with respect to process control, automation, and closed-system integration.

Thermo Fisher Expands Bioproduction Facility in Singapore in Response to Asia-Pacific Demand Surge

In July 2024, Thermo Fisher Scientific announced an investment of USD 125 million to expand its biologics manufacturing facility in Singapore, focusing on the integration of single-use bioreactor systems for GMP-scale vaccine and therapeutic production.

Danaher’s Cytiva Launches Flexible SUB Platform to Support Modular Biomanufacturing Facilities

In January 2024, Cytiva Danaher company released its FlexFactory™ Xpress solution featuring ready-to-deploy single-use bioreactors designed for fast implementation in mobile bioprocessing suites, thus drastically shortening setup timelines.

Market Dynamics

This simply means acceleration in producing larger volumes of biologics.

By transforming the products into high-value biologics and therapeutic products such as monoclonal antibodies, cell therapies, and recombinant proteins, the biopharmaceutical industry is tending towards the area of producing high-value biologics. Because of the nature of their processing, single-use bioreactors are increasingly attracting manufacturers to rationalize production cycles and manage costs. Modularity and scalability allow those implementing such a solution to make their response to changing requirements at a particular stage, especially during development phases such as clinical trials.

Increasing Demand for Flexibility and Contamination-Free Production Environment in Biomanufacturing

Traditional bioreactors are configurable enough to require rigorous cleaning validation and expose cross-product contamination risks. Single-use systems address this dilemma head-on: every run is a clean slate. It is especially critical for multiproduct plants and CMO/CDMOs, which essentially provide diverse therapeutic pipelines and thereby allow switching products rapidly with no concerns about sterility.

Emerging Most Ultimate Features of Automated Digitized Integrated Single-Use Bioreactor Platforms Across Facilities

SUB platforms are changing the process reliability and integrity of data through their automation and digital control systems. The result: very reliable and constantly processed smart bioreactors, which address state-of-the-art process analytics and real-time monitoring, resulting in strong consistency and adaptive optimization of processes, which are essential in maintaining stringent compliance with GMP and higher productivity gains within the overall bioprocess.

Emerging Personalized Medicine and Batch Conditioning Change Paradigms in Bioreactor Needs

Personalized medicines and orphan drugs have set in motion a paradigm shift toward small-batch manufacturing systems. The high flexibility of single-use bioreactors, with super-low hold-up volumes and adjustable geometries-makes them ideal for flexible manufacturing models that produce less waste and lower cost per batch, defining requirements in these niche markets.

Sustainability Concerns Heighten Innovations in Biodegradable and Recyclable Disposable Bioreactor Bags

The fairly adamant concern about the environmental impact of single-use systems is surely changing pages toward a whole new sustainability story, with ongoing studies on recyclable polymers and development towards biodegradable bags. What is even more encouraging is the trend being set by many of their top manufacturers toward closed-loop recycling of these product offerings, a seeming tilt to lifecycle sustainability balance with reduced energy use owing to the smaller cleaning Professor Boxes.

Attractive Opportunities in the Market

Expanding Biologics Market – Pipeline growth in mAbs and fusion proteins fuels scalable SUB demand.
Cell and Gene Therapy Surge – SUBs offer high containment and scalability for sensitive cell lines.
Decentralized Biomanufacturing – SUBs support mobile, modular GMP facilities globally.
Digital Bioprocessing – Integration of PAT tools and AI enhances process predictability and control.
Reusable-Single Use Hybrids – Innovations bridge reusability and disposability for performance-flexibility balance.
Asia-Pacific Investment – Regional biomanufacturing initiatives drive localized SUB adoption.
Reduced Validation Time – Disposable systems eliminate CIP/SIP, fast-tracking facility readiness.
Low Capital Footprint – SUBs minimize infrastructure costs in greenfield biomanufacturing projects.

Report Segmentation

By Product Type: Single-use, Reusable

By Cell: Mammalian, Bacterial, Yeast

By Region: North America (U.S., Canada, Mexico), Europe (UK, Germany, France, Spain, Italy, Spain, Rest of Europe), Asia-Pacific (China, India, Japan, Australia, South Korea, Rest of Asia-Pacific), LAMEA (Brazil, Argentina, UAE, Saudi Arabia (KSA), Africa Rest of Latin America)

Key Market Players

Sartorius AG, Thermo Fisher Scientific Inc., Danaher Corporation, Eppendorf AG, Merck KGaA, PBS Biotech, Inc., Cellexus Ltd, ABEC Inc., Celltainer Biotech B.V., Applikon Biotechnology (a Getinge company)

Report Aspects

Base Year: 2024
Historic Years: 2022, 2023, 2024
Forecast Period: 2025-2035
Report Pages: 293

Dominating Segments

Operational Simplicity and Cost-Effective Flexibility in Bioreactors

Single-use bioreactor systems have arguably swept the market clean owing to their capability of drastically shortening turnaround times, lessening contamination risks, and cutting infrastructure requirements. In addition, thanks to their modular design, these systems can be scaled up straightforwardly, making them rather popular in clinical and commercial production lines. With the rest of the world regaining the thrust of disposable technologies by different regulatory agencies, it is forecasted that this adoption will continue its phenomenal growth trajectory with both giant biopharma and new biotech companies.

Applications of Mammalian Cell Lines are Leading Market Demand Because of Their Wide Application in the Production of Biologics

CHO and HEK cell lines are the most common expression systems used in the biopharmaceutical production arena to date. Mammalian cells usually require very strict controlled environments that single-use systems would be able to incorporate very well, particularly using improvements in oxygenation, tighter pH control, and customizable bioprocess parameters. The share of this segment soars high since it's at the center of the production of therapeutic proteins, vaccines, and gene therapies with high fidelity and yield.

Finds a Niche in Long-haul, High-throughput Bioproduction Operation

Reusable bioreactor segment, while not very big, is relevant for some applications at a large scale and high volume where long batch durations justify upfront investment and validation costs. This segment experiences a much slower growth rate owing to agility within manufacturing and flexibility in facility design, with single-use systems offering the advantages thereof.

Key Takeaways in the Market

Single-use Bioreactor Leadership – Disposable systems dominate due to scalability, sterility, and speed.
Mammalian Cell Dominance – CHO and HEK-based processes drive biopharma reliance on SUBs.
Reusable Systems See Limited Growth – Reusables persist in niche, large-batch production.
Automated Process Control – Real-time analytics and AI transform SUB consistency and outcomes.
Sustainability Innovation – Recyclable bags and lower water/energy use improve ecological balance.
Regulatory Acceptance – Agencies embracing SUB standards accelerate global adoption.
CDMO Preference – Contract manufacturers use SUBs to handle diverse client pipelines.
Global Infrastructure Growth – APAC and LATAM bioproduction centers stimulate equipment demand.
Personalized Medicine Compatibility – Small-batch therapies benefit from SUB’s low-volume capacity.
Hybrid Systems Emerge – Flexible reactor designs combine disposability with durability.

Regional Insights

North America is the Market Leader through Innovation, Advanced Infrastructure, and Regulatory Maturity

Currently, North America continues to take a good portion of the world's single-use bioreactors market. The primary reason for this is the country's strong biopharmaceutical innovation ecosystem, advanced biomanufacturing infrastructure, and the rapid uptake of modern production technologies. The U.S. is the global hub and center of gravity for biologics development and thus offers great potential benefits for the integration of SUBs in clinical and commercial pipelines. The region's dominant position is further fortified by strategic collaborations between CDMOs and large biopharma companies.

Europe follows with the investment in biomanufacturing and regulatory harmonization efforts.

Like the rest of Europe, those countries such as Germany, Switzerland, and the U.K. continue to have a notable proportion of market share as they are also developing their capacity for producing biologics. Indeed, the region has implemented a very supportive regulatory framework, all of which are in line with GMP standards for single-use systems. Investment in pandemic preparedness and domestic vaccine production infrastructures has also catalyzed the use of SUBs across both public and private sector labs.

Asia-Pacific To Enjoy The Rapidest Growth Of Markets In the Future Due To Scaling Bioproduction In The Region

Asia-Pacific is going to grow at a very fast pace, strengthened by newly added local biologics pipelines, governmental support for establishing pharma manufacturing parks, and even a growing population excellently trained in biotechnology. Countries like China, South Korea, and India strategically focus on modular, cost-effective suites of bioproduction that prefer single-use technologies, and therefore, these make the region an ideal global site for next-gen manufacturing innovation.

Latin America and MEA Started to Integrate SUBs Slowly, Along with the Biomanufacturing Infrastructure Development

Still emerging, in terms of single-use bioreactor adoption, Latin America and the Middle East & Africa are starting to see increasing numbers of local adopters as they strengthen their production capabilities and forge partnerships with various global CDMOs. These initiatives are expected to improve standards of healthcare self-sufficiency and bring in more biopharmaceutical investments, attracted by regulatory reforms and capacity building.

Core Strategic Questions Answered in This Report

Q. What is the expected growth trajectory of the single-use bioreactors market from 2024 to 2035?

The global single-use bioreactors market is projected to grow from USD 11.63 billion in 2024 to USD 39.67 billion by 2035, exhibiting a CAGR of 11.80% during the forecast period. This surge is driven by the widespread shift toward disposable, scalable, and flexible bioproduction technologies that align with the growing demand for biologics and personalized medicine.

Q. Which key factors are fuelling the growth of the single-use bioreactors market?

Key growth drivers include the rise of biologics and biosimilars, the shift to modular and decentralized manufacturing, increasing preference for contamination-free disposable systems, and automation-enabled process optimization. Additionally, regulatory acceptance and cost savings from infrastructure and operational simplification contribute significantly to market expansion.

Q. What are the primary challenges hindering the growth of the single-use bioreactors market?

Challenges include concerns about plastic waste and environmental impact, limitations in scalability for ultra-large batches, and the need for specialized training to operate digitally integrated SUB systems. Regulatory variability across regions and high initial costs for hybrid systems may also pose barriers to adoption in some geographies.

Q. Which regions currently lead the single-use bioreactors market in terms of market share?

North America leads the market due to its strong biologics pipeline, cutting-edge manufacturing infrastructure, and early adoption of single-use systems. Europe follows closely, driven by its emphasis on GMP-aligned biomanufacturing and strategic investments in domestic bioproduction capabilities.

Q. What emerging opportunities are anticipated in the single-use bioreactors market?

Emerging opportunities include the integration of AI and machine learning in process analytics, the development of sustainable and recyclable bioreactor bags, the rise of cloud-based digital twins, and the expansion of personalized cell therapy manufacturing. Additionally, the establishment of new CDMO hubs in Asia-Pacific and Latin America offers substantial growth potential.

Key Benefits for Stakeholders

The report offers a quantitative assessment of market segments, emerging trends, projections, and market dynamics for the period 2024 to 2035.
The report presents comprehensive market research, including insights into key growth drivers, challenges, and potential opportunities.
Porter's Five Forces analysis evaluates the influence of buyers and suppliers, helping stakeholders make strategic, profit-driven decisions and strengthen their supplier-buyer relationships.
A detailed examination of market segmentation helps identify existing and emerging opportunities.
Key countries within each region are analysed based on their revenue contributions to the overall market.
The positioning of market players enables effective benchmarking and provides clarity on their current standing within the industry.
The report covers regional and global market trends, major players, key segments, application areas, and strategies for market expansion. Show more