Single-Use Bioreactors Market Poised for Rapid Expansion to US$10.8 Bn by 2031 - Persistence Market Research

The global single-use bioreactors (SUBs) market is experiencing a transformative surge, characterized by the increasing preference for disposable bioprocessing systems in pharmaceutical and biotechnology manufacturing. Estimated at US$3.8 Bn in 2024, the market is projected to expand at a robust CAGR of 15.8% to reach US$10.8 Bn by 2031. SUBs offer unique advantages over conventional stainless-steel bioreactors, including reduced cross-contamination risks, lower water and energy requirements, simplified cleaning processes, and faster turnaround times. These attributes make them especially attractive to contract research organizations (CROs) and contract manufacturing organizations (CMOs), which prioritize flexibility and cost-efficiency.

Stirred-tank SUBs dominate the market, owing to their superior oxygen transfer rates, mixing capabilities, and scalability. North America leads the global market, underpinned by strong biopharmaceutical infrastructure, an increasing prevalence of chronic diseases, and the presence of regulatory frameworks conducive to biopharmaceutical innovation. The region's high demand for novel drug development, supported by the FDA's extensive biologics and human drug manufacturing infrastructure, solidifies its position as the market leader.

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Key Highlights from the Report:

✦ The global single-use bioreactors market is forecast to grow at a CAGR of 15.8% from 2024 to 2031.
✦ Market valuation is projected to rise from US$3.8 Bn in 2024 to US$10.8 Bn by 2031.
✦ Stirred-tank bioreactors hold the largest market share due to efficient mixing and scalability.
✦ North America dominates the market, driven by chronic disease prevalence and strong biopharma infrastructure.
✦ Single-use systems are favored for their cost-effectiveness, flexibility, and reduced cross-contamination risks.
✦ Asia Pacific is the fastest-growing region, driven by rising biologics production and facility investments.

Market Segmentation

The single-use bioreactors market is segmented based on product type, bioreactor design, and end users. Among these, single-use bioreactor systems generate the maximum revenue. These systems are highly sought after for their ability to deliver cost-efficient, high-yield mass production of biologics such as vaccines, antibodies, and enzymes. With increasing demand for rapid production cycles, especially in the wake of global health emergencies like COVID-19, single-use systems have become essential in streamlining bioprocesses.

In terms of bioreactor type, stirred-tank SUBs remain the leading segment due to their versatile design and operational efficiency. They support high-density cell cultures with effective oxygen transfer and mixing, ensuring better scalability and regulatory compliance with current Good Manufacturing Practices (cGMP). The end-user segmentation highlights biopharmaceutical and pharmaceutical companies as the primary drivers of demand. Approximately two-thirds of biopharma entities incorporate disposable bioreactors into their core manufacturing workflows, recognizing their role in improving time-to-market and operational agility.

Regional Insights

North America stands at the forefront of the global single-use bioreactors market. This leadership is attributed to the region's strong biopharmaceutical manufacturing base, rising chronic disease burden, and growing investment in novel drug development. According to the CDC, millions of Americans suffer from chronic ailments like diabetes and heart disease, which necessitate continual therapeutic development. The FDA's regulatory ecosystem, encompassing thousands of biologics and drug manufacturing facilities, further propels market growth in the region.

Meanwhile, the Asia Pacific region is emerging as the fastest-growing market. Local and global players in countries such as China, India, and South Korea are ramping up investments in bioprocessing infrastructure. Approximately 50% of newly established bioprocessing facilities globally are being developed in Asia, reflecting the region's critical role in expanding global biologics production. As demand for biosimilars and personalized medicine grows in these countries, the market for SUBs is poised for unprecedented expansion.

Market Drivers

One of the principal growth drivers in the single-use bioreactors market is the rising adoption of single-use technologies across pharmaceutical manufacturing. These systems significantly reduce capital expenditure, streamline operational workflows, and eliminate the need for time-consuming cleaning and sterilization procedures. They also minimize contamination risks, which is crucial for sensitive biopharmaceutical products. Technological innovations-such as Thermo Fisher Scientific's introduction of high-volume DynaDrive SUBs-are propelling market acceptance across large-scale manufacturing setups. The shift towards continuous perfusion processes further supports this trend, as SUBs enable cost-effective and scalable solutions.

Market Restraints

Despite their growing popularity, SUBs face notable restraints. Chief among these is the concern regarding leachables and extractables, which are chemical compounds that can migrate from plastic components into the bioproduct. These contaminants can compromise drug safety and efficacy, presenting regulatory and quality assurance challenges. Additionally, the environmental impact associated with disposable systems-particularly the generation of plastic waste-raises sustainability concerns. Current disposal methods such as incineration and landfilling, though commonly practiced, may not align with long-term environmental objectives, prompting a call for more sustainable alternatives.

Market Opportunities

The global surge in chronic and infectious diseases represents a significant growth opportunity for the single-use bioreactors market. Diseases such as cancer, cardiovascular ailments, and respiratory disorders require continuous innovation in biopharmaceutical therapies-an area where SUBs play a critical role. Moreover, the COVID-19 pandemic showcased the utility of SUBs in accelerating vaccine development. Notably, ABEC's deployment of 4,000L bioreactors at the Serum Institute of India was instrumental in expediting the production of Novavax's COVID-19 vaccine candidate. These events underscore the potential of SUBs to support global health initiatives and facilitate rapid therapeutic production in times of crisis.

Reasons to Buy the Report:

✔ Gain comprehensive insights into the global single-use bioreactors market dynamics, trends, and growth projections.
✔ Understand detailed market segmentation by product type, application, and end-user to identify high-growth areas.
✔ Explore regional performance across North America, Europe, Asia Pacific, and emerging markets.
✔ Access strategic company profiles, competitive benchmarking, and key developments driving innovation.
✔ Leverage forecast data up to 2031 to support informed business decisions and strategic planning.

# Frequently Asked Questions (FAQs)

How Big is the Single-use Bioreactors Market in 2024?

Who are the Key Players in the Global Market for Single-use Bioreactors?

What is the Projected Growth Rate of the Market Through 2031?

What is the Market Forecast for Single-use Bioreactors for 2032?

Which Region is Estimated to Dominate the Industry through the Forecast Period?

Company Insights

• Applikon Biotechnology BV
• Cellexus Ltd.
• Celltainer Biotech B.V.
• Cesco Bioengineering Co. Ltd.
• Danaher Corporation
• ABEC, Inc.
• Distek, Inc.
• Eppendorf SE
• Thermo Fischer Scientific
• Pall Corporation
• Sartorius AG
• Merck KGaA
• GE Healthcare
• Pierre Guerin

Recent Developments:

Thermo Scientific, in March 2021, launched 3,000 L and 5,000 L HyPerforma DynaDrive SUBs to support high-density cell cultures in large-scale bioprocesses.
Impact: This product line expansion addresses the increasing demand for scalable, high-efficiency single-use systems in cGMP environments.

ABEC Inc., in September 2019, introduced a groundbreaking single-use bioreactor system with a 6,000 L working volume-tripling the industry standard.
Impact: The innovation significantly enhances cell culture capacity per square foot, reducing operational costs and space requirements.

Conclusion

The single-use bioreactors market is positioned at the intersection of technological innovation and biopharmaceutical scalability. As the industry shifts towards more flexible and cost-effective manufacturing paradigms, SUBs are rapidly becoming the cornerstone of modern bioprocessing. With a projected CAGR of 15.8% and a market valuation expected to triple by 2031, the future of SUBs looks promising. While concerns around sustainability and product safety persist, ongoing R&D efforts and strategic industry collaborations are addressing these challenges. With rising global demand for personalized medicine, biologics, and rapid vaccine development, the adoption of single-use bioreactors is set to accelerate across developed and emerging markets alike.

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