Single-Use Bioreactor Market Demand and Growth Forecast to 2035

The SINGLE-USE BIOREACTORS MARKET(SUBs) has become one of the fore-most segments of bioprocessing technologies, changing the landscape of biopharmaceutical manufacturing. 

It is valued at $8.23 billion in 2024 and is expected to grow rapidly to $35.35 billion by 2035, which represents a 12.7% compound annual growth rate (CAGR). The underlying causes for rapid growth stem from increasing demand for biologics, more investments in personalized medicine, technological advances, and the global rise of chronic, complex diseases.

What Are Single-Use Bioreactors and How Are They Impacting their Market?

Single-use bioreactors referred to as SUPs use consumable components (such as bags and tubing) that replace conventional stainless steel vessels, reducing risk for contamination, the number of times cleaning is required, and the duration for production. 

There is flexibility in addition to cost savings (approximately 40% lower price and 35% shorter manufacturing cycles) which has made SUPs the manufacturer for choice for monoclonal antibodies, vaccines, cell and gene therapies, and biologics.

The momentum behind single-use technology has accelerated over the past few years, especially due to the rapid demand for vaccines associated with the COVID-19 pandemic, which highlighted the need for flexible and scalable bioprocessing approaches.

With these bioreactors, biopharma and biotechnological companies can utilize these technologies to provide increased production of high-quality biologics, with less overhead and shorter lead times for meeting complex regulations.

Leading Companies and Industry Landscape

The Single-Use Bioreactor market is marked by a fragmented competitive landscape with diverse players ranging from large multinational corporations to innovative startups. 

Here is the list of key players in the Single-Use Bioreactor Market:

⦁    Sartorius AG
⦁    Thermo Fisher Scientific Inc.
⦁    Danaher Corporation
⦁    Cytiva (formerly GE Healthcare Life Sciences)
⦁    Eppendorf AG

•Sartorius AG

Established in Germany in 1870, Sartorius is a prominent provider in bioprocessing technology. With pioneering single-use bioreactors, Sartorius offers innovative bioprocessing systems combined with integrated digital controls for a vast array of biopharmaceutical customers.

•Thermo Fisher Scientific Inc.

Founded in 1956 in the United States, Thermo Fisher offers complete life sciences solutions that include single-use bioreactors. Their strong presence in the biological processing industry is supported by a wide range of experience in the industry and an emphasis on scalability and quality.

•Danaher Corporation

Founded in the United States in 1969, Danaher's Life Science segment is one of the leading suppliers of single-use bioreactors. Their focus is on enabling the efficiency and flexibility of biomanufacturing, whilst meeting exacting regulatory and production standards.

•Cytiva (formerly GE Healthcare Life Sciences) 

Cytiva has a long and established history in biomanufacturing technologies as part of GE Healthcare. Cytiva delivers reliable, innovative, and easy-to-use single-use bioreactor systems for biomanufacturers world-wide, with direct ease of transfer into a producer's biomanufacturing process.

•Eppendorf AG

Eppendorf is a German company surveyed as part of this report. Founded in 1945, the company is known for its reliable and efficient single-use bioreactors designed specifically for small- and medium-scale bioproduction. Eppendorf has a strong reputation in the life science research and life sciences.

These companies and a number of specialized companies have worked together to improve the features of bioreactors, including real-time capability, alarm systems, and biosensor technologies to improve process control and decrease the risk of contamination. 

Market segmentation and regional analysis

The global Single-Use Bioreactor market is segmented by product type, operating scale, type of cell culture, biologics synthesized, end users, and geography. 

•By product: Single-use bioreactor systems have the largest market share because of their extensive use, ability, and operational capacity in the field. They have media bags, filtration assemblies, and their related disposables to build an ecosystem. 

•By scale: The global single-use bioreactor market is segmented by laboratory, pilot, and industrial scales. The industrial scale has the greater market share because of the demand for large-scale bioproduction. 

•By cell type: The mammalian cells have the greatest market share due to their extensive use in the production of biologics.

•By application: The main drivers of market adoption are demand and production applications, for example, manufacturing therapeutic proteins, vaccines, gene therapy, and research applications. 

•By end user: The key constituent end-users and buyers are pharmaceutical and biopharmaceutical companies, contract manufacturing organization CMOs, and research institutes. 

North America is the leading region for the market, primarily due to spending in research and development by the US, a well-established biotech industry in the region, and an early adoption of advanced technologies.

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Key Market Drivers & Challenges

Key demand drivers for single-use bioreactors are the surging demand for biologics and biosimilars, the need for cost and scale-effective manufacturing solutions, and the push for faster time to market for new therapies.

Advances in bioreactor technology, including integrated digital process control and monitoring capabilities, will improve efficiency and reliability while decreasing consistencies in manual operations.

Challenges such as a higher cost relative to traditional systems, regulatory certifications for single-use bioreactor standardized systems, and operational challenges relating to sterility assurance protocols exist to a lesser degree but are being addressed through ongoing R&D and regulatory alignment.

Future Outlook 

The Single-Use Bioreactor Market is poised to have transformative growth, driven by ongoing innovation, increased need for biopharmaceutical production, and broader applications in or new therapy targets such as cell and gene therapy.

The future state of the market will involve modular, flexible, and hybrid manufacturing solutions that will open the door for potential growth in the market.

Investment in new and emerging markets, strategic alliances and regulatory guidance to facilitate improved biomanufacture technology will continue to have significant role in the market foot print and sustainability.

As biotherapeutics continue to develop, single-use bioreactors will be at the forefront of efficient, scalable bioprocessing technology that is configured specifically for rapid bioprocessing.

Conclusion 

Single-Use Bioreactor (SUB) market is undergoing dramatic growth and change due to increasing global demand for biologics, vaccines, and other advanced gene- and cell-based therapies. Single-use bioreactors have quickly become the business case for biomanufacturing due to their flexibility, less risk of contamination, and cost-efficient use in 

The companies that will continue to lead this ingredient into the future will be those ffwhose focus involves getting further integration, robust process monitoring, and disposable technologies. 

The reality is that single-use bioreactors will benefit from continued use as they become even easier to use and help define the very fabric of efficient and flexible biologics manufacturing.

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