SINGLE-USE BIOREACTOR MARKET ANALYSIS

Market Size and Trends

The Single Use Bioreactor Market is estimated to be valued at USD 3.51 Billion in 2024 and is expected to reach USD 11.2 Billion by 2031, exhibiting a compound annual growth rate (CAGR) of 18% from 2024 to 2031.

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The market growth is driven by growth in the biopharmaceutical industry and advantages of single-use technologies over stainless steel bioreactors. The trend in the single use bioreactor market has been rising adoption rates across small companies and contract manufacturing organizations. Traditionally, large biopharma companies were the primary adopters of single-use bioreactors due to high capital investment required for stainless steel bio reactors. However, small biotech startups and contract pharma manufacturing players now see single-use bioreactors as advantageous due to low installation and maintenance costs. This has allowed these entities to benefit from the flexibility of single-use bioreactors. Going forward, this trend is expected to continue and drive the market growth during the forecast period.

Advancements in Single-Use Bioreactors

The demand for single-use bioreactors is growing significantly among pharmaceutical companies as they look to streamline their drug production processes. A major driver pushing this adoption is the operation and manufacturing advantages offered by single-use bioreactors over their stainless-steel counterparts. Pharmaceutical companies are dealing with greater regulatory requirements today to ensure drug safety and quality. With single-use bioreactors, they can reduce the risks of cross-contamination between different drug batches as each bioreactor is used only once. This helps improve compliance with stringent cGMP guidelines.

Noteworthy advancements are underway in the single-use bioreactor sector, driving the market expansion. For instance, in March 2021, Thermo Fisher Scientific introduced the 3,000 L and 5,000 L HyPerforma DynaDrive single-use bioreactors. These vessels share the same footprint, featuring simplified hardware optimized for perfusion cell culture processes, thereby aiding in conserving manufacturing suite space. These advancements are expected to propel the market growth in the foreseeable future.

Market Concentration and Competitive Landscape

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Rising Demand for Increased Bioproduction Capacity

Global demand for biologics has grown substantially in recent years, driven by the expanding markets for vaccines, monoclonal antibodies, and other biomolecules. As biopharmaceutical pipelines continue delivering promising new drug candidates, the need to scale up biomanufacturing capabilities is increasingly crucial. However, building additional stainless-steel facilities requires sizable capital investments and can take 2-3 years to complete. In contrast, single-use bioreactors provide a faster and more cost-effective means to accelerate bioproduction without significant facility expansion. Their implementation can help gain vital biomanufacturing capacity within a much shorter timeframe to better address market needs. By offering a highly scalable approach, single-use bioreactors have enabled facilities to smoothly transition production volumes across different batch and product sizes. Their modular, standardized design allows for more predictable scale-up studies compared to conventional systems.

Key Takeaways

The single use bioreactor market is experiencing strong growth driven by increasing adoption in manufacturing of biopharmaceuticals. Biopharma companies are leveraging single use bioreactors as they provide increased flexibility and save on validation and cleaning costs compared to stainless steel bioreactors. North America currently dominates the market due to presence of major biopharma players while Asia Pacific is expected to be the fastest growing region over the forecast period.

While single use bioreactors offer significant advantages, initial capital investment can be higher than conventional glass and stainless-steel bioreactors. Additionally, concerns around extractables and leachable from disposable bioreactor components may hamper market growth. However, advances in material science are resolving many of these issues. The development of novel surfaces and materials for single use bioreactors also presents an opportunity for vendors.

With the rise of personalized medicine and demand for biosimilars, contract manufacturing organizations are expanding production capacity by leveraging single use bioreactors. Their modular, scalable and deployable nature makes them an attractive solution for CMOs. Going forward, the availability of customized single use bioreactor solutions catered for specific manufacturing workflows will further support market growth.

Market Challenges: High Production costs

The single-use bioreactor market currently faces some challenges. Production costs are still relatively high compared to stainless steel bioreactors, although the price differential is narrowing as single-use technologies gain more widespread adoption. There are also concerns from some biopharmaceutical companies around reliability and consistency of performance from bag to bag. Ensuring sterility during assembly and operation also adds complexity. Standardization across suppliers is another challenge area that could help reduce costs if realized.

Market Opportunities: Rising Biologics Demand Spurs Single-Use Bioreactor Integration

The single-use bioreactor market also presents substantial opportunities. As the baby-boomer generation ages, demand for biologics will continue growing rapidly. Their advantages of speed and flexibility make single-use technologies particularly appealing for emerging applications like personalized and oral vaccines. Their compact footprint also enables distributed manufacturing models. If production costs decrease further and reliability concerns are addressed, the complete integration of single-use bioreactors into mainstream bioprocessing workflows seems inevitable.

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Insights, by product: Increasing Adoption of Single-Use Technologies

In terms of Product, the Single-use Bioreactor Systems segment is estimated to hold the highest share of 79.20% in 2024 wing to their increasing adoption across small-mid-sized biopharmaceutical manufacturers. Single-use bioreactor systems offer significant advantages over stainless steel counterparts including reduction in validation efforts and capital costs. They eliminate cleaning and sterilization steps between production batches, thereby increasing manufacturing flexibility and throughput. The use of pre-assembled and gamma-sterilized single-use bags also reduces the risks of cross-contamination. With growing demand for personalized medicines and preference for smaller batch sizes, single-use bioreactor systems help organizations to achieve faster product development and market launch.

Insights, by Cell Type: Growing Focus on Mammalian Cell Culture Production

In terms of Cell Type, the Mammalian Cell segment is estimated to hold the highest share of 40.23% in 2024 driven by its widespread use in vaccine and antibody production. A majority of clinically approved biosimilars, recombinant proteins and monoclonal antibodies are developed using mammalian cell lines like CHO cells. They allow for human-like post-translational modifications of proteins which bacteria or yeast cannot replicate. With rising demand for biologics, biopharmaceutical manufacturers are focusing on increasing production capacities for mammalian cell culture-based biologics. This in turn is positively impacting the growth of single-use bioreactors optimized for mammalian cell culture processes.

Insights by Molecule Type: Surging Demand for Monoclonal Antibody Therapeutics

In terms of Molecule Type, the Monoclonal Antibodies segment is estimated to hold the highest share of 40.13% in 2024 owing to the rising popularity of antibody drugs across various disease indications. Monoclonal antibodies have emerged as a major category of biologics in the last decade with more than 80 FDA-approved mAbs. Their target specificity and favorable safety profiles have broadened their therapeutic applications in oncology, immunology and infectious diseases. With robust clinical pipeline and continued approvals, demand for manufacturing capacities of mAbs is surging. Leading players are heavily investing in single-use bioreactor technologies optimized for high yield production of monoclonal antibody therapeutics to support their commercial requirements.

Regional Insights

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North America has established itself as the dominant region in the single use bioreactor market with highest share of 39.2% in 2024. The U.S., in particular, boasts a large presence of leading biopharmaceutical manufacturers that have made significant investments in advanced biomanufacturing capabilities using single use bioreactors. This is primarily due to stricter regulation around sterility and validation in the pharma industry in the U.S. The FDA's focus on producing biologics under aseptic conditions safely and effectively has spurred widespread adoption of single use systems that eliminate complex and costly cleaning and validation requirements of conventional stainless-steel bioreactors.

The Asia Pacific region is emerging as the fastest-growing market for single use bioreactors globally. Countries such as China, India, Japan, and South Korea house a significant number of generic drug manufacturers as well as new entrants in the biosimilars space. These companies are under commercial pressure to rapidly scale up production at lower costs using disposable technologies. With the demand for biopharmaceuticals and vaccines rising rapidly across Asia due to a growing population and changing disease landscapes, local manufacturers are choosing single use systems in order to fast track facility builds and come online faster.

Market Report Scope

Key Developments

• On March 28, 2024, Getinge, a medtech company has expanded its bioreactor portfolio with larger single-use systems. Getinge introduces the Single-Use Production Reactor (SUPR) system, initially available in 50-liter and 250-liter sizes.
• In June 2022, mAbxience, a biotechnology company, enhanced its cGMP (Current Good Manufacturing Practice) facility in León, Spain by installing an additional ABEC 4,000L CSR bioreactor, following the successful delivery of the first 4,000L CSR bioreactor in 2021. mAbxience opted for ABEC's single-use technology to expand its CDMO (contract development and manufacturing organization) business and capacity.
• In May 2022, RD-Biotech, a Contract Research Organization (CRO) specializing in plasmid DNA (pDNA) production for early-phase clinical trials, collaborated with Pall Corporation, global provider in high-tech filtration, separation to provide single-use solutions and purification technology to facilitate the manufacturing of industrially relevant volumes of GMP-grade pDNA.
• In April 2020, Celltainer Biotech BV, a life science equipment company, announced intentions to collaborate with PAN-Biotech, manufactures and supplies a wide range of high quality reagents for use in cell culture as part of a strategic alliance aimed at providing comprehensive solutions for cell culture processes.

*Definition: A single-use bioreactor (SUB) is a bioreactor with the disposable bag instead of a culture vessel. Single-use bioreactor can promote efficient ways for pharmaceutical companies to speed up and secure start-up and product development. Single-use bioreactors are emerging as a key technology in the field of pharmaceuticals.

Market Segmentation

• Product: Insights (Revenue, USD Bn, 2019 - 2031)
  • Single-use Bioreactor Systems
  • Media Bags
  • Filtration Assemblies
  • Other Products
• Cell Type: Insights (Revenue, USD Bn, 2019 - 2031)
  • Mammalian Cell
  • Bacteria
  • Yeast
  • Other Cell Types
• Molecule Type: Insights (Revenue, USD Bn, 2019 - 2031)
  • Vaccines
  • Monoclonal Antibodies
  • Stem Cells
  • Recombinant Proteins
• End User: Insights (Revenue, USD Bn, 2019 - 2031)
  • Pharmaceutical and Biopharmaceutical Industries
  • Contract Research Organizations (CRO)
  • Academic & Research Institutes
  • Other End Users
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Sartorius Stedim Biotech
  • Thermo Fisher Scientific
  • Danaher
  • Merck KgaA
  • Celltainer Biotech BV
  • Getinge AB
  • Eppendorf AG
  • Cellexus
  • PBS Biotech Inc.
  • Distek Inc.
  • ABEC
  • Able Corporation & Biott Corporation
  • G&G Technologies Inc.
  • Solida Biotech GmbH
  • Satake Chemical Equipment Mfg., Ltd.
  • Stobbe Pharma GmbH
  • bbi-biotech GmbH