Singleuse Bioreactors Market

Single-use Bioreactors Market Size

Single-Use Bioreactors Market size was valued at USD 2.1 billion in 2022 and is estimated to account for USD 9.2 billion by 2032. Single-use bioreactors are also known as disposable bioreactors, in which disposable bag is used instead of a culture vessel. Processors can use disposable technologies, such as single-use bags, in the manufacturing process stage using single-use bioreactors.

This product of bioreactor is inexpensive and is primarily used for research. Rising prevalence regarding chronic disorders and severe infections will drive the demand for biopharmaceutical products. As per the Centers for Disease Control and Prevention (CDC), chronic disorders are among the leading causes of deaths in the U.S. Six out of ten people in the country suffer from a chronic disease.

Rise in incidence of chronic conditions has enabled growth opportunities to the pharmaceutical market, especially for vaccines and therapeutics segments. Pharmaceutical manufacturers are adopting advanced bioreactor systems to enhance productivity. With escalating product demand, the companies are focusing on R&D for drug development and expanding manufacturing facilities that will positively influence the demand for single-use bioreactors.

COVID-19 Impact

The usage of single-use bioreactors increased significantly since the COVID-19 pandemic. Increasing demand from governmental vaccination program and COVID-19 compelled scientists to work under pressure to shorten the time to market developed vaccine. The usage of scale down strategies along with single-use bioreactors reduced over consumption of resources, thereby accelerating vaccine manufacturing. The companies witnessed exponential demand for single-use bioreactors owing to cheaper investment and availability in low volume.

Single-use Bioreactors Market Trends

Increasing focus of the U.S. FDA and researchers on rare disease therapies have significantly increased the number of novel therapies in recent time. Growing scientific advances such as genetics and the application of next generation therapeutic approaches such as use of biomarkers is propelling the demand for orphan therapies.

• Orphan drugs are generally classified as those medicines that fall under one or more medicines approved under the Orphan Drug Act. Increasing use of orphan drugs in various clinical applications and increasing number of FDA approvals are the factors contributing to the drug development.
  
• Moreover, increasing use of orphan drugs in rare diseases and presence of large FDA approved drugs are also augmenting the sales of orphan drugs. In 2020, nearly 32 novel drugs along with biologics designated as orphan drugs were approved by the U.S. FDA. Thus, with development and growing demand for orphan drugs, the requirement of bioreactor systems will expand in upcoming years.  

Single-use Bioreactors Market Analysis

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The market by product is categorized into stirred tank single-use bioreactors, wave-mixed single-use bioreactors, bubble column single-use bioreactors, and others. The stirred tank single-use bioreactors segment garnered USD 1.5 billion revenue size in the year 2022.

• Single-use bioreactors eliminate the need for cleaning and sterilization between batches, significantly reducing the risk of cross-contamination between different products or batches. This is crucial in the production of biopharmaceuticals, where even trace amounts of contaminants can compromise the entire batch.
  
• Moreover, traditional stainless-steel bioreactors require significant capital investment and operating costs for cleaning, sterilization, and maintenance. Single-use bioreactors eliminate these costs associated with cleaning and validation, leading to overall cost savings.
  
  

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Based on cell, the single-use bioreactors market is segmented into mammalian cells, bacterial cells, yeast cells, other cells. The mammalian cells segment accounted for over 79% business share in 2022. The segment's growth can be attributed to enhanced demand for mammalian cells in the discovery and commercial manufacturing of therapeutic proteins, viral vaccines, and several other biopharmaceuticals, which will drive demand for single-use bioreactors.

• Moreover, these cells are widely used to develop tissue analogues for regenerative therapeutics which will further drive the segment share.  
  
• In addition, extensive usage of mammalian cells in the research for various applications coupled with capacity of adding human-like post-translational variations to complex protein therapeutics will drive the segment trends.
  

Based on molecule, the single-use bioreactors market is segmented into monoclonal antibodies, vaccines, recombinant proteins, stem cells, gene therapy, other molecules.

The vaccines segment accounted for over 50% revenue share in 2022 and is anticipated to witness highest growth during the forecast period.

• The segment growth is primarily attributable to extensive vaccine development activities owing to sudden upsurge in demand for COVID-19 vaccines. Expansion of vaccination and opening of mass COVID-19 vaccination sites are the factors contributing to the growth of the segment.
  
• Also, the increasing prevalence rate of numerous chronic infectious ailments will boost the research & development activities for vaccine development thereby, stimulating the demand for the single-use bioreactors.
  

Based on usage, the single-use bioreactors market is segmented into developmental, pre-clinical & clinical and commercial production. The developmental, preclinical, and clinical segment is projected to grow at 16.5% CAGR during the forecast period.  

• High demand for infectious disease vaccines and drugs has increased the number of preclinical and clinical research activities. Increasing use of single-use bioreactors in preclinical and clinical studies is augmenting its market expansion. Thus, emphasis on speedy FDA approval and improvement in vaccination criteria are the factors responsible for rise in preclinical and clinical studies.
  
• Moreover, the strong presence of biopharmaceutical manufacturers that are highly involved in R&D activities for product innovation will foster the market demand.
  

Thus, growing focus on novel innovation will create lucrative growth opportunities for the market in the foreseeable future.

The single-use bioreactors market by end-use is categorized into R&D organizations, biopharma manufacturers, contract manufacturing organizations. Biopharma manufacturers held 45% of industry share in 2022.

• Increase in number of biopharmaceutical products in pipeline including antibodies and antibody drug conjugates coupled with rising number of new facilities to meet the production needs is anticipated to augment segment landscape.
  
• Growing adoption of advanced technologies to ease complex manufacturing will stimulate industry demand in upcoming years.
  
• Moreover, single-use bioreactors cater wide applications in development and manufacturing of complex molecules such as proteins and nucleic acids is estimated to drive the segment size.
  

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U.S. single-use bioreactors market accounted for USD 795 million revenue size in 2022 and is predicted to witness substantial market growth over the analysis timeline.

• Technological advancements coupled with increasing healthcare expenditure on R& D activities are the factors driving the market growth. Increasing incidence of infectious diseases along with rising demand for vaccine production will stimulate the use of single-use bioreactors.
  
• Major players in the pharmaceutical industry are focusing on expanding production capacity and developing new therapies including gene therapy and recombinant protein therapy, thereby creating new opportunities for the U.S. market demand.
  
• Further, contract manufacturing organizations (CMOs) are being used for most of the processes in the healthcare industry as several players from emerging countries are entering the market. Companies from the U.S. are establishing operations in the emerging countries such as India, South Korea, Singapore, and China.
  

Single-use Bioreactors Market Share

The single-use bioreactors industry is consolidated in nature, with major companies competing to offer superior products in this business space. Prominent players such as GE Healthcare holds a significant share in this market. These companies are diligently directing their efforts towards continuous product innovation to gain substantial market share. For instance, GE Healthcare Life Sciences introduced Xcellerex XDR, to minimize production risks, enhance the purity, and facilitate maximum potency.  

Some of the eminent market participants operating in the single-use bioreactors industry include:

• Thermo Fisher Scientific
• Solaris Biotech Solutions
• Shanghai Bailun Biotechnology Co. Ltd.
• Sartorius Stedim Biotech Group
• Pierre Guerin Sas (Engie)
• PBS Biotech
• Danaher Corporation
• Merck Group
• GEA Group Aktiengesellschaft
• Eppendorf AG
• CESCO Bioengineering Co. Ltd.
• CerCell ApS
• Cellexus Ltd
• Bbi Biotech
• Applikon Biotechnology, Inc. (Getinge)
  

Single-use Bioreactors Industry News:

• In December 2022, MilliporeSigma, a part of Merck KGaA acquired Erbi Biosystems, a prominent manufacturer of bioreactors. This has strengthened the company’s product offerings and development capabilities in the significant market, thereby strengthening the position of the company in the market.
  
• In March 2021, Thermo Scientific launched the HyPerforma DynaDrive single use bioreactors 3,000 L and 5,000 L models. These devices provide advantages for large scale bioprocesses such as cGMP manufacturing at very high cell density. This has strengthened the company’s product portfolio and overall customer base.
  

Single-use bioreactors market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032 for the following segments:

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By Product, 2018-2032 (USD Million)

• Stirred tank single-use bioreactors
• Wave-mixed single-use bioreactors
• Bubble column single-use bioreactors
• Other products

By Cell, 2018-2032 (USD Million)

• Mammalian cells
• Bacterial cells
• Yeast cells
• Other cells

By Molecule, 2018-2032 (USD Million)

• Monoclonal antibodies
• Vaccines
• Recombinant proteins
• Stem cells
• Gene therapy
• Other molecules

By Usage, 2018-2032 (USD Million)

• Developmental, pre-clinical & clinical
• Commercial production

By End-use, 2018-2032 (USD Million)

• R&D organizations
• Biopharma manufacturers
• Contract manufacturing organizations

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • The Netherlands
  • Denmark
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Singapore
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • UAE
  • Rest of Middle East & Africa