A Detailed Analysis of the Single-Use Bioreactors Market Is Influenced by the Increasing Pace of Technological Advancements, the Introduction Of New Products, And the Implementation of Regulations Specific to Single-Use Bioreactors
Report ID: PMRREP33957
Number of Pages: 219
Format: PPT, PDF, EXCEL
Industry: Healthcare
Published Date: January-2024
The global single-use bioreactors market is forecast to expand at a CAGR of 15.8% and thereby increase from a value of US$3.8 Bn in 2024, to US$10.8 Bn by the end of 2031.
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Attributes |
Key Insights |
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Single-use Bioreactors Market Size (2024E) |
US$3.8 Bn |
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Projected Market Value (2031F) |
US$10.8 Bn |
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Global Market Growth Rate (CAGR 2024 to 2031) |
15.8% |
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Historical Market Growth Rate (CAGR 2019 to 2023) |
17.0% |
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A single-use bioreactor (SUB), also known as a disposable bioreactor, utilizes a disposable bag instead of a traditional stainless steel or glass culture vessel. It offers flexibility, ease of use, and simplified installation, requiring fewer utility resources such as steam and water. The SUB system reduces labour costs, mitigates the risk of cross-contamination, and eliminates cleaning processes and validation challenges. These advantages make it a preferred choice, particularly in contract research organizations (CROs) and contract manufacturing organizations (CMOs) globally.
SUBs play a crucial role in the pharmaceutical sector for tasks like media and buffer preparation, cell harvesting, filtration, purification, and virus inactivation. They are also utilized in academic and commercial-scale laboratories for applications such as drug discovery, biofuel manufacturing, and the development of vaccines and antibodies. The increasing demand in the biopharmaceutical industry is a significant driver for the market's growth.
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The industry's increasing preference for single-use bioreactors (SUBs) is currently influenced by factors such as the criticality of the step, product value, and the time required for product development and production. According to a July 2022 article titled 'Advancing Upstream Biomanufacturing: Continuous Perfusion Cell Culture', the initial development of continuous perfusion processes often takes more time compared to batch and fed-batch processes. However, once implemented, the productivity gains can offset this initial investment of time. These gains allow manufacturers to more easily achieve clinical production quantities with reduced scale-up operational volume requirements, making single-use bioreactors advantageous. The utilization of such benefits in manufacturing facilities is expected to contribute significantly to market growth.
In the bioprocessing sector, SUBs have become a standard for both clinical and industrial batches, driving notable developments in the single-use bioreactor segment. For instance, in March 2021, Thermo Fischer Scientific introduced the 3,000 L and 5,000 L HyPerforma DynaDrive single-use bioreactors. These vessels share the same footprint, featuring simplified and optimized hardware for perfusion cell culture procedures to conserve manufacturing suite space. Such advancements are poised to propel market growth in the foreseeable future.
Concerns Regarding Leachable and Extractables
Leachable and extractables have been a persistent concern in single-use bioprocessing for over a decade. Single-use bioreactors are predominantly constructed with polymer layers fused, and each layer contributes specific physical and chemical properties essential for the proper functioning of the bioreactor. These polymer layers may contain various additives such as antioxidants, fillers, plasticizers, and stabilizers to achieve the required characteristics. Over time, these additives can leach into the drug substance being processed in the single-use bioreactor bags. Additionally, there is a lack of well-established regulations governing the use of these polymers. Consequently, this factor is expected to pose a certain level of constraint on market growth.
Single-use bioreactors, comprising stainless-steel bodies equipped with bioreactor bags, assemblies, and related accessories, find applications in bioproduction, process development, and research & development. These bags and assemblies are discarded after a single use, resulting in the generation of substantial plastic waste with each production cycle. While biopharmaceutical companies increasingly embrace single-use bioprocessing systems for benefits like cost reduction, faster process development, and lower capital investments, there are growing concerns about the environmental impact of waste disposal associated with this technology. To address these concerns, many single-use suppliers are actively exploring sustainable options for manufacturers.
Currently, materials from used single-use manufacturing are typically decontaminated and either commercially landfilled or incinerated. However, there is an opportunity to mitigate the negative environmental impact of single-use systems by exploring alternatives such as incineration with energy recovery and other more sustainable waste streams. These alternatives include landfill (untreated, treated, or with grinding), recycling, incineration (with and without energy recovery), and pyrolysis.
Global Rise in Chronic and Infectious Diseases, Coupled with The COVID-19 Outbreak, Holds Significant Promise
The Rising global burden of chronic and infectious diseases presents lucrative growth opportunities for participants in the single-use bioreactor market. Bioreactors, with a longstanding history in therapeutic production, exhibit potential for treating a broad spectrum of acute and chronic illnesses. Chronic diseases, being major contributors to global mortality and disability, offer a substantial market for bioreactor applications. According to the World Health Organization (WHO), cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes are leading causes of non-communicable disease (NCD) deaths.
Furthermore, the global outbreak of COVID-19 has created significant growth prospects for players in the single-use bioreactor market. Bioreactors play a pivotal role in cell culture-based viral vaccine production, especially amid the COVID-19 pandemic. A notable example is ABEC's delivery of six 4,000L CSR bioreactors to the Serum Institute of India in September 2020, aimed at accelerating the production of NVX CoV2373, Novavax's COVID-19 vaccine candidate. Additionally, the use of ABEC's single-use technology facilitated the expedited supply of NVX CoV2373 to India and other low- and middle-income countries.
Which Product Category Contributes the Maximum Revenue?
Sales of Single-use Bioreactor Systems Prominent, Cost-efficient Mass Production Ability Drives Demand
Single-use bioreactor systems are extensively utilized in biopharmaceutical manufacturing processes demanding elevated product yield. The widespread adoption is attributed to the versatility, cost-effectiveness, and high mass-production capability of these bioreactors, driving increased demand and fostering rapid market growth. Additionally, the escalating need for accelerated development and increased production of novel bio-therapeutics such as vaccines, antibodies, enzymes, and hormones further fuels the ongoing expansion of the market.
Which is the Topmost Segment by Type?
Stirred-Tank Subs Dominate Due to Efficient Oxygen Transfer and Fluid Mixing
The advantages provided by these bioreactors, including efficient oxygen transfer, adept fluid mixing, seamless scale-up capabilities, economical operational costs, adherence to cGMP requirements, and the availability of alternative impellers, have resulted in the widespread adoption of stirred tank bioreactors, making them the dominant choice in the market.
Which is the Leading End User Segment?
Biopharma and Pharma Companies Register Maximum Demand Generation
Approximately 66% of biopharmaceutical companies incorporate disposable bioreactors into their regular operations, as per industry estimates. Moreover, strategic initiatives undertaken by key market players present lucrative opportunities within the review period. A notable example is the collaboration between BioCentriq and Pall Corporation in July 2021, aimed at the clinical manufacturing of Zolgensma, an FDA-approved gene therapy, utilizing an iCELL is fixed bed bioreactor.
North America's Dominance Grows with Rising Chronic Diseases
North America is poised to assert dominance in the single-use bioreactors (SUBs) market, driven by the increasing prevalence of chronic diseases and a growing demand for novel drug development. Recent data from the Centers for Disease Control and Prevention (CDC) highlights the substantial health challenges in the region, with over 34.2 million Americans diagnosed with diabetes, and an annual death toll exceeding 868,000 attributed to heart disease.
Furthermore, the updated data from the Food and Drug Administration (FDA) indicates a significant infrastructure for pharmaceutical development, with 4,944 FDA-Registered Facilities dedicated to biologics and 6,799 for human drugs as of November 2021. This extensive network of manufacturing facilities is anticipated to present opportunities for the adoption of SUBs, thereby driving market growth in the region.
Asia Pacific Gains Momentum as Demand for Biologics Development Rises
The Asia Pacific region exhibits the most rapid growth rate in the market for Single-use Bioreactors. Asian enterprises, encompassing both local players and international giants, are responsible for constructing around 50% of all newly established bioprocessing facilities globally. This trend is expected to substantially contribute to the expansion of the single-use bioreactors market in the Asia Pacific region in the foreseeable future.
Prominent organizations, including Applikon Biotechnology BV, Cellexus Ltd., and Celltainer Biotech B.V, are at the vanguard of this sector, providing inventive solutions by capitalizing on their technological prowess and vast experience in the bioprocessing industry. Prominent manufacturers of single-use bioreactors may make substantial investments in research and development to consistently advance their technology. Their emphasis could be on improving performance, scalability, and compatibility with various cell types, aiming to enhance the efficiency and flexibility of bioprocessing.
Key industry players are likely to engage in partnerships and collaborations with biopharmaceutical companies, contract manufacturing organizations (CMOs), and research institutions. These collaborative efforts are expected to promote technology sharing, co-development of tailored solutions, and the diversification of product offerings to cater to a broader spectrum of applications. To distinguish themselves in this highly competitive market, these businesses strive to differentiate their products. They achieve this by providing unique features, innovative technologies, and superior quality in their single-use bioreactor solutions.
New Product Launch
In March 2021, Thermo Scientific introduced the 3,000 L and 5,000 L models of HyPerforma DynaDrive single-use bioreactors. These devices offer benefits for large-scale bioprocesses, including cGMP manufacturing at exceptionally high cell density. This strategic product launch has enhanced the company's product portfolio and expanded its overall customer base.
Market Impact: With the new models, the single-use Bioreactors Market is expected to develop overall as they meet the growing need for cutting-edge technologies in the bioprocessing industry. Biopharmaceutical organizations looking for reliable and effective solutions are anticipated to be drawn to these innovative bioreactors' capabilities, propelling the market's expansion.
In September 2019, ABEC Inc. unveiled a single-use bioreactor system featuring an impressive working volume of 6,000 L, tripling the industry standard maximum limit. This release marked a significant advancement from the company's previous threshold set in 2017, which stood at a total production volume capability of 4,900 L. ABEC's strategic move to enhance cell culture capacity per unit of floor space through the CSR bioreactors is anticipated to yield substantial savings in facility space, capital expenditures, and disposable costs in the future.
Market Impact: In addition to demonstrating technological advancement, ABEC's initiative to use CSR bioreactors to boost cell culture capacity per unit of floor space is in line with industry expectations for more affordable and space-efficient solutions. The launch of such high-capacity single-use bioreactors places ABEC as a prominent participant in the market and is likely to boost adoption among manufacturers looking for greater efficiency and cost savings, as biopharmaceutical businesses seek out advanced and scalable technology.
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Details |
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Forecast Period |
2024 to 2031 |
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Historical Data Available for |
2019 to 2023 |
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Market Analysis |
US$ Million for Value |
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Key Regions Covered |
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Key Countries Covered |
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Key Market Segments Covered |
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Key Companies Profiled |
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Report Coverage |
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Customization & Pricing |
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The market is anticipated to grow at a CAGR of 15.8% during the projected period.
The single-use bioreactors market was valued at US$3.8 billion in 2023.
The US held the largest market share in 2023.
Some of the prominent players in the market are Applikon Biotechnology BV, Cellexus Ltd., Celltainer Biotech B.V., Cesco Bioengineering Co. Ltd., and Danaher Corporation.
The single-use bioreactor systems segment is expected to grow at the fastest CAGR during the forecast period.
