1. Since their introduction in 1982, biologics have gained popularity owing to their therapeutic efficacy, favorable safety profiles and ability to treat a wide variety of disease indications, which are otherwise hard to treat. In fact, in the past two decades, over 170 biopharmaceuticals have already been granted approval by the FDA and over 7,500 biological interventions are under evaluation in clinical trials.
2. It is a well-known fact that the commercial and clinical-scale manufacturing of such complex biomolecules require highly specialized bioprocessing equipment to facilitate the maintenance of ideal conditions, such as optimal temperature, pH, dissolved oxygen, fluid delivery, and other critical process parameters that are essential for steady cell growth. Bioreactors are capable of providing such optimal conditions and are critical to the upstream biomanufacturing process.
3. These systems are designed to increase the concentration of viable cells, thereby enabling the production of large amounts of recombinant proteins, such as vaccines, fusion proteins, antibodies and enzymes.
4. Apart from producing conventional therapeutic proteins, bioreactors can also be used to produce advanced medicinal products (ATMPs), namely cell-based and oligonucleotide-based therapies, retroviral vectors for gene therapy and cellular components of three-dimensional tissue / artificial organs. In contrast to bioreactors, fermenters are used for the anaerobic cultivation of microbial (fungal or bacterial) cell populations to produce biologics that do not require significant post translational modifications.
5. It is worth highlighting that the use of fermenters for the manufacturing of bioproducts provides faster development, higher yields and quality, reduced variation between batches, better scalability, and lower production costs, in comparison to the biomanufacturing carried out in bioreactors.
DEMAND FOR BIOREACTORS AND FERMENTERS
1. Over the past 25 years, there has been a steady increase in the sales of biologics, growing at a rate of 12-14% annually. In order cater to this growing demand, over 1,500 commercial scale biomanufacturing and contract manufacturing organization (CMO) facilities, equipped with bioreactors and / or fermenters have been established, globally.
2. Further, during the COVID-19 pandemic, several companies enhanced their vaccine production capabilities (through capacity expansion / technology upgradation), resulting in a surge in the sales of bioreactors.
3. Moreover, the transition in the industry from high-volume biologics towards innovative specialized biologics, particularly those focused on treating rare conditions, has created a requirement for flexible manufacturing systems.
4.Consequently, there is an increasing demand for a diverse range of bioreactor systems (in term of design and mechanism of action), which includes disposable (single-use), stirred-tank, mini / micro, air lift, rocker, perfusion, wave bed, bubble column, fixed-bed, fluidized bed, membrane, packed bed, fibrous bed and photobioreactors. All these developments represent an additional avenue for revenue generation in this growing market.
ROLE OF BIOPROCESS EQUIPMENT MANUFACTURERS
1. The design aspect of both bioreactors and fermenters, operational across different types of bioprocesses (batch, fed batch and continuous), is a complex engineering task, requiring extensive understanding of cell growth, metabolism, genetic manipulation, and product expression.
2. As a result, industry and non-industry players producing biomolecules / cellular therapies, are relying on original equipment manufacturers (OEMs) that produce different components of bioreactors, and / or engineering, procurement, and construction (EPCs) companies that integrate all the equipment designed by OEM engineers into a complete performing system.
3. Manufacturers that are able to offer their clients modern equipment and infrastructure upgrades, effective life cycle management for their products, responsive customer service, expert troubleshooting of equipment issues, and annual maintenance contract to ensure efficient functioning of installed bioreactors without disruption, are the preferred partners.
MARKET LANDSCAPE OF BIOREACTORS AND FERMENTERS
1. The global bioreactors and fermenters market landscape features more than 255 companies, which claim to possess the necessary technical expertise for manufacturing high-quality bioreactors and fermenters, in order to serve the biotechnology and biopharmaceutical industry. The market is currently dominated by small companies (1-50 employees), which represent 56% of the total number of players.
2. Based on the requirement, bioreactors are produced using different fabrication materials, such as stainless steel, glass, and plastic, and are available in varying dimensions and volumes, ranging from micro-mini (less than 1 mL and 1 to 10 mL) to large-scale (more than 10,000 L). It is interesting to highlight that companies manufacturing miniature and small-scale bioreactors represent nearly 30% of the total players in this market.
3. These bioreactor models are essential for conducting high-throughput experimental studies related to media development, strain improvement or process optimization. Further, recent developments in this domain indicate that majority of the bioreactor manufacturers have switched to advanced bioprocessing technology by integrating the automatic mode of operation.
KEY CHALLENGES
1. Although disposable (single-use) bioreactors and fermenters have gained popularity due to their advantages, such as lower water and energy consumption (by approximately 45%), reduced initial investment costs (by 40%), and faster processing times for biologics (by 33%), they pose a risk of leachables and extractables (L&E).
2. These bioreactors are constructed using plastic materials that can release organic or inorganic chemicals into liquid pharmaceutical products, potentially jeopardizing the safety of the drug and the well-being of the patient. The need for frequent purchases, variable costs per run, recurrent plastic disposal, and restricted capacity are some other potential bottlenecks restricting the widespread use of disposable (single-use) bioreactors.
3. While bioreactor manufacturers are striving to tackle these challenges through innovation in design and manufacturing methods, the increasing costs of procuring raw materials and ensuring that they align with the customers' budget, still remain a pressing concern.
MARKET SIZE OF THE GLOBAL BIOREACTORS AND FERMENTERS MARKET
1. Driven by the rising demand for novel biopharmaceuticals, high adoption rates of precision medicine and regenerative medicine, along with advancement in bioprocessing technologies, the bioreactors and fermenters market is anticipated to witness a noteworthy growth in the foreseen future.
2. Specifically, in terms of types of biologics, the market is anticipated to be driven by the high demand for manufacturing different antibody formats, including monoclonal and bispecific antibodies. Currently, majority of the revenues are generated from the sales of bioreactors that operate in batch and fed-batch modes; however, in the near future, market for bioreactors that operate in continuous mode is anticipated to grow at a relatively higher rate.
KEY EMERGING TRENDS IN BIOREACTORS AND FERMENTERS MARKET
1. The bioreactors and fermenters market is witnessing the adoption of bioprocessing 4.0 solutions that leverage machine learning (ML) and artificial intelligence (AI) for real-time process monitoring.
2. For instance, a US based company, Culture Biosciences, has designed an integrated bioreactor platform to design, monitor and analyze experiments, remotely via the cloud. The industry is also embracing advanced modular bioreactors that can be configured sequentially or in parallel.
3. Further, the integration of controllers and automated systems is another technological advancement, that not only ensures that the processes continue to run within precise limits but also make the necessary adjustments, while minimizing the risk of human errors.
4. Global market - The current global bioreactors and fermenters market size is anticipated to be over USD 25 billion.
5. Top players - Presently, more than 255 companies are engaged in manufacturing bioreactors and fermenters, worldwide. The top players engaged in this domain (which have also been captured in this report) include Applikon Biotechnology, Bionet, Cytiva, Eppendorf, Merck, Ollital Technology, Parr Instrument Company, Sartorius, Shanghai Bailun Biological Technology, Solaris Biotech, Solida Biotech and Zhengzhou Laboao Instrument Equipment (LABAO).
6. Driving Factors - The factors driving the global bioreactors and fermenters market include advancement in bioprocessing technologies, and the surge in demand for novel biopharmaceuticals, such as precision and regenerative medicine.
7. Region with highest market share - North America and Europe capture around 60% share in the current global bioreactors and fermenters market, followed by Asia-Pacific. It is worth mentioning that, within Asia-Pacific, majority of the market share is contributed by China and India.
8. Leading market segments - Currently, in terms of fabrication material, stainless steel bioreactors / fermenters capture the largest share of this market. However, single-use bioreactors / fermenters are likely to witness higher annual growth rates in the upcoming years, owing to their smaller footprint, cost efficiency and increased productivity. Further, in terms of type of biologic, cell culture systems used for the production of antibodies are anticipated to capture a prominent share of the current and future market.
9. Segment with largest share - The capacity of the bioreactors varies, ranging from a few milliliters to several liters, contingent upon the specific design and operational mode employed across diverse bioprocesses. At present, the global bioreactors and fermenters market is dominated by laboratory-scale bioreactors / fermenters. This category considers bioreactors / fermenters in the volume range of 1 L to 299 L. This is followed by pilot-scale bioreactors (300 L to 10,000 L) and bench-scale bioreactors (101 mL to 999 mL).
10. Growth rate (CAGR) - The global bioreactors and fermenters market size is projected to grow at a CAGR of ~12% in the coming years.
11. Upcoming Trends - The industry is presently witnessing the rising adoption of bioprocessing 4.0 solutions leveraging AI and ML for real-time process monitoring. Further, in order to ensure that the bioprocess runs within the precise limits, several players have integrated automated bioprocess controllers that offer various additional benefits, such as lowering of production and labor cost (by 20-30%), optimizing the energy consumption (by 5-30%) and increasing the overall productivity (by 10-20%).
Source:
https://www.globenewswire.com/en/news-release/2023/04/07/2643150/28124/en/Global-Bioreactors-and-Fermenters-Market-to-2035-Surge-in-Demand-for-Novel-Biopharmaceuticals-Such-as-Precision-and-Regenerative-Medicine-Drives-Growth.html
