Bioreactor is an engineered or manufactured vessel that is used in the production of wide range of biological products. Industrial bioreactor is a vessel in which biochemical process is carried out using microbes and animal cells or biologically active compounds that are derived from living cells. Bioreactors are cylindrical in shape with capacity of liters to cubic meters and is the most important component involved in bioprocessing. Fermentation processes such as wine, and beer production are carried out in bioreactors. Bioreactors for large scale production of therapeutic products are made of stainless steel. In biopharmaceutical companies, small glass bioreactors are used for research and development purpose and for scale up activities. Another type of bioreactors are disposable bioreactors, which are meant for single use and hence are called as single-use bioreactors. It is generally used for extensive research and manufacturing. Bioreactors can operate in batch, fed batch, and continuous stirred tank processes. Bioreactors are used to produce therapeutics, which include monoclonal antibodies, vaccines, stem cells, and gene modified cells.
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The efficiency of single-use bioreactors has increased across pharmaceutical industries in terms of production, quality control, and procurement. Single-use bioreactors offer advantages such as consistency in production, increase in speed of manufacturing, reduced operational cost, and reduction in manufacturing time of finished dosage form, which foster growth of bioreactors market. In 2016, as per the National Centre for Biotechnology Information (NCBI), operational cost per gram of monoclonal antibody production (mAb) for single-use bioreactor is around 22% lower than conventional system, mainly due to less labor, utilities, maintenance, and waste. For commercial scale of monoclonal antibody production (mAb), conventional fed-batch bioreactors usually require 10000L – 25000L stainless steel tank to culture cells and produce yield of 2-6 g/L. However, single-use bioreactors employ continuous cell culture supply in 500L - 2000L tank and produces 10 - 30 times higher cell density. Therefore, more quantity of products can be produced by using this single-use bioreactors, with less space and capital cost. Other factors that contribute to growth of the market include low water usage by single-use systems, less floor space requirement, and low risk of cross contamination in single-use system. Furthermore, in 2016, a case study by Cambridge Healthtech Institute stated that by using single-use (SU) bioreactors, there can be an annual savings of US$ 250,000 in water generation for injections and US$ 60,000 in labor time required to set up and cleaning of stainless steel tank. These factors are expected to drive growth of the bioreactors market over the forecast period.
Moreover, in bioprocessing, enzymes used are specific in their action and produce a pure product. Diseases such as diabetes and anemia are widespread globally, and according to the World Health Organization (WHO), in 2014, around 415 million people were living with diabetes, which indicates the need for increasing availability of bioprocessed products at faster rates, wherein, advanced bioreactors could be useful. For instance, bioprocessed products such as Amaryl manufactured by Sanofi Aventis U.S. Llc, and Acarbose by Emcure Pharmaceutical Ltd. are used as anti-diabetic drugs. Thus, implementation of single-use bioreactors has made clinical and commercial production of biopharmaceuticals fast and efficient in limited time and has reduced the cost associated with production, in turn driving growth of bioreactors market.
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Market Regional Insights
North America is expected to hold dominant position in bioreactors market due to presence of major biopharmaceutical manufacturing companies. Biopharmaceutical companies such as Gilead Science, Inc., Amgen, and Biogen, Inc. in the U.S. actively conducts research on novel therapies for the treatment of various diseases. Research of therapies associated with oncology such as monoclonal antibodies require usage of bioreactors on small as well as large scale for production purposes. Furthermore, according to the National Centre for Biotechnology Information (NCBI), in 2014, 65.6% of the clinical scale manufacturers and around 42% of the commercial manufacturers used single-use bioreactors to improve their bioprocessing. Europe is expected to witness significant growth rate in the bioreactors market due to increasing usage of bioreactors in biopharmaceutical companies. According to the Organization for Economic Co-operation and Development (OECD), in 2015, around 1,700 biopharmaceutical companies, which utilize bioreactors, are from Europe.
Key players operating in bioreactors market include Thermo Fisher Scientific, Inc., Merck KGaA, GE Healthcare, Pall Corporation, ZETA Holdings GmbH, Sartorius AG BBI, Solaris, Praj HiPurity Systems Limited, BiOENGiNEERiNG, INC., Infors AG, and Appplikon Biotechnology, Inc.
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