Pune, India -- (SBWIRE) -- 03/06/2019 -- The growth of the Bioreactors Market is primarily attributed to the increasing investments in R&D and other activities. Moreover, the rapid growth of pharmaceutical and biotechnology industry is also expected to drive the growth of bioreactors market. However, availability of alternative techniques for bioreactors and stringent regulatory framework is expected to obstruct the growth of bioreactors market. On the other hand, rapid use of single use bioreactors are expected to be trending in the manufacturing companies and research institutes in the market. The single-use bioreactors are helpful in providing next-generation cell- and gene-therapies and continuous bioprocessing.

The betterments and improvements in cell-culture processes have developed higher titers and cell densities, which have facilitated the adoption of single-use bioreactors through reductions in needed reactor volumes. Single-use bioreactors reduce the risks of contamination from the other products and decrease production turnaround times. Moreover, reduction in validation time shortens time which is a tremendous value for the advanced development of the bio products. The S.U.B. combines elements of stirred-tank systems with the efficiencies in cleanup and validation found in single-use processing, and supports scale-up needs and optimal cell growth, viability, and general metabolism.

According to a new market research study titled 'Bioreactors Market - Global Analysis and Forecasts By Product Class and Application. The global bioreactors market is expected to reach US$ 4,453.1 Mn in 2025 from US$ 2,760.5 Mn in 2017. The market is estimated to grow with a CAGR of 6.5% from 2018-2025. The report highlights the trends prevalent in the global bioreactors market and the factors driving the market along with those that act as deterrents to its growth. The market is expected to grow due to due to increasing healthcare expenditures research and development as well as outsourcing services, however, the availability of alternative virus clearance methods is hindering the market.

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Single-use bioreactors (S.U.B.) are developed from various manufacturers which is robust and provides high-performance that is necessary for commercial manufacturing of biopharmaceuticals. Many advantages offered in film technologies, bioreactor designs, stirring mechanisms, and sensor systems have contributed to the increasing adoption of disposable reactors from the lab to production scale. The single-use bioreactors are helpful in providing next-generation cell- and gene-therapies and continuous bioprocessing. The betterments and improvements in cell-culture processes have developed higher titers and cell densities, which have facilitated the adoption of single-use bioreactors through reductions in needed reactor volumes. The single-use technologies have gained the widespread acceptance with the support from regulators. While existing cGMP processes are using stainless steel infrastructure, many new products are directly into single-use production equipment. The increasing acceptance of the single use bioreactors are rising the production of the bioreactors and eventually increasing the market of the bioreactors.

Global bioreactors market, based on the application was segmented into microbial application and cell culture. In 2017, microbial segment held the largest share of the market, by application. Moreover, the microbial segment is expected to grow at the fastest rate during the coming years as microbial cultures are being used on a large scale for research purposes as well as industrial applications. Growth in the number of biotechnology companies and rise in research funding offered by government bodies are considered to be the factors driving the growth of the segment during the forecast period.

Some of the prominent players operating in bioreactors market are Thermo Fisher Scientific Inc., Applikon Biotechnology BV, Merck KGaA, Sartorius AG, Eppendorf, General Electric, Bioengineering AG, Solaris Biotechnology Srl, Danaher (Pall Corporation), and Praj Industries. The market players are focused towards expanding their manufacturing and services capabilities by opening new manufacturing plants and service portfolio. For instance, in July 2018, Merck expanded its operations in Gillingham, UK to expand distribution centre for Life Science products to support future business growth. Similarly, Bioengineering opened its new branch-office in South Korea in June, 2018. This has helped the company to have a strong presence in the Asian countries.

In the recent years, pharmaceutical industry has been developing at an unusually rapid pace. Manufacturers along with their alliance with the CROs are confronting to the enormous healthcare challenges through new medicines, therapy forms, progressing digitalization and constantly changing the regulations. According to the World Health Organization, the global population is increasing by 1.24% per annum leading to rise in number of people in the geriatric class. The WHO also suggests that the proportion of people aged 65 to 80 will rise to 28% in 2030, compared to 22% in 2000. Moreover, according to a survey report published by Torreya Economical Model 2017, pharmaceutical industry is 30% larger than its previous estimations till 2017 and contributes to one of the top five industries increasing global economy value. Additionally, increasing urbanization as well as rising number of middle income population is resulting into drug makers producing inexpensive and affordable medications leading to the market growth. These factors are expected to increase the demand of the pharmaceutical and biotechnology companies leading to an increase in the demand for bioreactors during the forecast period.

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The presence of alternatives to the bioreactors is well recognized for the biologic production. The alternatives are taken into consideration while making a choice for bio process. There exists numerous methods that can be employed at certain instances for viral clearance during upstream and downstream processing. Roller bottles are available with surface areas of 1050cm2. Roller bottles with expanded inner surfaces have become available which has made handling large surface area bottles more manageable. The other alternative to bioreactors is availability of disposable multi-layer vessels for simple and rapid scale-up of anchorage dependent cells with little or no process optimization. These include triple layer flasks which are useful for maximizing incubator space, however it is vessels such as CellStacks and Hyperflasks that offer the greatest advantages. Hence, the availability of alternatives for bioreactors are expected to offer hindrance to the growth of the market during the coming years.

Advancement in the field of bioreactors and biotechnology has enhanced the market. Many industry players have come up with innovative types of bioreactors in last few years. The advancement in the bioreactors has led to the faster and easier production of the bio products, and reduced the cost of production. In addition, the investments from public and private investors are rising for the bioreactors. The rise in the investment are enabling technological developments and standard biological parts. For instance, in April 2018, Sartorius Stedim Biotech launched the advanced mini bioreactor vessel for ambr 250 high throughput (ht) system. The new bioreactor is developed for the growth of adherent cells on micro carriers that will enable rapid, scalable cell culture process development of vaccines. The launch enhanced the portfolio of the company in biotechnology market. Moreover, in July 2017, Pall Corporation (subsidiary of Danaher) launched the mPath bioreactor control system to the biopharmaceutical market. The mPath benchtop bioreactor control system delivers accurate measurement and control of single-use process development-scale bioprocesses.

Advancement in bioreactors has added various solution for most of the industries such as, pharmaceutical, petrochemical, food and agriculture among others. These technological advancement are likely to grow the market in near future. Thus, technological advancements are expected to bring about innovative methods in the market thereby driving the global bioreactors market growth over the forecast years.

Regulatory authorities such as Food & Drug Administration, European Medicine Agency (EMA) and others has consistently shown a tough stance towards pharmaceutical can biotechnology manufacturers. Till date, the FDA's CBER regulations do not mention anything about single?use bioreactors. Any deviations from the registered protocols, demands and requirements of these guidance leads to termination of the clinical trials undertaken by the manufacturers or outsourced organization. Moreover, the recalls for marketed products due to instances recorded for deficit of the promises in the function and performance of the product or therapeutic may tarnish the company's reputation risking its future growth. The stringent regulations enforced by healthcare governing bodies for the bioreactors is expected to decrease the demand of bioreactors market not only in the pharmaceutical sectors but also in the medical device manufacturing capabilities. Moreover, the lack of regulatory framework in the emerging markets such as India manufacturing process is further expected to hinder the growth of the market.

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