Single-use bioprocessing system is a disposable bioprocessing process in which the systems such as disposable bioreactor, single-use bags, and disposable filters are disposed after use instead of cleaning or sterilization. Single-use systems are majorly adapted in upstream and downstream bioprocessing, owing to its benefits over conventional bioprocessing systems, which includes reduction of cost, increased speed of implementation, and reduced risk of cross-contamination. Moreover, increasing adoption of single-use bioprocessing systems, increasing investment in research and development (R&D) sector by various government and private organizations, increasing demand for single-use systems in biopharmaceutical sector and increasing number of key players offering technologically advanced bioprocessing products are projected to augment growth of the single-use bioprocessing systems market over the forecast period.
The global single-use bioprocessing systems market was valued at US$ 2.80 billion in 2018, and is expected to witness a CAGR of 17.2% over the forecast period (2018 – 2026).
Fig: Global Single-use Bioprocessing Systems Market Share (%), By Product Type
Source: Coherent Market Insights Analysis (2018)
Increasing Adoption of Single-Use Bioprocessing Technologies is expected to Drive Growth of the Single-use Bioprocessing Systems Market
Increasing demand for biologics, need for production capacity expansion, patent expiry of blockbuster molecules, and a limited number of potential products in the pipeline have driven the companies to adopt new technologies such as single-use bioprocessing systems. Single-use equipment offers various benefits making biomanufacturing process more efficient and cost effective. Single-use technologies is a rapidly evolved and adopted owing to their ability to offer significant cost reduction, ease of disposable, time saving, less energy and water demand for bioprocessing process, reduced risk of contamination and increase in productivity. Moreover, single-use bioprocessing systems reduces the initial investments and research and development (R&D) cost involved in the manufacturing of biologics and biopharmaceuticals. Conventional manufacturing of biopharmaceuticals and biologics involves use of stainless steel-based bioreactor and their subcomponents. Most of these products require sterilization and associated units for manufacturing contamination-free bio-products and biologics, which significantly increases overall investment cost. Moreover, according to the data published in Bioprocess International Journal in December 2015, single-use bioprocessing systems eliminate additional investment cost, as sterilization is not required. This lower around 40% of investment costs compared to stainless steel facility.
Furthermore, increasing research and development investment by various government and private organizations in therapeutic, biopharmaceutical, and clinical diagnostics area is expected to propel demand for efficient and cost-effective bioprocessing pilot study plants designed with single-use bioprocessing technologies. For instance, according to Farmaindustria: the National Business Association of the Pharmaceutical Industry in Spain, pharmaceutical companies in Spain invested US$ 1,154.7 million in research and development activities in 2014. Among these total amount invested, more than half of the amount (US$ 591.9, 51.26%) was allocated to fund clinical trials, which is the 63% increase in investment over the last decade (2004 to 2014).
Furthermore, National Cancer Institute (NCI) invested US$ 749.8 million, US$ 769.2 million and US$ 801 million on cancer related clinical trials in 2014, 2015, and 2016, respectively. Moreover, according to the World Intellectual Property Indicators 2017 report, Asia (64.6%) accounted to register highest percentage of patent applications for 2016, followed by North America (20.5%), Europe (11.3%), Latin America and the Caribbean (2%), Oceania (1.1%), and Africa (0.5%). According to the same source, in 2016, China registered highest number of patents (1,338,503 patent applications), with 21.5% annual growth. Moreover, increasing R&D activities coupled with increasing adoption of disposable systems is expected to drive growth of single-use bioprocessing systems market.
Increasing Demand for Biopharmaceuticals is Driving Growth of Single-use Bioprocessing Systems Market
Single-use bioprocessing systems are increasingly adopted by biopharmaceutical industry owing to their increased efficiency, low cost investment, and low maintenance, with significant time savings during bioprocessing process. For instance, according to the Office for National Statistics(ONS): 2014 Business Enterprise Research and Development data findings, in 2013, the pharmaceutical industry in U.K. accounted for 22% of all research and development (R&D) expenditure, investing around US$ 6.76 billion. According to The International Trade Administration (ITA), the U.S. accounted for the largest market for biopharmaceutical sector, accounting for 17% of all domestic research and development (R&D) funded by U.S. private organizations, with added an estimated US$ 1.2 trillion in economic output in 2014. Furthermore, according to the 14th Annual report and Survey of Biopharmaceutical Manufacturing report: 2017, biopharmaceutical industry exhibit an overall consistent 14-15% industry growth. Moreover, increasing investment by various government organizations to boost the biopharmaceutical industry is expected to increase the demand for biopharmaceutical; thereby accelerating demand for single-use bioprocessing systems in near future. For instance, in June 2017, Ministry of Science and Technology, India; launched US$ 250 million program to promote the production of biological drugs and thereby boost India's biopharmaceutical industry.
However, extractability and leachability issues related to single-use bioprocessing systems is expected to hinder the growth of single-use bioprocessing systems market over the forecast period. Single-use systems bioreactors are more susceptible to problems associated with compound leaching into the bioprocessing fluid as compared to conventional stainless steel bioreactor. Leachables are any compounds, both organic or inorganic that migrate into drug product formulations from the container closure as a result of direct contact with the formulation. With the rapid expansion of single-use systems for bioprocessing, plastics-based bioprocessing reactors are extensively used in biopharmaceutical production. According to the data published in American Pharmaceutical Review Journal in December 2017, leachables from single-use bioprocessing assemblies can adversely affect cell culture performance. Furthermore, excessive quantities of leached bDtBPP were shown to be toxic to various array of cell lines. Moreover, evaluation of leachables to reduce patient safety risks is necessary during single-use bioprocessing.
Key players operating in single-use bioprocessing systems market include Compagnie de Saint-Gobain S.A., Thermo Fisher Scientific Inc., Applikon Biotechnology BV, Parker-Hannifin Corporation, Sartorius AG, Eppendorf AG, Danaher Corporation, Merck KGaA, and General Electric Company.