Growth in the bioprocess containers market is mainly driven by factors such as the growing biologics market, affordability and sustainability of single-use bioprocess technologies, and rising biopharmaceutical R&D. Emerging countries and the patent expiry of biologics are expected to offer growth opportunities for players operating in the bioprocess containers market during the forecast period.
COVID-19 is an infectious disease caused by the most recently discovered novel coronavirus. Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has since moved from being a regional crisis to a global pandemic.
Since most of the leading COVID-19 vaccine programs are using novel approaches, including mRNA, DNA vaccine, and vectors, these platforms are largely built on single-use technology. Most of the pandemic-related new facilities are largely engaging single-use systems due to their flexibility combined with high speed and much lower capital investment compared to traditional stainless steel equipment.
The 2D bioprocess containers segment accounted for the largest share of the type segment in the bioprocess containers market in 2020.
On the basis of type, the bioprocess containers market is segmented into 2D bioprocess containers, 3D bioprocess containers, and other containers and accessories. In 2020, the 2D bioprocess containers segment accounted for the largest share of the bioprocess containers market. 2D bioprocess containers are frequently used in cell harvesting and for the transportation of bulk drug products and bulk drug precursors.
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The pharmaceutical & biopharmaceutical companies segment accounted for the largest share of the end user segment in the bioprocess containers market in 2020.
On the basis of end user, the bioprocess containers market is segmented into pharmaceutical & biopharmaceutical companies, CROs & CMOs, and academic & research institutes. In 2020, the pharmaceutical & biopharmaceutical companies segment accounted for the largest share of the bioprocess containers market. The demand for biopharmaceuticals among the senior population is increasing as the elderly are more prone to various diseases/disorders that can be treated using biologics.
The growth of single-use technologies can be attributed to the growing need for better, cheaper, and faster biologics production. Active development of individualized biologics and personalized medicines, including patient-specific cellular & gene therapies and therapeutic vaccines, demands high sterility and is therefore manufactured using single-use equipment and consumables.
In 2020, the US FDA approved 53 new medicines and therapeutic biologics (Source: US FDA). Growth in the biologics market is mainly driven by monoclonal antibodies and human insulin, which are among the leading contributors to the bioprocess containers market.
Additionally, the Centre for Biologics Evaluation and Research’s (CBER) (2021-25) strategic plan involves various schemes for boosting the growth of the biologics market. With increasing growth in the biologics market, the number of bioprocess containers needed for R&D and biologics manufacturing is also expected to increase in the coming years.
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Extractables are compounds that can be extracted from source materials using appropriate solvents under vigorous laboratory conditions, while leachables are compounds present in drug products caused by leaching from containers, closures, and processing components. Therefore, leachables can be considered a subset of extractables.
Extractables and leachables are commonly associated with polymeric and elastomeric materials due to the use of additives to increase stability and aid in the formation of material components.
According to a survey conducted by BioPlan Associates in 2018, 73.3% of respondents agreed that leachables and extractables are major concerns that may limit the use of bioprocessing in the near future. As single-use assembly products are made of processed plastic materials, they often face the problem of contamination from the container due to leachables.
bioprocess containersSartorius Stedim Biotech (France), Thermo Fisher Scientific (US), Danaher Corporation (US), and Merck Millipore (Germany).