(PharmaNewsWire.Com, November 16, 2021 ) The global bioprocess containers (BPCs) market is projected to grow from USD 2.9 billion in 2021 to USD 9.6 billion by 2026, at a CAGR of 26.3% during the forecast period. 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 RD.
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. With the World Health Organization (WHO) officially declared the outbreak of the virus as a pandemic, a mix of established pharmaceutical companies, as well as players in the bioprocess containers market.
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 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.
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 RD and biologics manufacturing is also expected to increase in the coming years.
Despite these advantages, there is a possibility that the plastic materials used for SUS may leach organic compounds or inorganic substances into the processing fluid or the final drug product, which remains a major concern. Such an undesired change could eventually compromise bioprocessing and might significantly impact the safety, quality, and purity of the drug product.
herefore, 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.
As many patented products are going off-patent in the future, companies are falling short of funds to invest in their RD pipelines. According to data published in the Generics and Biosimilars Initiative Journal, around twelve biological products with global sales of more than USD 67 billion will be exposed to biosimilar competition by 2020.
The patent expiry of blockbuster drugs has resulted in increased RD spending by pharmaceutical and biotechnology companies. Patent expiry of biologics leads to increasing RD of biologics and shifts biologics from the pipeline to commercial production.
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