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Single-use systems noticeably lower probabilities of cross-contamination, thereby maintaining product integrity and purity. Better operational efficiency is guaranteed with 0% sterilization and washing between the batches.
Additionally, higher production flexibility is offered with single-use technology, thereby allowing the manufacturers to adapt to the altering market demands. This flexibility is of gret use in upstream bioprocessing, wherein even a slight change in manufacturing volume can result in efficient usage of the resources, which could also be equated with cost of operation.
By outsourcing, the bioprocessing companies can really build upon and refine their core competencies, while achieving cost savings and greater efficiency. However, in recent years, there has been a marked trend toward large manufacturers hiring CMOs to proceed with their manufacturing aspects, so they can focus on the development of new products.
Lately, CMOs have begun increasingly integrating single-use technologies into bioprocessing to address pressing challenges such as speeding up processes and simplifying process changeovers, hence presenting another promising growth avenue for the market.
Expanding upstream bioprocessing is foremost exerted upon by increased investment in research and development (R&D) by the pharmaceutical industry. With practically elevated capital in R&D by biopharmaceutical companies, drug development pipelines have essentially grown in scale and diversity, with over 23,000 drug candidates in development and more than 10,000 at different stages of clinical trials.
The resultant accumulation of R&D activities calls for timely upstream bioprocessing services needed to accommodate the discovery and production of complex biologics, biosimilar, and advanced therapies such as cell and gene therapies.
Modern biologicals are becoming more complex and thus require more technical and flexible upstream processes to produce high yields and maintain consistent product quality through the implementation of intermediate-process-control.
Advanced cell culture systems and bioreactor design have played the major roles in facilitating such advancement. Disposable bioreactors and disposable components eliminate the need for cleaning and validation, allowing companies to switch and produce diverse and customized biologics with ease. This is important as the industry is responding to rising demand for personalized medicine and biosimilar, which require smaller batch sizes and faster product changeovers.
The bioreactor product market segment is dominating the upstream bioprocessing market with its central and key role of growing and maturing the cells and the microorganisms, the very foundation of biopharmaceuticals manufacturing.
Bioreactors create the conditions for maximum cell growth with the ability to accurately control pH, temperature, oxygen, and feed nutrients, all of which are needed to produce high concentrations of biologics such as monoclonal antibodies, vaccines, and recombinant proteins.
Large-scale product development and innovation by industry leaders are also the reasons behind leadership in bioreactor market share. Examples include launching innovative single-use bioreactors such as Getinge's AppliFlex ST GMP, employed in clinical gene and cell therapy and mRNA production.
Automated and single-use bioreactors are more adaptive, lower the risk of cross-contamination, decrease turnaround time and are particularly in demand for large-scale and customized medicine production.
North America dominates the upstream bioprocessing market because of a myriad of elements that render the environment particularly favorable for commercialization, production, and innovation of bioprocessing.
It holds around 40% of the total global market share spearheaded by its healthy biopharmaceutical industry, disproportionate R&D expenditure, and highly developed healthcare infrastructure.
Market leadership in the region by large pharma and biotech companies, centralized research institutes, and universities facilitate relentless innovation and coordination, hence driving progress in upstream bioprocessing technology.
Governmental spending is among the drivers of market leadership of North America. For example, Federal Governments such as the U.S. government and its Department of Health and Human Services annually invests billions of dollars in R&D, which fund vaccine manufacturing, drug discovery, and clinical trials all relying on upstream bioprocessing.
This investment allows firms to expand capacity and install next-generation technologies like single-use bioreactors, continuous processing, and automation with resulting increased efficiency and scalability.
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Upstream Bioprocessing Market
