Market Trends of Bioprocess Validation Industry
Bioreactor Expected to Hold Significant Market Share
The pharmaceutical sector uses bioreactors for the manufacture of medicines, vaccines, and other components. Bioreactors are also used for the production of monoclonal antibodies for the treatment of cancer, rheumatoid arthritis, and other diseases. Bioreactors have been utilized in many different areas of industry and research and for the progression of in vitro models of 2D cultures and suspensions to 3D constructs, mimicking the natural physiological state in situ.
In the pharmaceutical sector, bioreactors are used to hold organisms for the purpose of harnessing their natural biochemical processes. Bioreactors are designed to allow microorganisms to thrive, causing the contents of the tank to ferment and creating a usable end product. In a batch bioreactor, everything is added at once to a controlled and sealed environment, and the biochemical reactions are allowed to run their course before the reactor is opened so that the contents can be extracted and utilized, disposed of, or further processed. Others operate on a continuous flow method, in which materials constantly flow through the bioreactor.
According to the OECD, 2021, the gross domestic expenditure towards R&D was 12.5% in Germany, 12.4% in France, 11.5% in Austria, 11.4% in Sweden, and 11.3% in Norway. Hence, the increasing research and development activities is driving the usage of various bioprocess valadation devices such as bioreactors, thus elevating the segment growth.
For instance, in April 2020, researchers from Ology Bioservices and Univercells SA announced that they had developed a high-yield live-virus vaccine production platform by using a novel fixed-bed bioreactor in a paper published in the 'Vaccine' magazine. The scientists from these companies further stated that their bioreactor platform allows for a cost-effective and scalable process for viral vaccine production. Initiatives such as these are expected to boost segment growth.
In addition, as per the article published by researchers from Denmark in June 2021 under the title 'SARS-CoV-2 Production in a Scalable High Cell Density Bioreactor', researchers have established a process for COVID-19 vaccine manufacturing in Vero cells cultivated in a single-use tide-motion bioreactor (CelCradle 500-AP), one of the few scalable packed-bed bioreactors available and an attractive option for large-scale cost-effective production.
Therefore, the rising demand and use of bioreactors for applications in the pharmaceutical sector are expected to boost the innovation and usage of bioreactors, thus propelling the segment growth.
North America to Hold a Significant Market Share
North America holds a significant share in the bioprocess validation market owing to the increasing number of R&D activities and investments as well as rising demand for biopharmaceuticals and increasing demand for outsourcing bioprocess validation.
According to a report published in September 2021 by the Pharmaceutical Research and Manufacturers of America (PhRMA), in the last decade, biopharmaceutical companies invested more than USD 1 trillion in research and development, including a record-breaking year in 2020, where PhRMA member companies invested about USD 91 billion in research and development. Outsourcing drug development helps biotechnology firms properly utilization of their resources and limit financial risks. As a result, the bioprocess validation market is anticipated to grow over the forecast period.
In September 2022, The US government invested over USD 2 billion to launch its biomanufacturing initiative, which aims to expand manufacturing capacity in the country and ensure pandemic preparedness. Around USD 20.6 million from the initiative will be distributed to the independent, nonprofit Manufacturing Innovation Institute BioMADE to support nine tech and innovation projects. Thus, such funding is expected to increase the growth of clinical research institutes in the country which is expected to increase segmental growth.
Thus, owing to the abovementioned factors, the market is expected to show growth over the forecast period.
