The pharmaceutical isolator market was valued at 5,966.07 million in 2021 and is projected to reach US$ 10,560.30 million by 2028; it is expected to grow at a CAGR of 8.5 % from 2021 to 2028. The growth of the pharmaceutical isolator market is attributed to factors such as an increase in investments by the pharmaceutical and biotechnology industry and a regulatory framework to support the adoption of pharmaceutical isolators. However, the market is likely to get impacted by the high cost involved in the operation and maintenance of pharmaceutical isolators.
A pharmaceutical isolator is a device that keeps a pharmaceutical process or activity isolated from the operator and the rest of the world.This might be for the aim of safeguarding a process or activity from microbiological and/or nonviable contamination caused by the operator and the surrounding environment by creating a classified clean or classified aseptic environment.
This is referred to as product protection.Moreover, it can be used in protecting the operator and the surrounding environment from hazards arising from the process or activity.
This is referred to as “operator protection” or “containment.”
A pharmaceutical isolator offers a superior sterile environment than conventional clean rooms.Positive or negative pressures inside the chamber prevent contamination due to operator interference.
It ensures long-lasting sterility in accordance with pharmaceutical regulations related to the manufacturing of sterile medical products.Moreover, most of the experts agree that regulatory agencies are no longer impeding progress when it comes to technologies such as pharmaceutical isolators.
The guidelines set by the US Food and Drug Administration (US FDA) and the European Medicines Agency regarding isolators play an important role in the adoption of isolators in comparison to cleanrooms.FDA mentions isolators 55 times in its latest guideline of manufacturing in an aseptic environment.
A well-designed positive pressure isolator, supported by adequate procedures for its maintenance, monitoring, and controls, offers significant advantages over traditional aseptic processing, including fewer opportunities for microbial contamination during processing. Moreover, FDA acknowledges the removal of operators in the critical areas of pharmaceutical manufacturing, which is expected to propel the adoption of pharmaceutical isolators in the coming years. Trend analysis shows an increasing number of pharmaceutical facilities using isolator technology in the US. In 1998, only 84 facilities were equipped with aseptic filling in isolators. This number increased to 174 facilities in 2000, 201 in 2002, and 258 in 2004. The growth in the number of facilities offering aseptic processing is related to the growth in the production of high-potency drugs. Hence, a supportive regulatory framework will increase the adoption of pharmaceutical isolators and subsequently drive the market. The COVID-19 pandemic has become the most significant challenge across the world.It has disturbed various trades and businesses across the world.
However, the pandemic has brought several growth opportunities to the pharmaceutical and biopharmaceutical companies to strengthen their research and development for innovating vaccines against the novel coronavirus.The companies are performing clinical trials to curb the spread of the COVID-19 virus.
Thus, increased clinical trials will lead to vital opportunities for the pharmaceutical isolator providers for biopharmaceutical companies. Based on type, the pharmaceutical isolator market is segmented into open isolator and closed isolator. The open isolator segment held a larger share of the market in 2021, and the same segment is anticipated to register a higher CAGR in the market during the forecast period.
Based on pressure, the pharmaceutical isolator market is segmented into positive pressure and negative pressure. In 2021, the positive pressure segment held a larger share of the market; however, the negative pressure segment is expected to grow at the fastest rate during the forecast period.
Based on configuration, the pharmaceutical isolator market is segmented into floor standing, modular, mobile, compact, tabletop, and portable.The floor standing segment is likely to hold the largest share of the market, and the same segment is anticipated to register the highest CAGR in the market during the forecast period.
Growth of the floor standing segment is attributed to improved efficiency, coupled with more quick operations.
Based on application, the pharmaceutical isolator market is segmented into aseptic isolators, containment isolators, sampling and weighing isolators, fluid dispensing isolators, and others.The aseptic isolator segment is likely to hold the largest share of the market.
Also, the same segment is anticipated to register the highest CAGR in the market during the forecast period.
Based on end user, the pharmaceutical isolator market is segmented into hospitals, pharmaceutical and biotechnology companies, research and academic laboratories, and others. The pharmaceutical and biotechnology companies’ segment is likely to hold the largest share of the market, and the same segment is anticipated to register the highest CAGR in the market during the forecast period. The European Union, National Health Service, The Food and Drug Administration, The World Health Organization, National Center for Biotechnology Information, Pharmaceutical and Medical Devices Agency, and Organization for Economic Co-operation and Development are among the major primary and secondary sources referred to while preparing this report.
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