DUBLIN–(BUSINESS WIRE)–The “Global Pharmaceutical Isolator Market Forecast to 2028 – COVID-19 Impact and Global Analysis By Type (Open Isolator and Closed Isolator), Pressure (Positive Pressure and Negative Pressure), Configuration, Application, and End User; and Geography” report has been added to ResearchAndMarkets.com’s offering.
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.
Reasons to buy
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Market Dynamics
Drivers
- Increase in Investments by Pharmaceutical and Biotechnology Industry
- Regulatory Framework to Support Adoption of Pharmaceutical Isolators
Restraint
- High Cost Involved in Operation and Maintenance of Pharmaceutical Isolators
Opportunities
- Growing Pharmaceutical and Biotechnological Industries in Emerging Economies
Future Trends
- Adoption of Automation in Pharmaceutical Isolator
Companies Mentioned
- ITECO S.R.L.
- Schematic Engineering Industries
- Nuaire Inc.
- Comecer
- Getinge AB
- Hosokawa Micron Group
- Fedegari Autoclavi S.p.A.
- Azbil Telstar
- Gelman Singapore
- Bioquell (Ecolab Solution)
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