U.S. Pharmaceutical Isolators Market Size, Share & Trends Analysis Report By Type (Open Isolator, Close Isolator), By Pressure (Positive Pressure, Negative Pressure), And Segment Forecasts, 2020 - 2028

Report Overview

The U.S. pharmaceutical isolators market size was estimated at USD 130.4 million in 2020 and is expected to expand at a compounded annual growth rate (CAGR) of 5.8% from 2020 to 2028. The growth is expected to be driven by the rapid growth of the pharmaceutical industry coupled with advancements in technologies used in the pharmaceutical industry.

The COVID-19 pandemic has boosted the demand for drug manufacturing and has increased the demand for aseptic process manufacturing. Furthermore, the increasing requirement for equipment that allows the containment of pharmaceutical processes has brought isolators to the forefront. The demand for pharmaceutical isolators on a small scale and the possibility of faster lead times have given a new boost to market growth.

The COVID-19 pandemic has boosted demand for smaller batch processing systems that helps save costs and reduce batch contamination. Furthermore, the U.S. is focusing on domestic competitiveness and has prioritized ‘reshoring’ of pharmaceutical manufacturing to reduce dependence on China which is expected to boost the market growth in the country.

Pharmaceutical isolators are used extensively in pharmaceutical manufacturing facilities since they provide tight enclosures, which maintain aseptic conditions and ensure worker safety. It eliminates the changing areas required in cleanrooms, aids in keeping the operating costs low and eliminates the need for personal protective equipment.

Fill-finish manufacturing of prefilled syringes and development of new drugs, generic medicines, and biosimilars, coupled with stringent government regulations related to controlling the quality of medicines and ensuring the deployment of good manufacturing practices are factors expected to augment the demand for pharmaceutical isolators in the U.S.

Rapid developments in the pharmaceuticals and healthcare industries have led to the increased development of modern therapies. Continuous progress in gene therapies has improved the demand for batch development of treatment methods for a small and specific population thereby boosting the demand for pharmaceutical isolators in the U.S.

Type Insights

The open pharmaceutical isolator led the market and accounted for the largest revenue share of 61.5% in 2020. Open isolators are different from closed isolators as they are designed for continuous or semi-continuous egress and/or ingress of materials during operation through one or more openings while maintaining a protective internal environment.

Open isolators have openings to the surrounding environment that are cautiously engineered to separate the inner isolator environment from the surrounding room. The equipment is utilized for the aseptic filling of pharmaceutical products. For maintenance operations on this isolator type, products do not necessarily have to be sterile.

The demand for closed isolators is projected to witness a CAGR of 5.5% over the forecast period. The equipment can operate without personnel access to the critical zone, making them capable of levels of separation between the external and internal environment unattainable with other technologies.

Closed isolator systems eliminate external contamination from the system’s interior by undertaking material transfer through auxiliary equipment to aseptic connection, rather than the usage of openings to the surrounding environment. Closed systems are sealed throughout operations.

Pressure Insights

The positive pressure segment led the U.S. pharmaceutical isolators market and accounted for the largest revenue share of 53.9% in 2020. Positive pressure isolators protect the process while negative pressure isolators protect the person. In positive pressure, the pressure inside the containment system is larger than that outside.

Positive pressure systems are utilized in the pharmaceutical industry to maintain process integrity. In the pharmaceutical industry, these systems are utilized in sterile processes when the process is of particular significance, and keeping any contaminants or germs out of the isolator is a priority.

The negative pressure segment is projected to witness a CAGR of 5.4% over the forecast period. Negative pressure pharmaceutical isolators are utilized to protect the environment and the operator from a wide range of active ingredients, volatile drugs, and hazardous molecules.

In negative pressure isolators, the air pressure outside is higher than the pressure inside the isolator. This is accomplished by running the inlet air at 10-30% lower than the supply air. Negative pressure is sustained from -30 to -20 Pa so that it stops particles from evading the isolator.

Key Companies & Market Share Insights

The competitive environment in the market is driven by innovations in technology for the use of isolators. Companies operating in the market are investing heavily in R&D as well as developing instruments to optimize production and improve the efficiency of bio-decontamination systems.

Manufacturers in the market have been focusing on technological advancements and integrating Artificial Intelligence (AI) and Industry 4.0 into their product offerings. In addition, increasing collaborations with contract manufacturers are expected to result in high competitive rivalry over the coming years. Some of the prominent players in the U.S. pharmaceutical isolators market include:

• COMECER S.p.A.

• LAF Technologies

• Iso Tech Design

• Nuaire

• Getinge AB

• SKAN AG

• M. BRAUN INERTGAS-SYSTEME GMBH

• I.M.A. SpA

• AZBIL TELSTAR, S.L.U.

• Syntegon Technologies GmbH

U.S. Pharmaceutical Isolators Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at country level and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this study, Grand View Research has segmented the U.S. pharmaceutical isolators market report on the basis of type and pressure:

• Type Outlook (Revenue, USD Million, 2017 - 2028)

  • Open Isolator

  • Closed Isolator

• Pressure Outlook (Revenue, USD Million, 2017 - 2028)

  • Positive Pressure

  • Negative Pressure