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Open System Isolator Market Share

ID: MRFR//5053-HCR | 85 Pages | Author: Rahul Gotadki| November 2024

When manufacturing pharmaceutical products that contain powerful active ingredients like cytostatic, hormones, and antibiotics, it's essential to have safe conditions to protect the workers and ensure the quality of the final product. Isolators are special systems that provide a more sterile environment compared to regular cleanrooms. They are used for making injectable medicines and high-potency drugs. Isolators are either sealed or have air supplied through a filter system that captures microorganisms (HEPA minimum).

In regular cleanrooms, even though they are sanitized, there is still a chance of contamination brought in by the workers. However, inside an isolator, there is a completely decontaminated environment where only the necessary drugs and materials come into contact with the processing system. This decontamination is done using vaporized hydrogen peroxide (H2O2), which eliminates all microorganisms. The process is automated, ensuring consistent and thorough decontamination of the isolator's interior. As a result, isolators have a higher level of sterility assurance compared to regular cleanrooms because of the repeated and rigorous decontamination process.

The advantages of isolators over regular cleanrooms have led to their increasing use in the pharmaceutical industry. The growing adoption of isolators for handling potent products is driven by their superior ability to maintain sterility. This creates a favorable environment for the market to expand as pharmaceutical companies prioritize the safety and quality of their products.

In conclusion, isolators provide a highly sterile environment for making pharmaceutical products with potent active ingredients. They offer advantages over regular cleanrooms, such as higher sterility assurance. Inside an isolator, the environment is completely decontaminated, and only the necessary drugs and materials come into contact with the processing system. This is achieved through the automated decontamination process using vaporized hydrogen peroxide. The increasing use of isolators in the pharmaceutical industry is due to their ability to maintain high levels of sterility. This trend presents opportunities for market growth in the pharmaceutical isolator sector.

Covered Aspects:

Report Attribute/Metric Details
Base Year For Estimation 2022
Historical Data 2021
Forecast Period 2030
Growth Rate 8.30

Open System Isolator Market Scenario


Open System Isolator Market Size was valued at USD 8.40 Billion in 2023. The Open System Isolator industry is projected to grow from USD 9.21 Billion in 2024 to USD 17.69 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.5% during the forecast period (2024 - 2032).

Pharmaceutical isolators are used to eliminate the risk of contamination and essential in many manufacturing and research activities. Open system isolators are commonly used in the pharmaceutical and biotechnology industry to maintain the aseptic environment and to protect the operator from hazardous elements. The growing pharmaceutical industry and increasing number of drug manufacturers, increasing research and development activities and stringent policies implemented by government and regulatory authorities to maintain the safety and efficacy of the drug are contributing to the growth of the market. According to the International Federation of Pharmaceutical Manufacturers & Associations global pharmaceutical industry will achieve the target of USD 1,430 billion by 2020.

The high costs of Open System Isolators, availability of other substitutes and scarcity of technicians may hamper the growth of the market during the assessment period.

 

Segmentation

The global open system isolator market has been segmented on the basis of pressure, application, and end-user.

On the basis of pressure, the market has been divided into positive pressure isolators and negative pressure isolators.

The market, by application, has been divided into fluid dispensing isolators, aseptic filling isolators, product contaminants isolators, sampling/weighing/distribution isolators, and others   

The market, by end-user, has been segmented into pharmaceutical and biotechnological industries, academic & research institutes, hospitals and diagnostic laboratories, and others.

 The market has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The open system isolator market in the Americas has further been segmented into North America and South America, with the North American market divided into the US and Canada.

The European open system isolator market has been segmented into Western Europe and Eastern Europe. Western Europe has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe. 

The open system isolator in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The open system isolator market in the Middle East & Africa has been segmented into the Middle East and Africa.

Regional Market Summary


Global Open System Isolator Market Share, by Region, 2017 (%)


Open System Isolator Market Share


Source: MRFR Analysis


The Americas are likely to hold the first place in the global open system isolator market due to the presence of well-established pharmaceutical industry, technological advancement in the region and adoption of high technology, and presence of strict government policies in the region.  According to the International Trade Administration (ITA), in 2015, the biopharmaceutical industry in the US spent more than USD 75 billion on research and development activities, which is half of the global biopharma R&D spending.


The European market is expected to be the second-largest open system isolator global market. The market growth in this region is the result of an increasing number of research and development activities in the region, growing concern about the safety of the drug and increasing inspections by regulatory authorities. The contribution of Germany and France is noticeable in the growth of European open system isolator market. For instance, according to the report published by Germany Trade & Invest in 2017, the German pharmaceutical market was worth USD 45 billion (2017) and is the largest market in Europe and holds fourth place in the global pharmaceutical industry.


Asia-Pacific is expected to be the fastest-growing open system isolator global market during the forecast period owing to the presence of a strong generics market and increasing export of generic drugs from the countries like China and India. For instance, according to the Indian Brand Equity Foundation (Ministry of Commerce & Industry, Government of India), Indian companies exported pharmaceuticals worth USD 17.27 billion during 2017 to 2018 which is expected to grow at a rate of 30% to reach USD 20 billion by 2020.


The market in the Middle East & Africa is expected to account for the smallest share of the open system isolator global market due to poor infrastructure and slow development of the healthcare sector.


Key Players


Some of the key players in the open system isolator are Gelman Singapore Pte Ltd, COMECER S.p.A. cf. p.iva, IsoTech Design, LAF Technologies Pty Ltd, Fedegari Autoclavi S.p.A, Hosokawa Micron Ltd, Robert Bosch GmbH, MBRAUN, Schematic Engineering Industries, NuAire Inc, VanRx Pharmasystems Inc, Azbil Telstar, Getinge AB, Skan AG, Chamunda Pharma Machinery Pvt. Ltd., and GERMFREE


Global Open System Isolator Market, by Pressure



  • Positive Pressure Isolators

  • Negative Pressure Isolators


Global Open System Isolator Market, by Application



  • Fluid Dispensing

  • Product Contaminants

  • Sampling/Weighing/Distribution

  • Others


Global Open System Isolator Market, by End-User



  • Pharmaceutical and Biotechnological Industries

  • Academic & Research Institutes

  • Hospitals and diagnostics laboratories

  • Others


Global Open System Isolator Market, by Region


Americas

  • North America

  • US

  • Canada

  • South America


Europe

  • Western Europe

  • Germany

  • France

  • Italy

  • Spain

  • UK

  • Rest of Western Europe

  • Eastern Europe


Asia-Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Rest of Asia-Pacific


Middle East & Africa

  • Middle East

  • Africa


Intended Audience



  • Open System Isolator Manufacturers

  • Open System Isolator Distributors and Suppliers

  • Healthcare Providers and Diagnostic Laboratories

  • Pharmaceutical and Biotechnology companies

  • Research Institutes and Academic Centers

  • Contract research organizations (CROs)

  • Market Research and Consulting

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