ID: MRFR/Pharma/3262-CR | 117 Pages | Published By Rahul Gotadki on March 2023
Pharmaceutical Isolator Market size was valued at USD 6.54 billion in 2021. The pharmaceutical isolator market industry is projected to grow from USD 7.16 Billion in 2022 to USD 14.88 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 9.57% during the forecast period (2022 - 2030). The rising demand for pharmaceutical isolators across booming pharmaceutical & biotechnological sectors, and growing R&D Initiatives in the pharmaceutical industry are driving the market growth.
Source Secondary Research, Primary Research, MRFR Database and Analyst Review
Pharmaceutical Isolator Market Trends
A pharmaceutical isolator is a decontaminated unit supplied with an air of 100 (ISO 5) or improved quality, allowing for complete and continuous isolation of its interior from its external environment. In recent years, pharmaceutical isolators have witnessed a robust demand due to the wide range of applications in the pharmaceutical & biotechnological sector for production & control purposes such as microbiological tests, cell therapy processing, in production of advanced therapy medicinal products (ATMP), and for handling & transferring of drugs.
Moreover, the pharmaceutical isolator is increasingly significant in the pharmaceutical & biotech industry. It aids in reducing operating costs and enhancing production run capability. In addition, the pharmaceutical isolator takes up less space and may require less maintenance. They also have low operating expenses. Thus, the rising demand for pharmaceutical isolators across booming pharmaceutical & biotechnological sectors is projected to boost the market growth during the forecast period.
Pharmaceutical Isolator Market Segment Insights
Pharmaceutical Isolator Type Insights
The Pharmaceutical Isolator Market segmentation, based on type, includes open isolator and closed isolator. The open isolator segment held the majority share in 2021 in the Pharmaceutical Isolator Market revenue. This is due to the open isolator systems allowing the continuous or semi-continuous ingress and egress of materials during operations through one or more openings. These openings are designed and validated to preclude the transfer of contamination by maintaining the pressure gradient at all times. Furthermore, these openings act as a significant control measure in preventing staff exposure to cytotoxic substances, some of which could be carcinogens. Additionally, it also protects the material from microbiological contamination during drug fabrication.
February 2021 Cytiva(US) acquired Vanrx Pharmasystems(Canada), a Canadian company that makes robotic aseptic filling machines to fill vials, syringes, and cartridges with reduced risk and increased speed to patients. Due to this strategy, Cytiva acquired Vanrx's flagship products such as Microcell Vial Filler and SA25 Aseptic Filling Work cell. These devices can automate aseptic filling using robotics within closed and gloveless isolators.
Pharmaceutical Isolator, product type Insights
The Pharmaceutical Isolator Market segmentation is based on the product type that includes, sterility test isolator, process isolator, and decontamination pass box. The sterility test isolator segment has dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2022-2030. This is attributed to the sterility test isolators allowing operators to conduct sterility testing in an aseptic environment, ensuring the procedure's integrity. In addition, they further offer controlled means of loading and unloading the processed product and waste materials from the isolator enclosure. In addition, according to the article published by Ecolab in October 2021, the adoption of isolators for sterility testing minimizes the chance of a false-positive test result. Obtaining sterility test isolators to avoid the risk of both false positive and false negative results on sterile drugs before releasing them to patients is driving the segment growth.
Pharmaceutical Isolator, product class Insights
The Pharmaceutical Isolator Market segmentation is based on product class that includes, ISO class 3 and ISO class 5. ISO Class 5 segment has dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2022-2030. This is attributed to the ISO cleanliness standards are based upon a room’s particle levels within a given area and are measured according to the size and quantity of particles per air volume. Moreover, the increased availability of equipment adhering to regulatory standards is driving market growth.
Figure 2 PHARMACEUTICAL ISOLATOR MARKET, BY PRODUCT CLASS, 2021 & 2030 (USD BILLION)
Source Secondary Research, Primary Research, MRFR Database, and Analyst Review
Pharmaceutical Isolator, Application Insights
The Pharmaceutical Isolator Market segmentation is based on application that includes, sterility testing, sampling/weighing/distribution, animal laboratories, aseptic tissue handling/microbiology testing/pathogenic sampling, defiltration and drying, and others. The sterility testing segment has dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2022-2030. Sterility testing is a Good Manufacturing Practice (GMP) microbiology testing is required to confirm that the sterile products do not contain viable micro-organisms before release and patient administration. Moreover, sterility testing methods must be as accurate as possible for their significance for pharmaceutical products, medical devices, formulations, tissue materials, and other products that claim to be sterile or free from viable microorganisms.
Pharmaceutical Isolator End User Insights
The Pharmaceutical Isolator Market segmentation is based on end-user that includes biopharma/cell & gene therapy companies, academic & research institutes, hospitals, and contract research organization & contract manufacturing organization. The biopharma/cell & gene therapy companies segment has dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2022-2030. This is due to the increasing applications of isolators in various sectors and stringent regulatory authorities to maintain the safety and efficacy of drugs. In addition, Companies related to pharmaceuticals and biotechnology use isolators in the manufacturing process to avoid contamination and to keep operators away from exposure to toxic materials. Furthermore, the increasing concern about maintaining the aseptic environment for manufacturing and research and development of healthcare products are propelling the market's growth
June 2021 SKAN AG (Switzerland) moved into its new headquarters in the Bachgraben area, Allschwil, which is located about 500m airline from the previous location.
Pharmaceutical Isolator Regional Insights
By Region, the study segments the market into North America, Europe, Asia-Pacific, and the Rest of the World. The North American pharmaceutical isolator market is expected to account for USD 4.61 billion in 2021 and is expected to exhibit a 7.28% CAGR during the study period. This is attributed to developed healthcare infrastructure, growing demand for pharmaceutical isolators, low operational cost, and the presence of a large number of market players in the region. In addition, increased usage of sterilized methods related to pharmaceutical isolators contributes to regional market growth.
Further, the major countries studied are the U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3 PHARMACEUTICAL ISOLATOR MARKET SHARE BY REGION 2021 (%)
Source Secondary Research, Primary Research, MRFR Database, and Analyst Review
Europe pharmaceutical isolator market is expected to account for the second-largest market share due to the rise in the demand for pharmaceutical isolators from pharmaceutical and biotechnological industries, high sterility assurance, and low operational costs. Further, the Rest of the Europe pharmaceutical isolator market is held the largest market share, and the UK pharmaceutical isolator market is expected to fastest-growing market, in the European region.
The Asia-Pacific pharmaceutical isolator market is expected to grow at a CAGR of 9.08% from 2022 to 2030. This is due to the growing healthcare expenditures and growing usage of sterilized methods. India pharmaceutical isolator market was the fastest-growing market in the Asia-Pacific region.
For instance, the Coronavirus outbreak in China led to the launch of several drugs to counter the coronavirus (Covid-19). It has also increased contract manufacturing in the country, leading to the growth of the pharmaceutical isolators market. Similarly, in Japan, Gilead's Remdesivir and Fujifilm's antiviral Avigan are in Phase III clinical trials. Thus, with the growing production by the biopharmaceutical industry, the pharmaceutical isolators market is likely to have vital growth opportunities in the forthcoming years for the pharmaceutical isolator market.
The Rest of the World includes the Middle East, Africa, and Latin America. The growing prevalence of chronic disorders or increased focus on R&D proficiencies regarding medical devices significantly contributes to market growth. Furthermore, rising advancements such as portability, connectivity, grabbing the stationary position, growing focus on medical devices sterilization technology, and rising medical tourism are other important factors that will further increase lucrative market growth opportunities in the Middle East, Africa, and Latin America.
Pharmaceutical Isolator Key Market Players & Competitive Insights
The Pharmaceutical Isolator Market is characterized by the presence of many global, regional, and local vendors catering to the demand created by research scientists and pharmaceutical and biotechnology companies operating in the industry. The market comprises tier-1, tier-2, and local players. The tier-1 and tier-2 players have reach across the globe with diverse product portfolios. Companies such as Skan AG (Switzerland), Azbil Telstar s.l.u (Spain), Cytiva (US), and NuAire Inc (US) dominate the Pharmaceutical Isolator Market due to product differentiation, financial stability, strategic developments, and diversified regional presence. The players are focused on investing in research and development. Furthermore, they adopt strategic growth initiatives, such as expansion, product launches, joint ventures, and partnerships, to strengthen their market position and capture a large customer base. Furthermore, manufacturers are entering into agreements with biopharma/cell and gene therapy companies, academic & research institutes, hospitals, and contract research organizations for supply contracts. Therefore, manufacturers develop new products with refined features to increase favorability and stay ahead of their competitors
One of the primary business strategies adopted by software services in the global pharmaceutical isolator industry to benefit clients and expand the pharmaceutical isolator market sector is to services locally to reduce operating costs.
SKAN AG (Switzerland) is a technological leader in cleanroom devices, isolators, and decontamination processes for the aseptic production of biopharmaceutical substances. Its focuses on the design and development of process isolators for the contamination-free filling of biopharmaceutical products. Furthermore, SKAN offers its customers process support, services, and consumables. It markets its products in Europe, North America, Japan, South Korea, Singapore, China, India, and Brazil. Skan has leading research laboratories globally.
Also, Azbil Telstar S.L.U (Spain) operates as a part of the Azbil Group, and it deals with the development of engineering projects, equipment, and services for companies related to life sciences, healthcare, and research. The company operates in over a hundred countries. It has four production plants, seven technology centers, 12 consultancy and engineering services centers, and commercial offices worldwide. It also has manufacturing plants based in China and the UK.
Key Companies in the Pharmaceutical Isolator Market include
Pharmaceutical Isolator Industry Developments
February 2021 Cytiva acquired Vanrx Pharmasystems, a Canadian company that makes robotic aseptic filling machines to fill vials, syringes, and cartridges with reduced risk and increased speed to patients. Due to this strategy Cytiva acquired Vanrx's flagship products such as Microcell Vial Filler and SA25 Aseptic Filling Workcell. These devices can automate aseptic filling using robotics within closed and gloveless isolators.
June 2021 SKAN AG moved into their new headquarters in the Bachgraben area, Allschwil, which is located about 500m air line from the previous location.
June 2020 SKAN AG built new administrative building in Görlitz creating additional office space.
Pharmaceutical Isolator Market Segmentation
Pharmaceutical Isolator Type Outlook
Pharmaceutical Isolator Product Type Outlook
Pharmaceutical Isolator Product Class Outlook
Pharmaceutical Isolator Application Outlook
Pharmaceutical Isolator End User Outlook
Pharmaceutical Isolator Regional Outlook
Rest of the World
|Market Size 2021||USD 6.54 billion|
|Market Size 2022||USD 7.16 billion|
|Market Size 2030||USD 14.88 billion|
|Compound Annual Growth Rate (CAGR)||9.57% (2022-2030)|
|Historical Data||2018 & 2020|
|Forecast Units||Value (USD Billion)|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, and Trends|
|Segments Covered||Type, Product Type, Product Class, Application, End User, and Region|
|Geographies Covered||North America, Europe, Asia Pacific, and the Rest of the World|
|Countries Covered||The U.S, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil|
|Key Companies Profiled||Skan AG (Switzerland), Azbil Telstar s.l.u (Spain), Cytiva (US), NuAire Inc (US), Schematic Engineering Industries (India), MBraun GMBH (Germany), Fedegari Autoclavi S.p.A(Italy), Hosokawa Micron B.V (Netherlands), Syntegon Technology (Germany), Isotech Design (Canada), and Getinge AB (Sweden)|
|Key Market Opportunities||Increasing adoption of pharmaceutical isolators in emerging economies|
|Key Market Dynamics||Rising demand for the pharmaceutical isolators across booming pharmaceutical & biotechnological sectors Growing R&D initiatives in the pharmaceutical industry|
The Pharmaceutical Isolator Market is anticipated to reach USD 14.88 billion at a CAGR of 9.57% during the forecast period of 2022 to 2030.
The U.S. pharmaceutical isolator market is anticipated to reach USD 4.26 billion at a CAGR of 7.19% during the forecast period of 2022 to 2030.
The Pharmaceutical Isolator Market is expected to register a CAGR of 9.57% during the forecast period of 2022 to 2030.
The North America pharmaceutical isolator market accounted for USD 2.45 billion in 2021 and is expected to exhibit a 7.28% CAGR during the study period.
Skan AG (Switzerland), Azbil Telstar s.l.u (Spain), Cytiva (US), NuAire Inc (US), Schematic Engineering Industries (India), MBraun GMBH (Germany), Fedegari Autoclavi S.p.A(Italy), Hosokawa Micron B.V (Netherlands), Syntegon Technology (Germany), Isotech Design (Canada), and Getinge AB (Sweden).
The ISO Class 5 segment held the majority share in 2021 contributing to around 72.2% with respect to the Pharmaceutical Isolator Market.
The biopharma/cell & gene therapy companies segment dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2022-2030.