The pharmaceutical isolator market was valued at US$ 5,966.07 million in 2021, it is expected to grow at a CAGR of 8.5% from 2021 to 2028.
The pharmaceutical isolator is a bacteriologically sealed enclosure used in the medical and pharmaceutical environment for toxic processes and aseptic filling processes. It also includes transfer systems that allow the entry and exit of the products and the elimination of waste without breaking aseptic conditions.
The scope of the pharmaceutical isolator market includes type, pressure, configuration, application, end user, and region. The pharmaceutical isolator market is analyzed based on regions such as North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. The report offers insights and in-depth analysis of the pharmaceutical isolator market, emphasizing various parameters such as market trends, technological advancements, market dynamics, and competitive landscape analysis of leading market players across the world.
Lucrative Regions for Pharmaceutical Isolator Market
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Market Insights
Regulatory Framework to Support Adoption of Pharmaceutical Isolators
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.
Type-Based Insights
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, and the same segment is anticipated to register a higher CAGR in the market during the forecast period.
Pressure-Based Insights
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. Growth of the positive pressure segment is attributed to their advantages such as advanced product protection and higher adoption in sterile drug compounding.
Global Pharmaceutical Isolator Market, by Pressure – 2021 & 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
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Pharmaceutical Isolator Market: Strategic Insights
Market Size Value in US$ 5,966.07 Million in 2021 Market Size Value by US$ 10,560.30 Million by 2028 Growth rate CAGR of 8.5% from 2021-2028 Forecast Period 2021-2028 Base Year 2021
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We can optimize and tailor the analysis and scope which is unmet through our standard offerings. This flexibility will help you gain the exact information needed for your business planning and decision making.
Pharmaceutical Isolator Market: Strategic Insights
| Market Size Value in | US$ 5,966.07 Million in 2021 |
| Market Size Value by | US$ 10,560.30 Million by 2028 |
| Growth rate | CAGR of 8.5% from 2021-2028 |
| Forecast Period | 2021-2028 |
| Base Year | 2021 |
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Configuration-Based Insights
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.
Application-Based Insights
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.
End User–Based Insights
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 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.
Acquisition, collaboration, partnerships, new product launches, and expansion strategies are commonly adopted by companies to expand their footprint worldwide and meet the growing demand.
The market players operating in the pharmaceutical isolator market have adopted the strategy of product innovation to cater to the changing customer demand across the world, which also helps players to maintain their brand name globally.
Company Profiles
- 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)
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Type , Pressure , Configuration , Application , and End User ; and Geography
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, RoAPAC, RoE, RoMEA, RoSCAM, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
The pharmaceutical isolator is a bacteriologically sealed enclosure used in the medical and pharmaceutical environment for toxic processes and aseptic filling process. It also includes transfer systems that allow the entry and exit of the products and the elimination of waste without breaking aseptic conditions.
The factors that are driving growth of the market are increase in investments by pharmaceutical and biotechnology industry, and regulatory framework to support adoption of pharmaceutical isolators are expected to boost the growth of the global Pharmaceutical isolator market.
The factors that are restraining the adoption of pharmaceutical isolator are high cost involved in operation and maintenance of pharmaceutical isolators.
The pharmaceutical isolator market majorly consists of the players such as 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) and among others.
The market players are involved in acquisitions, strategic collaborations, and new product launches to withstand the competition. For instance, in June 2021, Comecer partners with G-CON o speed up the implementation of Cell & Gene Therapy cGMP manufacturing facility. G-CON’s new Aseptic facility integrate Comecer’s upstream processing & downstream filling technologies for turnkey aseptic facility solutions including isolation technologies.
North America dominated the pharmaceutical isolator market with a share of 42% in 2020. This is attributable to increase in investments by pharmaceutical and biotechnology industry, the presence of advanced infrastructure, and regulatory framework supporting adoption of pharmaceutical isolators.
The List of Companies - Pharmaceutical Isolator Market
- 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)
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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