Mercado de aisladores farmacéuticos: mapeo competitivo y perspectivas estratégicas para 2031

  • Report Code : TIPRE00023786
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 202
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El mercado de aisladores farmacéuticos se valoró en 5.966,07 millones de dólares estadounidenses en 2021 y se espera que crezca a una tasa compuesta anual del 8,5 % de 2021 a 2028.

El aislador farmacéutico es un recinto bacteriológicamente sellado que se utiliza en el entorno médico y farmacéutico para procesos tóxicos y procesos de llenado aséptico. También incluye sistemas de transferencia que permiten la entrada y salida de los productos y la eliminación de residuos sin romper las condiciones asépticas.   

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El alcance del mercado de aisladores farmacéuticos incluye el tipo, la presión, la configuración, la aplicación, el usuario final y la región. El mercado de aisladores farmacéuticos se analiza en función de regiones como América del Norte, Europa, Asia Pacífico, Medio Oriente y Asia. África y el Sur y el Sur. Centroamérica. El informe ofrece información y un análisis en profundidad del mercado de aisladores farmacéuticos, enfatizando varios parámetros como tendencias del mercado, avances tecnológicos, dinámica del mercado y análisis del panorama competitivo de los principales actores del mercado en todo el mundo.


regiones lucrativas para el mercado de aisladores farmacéuticos


Perspectivas del mercado

Marco regulatorio para respaldar la adopción de aisladores farmacéuticos

Un aislador farmacéutico ofrece un entorno estéril superior al de las salas blancas convencionales. Las presiones positivas o negativas dentro de la cámara evitan la contaminación debido a la interferencia del operador. Garantiza una esterilidad duradera de acuerdo con las normativas farmacéuticas relacionadas con la fabricación de productos médicos estériles. Además, la mayoría de los expertos coinciden en que las agencias reguladoras ya no impiden el progreso en tecnologías como los aisladores farmacéuticos. Las directrices establecidas por la Administración de Alimentos y Medicamentos de EE. UU. (FDA de EE. UU.) y la Agencia Europea de Medicamentos con respecto a los aisladores desempeñan un papel importante en la adopción de aisladores en comparación con las salas blancas. La FDA menciona los aisladores 55 veces en su última directriz de fabricación en un entorno aséptico. Un aislador de presión positiva bien diseñado, respaldado por procedimientos adecuados para su mantenimiento, monitoreo y controles, ofrece ventajas significativas sobre el procesamiento aséptico tradicional, incluidas menos oportunidades de contaminación microbiana durante el procesamiento. Además, la FDA reconoce la eliminación de operadores en áreas críticas de la fabricación farmacéutica, lo que se espera que impulse la adopción de aisladores farmacéuticos en los próximos años. El análisis de tendencias muestra un número cada vez mayor de instalaciones farmacéuticas que utilizan tecnología de aisladores en los EE. UU. En 1998, sólo 84 instalaciones estaban equipadas con llenado aséptico en aisladores. Este número aumentó a 174 instalaciones en 2000, 201 en 2002 y 258 en 2004. El crecimiento en el número de instalaciones que ofrecen procesamiento aséptico está relacionado con el crecimiento en la producción de medicamentos de alta potencia.

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Información basada en tipo ;                 

Según el tipo, El mercado de aisladores farmacéuticos se segmenta en aisladores abiertos y aisladores cerrados. El segmento de aisladores abiertos tuvo una mayor participación del mercado y se prevé que el mismo segmento registre una CAGR más alta en el mercado durante el período de pronóstico.  

Información basada en la presión                ;                  

El mercado de aisladores farmacéuticos se segmenta en presión positiva y presión negativa. En 2021, el segmento de presión positiva ocupó una mayor participación del mercado; sin embargo, se espera que el segmento de presión negativa crezca al ritmo más rápido durante el período de pronóstico. El crecimiento del segmento de presión positiva se atribuye a sus ventajas, como la protección avanzada del producto y una mayor adopción en la formulación de fármacos estériles.  

Mercado mundial de aisladores farmacéuticos, por presión: 2021 y 2021 2028


Información estratégica

Información basada en la configuración                        

Basado En cuanto a la configuración, el mercado de aisladores farmacéuticos se segmenta en de suelo, modulares, móviles, compactos, de mesa y portátiles. Es probable que el segmento de suelo tenga la mayor participación del mercado, y se prevé que el mismo segmento registre la CAGR más alta del mercado durante el período de pronóstico. El crecimiento del segmento de suelo se atribuye a una mayor eficiencia, junto con operaciones más rápidas.

Información basada en aplicaciones

Basado en la aplicación, el El mercado de aisladores farmacéuticos se segmenta en aisladores asépticos, aisladores de contención, aisladores de muestreo y pesaje, aisladores de dispensación de fluidos y otros. Es probable que el segmento de aisladores asépticos tenga la mayor participación del mercado. Además, se prevé que el mismo segmento registre la CAGR más alta del mercado durante el período de pronóstico.  

Información basada en el usuario final

Según el usuario final, el mercado de aisladores farmacéuticos se segmenta en hospitales, empresas farmacéuticas y de biotecnología, y laboratorios académicos, entre otros. Es probable que el segmento de empresas farmacéuticas y de biotecnología tenga la mayor participación del mercado, y se prevé que el mismo segmento registre la CAGR más alta del mercado durante el período de pronóstico.

< p>La pandemia de COVID-19 se ha convertido en el desafío más importante en todo el mundo. Ha perturbado diversos oficios y negocios en todo el mundo. Sin embargo, la pandemia ha brindado varias oportunidades de crecimiento a las empresas farmacéuticas y biofarmacéuticas para fortalecer su investigación y desarrollo de vacunas innovadoras contra el nuevo coronavirus. Las empresas están realizando ensayos clínicos para frenar la propagación del virus COVID-19. Por lo tanto, el aumento de los ensayos clínicos generará oportunidades vitales para los proveedores de aisladores farmacéuticos para las empresas biofarmacéuticas.

Adquisiciones, colaboraciones, asociaciones, lanzamientos de nuevos productos y estrategias de expansión. son comúnmente adoptados por las empresas para expandir su presencia en todo el mundo y satisfacer la creciente demanda.

Los actores del mercado que operan en el mercado de aisladores farmacéuticos han adoptado la estrategia de innovación de productos para atender a los cambios. demanda de los clientes en todo el mundo, lo que también ayuda a los jugadores a mantener su marca a nivel mundial.

Perfiles de la empresa

  • ITECO srl                           &n bsp;            
  • Industrias de ingeniería esquemática
  • Nuaire Inc. ;                           ;       
  • Comer      
  • Getinge AB                                       
  • Hosokawa Micron Group ;  
  • Fedegari Autoclavi SpA                   ;    
  • Azbil Telstar                                          
  • Gelman Singapur                                 
  • Bioquell (Solución Ecolab)
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is Pharmaceutical isolator?

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.

What are the driving factors for the Pharmaceutical isolator market across the globe?

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.

What are the challenges hindering the adoption of Pharmaceutical Isolator?

The factors that are restraining the adoption of pharmaceutical isolator are high cost involved in operation and maintenance of pharmaceutical isolators.

Who are the major players in the pharmaceutical isolator market?

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.

What are the growth strategies being implemented by major market players?

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.

Which region accounted for the largest pharmaceutical isolator market share?

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

  1. ITECO S.R.L.      
  2. Schematic Engineering Industries   
  3. Nuaire Inc.           
  4. Comecer             
  5. Getinge AB          
  6. Hosokawa Micron Group              
  7. Fedegari Autoclavi S.p.A.             
  8. Azbil Telstar        
  9. Gelman Singapore           
  10. 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.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client 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 organization 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 last 3 years are scrutinized and analyzed to understand the current market trends.

  1. 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/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:

Research Methodology

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.

  1. 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.

  • 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.

  • 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.

  • 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.

  • 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.

  1. 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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