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Global Isolator Market: Analysis By Tier (High-value & Low-value), By Type (Premium & Mid-tier), By Region (North America, Europe, Asia Pacific and ROW), Size and Trends with Impact of COVID-19 and Forecast up to 2028

June 2023 | 122 pages | ID: GE3BB67B1878EN
Daedal Research

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The global isolator market was valued at US$1.63 billion in 2022 and is expected to be worth US$3.14 billion in 2028. An isolator is a bacteriologically sealed enclosure used in the medical and pharmaceutical environment for toxic processes and aseptic filling process. It is made of a perfectly sterile main isolator where the products are handled, stored or packaged using shoulder high gloves placed on one of the walls. It also includes transfer systems that allow the entry and exit of the products and the elimination of waste without breaking aseptic conditions.

The market is projected to grow at a CAGR of 11.52% over the projected period of 2023-2028. Isolators, also known as isolation systems or isolator gloves, are specialized devices used to provide physical and/or microbiological isolation for handling hazardous substances or carrying out sensitive operations. They are commonly used in industries such as pharmaceuticals, biotechnology, healthcare, and research laboratories. The isolator market is growing due to increasing demand for high quality, contamination-free products across various industries. Furthermore, the growing preference for injectable medications and personalized medicines, accompanied by the movement towards re-shoring, is contributing to the higher demand for isolators. Consequently, cleanrooms and Restricted Access Barrier Systems (RABS) are being substituted, providing lucrative opportunities to the market.

Market Segmentation Analysis:

By Tier: The report identifies two segments based on tier: High-value and Low-value. The high-value isolator market refers to the sector of pharmaceutical manufacturing that has stringent regulatory standards. On the other hand, the low-value isolator market includes countries with lower manufacturing costs, where the use of isolators is not as widespread. The high-value segment is further classified in two types: premium and mid-tier. The share of high value isolators has grown significantly throughout the years due to the presence of standard quality in providing sterile environment. Within this segment, premium high value isolators are gaining high popularity due their increasing adoption by CDMOs (Contract Development Manufacturing Organizations).

By Region: In the report, the global isolator market is divided into four regions: North America, Europe, Asia Pacific, and ROW. North America accounted for the maximum share in the global market in 2022. This can be attributed to the region's well-established healthcare infrastructure, the presence of key pharmaceutical and medical device companies in the region, an increase in the burden of noncommunicable diseases, and increased awareness of cosmeceuticals and nutraceuticals. Furthermore, strict regulations governing the approval of healthcare products in this region, such as the US, have increased demand for isolators.

However, the market in Asia Pacific is expected to grow rapidly over the forecast period. Investment in healthcare development is also increasing in this region. The increase in generic drug production due to branded drug patent expirations, growing geriatric population, and increasing burden of noncommunicable diseases are the major factors driving the growth of the pharmaceutical industry in Asia Pacific, thereby attributing to the growth of the isolator market.

Market Dynamics:

Growth Drivers: One of the key drivers of the market's expansion is the growth in biopharmaceuticals industry. The growth of the biopharmaceuticals industry has fueled the demand for isolators, specialized containment systems used in pharmaceutical manufacturing. Biopharmaceuticals, derived from biological sources, require a controlled and sterile environment to ensure product safety and efficacy. Isolators meet this need by providing a closed system that prevents contamination and cross-contamination. The biopharmaceutical industry faces stringent regulatory requirements, and isolators help companies comply with these regulations by creating a controlled environment. Additionally, isolators ensure the quality of biopharmaceutical products by minimizing the risk of contamination from external sources. The rising demand for personalized medicine, which involves small-scale production of specialized drugs, also drives the need for isolators. Other significant growth factors of the market include increasing prevalence of infectious diseases, growing demand from hospitals & ambulatory surgery centers, regulatory framework to support adoption of pharmaceutical isolators, rising demand for sterile products and increase in use of high potency active pharmaceutical ingredients.

Challenges: However, some challenges are impeding the growth of the market such as complex installation and maintenance, barriers to entry and limited flexibility. Installing isolators can be a complex process that requires expertise and specialized knowledge. The installation typically involves integrating the isolator system into existing infrastructure, such as cleanrooms or laboratories. This may require modifications to the facility, including HVAC (heating, ventilation, and air conditioning) systems, to ensure proper air filtration and pressure differentials. The installation process must also comply with regulatory guidelines and standards. Moreover, maintaining isolator systems is crucial to ensure their optimal performance and maintain the desired sterility levels. The complexity of maintenance and the need for trained personnel can increase the overall cost and time involved in managing isolator systems, thus hampering the market growth.

Trends: The market is projected to grow at a fast pace during the forecast period, due to explosive growth of cell & gene therapies in development, digital isolators, shift toward personalized medicine, and automation inside isolators. Digital isolators are a significant trend in the isolator market, offering numerous advantages over traditional optocouplers and other forms of isolation technology. Digital isolators use semiconductor-based technology to provide electrical isolation between input and output circuits, ensuring safety and data integrity in various applications. One key advantage of digital isolators is their superior performance and reliability. Unlike optocouplers, which rely on light-sensitive components, digital isolators use integrated circuits that are less prone to aging, temperature variations, and degradation over time. This results in improved long-term performance and stability. Digital isolators can operate at high data rates, enabling reliable communication in applications such as industrial automation, medical devices, and telecommunications.

Impact Analysis of COVID-19 and Way Forward:

The emergence of COVID-19 at the beginning of 2020 brought about unprecedented events. The pandemic highlighted the importance of isolators in preventing the spread of infectious diseases and protecting public health. The pharmaceutical and biotech industries, in particular, have seen a surge in demand for isolators as they ramp up production of COVID-19 vaccines and treatments, thus driving the market upwards in 2020. Moreover, during the year, the CDER has approved several novel drugs and biologics, which also influenced the demand for isolators. The post-COVID environment also appears to be fortunate for the market. With the emergence of highly contagious diseases like COVID-19, there is a heightened emphasis on bio containment capabilities in isolators. Manufacturers are investing in developing isolators with enhanced biosecurity measures, such as negative pressure systems, multiple airlocks, and decontamination systems. These advancements aim to provide maximum protection to operators and prevent the release of harmful substances or pathogens. The post-COVID era has witnessed a rise in the adoption of advanced technologies in isolators. These include features such as HEPA (High-Efficiency Particulate Air) filtration systems, enhanced airflow management, and innovative sealing mechanisms. The integration of smart technologies and automation within isolators has also gained prominence to ensure efficient and safe operations.

Competitive Landscape:

Global isolator market is moderately consolidated across six companies: Skan, Syntegon, OPTIMA, FZ Franz Ziel, IMA and Comecer. SKAN is the global market leader in high-end aseptic manufacturing solutions that prevent contamination for the biopharmaceutical industry, with products ranging from customized and standard isolator solutions to automated aseptic filling stations.

The key players in the global isolator market are:
  • Azbil Corporation
  • Getinge AB
  • Hosokawa Micron Corporation
  • SKAN Group AG
  • ATS Automation Tooling Systems Inc. (Comecer)
  • Syntegon Packaging Technology GmbH
  • Franz Ziel GmbH
  • IMA (Industria Macchine Automatiche) S.p.A.
  • Optima Packaging Group
  • Germfree Laboratories Inc.
  • NuAire Inc.
  • HECHT Technologie Inc.
These players dominate the 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. Moreover, 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.
1. EXECUTIVE SUMMARY

2. INTRODUCTION

2.1 Isolator: An Overview
  2.1.1 Definition of Isolator
2.2 Isolator Segmentation: An Overview
  2.2.1 Isolator Segmentation by Tier

3. GLOBAL MARKET ANALYSIS

3.1 Global Isolator Market: An Analysis
  3.1.1 Global Isolator Market: An Overview
  3.1.2 Global Isolator Market by Value
  3.1.3 Global Isolator Market by Tier (High-value & Low-value)
  3.1.4 Global Isolator Market by Region (North America, Europe, Asia Pacific and ROW)
3.2 Global Isolator Market: Tier Analysis
  3.2.1 Global Isolator Market by Tier: An Overview
  3.2.2 Global High-value Isolator Market by Value
  3.2.3 Global High-value Isolator Market by Type (Premium & Mid-tier)
  3.2.4 Global Low-value Isolator Market by Value
3.3 Global High-value Isolator Market: Type Analysis
  3.3.1 Global High-value Isolator Market by Type: An Overview
  3.3.2 Global Premium High-value Isolator Market by Value
  3.3.3 Global Mid-tier High-value Isolator Market by Value

4. REGIONAL MARKET ANALYSIS

4.1 North America Isolator Market: An Analysis
  4.1.1 North America Isolator Market: An Overview
  4.1.2 North America Isolator Market by Value
  4.1.3 North America Isolator Market by Region (The US, Canada & Mexico)
  4.1.4 The US Isolator Market by Value
  4.1.5 Canada Isolator Market by Value
  4.1.6 Mexico Isolator Market by Value
4.2 Europe Isolator Market: An Analysis
  4.2.1 Europe Isolator Market: An Overview
  4.2.2 Europe Isolator Market by Value
  4.2.3 Europe Isolator Market by Region (Germany, France, UK, Italy and Rest of Europe)
  4.2.4 Germany Isolator Market by Value
  4.2.5 France Isolator Market by Value
  4.2.6 The UK Isolator Market by Value
  4.2.7 Italy Isolator Market by Value
  4.2.8 Rest of Europe Isolator Market by Value
4.3 Asia Pacific Isolator Market: An Analysis
  4.3.1 Asia Pacific Isolator Market: An Overview
  4.3.2 Asia Pacific Isolator Market by Value
  4.3.3 Asia Pacific Isolator Market by Region (China, Japan, India, South Korea and Rest of Asia Pacific)
  4.3.4 China Isolator Market by Value
  4.3.5 Japan Isolator Market by Value
  4.3.6 India Isolator Market by Value
  4.3.7 South Korea Isolator Market by Value
  4.3.8 Rest of Asia Pacific Isolator Market by Value
4.4 ROW Isolator Market: An Analysis
  4.4.1 ROW Isolator Market: An Overview
  4.4.2 ROW Isolator Market by Value

5. IMPACT OF COVID-19

5.1 Impact of COVID-19
  5.1.1 Impact of COVID-19 on Isolator Market
  5.1.2 Growth in FDA Approval for Biologics
  5.1.3 Post COVID Scenario

6. MARKET DYNAMICS

6.1 Growth Drivers
  6.1.1 Growth in Biopharmaceuticals Industry
  6.1.2 Increasing Prevalence of Infectious Diseases
  6.1.3 Growing Demand from Hospitals & Ambulatory Surgery Centers
  6.1.4 Regulatory Framework to Support Adoption of Pharmaceutical Isolators
  6.1.5 Rising Demand for Sterile Products
  6.1.6 Increase in Use of High Potency Active Pharmaceutical Ingredients
6.2 Challenges
  6.2.1 Complex Installation and Maintenance
  6.2.2 Limited Flexibility
  6.2.3 Barriers to Entry
6.3 Market Trends
  6.3.1 Explosive Growth of Cell & Gene Therapies in Development
  6.3.2 Shift towards Personalized Medicine
  6.3.3 Digital Isolators
  6.3.4 Automation inside Isolators

7. COMPETITIVE LANDSCAPE

7.1 Global High-value Isolator Players by Market Share
7.2 Global Premium High-value Isolator Players by Market Share

8. COMPANY PROFILES

8.1 Azbil Corporation
  8.1.1 Business Overview
  8.1.2 Operating Segments
  8.1.3 Business Strategies
8.2 Getinge AB
  8.2.1 Business Overview
  8.2.2 Operating Segments
  8.2.3 Business Strategy
8.3 Hosokawa Micron Corporation
  8.3.1 Business Overview
  8.3.2 Operating Segments
  8.3.3 Business Strategy
8.4 SKAN Group AG
  8.4.1 Business Overview
  8.4.2 Operating Segments
  8.4.3 Business Strategy
8.5 ATS Automation Tooling Systems Inc. (Comecer)
  8.5.1 Business Overview
  8.5.2 Revenues by Market
  8.5.3 Business Strategy
8.6 Syntegon Packaging Technology GmbH
  8.6.1 Business Overview
  8.6.2 Business Strategy
8.7 Franz Ziel GmbH
  8.7.1 Business Overview
8.8 IMA (Industria Macchine Automatiche) S.p.A.
  8.8.1 Business Overview
8.9 Optima Packaging Group
  8.9.1 Business Overview
8.10 Germfree Laboratories Inc.
  8.10.1 Business Overview
8.11 NuAire Inc.
  8.11.1 Business Overview
8.12 HECHT Technologie Inc.
  8.12.1 Business Overview

LIST OF FIGURES

Figure 1: Types of Isolators
Figure 2: Isolator Segmentation by Tier
Figure 3: Global Isolator Market by Value; 2018-2022 (US$ Billion)
Figure 4: Global Isolator Market by Value; 2023-2028 (US$ Billion)
Figure 5: Global Isolator Market by Tier; 2022 (Percentage, %)
Figure 6: Global Isolator Market by Region; 2022 (Percentage, %)
Figure 7: Global High-value Isolator Market by Value; 2018-2022 (US$ Million)
Figure 8: Global High-value Isolator Market by Value; 2023-2028 (US$ Billion)
Figure 9: Global High-value Isolator Market by Type; 2022 (Percentage, %)
Figure 10: Global Low-value Isolator Market by Value; 2018-2022 (US$ Million)
Figure 11: Global Low-value Isolator Market by Value; 2023-2028 (US$ Million)
Figure 12: Global Premium High-value Isolator Market by Value; 2018-2022 (US$ Million)
Figure 13: Global Premium High-value Isolator Market by Value; 2023-2028 (US$ Million)
Figure 14: Global Mid-tier High-value Isolator Market by Value; 2018-2022 (US$ Million)
Figure 15: Global Mid-tier High-value Isolator Market by Value; 2023-2028 (US$ Million)
Figure 16: North America Isolator Market by Value; 2018-2022 (US$ Million)
Figure 17: North America Isolator Market by Value; 2023-2028 (US$ Million)
Figure 18: North America Isolator Market by Region; 2022 (Percentage, %)
Figure 19: The US Isolator Market by Value; 2018-2022 (US$ Million)
Figure 20: The US Isolator Market by Value; 2023-2028 (US$ Million)
Figure 21: Canada Isolator Market by Value; 2018-2022 (US$ Million)
Figure 22: Canada Isolator Market by Value; 2023-2028 (US$ Million)
Figure 23: Mexico Isolator Market by Value; 2018-2022 (US$ Million)
Figure 24: Mexico Isolator Market by Value; 2023-2028 (US$ Million)
Figure 25: Europe Isolator Market by Value; 2018-2022 (US$ Million)
Figure 26: Europe Isolator Market by Value; 2023-2028 (US$ Million)
Figure 27: Europe Isolator Market by Region; 2022 (Percentage, %)
Figure 28: Germany Isolator Market by Value; 2018-2022 (US$ Million)
Figure 29: Germany Isolator Market by Value; 2023-2028 (US$ Million)
Figure 30: France Isolator Market by Value; 2018-2022 (US$ Million)
Figure 31: France Isolator Market by Value; 2023-2028 (US$ Million)
Figure 32: The UK Isolator Market by Value; 2018-2022 (US$ Million)
Figure 33: The UK Isolator Market by Value; 2023-2028 (US$ Million)
Figure 34: Italy Isolator Market by Value; 2018-2022 (US$ Million)
Figure 35: Italy Isolator Market by Value; 2023-2028 (US$ Million)
Figure 36: Rest of Europe Isolator Market by Value; 2018-2022 (US$ Million)
Figure 37: Rest of Europe Isolator Market by Value; 2023-2028 (US$ Million)
Figure 38: Asia Pacific Isolator Market by Value; 2018-2022 (US$ Million)
Figure 39: Asia Pacific Isolator Market by Value; 2023-2028 (US$ Million)
Figure 40: Asia Pacific Isolator Market by Region; 2022 (Percentage, %)
Figure 41: China Isolator Market by Value; 2018-2022 (US$ Million)
Figure 42: China Isolator Market by Value; 2023-2028 (US$ Million)
Figure 43: Japan Isolator Market by Value; 2018-2022 (US$ Million)
Figure 44: Japan Isolator Market by Value; 2023-2028 (US$ Million)
Figure 45: India Isolator Market by Value; 2018-2022 (US$ Million)
Figure 46: India Isolator Market by Value; 2023-2028 (US$ Million)
Figure 47: South Korea Isolator Market by Value; 2018-2022 (US$ Million)
Figure 48: South Korea Isolator Market by Value; 2023-2028 (US$ Million)
Figure 49: Rest of Asia Pacific Isolator Market by Value; 2018-2022 (US$ Million)
Figure 50: Rest of Asia Pacific Isolator Market by Value; 2023-2028 (US$ Million)
Figure 51: ROW Isolator Market by Value; 2018-2022 (US$ Million)
Figure 52: ROW Isolator Market by Value; 2023-2028 (US$ Million)
Figure 53: Total Number of Novel Drugs Approved by CDER, 2019-2022 (Number of Approvals)
Figure 54: Global Biopharmaceuticals Market; 2020-2030 (US$ Billion)
Figure 55: Global HIV Patients by Age Group; 2021 (Million)
Figure 56: The US Projected Cell Therapies Launches; 2021 & 2024 (Units)
Figure 57: The US Projected Gene Therapies Launches; 2021 & 2024 (Units)
Figure 58: Global High-value Isolator Players by Market Share; 2022 (Percentage, %)
Figure 59: Global Premium High-value Isolator Players by Market Share; 2022 (Percentage, %)
Figure 60: Azbil Corporation Sales by Segments, 2022 (Percentage, %)
Figure 61: Getinge AB Net Sales by Segment; 2022 (Percentage,%)
Figure 62: Hosokawa Micron Corporation Sales by Segments; 2022 (Percentage, %)
Figure 63: SKAN Group AG Net Sales by Segments, 2022 (Percentage, %)
Figure 64: ATS Automation Tooling Systems Inc. Revenues by Market; 2022 (Percentage, %)


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