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アイソレータの世界市場:階層別(高価値・低価値)、タイプ別(プレミアム・中級)、地域別(北米、欧州、アジア太平洋地域、ROW)、COVID-19の影響による規模と動向、2028年までの予測分析


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

アイソレーターの世界市場規模は2022年に16.3億米ドルで、2028年には31.4億米ドルになると予測されている。アイソレーターは、医療・製薬環境で毒性プロセスや無菌充填プロセスに使用される細菌学的に密閉された... もっと見る

 

 

出版社 出版年月 電子版価格 ページ数 言語
Daedal Research
デダルリサーチ
2023年6月27日 US$2,250
シングルユーザライセンス(印刷不可)
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注文方法はこちら
122 英語

 

サマリー

アイソレーターの世界市場規模は2022年に16.3億米ドルで、2028年には31.4億米ドルになると予測されている。アイソレーターは、医療・製薬環境で毒性プロセスや無菌充填プロセスに使用される細菌学的に密閉されたエンクロージャーである。完全に無菌化されたメインアイソレーターで構成され、製品は壁の一面に設置された肩まである手袋を使用して取り扱われ、保管または包装される。また、無菌状態を壊すことなく、製品の出入りと廃棄物の除去を可能にする移送システムも含まれています。

同市場は、2023~2028年の予測期間中にCAGR 11.52%で成長すると予測されている。アイソレーターは、隔離システムまたはアイソレーター手袋としても知られ、危険物質の取り扱いや繊細な作業を行う際に物理的および/または微生物学的隔離を行うために使用される特殊な装置である。製薬、バイオテクノロジー、ヘルスケア、研究所などの産業で一般的に使用されている。アイソレーター市場は、様々な産業において高品質で汚染のない製品への需要が高まっていることから成長している。さらに、注射薬や個別化された医薬品への嗜好の高まりや、再シェアリングへの動きがアイソレーターの需要拡大に寄与している。その結果、クリーンルームやアクセス制限バリアシステム(RABS)が代替され、市場に有利な機会をもたらしている。

市場細分化分析:

階層別:本レポートでは、階層別に高付加価値と低付加価値の2つのセグメントを特定している。高価値アイソレーター市場は、規制基準が厳しい医薬品製造セクターを指す。一方、低価値アイソレーター市場には、アイソレーターの使用がそれほど普及していない製造コストの低い国が含まれる。高付加価値セグメントはさらに、プレミアムとミッドティアの2種類に分類される。高付加価値アイソレーターのシェアは、無菌環境を提供する標準的な品質の存在により、年々大きく伸びている。このセグメントの中では、CDMO(開発受託製造機関)での採用が増加しているため、プレミアム高価値アイソレーターが高い人気を集めている。

地域別:本レポートでは、世界のアイソレーター市場を4つの地域に分けている:北米、欧州、アジア太平洋、ROWである。北米は2022年の世界市場で最大シェアを占めた。これは、同地域の医療インフラが確立されていること、同地域に主要な製薬会社や医療機器会社が存在すること、非感染性疾患の負担が増加していること、コスメシューティカルズやニュートラシューティカルズに対する意識が高まっていることなどに起因している。さらに、米国などこの地域のヘルスケア製品の認可を管理する厳しい規制がアイソレーターの需要を高めている。

しかし、アジア太平洋地域の市場は予測期間中に急成長すると予想される。同地域では医療開発への投資も増加している。ブランド薬の特許切れによるジェネリック医薬品生産の増加、高齢者人口の増加、非感染性疾患の負担増は、アジア太平洋地域の製薬産業の成長を促進する主な要因であり、アイソレーター市場の成長に寄与している。

市場ダイナミクス:

成長ドライバー:市場拡大の主な要因の1つは、バイオ医薬品産業の成長である。バイオ医薬品産業の成長は、医薬品製造に使用される特殊な封じ込めシステムであるアイソレーターの需要を促進している。生物由来のバイオ医薬品は、製品の安全性と有効性を確保するため、管理された無菌環境を必要とする。アイソレーターは、汚染や二次汚染を防ぐ閉鎖システムを提供することで、このニーズに応えます。バイオ医薬品業界は厳しい規制要件に直面しており、アイソレーターは管理された環境を作り出すことで、企業がこれらの規制を遵守するのに役立ちます。さらにアイソレーターは、外部からの汚染リスクを最小限に抑えることで、バイオ医薬品の品質を保証します。特殊な医薬品の小規模生産を伴う個別化医療に対する需要の高まりも、アイソレーターの必要性を高めている。市場のその他の重要な成長要因としては、感染症の流行、病院や外来手術センターからの需要の増加、医薬品アイソレーターの採用を支援する規制の枠組み、無菌製品に対する需要の増加、高活性医薬品成分の使用の増加などが挙げられる。

課題しかし、複雑な設置やメンテナンス、参入障壁、柔軟性の制限など、市場の成長を阻害する課題もある。アイソレーターの設置は、専門知識と専門的知識を必要とする複雑なプロセスである可能性がある。設置には通常、アイソレーター・システムをクリーンルームや研究室などの既存のインフラに組み込む必要がある。これには、適切な空気ろ過と圧力差を確保するために、HVAC(暖房、換気、空調)システムを含む施設の改造が必要になる場合がある。また、設置プロセスは、規制ガイドラインや基準に準拠しなければならない。さらに、アイソレーター・システムの最適な性能を確保し、望ましい無菌レベルを維持するためには、メンテナンスが極めて重要である。メンテナンスの複雑さと訓練された人員の必要性は、アイソレーター・システムの管理に関わる全体的なコストと時間を増大させ、市場成長の妨げとなる。

動向:予測期間中、細胞・遺伝子治療の開発、デジタルアイソレーター、個別化医療へのシフト、アイソレーター内の自動化などの爆発的な成長により、市場は速いペースで成長すると予測される。デジタル・アイソレータはアイソレータ市場の重要なトレンドであり、従来のオプトカプラや他のアイソレータ技術に比べ多くの利点を提供している。デジタル・アイソレータは、半導体をベースとした技術で入力回路と出力回路を電気的に絶縁し、さまざまな用途で安全性とデータの完全性を確保する。デジタル・アイソレータの主な利点の1つは、その優れた性能と信頼性です。光に敏感な部品に依存するオプトカプラとは異なり、デジタル・アイソレータは、経年劣化、温度変化、経年劣化の影響を受けにくい集積回路を使用しています。その結果、長期的な性能と安定性が向上します。デジタル・アイソレータは高いデータ・レートで動作するため、産業オートメーション、医療機器、電気通信などの用途で信頼性の高い通信を可能にします。

COVID-19の影響分析と今後の方向性:

2020年初頭のCOVID-19の出現は、前例のない出来事をもたらした。パンデミックは、感染症の蔓延を防ぎ公衆衛生を守るアイソレーターの重要性を浮き彫りにした。特に製薬業界やバイオテクノロジー業界では、COVID-19ワクチンや治療薬の生産拡大に伴いアイソレーターの需要が急増し、2020年の市場を押し上げた。さらに、この年、CDERはいくつかの新薬や生物製剤を承認したが、これもアイソレーターの需要に影響を与えた。COVID後の環境も市場にとって幸運であるように思われる。COVID-19のような伝染性の高い疾病の出現により、アイソレーターの生物学的封じ込め機能が重視されるようになっている。メーカーは、陰圧システム、複数のエアロック、汚染除去システムなど、バイオセキュリティ対策が強化されたアイソレーターの開発に投資している。これらの進歩は、作業者を最大限に保護し、有害物質や病原体の放出を防ぐことを目的としている。ポストCOVID時代には、アイソレーターにおける先進技術の採用が増加した。これには、HEPA(高効率粒子状空気)ろ過システム、強化された気流管理、革新的な密閉機構などの機能が含まれる。また、効率的で安全な操業を確保するため、アイソレーター内にスマートテクノロジーと自動化を統合する動きも目立ってきた。

競争環境:

世界のアイソレーター市場は、6社によって適度に統合されている:Skan、Syntegon、OPTIMA、FZ Franz Ziel、IMA、Comecerである。SKANは、バイオ医薬品業界の汚染を防ぐハイエンドの無菌製造ソリューションの世界的なマーケットリーダーであり、カスタマイズされた標準アイソレーター・ソリューションから自動無菌充填ステーションまで幅広い製品を提供している。

世界のアイソレーター市場の主要企業は以下の通り:

アズビル株式会社
ゲティンゲAB
ホソカワミクロン株式会社
SKAN Group AG
ATS Automation Tooling Systems Inc.
Syntegon Packaging Technology GmbH
フランツ・ジール社
IMA (Industria Macchine Automatiche) S.p.A.
オプティマ・パッケージング・グループ
株式会社ジャームフリーラボラトリーズ
ニューエア社
HECHT Technologie Inc.

これらのプレーヤーは、製品の差別化、財務の安定性、戦略的開発、多様な地域展開により市場を支配している。これらの企業は、研究開発への投資に注力している。さらに、市場ポジションを強化し、大規模な顧客基盤を獲得するために、事業拡大、製品発売、合弁事業、パートナーシップなどの戦略的成長イニシアティブを採用している。さらに、メーカーはバイオ医薬品/細胞・遺伝子治療企業、学術・研究機関、病院、受託研究機関と供給契約を結んでいる。そのため、メーカーは好感度を高め、競合他社より優位に立つために、洗練された機能を備えた新製品を開発している。

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目次

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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Summary

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.



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Table of Contents

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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