無菌充填機市場：産業動向と世界予測 (～2035年) - 適合する一次容器タイプ別、運用規模別、システムスループット別、エンドユーザー別、主要地域別

無菌充填機の市場規模は、2024年に13億6,500万米ドルとなるとみられ、予測期間の2024年～2035年にCAGR 8.7%で拡大すると予測されています。

充填/仕上げは医薬品製造の重要な側面であり、一次容器に封入された製剤の安全性を確保することは必須です。確立されたプロセスであるにもかかわらず、現代の医薬品充填プロセスは、汚染、充填ミス、ラベリング問題などの懸念に悩まされています。実際、専門家は、製品リコールの約80％が包装関連の懸念に起因すると推定しており、重要な懸念事項としての汚染の重要性を強調しています。消費者の安全を確保するため、充填／仕上げ工程では無菌環境が維持されます。しかし、充填ラインでの手作業による介入は、労働者との接触による汚染のリスクを高めるため、製品の安全性に脅威をもたらします。さらに、手作業は非効率的であり、投与量の分注に不正確さが生じる可能性があります。

現代の医薬品は複雑さを増しており、充填/仕上げなどのルーチン作業の自動化の必要性が生じています。その結果、専門的な機器やインフラ、取り扱いに関する専門知識に対する需要が高まっています。過去20年以上にわたり、製薬機器メーカーは、独自の無菌充填／仕上げラインにアイソレーターやアクセス制限バリアシステム（RABS）を組み込んだ、より効率的で信頼性が高く、コスト効率の高い機械を開発してきました。これらのシステムにより、人の介在が不要になるため、オペレーターによる汚染のリスクが低減します。さらに、隔離された機器による充填ラインは、大幅なコスト削減の機会とも関連しています。このような場合、開発者は大規模なハイエンド設備に投資する代わりに、小規模で低コストのクリーンルームを選択することができます。

現在までに、230を超えるアイソレーターベースの充填・閉鎖システムが市場で入手可能であり、性能向上を目指した技術革新の努力が続けられています。開発中のバイオ医薬品候補の数が増加していることから、無菌充填・終了装置開発企業のビジネスチャンスは今後10年間、かなりのペースで拡大し続けると予想されます。

当レポートでは、世界の無菌充填機市場について調査し、市場の概要とともに、適合する一次容器タイプ別、運転規模別、システムスループット別、エンドユーザー別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 序文

第2章 エグゼクティブサマリー

第3章 イントロダクション

第4章 アイソレータベースの無菌充填システム：市場情勢の状況

第5章 アイソレータベースの無菌充填および閉鎖システム：製品競合分析

第6章 企業プロファイル

• 章の概要
• AST
• Bausch+Strobel
• Dara Pharma
• Groninger
• IMA Group
• Marchesini Group
• OPTIMA
• Syntegon
• Tofflon

第7章 最近の動向

第8章 規制ガイドライン：無菌処理

第9章 市場予測と機会分析

第10章 結論

第11章 エグゼクティブ洞察

第12章 付録I：表形式データ

第13章 付録II：企業および団体一覧

List of Tables

• Table 4.1 Isolator based Aseptic Filling Systems: Information on Developer, Type of System and Scale of Operation
• Table 4.2 Isolator based Aseptic Filling Systems: Information on System Throughput
• Table 4.3 Isolator based Aseptic Filling Systems: Information on Compatible Primary Container
• Table 4.4 Isolator based Aseptic Filling Systems: Information on Fill Volume and Type of Formulation
• Table 4.5 List of Companies Providing Isolator based Aseptic Filling Systems
• Table 6.1 Isolator based Aseptic Filling Machines: List of Companies Profiled
• Table 6.2 AST: Company Snapshot
• Table 6.3 AST: Isolator based Aseptic Filling Machines Portfolio
• Table 6.4 AST: Recent Developments and Future Outlook
• Table 6.5 Bausch+Strobel: Company Snapshot
• Table 6.6 Bausch+Strobel: Isolator based Aseptic Filling Machines Portfolio
• Table 6.7 Dara Pharmaceutical Packaging: Company Snapshot
• Table 6.8 Dara Pharmaceutical Packaging: Isolator based Aseptic Filling Machines Portfolio
• Table 6.9 Dara Pharmaceutical Packaging: Recent Developments and Future Outlook
• Table 6.10 Groninger: Company Snapshot
• Table 6.11 Groninger: Isolator based Aseptic Filling Machines Portfolio
• Table 6.12 Groninger: Recent Developments and Future Outlook
• Table 6.13 IMA Group: Company Snapshot
• Table 6.14 IMA Group: Isolator based Aseptic Filling Machines Portfolio
• Table 6.15 Marchesini Group: Company Snapshot
• Table 6.16 Marchesini Group: Isolator based Aseptic Filling Machines Portfolio
• Table 6.17 Marchesini Group: Recent Developments and Future Outlook
• Table 6.18 OPTIMA Packaging Group: Company Snapshot
• Table 6.19 OPTIMA Packaging Group: Isolator based Aseptic Filling Machines Portfolio
• Table 6.20 OPTIMA Packaging Group: Recent Developments and Future Outlook
• Table 6.21 Syntegon: Company Snapshot
• Table 6.22 Syntegon: Isolator based Aseptic Filling Machines Portfolio
• Table 6.23 Syntegon: Recent Developments and Future Outlook
• Table 6.24 Tofflon Group: Company Snapshot
• Table 6.25 Tofflon Group: Isolator based Aseptic Filling Machines Portfolio
• Table 7.1 Isolator based Aseptic Filling Systems: List of Partnerships and Collaborations, 2017-2020
• Table 7.2 Isolator based Aseptic Filling Systems: List of Conferences, 2017-2020
• Table 12.1 Isolator based Aseptic Filling Systems: Distribution by Type of System
• Table 12.2 Isolator based Aseptic Filling Systems: Distribution by System Throughput
• Table 12.3 Isolator based Aseptic Filling Systems: Distribution by Compatible Primary Container
• Table 12.4 Isolator based Aseptic Filling Systems: Distribution by Type of Formulation
• Table 12.5 Isolator based Aseptic Filling System Providers: Distribution by Year of Establishment
• Table 12.6 Isolator based Aseptic Filling System Providers: Distribution by Company Size
• Table 12.7 Isolator based Aseptic Filling System Providers: Distribution by Location of Headquarters
• Table 12.8 Isolator based Aseptic Filling System Providers: Leading Players
• Table 12.9 Isolator based Aseptic Filling Systems Market Partnership Activity: Analysis by Year of Partnership
• Table 12.10 Isolator based Aseptic Filling Systems Market Partnership Activity: Analysis by Type of Partnership
• Table 12.11 Isolator based Aseptic Filling Systems Market Partnership: Analysis by Number of Partnerships
• Table 12.12 Isolator based Aseptic Filling Systems Market Recent Conferences: Analysis by Year of Occurrence
• Table 12.13 Isolator based Aseptic Filling Systems Market Recent Conferences: Analysis by Geographical Location
• Table 12.14 Global Isolator based Filling Systems Market: Historical Trends, 2019-2023 (USD Million)
• Table 12.15 Global Isolator based Aseptic Filling Systems Market: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.16 Isolator based Aseptic Filling Systems Market: Distribution by Scale of Operation, 2019, 2024 and 2035
• Table 12.17 Isolator based Aseptic Filling Systems Market for Commercial Scale Systems: Historical Trends, 2019-2023 (USD Million)
• Table 12.18 Isolator based Aseptic Filling Systems Market for Commercial Scale Systems: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.19 Isolator based Aseptic Filling Systems Market for Clinical Scale Systems: Historical Trends, 2019-2023 (USD Million)
• Table 12.20 Isolator based Aseptic Filling Systems Market for Clinical Scale Systems: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.21 Isolator based Aseptic Filling Systems Market: Distribution by Type of Compatible Primary Container, 2019, 2024 and 2035
• Table 12.22 Isolator based Aseptic Filling Systems Market for Vials, 2019-2023 (USD Million)
• Table 12.23 Isolator based Aseptic Filling Systems Market for Vials: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.24 Isolator based Aseptic Filling Systems Market for Syringes: Historical Trends, 2019-2023 (USD Million)
• Table 12.25 Isolator based Aseptic Filling Systems Market for Syringes: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.26 Isolator based Aseptic Filling Systems Market for Cartridges: Historical Trends, 2019-2023 (USD Million)
• Table 12.27 Isolator based Aseptic Filling Systems Market for Cartridges: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.28 Isolator based Aseptic Filling Systems Market for Ampoules: Historical Trends, 2019-2023 (USD Million)
• Table 12.29 Isolator based Aseptic Filling Systems Market for Ampoules: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.30 Isolator based Aseptic Filling Systems Market for Capsules: Historical Trends, 2019-2023 (USD Million)
• Table 12.31 Isolator based Aseptic Filling Systems Market for Capsules: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.32 Isolator based Aseptic Filling Systems Market for Other Containers: Historical Trends, 2019-2023 (USD Million)
• Table 12.33 Isolator based Aseptic Filling Systems Market for Other Containers: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.34 Isolator based Aseptic Filling Systems Market: Distribution by System Throughput, 2019, 2024 and 2035
• Table 12.35 Isolator based Aseptic Filling Systems Market for Low Throughput Systems, 2019-2023 (USD Million)
• Table 12.36 Isolator based Aseptic Filling Systems Market for Low Throughput Systems: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.37 Isolator based Aseptic Filling Systems Market for Medium Throughput Systems, 2019-2023 (USD Million)
• Table 12.38 Isolator based Aseptic Filling Systems Market for Medium Throughput Systems: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.39 Isolator based Aseptic Filling Systems Market for High Throughput Systems, 2019-2023 (USD Million)
• Table 12.40 Isolator based Aseptic Filling Systems Market for High Throughput Systems: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.41 Isolator based Aseptic Filling Systems Market: Distribution by End-User, 2019, 2024 and 2035
• Table 12.42 Isolator based Aseptic Filling Systems Market for Pharma/ Biotech Companies, 2019-2023 (USD Million)
• Table 12.43 Isolator based Aseptic Filling Systems Market for Pharma/ Biotech Companies: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.44 Isolator based Aseptic Filling Systems Market for Contract Service Providers, 2019-2023 (USD Million)
• Table 12.45 Isolator based Aseptic Filling Systems Market for Contract Service Providers: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.46 Isolator based Aseptic Filling Systems Market: Distribution by Key Geographical Regions, 2019, 2024 and 2035
• Table 12.47 Isolator based Aseptic Filling Systems Market in North America, 2019-2023 (USD Million)
• Table 12.48 Isolator based Aseptic Filling Systems Market in North America: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.49 Isolator based Aseptic Filling Systems Market in the US, 2019-2023 (USD Million)
• Table 12.50 Isolator based Aseptic Filling Systems Market in the US: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.51 Isolator based Aseptic Filling Systems Market in Canada, 2019-2023 (USD Million)
• Table 12.52 Isolator based Aseptic Filling Systems Market in Canada: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.53 Isolator based Aseptic Filling Systems Market in Europe, 2019-2023 (USD Million)
• Table 12.54 Isolator based Aseptic Filling Systems Market in Europe: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.55 Isolator based Aseptic Filling Systems Market in France, 2019-2023 (USD Million)
• Table 12.56 Isolator based Aseptic Filling Systems Market in France: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.57 Isolator based Aseptic Filling Systems Market in Germany, 2019-2023 (USD Million)
• Table 12.58 Isolator based Aseptic Filling Systems Market in Germany: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.59 Isolator based Aseptic Filling Systems Market in the UK, 2019-2023 (USD Million)
• Table 12.60 Isolator based Aseptic Filling Systems Market in the UK: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.61 Isolator based Aseptic Filling Systems Market in Italy, 2019-2023 (USD Million)
• Table 12.62 Isolator based Aseptic Filling Systems Market in Italy: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.63 Isolator based Aseptic Filling Systems Market in Spain, 2019-2023 (USD Million)
• Table 12.64 Isolator based Aseptic Filling Systems Market in Spain: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.65 Isolator based Aseptic Filling Systems Market in Austria, 2019-2023 (USD Million)
• Table 12.66 Isolator based Aseptic Filling Systems Market in Austria: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.67 Isolator based Aseptic Filling Systems Market in Switzerland, 2019-2023 (USD Million)
• Table 12.68 Isolator based Aseptic Filling Systems Market in Switzerland: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.69 Isolator based Aseptic Filling Systems Market in Rest of Europe, 2019-2023 (USD Million)
• Table 12.70 Isolator based Aseptic Filling Systems Market in Rest of Europe: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.71 Isolator based Aseptic Filling Systems Market in Asia-Pacific, 2019-2023 (USD Million)
• Table 12.72 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.73 Isolator based Aseptic Filling Systems Market in China, 2019-2023 (USD Million)
• Table 12.74 Isolator based Aseptic Filling Systems Market in China: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.75 Isolator based Aseptic Filling Systems Market in India, 2019-2023 (USD Million)
• Table 12.76 Isolator based Aseptic Filling Systems Market in India: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.77 Isolator based Aseptic Filling Systems Market in South Korea, 2019-2023 (USD Million)
• Table 12.78 Isolator based Aseptic Filling Systems Market in South Korea, 2019-2023 (USD Million)
• Table 12.79 Isolator based Aseptic Filling Systems Market in Japan, 2019-2023 (USD Million)
• Table 12.80 Isolator based Aseptic Filling Systems Market in Japan, 2019-2023 (USD Million)
• Table 12.81 Isolator based Aseptic Filling Systems Market in Rest of Asia-Pacific, 2019-2023 (USD Million)
• Table 12.82 Isolator based Aseptic Filling Systems Market in Rest of Asia-Pacific: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.83 Isolator based Aseptic Filling Systems Market in Rest of the World, 2019-2023 (USD Million)
• Table 12.84 Isolator based Aseptic Filling Systems Market in Rest of the World: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.85 Isolator based Aseptic Filling Systems Market in Argentina, 2019-2023 (USD Million)
• Table 12.86 Isolator based Aseptic Filling Systems Market in Argentina: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.87 Isolator based Aseptic Filling Systems Market in Brazil, 2019-2023 (USD Million)
• Table 12.88 Isolator based Aseptic Filling Systems Market in Brazil: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.89 Isolator based Aseptic Filling Systems Market in Israel, 2019-2023 (USD Million)
• Table 12.90 Isolator based Aseptic Filling Systems Market in Israel: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.91 Isolator based Aseptic Filling Systems Market in Iran, 2019-2023 (USD Million)
• Table 12.92 Isolator based Aseptic Filling Systems Market in Iran: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)
• Table 12.93 Isolator based Aseptic Filling Systems Market in Other Countries, 2019-2023 (USD Million)
• Table 12.94 Isolator based Aseptic Filling Systems Market in Other Countries: Forecasted Estimates, 2024-2035, Conservative, Base and Optimistic Scenarios (USD Million)

List of Figures

• Figure 3.1 Drug Fill / Finish Process
• Figure 3.2 Aseptic Fill / Finish Workflow
• Figure 3.3 Comparison of Traditional Filling with Blow / Fill / Seal Technologies
• Figure 3.4 Aseptic Processing Equipment and Degrees of Sterility
• Figure 3.5 Comparison of RABS with Isolators
• Figure 4.1 Isolator based Aseptic Filling Systems: Distribution by Type of System
• Figure 4.2 Isolator based Aseptic Filling Systems: Distribution by Maximum System Throughput
• Figure 4.3 Isolator based Aseptic Filling Systems: Distribution by Compatible Primary Container
• Figure 4.4 Isolator based Aseptic Filling Systems: Distribution by Type of Formulation
• Figure 4.5 Isolator based Aseptic Filling System Providers: Distribution by Year of Establishment
• Figure 4.6 Isolator based Aseptic Filling System Providers: Distribution by Company Size
• Figure 4.7 Isolator based Aseptic Filling System Providers: Distribution by Location of Headquarters
• Figure 4.8 Most Active Players: Distribution by Number of Systems Offered
• Figure 5.1 Competitiveness Analysis: Products in Peer Group I
• Figure 5.2 Competitiveness Analysis: Products in Peer Group II
• Figure 5.3 Competitiveness Analysis: Products in Peer Group III
• Figure 7.1 Partnerships and Collaborations: Distribution by Year of Partnership
• Figure 7.2 Partnerships and Collaborations: Distribution by Type of Partnership
• Figure 7.3 Partnerships and Collaborations: Distribution by Focus Area
• Figure 7.4 Most Active Players: Distribution by Number of Partnerships
• Figure 7.5 Recent Conferences: Distribution by Year of Occurrence
• Figure 7.6 Recent Conferences: Distribution by Geographical Location
• Figure 8.1 Airborne Particulate Classification for Different Cleanroom Grades
• Figure 9.1 Global Isolator based Filling Systems Market, Historical Trends (2018-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.2 Isolator based Aseptic Filling Systems Market, Distribution by Scale of Operation, 2019, 2024 and 2035
• Figure 9.3 Isolator based Aseptic Filling Systems Market for Commercial Scale Systems, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.4 Isolator based Aseptic Filling Systems Market for Clinical Scale Systems, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.5 Isolator based Aseptic Filling Systems Market, Distribution by Type of Compatible Primary Container, 2019, 2024 and 2035
• Figure 9.6 Isolator based Aseptic Filling Systems Market for Vials, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.7 Isolator based Aseptic Filling Systems Market for Syringes, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.8 Isolator based Aseptic Filling Systems Market for Cartridges, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.9 Isolator based Aseptic Filling Systems Market for Ampoules, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.10 Isolator based Aseptic Filling Systems Market for Capsules, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.11 Isolator based Aseptic Filling Systems Market for Other Primary Containers, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.12 Global Isolator based Aseptic Filling Systems, Market Distribution by System Throughput, 2019, 2024 and 2035
• Figure 9.13 Isolator based Aseptic Filling Systems Market for High Throughput Systems, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.14 Isolator based Aseptic Filling Systems Market for Medium Throughput Systems, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.15 Isolator based Aseptic Filling Systems Market for Low Throughput Systems, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.16 Global Isolator based Aseptic Filling Systems Market, Distribution by End-user, 2019, 2024 and 2035
• Figure 9.17 Isolator based Aseptic Filling Systems Market for Pharma/ Biotech Companies, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.18 Isolator based Aseptic Filling Systems Market for Contract Service Providers, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.19 Isolator based Aseptic Filling Systems Market, Distribution by Key Geographical Regions, 2019, 2024 and 2035
• Figure 9.20 Isolator based Aseptic Filling Systems Market in North America, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.21 Isolator based Aseptic Filling Systems Market in the US, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.22 Isolator based Aseptic Filling Systems Market in Canada, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.23 Isolator based Aseptic Filling Systems Market in Europe, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.24 Isolator based Aseptic Filling Systems Market in France, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.25 Isolator based Aseptic Filling Systems Market in Germany, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.26 Isolator based Aseptic Filling Systems Market in the UK, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.27 Isolator based Aseptic Filling Systems Market in Italy, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.28 Isolator based Aseptic Filling Systems Market in Spain, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.29 Isolator based Aseptic Filling Systems Market in Austria, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.30 Isolator based Aseptic Filling Systems Market in Switzerland, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.31 Isolator based Aseptic Filling Systems Market in Rest of Europe, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.32 Isolator based Aseptic Filling Systems Market in Asia-Pacific, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.33 Isolator based Aseptic Filling Systems Market in China, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.34 Isolator based Aseptic Filling Systems Market in India, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.35 Isolator based Aseptic Filling Systems Market in Japan, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.36 Isolator based Aseptic Filling Systems Market in South Korea, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.37 Isolator based Aseptic Filling Systems Market in Rest of Asia-Pacific, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.38 Isolator based Aseptic Filling Systems Market in Rest of the World, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.39 Isolator based Aseptic Filling Systems Market in Argentina, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.40 Isolator based Aseptic Filling Systems Market in Brazil, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.41 Isolator based Aseptic Filling Systems Market in Israel, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.42 Isolator based Aseptic Filling Systems Market in Iran, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 9.43 Isolator based Aseptic Filling Systems Market in Other Countries, Historical Trends (2019-2023) and Forecasted Estimates (2024-2035) (USD Million)
• Figure 10.1 Concluding Remarks: Current Market Landscape of Isolator based Aseptic Filling Systems
• Figure 10.2 Concluding Remarks: Current Developer Landscape of Isolator based Aseptic Filling Systems
• Figure 10.3 Concluding Remarks: Market Sizing and Opportunity Analysis (I/II)
• Figure 10.4 Concluding Remarks: Market Sizing and Opportunity Analysis (II/II)

The Aseptic Filling Machine Market is valued at USD 1,365 million in 2024 growing at a CAGR of 8.7% during the forecast period 2024-2035.

Fill/finish is a critical aspect of pharmaceutical manufacturing, and ensuring the safety of formulations enclosed in primary containers is imperative. Despite being a well-established process, the contemporary drug filling process is plagued by concerns such as contamination, filling errors, and labelling issues. In fact, experts estimate that around 80% of product recalls can be attributed to packaging-related concerns, highlighting the significance of contamination as a key concern. To ensure consumer safety, an aseptic environment is maintained during the fill/finish step. However, manual intervention in filling lines poses a threat to product safety, as it increases the risk of contamination from contact with laborers. Furthermore, it is inefficient and can lead to inaccuracies in dose dispensation.

The growing complexity of modern pharmaceuticals has created a need for automation of routine tasks, such as fill/finish. This has resulted in increased demands for specialized equipment and infrastructure, as well as handling expertise. Over the past two decades, pharma equipment manufacturers have developed more efficient, reliable, and cost-effective machinery that incorporates isolators and restricted access barrier systems (RABS) in their proprietary aseptic fill/finish lines. These systems eliminate the need for human intervention, thereby reducing the risk of operator-associated contamination. Moreover, filling lines with isolated equipment has been associated with significant cost savings opportunities. In such cases, developers can opt for smaller, lower-cost cleanrooms instead of investing in large high-end facilities.

To date, over 230 isolator-based filling and closing systems are available in the market, with ongoing innovation efforts aimed at improving performance. Given the growing number of biopharmaceutical product candidates under development, the opportunity for aseptic fill/finish equipment developers is expected to continue growing at a substantial pace over the next decade.

Key Market Segments

Type of Primary Container

• Vials
• Syringes
• Cartridges
• Ampoules
• Capsules
• Other Container

Scale of Operation

• Clinical
• Commercial

System Throughput

• Low
• Medium
• High

End-user

• Pharma / Biotech Companies
• Contract Manufacturing Organizations

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

Research Coverage:

• The report provides a comprehensive analysis of the isolator-based aseptic filling systems landscape, highlighting the key contributions of industry players and offering insights into various aspects of the systems. This includes information on the type of system (filling, filling and closing, and turnkey), maximum system throughput (ranging from up to 1,000 units per hour to over 60,000 units per hour), and compatible primary container types (such as ampoules, bags, bottles, capsules, cartridges, syringes, vials, and other containers). Additionally, the report delves into the features of isolator-based aseptic filling systems developers, including their year of establishment, company size (measured by employee count), and location of headquarters (North America, Europe, Asia-Pacific, and Rest of the World). The report also provides an in-depth analysis of leading players in this space.
• Comprehensive competitiveness analysis of isolator based aseptic filling systems, taking into consideration the scale of operation, system throughput, compatible primary containers, type of formulation and other important product related specifications.
• Detailed profiles of companies offering isolator based aseptic filling systems. Each profile features a brief overview of the company, proprietary products, recent developments and an informed future outlook.
• In-depth discussion on the general regulatory guidelines for aseptic processing, and specific recommendations related to isolator and blow-fill-seal technologies used in the aseptic fill / finish process.
• An analysis of various developments / recent trends related to aseptic processing market, offering insights on partnerships and collaborations established within the aseptic filling machine industry, and conferences held in this space.
• Detailed estimate of the current market size and potential future growth of the isolator-based aseptic filling machine market over the next decade. This estimate is based on various factors, including likely adoption trends and data from both primary and secondary sources. Our forecast for the market's revenue growth period till 2035 is informed and reliable. To account for future uncertainties and add robustness to our model, we have also developed three isolator-based aseptic filling machine market forecast scenarios: conservative, base, and optimistic. These scenarios represent different possible tracks of market growth.

Key Benefits of Buying this Report

• The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with a pulse on the Aseptic Filling Machine Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

TABLE OF CONTENTS

1. PREFACE

• 1.1 Introduction
• 1.2 Market Share Insights
• 1.3 Key Market Insights
• 1.4 Report Coverage
• 1.5 Key Questions Answered
• 1.6 Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

• 3.1 Chapter Overview
• 3.2 Overview of Drug Fill / Finish Processes
• 3.3 Traditional Methods of Fill / Finish
• 3.4 Aseptic Fill / Finish Technique
• 3.5 Need for Aseptic Fill / Finish Techniques
• 3.6 Advanced Aseptic Fill / Finish Processes: Blow-Fill-Seal Aseptic Technology
  • 3.6.1 Isolator Systems
  • 3.6.2 Restricted Access Barrier Systems (RABS)
  • 3.6.3 Comparison between Isolator Systems and RABS
• 3.7 Advantages of Advanced Aseptic Fill / Finish Techniques
• 3.8 Regulatory Guidelines for Aseptic Fill / Finish
• 3.9 Future Perspectives

4. ISOLATOR BASED ASEPTIC FILLING SYSTEMS: OVERALL MARKET LANDSCAPE

• 4.1 Chapter Overview
• 4.2 Isolator based Aseptic Filling Systems: Overall Market Landscape
  • 4.2.1 Analysis by Type of System
  • 4.2.2 Analysis by Maximum System Throughput
  • 4.2.3 Analysis by Type of Compatible Primary Container
  • 4.2.4 Analysis by Type of Formulation
• 4.3 Isolator based Aseptic Filling Systems: Developer Landscape
  • 4.3.1 Analysis by Year of Establishment
  • 4.3.2 Analysis by Company Size
  • 4.3.3 Analysis by Location of Headquarters
  • 4.3.4 Leading Players: Analysis by Number of Systems Offered

5. ISOLATOR BASED ASEPTIC FILLING AND CLOSING SYSTEMS: PRODUCT COMPETITIVENESS ANALYSIS

• 5.1 Chapter Overview
• 5.2 Methodology and Key Parameters
• 5.3 Product Competitiveness Analysis: Peer Group I
• 5.4 Product Competitiveness Analysis: Peer Group II
• 5.5 Product Competitiveness Analysis: Peer Group III

6. COMPANY PROFILES

• 6.1 Chapter Overview
• 6.2 AST
  • 6.2.1 Company Overview
  • 6.2.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.2.3 Recent Developments and Future Outlook
• 6.3 Bausch+Strobel
  • 6.3.1 Company Overview
  • 6.3.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.3.3 Recent Developments and Future Outlook
• 6.4 Dara Pharma
  • 6.4.1 Company Overview
  • 6.4.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.4.3 Recent Developments and Future Outlook
• 6.5 Groninger
  • 6.5.1 Company Overview
  • 6.5.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.5.3 Recent Developments and Future Outlook
• 6.6 IMA Group
  • 6.6.1 Company Overview
  • 6.6.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.6.3 Recent Developments and Future Outlook
• 6.7 Marchesini Group
  • 6.7.1 Company Overview
  • 6.7.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.7.3 Recent Developments and Future Outlook
• 6.8 OPTIMA
  • 6.8.1 Company Overview
  • 6.8.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.8.3 Recent Developments and Future Outlook
• 6.9 Syntegon
  • 6.9.1 Company Overview
  • 6.9.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.9.3 Recent Developments and Future Outlook
• 6.10 Tofflon
  • 6.10.1 Company Overview
  • 6.10.2 Isolator based Aseptic Filling Machines Portfolio
  • 6.10.3 Recent Developments and Future Outlook

7. RECENT DEVELOPMENTS

• 7.1 Chapter Overview
• 7.2 Partnership Models
• 7.3 Isolator based Aseptic Filling Systems Market: Partnership Activity
  • 7.3.1 List of Partnerships and Collaborations
    • 7.3.1.1 Analysis by Year of Partnership
    • 7.3.1.2 Analysis by Type of Partnership
    • 7.3.1.3 Most Active Players: Analysis by Number of Partnerships
• 7.4 Isolator based Aseptic Filling Systems Market: Recent Conferences
  • 7.4.1 List of Recent Conferences
    • 7.4.1.1 Analysis by Year of Occurrence
    • 7.4.1.2 Analysis by Geography
• 7.5 Concluding Remarks

8. REGULATORY GUIDELINES: ASEPTIC PROCESSING

• 8.1 Chapter Overview
• 8.2 Overview of Cleanroom Grades
• 8.3 General Guidelines for Aseptic Processing
  • 8.3.1 Requirements for Buildings and Facilities
  • 8.3.2 Requirements for Personnel Training, Qualification and Monitoring
  • 8.3.3 Requirements for Components and Containers / Closures
• 8.4 Guidelines for Using Isolator Technology
• 8.5 Guidelines for Using Blow / Fill / Seal Technology

9. MARKET FORECAST AND OPPORTUNITY ANALYSIS

• 9.1 Chapter Overview
• 9.2 Key Assumptions and Methodology
• 9.3 Global Isolator based Aseptic Filling Systems Market: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
• 9.4 Isolator based Aseptic Filling Systems Market: Distribution by Scale of Operation, 2019, 2024 and 2035
  • 9.4.1 Isolator based Aseptic Filling Systems Market for Commercial Scale Systems: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.4.2 Isolator based Aseptic Filling Systems Market for Clinical Scale Systems: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
• 9.5 Global Isolator based Aseptic Filling Systems Market: Distribution by Type of Compatible Primary Container, 2019, 2024 and 2035
  • 9.5.1 Isolator based Aseptic Filling Systems Market for Vials: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.5.2 Isolator based Aseptic Filling Systems Market for Syringes: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.5.3 Isolator based Aseptic Filling Systems Market for Cartridges: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.5.4 Isolator based Aseptic Filling Systems Market for Ampoules: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.5.5 Isolator based Aseptic Filling Systems Market for Capsules: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.5.6 Isolator based Aseptic Filling Systems Market for Other Primary Containers: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
• 9.6 Global Isolator based Aseptic Filling Systems Market: Distribution by System Throughput, 2019, 2024 and 2035
  • 9.6.1 Isolator based Aseptic Filling Systems Market for High Throughput Systems: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.6.2 Isolator based Aseptic Filling Systems Market for Medium Throughput Systems: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.6.3 Isolator based Aseptic Filling Systems Market for Low Throughput Systems: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
• 9.7 Global Isolator based Aseptic Filling Systems Market: Distribution by End-user, 2019, 2024 and 2035
  • 9.7.1 Isolator based Aseptic Filling Systems Market for Pharma / Biotech Companies: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.7.2 Isolator based Aseptic Filling Systems Market for Contract Service Providers: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
• 9.8 Isolator based Aseptic Filling Systems Market: Distribution by Key Geographical Regions, 2019, 2024 and 2035
  • 9.8.1 Isolator based Aseptic Filling Systems Market in North America: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.1.1 Isolator based Aseptic Filling Systems Market in the US: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.1.2 Isolator based Aseptic Filling Systems Market in Canada: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.8.2 Isolator based Aseptic Filling Systems Market in Europe: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.1 Isolator based Aseptic Filling Systems Market in France: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.2 Isolator based Aseptic Filling Systems Market in Germany: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.3 Isolator based Aseptic Filling Systems Market in the UK: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.4 Isolator based Aseptic Filling Systems Market in Italy: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.5 Isolator based Aseptic Filling Systems Market in Spain: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.6 Isolator based Aseptic Filling Systems Market in Austria: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.7 Isolator based Aseptic Filling Systems Market in Switzerland: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.2.8 Isolator based Aseptic Filling Systems Market in Rest of Europe: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.8.3 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.3.1 Isolator based Aseptic Filling Systems Market in China: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.3.2 Isolator based Aseptic Filling Systems Market in India: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.3.3 Isolator based Aseptic Filling Systems Market in Japan: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.3.4 Isolator based Aseptic Filling Systems Market in South Korea: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.3.5 Isolator based Aseptic Filling Systems Market in Rest of Asia-Pacific: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
  • 9.8.4 Isolator based Aseptic Filling Systems Market in Rest of the World: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.4.1 Isolator based Aseptic Filling Systems Market in Argentina: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.4.2 Isolator based Aseptic Filling Systems Market in Brazil : Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.4.3 Isolator based Aseptic Filling Systems Market in Israel: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.4.4 Isolator based Aseptic Filling Systems Market in Iran: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)
    • 9.8.4.5 Isolator based Aseptic Filling Systems Market in Other Countries: Historical Trends (2019-2023) and Forecasted Estimates (2024-2035)

10. CONCLUSION

• 10.1 Chapter Overview

11. EXECUTIVE INSIGHTS

• 11.1 Chapter Overview
• 11.2 Automated Systems of Tacoma (AST)
• 11.3 Interview Transcript: Joe Hoff, Chairman and CEO

12. APPENDIX I: TABULATED DATA

13. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS