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Isolator based Aseptic Filling Systems Market, 2020-2030

  • ID: 5215164
  • Report
  • October 2020
  • Region: Global
  • 170 Pages
  • Roots Analysis

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FEATURED COMPANIES

  • ACG
  • Carlo Corazza
  • Extract Technology
  • LG Life Sciences
  • Pfizer
  • Singota Solutions

Overview

Fill/finish is considered a critical aspect of pharmaceutical manufacturing. It is, therefore, imperative for drug manufacturers to ensure that formulations enclosed in primary containers are safe for consumption/administration. Despite being well established, there are several concerns associated with the contemporary drug filling process, such as the risk of contamination, filling errors (inaccurate dose dispensation), and labelling-related issues. In fact, experts in the industry believe that around 80% of product recalls may be attributed to packaging-related concerns.  Contamination is one of the key concerns related to fill/finish operations. To ensure the safety of consumers, a lot of effort is put into maintaining an aseptic environment during the fill/finish step. In this regard, manual intervention in filling lines is not only a threat to product safety (being more susceptible to contamination from contact with laborers), but also inefficient. Over the years, the growing complexity of modern pharmaceuticals (especially biologic drugs and complex small molecule APIs), has created a corresponding need for the automation of routine, repetitive tasks, such as fill/finish. As a result, the drug filling process is gradually becoming more demanding, in terms of specialized equipment and infrastructure, and handling expertise.

Over the past couple of decades, pharma equipment manufacturers have developed more efficient, reliable and cost-effective machinery, involving the required isolators and restricted access barrier systems (RABS), to their proprietary filling lines. Many of such systems are designed to eliminate the need for human intervention, thereby, addressing the risk of operator-associated contamination. In addition, the use of filling lines where parts of the equipment are individually isolated, has been associated with notable cost saving opportunities. In such cases, developers need not invest in large, high-end cleanrooms for housing such filling lines. Currently, over 130 isolator-based filling and closing systems are available in the market, and equipment developers are still engaged in further improvement efforts.Given that more than 5,000 biopharmaceutical product candidates are currently under development, the opportunity for aseptic fill/finish equipment developers is anticipated to continue to grow at a substantial pace over the next decade.

Scope of the Report

The ‘Isolator based Aseptic Filling Systems Market, 2020-2030’ report features an extensive study of the current landscape of isolator based aseptic filling systems and the future opportunities associated with such systems. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain.

In addition to other elements, the report features:

A detailed assessment of the overall landscape of the isolator based aseptic filling systems, highlighting the contribution of industry players and providing information on various types of systems (filling, and turnkey solutions), scale of operation (clinical and commercial), system throughput, compatible primary containers (ampoules, bottles, capsules, cartridges, syringes, vials and others), type of formulation and range of fill volume.
An insightful 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.
Elaborate profiles of companies offering isolator based aseptic filling systems. Each profile features a brief overview of the company, its financial information (if available), proprietary product(s), recent developments and an informed future outlook.
A discussion on 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 [A] partnerships and collaborations established within the industry, and [B] conferences held in this space.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity within the market. Based on several parameters, such as annual fill/finish pharma capacity, number of automatic filling lines installed and growth trends across various geographies, we have provided an informed estimate of the likely evolution of the market, in the mid to long term, for the period 2020-2030. The chapter features the likely distribution of the opportunity across [A] scale of operation (clinical and commercial), [B] type of compatible primary container (ampoules, bottles, capsules, cartridges, syringes, vials and others), [C] system throughput (low throughput, medium throughput and high throughput), [D] end-user (pharmaceutical companies, contract service providers and others) and [E] geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with stakeholders in this domain.

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • ACG
  • Carlo Corazza
  • Extract Technology
  • LG Life Sciences
  • Pfizer
  • Singota Solutions

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Drug Fill/Finish Processes
3.3. Aseptic Fill/Finish Technique
3.4. Need for Aseptic Fill/Finish
3.5. Traditional Aseptic Fill/Finish Processes
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: CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Isolator based Aseptic Filling Systems: Overall Market Overview
4.2.1. Analysis by Type of System
4.2.2. Analysis by Scale of Operation
4.2.4. Analysis by System Throughput
4.2.5 Analysis by Compatible Primary Container(s)
4.2.6. Analysis by Type of Formulation
4.2.7. Analysis by Fill Volume Range
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 Proprietary Systems

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. AST
6.1.1. Company Overview
6.1.2. Recent Developments and Future Outlook
6.2. Bausch+Ströbel
6.2.1. Company Overview
6.2.2. Recent Developments and Future Outlook
6.3. Dara Pharmaceutical Packaging
6.3.1. Company Overview
6.3.2. Recent Developments and Future Outlook
6.4. Groninger
6.4.1. Company Overview
6.4.2. Recent Developments and Future Outlook
6.5. IMA Group
6.5.1. Company Overview
6.5.2. Recent Developments and Future Outlook
6.6. Marchesini Group
6.6.1. Company Overview
6.6.2. Recent Developments and Future Outlook
6.7. OPTIMA Packaging Group
6.7.1. Company Overview
6.7.2. Recent Developments and Future Outlook
6.8. Syntegon
6.8.1. Company Overview
6.8.2. Recent Developments and Future Outlook
6.9. Tofflon Group
6.9.1. Company Overview
6.9.2. Recent Developments and Future Outlook
6.10. Vanrx Pharmasystems
6.10.1. Company Overview
6.10.2. 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
7.3.2.1. Analysis by Year of Partnership
7.3.2.2. Analysis by Type of Partnership
7.3.2.3. Analysis by Focus Area
7.3.2.4. 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
7.4. 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
9.1. Chapter Overview
9.2. Forecast Methodology and Key Assumptions
9.3. Overall Isolator based Aseptic Filling Systems Market, 2020-2030
9.4. Overall Isolator based Aseptic Filling Systems Market: Distribution by Scale of Operation, 2020-2030
9.5. Overall Isolator based Aseptic Filling Systems Market: Distribution by Type of Compatible Primary Container, 2020-2030
9.6. Overall Isolator based Aseptic Filling Systems Market: Distribution by System Throughput, 2020-2030
9.7. Overall Isolator based Aseptic Filling Systems Market: Distribution by End-User, 2020-2030
9.8. Overall Isolator based Aseptic Filling Systems Market in North America, 2020-2030
9.8.1. Isolator based Aseptic Filling Systems Market in North America: Distribution by Scale of Operation, 2020-2030
9.8.1.1 Isolator based Aseptic Filling Systems Market in North America: Share of Clinical Scale Systems, 2020-2030
9.8.1.2. Isolator based Aseptic Filling Systems Market in North America: Share of Commercial Scale Systems, 2020-2030
9.8.2. Isolator based Aseptic Filling Systems Market in North America: Distribution by Type of Compatible Primary Container, 2020-2030
9.8.2.1 Isolator based Aseptic Filling Systems Market in North America: Share of Ampoules, 2020-2030
9.8.2.2 Isolator based Aseptic Filling Systems Market in North America: Share of Bottles, 2020-2030
9.8.2.3. Isolator based Aseptic Filling Systems Market in North America: Share of Capsules, 2020-2030
9.8.2.4. Isolator based Aseptic Filling Systems Market in North America: Share of Cartridges, 2020-2030
9.8.2.5. Isolator based Aseptic Filling Systems Market in North America: Share of Syringes, 2020-2030
9.8.2.6. Isolator based Aseptic Filling Systems Market in North America: Share of Vials, 2020-2030
9.8.2.7. Isolator based Aseptic Filling Systems Market in North America: Share of Other Primary Containers, 2020-2030
9.8.3. Isolator based Aseptic Filling Systems Market in North America: Distribution by System Throughput, 2020-2030
9.8.3.1. Isolator based Aseptic Filling Systems Market in North America: Share of Low Throughput Systems, 2020-2030
9.8.3.2. Isolator based Aseptic Filling Systems Market in North America: Share of Medium Throughput Systems, 2020-2030
9.8.3.4. Isolator based Aseptic Filling Systems Market in North America: Share of High Throughput Systems, 2020-2030
9.8.4. Isolator based Aseptic Filling Systems Market in North America: Distribution by End-User, 2020-2030
9.8.4.1 Isolator based Aseptic Filling Systems Market in North America: Share of Contract Service Providers, 2020-2030
9.8.4.2 Isolator based Aseptic Filling Systems Market in North America: Share of Pharmaceutical Companies, 2020-2030
9.8.4.3 Other End-Users, 2020-2030Isolator based Aseptic Filling Systems Market in North America: Share of Other End-Users, 2020-2030
9.9. Overall Isolator based Aseptic Filling Systems Market in Europe, 2020-2030
9.9.1. Isolator based Aseptic Filling Systems Market in Europe: Distribution by Scale of Operation, 2020-2030
9.9.1.1 Isolator based Aseptic Filling Systems Market in Europe: Share of Clinical Scale Systems, 2020-2030
9.9.1.2. Isolator based Aseptic Filling Systems Market in Europe: Share of Commercial Scale Systems, 2020-2030
9.9.2. Isolator based Aseptic Filling Systems Market in Europe: Distribution by Type of Compatible Primary Container, 2020-2030
9.9.2.1 Isolator based Aseptic Filling Systems Market in Europe: Share of Ampoules, 2020-2030
9.9.2.2 Isolator based Aseptic Filling Systems Market in Europe: Share of Bottles, 2020-2030
9.9.2.3 Isolator based Aseptic Filling Systems Market in Europe: Share of Capsules, 2020-2030
9.9.2.4 Isolator based Aseptic Filling Systems Market in Europe: Share of Cartridges, 2020-2030
9.9.2.5 Isolator based Aseptic Filling Systems Market in Europe: Share of Syringes, 2020-2030
9.9.2.6 Isolator based Aseptic Filling Systems Market in Europe: Share of Vials, 2020-2030
9.9.2.7 Isolator based Aseptic Filling Systems Market in Europe: Share of Other Primary Containers, 2020-2030
9.9.3. Isolator based Aseptic Filling Systems Market in Europe: Distribution by System Throughput, 2020-2030
9.9.3.1 Isolator based Aseptic Filling Systems Market in Europe: Share of Low Throughput Systems, 2020-2030
9.9.3.2 Isolator based Aseptic Filling Systems Market in Europe: Share of Medium Throughput Systems, 2020-2030
9.9.3.3. Isolator based Aseptic Filling Systems Market in Europe: Share of High Throughput Systems, 2020-2030
9.9.4. Isolator based Aseptic Filling Systems Market in Europe: Distribution by End-User, 2020-2030
9.9.4.1 Isolator based Aseptic Filling Systems Market in Europe: Share of Contract Service Providers, 2020-2030
9.9.4.2 Isolator based Aseptic Filling Systems Market in Europe: Share of Pharmaceutical Companies, 2020-2030
9.9.4.3 Isolator based Aseptic Filling Systems Market in Europe: Share of Other End-Users, 2020-2030
9.10. Overall Isolator based Aseptic Filling Systems Market in Asia-Pacific, 2020-2030
9.10.1. Isolator based Aseptic Filling Systems Market in Asia-Pacific: Distribution by Scale of Operation, 2020-2030
9.10.1.1 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Clinical Scale Systems, 2020-2030
9.10.1.2. Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Commercial Scale Systems, 2020-2030
9.10.2. Isolator based Aseptic Filling Systems Market in Asia-Pacific: Distribution by Type of Compatible Primary Container, 2020-2030
9.10.2.1 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Ampoules, 2020-2030
9.10.2.2 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Bottles, 2020-2030
9.10.2.3 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Capsules, 2020-2030
9.10.2.4 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Cartridges, 2020-2030
9.10.2.5 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Syringes, 2020-2030
9.10.2.6 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Vials, 2020-2030
9.10.2.7 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Other Primary Containers, 2020-2030
9.10.3. Isolator based Aseptic Filling Systems Market in Asia-Pacific: Distribution by System Throughput, 2020-2030
9.10.3.1 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Low Throughput Systems, 2020-2030
9.10.3.2 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Medium Throughput Systems, 2020-2030
9.10.3.3 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of High Throughput Systems, 2020-2030
9.10.4. Isolator based Aseptic Filling Systems Market in Asia-Pacific: Distribution by End-User, 2020-2030
9.10.4.1 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Contract Service Providers, 2020-2030
9.10.4.2 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Pharmaceutical Companies, 2020-2030
9.10.4.3 Isolator based Aseptic Filling Systems Market in Asia-Pacific: Share of Other End-Users, 2020-2030
9.11. Overall Isolator based Aseptic Filling Systems Market in Rest of the World, 2020-2030
9.11.1. Isolator based Aseptic Filling Systems Market in Rest of the World: Distribution by Scale of Operation, 2020-2030
9.11.1.1 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Clinical Scale Systems, 2020-2030
9.11.1.2. Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Commercial Scale Systems, 2020-2030
9.11.2. Isolator based Aseptic Filling Systems Market in Rest of the World: Distribution by Type of Compatible Primary Container, 2020-2030
9.11.2.1 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Ampoules, 2020-2030
9.11.2.2 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Bottles, 2020-2030
9.11.2.3 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Capsules, 2020-2030
9.11.2.4 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Cartridges, 2020-2030
9.11.2.5 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Syringes, 2020-2030
9.11.2.6 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Vials, 2020-2030
9.11.2.7 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Other Primary Containers, 2020-2030
9.11.3. Isolator based Aseptic Filling Systems Market in Rest of the World: Distribution by System Throughput, 2020-2030
9.11.3.1 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Low Throughput Systems, 2020-2030
9.11.3.2 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Medium Throughput Systems, 2020-2030
9.11.3.3 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of High Throughput Systems, 2020-2030
9.11.4. Isolator based Aseptic Filling Systems Market in Rest of the World: Distribution by End-User, 2020-2030
9.11.4.1 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Contract Service Providers, 2020-2030
9.11.4.2 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Pharmaceutical Companies, 2020-2030
9.11.4.3 Isolator based Aseptic Filling Systems Market in Rest of the World: Share of Other End-Users, 2020-2030

10. CONCLUSION
10.1. Chapter Overview
10.2. Key Takeaways

11. EXECUTIVE INSIGHTS
11.1. Chapter Overview
11.2. Automated Systems of Tacoma (AST)
11.2.1. Interview Transcript: Joe Hoff, Chairman and CEO

12. APPENDIX 1: TABULATED DATA

Note: Product cover images may vary from those shown
  • ACG
  • ACIC Pharmaceutical Machinery
  • Advaxis
  • Aflex Hose
  • Ambica Pharma Machines
  • Anchor Mark
  • Antares Vision
  • ARaymondlife
  • Argonaut Manufacturing Services
  • Aseptic Technologies
  • Auteco Sistemi
  • Automated Systems of Tacoma (AST)
  • AWS Bio-Pharma Technologies
  • AXOMATIC
  • BAUSCH Advanced Technology Group
  • Bausch+Ströbel
  • Bosch Packaging Technology
  • Carlo Corazza
  • Catalent
  • Charles Thompson
  • CMP PHAR.MA
  • Comecer
  • COOLVACUUM Technologies
  • CPi Technology
  • Creinox
  • CVC Capital Partners
  • Daikyo Seiko
  • Dara Pharma
  • Extract Technology
  • FUJIFILM Diosynth Biotechnologies
  • G-CON Manufacturing
  • GEA Group
  • Getinge
  • gmp-experts Beratungs
  • groninger
  • Harro Höfliger
  • i-Dositecno
  • IMA Group
  • Inno4Life
  • Klenzaids
  • LG Life Sciences
  • Libbs Farmaceutica
  • M&O Perry Industries
  • Maier Packaging
  • Marchesini Group
  • Martin Christ Freeze Dryers
  • Massachusetts Institute of Technology
  • MEDInstill
  • Netsteril
  • NJM Packaging
  • Nova Laboratories
  • OPTIMA
  • PennTech Machinery
  • Pfizer
  • Pharmaceutics International (Pii)
  • Quality Machines
  • Romaco
  • ROTA
  • säntis Packaging
  • Schematic Engineering Industries
  • Schmucker
  • SCHOTT KAISHA
  • SEA Vision
  • Shanghai Divine Medical Technology
  • Shanghai Jianzhong Medical Packaging
  • Shibuya
  • Shilpa Medicare
  • Shree Bhagwati Machtech
  • Singota Solutions
  • SKAN
  • Snowbell Machines
  • SP Scientific
  • SPIMACO
  • Steriline
  • Stevanato Group
  • Syntegon
  • TELSTAR
  • Terra Asia Consulting
  • Thai Industrial Pharmacist Association (TIPA)
  • Tofflon
  • TRUKING TECHNOLOGY
  • Vanrx Pharmasystems
  • Vibrotech
  • VITRONIC Machine Vision
  • Watson-Marlow Fluid Technology Group
  • Wipf
Note: Product cover images may vary from those shown

 

 

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