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Container Closure Integrity Testing Market by Type of Container Closure Systems, Type of Container Materials Tested, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035

January 2022 | 212 pages | ID: CA6566AAE59CEN
Roots Analysis

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Container Closure Integrity Testing Market by Type(s) of Container(s) Tested (Vials, Syringes, and Cartridges), Type(s) of Container Material(s) Tested (Glass and Plastic), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World): Industry Trends and Global Forecasts, 2022-2035

Report Link: https://www.rootsanalysis.com/reports/container-closure-integrity-testing-services-market.html

The container closure integrity testing market is currently valued at $228 million in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of 7% throughout the forecast period.

Packaging plays a pivotal role in pharmaceutical manufacturing, making it crucial for drug manufacturers to ensure the safety of formulations enclosed in primary containers. Despite its well-established nature, drug packaging processes raise several concerns, including the risk of contamination, filling errors, the complexity of packaging systems, and integrity-related issues (such as pores, cracks, and scratches) in container closure systems like vials, syringes, cartridges, IV bags, and ampoules. Labeling issues also contribute to these concerns, and it's estimated that packaging-related problems account for about 80% of product recalls. To safeguard consumers, extensive efforts are directed towards eliminating contamination, preventing filling errors, and preserving the integrity of packaged formulations.

The industry has introduced numerous innovative techniques and technologies for evaluating both primary and secondary packaging components to maintain the sterility and stability of drug products. Regulatory bodies have implemented stringent guidelines for packaging integrity testing, making it a critical aspect of the overall manufacturing process. These testing methods ensure precision and accuracy in leak detection, offer rapid results, are non-destructive, cost-effective, reliable, and can be easily integrated into the manufacturing process.

Despite the advantages of container closure and packaging integrity testing methods, there is no one-size-fits-all solution to evaluate all types of primary packaging. Pharmaceutical and biopharmaceutical companies face various challenges when it comes to implementing container closure and packaging integrity testing equipment due to limited expertise and infrastructure. As a result, drug manufacturers often rely on container closure integrity testing service providers that possess well-equipped infrastructure, employ novel technology platforms, and have the required expertise. Outsourcing container closure and packaging integrity testing helps innovators serve clients in a timely and regulation-compliant manner. With the expected growth in the drug product market, the demand for packaging services is likely to increase in the future, leading to a rising demand for integrity testing services. Continuous advancements in testing methods and the cost-saving potential of these methods, by reducing product wastage and ensuring drug and patient safety, are anticipated to drive steady market growth in the overall container closure integrity testing market during the forecast period.

Key Market Segments

Type(s) of Container(s) Tested
  • Vials
  • Syringes
  • Cartridges
Type(s) of Container Material(s) Tested
  • Glass
  • Plastic
Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • MENA
  • Rest of the World
Research Coverage:
  • The report studies the container closure integrity testing market by type of sensor, type of bioprocessing and key geographical regions.
  • The report analyzes factors (such as drivers, restraints, opportunities, and challenges) affecting the market growth.
  • The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.
  • The report forecasts the revenue of market segments with respect to major regions.
  • An overview of key findings from our research on the container closure integrity testing market, offering insights into its current state and likely evolution in the short, mid, and long term.
  • Detailed assessment of the current container closure integrity testing service providers, including year of establishment, company size, headquarters location, analytical facility location, types of analytical methods (probabilistic and deterministic), types of probabilistic methods (microbial ingress analysis, aerosol testing, dye ingress analysis, bubble testing, and tracer gas detection), types of deterministic methods (helium leak analysis, vacuum/pressure decay analysis, mass extraction analysis, high voltage leak detection, headspace analysis), leakage susceptibility (solid, liquid, gas), types of containers tested (vials, syringes, cartridges, pouches, IV bags, ampoules, others), and accreditations (EMA, FDA, USP, ATSM, JP, ICH Q2, ISO, others).
  • Competitiveness analysis of container closure integrity testing service providers based on supplier power (experience, company size), service strength (analytical methods, probabilistic methods, deterministic methods, containers tested), and service applicability (container materials, leakage susceptibility).
  • Tabulated profiles of key North American and European container closure integrity testing service providers, including company overview, financial performance (if available), service portfolio, analytical methods, containers tested, recent developments, and future outlook.
  • Case study listing equipment used for container closure integrity testing, highlighting key features, analytical methods, containers tested, and container closure material.
  • Competitiveness analysis of container closure integrity testing equipment based on product strength (scale of operation, analytical methods) and product applicability (material types, container types).
  • Regional capability assessment framework comparing container closure integrity testing capabilities across regions based on several parameters like the number of service providers, analytical facilities, technology manufacturers, testing technologies, patents, and demand.
  • Detailed analysis of various container closure integrity testing analytical techniques, highlighting popularity and providing a benchmark for comparison.
  • Case study on the use of robotic machinery in pharmaceutical manufacturing and fill/finish operations, focusing on automation advantages and industry player profiles.
  • In-depth analysis to estimate current and future demand for container closure integrity testing services based on container closure systems and materials, across regions for 2022-2035.
  • Discussion on industry trends, key drivers, challenges within a comprehensive SWOT framework, including a Harvey ball analysis showing the relative impact of each SWOT parameter on the industry.
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 container closure integrity testing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.
  • You will get access to complimentary PPT insights and excel data packs / dynamic dashboards to easily navigate through complex analyses / charts.
Key Market Companies
  • Confarma, Eurofins
  • SGS
  • Stevanato
  • Wilco
  • Berkshire Sterile Manufacturing
  • Curia
  • DDL
  • Nelson Labs
1. PREFACE

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

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Primary Packaging: Container Closure Systems
3.3. Types of Container Closure Systems
3.4. Problems Related to Container Closure Systems
  3.4.1. Types of Contamination
  3.4.2. Defects in Container Closure Systems
3.5. Container Closure Integrity testing (CCI Testing)
3.6. Methods of Container Closure Integrity Testing
3.7. Advantages of Container Closure Integrity Testing Over Sterility Testing
3.8. Role of CCIT Service Providers
3.9. Future Perspective

4. MARKET LANDSCAPE

4.1. Chapter Overview
4.2. Container Closure Integrity Testing Service Providers: Market Landscape
  4.2.1. Analysis by Year of Establishment
  4.2.2. Analysis by Company Size
  4.2.3. Analysis by Location of Headquarters
  4.2.4. Analysis by Company Size and Location of Headquarters
  4.2.5. Analysis by Location of Analytical Facilities
  4.2.6. Analysis by Type(s) of Analytical Method(s) Offered
    4.2.6.1. Analysis by Type(s) of Probabilistic Method(s) Offered
    4.2.6.2. Analysis by Type(s) of Deterministic Method(s) Offered
  4.2.7. Analysis by Leakage Susceptibility
  4.2.8. Analysis by Type(s) of Container(s) Tested
  4.2.9. Analysis by Type(s) of Container Material(s) Tested
  4.2.10. Analysis by Accreditation(s) Received

5. COMPANY COMPETITIVENESS ANALYSIS

5.1. Chapter Overview
5.2. Methodology
5.3. Key Parameters
5.4. Competitiveness Analysis: Companies Offering Container Closure Integrity Testing Services in North America
5.5. Competitiveness Analysis: Companies Offering Container Closure Integrity Testing Services in Europe and Asia-Pacific
5.6. Competitiveness Analysis: Companies Offering Container Closure Integrity Testing Services in One Analytical Facility
5.7. Competitiveness Analysis: Companies Offering Container Closure Integrity Testing Services in More than Analytical Facility

6. CONTAINER CLOSURE INTEGRITY TESTING SERVICE PROVIDERS IN NORTH AMERICA: COMPANY PROFILES

6.1. Chapter Overview
6.2. Berkshire Sterile Manufacturing
  6.2.1. Company Overview
  6.2.2. Financial Information
  6.2.3. Service Portfolio
  6.2.4. Recent Developments and Future Outlook
6.3. Curia
  6.3.1. Company Overview
  6.3.2. Financial Information
  6.3.3. Service Portfolio
  6.3.4. Recent Developments and Future Outlook
6.4. DDL
  6.4.1. Company Overview
  6.4.2. Financial Information
  6.4.3. Service Portfolio
  6.4.4. Recent Developments and Future Outlook
6.5. Nelson Labs
  6.5.1. Company Overview
  6.5.2. Financial Information
  6.5.3. Service Portfolio
  6.5.4. Recent Developments and Future Outlook

7. CONTAINER CLOSURE INTEGRITY TESTING SERVICE PROVIDERS IN EUROPE: COMPANY PROFILES

7.1. Chapter Overview
7.2. Confarma
  7.2.1. Company Overview
  7.2.2. Financial Information
  7.2.3. Service Portfolio
  7.2.4. Recent Developments and Future Outlook
7.3. Eurofins
  7.3.1. Company Overview
  7.3.2. Financial Information
  7.3.3. Service Portfolio
  7.3.4. Recent Developments and Future Outlook
7.4. SGS
  7.4.1. Company Overview
  7.4.2. Financial Information
  7.4.3. Service Portfolio
  7.4.4. Recent Developments and Future Outlook
7.5. Stevanato
  7.5.1. Company Overview
  7.5.2. Financial Information
  7.5.3. Service Portfolio
  7.5.4. Recent Developments and Future Outlook
7.6. Wilco
  7.6.1. Company Overview
  7.6.2. Financial Information
  7.6.3. Service Portfolio
  7.6.4. Recent Developments and Future Outlook

8. CASE STUDY: MARKET LANDSCAPE OF CONTAINER CLOSURE INTEGRITY TESTING EQUIPMENT PROVIDERS

8.1. Chapter Overview
8.2. Container Closure Integrity Testing Equipment: Market Landscape
  8.2.1. Analysis by Scale of Operation
  8.2.2. Analysis by Key Features
  8.2.3. Analysis by Type(s) of Analytical Method(s) Offered
  8.2.4. Analysis by Type(s) of Container Material(s) Tested
  8.2.5. Analysis by Type(s) of Container(s) Tested
8.3. Container Closure Integrity Testing Equipment Providers: Developer Landscape
  8.3.1. Analysis by Year of Establishment
  8.3.2. Analysis by Company Size
  8.3.3. Analysis by Location of Headquarters
  8.3.4. Analysis by Company Size and Location of Headquarters
  8.3.5. Leading Developers: Analysis by Number of Products

9. PRODUCT COMPETITIVENESS ANALYSIS

9.1. Chapter Overview
9.2. Methodology
9.3. Assumptions / Key Parameters
9.4. Product Competitiveness Analysis: Container Closure Integrity Testing Equipment Offered by Small Players
9.5. Product Competitiveness Analysis: Container Closure Integrity Testing Equipment Offered by Mid-Sized Players
9.6. Product Competitiveness Analysis: Container Closure Integrity Testing Equipment Offered by Large Players
9.7. Product Competitiveness Analysis: Container Closure Integrity Testing Equipment Offered by Players Headquartered in North America
9.8. Product Competitiveness Analysis: Container Closure Integrity Testing Equipment Offered by Players Headquartered in Europe
9.9. Product Competitiveness Analysis: Container Closure Integrity Testing Equipment Offered by Players Headquartered in Asia-Pacific

10. REGIONAL CAPABILITY ASSESSMENT

10.1. Chapter Overview
10.2. Assumptions and Key Parameters
10.3. Container Closure Integrity Testing Capabilities in North America
10.4. Container Closure Integrity Testing Capabilities in Europe and Asia-Pacific
10.5. Concluding Remarks

11. BENCHMARKING ANALYSIS

11.1. Chapter Overview
11.2. Methodology Assumptions and Key Assumption
11.3. Advantages and Disadvantages of Deterministic Methods
11.4. Advantages and Disadvantages of Probabilistic Methods
11.5. Benchmarking of CCIT Techniques
  11.5.1. Distribution by Type(s) of Container(s) Tested
  11.5.2. Distribution by Type of Container Material Tested
  11.5.3. Distribution by Key Geographical Regions

12. CASE STUDY: ROBOTICS IN PHARMACEUTICAL PACKAGING

12.1. Chapter Overview
12.2. Role of Robots in the Pharmaceutical Industry
  12.2.1. Key Considerations for Selecting a Robotic System
  12.2.2. Advantages of Robotic Systems
  12.2.3. Disadvantages of Robotic Systems
12.3. Companies Providing Robots for Pharmaceutical Industry
12.4. Companies Providing Equipment Integrated with Robotic Systems for Pharmaceutical Packaging
  12.4.1. Aseptic Technologies
    12.4.1.1. Crystal® L1 Robot Line
    12.4.1.2. Crystal® SL1 Robot Line
  12.4.2. AST
    12.4.2.1. ASEPTiCell® Series
    12.4.2.2. ASEPTiCell® VSM-25
  12.4.3. Bosch Packaging Technology
    12.4.3.1. ATO
  12.4.4. Dara Pharmaceutical Packaging
    12.4.4.1. SYX-E CARTRIDGE + RABS
  12.4.5. Fedegari Group
    12.4.5.1. Fedegari Isolator
  12.4.6. IMA
    12.4.6.1. INJECTA
    12.4.6.2. STERI LIF3
  12.4.7. Steriline
    12.4.7.1. Nest Filling Line RNFM
  12.4.8. Vanrx Pharmasystems
    12.4.8.1. Microcell Vial Filler
    12.4.8.2. SA25 Aseptic Filling Workcell

13. DEMAND ANALYSIS

13.1. Chapter Overview
13.2. Scope and Methodology
13.3. Global Demand for Container Closure Integrity Testing Services, 2022-2035
  13.3.1. Analysis by Type of Container
    13.3.1.1. Global Demand for Vials, 2022-2035
    13.3.1.2. Global Demand for Syringes, 2022-2035
    13.3.1.3. Global Demand for Cartridges, 2022-2035
  13.3.2. Analysis by Type of Container Material
    13.3.2.1. Global Demand for Glass Containers, 2022-2035
      13.3.2.1.1. Global Demand for Glass Vials, 2022-2035
      13.3.2.1.2. Global Demand for Glass Syringes, 2022-2035
      13.3.2.1.3. Global Demand for Glass Cartridges, 2022-2035
    13.3.2.2. Global Demand for Plastic Containers, 2022-2035
      13.3.2.2.1. Global Demand for Plastic Vials, 2022-2035
      13.3.2.2.2. Global Demand for Plastic Syringes, 2022-2035
      13.3.2.2.3. Global Demand for Plastic Cartridges, 2022-2035
  13.3.3. Analysis by Geography
    13.3.3.1. Demand for Container Closure Integrity Testing Services in North America, 2022-2035
      13.3.3.1.1. Demand for Vials in North America, 2022-2035
      13.3.3.1.2. Demand for Syringes in North America, 2022-2035
      13.3.3.1.3. Demand for Cartridges in North America, 2022-2035
    13.3.3.2. Demand for Container Closure Integrity Testing Services in Europe, 2022-2035
      13.3.3.2.1. Demand for Vials in Europe, 2022-2035
    13.3.2.2. Demand for Syringes in Europe, 2022-2035
      13.3.3.2.3. Demand for Cartridges in Europe, 2022-2035
    13.3.3.3. Demand for Container Closure Integrity Testing Services in Asia Pacific, 2022-2035
      13.3.3.3.1. Demand for Vials in Asia Pacific, 2022-2035
      13.3.3.3.2. Demand for Syringes in Asia Pacific, 2022-2035
      13.3.3.3.3. Demand for Cartridges in Asia Pacific, 2022-2035
    13.3.3.4. Demand for Container Closure Integrity Testing Services in Middle East and North Africa, 2022-2035
      13.3.3.4.1. Demand for Vials in Middle East and North Africa, 2022-2035
      13.3.3.4.2. Demand for Syringes in Middle East and North Africa, 2022-2035
      13.3.3.4.3. Demand for Cartridges in Middle East and North Africa, 2022-2035
    13.3.3.5. Demand for Container Closure Integrity Testing Services in Latin America, 2022-2035
      13.3.3.5.1. Demand for Vials in Latin America, 2022-2035
      13.3.3.5.2. Demand for Syringes in Latin America, 2022-2035
      13.3.3.5.3. Demand for Cartridges in Latin America, 2022-2035
    13.3.3.6. Demand for Container Closure Integrity Testing Services in Rest of the World, 2022-2035
      13.3.3.6.1. Demand for Vials in Rest of the World, 2022-2035
      13.3.3.6.2. Demand for Syringes in Rest of the World, 2022-2035
      13.3.3.6.3. Demand for Cartridges in Rest of the World, 2022-2035
13.4. Concluding Remarks

14. MARKET FORECAST AND OPPORTUNITY ANALYSIS

14.1. Chapter Overview
14.2. Forecast Methodology and Key Assumptions
14.3. Global Container Closure Integrity Testing Services Market, 2022-2035
  14.3.1. Container Closure Integrity Testing Services Market, 2022-2035: Distribution by Type of Container
    14.3.1.1. Container Closure Integrity Testing Services Market for Vials, 2022-2035
    14.3.1.2. Container Closure Integrity Testing Services Market for Syringes, 2022-2035
    14.3.1.3. Container Closure Integrity Testing Services Market for Cartridges, 2022-2035
  14.3.2. Container Closure Integrity Testing Services Market, 2022-2035: Distribution by Type of Container Material Tested
    14.3.2.1. Container Closure Integrity Testing Services Market for Glass Containers, 2022-2035
      14.3.2.1.1. Container Closure Integrity Testing Services Market for Glass Vials, 2022-2035
      14.3.2.1.2. Container Closure Integrity Testing Services Market for Glass Syringes, 2022-2035
      14.3.2.1.3. Container Closure Integrity Testing Services Market for Glass Cartridges, 2022-2035
    14.3.2.2. Container Closure Integrity Testing Services Market for Plastic Containers Market, 2022-2035
      14.3.2.2.1. Container Closure Integrity Testing Services Market for Plastic Vials, 2022-2035
      14.3.2.2.2. Container Closure Integrity Testing Services Market for Plastic Syringes, 2022-2035
      14.3.2.2.3. Container Closure Integrity Testing Services Market for Plastic Cartridges, 2022-2035
  14.3.3. Container Closure Integrity Testing Services Market, 2022-2035: Distribution by Geography
    14.3.3.1. Container Closure Integrity Testing Services Market in North America, 2022-2035
      14.3.3.1.1. Container Closure Integrity Testing Services Market for Vials in North America, 2022-2035
      14.3.3.1.2. Container Closure Integrity Testing Services Market for Syringes in North America, 2022-2035
      14.3.3.1.3. Container Closure Integrity Testing Services Market for Cartridges in North America, 2022-2035
    14.3.3.1. Container Closure Integrity Testing Services Market in Europe, 2022-2035
      14.3.3.1.1. Container Closure Integrity Testing Services Market for Vials in Europe, 2022-2035
      14.3.3.1.2. Container Closure Integrity Testing Services Market for Syringes in Europe, 2022-2035
      14.3.3.1.3. Container Closure Integrity Testing Services Market for Cartridges in Europe, 2022-2035
    14.3.3.1. Container Closure Integrity Testing Services Market in Asia-Pacific, 2022-2035
      14.3.3.1.1. Container Closure Integrity Testing Services Market for Vials in Asia-Pacific, 2022-2035
      14.3.3.1.2. Container Closure Integrity Testing Services Market for Syringes in Asia-Pacific, 2022-2035
      14.3.3.1.3. Container Closure Integrity Testing Services Market for Cartridges in Asia-Pacific, 2022-2035
    14.3.3.1. Container Closure Integrity Testing Services Market in Middle East and North Africa, 2022-2035
      14.3.3.1.1. Container Closure Integrity Testing Services Market for Vials in Middle East and North Africa, 2022-2035
      14.3.3.1.2. Container Closure Integrity Testing Services Market for Syringes in Middle East and North Africa, 2022-2035
      14.3.3.1.3. Container Closure Integrity Testing Services Market for Cartridges in Middle East and North Africa, 2022-2035
    14.3.3.1. Container Closure Integrity Testing Services Market in Latin America, 2022-2035
      14.3.3.1.1. Container Closure Integrity Testing Services Market for Vials in Latin America, 2022-2035
      14.3.3.1.2. Container Closure Integrity Testing Services Market for Syringes in Latin America, 2022-2035
      14.3.3.1.3. Container Closure Integrity Testing Services Market for Cartridges in Latin America, 2022-2035
    14.3.3.1. Container Closure Integrity Testing Services Market in Rest of the World, 2022-2035
      14.3.3.1.1. Container Closure Integrity Testing Services Market for Vials in Rest of the World, 2022-2035
      14.3.3.1.2. Container Closure Integrity Testing Services Market for Syringes in Rest of the World, 2022-2035
      14.3.3.1.3. Container Closure Integrity Testing Services Market for Cartridges in Rest of the World, 2022-2035

15. SWOT ANALYSIS

15.1. Chapter Overview
15.2. Strengths
15.3. Weaknesses
15.4. Opportunities
15.5. Threats
15.6. Comparison of SWOT Factors

16. CONCLUSION

16.1. Chapter Overview

17. EXECUTIVE INSIGHTS

18. APPENDIX 1: TABULATED DATA

19. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS


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