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

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