Container Closure Integrity Testing Market

Container Closure Integrity Testing Market

The container closure integrity testing market is estimated to be worth $228 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 7% during the forecast period. Packaging 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 drug packaging process, such as the risk of contamination, filling errors (inaccurate dose dispensation), complex packaging systems, integrity related concerns (pores, cracks and scratches) of container closure systems (such as vials, syringes, cartridges, IV bags, ampoules), and labelling-related issues. In fact, experts believe that around 80% of product recalls may be attributed to packaging-related concerns. To ensure the safety of consumers, a lot of effort is put to eliminate contamination, filling errors and maintain integrity of packaged formulations. The industry has come up with several innovative techniques and technologies for the evaluation of both primary and secondary packaging components in order to maintain the sterility and stability of drug product. Moreover, regulatory bodies have enforced stringent guidelines to evaluate the packaging integrity testing of container closure systems. As a result, container closure integrity testing has become a critical part of the overall manufacturing process. The techniques used for this purpose ensure precision and accuracy in leak detection / package leak test, rapid results, non-destructive testing, affordable, reliable and easy integration in the manufacturing process. 

Despite the benefits of container closure / packaging integrity testing methods, there is no one-size -fits-all solution to evaluate all the types of primary packaging. Additionally, the pharmaceutical and biopharmaceutical companies face various challenges in installing container closure / packaging integrity testing equipment due to limited expertise and infrastructure. Owing to these challenges, the drug manufacturers rely on container closure integrity testing service providers, which have well-equipped infrastructure and novel technology platforms, along with the required expertise. Moreover, outsourcing of container closure / packaging integrity testing assists the innovators to serve the clients in a timely and regulation-compliant manner. With the anticipated rise in the drug product market, the demand for packaging services is likely to increase in the future; this, in turn, will likely result in rise in demand for integrity testing services. Further advancements in testing methods and cost saving potential of such methods (by reducing the product wastage and ensuring the drug and patients safety) are expected to drive steady market growth in the overall container closure integrity testing market during the forecast period.

Key Companies in Container Closure Integrity Testing Market

Examples of key companies engaged in container closure integrity testing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Confarma, Eurofins, SGS, Stevanato, Wilco, Berkshire Sterile Manufacturing, Curia, DDL and Nelson Labs. This market report includes an easily searchable excel database of all the companies providing container closure integrity testing services, worldwide.

Recent Developments in Container Closure Integrity Testing Market:

Several recent developments have taken place in the field of container closure integrity testing market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In September 2023, CS Analytical announced the expansion of USP 1207 Container Closure Integrity Testing Programs for IV Bag Systems. 
• In April 2023, DDL implemented GMP compliant quality system at California lab with an aim to meet regulatory needs for performing container closure integrity testing service on sterile package systems for parenteral drug and biologic products.

Scope of the Report

The “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” market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the container closure integrity testing service providers during the forecast period. The market research report also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field.

In addition to other elements, the market research report includes:

• A detailed assessment of the current market landscape of container closure integrity testing service providers, featuring information on their respective year of establishment, company size, location of headquarters, location of analytical facilities, type(s) of analytical method(s) offered (probabilistic methods and deterministic methods), type(s) of probabilistic method(s) (microbial ingress analysis, aerosol testing, dye ingress analysis, bubble testing, and  tracer gas detection (sniffle mode)), type(s) of deterministic method(s) offered (helium leak analysis / package leak test, vacuum / pressure decay analysis, mass extraction analysis, high voltage leak detection / package leak test, headspace analysis, and others), leakage susceptibility (solid, liquid, and gas), type(s) of container(s) tested (vials, syringes, cartridges, pouches, IV bags, ampoules, and others) and accreditations (EMA, FDA, USP, ATSM, JP, ICH Q2, ISO, and others).
• A competitiveness analysis of container closure integrity testing service providers based on various relevant parameters, such as supplier power (based on the experience / expertise of the service providers and company size), service strength (type(s) of analytical method(s) offered, type(s) of probabilistic method(s), type(s) of deterministic method(s), and type(s) of container(s) tested) and service applicability (type(s) of container material(s) and leakage susceptibility).
• Tabulated profiles of the key players providing container closure integrity testing, which are headquartered in North America and Europe. Each profile includes an overview of the company, information on the financial performance (if available), service portfolio, location of analytical facilities, type(s) of analytical method(s) used, types(s) of container(s) tested, recent developments, and an informed future outlook.
• A case study providing the list of equipment used by various manufacturers to test container closure integrity, highlighting their key features, type(s) of analytical method(s) offered, type(s) of container(s) tested, container material(s) of container closure integrity testing technologies.
• A detailed competitiveness analysis of container closure integrity testing equipment, taking into consideration several relevant parameters, such as the product strength (scale of operation, type(s) of analytical method(s) used) and product applicability (type(s) of material(s) used, and type(s) of container(s) tested).
• A regional capability assessment framework, which compares the container closure integrity testing capability across key geographies, based on a number of parameters, such as the number of container closure integrity testing service providers, number of analytical testing facilities, number of container closure integrity technology manufacturers in that particular geographical region, number of container closure integrity testing technologies, number of patents and demand of container closure integrity testing service in that particular geographical region.
• A detailed analysis of the various container closure integrity testing analytical techniques. It highlights the popularity of analytical techniques (in terms of number of service providers offering analytical technique for testing purpose, equipment providers developing equipment for particular technique, number of equipment and number of container closure systems tested) and offers a benchmark to compare analytical techniques.
• A case study on the use of robotic machinery in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of using automation / automated technologies in such processes. Further, it presents the profiles of industry players that provide such equipment for aseptic processing of pharmaceuticals.
• An in-depth analysis to estimate the current and future demand of container closure integrity testing service based on various relevant parameters, such as type of container closure system tested and type of material used, across different regions, for the period 2022-2035.
• A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.

One of the key objectives of this market report is to provide a detailed market forecast analysis in order to estimate the existing market size and future opportunity of container closure integrity testing market during forecast period. Based on multiple parameters, such as overall container closure systems market, and percentage of container closure system tested, we have provided an informed estimate of the evolution of the market for the forecast period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of container (vials, syringes, and cartridges), [B] type of container materials tested (glass and plastic), and [C] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this market report were also influenced by discussions held with senior stakeholders in the industry. The market research report features detailed transcript(s) of interview(s) held with the industry and non-industry players. 

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

Frequently Asked Questions

Question 1: What is container closure integrity testing?

Answer: Container closure integrity testing in pharmaceutical packaging refers to the process of ensuring the structural and chemical integrity of the container in which the drug is packed to ensure the safety of consumers and eliminate contamination / filling errors.

Question 2: How big is the container closure integrity testing market?

Answer: The container closure integrity testing market size is estimated to be worth $228 million in 2022.

Question 3: What is the projected market growth of the container closure integrity testing market?

Answer: The container closure integrity testing market is expected to grow at compounded annual growth rate (CAGR) of 7% during the forecast period 2022 - 2035.

Question 4: Who are the leading companies in the container closure integrity testing market?

Answer: Examples of key companies engaged in container closure integrity testing (which have also been profiled in this market report; the complete list of companies is available in the full report) include Confarma, Eurofins, SGS, Stevanato, Wilco, Berkshire Sterile Manufacturing, Curia, DDL and Nelson Labs.

Question 5: How many companies are currently engaged in the container closure integrity testing market?

Answer: Over 40 companies are currently engaged in the container closure integrity testing market.

Question 6: How many equipment have been developed by companies engaged in the container closure integrity testing market?

Answer: More than 80 equipment have been developed by companies engaged in the container closure integrity testing market, to optimize the testing and integrity of complex containers.

Question 7: Which region is the hub for companies engaged in the container closure integrity testing market?

Answer: North America emerged as the hub for companies engaged in the container closure integrity testing market, with majority of the players established in the region.