Container Closure Integrity Testing Services Market by Type of Container Closure Systems (Vials, Syringes and Cartridges), Type of Container Materials Tested (Glass and Plastic), and Key Geographical Regions (North America, Europe, Asia-Pacific, MENA, Lat

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

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 integrity 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, rapid results, non-destructive testing, affordable, reliable and easy integration in the manufacturing process.

Despite the benefits of container closure 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 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 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 growth in the overall container closure integrity testing services market in the foreseen future.

SCOPE OF THE REPORT
The “Container Closure Integrity Testing Services 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 features an extensive study of the current landscape and the likely future potential of container closure integrity testing service providers, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. In addition to other elements, the study 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, vacuum / pressure decay analysis, mass extraction analysis, high voltage leak detection, 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 the report was to understand the primary growth drivers and estimate the future size of container closure integrity testing market. 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 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 forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study were also influenced by discussions held with senior stakeholders in the industry. The 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 report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED
Who are the leading players offering container closure integrity testing service?
What is the relative competitiveness of container closure integrity testing service providers?
In which regions are majority of the container closure integrity testing facilities located?
Which type of equipment have the competitive edge over the other container closure integrity testing equipment?
What is the current and future demand for container closure integrity testing services?
How is the current and future opportunity likely to be distributed across key market segments?

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market over the coming 15 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the container closure integrity testing services market and its likely evolution in the short to mid-term and long term.

Chapter 3 provides a general introduction to container closure integrity testing, covering details related to the current trends in the domain. The chapter also highlights the primary packaging, type of container closure systems, problems related to these systems, type of contaminations, defects in container closure systems, type of methods used for testing integrity. In addition, it discusses the advantages of container closure integrity over sterility testing, role of service providers and future prospects.

Chapter 4 provides a comprehensive review 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 and location of analytical facilities. In addition, the chapter includes details related to container closure integrity testing services, along with information on 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) (helium leak analysis, vacuum / pressure decay analysis, mass extraction analysis, high voltage leak detection, headspace analysis, and others), leak susceptibility (solid, liquid, and gas), type(s) of container(s) tested (vials, syringes, cartridges, pouches, IV bags, ampoules, and others), accreditation(s) (EMA, FDA, USP, ATSM, JP, ICH Q2, ISO, and others).

Chapter 5 provides 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).

Chapter 6 features tabulated profiles of the key players providing container closure integrity testing services, which are headquartered in North America. Each profile includes an overview of the company, information on the financial performance (if available), service portfolio, location of analytical facilities, type of methods used, types(s) of container(s) tested, recent developments, and an informed future outlook.

Chapter 7 features tabulated profiles of the key players providing container closure integrity testing, which are headquartered in Europe. Each profile includes an overview of the company, information on the financial performance (if available), service portfolio, location of analytical facilities, type of methods used, types(s) of container(s) tested, recent developments, and an informed future outlook.

Chapter 8 provides a detailed case study on list of equipment offered by various manufacturers to test container closure integrity, highlighting the key features, type(s) of method(s) offered, type of container(s) tested, container material(s) of container closure integrity testing technologies.

Chapter 9 provides a detailed competitiveness analysis of container closure integrity testing equipment, taking into consideration several relevant parameters, such as the product strength (scale of operation, and type(s) of method(s) used) and product applicability (type(s) of material(s) used, and type(s) of container(s) tested).

Chapter 10 presents 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.

Chapter 11 presents a detailed analysis of the various container closure integrity testing analytical techniques. It highlights the popularity of analytical techniques across key geographies, based on a number of parameters, such as the number of service providers offering analytical technique for testing purpose, equipment providers developing equipment for particular technique, number of equipment, number of container closure systems tested and offers a benchmark to compare analytical techniques.

Chapter 12 presents a detailed case study on the role of robots in the pharmaceutical manufacturing and fill / finish process, highlighting its benefits and capabilities. It provides a list of the various types of pharmaceutical robots, along with details on their respective manufacturer and applications. Additionally, the chapter features profiles of players that offer robotic equipment for pharmaceutical manufacturing and fill / finish operations, along with information on the key specifications of their respective machinery.

Chapter 13 features an 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.

Chapter 14 features a comprehensive market forecast analysis, highlighting the future potential of the market till 2035, based on multiple parameters, such as current demand for respective container closure systems, percentage of container closure systems tested. It includes future sales projections of various container closure systems. We have segregated the current and future opportunity have further been segmented on the basis of [A] type(s) of container(s) (vials, syringes, and cartridges), [B] type(s) of container material(s) tested (glass and plastic), and [C] key geographical regions (North America, Europe, Asia-Pacific, Latin America, MENA and Rest of the World). It is worth mentioning that we adopted a top-down approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 15 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of the container closure integrity testing market within the biopharmaceutical industry, under a comprehensive SWOT framework.

Chapter 16 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 17 is a collection of interview transcripts of discussions held with various key stakeholders in this market.

Chapter 18 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix, which contains the list of companies and organizations mentioned in the report.

LIST OF COMPANIES AND ORGANIZATIONS

1. Alcami
2. Alfa Chemistry
3. ALPS Inspection
4. AptarGroup
5. ARL Bio Pharma
6. Aseptic Technologies
7. AST
8. Astellas Pharma
9. Advanced Test Concepts (Acquired by Pfeiffer Vacuum)
10. Berkshire Sterile Manufacturing (BSM)
11. Bonfiglioli Engineering
12. Bosch Packaging Technology (now Syntegon)
13. Confarma (a subsidiary of Solvias)
14. Coriolis Pharma
15. Corning
16. CS Analytical
17. Curia (Formerly known as AMRI)
18. Dara Pharmaceutical Packaging
19. Datwyler
20. DDL Diagnostic Laboratory
21. Eagle Analytical
22. Eurofins Scientific
23. Fedegari
24. Fresenius Kabi
25. Gateway Analytical
26. Gerresheimer
27. Gibraltar Laboratories
28. Groupe IDEA TESTS (Acquired by SGS)
29. IMA
30. Infinity Laboratories
31. Integrity Bio (Acquired by Curia)
32. Jubilant HollisterStier
33. Labor LS
34. Labthink
35. LakePharma (Acquired by Curia)
36. LexaMed
37. Lighthouse Instruments
38. Lonza
39. Medical Engineering Technologies
40. Metair Health & Hygiene Testing Lab (Acquired by SGS)
41. Mithra CDMO
42. Nelson Labs
43. NEUMA
44. Nikka Densok
45. Nitto Avecia Pharma Services (Formerly known as Irvine Pharmaceutical Services and Avrio Biopharmaceuticals)
46. NUVISAN
47. OFI
48. Pace Analytical Life Sciences
49. Pacific Biolabs
50. Pfeiffer Vacuum
51. PPD
52. Packaging Technologies & Inspection (PTI)
53. Sepha
54. SGS
55. Signify
56. Smithers
57. STEMart
58. Steriline
59. Stevanato Group
60. Syntegon
61. Tepnel Pharma Services
62. Vanrx Pharmasystems (Acquired by Cytiva)
63. VITAS AS
64. West Pharmaceutical Services
65. Wickham Laboratories
66. WILCO
67. WuXi Advanced Therapies
68. ZebraSci

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