Elastomeric Closures Market: Focus on Parenteral Containers, 2019-2030

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Jun 18, 2019, 16:01 ET

NEW YORK, June 18, 2019 /PRNewswire/ -- INTRODUCTION
Pharmaceutical packaging plays a crucial role in ensuring the sterility and quality of a drug product, while also providing information related to its identity and, in certain cases, dosing instructions. Primary packaging material, owing to the fact that it is in immediate contact with the drug / therapy formulation, is considered to be extremely important when it comes to preserving the stability, efficacy and safety of the packaged drug product. Further, given the growing complexity of modern pharmacological interventions, especially biologics, it has become imperative for drug / therapy packaging considerations to be re-evaluated, taking into consideration the evident shift from large batches of one remedy for everyone to smaller batches of more personalized therapeutic solutions. In addition to optimizing drug-packaging compatibility, stakeholders in the pharmaceutical packaging industry have also adopted a number of other flexible solutions to reduce the overall cost and expedite time to market.

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The use of elastomeric materials, along with various types of coatings (such as FluoroTec® and Teflon®) have emerged as a promising alternative to conventional, non-coated closures used for primary packaging containers, which were prone to leaching and shedding of particulate contaminants. The advantages of using elastomeric materials in manufacturing container closures are many, including low leaching potential, minimal chemical interaction with the pharmacological formulation, and the fact that they can be used to make waterproof and airtight closures. Moreover, such closures can also be manufactured in the ready-to-use (RTU) format, which saves a significant amount of time by eliminating the need for multiple steps in the overall fill / finish process. Owing to the aforementioned benefits, the industry has witnessed an evident growth in preference for elastomeric container closures.

SCOPE OF THE REPORT
The 'Elastomeric Closures Market: Focus on Parenteral Containers, 2019-2030' report features a comprehensive study of the current scenario and future potential of the elastomeric, primary packaging closure market. It features an in-depth analysis, highlighting the various types of elastomeric closures including stoppers, needle shields and plungers, available in the market for various types of primary packaging containers, such as cartridges, syringes and vials. In addition to other elements, the study includes:
A detailed assessment of the current market landscape of companies manufacturing elastomeric container closures, featuring information on the type of closure (cap, needle shield, plunger, seal, stopper, and tip cap), type of respective primary container(s) (vial, syringe, and cartridge), elastomeric material(s) used for fabricating the aforementioned closures (such as bromobutyl, chlorobutyl, and others), drug type(s) that are compatible with elastomeric closures, sterilization status of closures (pre-sterilized and unsterilized), affiliated sterilization technique (if the closure(s) is available in the pre-sterilized format), scale of production (small scale, and large scale), type of customization (if available), affiliated dimensions, along with compliance certifications of the product.
A comprehensive analysis on the packaging trends of over 230 drug products (including both biologics and small molecule drugs) that were approved over the last five years (beginning 2014), featuring an assessment of the packaging requirements of various container-closure systems based on parameters, such as year of approval of drug, type of molecule, dosage form, route of administration, holding temperature, type of packaging material(s) used for manufacturing primary container and affiliated closure, and leading drug developers (in terms of number of drugs packaged using elastomeric closures).
An analysis of various developments / recent trends related to elastomeric packaging materials, offering insights on [A] partnerships and collaborations established within the industry, and [B] recent global conferences related to pharmaceutical packaging industry.
Elaborate profiles of key players in this domain (shortlisted on the basis of size of product portfolio), featuring a brief overview of the company (including information on company headquarters, year of establishment, number of employees, and key members of the executive team), financial information (if available), detailed description of proprietary elastomeric closures, recent developments, and an informed future outlook.
A case study on the role of robotics in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of using automation / automated technologies in such processes. It includes profiles of industry players offering such equipment for the aseptic processing of pharmaceutical products.
• An elaborate discussion on emerging trends (such as focus on personalized therapies, shift towards more flexible packaging, upgrading packaging components to enhance drug product safety, and growing adoption of smart packaging solutions) that are likely to have an impact on the future adoption of elastomeric container-closure components in the pharmaceutical packaging industry. It also features a Harvey ball analysis, highlighting the relative effect of each trend on the overall pharmaceutical packaging industry.
An in-depth analysis to estimate the current and future demand for elastomeric closures across key primary packaging containers, including vials, syringes and cartridges, in different regions for the period 2019-2030. Input parameters considered for this analysis include current supply of different primary packaging components and their respective closures and the estimated the proportion of elastomeric closures that are likely to be supplied, which is indicative of the demand.

One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for elastomeric closures over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of such products, we have provided an informed estimate on the likely evolution of the market over the period 2019-2030. The report provides sales forecasts for the overall elastomeric closure market, wherein both the current and upcoming opportunity is segmented across [A] type of packaging container(s) (vials, syringes and cartridges), [B] type of closure(s) used (seal, stopper, cap, plunger, barrel, and needle shield), [C] sterilization status (pre-sterilized and unsterilized), and [D] key geographies (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 market 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 conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals (in alphabetical order of company names):
Julien Maréchal (Business Development and Technology Director, Aseptic Technologies)
Malcolm Gilmore (Facilitator, BioPhorum Operations Group)
Marco Pederiva (Marketing and Sales Director, Lonstroff)
Konstantin Kazarian (Project Manager of Business Development, PYRAMID Laboratories)

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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry 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 segments. Where 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 till 2030, the report also provides our independent view on various 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 provides an executive summary of the insights captured during our research. It offers a high-level view on the current state of the market of elastomeric closures and its likely evolution in the short-mid term and long term.

Chapter 3 provides an overview of conventional pharmaceutical packaging and the limitations associated with the currently used container-closure systems. The chapter also lays emphasis on innovation in the pharmaceutical packaging industry and the consequent growth of flexible fill / finish solutions. It features an elaborate discussion on the different considerations for choosing a suitable material for fabricating container-closure systems. Further, the chapter includes a detailed discussion on elastomeric materials, highlighting their properties, and applications across various industries. In addition, it provides an overview of regulatory guidelines associated with elastomeric container-closure systems. It elaborates on the various tests that are necessary to assess and control the quality of elastomeric closures. It concludes with a brief discussion on the advantages and limitations of elastomeric closures, highlighting the growing importance of coated elastomeric materials.

Chapter 4 provides a comprehensive review of the current market landscape of nearly 100 elastomeric closures. It includes a detailed analysis of the aforementioned products based on the type of closure (cap, needle shield, plunger, seal, stopper, and tip cap), type of respective primary container(s) (vial, syringe, and cartridge), elastomeric material(s) used for fabricating the aforementioned closures (such as bromobutyl, chlorobutyl, and others), drug type(s) that are compatible with elastomeric closures, sterilization status of closures (pre-sterilized and unsterilized), affiliated sterilization technique (if closure(s) is available in the pre-sterilized format), scale of production (small scale, and large scale), type of customization (if available), affiliated dimensions, along with compliance certifications of the product. It also provides details of the manufacturer companies, such as year of establishment, company size, and location of headquarters.

Chapter 5 features detailed profiles of key players (shortlisted on the basis of size of product portfolio) that are involved in fabricating and supplying elastomeric closures. Each company profile features a brief overview of the company (including information on company headquarters, year of establishment, number of employees, and key members of executive team), financial information (if available), detailed descriptions of proprietary elastomeric closures, recent developments and an informed future outlook.

Chapter 6 features packaging trends of over 230 drugs products (including both biologics and small molecule drugs) that were approved over the last five years (beginning 2014). The chapter comprises of in-depth analyses, highlighting the packaging requirements of various container-closure systems based on several parameters, including year of approval of drug, type of molecule, dosage form, route of administration, holding temperature, type of packaging material(s) used for manufacturing primary container and affiliated closure. Furthermore, we have highlighted the leading players in this domain, based on the number of approved drugs packaged using elastomeric closures in the given time period.
Chapter 7 features a detailed assessment of various developments / recent trends related to elastomeric packaging materials. The analysis presented in this chapter offers insights on [A] recent partnerships and collaborations that have been established in the last decade, featuring a comprehensive set of analyses, based on various parameters, such as the year of establishment and headquarters of each company, type of partnership, purpose of collaboration, and type of product, and [B] recent global conferences related to pharmaceutical packaging industry, featuring a set of analyses based on various parameters, such as year, location, and agenda of the conference.

Chapter 8 provides an overview of the current and future demand for elastomeric closures for key primary packaging containers, including vials, syringes and cartridges, in the contemporary market. In order to estimate the aforementioned demand, we considered the current supply of different primary packaging components and their respective closures and estimated the proportion of elastomeric closures that are likely to be supplied to the pharmaceutical industry. We also estimated the likely adoption of such products across geographical regions, over the period 2019-2030.

Chapter 9 presents a comprehensive market forecast analysis, highlighting the future potential of the market till 2030, based on multiple parameters, such as current demand for respective packaging components, likely adoption rates and the estimated price of components. It includes future sales projections of various closures of key packaging containers. We have segregated the current and upcoming opportunity on the basis of [A] type of packaging container(s) (vials, syringes and cartridges), [B] type of packaging closure(s) (seal, stopper, cap, plunger, barrel, and needle shield), [C] sterilization status (pre-sterilized and unsterilized), and [D] key geographies (North America, Europe and, Asia-Pacific and Rest of the World). It is worth mentioning that we adopted a bottom-up approach for this analysis, backing our claims with relevant datapoints and credible inputs from primary research.

Chapter 10 presents an elaborate case study on the role of robots in the pharmaceutical manufacturing and fill / finish process. It features a list of the various types of pharmaceutical robots, along with details on their respective manufacturer(s) and applications. Further, the chapter includes profiles of players that offer robotic machinery for pharmaceutical manufacturing and fill / finish operations, along with information on the key specifications of such products.

Chapter 11 discusses key trends in the overall pharmaceutical manufacturing industry. Specifically, it elaborates on the emerging focus on personalized therapies, shift towards more flexible packaging, development of modular facilities, upgrading packaging components to enhance drug product safety, increase in partnership activity, and growing adoption of smart packaging solutions, among others.

Chapter 12 is a collection of interview transcripts of discussions held with key stakeholders in this market. In this chapter, we have presented the details of interviews held with (in alphabetical order of company names) Julien Maréchal (Business Development and Technology Director, Aseptic Technologies), Malcolm Gilmore (Facilitator, BioPhorum Operations Group), Marco Pederiva (Marketing and Sales Director, Lonstroff), and Konstantin Kazarian (Project manager of Business Development Project Manager, PYRAMID Laboratories).

Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 14 is an appendix, which provides the list of companies and organizations mentioned in this report.

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