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Pre-Sterilized / Ready-to-Use Primary Packaging: Focus on Cartridges, Syringes and Vials, 2018-2030

Pre-Sterilized / Ready-to-Use Primary Packaging: Focus on Cartridges, Syringes and Vials, 2018-2030

  • September 2018
  • 205 pages
  • ID: 5603948
  • Format: PDF
  • Roots Analysis Private Ltd.


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Pharmaceutical packaging plays a key role in ensuring the sterility and quality of a drug product, while providing information related to its identity and, in certain cases, dosing instructions as well. Primary packaging, owing to the fact that it is in direct contact with the drug / therapy, is considered to be critical to the preservation of the product’s stability, efficacy and safety. Further, given the growing complexity of modern pharmacological interventions, especially biologics, it has become imperative for drug / therapy packaging considerations to be reevaluated, taking into consideration the evident shift from large batches of one remedy for everyone to smaller batches of more personalized treatment options. In addition to optimizing drug-packaging compatibility, stakeholders in the pharmaceutical packaging industry have adopted a number of other flexible solutions to reduce overall cost and expedite time to market.

The use of ready-to-use (RTU), or pre-sterilized / pre-treated, container-closure systems have emerged as a promising alternative to conventional primary packaging, adding significant value to streamline pharmaceutical fill / finish operations. These packaging components eliminate multiple steps in the overall fill / finish process (mainly washing, sterilizing and preparing containers), thereby, helping improve operational efficiencies in compliance to existing regulatory standards. Owing to several other benefits, RTU container-closure systems have gradually gained popularity in the pharmaceutical industry. Moreover, many drug product manufacturers and fill / finish service providers have also adopted such systems to better serve their clients. In the future, as drug developers continue to strive to achieve greater flexibility in their operational protocols, RTU containers and closure systems are expected to play a key role.

The ‘Pre-Sterilized / Ready-to-Use Primary Packaging: Focus on Cartridges, Syringes and Vials, 2018-2030’ report offers a comprehensive study of the current scenario and future potential of the RTU primary packaging components market. The study features an in-depth analysis, highlighting the various types of containers that are available in the aforementioned format, including cartridges, syringes and vials, and their respective closure systems (such as stoppers, needle shields and plungers). In addition to other elements, the study includes:
• A detailed assessment of the current market landscape of containers and closures that are available in the RTU format, featuring information on the companies that manufacture such products, their respective scale(s) of production, material(s) used for fabricating such components, packaging formats and affiliated fill volumes.
• Elaborate profiles of key players in this domain; each profile features an overview of the company, its financial details, recent developments and a comprehensive future outlook.
• An analysis of the partnerships that have been established in this domain in the recent past, covering acquisitions, supply agreements, product development agreements, licensing agreements and other relevant deals established in the period between 2011 and 2018.
• An elaborate discussion on upcoming trends in the pharmaceutical industry that are likely to have an impact on the adoption of RTU container-closure systems.
• A case study on the use of robots / robotics-based technologies in pharmaceutical manufacturing and fill / finish operations, along with profiles of industry players offering such equipment for handling RTU systems.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future size of the market. Based on various parameters, such as target consumer segments, likely adoption rates and expected pricing, we have provided an informed estimate of the financial evolution of the market in the short and long terms, for the period 2018-2030. To account for the uncertainties associated with the adoption of RTU components and to add robustness to our predictions, we have provided three scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution. The research, analysis and insights presented in this report are backed by a deep understanding of insights gathered both from secondary and primary sources. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

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. 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 over the coming twelve 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 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 RTU primary packaging components and its likely evolution in the long term.

Chapter 3 provides a general overview of the various types of RTU packaging containers and closures, highlighting their benefits over conventional primary packaging solutions and the growing demand for such alternatives in the pharmaceutical fill / finish operations. In addition, the chapter includes a discussion on innovation in pharmaceutical packaging industry and the growth of flexible fill / finish solutions.

Chapter 4 provides a comprehensive review of the current market landscape of RTU primary packaging components and the associated handling equipment. The chapter features details on packaging components, such as information on the manufacturers of such products, fill volumes of various types of containers, material(s) used for fabricating such components, and packaging formats. In addition, with regard to RTU package processing, the chapter includes information on the manufacturers of such equipment, type of operations supported by the machinery, type(s) of packaging components processed, fill / finish capacity and compliance certifications.

Chapter 5 includes detailed profiles of active players that are involved in providing packaging components in the RTU format. Each profile features an overview of the company, its financial details, recent developments and a comprehensive future outlook.

Chapter 6 features an elaborate discussion and analysis of the various collaborations and partnerships that have been inked amongst various stakeholders in this domain. In this section, we have also described the different partnership models (including acquisitions, supply agreements, product development agreements, licensing agreements and other agreements) adopted by collaborating entities, highlighting the most common forms of deals / agreements that have been established in the period between 2011 to 2018.

Chapter 7 discusses the key trends in the pharmaceutical manufacturing industry impacting the adoption of the RTU components. Specifically, it features brief discussion on focus on personalized therapies, shift towards more flexible packaging, improvements in packaging components for enhanced safety profiles and increase in partnerships between various industry players, among others.

Chapter 8 features an elaborate case study, presenting information on the role of robots / robotics-based technologies 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 their applications. Further, the chapter includes profiles of players that offer robotic machinery for pharmaceutical manufacturing and fill / finish, along with key specifications of such products.

Chapter 9 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of various packaging components (cartridges, syringes, vials and closures). The sales potential and growth opportunity were estimated based on the current demand for respective packaging components, likely adoption rates and the estimated price of components. The chapter also presents a detailed segmentation on the basis of type of packaging component, material(s) used for fabrication (glass and plastic) and geography (the US, Europe, Asia Pacific and the rest of the world).

Chapter 10 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, expressing our independent opinion related to the research and analysis described in the previous chapters.

Chapter 11 includes an interview transcript of a discussion that was held with a key stakeholder in this market. It provides details of the interview conducted with Konstantin Kazarian (Business Development Project Manager, PYRAMID Laboratories).

Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 13 is an appendix, which provides the list of companies and organizations mentioned in the report.

1. Currently, over 45 players are actively involved in providing RTU containers and / or closures, or equipment and services for RTU components. More than 50% of these players are based in Europe. Examples of recently established companies based in this region include (in alphabetical order, no selection criteria) ARaymond Life, Aseptic Technologies, Bio Elpida, Disposable Lab and Zellwag Pharmtech.
2. The market for RTU packaging components is fragmented, featuring a mix of small-sized, mid-sized and large players. Presently, the more established stakeholders hold the majority share in the industry, offering multiple types of packaging products. Examples include players (in alphabetical order, no selection criteria) Aptar Pharma, Becton Dickinson, BioPharma Solutions, Daikyo Seiko, Gerresheimer and SCHOTT.
3. More than 70 primary packaging containers and / or closures are available in the RTU format. Around 50% of the products that we came across are RTU closures, while 35% are containers. Further, nearly 20% of the components are available as a combination of containers and their affiliated closures.
4. Close to 40% of the partnership agreements inked in the period between 2011 to 2018 were acquisitions. Most recently, in 2018, CSP Technologies and Triveni Polymer were acquired by Aptar Pharma and Gerresheimer, respectively. Other partnership models adopted by companies include supply agreements, product development agreements, licensing agreements and distribution agreements.
5. Driven by the rising demand for flexible fill / finish solutions and various initiatives to automate such operations, we expect the market for RTU packaging components to grow at an annualized rate of 11.9% till 2030. Owing to the rise in personalized therapeutics, RTU syringes are anticipated to witness the highest growth rate over the forecasted period.
6. The majority share of the revenues (close to 70%) is likely to be occupied by North America and Europe; however, we believe that Asia Pacific region will grow at a faster rate of 14% as compared to other geographies over the next decade; this is attributed to the availability of low cost labor (ideal for large scale manufacturing operations), as well the growing demand for high quality packaging components in this region.

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