Overview
Primary packaging, such as vials, syringes, and cartridges, and their affiliated closures, play a vital role in ensuring the stability, and sterility, and thereby, the overall quality, efficacy and safety of a drug product. Moreover, the packaging bears the product label, which provides information related to the drug and, in certain cases, dosing instructions. Pharmaceutical packaging is typically carried out under controlled conditions; specifically, for therapeutics that are designed for parenteral administration, fill/finish is carried out in sterile and aseptic environments. It is also crucial for innovators (or packaging service providers) to choose the appropriate, high quality primary packaging for their respective products; this is because the packaging material is in direct contact with the drug/therapy. Building and maintaining the necessary expertise and infrastructure to support pharmacological fill/finish is a capital-intensive ordeal. Further, the growing complexity of modern pharmacological interventions, such as monoclonal antibodies, cell and gene therapies (which are typically produced in small batches) and the gradual (but imminent) shift to personalized therapies, has prompted drug developers to look for leaner manufacturing and packaging solutions. In this context, cost optimization is important and one of the available ways to save both time and capital is by bypassing manual processing and sterilization of primary packaging and switching to ready-to-use (RTU) formats.
Pre-sterilized RTU container-closure systems have gradually become very popular and are widely used in the modern pharmaceutical industry. As indicated earlier, such components significantly simplify the overall fill/finish process, primarily by eliminating the need for several additional steps (such as washing, drying and sterilization), which were previously required to prepare primary containers for filling. In other words, using RTU components helps improve operational efficiencies. Drug product manufacturers and fill/finish service providers claim that these off-the-shelf packing and closure systems, help them to better serve their clients in a timely and regulation-compliant manner. In this context, it is worth highlighting that RTU packaging systems were in high demand during the COVID-19 pandemic, when novel vaccines and experimental therapies needed to be produced and packaged for distribution in large quantities. The surge in demand for appropriate packaging solutions in adequate quantities, is likely to persist, significantly adding to the opportunity for RTU package and affiliated closure developers/suppliers. In future, as drug developers continue to strive to achieve greater flexibilities in their operations, we believe that the RTU packaging components market is likely to witness steady growth over the next decade.
Scope of the Report
The “Pre-Sterilized/Ready-to-Use Primary Packaging: Focus on Cartridges, Syringes and Vials (2nd Edition) - Market Distribution by Type of Packaging System (Vials, Syringes, Cartridges and Closures), Packaging Material (Glass and Plastic) and Key Geography (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa and Rest of the World) – Global Forecast 2021-2030” report features an extensive study of the current market landscape and future potential of ready-to-use primary packaging components, including cartridges, syringes and vials, and their respective closure systems (such as stoppers, needle shields and plungers) over the next decade. The study features an in-depth analysis of the key drivers and trends related to this domain.
Amongst other elements, the report includes:
- A detailed assessment of the current market landscape of ready-to-use primary packaging components, featuring information on the type of container (vials, syringes, cartridges and others), type of fabrication material used (glass and plastic), sterilization technique used (ethylene oxide sterilization, steam sterilization, gamma irradiation, electron beam sterilization and dry heat sterilization), volume of container (less than 50 ml, 50 ml to 100 ml and more than 100 ml), compatible drug class (biologics and small molecules) and type of closure (stoppers, plungers, tip caps/needle shields, caps and seals). In addition, the chapter includes details related to ready-to-use packaging system manufacturers, along with information on their respective year of establishment, company size, location of headquarters and key players (in terms of number of offerings).
- A competitiveness analysis of ready-to-use primary packaging system manufacturers based on various relevant parameters, such as supplier power (based on the experience/expertise of the manufacturer) and key product specifications (type of container, type of fabrication material used, type of closure, sterilization technique used and compatible drug class).
- Elaborate profiles of prominent players engaged in the development of ready-to-use primary packaging systems. Each profile features a brief overview of the company, details related to its financials (if available), product portfolio, recent developments and an informed future outlook.
- An analysis of the partnerships that have been inked by stakeholders engaged in this domain, during the period 2015-2021, covering acquisitions, product/technology integration agreements, supply agreements, product/technology licensing agreements, product/technology development agreements, service alliances, distribution agreements and other relevant types of deals.
- An insightful discussion on the impact of the recent COVID-19 pandemic on the businesses of primary pharmaceutical packaging manufacturers. In addition, we have provided information on the strategic initiatives undertaken by pharmaceutical players to mitigate the challenges affiliated with the current global crisis.
- An in-depth analysis to estimate the current and future demand for ready-to-use container-closure systems based on various relevant parameters, such as type of packaging system and type of fabrication material used, across different regions, for the period 2021-2030.
- An elaborate discussion on the key trends (such as the advent of personalized/targeted therapies, shift towards more flexible packaging, rise of modular manufacturing facilities and advancement in robotic packaging solutions) that are likely to have an impact on the future adoption of ready-to-use packaging systems. It also features a Harvey ball analysis, highlighting the relative effect of each trend on the overall pharmaceutical packaging industry.
- 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.
One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for RTU primary packaging over the coming decade. Based on several parameters, such as target consumer segments, region specific adoption rates and expected prices of these products, we have provided an informed estimate on the likely evolution of the market over the period 2021-2030. The report provides sales forecasts for the overall RTU primary packaging market, wherein both the current and upcoming opportunity is segmented across [A] type of packaging system (vials, syringes, cartridges and closures), [B] type of fabrication material used (glass and plastic) and [C] key geographies (North America, Europe, Asia Pacific, Middle East and North Africa, Latin America 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 influenced by discussions conducted with multiple stakeholders in this domain.
The report features detailed transcripts of interviews held with the following individuals:
- Julien Marechal (Business Development and Technology Director, Aseptic Technologies)
- Malcolm Gilmore (Facilitator, BioPhorum Operations Group)
- Konstantin Kazarian (Former Project Manager of Business Development, PYRAMID Laboratories)
- Daxesh Shah (Founder and Managing Director, Sagar Rubber)
Key Questions Answered
- Who are the prominent players engaged in the global pre-sterilized/ready-to-use primary packaging market?
- What is the relative competitiveness of different ready-to-use primary packaging system manufacturers?
- Which partnership models are most commonly adopted by stakeholders engaged in this industry?
- How is the recent COVID-19 pandemic likely to impact the global ready-to-use primary packaging systems market?
- What is the current, global demand for ready-to-use containers and closures?
- What are the major market trends and driving factors that are likely to impact the growth of ready-to-use primary packaging systems market?
- How is the current and future opportunity likely to be distributed across key market segments?
Table of Contents
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- ABB
- Afton Scientific
- ALK Life Science Solutions
- Allergy Laboratories
- American Nurses Foundation
- American Red Cross
- AptarGroup
- ARaymondlife
- Aseptic Technologies
- AST
- Becton Dickinson
- Berkshire Sterile Manufacturing
- Bharat Rubber Works
- Biomedical Advanced Research and Development Authority
- BioPharma Solutions
- Bormioli Pharma
- Catalent
- Centor
- China Lemon Trading
- Coalition for Epidemic Preparedness Innovations
- COLANAR
- Corning
- COVID-19 Solidarity Response Fund
- Credence MedSystems
- Daikyo Seiko
- Dara Pharmaceutical Packaging
- Datwyler Group
- DENSO
- Disposable-Lab (Acquired by Amatsigroup)
- DWK Life Sciences
- EMA Pharmaceuticals
- Amatsigroup (Acquired by Eurofins CDMO)
- FANUC America
- GCL Pharma (Acquired by Bormioli Pharma)
- Gerresheimer
- Government of Canada
- Helapet
- Hindustan Syringes and Medical Devices
- Huayi Isotopes Company
- IMA
- ISOLAB
- Jiangsu Hualan New Pharmaceutical Material
- Kawasaki Heavy Industries
- Klenzaids Contamination Controls
- KUKA
- Marchesini Group
- MedCision
- MedicoPack
- Merck
- Microsoft
- Momentive Technologies
- Muller + Muller (Acquired by DWK Life Sciences)
- Nelson Labs
- Nemera
- Ningbo Zhengli Pharmaceutical Packaging
- Nipro
- No Kid Hungry
- OMRON Industrial Automation
- Origin Pharma Packaging
- Ott (Acquired by Datwyler Group)
- Pall
- Pfeiffer Vacuum
- Pfizer
- Philabundance
- Prince Sterilization Services
- Qingdao Huaren Medical Product
- Radpharm Scientific
- Retractable Technologies
- Sagar Rubber
- Samsung Medical Rubber
- Sartorius
- SCHOTT
- SCHOTT KAISHA
- Seiko Epson
- SGD Pharma
- Sharp
- SiO2 Materials Science
- Sonata Rubber
- Staubli
- Steriline
- Sterisets International
- Stevanato Group
- SureCare
- SVM Automatik
- Swissfillon
- Syntegon
- Tekpak
- Terumo
- Toxikon Europe (Acquired by Sterigenics International)
- Transcoject
- Triveni Polymers (Acquired by Gerresheimer)
- Tyndall National Institute
- Universal Medicap
- Universal Robots
- United Pharmacy Partners (UPPI)
- US Government
- Vaccines Manufacturing and Innovation Centre
- Vanrx Pharmasystems
- Vetter Pharma
- VIGHNESH Rubbers
- Watson-Marlow Fluid Technology Group
- West Pharmaceutical Services
- YangZhong Wealth Metal
- Yaskawa Electric
- Ypsomed
Methodology
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