Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market (3rd Edition): Distribution by Type of Container, Type of Closure, Material of Fabrication and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

The global pre-sterilized / ready to use pharmaceutical packaging market is estimated to be worth USD 9.01 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of 6.62%, during the forecast period.

In the pharmaceutical industry, the integrity and safety of drugs and vaccines are of utmost importance. The primary packaging of such products plays an important role in ensuring their quality and protecting them from contaminants. Therefore, sterilization is crucial in pharmaceutical manufacturing as it helps to maintain product safety and uphold stringent quality standards. This has led to the emergence of pre-sterilized / ready to use containers and closures in pharmaceutical packaging. Ready to use vials, also known as RTU vials eliminate the need for in-house sterilization processes, reducing contamination risks and production timelines. It is worth noting that the increasing demand for safe drug delivery systems has driven the growth of the global pharmaceutical packaging market. As a result, ready-to-use components, such as sterile vials and sterile syringes have gained popularity, owing to their convenience and reliability across various applications.

Advancements in technology have further contributed to the development of innovative packaging solutions that ensure product integrity and patient safety. Sterile primary containers are a growing segment within the pharmaceutical packaging market. Companies, such as Thermo Fisher Scientific and Corning Incorporated have developed various innovative primary packaging solutions, including pre-sterilized / ready to use containers and closures. These solutions ensure product quality, meet regulatory requirements, and streamline manufacturing processes. The increasing adoption of sterile vials and other sterile primary containers is likely to contribute significantly towards the robust growth of pre-sterilized / ready to use pharmaceutical packaging market size during the forecast period.

Key Market Insights

This report features an extensive study of the current market landscape, market size and future opportunity for the companies providing pre-sterilized / ready to use containers and closures, during the forecast period. Key inclusions of the report are briefly discussed below. 

Advantages and Growing Demand for Ready to Use Pharmaceutical Primary Packaging

Owing to their numerous advantages, there is a growing demand for pre-sterilized / ready to use pharmaceutical primary packaging. The RTU containers and closures enhance time and cost efficiency by eliminating the need for sterilization equipment and associated expenses. Moreover, they improve productivity by streamlining the packaging process, while ensuring compliance with stringent quality standards and regulations. Additionally, the benefits offered by empty sterile vials and sterile syringes, and their growing demand in the healthcare sector, specifically post the pandemic has prompted stakeholders to implement advancements that are likely to drive market growth in the forecast period.

Competitive Landscape: Sterile Empty Vials Dominate the Market

The current landscape of pre-sterilized / ready to use pharmaceutical primary packaging features close to 95 RTU containers and 85 RTU closures. It is worth mentioning that, amongst pre-sterilized / RTU containers, 43% of the primary packaging is empty sterile vials; 10 are ready to use cartridges. The majority of the containers are glass vials, primarily made of borosilicate glass. Several manufacturers offer sterile vials to meet the growing demand for aseptic filling of parenteral drugs. In February 2023, Nexus Pharmaceuticals introduced its line of sterile vials. These vials can store different liquid volumes (20 ml, 10 ml, and 2 ml). In March 2022, SGD Pharma launched a 100 ml ready to use sterile glass vial, catering to the demand for small and large sterile vials. Further, in June 2022, Schott invested multi-million euros to increase the production of sterile RTU vials at its facility located in Pennsylvania, US. Such expansions reflect the rising demand for RTU primary containers for parenteral drugs. 

Recent Trends in Ready to Use Primary Packaging Systems: Innovation in Container Design and RTU Fill and Finish Machines

Recent trends and advancements in packaging materials and technologies have led to the emergence of innovative packaging solutions that offer enhanced drug compatibility, stability, and barrier properties. These solutions are made of high-quality medical polymers, elastomers, and glass compositions that are customized according to specific drug formulations. Furthermore, to increase patient convenience and medication adherence, there is a growing emphasis on simpler designs, such as integrated delivery systems and child-resistant closures. Such developments demonstrate the industry's dedication to producing efficient RTU primary packaging technologies that satisfy diverse patient needs.

Another development supporting the growth of ready to use primary pharmaceutical packaging market includes the launch of fill/finish machines that are capable of de-nesting, filling, and closing RTU vials, syringes, and cartridges. This has led to the increasing usage of robotic systems in the drug development processes, thereby enhancing flexibility and reproducibility in the production process. Further, given the increasing focus on the development of personalized therapies for smaller patient populations, drug manufacturers are prompted to adopt modern technology-based solutions, such as robotics, to augment the production of a higher number of small batches in different packaging formats.

Container and Closure Manufacturers are Collaborating to Provide Ready Packs, a Stop Solution for Customer Needs

Several stakeholders have been forging alliances related to RTU primary packaging with other industry / non-industry players for product/technology integration, distribution, product development, and technology licensing purposes. It is interesting to note that in February 2023, West Pharmaceutical Services entered into an agreement with Corning focused on the distribution of Corning Valor® Glass vials and West Ready Pack™; these systems employ Corning Valor® RTU vials and SG EZ-fill® technology. The West Ready Pack™ incorporates stoppers and seals provided by West Pharmaceutical Services, in addition to the Valor® RTU Vials supplied by Corning Incorporated.

Ready to Use Pharmaceutical Packaging Market Size: North America Holds the Largest Market Share

Due to the increasing interest of stakeholders in pharmaceutical packaging, the pre-sterilized / ready to use containers and closures market is expected to experience substantial growth in the forecast period. The market is expected to witness a steady compound annual growth rate (CAGR) of XX% during the period 2023-2035. Notably, in the long term, the market size in Asia is anticipated to grow at a relatively faster pace. This increase can be attributed to the expanding population of the region, thereby increasing the demand for healthcare products. In addition, factors, such as healthcare infrastructure, favorable government initiatives and investments in the pharmaceutical sector are likely to drive the growth opportunities in Asia, in the long term.

Key Drivers in the Pre-Sterilized / Ready to Use Pharmaceutical Packaging Market 

The pre-sterilized or ready to use pharmaceutical packaging market is driven by multiple factors. One of the primary drivers is the growing emphasis on patient safety, which involves ensuring the sterility and integrity of pharmaceutical products. The strict regulatory guidelines and compliance standards established by regulatory agencies, such as the FDA and EMA, also play an important role in driving the demand for pre-sterilized packaging. In addition, the increasing complexity of drug products, such as cell and gene therapies has created the demand for primary containers that are suitable for aseptic fill and finish of ATMPs. The integration of RTU (ready to use) packaging containers within the pharmaceutical industry enables swift product launch through an optimized value chain.

Further, the huge increase in the demand for COVID-19 vaccines has pushed the market growth, specifically for sterile vials. In March 2022, Stevanato expanded its vial manufacturing operations under a contract with the Biomedical Advanced Research and Development Authority (BARDA) to meet the need for vaccines, during the pandemic. The company invested in scaling up the production capacity of its standard RTU vials and EZ fill RTU vials.

Leading Pre-Sterilized / Ready to Use Container and Closure Manufacturers

Examples of key players (which have also been profiled in this report) manufacturing pre-sterilized / ready to use containers and closures include (in alphabetical order) APG Pharma Packaging, Aptar, Daikyo Seiko, Datwyler, DWK Life Sciences, Ningbo Zhengli Pharmaceutical Packaging, Nuova OMPI (a subsidiary of Stevanato), SCHOTT and West Pharmaceutical Services.

Scope of the Report

The market report features an in-depth analysis of various firms/organizations that are engaged in this industry, across different segments as defined below:

Base Year: 2023

Historical Period: 2018-2021

Base Year: 2022

Forecast Period: 2023-2035

Market Size 2023: $9.01 Billion

CAGR: 6.62%

Type of Container

• Sterile Cartridges
• Sterile Syringes
• Sterile Vials

Type of Closure

• Caps
• Plungers
• Seals
• Stoppers
• Tip Caps / Needle Shields

Material of Fabrication

• Aluminum
• Glass
• Rubber
• Plastic

Key Geographical Regions

• North America
• Europe
• Asia
• Latin America
• Middle East and North Africa
• Rest of the World

Key Companies Profiled

• APG Pharma
• Aptar
• Daikyo Seiko
• Datwyler
• DWK Life Sciences
• Ningbo Zhengli Pharmaceutical Packaging
• SCHOTT
• Stevanto
• West Pharmaceutical Services

(Full list of 70+ companies captured is available in the report)

The market research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the report includes:

• A preface providing an introduction to the full report, Pre-Sterilized / Ready to Use Pharmaceutical Packaging Market (3rd Edition), 2018-2022 (Historical Trends) and 2023-2035 (Forecasted Estimates).
• An outline of the systematic research methodology adopted to conduct the study on the pre-sterilized / ready to use pharmaceutical packaging market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure the accuracy and reliability of the findings.
• An overview of economic factors that impact the overall pre-sterilized / ready to use pharmaceutical packaging market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the insights captured during the research, offering a high-level view on the current state of the pre-sterilized / ready to use containers and closures market and its likely evolution in the short to mid and long term.
• A general introduction to pharmaceutical packaging and filing, highlighting the different types of packaging. It also presents information on the sterilization techniques used in primary packaging and the advantages of pre-sterilized / ready to use primary packaging. Further, the chapter concludes with a discussion of cost saving opportunities in this domain and the current demand for ready to use primary packaging.
• A detailed assessment of the overall market landscape of pre-sterilized / ready-to-use containers, based on several relevant parameters, including the type of container (sterile vials, sterile syringes, sterile bags, and sterile cartridges), material(s) of fabrication (glass and plastic), container color (clear and amber), type of compatible drug(s) (biologics and small molecules), the scale of operation (preclinical, clinical and commercial), packaging format(s) (nest and tub, and tray), sterilization technique(s) used (ethylene oxide sterilization, steam sterilization, gamma sterilization, and others), quality certification(s) obtained (ISO compliant, cGMP compliant, USP compliant, EP compliant, JP compliant, FDA compliant and others), target market (domestic and international and, domestic), availability of additional coating and RTU kits. In addition, it presents a list of pre-sterilized / ready to use container manufacturers, along with an analysis based on their year of establishment, company size (in terms of number of employees), and location of headquarters. 
• A detailed assessment of the overall market landscape of pre-sterilized / ready to use closures, based on several relevant parameters, including type of closure (stoppers, plungers, caps, tip caps/needle shields and seals), material(s) of fabrication (rubber, plastic and aluminum), type of compatible container(s) (vials, syringes and cartridges), type of compatible drug(s) (biologics and small molecules), sterilization technique(s) used (gamma sterilization, steam sterilization and others), available finish format(s) (bags, nest and tub and single-vented), quality certification(s) obtained (ISO compliant, cGMP compliant, USP compliant, EP compliant, JP compliant and others), target market (domestic and international and, domestic) and availability of additional coating. In addition, it presents a list of pre-sterilized / ready to use closure manufacturers, along with an analysis based on their year of establishment, company size (in terms of number of employees), and location of headquarters.
• An insightful analysis, highlighting the contemporary market trends in the pre-sterilized / ready to use containers and closures domain through different representations, based on relevant parameters, such as (type of container and scale of operation), (type of container, and packaging format(s)), (type of container and material(s) of fabrication), (type of container and container color), (type of container and sterilization technique(s) used), (type of container and type of compatible drug(s)), (material(s) of fabrication and sterilization technique(s) used), (type of closure and material(s) of fabrication), (type of closure and sterilization technique(s) used), (type of closure and available finish format(s)) and (type of closure and type of compatible drug(s)).
• A detailed product competitiveness analysis of various types of pre-sterilized / ready to use containers, based on the company strength (in terms of years of experience of manufacturers) and product competitiveness (in terms of target market, the scale of operation, quality certifications obtained, packaging format, the material of fabrication, container colour, sterilization technique used, type of compatible drug, availability of additional coating and RTU kits).
• A detailed product competitiveness analysis of various types of pre-sterilized / ready to use closures, based on company strength (in terms of years of experience of manufacturers) and product competitiveness (in terms of target market, quality certifications obtained, the material of fabrication, type of compatible container, sterilization technique used, available finish format, type of compatible drug and availability of additional coating).
• Elaborate profiles of prominent players offering pre-sterilized / ready to use containers and closures. Each profile includes a brief overview of the company, its financial information (if available), details on its product portfolio, recent developments, and an informed future outlook.
• A detailed analysis of partnerships inked between stakeholders engaged in this industry, since 2015, based on several relevant parameters, such as year of partnership, type of partnership, type of partner, focus area, type of packaging system, type of packaging material, most active players (in terms of number of partnerships) and geography.
• A strategic framework to identify the unmet needs and assist players in entering the pre-sterilized / RTU primary packaging industry, taking into consideration various factors, such as product reach, market activity, product differentiation, competitiveness, and manufacturing complexity.
• An in-depth analysis to estimate the current and future demand for pre-sterilized / ready to use containers and closures, based on various relevant parameters, such as type of primary packaging system, material of fabrication used, across different geographical regions, for the period 2023-2035.
• An in-depth analysis of the factors that can impact the growth of the pre-sterilized / ready to use pharmaceutical packaging market. It also features the identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
• An elaborate discussion on the emerging trends, including the advent of personalized therapies, the shift towards more flexible packaging, and advancements in robotic packaging solutions that are likely to impact the future adoption of RTU packaging systems.
• A case study on the use of robotic machinery in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of employing automation / automated technologies in such processes. Further, it presents the profiles of industry players providing such equipment for the aseptic processing of pharmaceuticals.

One of the key objectives of the market report was to estimate the current opportunity and future growth potential of the pre-sterilized / ready to use pharmaceutical packaging market over the coming years. The publisher has provided informed estimates on the likely evolution of the need for the forecast period, 2023-2035. The year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of container (sterile cartridges, sterile syringes, sterile vials), type of closure (caps, plunger, seals, stoppers and tip caps / needle shields), the material of fabrication (aluminum, glass, plastic, and rubber) and key geographical regions (North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to the model, the publisher has provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

The opinions and insights presented in this market analysis were influenced by discussions conducted with multiple stakeholders in this industry. The report features detailed transcripts of interviews held with the following individuals:

• Cara Qiu (Business Development Specialist, Jinan Youlyy Industrial)
• Daxesh Shah (Founder and Managing Director, Sagar Rubber)
• Julien Maréchal (Business Development and Technology Director, Aseptic Technologies)
• Malcolm Gilmore (Former Facilitator, BioPhorum Operations)
• Konstantin Kazarian (Former 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.

Frequently Asked Questions

Question 1: What is packaging in pharmaceutical industry?
Answer: Packaging in the pharmaceutical industry refers to the process of designing, manufacturing, and assembling containers and closures for storing drugs, vaccines, and other healthcare products. It offers protection against contamination, ensures product integrity, provides information and instructions for usage, and encourages safe and efficient distribution of these pharmaceutical products to end users.

Question 2: Why is pharmaceutical packaging important?
Answer: Pharmaceutical packaging is crucial because it ensures the safety, integrity, and efficacy of medicines. It protects drugs from external factors like light, moisture, and contamination, preserving their quality throughout their shelf life.

Question 3: Pharmaceutical packaging is crucial because it ensures the safety, integrity, and efficacy of medicines. It protects drugs from external factors like light, moisture, and contamination, preserving their quality throughout their shelf life.
Answer: There are three types of packaging, namely primary packaging, secondary packaging, and tertiary packaging. Primary packaging refers to the material that is in direct contact with the drug product and therefore, has a direct impact on its shelf life. Examples include vials, ampoules, syringes, and intravenous (IV) containers. Secondary packaging is the covering around the primary packaging that is used to collectively contain groups / sets of primary packages. Examples include cartons, boxes, and trays. Additionally, tertiary packaging refers to the type of packaging that is used when the product needs to be handled in bulk or shipped. Examples include barrels, containers, and edge protectors.

Question 4: What is RTU packaging?
Answer: RTU packaging refers to packaging that undergoes pre-sterilization, eliminating the need for additional preparation or sterilization before administration. This feature allows healthcare providers to directly use the medications without additional steps, enhancing efficiency and ensuring the safety and sterility of the drugs for patients.

Question 5: How are drug vials sterilized?
Answer: Drug vials can be sterilized using various methods, such as ethylene oxide, steam, and gamma irradiation.

Question 6: What are sterile vials used for?
Answer: Sterile vials are used as principal packaging containers for aseptic drugs in the pharmaceutical sector. These vials are specifically designed and manufactured to keep the products sterile throughout their shelf life. Additionally, such vials provide a safe and clean environment for storing and transporting medications, while ensuring product integrity and reducing contamination risks.

Question 7: What are the future trends in pharmaceutical packaging?
Answer: Robotics hold a promising future in RTU primary packaging. Automation through robotics can streamline and optimize various intermediate operations, including vial filling, capping, labeling, and inspection. Robots offer precision, speed, and consistency in handling RTU primary packaging components, preventing human errors and increasing efficiency. With advancements in robotic technology, the industry can expect improved production rates, enhanced quality control, and increased flexibility, enabling stakeholders to meet the growing demand for RTU primary packaging in the pharmaceutical sector.

Question 8: What is the most common type of partnership model being adopted by stakeholders engaged in this industry?
Answer: Mergers and acquisitions emerged as the most popular type of partnership model adopted by players engaged in manufacturing pre-sterilized / ready to use containers and closures. This is followed by product/technology integration agreements and supply agreements.

Question 9: How big is the ready to use pharmaceutical packaging market?
Answer: The ready to use pharmaceutical packaging market is substantial, with significant growth and a wide global reach. The market size is projected to reach USD 19.4 billion by 2035. Additionally, factors driving the growth in this domain include the increasing demand for innovative packaging solutions, strict regulatory requirements, and advancements in drug delivery systems.

Question 10: What is the growth rate and size of the sterile vials market?
Answer: The sterile vial market is experiencing significant growth, driven by factors, such as the increasing demand for injectable drugs, vaccines, and biologics. At present, the market size is estimated to be worth USD 9.01 billion and is expected to grow at a CAGR of 6.6%.