Aseptic Packaging for Pharmaceutical Market

Market Overview

The Aseptic Packaging for Pharmaceutical Market Size is expected to grow at a CAGR of 7.5% from 2023 to 2031.

Patient safety is an important aspect in the pharmaceutical industry. Aseptic packaging for pharmaceuticals is the packaging process which allows the sterilization of both the packaging material and the product to maintain sterility throughout the product's shelf life which ensures the safety of the patients. Aseptic packaging reduces the risk of contamination and microbial growth which ensures that the pharmaceutical products are safe and effective for patient use. Aseptic packaging is essential for maintaining the sterility and stability of these complex biologics, driving the demand for aseptic packaging solutions. As monoclonal antibodies are gaining prominence in the pharmaceutical industry it is driving the market of aseptic packaging in the industry. Regulatory authorities, such as the United States Food and Drug Administration and the European Medicines Agency (EMA), have strict guidelines and regulations to ensure pharmaceutical safety and efficacy of the product. Aseptic packaging is crucial in meeting these regulatory requirements which leads to increase in the adoption of aseptic packaging.

The biopharmaceutical sector is also experiencing significant growth globally. Aseptic packaging plays an important role in the packaging and delivery of biologics which contributes to expansion of the aseptic packaging market for pharmaceuticals.

West Pharma, Montagu, BD Medical, Southern Packing Group, Shandong Pharmaceutical Glass, Zhonghui are some of the leading players of the market.

Market Dynamics

Market Drivers

• Increasing Demand For Pharmaceutical Products

The demand for pharmaceuticals is increasing globally due to increase in different kind of diseases in various regions of the world. This is happening because of population growth, aging population and increase in the patients suffering from chronic diseases. The necessity of safe packaging solutions is increasing. The tablets, syrups are packaged aseptically in order to meet the regulatory compliances and patient safety. The drugs are tested then let out for the distribution. The demand of safety and regulation drives the market of aseptic Packaging in pharmaceutical industry. The need of pharmaceutical products in different regions globally are driving the market of aseptic packaging of pharmaceutical products.

• Regulatory Compliance and Quality Standards

There are different regulatory authorities in various regions to ensure the safety of the pharmaceutical products produced and distributed in the region. Stringent Quality standards are enforced to ensure the patients safety. Aseptic packaging helps pharmaceutical companies meet regulatory requirements and adhere to Good Manufacturing Practices (GMP) and other quality guidelines put forth by the government. The use of aseptic packaging systems supports compliance with regulatory standards which drives its market. There is Food and Drug Administration authority to ensure stringent aseptic pharmaceutical packaging in North America and Asian countries and European Union in European countries.

Market Restraints

• High Cost

Aseptic Packaging is important as well as expensive process while production of drugs. The high cost of packaging is due to various stringent processes which are carried out and components used for packaging and its processing. The investment of higher cost Is essential which ensures the safety of the product and patient who consumes it. The high prices of pharmaceutical products also include the cost of packaging processes and materials. This may be a restraint for purchasing the medicines in the economically developing country’s population who cannot afford it. This may lead to ignorance of the disease and resist them from purchasing the medical products.

• Risk of Contamination

There is a high risk of contamination of the products and the packaging material despite taking all the precautions. The packaging processes should be carried out by the skilled labour which reduces the risk of contamination of the products. If there is contamination of the products or packaging material during the manufacturing processes to incur the cost the pharmaceutical products may be highly prices which again affects the purchase of the products due to high prices. Even a small amount of contamination can be risky and the drug cannot be approved for distribution. All these factors can increase the price of the pharmaceutical products.

Market Scope

Segmental Analysis

Segment by Type

• Vials & Ampuls

Vials are used as a packaging material in pharmaceutical industry. These are made of glass or plastic and have narrow neck which allows filling of the product. These are usually used for liquid packaging such as vaccines, antibiotics, and chemotherapy drugs. There are two types of vails, Borosilicate glass vails and Polypropylene vaulted Borosilicate glass vails are mainly used in for heat-sensitive medications, such as biology as these types of vials are made from a type of glass that is resistant to thermal a shock and chemical corrosion. Polypropylene vials are made from plastic that is clear, inert, and lightweight. They are often used for less heat-sensitive medications, such as small-molecule drugs. Ampoules are mainly made up of borosilicate glass a type of glass that is resistant to thermal shock and breakage. Ampoules are sterilized by heating, either by dry heat or by steam. Ampoules are inert and do not interact with the drug product. They are transparent, which allows for visual inspection of the drug product and are also not so expensive to produce.

• Prefill able Syringes

Prefill able Syringes are preferred over Amplexus and Vails as they are ready to use and do not need manual handling which leads to contamination. Prefilled syringes can be accurately filled according to the need of the dosage which is important to provide medications that require precise dosage of medication. Prefilled syringes are small and lightweight, which makes them easy to transport and accessible. The most common type of prefilled syringe used for aseptic packaging of pharmaceuticals is the glass syringe. Glass syringes are inert and non-reactive, which makes them easy for storing and delivering sensitive medications. There are also plastic syringes used which are less expensive and easily mouldable than the Glass syringes.

• Solution IV Bags

Solution IV bags are made of a multilayer film that is composed of a plastic layer, a barrier layer, and an adhesive layer. The plastic layer provides strength and flexibility and the barrier layer prevents the passage of air, moisture, and microorganisms. The adhesive layer bonds the plastic and barrier layers together. These are sterilized bags and used for methods like including ethylene oxide (ETO), gamma radiation, and electron beam irradiation. After sterilization the bags are filled with the pharmaceutical product. They are compatible with most of the solutions which resists any reaction between the package and the product to avoid contamination. It is also not so expensive to produce.

• Sterilization Bags

Sterilization bags are used as packaging material for pharmaceuticals. They are made from a materials like paper, plastic, and aluminium foil. The specific material depends on the type of product being packaged and the required shelf life. These bags are sterilized using different methods like exposing them to the steam under pressure for a period of time which helps to kill the microorganisms present in it. Another method is Ethylene oxide gas sterilization but this method is not usually used for sterilization of material used for packaging of pharma products as it has harmful sterilant which can be harmful for the human beings and the environment. The bags are labelled with information about the product, the date of manufacture, and the expiration date which makes easy for the manufacturer for distribution and the customers while purchasing the medications.

Segment by Application

• Solid Medicines

Aseptic packaging can be used for a variety of solid medications, including tablets, capsules, powders. It is particularly important for medications that are sensitive to contamination, such as antibiotics and vaccines. it helps to ensure that the medications are sterile and free from bacteria, viruses, and other microorganisms. This is important for the safety and efficacy of the medications. aseptic packaging can help to extend the shelf life of medications. Blister packs, Cartridges, Vials, Ampules are commonly used for packaging for Slid medications. Blister Packs are used to pack then tablets with relatively bigger sizes and the vails are used when number of tablets is more and size is less. Cartridges are used for single dosage which allows to avoid confusion in dosages. This is used when particular amount of dosage is to be consumed.

• Liquid Chemicals

Liquid medications or chemicals include Injectable drugs, Intravenous fluids, Ophthalmic solutions and pain killer or nasal sprays etc. Aseptic packaging ensures its quality which is checked before distribution. Topical creams and ointments are sterile products that are applied to the skin. They are packaged in a sterile environment to prevent contamination, which could lead to skin infections. The Ophthalmic solutions are nothing but the eye drops which are usually packaged in the plastic bottles which ensure the safety and prevents from eye diseases due to contamination of the product. Injections or Intravenous fluids are generally packaged in the vails which have air tight covering which ensures the safety as it is hard to open the vail the chances of contamination are low.

• Intravenous Injections

Aseptic packaging is used in the Intravenous Injections to maintain the sterility and avoid contamination. Maintaining sterility in the injection liquids is important because intravenous injections are administered directly into the bloodstream, and any contamination could cause serious health problems to the patient. It prevents the spoilage of product while transportation which maintains the quality and quantity of the product throughout the process. It also can reduce the cost of packaging as aseptic packaging is relatively less expensive than the Terminal sterilization processes. The Intravenous Injections are generally packaged in vails as it has the desired conditions maintained and air tight rubber caps which prevent from entrance of microorganisms in the product.

Regional Analysis

North America

The North America pharmaceutical packaging market is expected to reach a CAGR of 9.2% from 2023 to 2031. The growing significance of modern packaging in the pharmaceutical industry has led to brands to create unique packaging in order to stand out from the competitors’ US pharmaceutical market is among the world’s most important national markets. The United States alone holds over 45% of the global pharmaceutical market. United States is facing costly pharmaceutical imports from other countries than Canada. The US government had authorized a pilot project for wholesalers and pharmacists to import versions of FDA-approved medicines from Canada. On the continuation of this plan, the demand for glass packaging for pharmaceuticals in Canada is expected to rise significantly in upcoming years.

Europe

The pharmaceutical industry in Europe is experiencing constant disruption as it experiences exponential growth with the changing lifestyle and more and more people being diagnosed with various diseases and increased spending on healthcare by the government bodies. European Union (EU) regulations mandating pharmaceutical serialization is added with the US Drug Supply Chain Security Act, compliance which is driving the serialization and track-and-trace efforts and are promoting pharmaceutical traceability and authenticity in the region.  The EU regulation now requires dimensional codes on the medical packaging to help identify the product and verify their authenticity; leveraging smartphone technology drives the digitalization of the packaging industry. Amcor ltd, CCL industries, Scotch AG are some of the prominent players in the region.

Asia Pacific

China is actively upgrading its pharmaceutical packaging facilities and materials by diversifying its pharmaceutical products which is bringing new opportunities to pharmaceutical packaging firms. South Korea is one of the fastest-growing pharma regions in Asia and a critical contributor to global healthcare innovation. It has tremendously advanced new drug research and development in the last few years. Especially during the past few years, Korea has developed new drug R&D capabilities in the global pharmaceutical and biotech landscape. India is the second most populated country, with 1.4 billion people, and is the fifth-largest economy. Despite significant improvements in healthcare in the past years, the number of chronic disease cases is increasing rapidly. According to the WHO report, over 20% of the country's population suffers from at least one of the non-communicable diseases or chronic diseases, such as cancer, heart ailments, respiratory diseases, and diabetes which is driving the need of aseptic packaging of the pharmaceutical products rapidly in the region.

South America

Increased foreign investment, growth in local manufacturing, and rising product development are strengthening the regional packaging industry in South America. Brazil, Argentina, Mexico, and Colombia are some of the significant markets for pharmaceutical packaging. The growing drugs consumption in the region and low manufacturing cost, due to supportive government policies, are also motivating many foreign nations, especially India, the United States, and Europe, to increase their investment in the region. Alkema Laboratories is branching out into Latin America, helping the firm to generate significant growth in the international markets.

Middle East and Africa

The Middle East and Africa (MEA) pharmaceutical packaging market is booming due to the growing spread of new HIV infections which is increasing cross-border trade, and increased exports of plastics and rubbers from the MEA region which is expected to grow at a CAGR of 6.7%. The rapid increase in the prevalence of numerous community and non-communicable diseases such as AIDS, diabetes, cancer, and respiratory diseases are some of the key factors driving the growth of the pharmaceutical packaging industry in the MEA region.

Key Players

1. Amcor
2. Bemis
3. Gerresheimer
4. Oliver-Tolas
5. SCHOTT
6. Bosch Packaging Technology
7. Catalent
8. WestRock
9. West Pharma
10. Montagu
11. BD Medical
12. Southern Packing Group
13. Shandong Pharmaceutical Glass
14. Zhonghui
15. Push Group
16. Dreure
17. YuCai Pharmaceutical Packaging Material

Recent Developments

February 2023 - Schott a European pharma company opened its first facility in the United States to expand its capabilities and manufacturing capacity for diagnostics and life sciences products. The construction of a new facility in Phoenix, Arizona, with a huge investment is dedicated to producing custom DNA and protein biosensors and other microarrays on glass, semiconductors, and polymer microfluidic consumable devices.

January 2023 - Amcor announced the acquisition of Shanghai-based MDK. MDK, is a medical device packaging and a key priority growth area for Amcor, has rapidly growing annual sale. The addition of MDK has strengthen Amcor's already strong healthcare platform in the Asia-Pacific region as it continues to focus its emphasis on higher growth priority categories.

May 2022 - CCL Industries Inc. announced plans for an expansion at its Innovia business unit near Leipzig in Germany. A new 8 m wide multi-layer co-extrusion line manufactures highly engineered thin gauge label films to meet the rising, sustainability-driven demand for materials with reduced resin contents. With a capacity of 36,000 ton annually and best-in-class energy efficiency, the new technology is exclusive to label films. Production will begin in the second half of 2024.