Sterile Medical Packaging Market Size, Share & Industry Analysis, By Material (Plastics, Glass, Metal, Paper & Paperboard, Others), By Type (Thermoform, Trays, Sterile Bottles & Containers, Sterile Closures, Pre-Fillable Inhalers, Pre-Fillable Syringes and Others), By Sterilization Method (Chemical Sterilization, Radiation Sterilization), By Application (Pharmaceutical & Biological, In-vitro Diagnostic Products, Medical Implants, Others), and Regional Forecast, 2024-2032

The global sterile medical packaging market size was valued at USD 47.62 billion in 2023 and is projected to grow from USD 51.21 billion in 2024 to USD 91.71 billion by 2032, exhibiting a CAGR of 7.56% during the forecast period. North America dominated the sterile medical packaging market with a market share of 35.13% in 2023. Moreover, the sterile medical packaging market in the U.S. is projected to grow significantly, reaching an estimated value of USD 26.02 billion by 2032, driven by the growing focus on sustainable medical packaging is a key trend influencing the market growth.

Sterilization is an important processing step performed in the healthcare industry. Hence, the usage of sterile packaging products or sterile barrier systems has gained significant importance in this industry. Sterile medical packaging is a non-reusable packaging material that acts as a barrier against microbial transmission. Most of these packaging, such as wraps, pouches, and containers, are designed to prevent medical products from the external environment and unintended transmission of infections. Furthermore, these sterile barrier systems maintain product sterility from the point of packaging and sterilization until the time of use. They offer beneficial properties such as tear resistance, durability, breathability, and a superior microbial barrier to keep the pharmaceuticals and medical equipment sterile throughout their lifecycle. These properties would surge the demand for such packaging in various applications ranging from in-vitro diagnostic products to surgical & medical instruments.

The COVID-19 pandemic positively impacted the market. Hospital systems became overwhelmed with the rapidly increasing number of patients, which weighed heavily on the healthcare industry. This led to an increase in the demand for these packaging materials as they can prevent contamination and mitigate the spread of the virus.

Sterile Medical Packaging Market Trends

Rising Adoption of Single-use Medical Equipment is a Prominent Trend

The rising cases of contagious diseases such as coronavirus, cold, flu, tuberculosis, and SARS have led to a surge in demand for single-use medical equipment or devices. The adoption of single-use packaging is becoming more popular in healthcare settings as it can reduce the risk of infection and contamination. These devices include syringes, needles, bandages, face masks, gloves, applicators, suction catheters, testing kits, and surgical sponges. As these devices are used only once, they prevent the spreading of bacteria or infection from one patient to another. The packaging used for such devices needs to be very efficient in maintaining their sterility. These products are considered to be effective packaging solutions for such devices. They keep the single-use medical equipment away from moisture and chemicals. These packaging solutions are available in different sizes and shapes according to the requirement of the application area. Hence, the rising demand for single-use medical equipment will fuel the market.

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Sterile Medical Packaging Market Growth Factors

Increasing Demand for Sterile Packaging Systems in Healthcare Industry to Drive Market Growth

The rising population, coupled with an increase in the prevalence of diseases and the adoption of new regulations by governments to control the spread of infectious diseases, are some of the major factors driving the growth of the healthcare industry. The growth of sterile medical packaging in the healthcare industry is attributed to its superior microbial barrier and durable properties. These packaging products keep the pharmaceutical and medical products sterile until the package is opened for use. The increasing demand for injectable pharmaceuticals and need for oncology and other high-potency drugs are driving the growth of the market. Furthermore, using suitable sterile packaging products is very important as it allows the withdrawal of packaged contents without infection and damage. Hence, the rising demand for packaging solutions in the healthcare industry will drive sterile medical packaging market growth during the forecast period.

RESTRAINING FACTORS

Stringent Regulatory Standards for Sterile Packaging to Restrict Market Growth

Sterile packaging systems must be designed to ensure sterility of packed contents until their point of use. Hence, stringent regulatory standards are made and implemented over their manufacturing. These standards ensure that the packed devices or instruments do not face any adverse reaction or damage from packaging products or external factors. EN ISO 11607 (part 1 and part 2) is the global standard that specifies the validation requirements of medical packaging systems used for sterilized medical devices or instruments. These validation requirements are used in various steps of packaging products, such as material selection, design qualification, design testing & control, and process validation. The standards are complex and act as a restraining factor for the market.

Sterile Medical Packaging Market Segmentation Analysis

By Material Analysis

Plastics Segment to Remain at Forefront Backed by its Cost-effective Property

Based on the material, the market is segmented into plastics, glass, metal, paper & paperboard, and others. Plastic is the largest and fastest-growing raw material used in the production of sterile medical packaging. They are mainly preferred in medical packaging and include polyvinyl chloride (PVC), polypropylene (PP), polycarbonate (PC), high impact polystyrene (HIPS), polyethylene terephthalate (PET), and high-density polyethylene (HDPE). These plastics are an ideal choice for medical packaging solutions as they offer easy moldability, cost-effectiveness, and protective properties. They protect the packed drugs, devices, and medical instruments from damage and contamination. Plastics find their application in thermoformed blister trays and packs, bottles, closures, pouches, vials, overwraps, and bags.

Glass is the second-largest material used in sterile medical packaging, owing to its chemical and moisture-resistant properties. It is a preferred material in the manufacturing of various types of medical packaging such as vials & ampoules, bottles, test tubes, and syringes. Moreover, metals, such as lead, tin, and aluminum, are highly used for the packaging of medical equipment. The paper & paperboard segment is anticipated to grow significantly, owing to its various beneficial properties such as high stiffness, durability, code ability, and reliability.  

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By Type Analysis

Thermoform Trays Segment to Account for Major Share Due to its Ability to Hold Medical Equipment Intact

Based on type, the market is categorized into thermoform trays, sterile bottles & containers, vials & ampoules, pre-fillable inhalers, sterile closures, pre-fillable syringes, and blister & clamshells, bags & pouches, wraps, and others. Among these, thermoform trays are the majorly used sterile medical packaging systems. These are mainly produced using rigid material and have a multi-compartment to support the medical equipment. These trays are used to pack sutures, implants, testing kits, and sensitive surgical items.

The pre-fillable syringes segment held the second-largest share in the market in 2021. These ready-to-fill syringes are lightweight, transparent, and break-resistant. Plastic is the preferred material used in these syringes as it can offer a glass-like appearance. The high moisture barrier property of syringes enables the long-term storage of drugs. Hence, it is suitable for multiple-dose injection therapies in various diseases. The rising use of multiple-dose injection therapies will surge the demand for pre-fillable syringes during the forecast period.

Moreover, blister packs reduce the cost of packaging and eliminate the need for additional cartons. Hence, their increasing preference will fuel the blister & clamshells segment. Several types of bags & pouches are adopted in the medical industry, which includes adhesive closure bags, sterilization bags, pharmacy bags, respiratory setup bags, and ziplock & reclosable bags.  

By Sterilization Method Analysis

Chemical Sterilization to be the Fastest-growing Sterilization Method as it is Suitable for Various Materials

Based on sterilization method, the market is classified into chemical sterilization, radiation sterilization, and high temperature/pressure sterilization. The chemical sterilization segment is segmented into ethylene oxide (ETO), hydrogen peroxide, and others. Similarly, the radiation sterilization segment is sub-segmented into gamma radiation, e-beam, and others. Further, the high temperature/pressure sterilization segment is bifurcated into the steam autoclave and dry heat. The chemical sterilization segment is the fastest-growing method adopted in the market, in which ethylene oxide is the most powerful chemical used for sterilization. It is an alkylating agent that disrupts the reproductive processes and cellular metabolism of microorganisms. Furthermore, it is well-suited for many materials, including plastics and glass, that degrade by radiation or heat sterilization.

Radiation sterilization is the second-largest method in which gamma radiation is the largest sub-segment. This method uses cobalt-60 as a radiation source that undergoes decomposition to release the high-energy gamma rays for sterilization and decontamination. In the sterilization process, gamma rays kill the contaminating microorganisms by breaking down bacterial DNA and inhibiting bacterial division. This makes gamma radiation a reliable and viable method for the healthcare system. In high temperature/pressure sterilization, the steam autoclave is the most effective method. It is a very effective decontamination method that uses saturated steam at 121–132 °C. It is mostly used for medical devices such as surgical instruments. Hence, the increasing demand for the sterilization of packaging products will boost the lucrative growth of the market.

By Application Analysis

Pharmaceutical & Biological Application to Account for Dominant Share due to Surged Medication and Blood Tests Demand

Based on application, the market is classified into pharmaceutical & biological, surgical & medical instruments, in-vitro diagnostic products, medical implants, and others. The pharmaceutical & biological segment held a dominant sterile medical packaging market share in 2021. The rapidly rising contagious and non-contagious diseases have led to an increase in the number of patients. This has resulted in the increasing demand for medication and blood tests. These positive factors are expected to surge the demand for such packaging in pharmaceutical & biological applications and thereby drive the market growth.     

The surgical & medical instruments segment is a rapidly growing application in the market. These include catheters, procedural kits, urine and drainage bags, gloves, drapes, and gowns. These instruments are majorly used during surgical procedures and operations. Hence, the rising need for surgeries and operations will increase the demand for surgical & medical instruments and will thereby lead to market expansion.

Furthermore, materials such as plastic and glass are mainly used in in-vitro diagnostic products. The medical implants segment is anticipated to grow at a significant rate during the forecast timeline. The demand for medical implants is associated with their biocompatibility, corrosion resistance, bio functionality, bio-adhesion, availability, and processibility properties.

REGIONAL INSIGHTS

The sterile medical packaging market size in North America stood at USD 14.15 billion in 2021. Based on the region, the market is categorized into North America, Europe, Asia Pacific, South America, and the Middle East & Africa.

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North America holds the largest share in the market. The U.S. is the most significant contributor to this region. The growth in this region is attributed to the rising pharmaceutical industry and increasing consumer healthcare spending. The rising number of patients, owing to the rapidly spreading contagious diseases such as coronavirus, has led to the growth of the pharmaceutical industry. These factors will fuel the demand for such packaging in this region.

Europe is the second-largest contributor to the market. The growth is due to the rising use of medical equipment such as thermoform trays, sterile bottles & containers, vials & ampoules, and pre-fillable syringes in various medical applications.

In Asia Pacific, China, Japan, and India are the leading contributors to the market growth. The increasing population and awareness of consumers toward healthcare requirements have boosted the healthcare industry in this region. Further, the high demand for in-vitro diagnostics and medical implants will drive the demand for sterile medical packaging. The increasing product need for medical implants & in-vitro diagnostic applications will boost the market growth in the Middle East & Africa. The rising infrastructure development and increasing product innovation will surge product adoption in South America.

List of Key Companies in Sterile Medical Packaging Market

Key Players Use Organic and Inorganic Growth Strategies to Maintain their Positions in the Market

At present, the competitive landscape of the market depicts a semi-consolidated industry with the top 15 companies accounting for the major share of the market. Key players in the market have invested a considerable amount of resources in the research and development of several products and technologies to produce them. A diversified product portfolio, supported by superior operational efficiency, and safe & novel technology development for sterile medical packaging applications, are the strategies used by market leaders for their growth. These companies have adopted the strategies of expansion, new product development, and acquisition to increase their regional presence and product portfolios.

LIST OF KEY COMPANIES PROFILED:

• Amcor Plc (Switzerland)


• Placon (U.S.)


• DuPont (U.S.)


• Steripack Ltd. (Ireland)


• Wipak Group (Finland)


• Nelipak Healthcare (U.S.)


• Tekni-Plex (U.S.)


• Sonoco (U.S.)


• BillerudKorsnäs AB (Sweden)


• ProAmpac (U.S.)


• West Pharmaceutical Services, Inc. (U.S.)


• Riverside Medical Packaging Company Ltd (U.K.)


• Oliver Healthcare Packaging (U.S.)


• GS Medical Packaging (Canada)


• Orchid (U.S.)


• Technipaq Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• October 2023 – Coveris, a leading medical packaging manufacturer, launched a new recyclable thermoforming film, Formpeel P, at the company’s show in Dusseldorf. Formpeel P is the latest addition to Coveris’ portfolio of sustainable materials, which includes Formpeel T, Cleerpeel, and Flexopeel T. It provides the same functionality and safety as traditional packaging materials, while minimizing product waste and packaging.


• September 2023 – Guardian Medical introduced a minimal footprint packaging solution. A new benchmark in medical device packaging, the product optimized device protection and improved the size and cost economy while using less packaging material. The packaging addressed cost pressures while ensuring exceptional outcomes in sterile packaging.


• January 2023 – Nelipak added Eastman Renew’s materials for sterile medical device packaging. The company used Eastman’s Easter Renew 6763 to produce rigid thermoformed sterile barrier packaging. Nelipak is the first healthcare packaging manufacturer to use Easter Renew 6763 to produce sterile barrier packaging for Class 2 and Class 3 medical packaging applications.


• September 2022 – Eastman collaborated with Ethicon, a Johnson & Johnson MedTech business, to source Eastman Renew materials for its medical device sterile barrier packaging. It was an essential step to help decrease waste in the healthcare system and contribute to a more circular future.


• June 2021 – Amcor launched ACT2100, a heat seal coating medical packaging solution. This product will enhance performance in healthcare applications and serve customers’ device packaging needs.

REPORT COVERAGE

An Infographic Representation of Sterile Medical Packaging Market

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The report provides a detailed analysis of the industry and focuses on key aspects such as leading companies, product types, materials used in packaging, sterilization methods adopted, and leading applications of the product. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market in recent years.

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