• 出版社/出版日：Mordor Intelligence / 2021年2月10日
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The medical devices packaging market was valued at USD 29.32 billion in 2020 and expected to reach USD 41.91 billion by 2026 and grow at a CAGR of 6.13% over the forecast period (2021-2026). The healthcare industry has evolved from its erstwhile traditional form of practices to the current position, where high-tech equipment and instruments are being deployed to improve efficiency. These developments have been providing scope for the expansion of medical appliances and other medical devices, driving the growth of the market studied.
– Medical device packaging provides a sterile environment for the contents within, and the sterility needs to be preserved until the package is opened for use. All the interfering procedures involve contact between a medical device or surgical instrument and a patient’s sterile tissue or mucous membranes. A significant risk of all such methods is the introduction of pathogenic microbes that could cause an infection. Failure to disinfect or sterilize reusable medical equipment carries a risk associated with a breach of the host barriers. Therefore, the level of disinfection or sterilization on the intended use of the object is an essential aspect of the usage of medical devices.
– With this trend of sterile instruments expanding rapidly, the market is being driven by the increasing number of hospitals, therapeutic equipment manufacturers, and diagnostic centers. Manufacturers are required to address these changes through constant innovations in packaging designs with changing end-user requirements and innovations in medical devices. The growing demand for tamper-proof, non-reactive, and sterile packaged products is driving technological advancements in the medical device’s packaging market.
– New companies in the market studied are innovating in terms of economical ways and smart labeling of medical devices. For instance, CleanCut Technologies’ Vault packaging system for devices is well suited for tray-style packaging. What such technologies imply for packaging companies is that they can use the same methods with a few modifications for similar medical devices, thus reducing their validation time and ultimately achieving smaller batch packages, in line with customer requirements. Counterfeiting, an evident problem in medical devices, is expected to promote the usage of NFC and RFID tags on the packaging materials.
– Also, as COVID -19 cases continue to rise in parts of the United States, the country is still struggling to secure the volume of PPE necessary to keep up with the spread of the virus. To help arm frontline workers, in May 2020, BIC North America announced to produce 2,000 medical-grade face shields every day at its factory in Milford. The face shields, approved by the FDA along with Level 1 medical devices, are all made of materials typically used in packaging (plastic) or would otherwise be scrap from materials used in the lighters. Besides, the shields are designed so the plastic can be removed and sterilized by the hospitals, rather than disposed of.
Key Market Trends
Pouches is Expected to Hold Major Share
– Pouches are widely used containers for small- to medium-sized soft and semi-soft medical goods sold in unit quantities and are not vulnerable to damage during shipment and storage. Pouches’ specific applications include intravenous (IV) catheters, IV administration sets, dialysis disconnect caps, wound dressings, small surgical instruments, diagnostic test packs, sutures, and dental supplies. Many films are used in medical device packaging applications. These materials offer a high degree of versatility and are available in a variety of forms in mono films, laminations, and coextrusions.
– Pouches have been manufactured from laminated paper with polyolefin layers. Uncoated nonwoven polyolefin materials for use in the manufacture of heat-sealable pouches are highly being used. Applications, such as the sterilization method (e.g., the material must tolerate high temperature) and protection requirements (e.g., high puncture resistance), are some features that cater to the demand. Further, selecting the appropriate pouch size prevents the overloading of instruments and allows penetration of the sterilant with adequate air removal and less puncture or tearing.
– Also, the partnerships and contracts to improve the product quality of pouches significantly cater to market growth. In July 2019, Diener Implants GmbH, a contract manufacturer for medical devices, announced its strategic partnership with 3dpac by Steripac, a German specialist for medical device packaging, to offer implants sterile packed to its customers. The 3dpac is a proprietary blister system developed by Steripac that ensures the optimal position fixation of sensitive products like 3 D printed implants within the sterile barrier. This provides flexibility and solves the typical problems of standard blister and pouch packaging of different geometries and sizes, like spinal fusion cages.
– Moreover, growth in the demand for pouches is expected to result from expanding applications in the unit -of -use packaging of small – to medium-sized medical instruments, appliances, and supplies. The expanding use in the secondary packaging of diagnostic test packs, prefilled inhalers and syringes, and surgical and dental trays are also expected to influence the demand for pouches. However, competition from lower-cost boxes will hold down the overall demand for pouches. Moreover, poor adaptability to rigid devices vulnerable to breakage and large multiple item kits will preclude medical device pouches from penetrating a number of the high value-added applications.
North America is Expected to Hold Significant Share
– The United States and Canada are developed countries, with prosperous economies, aging population segments, and advanced medical delivery systems. Still, the countries vary measurably in population size, healthcare spending intensities, aggregate gross domestic product (GDP) levels, and the structure of health insurance plans. With advanced primary medical community, extensive medical and life science research activities, high healthcare spending intensity, and large pharmaceutical and medical supply and device industries, the United States accounts for one of the world’s largest geographical markets for medical devices and related packaging products.
– In May 2020, Packaging Compliance Labs LLC announced to invest USD 2.57 million for the expansion of its headquarters in the greater Grand Rapids area. The medical device packaging, engineering, and testing firm were awarded a USD 135,000 Jobs Ready Michigan grant from the Michigan Strategic Fund. The expansion of the packaging company significantly contributes to the overall market growth. Further, the US Food and Drug Administration (FDA) regulates sterilization packaging intended for use in healthcare under CFR Title 21 880.6850 and classifies it as a class II medical device.
– In May 2020, MedAccred announced to continue its expansion and support for the medical device industry. The company has added new plastics mechanical assembly and sterile device packaging audit processes and accredited a lot of new suppliers within the last year. The program also entered its second year of partnering with the United States Department of Commerce through the Medical Manufacturers MedAccred Accreditation Pathway for manufacturers and suppliers seeking accreditation.
– Further, anticipated strong growth in the Canadian diagnostic product industry is expected to broaden applications for parenteral vials and specialty multiple-well trays, thus driving the country’s market. Moreover, in Canada, the Federal Minister of Health approved the interim order respecting the import and sale of medical devices for use concerning COVID -19 in March 2020. Under the temporary measure, Health Canada will allow certain products to be sold in Canada, where the requirement of packaging should be fully compliant with Health Canada requirements.
The medical devices’ packaging market is quite fragmented. The major players have used various strategies such as new product launches, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market, which increases the rivalry in the market. Key players are Amcor Limited, Bemis Company, Inc., Berry Plastics Pvt Ltd, etc.
– April 2020 – April 2020, Amcor’s ULTRA pouches were certified for vaporized hydrogen peroxide sterilization as well as steam sterilization at 134°C. This means that the pouches can provide a solution for the sterilization of all reusable medical devices. The new accreditation assures that ULTRA pouches are compliant with the latest international and European EN 868 and ISO 11607 standards, including the Sterile Barrier System (SBS) requirement.
– November 2019 – Wipak launched a new pouch specifically developed for packing robotic instruments and other long devices. The pouch keeps the devices sterile during transportation and storage. It is made with an extra-strong paper for better protection, with high puncture resistance and resistance to penetration of any microbial. The pouch also incorporates Wipak’s acclaimed Multi – X 9 multilayer film, which consists of nine layers, each with its features and functions.
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1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET INSIGHT
4.1 Market Overview
4.2 Industry Value Chain Analysis
4.3 Industry Attractiveness – Porter’s Five Force Analysis
4.3.1 Threat of New Entrants
4.3.2 Bargaining Power of Buyers/Consumers
4.3.3 Bargaining Power of Suppliers
4.3.4 Threat of Substitute Products
4.3.5 Intensity of Competitive Rivalry
4.4 Impact of COVID-19 on the Market
5 MARKET DYNAMICS
5.1 Market Drivers
5.1.1 Longer Shelf-life Packaging Products
5.1.2 Growing Innovations in the Medical Devices
5.2 Market Restraints
5.2.1 Stringent Government Regulations in Developed Countries
6 MARKET SEGMENTATION
6.1 By Material
6.1.2 Paper & Paper Board
6.1.3 Others Materials
6.2 By Product
6.2.1 Pouches & Bags
6.2.4 Clam Shells
6.2.5 Other Products
6.3 By Application
6.3.1 Sterile Packaging
6.3.2 Non – Sterile Packaging
6.4.1 North America
220.127.116.11 United States
18.104.22.168 United Kingdom
22.214.171.124 Rest of Europe
126.96.36.199 Rest of Asia-Pacific
6.4.4 Latin America
188.8.131.52 Rest of Latin America
6.4.5 Middle East & Africa
184.108.40.206 United Arab Emirates
220.127.116.11 Saudi Arabia
18.104.22.168 South Africa
22.214.171.124 Rest of Middle East & Africa
7 COMPETITIVE LANDSCAPE
7.1 Company Profiles
7.1.1 Amcor PLC
7.1.2 Berry Plastics Pvt. Ltd.
7.1.3 DuPont Company
7.1.4 WestRock Company
7.1.5 Mitsubishi Chemical Holdings
7.1.6 Chesapeake Pharmaceutical and Healthcare Packaging
7.1.7 Technipaq Inc.
7.1.8 SteriPack Group
7.1.9 Riverside Medical Packaging Company Ltd.
7.1.10 Wipak Group
8 INVESTMENT OPPORTUNITIES
9 FUTURE OF THE MARKET