In industries such as pharmaceutical, medical device, aerospace, automotive, and electronics, manufacturers place substantial emphasis on the cleanliness of the products. A cleanroom is typically a chamber that is temperature-controlled and has a low level of contaminants. These pollutants can be in several forms like airborne microbes, chemical vapors, dust, and aerosol particles, and in order to mitigate the dirt, pollutants, and other noxious substances, the pressure, and humidity of the room are monitored closely. The market refers to flexible packaging in clean rooms and is segmented into type (polyethylene, nylon, polyester, others) and finds applications in electronics, aerospace, medical device, pharmaceutical, automotive, and others.
Currently, the U.S. dominates the global medical device market; in 2017, the U.S. medical device market was valued at USD 156 billion, and the export of medical devices was accounted for USD 43 billion in 2018. In line with this, the demand for flexible packing for cleanroom medical devices such as syringes, catheter, feeding tube, valves, and stents for heart surgeries is expected to increase as they are required to be sterile and devoid of direct human contact. In the last few years, the demand for regular health check-ups and overall number of preventive surgeries such as coronary artery bypass grafting, pacemaker implantation, and heart surgeries have increased significantly. In 2018, Johnson & Johnson Services, Inc — North America's biggest medical device manufacturer — generated a total sales revenue of USD 27 billion in 2018 from medical devices, which was about 26 billion in 2017.
Polyethylene, nylon, and polyesters are some of the key materials used in cleanroom packaging. However, these materials are not environmentally-friendly and degradable. As per the American Chemistry Council, in 2017, around 35.4 million tons of plastic were generated in the U.S. alone, which also included high-density polyethylene (HDPE) or low-density polyethylene (LDPE) materials. In line with this, the U.S. government is imposing stringent regulations to reduce plastic pollution, which is further nudging the private players to invest in clean technologies.
The three main technology trends transforming packaging are the use of fiber-based material in packaging, inclusion of robotics, and smart packaging. Flexible packaging includes the extrusion process in the manufacturing, and extrusion process is the most common technology that accounts for more than half of all technologies used in flexible packaging manufacturing. Historically, flexible packaging was made from paper and thin tin; however, today, aluminum foil, polyethylene, and polyester are used.
Globally, the concern for plastic-based packaging has been rising at a significant rate across the globe as it does not decompose, further compelling the manufacturers to find alternatives such as plant-based fibers. For instance, recently, in February 2020, Plastopil Europe B.V. launched a ready-to-recycle flexible packaging range that is designed to meet packaging regulations, which is best suited for high barrier applications. Apart from this, robots and robotic technologies are used in the packaging industry as they offer flexibility and can be positioned and replaced for different types of works. Similarly, smart packaging includes technologies, such as RFID (radio frequency identification), which helps in reading the device and determines the current status of the product in a matter of seconds.
The North America flexible packaging for cleanroom market has been segmented into polyethylene, nylon, polyesters, and others. The polyethylene segment holds the largest market share. Medium and high-density polyethylene is the most commonly used materials in cleanroom packaging to maintain the shape of the packaging. In 2016, Asia and North America were the leading producers of high-density polyethylene. They hold about 36% and 20% share, respectively, in the global production capacity of polyethylene, as per Plastic Insight.
Low-density polyethylene (LDPE) is resistant to moisture and chemical, and can act as a gas barrier; therefore, it is commonly used for airtight storage of food where the exposure to oxygen is not required. As per the Observatory of Economic Complexity, in 2017, the U.S. was the largest exporter of polyethylene and generated revenue of USD 5000 million. On the other hand, China was the major importer of this product. However, the ongoing trade war between the U.S and China is likely to hamper the imports of polyethylene used in the manufacturing of cleanroom packaging.
From the last few years, the North America market has been witnessing declining demand for polyethylene as consumers are becoming aware of the harmful environmental impacts of plastic. In line with this, polyethylene producers are attracting flexible packaging manufacturers by offering polyethylene at a lower cost.
Apart from polyethylene, polyester is also among the preferred materials for flexible packaging and is extensively used in the food and beverage industry. In 2017, around 30.3 million tons of polyester was produced globally, out of which, North America contributed 16.9%, and the U.S. was the key producer. The recent breakdown of the coronavirus in China is projected to hamper market growth. The market is already facing a shortage in the supply of polyester due to several socio-political factors, which may further upsurge the prices in the years to come.
Numerous players have also introduced polyester recycling technology to convert polyester waste into polyethylene terephthalate (PET). PET is largely imported for its environmentally-friendly features. In November 2019, Poseidon Plastics Ltd. partnered with Dupont Teijin Films to construct a 10,000 tons per year facility in the U.K.
Based on the application, North America's flexible packaging for cleanroom market is segmented into electronics, aerospace, medical devices, pharmaceutical, automotive, and others. Apart from the above-mentioned industries, cleanroom packaging is also used in Lifesciences, optics, military, and food and beverage industries.
Cumulatively, the pharmaceuticals and medical devices segments hold significant share in the North America flexible packaging for cleanroom market. The demand for pharmaceutical products is growing with the increasing prevalence of various chronic diseases, number of surgeries, and growing adoption of medical devices. In 2017, North America accounted for 48.1% of world pharmaceutical sales, as per the European Federation of Pharmaceutical Industries and Associations (EFPIA). However, political instability between the U.S. and China continues to hamper the growth of the pharmaceutical industry as more than 80% of the pharmaceutical products in the U.S are manufactured in China.
Syringes, tubing, pen needles, drapes, gowns, IV sets, and surgical instruments are some of the medical devices that are required to be protected from the external environment before usage wherein flexible packaging plays a key role in providing adequate protection to such devices. With each passing year, North America is witnessing significant growth in the overall number of surgeries being performed. As per the National Health Statistics, around 48.3 million surgical and non-surgical procedures were performed in the U.S., further driving the market growth.
North America flexible packaging for cleanroom market is segmented into three categories, Tier I, Tier II, and Tier III on the basis of the manufacturer’s position in the market. Tier I players contribute approximately half of the total share of the North America flexible packaging for cleanroom market. Tier I players in the North America flexible packaging for cleanroom market include PPC Flexible Packaging LLC, Amcor PLC, UFP Technologies, Pro-Pack Materials, CDC Packaging Corporation. Tier II and Tier III players collectively contribute more than 45% of the market.
|Market Size||USD in Billion By 2030|
|Forecast Units||Value (USD Million)|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
|Segments Covered||by Type (Polyethylene, Nylon), Application (Medical Devices, Pharmaceutical, Automotive)|
|Geographies Covered||North America, Europe, Asia-Pacific, LAME and Rest of the World|
|Key Companies Profiled/Vendors||Nefab Group, Statclean Technology (S) Pte Ltd, SteriPackGroup, Performance Packaging, Assemblies Unlimited, Inc., J-Pac, LLC, UFP Technologies, Inc., United Technologies Corporation, GE Aviation, Amphenol Corporation, Nvidia Corporation, Micron Technology, Inc., Nippon Gohsei UK Limited, Arkema Group, Kuraray Co. Ltd, Foster Polymer Distribution, PolyIndex, DAK Americas, Mitsui Chemicals, Inc., SABIC, DuPont de Nemours, Inc., Celanese Corporation|
|Key Market Opportunities||Growing Prevalence Of Paper & Packaging Industry Helps To Grow North America Flexible Packaging For Cleanroom Market Share|