Packaging forms an integrated and vital component in the medical device market. Medical devices are packaged in order to maintain sterility of the product and to provide effective protection of the product and to maintain product integrity throughout the process of distribution and handling. The need for safety of medical devices has led to numerous innovations in the medical packaging industry such as methods of sealing, sterilization processes, and types of packages employed.
North American medical device packaging market is at growth stage as the medical device industry is constantly developing with continuous changes in the healthcare sector. With the constant need of medical equipments due to aging population and continuous advancements in the device industry, the medical device packaging market is expected to grow steadily maintaining the sustainability of the market. The market is segmented based on the functionality and the type of packages as:
● Thermoformed Trays and Lids
● Pouches
● Rollstocks and
● Bags
The market for medical device packaging in North America is consolidated with large market participants contributing to the major percent of the market share. Some of the major competitive factors that determine success in this market include product quality, prices, technology innovation and providing customized formed packages.
Challenges
Introduction of Combinational Drug Delivery Systems - exerts pressure on packagers
A combination product is comprised of two or more regulated components (drug eluting stents) such as drug/device, biologic/drug, biologic/device, or drug/biologic/device. Some of the examples for combinational drug delivery systems include eluting stents, antimicrobial coated catheters, and pre-filled drug or biologic delivery devices such as injector pens, metered dose inhaler, and transdermal patches. The introduction of drug eluting stents (DES) in 2002 was one of the major advances in cardiology as the re-occlusion rate in patients with diabetes and arteries reduced from 30 percent in 2003 to 5 percent in 2005.
The introduction of combinational products or drug eluting stents is one of the major challenges faced by medical device packagers as it is creating tremendous pressure to comply with a whole new set of packaging requirements, testing and distribution. The new package must have high barrier properties to provide protection against moisture, air, and light. Some of the issues faced by packagers include migration, sorption, permeation, and maintaining drug stability in the device.
With the introduction of combinational drug delivery systems, the sterilization process becomes complicated. The packaging design must be carefully designed in case of gamma radiation sterilization process as the drug must not be adversely affected by the radiation. Earlier, device packaging did not require barrier properties to the extent of drug packaging, however, with the advent of combination drug device, its packaging is expected to offer barrier properties as well as compatibility with sterilization process Therefore, medical device pacakagers are required to understand the pharmaceutical packaging techniques to fulfill the need of combinational drug delivery products.
Increase in pressure on cost reduction: Cost reduction is one of the major strategies followed by device manufacturers to improve profitability. Hence, packaging suppliers are under pressure to reduce price of the product year over year. To meet these requirements, the packaging manufacturers need to come up with new packaging materials, and packages that deliver optimum performance at reduced cost. Many medical device packaging companies are investing in research and development activity to come out with low cost packaging materials. For example Perfecseal, a Bemis company designed cost effective thermoformed tray and Tyvek lids for American Medical Systems (AMS).
Constant change in end-user requirements: One of the other major challenges includes increase in trend towards automatic computerized medical devices such as laser therapy, endoscopies and so on. These continuous advancement in the medical device industry led packaging manufacturers to constantly alter the production line in terms of type of material used and the type of packaging.
The other challenge that is likely to affect the medical device packaging manufacturers in North America is the acquisition of tier -3 participants by tier-1 companies. Companies such as Amcor Flexibles and Oracle Packaging acquired Rexam's Healthcare Flexibles business and Tolas Healthcare Packaging respectively. This industry might witness further consolidation activities in the forth coming years. For instance some of the niche medical device packaging companies such as Mangar Industries, Technipaq, medical packaging business of Richmond Technologies, Brentwood Industries, might be acquired by leading participants such as Prent Corporation, Perfecseal, Amcor Flexibles, and private equity companies. This is likely to challenge small and niche market participants, as they fail to compete with the lower prices or the extensive product lines offered by large companies.
Thus the above mentioned challenges are likely to be influential in the long run and hence it is essential for all packaging manufacturers to seek out solutions to prevail over the effects.
--Frost & Sullivan Market Insight