For companies involved in pharmaceutical packaging, 2018 looks like it will be a year of scrambling to meet new regulations on serialization, safety and security, while at the same time responding to market demands for personalized care and generational requirements.
The future of the global pharmaceutical packaging market looks good, according to a recent report released by MarketsandResearch.com. The global pharmaceutical packaging market is expected to reach an estimated $86.4 billion by 2023 and is forecast to grow at a CAGR of 5.5 percent from 2018 to 2023.
Pharmaceutical packaging is driven by growth of the pharmaceutical industry along with improving healthcare services in developing economies. In this market, plastic, glass, paper and aluminum foil are the main material types.
EFFECTS ON INDUSTRY DYNAMICS
The report goes on to say emerging trends, which have a direct impact on the dynamics of the pharmaceutical packaging industry, include rising demand for eco-friendly packaging, increasing use of nano-enabled packaging and increasing adoption of blow-fill-seal technology. Plastic packaging is expected to witness significant growth over the forecast period because plastic is lightweight and easy to handle. Plastics also have a superior aesthetic value and an excellent barrier against moisture and air.
However, depending on the source, many trends are impacting pharmaceutical packaging. Marsha Frydrychowski, director of marketing services at Resource Label Group (www.resourcelabel.com), a major label supplier to the industry, recently detailed six trends affecting pharmaceuticals.
First and foremost is the looming deadline for manufacturers to meet regulations of the 2013 Drug Supply Chain Security Act (DSCSA) which will increase industry focus on serialization, security and quality. All segments of the pharmaceutical supply chain are pushing to meet the new federal verification, serialization and transaction documentation regulations on time.
The DSCSA is a law aimed at preventing counterfeit products from infiltrating the supply chain—a problem that costs the industry almost $40 billion annually, Frydrychowski said. Serialization also could help identify drug lots throughout the supply chain in the event of a recall.
Originally set for Nov. 27, 2017, these regulations require manufacturers to include serialized numerical identifiers (SNIs) at the product and pallet level. The FDA released a draft guidance document extending enforcement of that deadline to Nov. 27, 2018, citing concerns about the industry’s readiness to meet the requirements by the original date. Once the one-year grace period expires, Frydrychowski and other industry observers say it is likely that a zero-tolerance policy will take its place.
MACHINERY AVAILABLE FOR IMPLEMENTATION
Jerry Martin, an industry expert and pharmaceutical and life sciences consultant to PMMI, The Association of Packaging and Processing Technologies, says many companies already have instituted or are far along on the path to serialization. He said the packaging industry has introduced a variety of machinery, such as printers and scanners to produce 2D barcodes or even laser marking on individual pills. Many of these machines are compact and modular so they can be easily added to existing packaging lines.
In addition to 2D barcodes, RFID tags are increasingly used to track packages and pallets throughout the supply chain. RFID tags eliminate the need for line-of-sight identification. All the goods within a pallet of packaged goods can be identified simultaneously, so long as it is within the range of the RFID reader. Beyond ease of identification, RFID labels are extremely difficult to counterfeit.
For companies that are latecomers to serialization, Martin says the biggest challenge to meeting the deadlines may be the software required to integrate the serialized data and ensure that it is accurately tied to the product in each step of the process. When companies are retrofitting this equipment to an existing line, they must find integrators who can write the software required to tie together equipment from diverse suppliers—and these coders are in limited supply.
It should be noted that a number of companies, such as the OPTEL Group (optelpharmaceutical.com), offer off-the-shelf systems that may aid drug companies trying to catch up with the requirements.
In a recent white paper, Optel points out that these serialization regulations are only the first step in the development of system that is scheduled to be phased in through 2023. There will be an aggregation stage, which requires associating “parent packages” to “child packages.” Product and transaction information from each sale will be required, tracking the drugs through the entire supply chain from materials suppliers to individual consumers.
DATA PROTECTION A CONCERN
Obviously, this will require huge amounts of data to captured and stored. Again, accuracy is paramount for the U.S. system to work as data are collected, stored and transferred down the pharmaceutical distribution supply chain. Another concern is that the robust enterprise software solutions to integrate the system also must offer advanced cybersecurity solutions to prevent counterfeiting and security breaches.
Complicating these efforts is the fact that other jurisdictions or countries may have varying data requirements. Martin says that while industry standards organizations are working to set global standards for serialization, different standards pose a problem. This forces the manufacturers to seek flexible equipment that allows for quick changes due to smaller batches and specialized software to handle a high level of complexity.
“We are seeing filling lines that are smaller, more modular and flexible, with shorter lead times,” Martin said, adding that the industry is moving away from a big-factory model due to the need for personalized medicines, smaller batches and an increase in regionalized manufacturing markets.
Another major trend in the industry is for pharmaceutical companies to increasingly outsource their production to contract manufacturers and co-packers.
As the market changes and regulations stiffen, pharmaceutical manufacturers are hard-pressed to keep up with their packaging needs, Frydrychowski said. The cost of replacing legacy equipment in the face of stricter regulations is high and the packaging itself is increasing in complexity.
TURNING TO CONTRACT PACKAGING
That’s why more pharmaceutical manufacturers are turning to specialized CMOs to ensure a higher level of speed and accuracy in their packaging operations. This allows pharma companies to focus on their core competencies—developing drugs—and leave the mounting complexities of pharmaceutical packaging to the experts, she adds.
With greater flexibility, shorter lead times and a wide portfolio of capabilities (i.e., blister packs, RFID tags, tamper-evident solutions, etc.), specialized pharmaceutical packaging companies are able to provide full-service solutions that pharma manufacturers just can’t, she says. Outsourcing the packaging can reduce total supply chain costs by 25 to 50 percent, so she predicts more pharma companies are likely to partner with CMOs for their packaging needs.
While pharma companies address serializations regulations, they also must respond to changes in consumer expectations. There is increasing demand for medicines in the U.S. with medical care available to a greater number of people and an aging population. In addition, the populations in developing countries have more financial resources and access to medications that might not have been available in the past.
Within the global pharmaceutical packaging market, bottles are expected to remain the largest product type driven by increased application in both solid and liquid oral medications as bottles provide convenience, safety and security. However, Martin suggests that plastics are making gaining share, especially for solid-dose medicines.
DEMAND FOR PERSONALIZED MEDS
This has led to a demand for more personalized medications and improved packaging that individuals can afford and which extends shelf life and aids in compliance. One of the major concerns expressed by physicians is that people often don’t take their medications according to direction, which has been estimated at 50 percent of all patients. Increasingly, companies are looking at ways the packaging can help in this area.
Adherence has been a major factor in the growth of blister packs for medications as they can help patients track which pills they take. Martin says the blister packs also can staunch prescription errors within pharmacies, while providing extended shelf life.
When it comes to pharma packaging, Martin notes one trend which may produce counteractive results. Due to liability fears, companies are making the packaging more child-resistant to prevent accidents. At the same, this action can make opening packaging more difficult for older adults who have lost some hand dexterity.
Martin also points out that new biological drugs are creating some unanticipated challenges in packaging. Biologics can sometimes cause drugs to interact with the packaging materials. He described a situation in which a novel biologic caused a glass vial to delaminate that sent glass flakes into the drug.
Other recent developments include the use of active packaging. More pharmaceutical packagers are using smart labeling technology—namely radio frequency identification (RFID) and near field communication (NFC) tags—to track products and engage with patients.
NFC labels have far-reaching implications in terms of improving medication adherence, Frydrychowski said. Small, programmable NFC tags embedded in labels enable pharmaceutical companies to communicate key information to consumers. Just by tapping their NFC-enabled smartphones to the label, patients can access dosage and usage information in real time from a company’s cloud server. This allows tracking of interactions with NFC labels, and companies can create reports on the success of various patient engagement or marketing campaigns.
Converter’s New Digital Press Expands Pharma Capabilities
Digital printing continues to make strides in the manufacture of packaging and regulated marketing materials for the pharmaceutical and medical device industries. As an example of its growing use, Rondo-Pak (www.rondopak.com) of Camden, N.J., recently purchased an HP Indigo 5900 press to expand its digital printing capabilities. The digital press can use variable-data printing for serialization and print numerous security features to help prevent counterfeiting.
In combination with a wide range of printed materials such as inserts, leaflets, medication guides and regulated marketing materials, Rondo-Pak’s packaging innovations address precise requirements for compliance, child resistance, anti-counterfeiting and e-pedigree. The investment helps expand Rondo-Pak’s capabilities for printing on a broad range of synthetics and extra thick substrates while ensuring precision color matching across a variety of packaging and materials applications.
“This latest equipment investment is especially valuable to Rondo-Pak’s folding carton customers,” says Bob Reilley, Rondo-Pak COO, “as it increases our ability to scale production from branded samples through steady state volumes.” This expansion of digital capabilities supports Rondo-Pak’s carton assembly and branded sampling service, by providing a wider selection of substrates, increased paperboard thickness (up to 24pt) and additional security applications.
For a company with as diverse a product portfolio as Rondo-Pak, versatility is critical. That said, the new HP press is compatible with a host of substrates, and works well with expanded material types, including synthetics like PVC, PET, Teslin and plastic cards. The 5900 provides increased production speeds, and also offers expanded primer technology for various paperboards, offset stock and specialty papers.