Access all areas – pharmaceutical packaging risks and regulations2 December 2015
It’s all change in pharmaceutical packaging. Barry Mansfield looks at this rapidly growing market and investigates the big trends in security and serialisation. What are the risks and regulations and what is the best way to tackle them?
Pharmaceutical packaging market demand is estimated to reach $80 billion globally by 2020, according to analyst firm Research and Markets. Packaging is a crucial part of the pharmaceutical product and drug delivery system, protecting goods from physical damage, biological contamination and from any adverse external influence that may damage the integrity of the item. Regulation, technological innovation and the arrival of more advanced manufacturing processes are driving factors in the development of the industry and changing demands of the brand-owner.
For example, regulations implemented by authorised agencies such as Food and Drug Administration (FDA), National Quality Forum (NQF) and Healthcare Compliance Packaging Council (HCPC) for packaging have boosted the growth of the pharmaceutical packaging market. But changing regulations also bring complications, as do price volatility and a lack of consistency in the availability of raw materials. Meanwhile, advancements in drug-delivery technologies are leading to the use of innovative packaging in multiple pharmaceutical sub-segments.
Pharma packaging itself is elaborate and changing. The material used in the industry typically consists of a primary system, secondary packaging system and tertiary packaging system. The primary system consists of those materials that have direct or immediate contact with the product. It includes bottles, caps, labels and cap liners. Ampoules, inhalers, blisters, pens, vials, tubes and syringes are examples of primary packaging for dosing and fillings. Secondary packaging systems include pallets, cartoons and corrugated shippers.
What is propelling the market?
Aging of the world population and rising health awareness among consumers are significant drivers of the pharmaceutical market. Rapid growth of the pharmaceutical industry globally, particularly in the emerging regions along with the surging demand for drug delivery devices and blister packaging, are also drivers. Growth in the demand for primary packaging and rapidly increasing third-party logistics give ample opportunity for further growth. On the other hand, increasing overall packaging cost along with stricter health regulations and compliance standards are hindering growth.
The global ampoules and blister-packaging market was valued at $10.30 billion last year and is estimated to reach $14.81 billion by 2020, according to Mordor Intelligence. But that's an extremely fragmented market, with myriad players in the industry catering to the exacting requirements of the pharmaceutical companies and brand-owners. As a consequence, companies are focusing on adopting new technologies to provide differentiation in the products, thus increasing market share.
Forming film represents around 80-85% of blister packaging, while lidding materials make up the rest of that segment. Glass ampoules and vials, holding just 4% of the total glass bottles and containers market in 2014, are widely used for packaging pharma products. It was estimated that, in 2014, 85% of solid-dose drugs were packaged with blisters in Europe; while this value was 20% in the US. However, the North American market is seeing a marked shift in applications of pharma packaging; this trend is expected to make blister packaging the highest growing material.
Asia-Pacific and Latin America regions are the fastest-growing for the glass ampoules packaging market, due to the rising expendable incomes in those nations. The major segmentation in the report includes market estimates by category of ampoules packaging such as glass and plastic, type of blister packaging such as polypropylene (PP), polyethylene terephthalate (PET) and polyvinyl chloride (PVC). The report gives an intricate analysis of the market across North America, Europe, Asia-Pacific, Middle East and Africa along with further country-wise segmentation.
Fighting the fakes
Secure packaging is one of the essential techniques to avoid counterfeiting. Anti-counterfeit packaging is defined as the process of tailoring secure packaging to the product in order to minimise counterfeiting or infringement. Anti-counterfeiting packaging is a type of secure packaging that prevents imitation and confirms the safety of the goods. Anti-counterfeit measurements are taken by companies to help them in their quest to minimise losses (in revenue and loyalty terms) as a result of widespread counterfeiting.
Pharma manufacturers will have to meet the 27 November 2017 deadline of the Drug Supply Chain Security Act (DSCSA), which demands unique product identifiers for some classes of prescription drug. This measure is part of 2013's Title II of the Drug Quality and Security Act (DQSA), a ten-year roadmap to phase in new counterfeiting-prevention methods for drugs distributed in the US. To help pharmaceutical manufacturers comply with this and other regulations, a number of industry events will provide access to advanced solutions for the entire pharmaceutical life cycle.
Customs departments all over the world are seizing more and more illegally produced drugs every day. Medicines are increasingly sold via the internet, making it much easier to put counterfeits into circulation. A report issued in August by Big Market Research looks closely at the explosion of track-and-trace technologies like ePedigree, RFID and barcode in the inventory management and product-tracking area, and their increasing relevance in the authentication technology industry by 2020. Analysts say the hologram authentication technology sector added 52% market share in 2014.
Industry experts remain positive that the anti-counterfeit RFID technology segment will record a CAGR of 21.5% from 2015 to 2020. The raw figures showing how ePedigree is likely to secure its position in the track-and-trace technology sector offer a sharper picture of the growing need for product security and cutting-edge operational procedures to limit counterfeiting. The industry and various stakeholders are mobilising on their sides for a serious battle to maximise brand protection through effective packaging and labelling.
The global anti-counterfeit packaging market accounted for $57.4 billion in 2013, and is forecast to generate revenue of $142.7 billion by 2020 at 13.9% CAGR. Another driver is demographic change, which has influenced greater take-up of age-based packaging with elements that support the taking of medication. Here, the focus is mostly on convenience and functionality, with an emphasis on the simple removal and handling of medication. Packaging can also aid the patients' routine or dosing schedule and amount through a number of supporting features.
Taken to task
In the latest instalment of Eli Lilly's decade-long fight against counterfeiters, the company will plough more than $110 million into stamping unique codes and serial numbers on every drug package it sells worldwide. The goal is to make them all trackable, shutting out the illegal knockoffs. This programme will enable Lilly to confirm the origin of each shipment as it travels along the supply chain, all the way from manufacturing plant to the patient. The bulk of the spending will take place up to 2016 as the firm works to implement the new system.
This scheme also positions Lilly strongly as the US implements the main stipulations of the national track-and-trace plan. Cialis manufacturer Lilly is installing computer-controlled, high-speed stamping equipment in 40 packaging lines internationally; the company has already spent $5 million designing and testing the machinery on a mock packaging line in Indianapolis.
"It's not necessarily something pharma companies are asking to do, but we certainly see the value in it," says Bryan Orton, Lilly's director of product protection.
Its popular erectile dysfunction drug is copied often, so Lilly is no stranger to counterfeiting. CEO John Lechleiter is aware of improved sophistication in the techniques used, so he decided to make anti-counterfeiting a priority, with the firm now employing a group of seven investigators working across three continents, in addition to its authentication lab in the base city where six chemists test hundreds of suspect drugs each year. Lilly also helped bring industry-wide attention to the problem, as one of four members to found the Alliance for Safe Online Pharmacies in 2009.
In the spring of 2013, it was one of 29 companies to provide investigative agency Interpol with $5.9 million over three years to train local authorities around the world on how to single out fakes. This issue was becoming urgent, since counterfeiters are now faking life-saving drugs for conditions such as cancer and heart failure, seriously risking patients' health and endangering the companies' brands. Although patient well-being is paramount, the knock-offs also represent further lost revenue at a time of faltering financial results for the company.
This was the year that Federal DSCSA drug-traceability requirements become mandatory. But it's important to note that the new DSCSA requirements will be implemented in three phases over the ten-year period. Phase one will be in effect until December 2022, and requires the exchange of "chain-of-ownership data". Beginning in November 2017, the second phase will require that "pharmaceutical products be marked with a national drug code, serial number, lot number, and expiration date in machine-readable and human-readable form."
The last phase of the DSCSA requirements, beginning in 2023, demands that trading partners share all data necessary to track serialised items back to the product's origins. All the dominant players in the pharmaceutical industry are implementing new equipment and systems and planning for these future DSCSA deadlines. Their advice for compliance is wide-ranging. For example, Jean-Pierre Allard, global programme manager at Optel Vision, believes "maximum overall equipment effectiveness" is the key to success. He is concerned that finding floor space can be a problem.
Allard warns that adding tracking and inspection systems can hinder line efficiency, adversely affecting a company's throughput and profits. He notes that most solution providers will end up settling on separate and dedicated machines for carton printing, in order to maintain print quality. On the other hand, Chris Flori, vice-president of business innovation at ASD Healthcare (part of AmerisourceBergen) likes to emphasise the view that all decisions should be centred on what is best for the patient and the business.
Flori urges distributors and brand-owners to pose the question: "How can the granular data being collected be used efficiently to identify trends in treatment and adherence, and to improve patient safety?" He sees the DSCSA as an opportunity, with the focus always placed on enhanced patient outcomes, upstream with manufacturers and downstream with providers.
Conversely, Tim Kearns, pharmaceutical and medical devices manager at Videojet, picks collaboration as his key word. "Identify a team and formulate a plan," he advises.
That includes identifying the correct equipment for the task at hand (including high-resolution, serialisation-ready printers) and implementing early.
"Be sure to work with partner companies with open communication," he concludes. Kearns wants firms to action line-level solutions that are prepared for aggregation, to set standard processes for rework, define responsibilities, and identify and address challenges as early as possible. Brand-owners should consider all potential products that may run on a particular line. For example, items for export may need extra planning.
As for 2023 compliance, Allard recommends a single-phase approach (that is, introducing new equipment in one go), which he says can enable savings of up to 25% in direct and indirect costs. Every time the machines are changed or replaced, the packaging line cannot operate for nearly two weeks, in order to install and run all the validation tests. Hence the line is not packaging over that period, meaning there is an indirect cost for the manufacturer, hurting profits. The idea is to equip packaging lines with cameras and controlled printers at the bundle, case and pallet stations.
Allard also brings up warehouse management. When working on improvements, consideration should be given to the effect of new serialisation in use cases like rework, deaggregation, heterogeneous packing, shipment and returns, he concludes.