A recent analysis by the market research firm Freedonia Group estimated that world demand for pharmaceutical packaging will rise 6.5% annually to more than $100 billion in 2019. The Africa/Mideast region is projected to be the fastest growing market, followed by the Asia/Pacific region, then Central and South America in third. Primary containers will remain the dominant segment, led by pre-fillable syringes, and parenteral vials.
Geographic expansions
Almost 60% of global demand will exist in the developed economies of Canada, Japan, the US, and Western Europe, according to the Freedonia analysis. India and China will be the fastest-growing markets due to rapidly expanding pharmaceutical manufacturing capabilities and the adoption of more stringent regulations aimed at improving the quality and integrity of domestically produced pharmaceuticals. Brazil, Mexico, Turkey, and various other countries of the Asia/Pacific, Central and South America, and Africa/Mideast regions are among developing markets that are expected to expand and diversify drug-producing industries and register above average gains in pharmaceutical packaging product demand.
Over the long term, the US will continue to form the largest national pharmaceutical packaging product market due to its role in advancing innovative pharmaceuticals and related packaging demand. But demand in Western Europe will remain comparatively high and expand steadily due to the impact of new product introductions and upgraded government standards covering unit dose, high barrier, and anti-counterfeit packaging of many types of medicines. Based on broad contingents of proprietary and generic drug producers, Canada and Japan will continue to be large, diverse consumers of pharmaceutical packaging products. However, both countries will see below average growth in demand as drug makers pursue greater packaging efficiencies to offset medication pricing pressures.
Product segment growth
Pre-fillable syringes and parenteral vials will see above average growth due to new injectable therapies. Based on uses in the bulk and prescription dose packaging of solid dose oral ethical drugs and the large quantity packaging of over-the-counter medicines and dietary supplements, plastic bottles will continue to have the largest demand globally among primary pharmaceutical containers, or $20.6 billion in 2019, according to the Freedonia analysis. Blister packaging will comprise the second largest selling group of primary pharmaceutical containers, based on adaptability to unit dose and clinical trial dosage formats with expanded label content, high visibility, and built-in track-and-trace features.
Freedonia estimates that pharmaceutical pouches will grow at a below average pace as uses remain limited to the unit-dose packaging of transdermal, powder, and topical medicines. Pre-fillable inhalers will exhibit faster demand gains as the number of chronic asthma, allergy, and migraine patients treated with inhalation drugs rises globally. Advances in aesthetic and barrier properties will keep tubes a leading container for topical medication. However, competition from plastic dispensing bottles and unit dose pouches will moderate overall revenue growth. The world market for glass pharmaceutical bottles will expand slowly as plastic bottles and blister packs capture oral drug applications, according to the analysis.
Developments in packaging
Schott’s new design for reducing possible interaction between the active ingredient and the primary packaging to provide a level of safety for sensitive active ingredients similar to that of pharmaceutical vials. The channel that connects the hub and the needle in the new syringes is made of flexible plastic. A seal keeps the liquid passageway closed during storage. The medication cannot come into contact with the metal needle or the adhesive in the syringe during shipment and storage. For added quality, tamper-proofing makes it immediately obvious whether the syringe is new or has already been used.
Another example was the development by a subsidiary of Harro Höfliger for a straw for children and the elderly that can be used to administer the active ingredient in pellet form. Patients can ingest the medication along with a beverage, and exact dosing and a control filter ensure that the correct dose is taken.
With regard to innovation in process control and quality in primary packaging, the report pointed to a new induction sealing inspection technique for pharmaceutical containers by DIR Technologies. During the sealing process, the system performs 100% sealing integrity inspection and fill-level detection on pharmaceutical containers such as bottles, bags and sachets. Inspection takes place in real time using thermal imaging technology through the closed cap. Future goals for the technology is to localize defects during induction sealing with greater precision and pinpoint exactly where to take corrective action at high throughput rates without slowing down production.
Another development from a team of developers in Singapore is self-expiring packaging that automatically draws the user’s attention to the expiry date. The blister pack is made of multi-layer plastic with warning symbols printed on the innermost layer. Once the expiration date has passed, the diffusible material between the layers disintegrates, exposing the warning symbols. Among other things, the system could be used for older patients who are unable to read the expiry date that appears on the packaging in small print. Another separate innovation was for printed electronics. The packaging has built-in temperature sensors made of nanomaterials which can remind patients to take their medication.
Track and trace
Global markets today are flooded with falsified medicines, posing a perilous threat to the pharmaceutical industry and patients alike.
A study, published in the journal American Journal of Hygiene and Tropical Medicine in April 2015, found that the scale of the issue is large, growing, and that the industry “knows little about the precise scope of the problem.”
The research by the team at the University of California San Diego suggests that counterfeiting increased by 122% between 2005 and 2010. The study looked at information collected in the Counterfeit Incident System, run by the Pharmaceutical Security institute (PSI), a non-profit organisation whose members include 28 major global pharma companies, between 2009 and 2011.
During this period there were 1,510 total reports of counterfeit incidents including 1,799 different counterfeit medicine detections. Nearly half involved a counterfeit product or packaging. The most counterfeited drug classes were anti-infectives (most commonly antimalarial drugs) (21%), followed by genito-urinary including erectile dysfunction drugs (15%), cardiovascular (12%) and central nervous system (11%), although every therapeutic class was represented. Other sources have compiled their own figures, and the World Health Organisation estimates that 10% of drugs sold globally are counterfeit.
Haydn Simpson, commercial director for Western Europe at NetNames, says: “Counterfeiting is a major problem for many market sectors, but fake medicines are the most dangerous threat. 10% to 30% of all pharmaceutical drugs in circulation globally are counterfeit and counterfeit pharmaceuticals are implicated in the deaths of up to 1 million people each year due to toxic or ineffective drugs.
“Counterfeiters have exploited the growing trend of consumers purchasing medicines online by taking advantage of genuine pharma brands, infringing their trademarks, packaging and products. This can ultimately damage the reputation of the brand, divert revenue and most importantly have serious health consequences for consumers.
Pharma companies have a responsibility to safeguard their customers and need to develop monitoring and enforcement capabilities that enable them to quickly identify and take down any fraudulent websites.”
This level of counterfeiting does the industry severe damage; it tarnishes the goodwill of the pharma companies who may be unaware about the dangers or problems posed by the counterfeits that make their way to their supply chain system. This chain typically consists of manufacturers, wholesalers, distributors and pharmacies before the medicines are made available for the end consumers at the pharmacy.
In such a scenario, track and trace technology plays a crucial role for any pharma supply chain. It avoids security lapses and works to the advantage of pharma companies. Track and trace regulation is one of the tools which aims to stop the illegal and dangerous counterfeit medicines from reaching the end consumers and ensures that all the products are easily identified. It helps in labelling the drugs and ascertains easy tracking at every level of the supply chain.
Most of the regulatory authorities across the globe are creating a two-step policy to implement track and trace regulations. The first phase is to implement serialisation at multiple packaging levels. The second phase is to implement an electronic pedigree, where companies will create a relationship between various packaging levels and share data across the supply chain.
All pharmaceutical companies selling drugs in the US will need to be partially compliant with the FDA serialisation regulations by January 1st 2015. And by the beginning of 2017 all drugs sold in the EU must comply with the EU ‘Falsified Medicines Directive’, with the aim of helping pharmaceutical companies better identify defective drugs as well as counterfeit pharmaceuticals that pose a serious danger to public health.
There are many regions where pharma regulatory systems are weak, due to which, the probability of spurious drugs increases. Globally, the importance of implementing a comprehensive track and trace system is to monitor the entire production and distribution cycle of pharma products has grown strong.
With disciplined rules and regulations, guiding the supply chain system of pharma companies, standardised identification solutions are sure to put an end to spurious medicines and secure the health of consumers worldwide.
Serialisation
The packaging challenges which the pharma industry faces today include counterfeiting, theft, diversion, and false returns to manufacturers. This is because the product passes through a complex distribution network where its authenticity at every level cannot be checked due to the absence of data-sharing systems. Serialisation makes every product unique and, therefore, it is believed that effective serialisation of medicines would cut down any chances of counterfeiting in the supply chain.
Serialisation involves printing a unique serial number on every product, in addition to other details such as batch number, shelf life and Global Trade Item Number (GTIN). It provides visibility and full traceability throughout the supply chain. Many regulatory bodies have built their framework around the GS1 Standard.
Serialisation is done across various levels of packaging and these are defined under three specific categories — Primary, secondary and tertiary.
– At the primary level, pharma companies use a GS1 2D Data Matrix to barcode products such as blisters, injections, and mono-cartons, although currently, this is not being enforced in many countries.
– At the secondary level, all the primary level packs are clubbed together as a parent unit of primary level packs and only one barcode is given to it with complete essential information.
– At the tertiary level, only the final packaging is chosen to identify every lot of the product, ensuring no malfeasance in the supply chain.
Success in serialisation is achieved through vigilance, planning and implementation. Serialisation, when followed diligently, results in economic benefits, better brand protection, and secures customers’ confidence in the brand as well as the company.
Norma Warwick-Smith, senior consultant at Interim Partners, comments: “Pharmaceutical companies are in a race against time to ensure they comply with the new regulations. Many are finding compliance is taking longer and is far harder than previously thought which means that highly skilled interim serialisation experts are now a necessity for most firms.”
“The sheer scale of many pharmaceutical companies means that the process of overhauling drug packaging systems, establishing new distribution processes and putting new tracking processes in place is a daunting task.”
“When you consider that the pharmaceutical giants have production lines across many countries around the world, and then process and sell millions of packages across thousands of product lines globally – and then add in the complexity of managing all of this under one robust system – pharmaceutical companies really are facing a daunting challenge.”
There is growing concern that the new regulatory burden may force many smaller pharmaceutical companies to the wall, especially if they haven’t yet started to take the serialisation regulations seriously. The pharma company Eli Lilly projects that the cost of its own serialisation programme will be $110m – costs that will not be able to be absorbed by smaller companies. Those businesses have to start their serialisation programmes now or there will be insufficient time to comply with the EU deadline in 2017.
Warwick-Smith says: “Serialisation experts will be the driving force behind creating and putting in place the right systems that will help to fight against counterfeit pharmaceuticals and shore up the safety of drugs being consumed globally.”
“Serialisation is going to have a major impact on the industry, which means experienced and talented professionals that can take this work on a project basis and have the experience needed to bring the company into line with the new regulations are highly sought after.”
Electronic pedigree – the next step
The pharma supply chain is dynamic and complex, and although a majority of the prescription drugs consumed by patients are safe, there are several opportunities to introduce a counterfeit drug into the supply chain. Serialisation was the first step towards attacking the counterfeiting markets. With the first phase in place, a customer would be able to tell if the products were genuine or not, through a simple verification process.
When a spurious drug enters into the system, the first question that arises in our minds is where and how did it enter into the system? This isn’t an easy question to answer, as there are numerous potential places from where the counterfeit drug could have been introduced into the supply chain. This is due to the lack of visible information throughout the chain.
In order to address this, regulatory boards are enforcing the implantation of an electronic pedigree. This contributes to protect the supply chain from any mishaps. It also helps pharma companies to address problems of counterfeiting wherever and whenever it arises, as data is recorded and shared at each and every point in the supply chain.
An electronic pedigree encapsulates all the details from sales to purchases made as well as trading of the drugs and their date of transactions through an electronic medium. The main purpose of the electronic pedigree is to safeguard consumers from counterfeit medicines.
The electronic pedigree is an auditable electronic record to track and trace drugs as they move from manufacturing unit to the end users. Its accuracy ensures safe and healthy drugs for consumers.
What segment will be benefited or damaged? The consumer, as it exposes him to harm or the industry as it lags behind its global competitors? It mostly depends on how objectively the norms and the laws are designed and implemented. The expertise implicit in serialisation and secure packaging should be easy to understand and implement.
Harmonisation at global level will not only be beneficial to the consumer world, but will also help various industrial players to implement efficient and universally proven solutions. Further, it will also ensure secure traceability of the entire supply chain at a global level.
Pharma packaging, communication and adherence
Researchers conducted a peer-reviewed study published in the journal Clinical Therapeutics, of more than 3.1 million customers at the pharmacy customers at the US giant Walmart who were dispensed a Shellpak calendar blister packaging produced by healthcare packaging specialists MWV. They concluded that “a Shellpak-based adherence strategy could provide a substantial cumulative public health benefit when broadly implemented over a large population.”
Not only does it increased medication compliance, it also reduced hospitalisations, nursing home stays, lost work days – key measures of healthcare resource utilisation. It also led to greater refill adherence, which would in theory result in financial benefits for pharma manufacturers—indeed an increase of eight to 14% could be achieved, estimates suggest. Savings of this type could make a significant difference to companies’ bottom lines.
In another research study, also drawn from dispensing at the same US pharmacy, Walmart, launched a new compliance pack to help patient compliance. The portable, calendar-style prescription packs increase patient adherence to drug regimens, as the pack provides a physical printed reminder and an opportunity for consumers to see whether a dose for a certain day has been taken or not. Greater adherence improves patient compliance and outcomes, and ultimately reduces healthcare costs across the supply chain.
But the above point has two components. Firstly, the responsibility of the pharma companies is much more than just researching and manufacturing the drug. Secondly, communicate through drug packaging in a way that the impact is felt across the value chain; the patients’ health, hospitals, doctors and the finally the company’s profitability.
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