The pharmaceutical industry continues to evolve, adopting new technologies and optimising resources and expertise to meet authentication and anti-counterfeiting challenges, says Dr Mark Deakes, chairman of the International Optical Technologies Association (IOTA).
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Global prescription drug sales are predicted to reach $1.6 trillion by 2028, according to one industry report. Other industry analysis forecasts a CAGR of 6.12% between 2025 and 2030, reaching $2,350.43 billion by 2030. Growth is being driven by increasing global healthcare demands and advancements in obesity, neurological conditions, and cancer treatment among other factors.
However, while new technologies propel global advances, the pharmaceutical industry continues to struggle to combat the threat from organised criminals and opportunist counterfeiters. Indeed, pharmaceuticals is among the world’s largest fraud markets, if not the largest.
The international trade in illicit or unauthorised pharmaceuticals is a very real and present danger to public health programmes. For example, according to Europol, over €11m worth of fake medicines were taken off markets in late 2024 across the Eurozone, while multinational pharmaceutical manufacturer Pfizer says counterfeit prescription medicines have become a $200bn illicit global business annually. The types of drugs being sold range from chronic medications for diabetes and heart disease to cancer drugs and antiretrovirals for HIV. At the same time, counterfeit prescription medications laced with fentanyl are being sold on the internet and social media, causing an uptake in fatal overdoses across the US, says Pfizer. We are also seeing counterfeiting activity continue to be abetted by compromises in global disruption networks, poor law enforcement in some regions, regulatory uncertainties and unprecedented demand for critical drugs and medical products.
The distribution of counterfeit pharmaceutical products, which include fake anti-cancer drugs, analgesics, antioestrogens, antivirals, anabolic substances and in recent times, Covid kits, continues to shift from the physical to online markets, particularly via the dark web, where anonymous transactions between manufacturers, distributors and consumers are allowed. The number of unauthorised and unregulated online outlets selling counterfeit pharmaceutical products grows annually, with many selling counterfeit medications via the internet typically posing as legitimate vendors.
Furthermore, as well as causing harm to people, pharmaceutical-related crime damages legitimate manufacturers, who are impacted by unsafe counterfeits that can erode brand reputation and reduce the funds available for legitimate new research and investment in product development.
Tackling pharmaceutical counterfeiting and brand piracy is therefore of paramount concern for manufacturers, healthcare authorities and law enforcement - and one area in which the problem can be tackled effectively is product packaging featuring optical security devices such as micro-lenses, micro-mirrors, colour shifting, print, diffractive and holographic technologies.
New trends in pharmaceutical packaging follow developments in emerging markets, demographic changes and new technologies, and with estimates that the total global value for tracking, tamper-evidence and product authentication in 2025 will reach US $4.0 billion, growth in authentication and anti-tamper devices appears to have a healthy future. This comes on the back of a rise in wider global healthcare concerns, higher adoption rates of anti-counterfeit technologies and greater awareness of the benefits of new track and trace technologies and system integration.
Combatting counterfeiting global examples
Packaging featuring security devices can ensure quality and thwart the distribution and smuggling of illicit products, while items not displaying optical security devices can be quickly seized and destroyed. Today, the advances in application, film coating and manufacturing technology are rolling back the boundaries for the use of a new technologies, facilitating fresh levels of visual effect, brand enhancement, regulatory compliance and anti-counterfeiting.
While some major manufacturing countries in Asia, continue to struggle with counterfeit medicines, Malaysia and Italy are good examples of countries that have adopted successful security pharmaceutical label programmes to serve the public interest effectively.
Malaysia became the first country to implement a nationwide holographic label anticounterfeit program for pharmaceuticals 20 years ago. This initiative, led by the Pharmaceutical Services Department under the Ministry of Health, has become one of the world’s longest-running and most effective anti-counterfeit medicine programmes and has consistently demonstrated success while other nations are also bringing forward their own initiatives. Developed by the Istituto Poligrafico e Zecca dello Stato (IPZS) in Italy, the IPZS Bollino security label, for example, which features optical elements and a barcode for enhanced security, illustrates how national printing authorities can innovate.
Other pharmaceutical organisations approach authentication with the same attention to a mix of brand identity and anti-counterfeiting features. In China, Gilead’s EPCLUSA and TRODELVY medicines carry tamper-evident seals on both the top and bottom of their carton packaging, with the top seal comprising a colour shifting hologram and variable QR code. When the hologram is tilted strongly forward, the image of the small ‘Leaf and Shield’ logo and ‘Gilead’ brand name appear bright green against a dark larger logo. In the case of the Gilead labels, when the top label is removed, the hologram will split into an ‘X’ to indicate the box has been opened, whereas the QR code remains on the box.
In addition, the label can be checked by scanning the QR code with a smartphone, which directs the user to a Gilead response page, notifying them if the QR code is valid. As for the label on the bottom of the medicine packaging, this has a ‘lock’ VOID effect. When the label is peeled off, two opened lock images appear. This effect is irreversible, i.e. the locks remain visible even when trying to reseal the label. Gilead also uses similar solutions for its premium Veklury (remdesivir) brand, which treats patients for COVID-19.
Multinational pharmaceutical, biotechnology, and medical technologies corporation Johnson & Johnson uses a range of authentication solutions to prevent counterfeiting and ensure the authenticity of its products. One example is its Janssen COVID-19 vaccine box and vial labels. While the box label carries a tamper-evident feature along with a datamatrix and QR code, the vials inside the box carry a datamatrix. The company also applies similar anticounterfeiting measures across its portfolio of high-risk products, including cancer treatments and medical devices. In 2022, J&J announced a significant milestone, completing a nearly decade-long effort to embed unique device identifiers (UDIs) into the barcodes of 70,000 different medical devices it sells in the United States – becoming one of the first healthcare companies in the world to do so. It is now focusing on expanding its UDI efforts in other countries.
In Japan Chugai Pharmaceutical, one of country’s top five pharma companies has intensified its efforts to protect patients and ensure the authenticity of its products, by implementing an anti-counterfeit strategy which includes the application of tamperproof tape and security holograms on product packaging. This augments the mandated use of a serialised traceability code on pharma products, in the form of a 2D data matrix code, to help the supply chain and law enforcement differentiate between counterfeit/adulterated and genuine/intact products.
One of India’s largest pharmaceutical companies, Mankind Pharma, sees the value of holograms and security labels embedded with advanced anti-counterfeiting features (3D holographic images, unique patterns and microtext) as the most difficult to replicate. Similarly, the use of blockchain improves traceability via end-to-end tracking of shipments, helping to curb counterfeit drugs in the Indian pharmaceutical industry, which is projected to reach $130 billion by 2030 as the country stands poised to become the ‘world’s pharmacy’.
Elements such as QR codes, holograms, and security labels help to verify the authenticity of products as India’s pharmaceutical companies invest in secure, distinctive, difficult-to-copy packaging that is changed periodically to make counterfeiting challenging. The ability to combine with new emerging digital technologies such as QR codes, AI, and blockchain further confirms holography’s evolving role and ability to remain relevant as one of the most used overt physical authentication measures.
Collaboration
Technology collaboration is increasingly a key ingredient in delivering successful pharmaceutical anti-counterfeiting strategies. For example, the partnership between Crane Authentication & MM Packaging is integrating advanced micro-optics technology into pharmaceutical packaging. Originally developed for banknote security, this technology involve making tiny lenses on the packaging that create three-dimensional effects that can be customised with specific icons or designs.
For example, German security technology firm Giesecke+Devrient (G+D) has been working with security printing partners for several years in the product authentication market. Another example is Giesecke+Devrient (G+D) authentication solution, SIGN, which is based on micro-optic technology and security features are embossed directly onto the packaging. The technology has been used for over one billion packages in the pharmaceutical sector.
One of G+D’s other notable innovations is its entry into smart packaging and logistics with the release of its second-generation Smart Label, a paper-thin IoT device that transforms packages into intelligent, trackable items. Developed in collaboration with Sensos, this new Smart Label includes hardware, iSIM, cloud connectivity, and firmware updates. It offers GPS-enabled location accuracy within 10 metres, motion sensing, tamper detection, and temperature monitoring, making it ideal for thwarting counterfeiting activity in the global pharmaceutical supply chain.
Indeed, we are seeing optical security technologies embracing some interesting roles beyond traditional security and authentication. For instance, they can assist in maintaining the time and temperature of packaging, offering some distinct advantages, notably combined tampering, authentication and temperature monitoring all with in the same solutions’ package. Photonic crystal-based time temperature indicators change colour based on fluctuations in the optical properties of a photonic crystal structure, which is affected by the infiltration of a polymer due to temperature changes.
Optical security technology has advanced to such a position that when it’s integrated with track and trace it can provide manufacturers with the tools to be fully compliant with shifting legislative landscapes - incorporating beneficial features can help users generate unique sequential, encrypted or random serial numbers, or identify and mark products overtly or covertly either via special self-adhesive labels or directly onto pharmaceutical products using a variety of print technologies.
Expansive role
The ability of optical security technology to incorporate a broad range of data forms and product tracking information continues to be paramount as it pushes forward and the nature of anti-counterfeiting changes with the times. This enables micro-lenses, micro-mirrors, colour shifting, print, diffractive and holographic technologies to be used for an expansive range of pharmaceutical authentication and brand protection roles, linking on-pack product identification with supply chain management, market enforcement and forensic support services. In this way, the identity and distribution of goods can be controlled through a total system solution involving security authentication features, tracking mechanisms and investigative services.
For example, TOPPAN Holdings new colour version of its innovative Illumigram hologram. Originally available only in white, the enhanced version now presents multi-colour 3D text and images that respond to strong light sources, such as a smartphone torch. The background of Illumigram appears cloudy under sunlight or fluorescent light (left), but the word ‘GENUINE’ appears in two colours when exposed to a smartphone’s flashlight. Launched this April, the new colour Illumigram is targeted at sectors that face high risks of counterfeiting, including pharmaceuticals.
Another example of next-level optical security with 3D spatial effects is Kurz TRUSTCOLOR PLUS. TRUSTCOLOR PLUS takes colour-shifting authentication to the next level by combining it with a stunning 3D Spatial Effect (SFX). This advanced technology creates a sense of depth and movement, resulting in a fascinating optical feature that is nearly impossible to replicate. The combination of metallic colour flip and customised 3D effects makes it an eye-catching yet highly secure solution for brand protection.
On the OVI front, an example is SICPA QUAZAR, a product security label that includes tamper-evidence, secure 2D codes, as well as covert and forensic security features. It comes with a spectrum of colours and can be customised into aesthetically creative labels corresponding to the design specifications and colour precision for strategic product branding and protection.
Of notable value to the brand owner and a strong financial incentive to make the investment in such systems, is the fact that the information generated at the labelling stage can be linked to the company’s ERP (enterprise resource planning) system; enabling business functions such as manufacturing, supply chain management, finance, projects, HR and customer relationship management to be captured and better managed.
Moves towards outsourcing the production of pharmaceutical and healthcare products might be beneficial in terms of reducing manufacturing costs but it can also impact upon the control of brand security and visibility. Here, optical security devices are integrated into the supply chain security process to allow companies to maintain control of their products. They can also be combined with secure web interfaces to help eliminate the rogue ordering of products while authorised distributors can pick, pack and ship items in carefully measured quantities to customers, with the product’s movements throughout the supply chain, fully tracked and documented. And it is important to encourage the brand owners to take the necessary steps to create awareness to unleash their full potential.