Global Counterfeit Drug Detection Devices Market Research Report 2016

The United States is supplied with regulated healthcare devices and pharmaceutical ingredients by over 300,000 foreign facilities from across 150 countries as estimated by the USFDA. World Health Organization calculations suggest over 1% of all drugs in developed nations are counterfeit representing a drug market that may be worth billions and lead to countless loss of lives. US-based Centre for Medicines in the public interest estimated that counterfeit drug sales were worth an estimate above US$ 75 billion globally in 2014. WHO estimates also show that over 10% drugs are counterfeit in developing countries with up to 30% fake drugs in extreme cases registered in some developing countries. Counterfeit anti-malaria drugs are one of the largest markets being operated world-wide and the FDA in 2013 has introduced a detection device for combating this challenge. Several drugs may be counterfeit or may contain ineffective amounts of API. The risk of consuming these drugs is untold. Not only would people consume other harmful substances, doctors may increase dosages, harming body further. A weak dose of anti-viral or anti-bacterial medication may increase drug resistance exponentially. Incorrect medication dose may result in renal failure, blood poisoning and liver damage among other serious conditions and even death. Asia-Pacific accounts for the largest share of counterfeit trade happening across the world.

Two of the popular devices currently being employed by authorities are the CD-3 introduced by FDA and PharmaCheck by Zaman. The working principles for both are different as the FDA device provides ultraviolet to infrared light on an object to detect and match the original drug product. The CD3 emits 10 different wavelengths of light between ultraviolet and infrared imaging which is used on tablets and capsules, powders, and packaging inks, papers and covert markings. The device also detects products tampered re-labelling or re-gluing. The CD3 has been used to analyze almost 100 counterfeit products including drugs like Crestor, Lipitor, Oxycontin, Viagra, Tamiflu, Singulair, Plavix and Wellbutrin. If the two images received by the CD3 are not similar, it can be presumed that they are made of different materials or ingredients.

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However this device was made for screening large lots of drugs. The point of use devices such as PharmaCheck is much more useful as they check not only the right amount of ingredients, but also the dissolution rate and quantity of API in a sample. Conventional devices for preventing the flow of counterfeit drugs consist of spectrometry techniques such as Raman Spectroscopy through devices such as Thermo Scientific TruScan. Ceram a global company involved in material testing and analysis has applied technologies such as XPS and ToFSIMS for identifying counterfeit drugs. The U.S. Pharmacopeial Convention USP is currently providing support for research in developing a portable or hand-held device for pharmaceutical regulation. Other techniques such as chromatography involve destructive techniques for analyzing a sample. However, these devices and technologies are very bulky and cannot be transported to point of usage such as remote villages and even to developing countries. Current technological developments are paving the way for devices that analyze samples with non-destructive techniques. A paper based technique which visually acts as a litmus test for pharmaceuticals particularly Panadol is being developed by undergraduate researchers in Indiana. The priority is to decrease the cost per test in order to make it viable for extremely large lots that are imported and exported.

Anti-counterfeit technologies in pharmaceutical industries include visible markings for easy identification, invisible markings which can be identifiable only by pharmacies and distributers that contain special ink visible only under UV light or infrared, complex tracking and labelling such as DNA marking, RFID tagging etc. which can recognize simple encrypted serial numbers among others. The market for barcoding, RFID and Spectroscopy such as Raman, NIR and others together constitute maximum share for the counterfeit detection technologies. Excellent market growth is anticipated for these devices due to introduction of life saving drugs and vaccines, increasing health expenditure, awareness in identification of drugs and their biological actions, increasing generic drugs which tend to attract the sale of counterfeit drugs.

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