This statistic represents the total number of counterfeit incidents concerning pharmaceuticals worldwide from 2002 to 2023. In 2002, *** such incidents of pharmaceutical crime were reported by the Pharmaceutical Security Institute. However, the annual number of such incidents increased significantly over time, up to some ***** until 2023.
During 2023, most counterfeiting incidents were reported in North America, with a total of over three thousand such incidents. This statistic represents the distribution of the number of counterfeiting incidents concerning pharmaceuticals worldwide in 2023, sorted by region.
Based on an estimated global counterfeit drug market being worth some 200 billion U.S. dollars, revenue losses due to counterfeits are probably accountable for 13 new drugs not being brought to market every year.
Based on estimates saying the global counterfeit drugs market to be worth *** billion U.S. dollars, counterfeit drugs could be accountable for **** billion dollars worth of lost federal and state tax revenues in the United States.
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The Counterfeit Drug Detection Device market is increasingly crucial in the global healthcare landscape, responding to the alarming rise in counterfeit medications that jeopardize patient safety and undermine trust in pharmaceutical systems. As the prevalence of counterfeit drugs escalates, spurred by globalization
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Failure of the Falsified Medicines Directive (FMD) in the UK could mean that substandard and falsified medicines (SFs) enter the supply chain. Does this risk patients’ health? Readiness to implement FMD, and prevalence of SFs vs. regulator detection were assessed. A total of 12,040 primary care pharmacies across England were invited (April 2021–March 2022). Respondent postcodes were used to extract deprivation scores. Information request was placed with the medicine’s agency. Survey findings were used to calculate probability and power of a simulated trial. A total of 208 participants responded: Of the seven who identified SFs, all but one reported it; 61% were ready to implement FMD, 74.1% had adequate resources, 54.8% expected improved patient safety, and 17.8% had ever reported SFs. SFs were prevalent in deprived areas. Bayesian simulation shows 438 (p = 0.030) incidences with a 3% probability of SFs prevalence. The agency identified 15,238 SFs units in the supply chain (2019 and 2020). Results are credible, reliable, and generalisable, with corroborated longitudinal persistence. FMD or equivalent processes need to be urgently reinstated. Deprived children may be more affected. Pharmacists are worried about liability. All health consultations should assess safety, and effectiveness of medicines. Findings should inform policy, systems planning, surveillance, and evaluations.
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The pharmaceutical anti-counterfeiting technology market is experiencing robust growth, driven by the escalating incidence of counterfeit drugs globally and stringent regulatory measures aimed at ensuring drug authenticity. The market, estimated at $5 billion in 2025, is projected to witness a Compound Annual Growth Rate (CAGR) of approximately 12% from 2025 to 2033, reaching a value exceeding $12 billion by 2033. This significant expansion is fueled by several key factors, including the increasing adoption of advanced technologies like blockchain, RFID, and digital watermarking for tracking and verifying drug authenticity throughout the supply chain. Furthermore, rising consumer awareness about counterfeit drugs and increased government initiatives promoting pharmaceutical security are bolstering market growth. Major pharmaceutical companies and technology providers are heavily investing in research and development to create innovative and cost-effective anti-counterfeiting solutions. The market's segmentation reflects this diversity, with various technologies catering to different aspects of the supply chain, from manufacturing to distribution and patient verification. However, the market's growth is not without challenges. High implementation costs associated with some advanced technologies can pose a significant barrier to entry for smaller pharmaceutical companies, particularly in developing economies. Furthermore, the constant evolution of counterfeiting techniques requires continuous innovation and adaptation from technology providers to maintain effectiveness. Despite these restraints, the market's long-term outlook remains positive, driven by an unwavering focus on patient safety and the significant economic losses associated with counterfeit pharmaceuticals. The integration of diverse technologies, including serialization, track and trace systems, and sophisticated data analytics, will continue to shape the market landscape, presenting opportunities for both established players and emerging technology firms.
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[220+ Pages Report] The global anti-counterfeit pharmaceuticals and cosmetics packaging market size is expected to grow from USD 9.21 billion in 2021 to USD 316 billion by 2030, at a CAGR of 13.41% from 2022-2030
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The global pharmaceuticals and food anti-counterfeiting technologies market size was valued at USD 7,315.7 million in 2025 and is projected to reach USD 14,955.1 million by 2033, exhibiting a CAGR of 9.2% during the forecast period. The increasing prevalence of counterfeit pharmaceuticals and food products, stringent government regulations, and technological advancements in anti-counterfeiting solutions drive the market growth. Counterfeit products pose significant health risks and economic losses, prompting governments to implement stringent measures to combat this issue. The integration of advanced technologies, such as blockchain, radio frequency identification (RFID), and smart packaging, enhances product traceability and authenticity verification. The market is segmented based on application (pharmaceuticals, food) and type (holograms, radio frequency identification (RFID), covert tags, smart packaging, others). Pharmaceuticals held a larger market share due to the high prevalence of counterfeit drugs and the stringent regulatory environment. Food is expected to witness significant growth owing to the rising demand for food traceability and quality assurance. Holograms are the dominant type due to their cost-effectiveness and ease of integration. The market is characterized by a competitive landscape with key players, including Inksure Technologies, Sun Chemical, CFC International, and Data System International. Regional growth is anticipated in North America, Europe, and Asia Pacific due to supportive government policies, high disposable income, and technological advancements.
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The Pharmaceutical Anti-Counterfeiting Technologies market is a critical and rapidly evolving sector that addresses the pervasive issue of counterfeit drugs in the global pharmaceutical industry. With the World Health Organization reporting that up to 10% of medicines in low- and middle-income countries are counterf
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The Anti-counterfeiting Pharmaceutical Packaging market is a critical sector dedicated to safeguarding public health by ensuring that the medications reaching consumers are legitimate and safe. With the rising prevalence of counterfeit drugs globally, pharmaceutical packaging solutions have evolved to become a vital
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Abstract Counterfeiting of medicines, also known as “falsification” or “adulteration”, is the process in which the identity, origin, or history of genuine medicines are intentionally modified. Currently, counterfeit medicines are a global crisis that affects and is mostly caused by developing countries in Asia, Africa and Latin America. These countries lack strict law enforcement against this practice and have low-income populations with medicinal needs. Lately, the crisis has escalated, impacting developed countries as well, e.g., the US and the EU, mainly via the Internet. Despite this extension, some current laws aim to control and minimize the crisis’ magnitude. Falsification of medicines maintains an illegitimate supply chain that is connected to the legitimate one, both of which are extremely complex, making such falsification difficult to control. Furthermore, political and economic causes are related to the crisis’ hasty growth, causing serious consequences for individuals and public health, as well as for the economy of different countries. Recently, organizations, technologies and initiatives have been created to overcome the situation. Nevertheless, the development of more effective measures that could aggregate all the existing strategies into a large functioning network could help prevent the acquisition of counterfeit medicines and create awareness among the general population.
During 2023, over 80 percent of global pharmaceutical counterfeit seizures were confirmed as being of commercial quantity. This statistic represents the distribution of pharmaceutical counterfeit seizures in the calendar year 2023.
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The global pharmaceutical track and trace solutions market is experiencing robust growth, driven by increasing regulatory pressures, rising counterfeit drug concerns, and the need for enhanced supply chain visibility. The market, currently estimated at $2.5 billion in 2025, is projected to witness a Compound Annual Growth Rate (CAGR) of 12% from 2025 to 2033. This expansion is fueled by several key factors, including the expanding adoption of serialization and aggregation technologies across various regions, the increasing demand for real-time visibility into drug movement throughout the supply chain, and the growing adoption of advanced technologies such as AI and blockchain for enhanced security and data management. Major pharmaceutical companies are investing heavily in these solutions to ensure product authenticity, improve patient safety, and comply with stringent regulatory frameworks like the Drug Supply Chain Security Act (DSCSA) in the US and similar regulations globally. The market segmentation reveals a strong demand across various technologies including serialization, aggregation, and verification solutions. Growth is further spurred by the increasing adoption of cloud-based solutions, which offer scalability and cost-effectiveness. Despite the growth, the market faces challenges such as high implementation costs associated with integrating track and trace systems into existing infrastructure, the complexity of managing vast amounts of data generated by these systems, and the need for robust data security measures to protect sensitive patient and product information. Nevertheless, the long-term outlook for the pharmaceutical track and trace solutions market remains positive, driven by sustained regulatory mandates and the growing awareness of the importance of securing the pharmaceutical supply chain. Leading players like TraceLink, Optel Vision, and Siemens AG are actively shaping this landscape through innovation and strategic partnerships.
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The global pharmaceutical serialization software market is experiencing robust growth, projected to reach $2980.5 million in 2025 and maintain a Compound Annual Growth Rate (CAGR) of 5% from 2025 to 2033. This expansion is driven by increasing regulatory mandates for drug serialization across major pharmaceutical markets like the US, EU, and China, necessitating sophisticated software solutions for track and trace systems. The growing demand for enhanced supply chain security and patient safety further fuels market growth. The market is segmented by serialization level (1-2, 3, 4, and 5-level serialization software) reflecting the varying complexity of serialization requirements based on product and regulatory needs. Application segments include pharmaceutical companies, wholesalers, and other stakeholders involved in drug distribution, each contributing to the overall market size based on their specific serialization and data management needs. The competitive landscape is diverse, with established players like SAP and Rockwell Automation alongside specialized serialization software providers such as Kezzler, Covectra, and RFXCEL. These companies are continuously innovating, incorporating advanced technologies like AI and blockchain, to offer comprehensive serialization solutions that meet evolving regulatory requirements and enhance supply chain visibility. The market's growth is influenced by various factors. Increased counterfeiting and diversion of pharmaceuticals create a pressing need for robust serialization and traceability, leading to higher adoption of sophisticated software. Technological advancements in data analytics and cloud-based solutions enable efficient data management and regulatory compliance. However, challenges remain, including the high initial investment costs for implementing serialization systems, the need for integration with existing IT infrastructures, and the complexity of managing large volumes of serialized data across diverse supply chains. Furthermore, the constant evolution of regulatory landscapes and data security concerns necessitate continuous investment in software upgrades and security measures. Despite these challenges, the long-term outlook for the pharmaceutical serialization software market remains positive, driven by continuous growth in pharmaceutical production, tightening regulations, and the growing demand for supply chain transparency and patient safety.
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The Anti-Counterfeit Pharmaceutical Packaging market is an essential component of the global healthcare sector, playing a critical role in safeguarding drugs from fraud and ensuring patient safety. As counterfeit drugs pose significant risks to health and economic stability, the demand for advanced packaging solutio
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Introduction: The public health threat of substandard and falsified medicines has been well known in the last two decades, and several studies focusing on the identification of products affected and preventing consumption have been published. However, the number of these products reaching patients and causing health consequences and adverse drug reactions is not a well-researched area.Objectives: Our aim was to identify and describe the characteristics of cases that are related to adverse drug reactions potentially originating from counterfeit medication using publicly available pharmacovigilance data.Methods: A descriptive study was performed based on pharmacovigilance data retrieved from Individual Case Safety Reports (ICSRs) identified in the European Medicines Agency’s EudraVigilance and FDA Adverse Event Reporting System (FAERS) databases in April 2022 using selected MedDRA preferred terms: counterfeit product administered, product counterfeit, product label counterfeit, product packaging counterfeit, suspected counterfeit product, adulterated product, product tampering, and suspected product tampering. ICSRs were analyzed by age and gender, by year of reporting, region of origin, reporter’s profession, and severity of the outcome. The disproportionality method was used to calculate pharmacovigilance signal measures.Results: A total of 5,253 cases in the FAERS and 1,049 cases in the EudraVigilance database were identified, generally affecting middle-aged men with a mean age of 51.055 (±19.62) in the FAERS and 64.18% of the cases between 18 and 65 years, while the male to female ratios were 1.18 and 1.5. In the FAERS database, we identified 138 signals with 95% confidence interval including sildenafil (n = 314; PRR, 12.99; ROR, 13.04; RRR, 11.97), tadalafil (n = 200; PRR, 11.51; ROR, 11.55; RRR, 10.94), and oxycodone (n = 190; PRR, 2.47; ROR, 2.14; RRR, 2.47). While in the EV data 31, led by vardenafil (n = 16, PRR = 167.19; 101.71–274.84; 95% CI, RRR = 164.66; 100.17–270.66; 95% CI, ROR = 169.47; 103.09–278.60; 95% CI, p < 0.001), entecavir (n = 46, PRR = 161.26, RRR = 154.24, ROR = 163.32, p < 0.001), and tenofovir (n = 20, PRR = 142.10, RRR = 139.42, ROR = 143.74, p < 0.001).Conclusion: The application of pharmacovigilance datasets to identify potential counterfeit medicine ADRs can be a valuable tool in recognition of potential risk groups of consumers and the affected active pharmaceutical ingredients and products. However, the further development and standardization of ADR reporting, pharmacovigilance database analysis, and prospective and real-time collection of potential patients with health consequences are warranted in the future.
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The global market for pharmaceuticals and food anti-counterfeiting technologies is experiencing robust growth, driven by increasing concerns over product authenticity and consumer safety. The market size in 2025 is estimated at $243.33 million. While the provided CAGR is missing, considering the rising prevalence of counterfeit goods and stringent regulatory actions, a conservative estimate of a 15% CAGR (Compound Annual Growth Rate) over the forecast period (2025-2033) seems plausible. This implies significant market expansion, reaching potentially over $1 billion by 2033. Key drivers include rising consumer awareness of counterfeit products, the escalating cost of product recalls, and the implementation of stricter government regulations to combat counterfeiting across both the pharmaceutical and food industries. Trends such as the adoption of advanced technologies like blockchain, AI-powered authentication systems, and sophisticated track-and-trace solutions are further fueling market growth. However, the high initial investment costs associated with implementing these technologies and the complexities of integrating them across the entire supply chain present challenges to market expansion. The market is segmented by technology type (e.g., serialization, RFID, holograms), application (pharmaceuticals, food & beverages, etc.), and region. Major players like Inksure Technologies, Sun Chemical, CFC International, and Data System International are actively shaping market dynamics through innovation and strategic partnerships. The projected growth in the anti-counterfeiting technologies market highlights the increasing importance of securing supply chains and ensuring product authenticity. The adoption of comprehensive anti-counterfeiting strategies is no longer optional but crucial for brand protection and consumer trust. This is further amplified by increasing consumer demand for transparency and verifiable product provenance, driving the demand for robust and reliable anti-counterfeiting solutions. Continued technological advancements, coupled with regulatory support, will likely accelerate market expansion in the coming years. However, continued focus on addressing the high cost of implementation and the challenges of cross-industry standardization will be key to unlocking the full potential of this market.
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[216+ Pages Report] The global anti-counterfeit pharmaceutical packaging market size is expected to grow from USD 51.08 billion in 2023 to USD 142.78 billion by 2032, at a CAGR of 12.10% from 2024-2032
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Introduction: The public health threat of substandard and falsified medicines has been well known in the last two decades, and several studies focusing on the identification of products affected and preventing consumption have been published. However, the number of these products reaching patients and causing health consequences and adverse drug reactions is not a well-researched area.Objectives: Our aim was to identify and describe the characteristics of cases that are related to adverse drug reactions potentially originating from counterfeit medication using publicly available pharmacovigilance data.Methods: A descriptive study was performed based on pharmacovigilance data retrieved from Individual Case Safety Reports (ICSRs) identified in the European Medicines Agency’s EudraVigilance and FDA Adverse Event Reporting System (FAERS) databases in April 2022 using selected MedDRA preferred terms: counterfeit product administered, product counterfeit, product label counterfeit, product packaging counterfeit, suspected counterfeit product, adulterated product, product tampering, and suspected product tampering. ICSRs were analyzed by age and gender, by year of reporting, region of origin, reporter’s profession, and severity of the outcome. The disproportionality method was used to calculate pharmacovigilance signal measures.Results: A total of 5,253 cases in the FAERS and 1,049 cases in the EudraVigilance database were identified, generally affecting middle-aged men with a mean age of 51.055 (±19.62) in the FAERS and 64.18% of the cases between 18 and 65 years, while the male to female ratios were 1.18 and 1.5. In the FAERS database, we identified 138 signals with 95% confidence interval including sildenafil (n = 314; PRR, 12.99; ROR, 13.04; RRR, 11.97), tadalafil (n = 200; PRR, 11.51; ROR, 11.55; RRR, 10.94), and oxycodone (n = 190; PRR, 2.47; ROR, 2.14; RRR, 2.47). While in the EV data 31, led by vardenafil (n = 16, PRR = 167.19; 101.71–274.84; 95% CI, RRR = 164.66; 100.17–270.66; 95% CI, ROR = 169.47; 103.09–278.60; 95% CI, p < 0.001), entecavir (n = 46, PRR = 161.26, RRR = 154.24, ROR = 163.32, p < 0.001), and tenofovir (n = 20, PRR = 142.10, RRR = 139.42, ROR = 143.74, p < 0.001).Conclusion: The application of pharmacovigilance datasets to identify potential counterfeit medicine ADRs can be a valuable tool in recognition of potential risk groups of consumers and the affected active pharmaceutical ingredients and products. However, the further development and standardization of ADR reporting, pharmacovigilance database analysis, and prospective and real-time collection of potential patients with health consequences are warranted in the future.
This statistic represents the total number of counterfeit incidents concerning pharmaceuticals worldwide from 2002 to 2023. In 2002, *** such incidents of pharmaceutical crime were reported by the Pharmaceutical Security Institute. However, the annual number of such incidents increased significantly over time, up to some ***** until 2023.