NEW YORK, Aug. 12, 2015 /PRNewswire/ -- INTRODUCTION
The problem of counterfeit products has been a common challenge to all the industries across the globe. However, when it comes to the pharmaceutical industry, the issue primarily revolves around the health of patients rather than revenue losses in the industry. Counterfeit drugs create substantial public health hazards and cause crucial safety concerns. Falsified or substandard drugs can lead to adverse reactions / side effects and consequently lead to the death of a patient.
The major challenge associated with a counterfeit drug is that a non-expert, such as a patient, cannot differentiate between genuine and counterfeit drug without the help of a special instrument or device. The packaging, shape and size of counterfeit drugs are made identical to that of an authentic drug by the counterfeiters. However, counterfeit drugs contain very less or no active ingredient; instead, they contain other useless and harmful materials such as dust, chalk or very low quality active ingredients posing serious threats to the patients. These issues have led to the development of many technologies that can be used to detect whether a drug is legitimate or fake. Apart from these technologies, many other significant measures have been taken by the pharmaceutical companies and government authorities to tackle this growing problem.
The market can be categorised into two segments, Authentication Technologies (the technologies providing overt and covert security features) and Track & Trace Technologies (the technologies facilitating visibility of products throughout the supply chain). Specifically in the Authentication segment, technologies providing covert security features are very popular and occupy a major share in of the overall authentication market. These technologies are very difficult to mimic and require special instruments / devices for verification of drugs by the manufacturers.
Managing supply chain, especially in case of pharmaceutical industry, is a big challenge. Pharmaceuticals supply chains are highly complex and therefore make it an ideal target for counterfeiters. However, recently many developments have taken place to overcome this challenge. Several countries across the globe have passed legislations, making it mandatory to implement serialisation by the manufacturers. Serialisation is being thought as a one stop solution to prevent counterfeiting in the pharmaceutical industry by securing the supply chain.
The field has attracted several companies which have developed many technologies with an aim to prevent counterfeiting in the pharma industry. The overall interest continues to rise as is evident from the number of counterfeit incidents and various laws and legislations being passed throughout the world. Small companies that have developed anti-counterfeiting technologies are likely to play a very active role in the near future
SCOPE OF THE REPORT
The 'Pharmaceutical Anti-Counterfeiting Technologies, 2015-2025' report provides a comprehensive study of the growing market of anti-counterfeiting technologies being used in the pharmaceutical industry. This study provides extensive details on technologies which offer overt and covert features to enable verification of drugs. In addition, it reviews the different track and trace technologies which enable tracking of a product through the supply chain. Counterfeiting of products is a big concern in several industries such as electronics, cosmetics, tobacco, wine&spirits and fast moving consumer goods. Specifically, within the pharmaceutical market, the magnitude of the problem is relatively high as it has a direct impact on the health of the wider community. It is worth highlighting that the pharmaceutical market is highly attractive for counterfeiters due to several benefits such as high price of patented drugs, lack of proper legislations and high demand of medicinescompared to their supply. The primary goal of anti-counterfeiting technologies is to prevent counterfeiting of products; this is done by making it difficult to copy patent protected drugs as well as preventing entry of substandard or fake drugs into the product supply chain.
The report covers multiple aspects such as key features of various technologies, scenario based future outlook of the market, SWOT analysis and our opinion on the likely drivers which will influence the market's evolution. We have provided a holistic view of the market landscape including detailed profiles of leading technologies highlighting the process by which they prevent counterfeiting. Further advancements in such technologies will make them more cost effective, encourage a wider adoption and result in a more mature market in the years to come.
In addition to the key benefits and the likely market drivers, this study also highlights some of the challenges associated with the use and implementation of these technologies in the pharmaceutical industry. Certain technologies require modifications in existing production processes and present operational challenges to the manufacturers. Cost is another factor that can significantly restrain the market.
The report also includes two case studies on serialisation. We have looked at the regulations that have been implemented already or are likely to be implemented to prevent counterfeiting. Most of these regulations favour item level serialisation as a task to be accomplished by the pharmaceutical manufacturers in the near future. However, some stakeholders are of the opinion that authentication technologies are much more effective as anti-counterfeiting measures rather than just providing a unique number to each product (the case of serialisation). The report covers various techniques and measures that have the potential to combat the challenges related to counterfeit medicines.
The scenario based forecast approach identifies short-midterm and long term market evolution for the period 2015-2020 and 2020-2025, respectively. The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research.
Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
§ Annual reports
§ Investor presentations
§ SEC filings
§ Industry databases
§ News releases from company websites
§ Government policy documents
§ Industry analysts' views
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
The sales/revenue data are actual sales as reported in the company annual reports and represent full year sales for respective fiscal years.
Chapter 2 provides an executive summary of major highlights captured in the report. It offers a high level view on the likely future of anti-counterfeiting technologies in the pharmaceutical industry.
Chapter 3 provides a general introduction to the anti-counterfeiting technologies. It identifies the needs and challenges faced by the pharmaceutical industry due to counterfeiting and highlights the extent of this problem. We have included examples of the products from leading pharmaceutical companies that have been counterfeited.
Chapter 4 provides a comprehensive analysis of the current market of anti-counterfeiting technologies. It lists more than 100 technologies that can be used to prevent counterfeiting; these technologies have been categorised as authentication technologies (offering overt and / or covert features) and track and trace technologies (including serialisation, RFID, barcodes, e-pedigree / m-pedigree).
Chapter 5 provides details of the well-known and emerging anti-counterfeiting technologies worldwide. This chapter covers insights on the companies developing these technologies as well as details of how the technologies help prevent counterfeiting by highlighting their unique features and applicability.
Chapter 6 presents a detailed discussion covering the developments related to serialisation. As a lot of countries have passed regulations making serialisation mandatory in the near future, there is a dramatic shift currently taking place in terms of how the pharmaceutical supply chains are likely to be managed in the future.
Chapter 7 highlights the likely future evolution of anti-counterfeiting technologies in pharmaceutical industry over the next ten years. We have adopted a scenario based approach to discuss the evolution of authentication technologies offering overt and covert features, across different regions, till 2025.
Chapter 8 provides the SWOT analysis of anti-counterfeiting technologies market giving strategic insights to the major factors that have contributed to the growth of this market. It also highlights the weaknesses and threats that can negatively impact the growth of the market.
Chapter 9 is a collection of interview transcripts; for the purposes of this study, we held discussions with experts from AlpVision, InfraTrac, Sproxil and Jura JSP to ascertain the key strategic initiatives and future roadmap of the industry.
Chapter 10 summarises the overall report. In this chapter, we have provided a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 11 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.
Chapter 12 is an appendix, which provides a list of companies and organisations mentioned in this report.
1. During our research, we identified over 100 technologies (including both authentication and track & trace technologies) developed by over 70 different companies. The landscape seems to be fairly well distributed between authentication and track & trace technologies. Due to the versatility of these technologies, they have wider applications in other industries making it highly lucrative for the current stakeholders.
2. Some solutions offer multiple features covering all forms of anti-counterfeiting approach; examples include N'Crypt (Amcor), CATS (Authentix), digital DNA (Applied DNA Sciences), nonclonable ID (Bilcaretech), TruTag Platform (TruTag Technologies) and Microparticle Technology (Stealth Mark).
3. As an industry, the focus seems to be divided between authentication and serialisation technologies; stakeholders view this both as a challenge as well as an opportunity to foster further innovation.There is a wider consensus that puts the onus back on different stakeholders to work collaboratively so that the opportunities can be monetised at a rapid pace; this will result in more robust and complex solutions likely to provide the required security to consumers and companies alike.
4. Many regions, including the EU and the US, have passed legislations that make serialisation mandatory for every pharmaceutical product. It is a very promising move that is likely to result in a paradigm shift in the way supply chains are managed today. However, there are several implementation hurdles which are expected to result in delays, providing a window of opportunity to the counterfeiters to take advantage of.
5. It is a known fact that most of counterfeiting happens in India and China. Though the focus on emerging markets has been relatively week so far, manufacturing companies are expected to increase their attention to deploy anti-counterfeiting technologies for products being manufactured or intended to be launched in these regions; going forward, we expect these markets to play a more prominent role in the overall growth of the opportunity.
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