Pharmaceutical Anti-counterfeiting Strategies and Commercial Analysis 2010-2020

1. Executive Summary
1.1 Pharmaceutical Anti-counterfeiting: Market Review
1.2 Overview of Chapters in this Report
1.3 Research and Analysis Methods
2. An Introduction to Drug Counterfeiting
2.1 Drug Counterfeiting: An Overview
2.1.1 Recent Drug Counterfeiting Events
2.1.2 The Most Commonly Counterfeited Drugs by Region
2.1.3 The Legal Definitions of a Counterfeit Drug
2.1.4 The Four Types of Counterfeit Drugs
2.1.5 Substandard Drugs as Counterfeits
2.1.6 Active Pharmaceutical Ingredients (APIs)
2.1.6.1 Heparin Contamination
2.1.6.2 API Legislation
2.1.7 The Conditions that Determine Which Drugs are Counterfeited
2.2 The Mechanics of Drug Counterfeiting
2.2.1 Methods of Producing Counterfeiting Drugs
2.2.2 Moving Counterfeit Drugs into the Supply Chain
2.2.3 Drug Counterfeiting and Criminality
2.2.4 The Distribution Network as the Place of Entry for Counterfeit Drugs
2.2.4.1 The Pharmaceutical Distribution System and Corruption
2.2.4.2 The FDA and Its Possible Role in Policing the US Distribution System for Counterfeit Drugs
2.2.5 Internet Pharmacies and Counterfeiting
2.2.5.1 The Role of Online Pharmacies
2.2.5.2 Verified Internet Pharmacy Practice Sites (VIPPS)
2.2.5.3 The Royal Pharmaceutical Society of Great Britain (RPSGB)
2.3 The Global Costs of Drug Counterfeiting
2.3.1 The Effect of Counterfeit Drugs on Consumers
2.3.2 The Effect of Counterfeit Drugs on Drug Manufacturers
2.3.3 The Effect of Counterfeit Drugs on Healthcare Providers
2.3.4 The Effect of Counterfeit Drugs on Governments
2.3.5 The Effect of Drug Counterfeiting on the Global Pharmaceutical Industry
2.4 Drivers of Drug Counterfeiting
2.4.1 Counterfeit Drugs Thrive Through Lack of Adequate and Enforceable Legislation
2.4.2 The Shortage and Erratic Supply of Drugs Encourages Counterfeiters
2.4.3 The Inappropriate Use of Drugs Generates a Demand for Black Market and Counterfeit Drugs
2.4.4 The High Prices of Some Medicines Drives People to Cheaper Counterfeit Alternatives
2.4.5 Inadequate Co-Operation Between a Country’s Governmental Organisations Aids Drug Counterfeiters
2.4.6 Lack of Control Over Standards for Export Drugs Helps Counterfeiters
2.4.7 The Trade of Pharmaceuticals Through Several Intermediaries Helps Hide Counterfeit Drugs
2.4.8 Trade Through Free-Trade Zones/Free Ports is an Important Route for Counterfeiters
2.4.9 Unlicensed Drug Outlets Sell Counterfeit Drugs Directly
2.4.10 Drug Diversion Has Links with Counterfeiting
2.4.11 Parallel Trade Has Links with Drug Counterfeiting
2.4.12 Drug Counterfeiting in the Developed World
2.4.13 Corruption is a Tool of the Counterfeiter
3. Anti-counterfeiting Technologies and Companies
3.1. The Major Anti-counterfeiting Technologies, 2010
3.1.1 Visual Inspection as the First Defence Against Drug Counterfeiting
3.1.2 Holograms as an Anti-counterfeiting Technology
3.1.3 Security Printing as an Anti-counterfeiting Technology
3.1.4 Taggants as an Anti-counterfeiting Technology
3.1.5 Radio Frequency Identification (RFID) Tags as an Anti-counterfeit Technology
3.2 Commercial Printers Used in Pharmaceutical Packaging
3.2.1 Ink Jet Printers
3.2.2 Laser Printers
3.2.3 Flexographic Printers
3.2.4 Thermal Transfer Printers
3.3 Anti-counterfeiting Technology Companies
3.3.1 NanoGuardian
3.3.1.1 The NanoEncryption Process
3.3.1.2 NanoGuardian Closed-Loop Protection System
3.3.1.3 NanoGuardian’s Global Collaboration Agreement with Capsugel
3.3.2 Ahura Scientific
3.3.2.1 Ahura Scientific’s TruScan Technology
3.3.3 TruTag Technologies
3.3.3.1 TruTag’s Proprietary Technology
3.3.4 Colorcon
3.3.4.1 Colorcon Brand Enhancement Service
3.3.4.2 Colorcon’s Taggants - On-Dose ID
3.3.4.3 Colorcon’s Other Identifiers
3.3.5 Authentix
3.3.5.1 Authentix’ Brand Protection Solutions
3.3.5.2 Authentix’ Packaging Solutions
3.3.5.3 Authentix Track-and-Trace
3.3.6 3M
3.3.6.1 3M’s Anti-counterfeiting Solutions
3.3.6.2 3M Technology Case Study: Lupron-Link
3.3.7 Cortegra Group
3.3.7.1 Cortegra’s RxTrackNSecure
3.3.7.2 Cortegra’s Item Level Serialization
3.3.8 Covectra
3.3.8.1 Covectra’s Authenti-Track Platform
4. Regulatory Strategies and Legislation for Combating Drug Counterfeiting
4.1 The Existence of a Trademark Proves Ownership
4.2 Existing Laws Not Adequately Enforced?
4.3 The Legal Loopholes in Existing Pharmaceutical Legislation
4.4 Pharmaceutical Companies Fear Boycott
4.5 Pharmaceutical Pedigrees
4.5.1 Pharmaceutical Pedigrees and Drug Counterfeiting/Diversion
4.6 The Lack of Appropriate Drug Legislation
4.7 Research is Necessary into Levels of Drug Counterfeiting
4.8 The Establishment of National Drug Regulatory Authorities (NDRAs)
4.9 The Weak Enforcement of Legislation Aids Counterfeiters
4.10 Resources and Training are Important to Combat Counterfeiters
4.11 Mobilising the Healthcare Community is Essential in Combating Counterfeiting
4.12 New Strategies Necessary to Inform Healthcare Professionals
4.13 The Ease of Reporting Counterfeits by Healthcare Professionals is Needed
4.14 The Role of the Pharmaceutical Company in Combating Drug Counterfeiting
4.14.1 Improved Openness in Reporting Cases of Counterfeiting
4.14.2 Drug Prices and Funding of NDRA’s
4.15 Role of The International Community in Combating Drug Counterfeiting
4.15.1 Improved Cooperation in Anti-counterfeiting Strategies
4.15.2 World Health Organisation’s Role in Anti-counterfeiting
4.16 Internet Policing and Drug Counterfeiting in the Developed World
4.17 Drug Counterfeit Reduction in Developing Countries
4.18 The World Trade Organisation (WTO)
4.18.1 WTO: Intellectual Property Protection and Enforcement
4.19 Recent Strategies and Legislation of Drug Regulatory Authorities
4.19.1 UK Medicines and Healthcare Products Regulatory Agency (MHRA) Anti-counterfeiting Strategy 2007-2010
4.19.1.1 Communication for Public Awareness
4.19.1.2 Collaboration and International Engagement
4.19.1.3 MHRA Guidance for Pharmacies
4.19.2 FDA Guidance on the Incorporation of Physical Chemical Identifiers (PCIDs) into Solid Oral Dosage Forms
4.19.2.1 Pharmacology and Toxicology Factors
4.19.2.2 Other Design Factors
4.19.2.3 Assurance of Quality, Performance and Stability of a Drug Product Containing a PCID
4.19.2.4 Reporting Factors for Incorporating PCIDs into Products
4.19.2.5 Standards for Securing the Drug Supply Chain
5. Qualitative Analysis of the Pharmaceutical Anti-counterfeiting Sector
5.1 Introduction
5.2 Strengths of the Pharmaceutical Anti-counterfeiting Market
5.2.1 Increased Supply Chain Efficiency using RFID
5.2.1.1 RFID Reduces Costs of Pharmaceutical Returns and Recalls
5.2.1.2 RFID in Product Recalls: Genco Pharmaceutical Services
5.2.1.3 RFID Return on Investment
5.2.2 New Technologies are Available or Are in Development
5.2.3 Significant Interest from Pharmaceutical Industry in Tackling Counterfeiting
5.2.3.1 The Pharmaceutical Security Institute
5.2.3.2 Merck’s Anti-counterfeiting Strategy
5.2.3.3 Abbott’s Anti-counterfeiting Strategy
5.2.3.4 GlaxoSmithKline’s Anti-counterfeiting Strategy
5.3 Drivers of the Pharmaceutical Anti-counterfeiting Market
5.3.1 Public Awareness of the Scale of Drug Counterfeiting
5.3.1.1 Pfizer Public Awareness Campaign
5.3.2 Pharmaceutical Theft
5.3.2.1 Pharmaceutical Theft - An Increasing Scourge
5.3.3 Manufacturer and Distributor Liability for Counterfeit Medicines
5.3.3.1 The Fagan Civil Case
5.3.3.2 Effects of Litigation on Players in the Drug Supply Chain
5.3.4 New Supply Chain Security Legislation
5.3.4.1 E-pedigree Legislation: California and Florida
5.3.4.2 E-pedigree: What Does it Entail?
5.3.4.3 E-pedigree Solutions
5.4 Threats Facing the Pharmaceutical Anti-counterfeiting Market
5.4.1 Lack of Industry-Wide Standards Impedes Adoption of RFID
5.4.1.1 High Frequency (HF) and Ultra High Frequency (UHF) RFID
5.4.1.2 Which RFID Technology is Best Suited to Pharmaceutical Supply Chain Applications?
5.4.2 Commercial Benefits of Anti-counterfeiting Technologies Unproven
5.4.2.1 Which Metrics Can be Used to Prove Anti-counterfeiting Success?
5.4.2.2 Preventing Counterfeiting Online
5.5 Weaknesses of the Pharmaceutical Anti-counterfeiting Market
5.5.1 Implementation Costs of Anti-counterfeiting Technologies
5.5.2 Anti-Counterfeiting Technologies Require R&D Investment
5.5.3 Reliability of Anti-counterfeiting Technology and Integration into Manufacturing Processes
5.5.3.1 Pfizer’s Viagra RFID Programme
5.5.3.2 SecureTrace Pilot
6. The World Pharmaceutical Anti-counterfeiting Market Outlook
6.1 The World Pharmaceutical Anti-counterfeiting Market in 2010
6.2 Current Market for Anti-counterfeiting Technologies
6.3 Sales Forecast for the Global Pharmaceutical Anti-counterfeiting Market, 2009-2014
6.4 Sales Forecast for the Global Pharmaceutical Anti-counterfeiting Market, 2015-2020
6.5 Sales Forecast for the Pharmaceutical RFID Market, 2009-2014
6.6 Sales Forecast for the Pharmaceutical RFID Market, 2015-2020
6.7 Sales Forecast for the Pharmaceutical Security Ink Market, 2009-2014
6.8 Sales Forecast for the Pharmaceutical Security Ink Market, 2015-2020
6.9 Sales Forecast for the Pharmaceutical Taggant Market, 2009-2014
6.10 Sales Forecast for the Pharmaceutical Taggant Market, 2015-2020
6.11 Sales Forecast for the Pharmaceutical Hologram/OVD Market, 2009-2014
6.12 Sales Forecast for the Pharmaceutical Hologram/OVD Market, 2015-2020
6.13 Sales Forecast for the Pharmaceutical Watermark Market, 2009-2014
6.14 Sales Forecast for the Pharmaceutical Watermark Market, 2015-2020
7. Geographical Profile of the Pharmaceutical Anti-counterfeiting Market
7.1 North America Leads the Pharmaceutical Anti-counterfeiting Market
7.2 Leading Pharmaceutical Anti-counterfeiting Country Markets, 2009
7.3 The US Pharmaceutical Anti-counterfeiting Market, 2010-2020
7.4 The Leading European Pharmaceutical Anti-counterfeiting Markets, 2010-2020
7.5 The Japanese Pharmaceutical Anti-counterfeiting Market, 2010-2020
7.6 Pharmaceutical Anti-counterfeiting Market: Forecast for Leading Countries, 2009-2020
7.7 Emerging Economy Pharmaceutical Anti-counterfeiting Markets
7.8 The Chinese Pharmaceutical Anti-counterfeiting Market, 2010-2025
7.9 The Indian Pharmaceutical Anti-counterfeiting Market, 2010-2020
8. Expert Opinion on Pharmaceutical Anti-counterfeiting
8.1 Interview with David Bear (MD) and Steve Wood (CEO), Covectra
8.1.1 Efforts Being Made by the Pharmaceutical Industry to Secure the Drug Supply Chain
8.1.2 Key Drivers of Pharmaceutical Companies Adopting Anti-counterfeiting Technologies
8.1.3 Barriers to RFID Adoption Across the Industry
8.1.4 Covectra’s Response to E-pedigree Legislation
8.1.5 Feasibility of Adopting 2D Barcoding Across the Drug Supply Chain
8.1.6 Expected Integration Times for Anti-counterfeiting Technologies into Existing Production Lines
8.1.7 On Covectra’s Proprietary Technologies
9. Conclusions
9.1 The Pharmaceutical Anti-counterfeiting Sector - What will the Future Hold?
9.2 Closing Thoughts on the Industry and Market
List of Tables
Table 2.1 World Drug Counterfeiting Events, 2006-2010
Table 2.2 The Four Types of Counterfeit Drug
Table 3.1 Some Leading Pharmaceutical Anti-counterfeiting Technology Providers, 2010
Table 3.2 Leading Hologram Producers, 2010
Table 3.3 Leading Security Printing Firms, 2010
Table 3.4 Leading RFID Providers, 2010
Table 3.5 Leading Pharmaceutical Taggant Providers, 2010
Table 5.1 SWOT Chart for the Pharmaceutical Anti-counterfeiting Market, 2010-2020
Table 6.1 World Pharmaceutical Anti-counterfeiting Sales, 2009-2014
Table 6.2 World Pharmaceutical Anti-counterfeiting Sales, 2015-2020
Table 6.3 World Pharmaceutical RFID Market: Sales, 2009-2014
Table 6.4 World Pharmaceutical RFID Market: Sales, 2015-2020
Table 6.5 World Pharmaceutical Security Ink Market: Sales, 2009-2014
Table 6.6 World Pharmaceutical Security Ink Market: Sales, 2015-2020
Table 6.7 World Pharmaceutical Taggant Market: Sales, 2009-2014
Table 6.8 World Pharmaceutical Taggant Market: Sales, 2015-2020
Table 6.9 World Pharmaceutical Hologram/OVD Market: Sales, 2009-2014
Table 6.10 World Pharmaceutical Hologram/OVD Market: Sales, 2015-2020
Table 6.11 World Pharmaceutical Watermark Market: Sales, 2009-2014
Table 6.12 World Pharmaceutical Watermark Market: Sales, 2015-2020
Table 7.1 Pharmaceutical Anti-counterfeiting Market Shares by Geographical Area, 2009
Table 7.2 Leading Anti-counterfeiting Country Markets, 2009
Table 7.3 Leading Pharmaceutical Anti-counterfeiting National Market Sales, 2009-2014
Table 7.4 Leading Pharmaceutical Anti-counterfeiting National Market Sales, 2015-2020
List of Figures
Figure 6.1 World Pharmaceutical Anti-counterfeiting Market: Sales, 2009-2014
Figure 6.2 World Pharmaceutical Anti-counterfeiting Market: Sales, 2015-2020
Figure 6.3 Breakdown of Pharmaceutical Anti-counterfeiting Market: Sales, 2009
Figure 6.4 Breakdown of Pharmaceutical Anti-counterfeiting Market: Sales, 2009
Figure 6.5 World Pharmaceutical RFID Market: Sales, 2009-2014
Figure 6.6 World Pharmaceutical RFID Market: Sales, 2015-2020
Figure 6.7 World Pharmaceutical Security Ink Market: Sales, 2009-2014
Figure 6.8 World Pharmaceutical Security Ink Market: Sales, 2015-2020
Figure 6.9 World Pharmaceutical Taggant Market: Sales, 2009-2014
Figure 6.10 World Pharmaceutical Taggant Market: Sales, 2015-2020
Figure 6.11 World Pharmaceutical Hologram/OVD Market: Sales, 2009-2014
Figure 6.12 World Pharmaceutical Hologram/OVD Market: Sales, 2015-2020
Figure 6.13 World Pharmaceutical Watermark Market: Sales, 2009-2014
Figure 6.14 World Pharmaceutical Watermark Market: Sales, 2015-2020
Figure 6.15 Breakdown of Pharmaceutical Anti-counterfeiting Market: Sales, 2014
Figure 6.16 Breakdown of Pharmaceutical Anti-counterfeiting Market: Sales, 2020
Figure 7.1 Pharmaceutical Anti-counterfeiting Market Shares by Geographical Area, 2009
Figure 7.2 Pharmaceutical Anti-counterfeit Market Shares by Leading Countries, 2009
Figure 7.3 Leading (Non US) Pharmaceutical Anti-counterfeiting Markets: Sales, 2009-2020
Figure 7.4 US Pharmaceutical Anti-counterfeiting Market: Sales, 2009-2020
Figure 7.5 Pharmaceutical Anti-counterfeit Market Shares by Leading Countries, 2014
Figure 7.6 Pharmaceutical Anti-counterfeit Market Shares by Leading Countries, 2020
Figure 9.1 Breakdown of Pharmaceutical Anti-counterfeiting Market: Sales, 2009