THIS REPORT CONTAINS

Descriptions of anti-counterfeiting packaging technologies and their potential applications
Analyses of U.S. market trends, with data for 2009, estimates for 2010, and projections of compound annual growth rates (CAGRs) through 2015
A focus on technological issues, including the latest developments

INTRODUCTION

STUDY GOALS AND OBJECTIVES

The goal in conducting this study is to present a comprehensive and balanced picture of recent trends in anti-counterfeiting packaging technologies and to develop market projections for global sales of anti-counterfeiting packaging technologies to the pharmaceutical and food industries through 2015. The report identifies important factors that shaped the historical trends in sales and makes informed assumptions regarding key factors that are projected to contribute to future sales of anti-counterfeiting packaging technologies to the global drug and food industries. The impact of government regulatory requirements, growing sophistication of counterfeiters, concern for brand protection, industry mandates, and inter-governmental initiatives are discussed in detail.

REASONS FOR DOING THE STUDY

Global counterfeiting is a growing problem that poses public health and safety concerns for consumers and law enforcement agencies, and also creates financial concerns for legitimate global businesses. As part of the global market, the pharmaceutical and food industries are not immune from the increasingly sophisticated activity of counterfeiters. Anti-counterfeiting initiatives include the use of technology-based measures, regulatory provisions, secure business practices, consumer awareness and education, and increased global collaborative surveillance by government and non-governmental agencies.

BCC reviews these anti-counterfeiting initiatives and closely examines available authentication and track and trace technologies with applications in the packaging of pharmaceutical and food products. The report presents a balanced view of the current usage, challenges, market drivers, and areas of prospective applications of anti-counterfeiting packaging technologies in the global pharmaceutical and food industries.

CONTRIBUTIONS OF THE STUDY

This report contains valuable information relating technological and regulatory solutions to a global commercial and social problem. The clandestine and often undocumented nature of product counterfeiting creates room for experts to debate the pervasiveness of the problem. There is consensus, however, that wherever they are, fake drug and food products pose actual and potential danger to public health. This study serves as a resource for readers who are interested in exploring existing and prospective anti-counterfeiting technologies. Market projections developed in the study provide a context for assessing viable commercial opportunities in anti-counterfeiting technologies through 2015. Companies invested in the industry and those contemplating industry participation will find the contents of this report beneficial to the decision-making process. Additionally, the study provides comprehensive coverage of recent and foreseeable regulatory changes with implications for brand owners, distributors, developers of secure technologies, and other stakeholders in global supply chain management.

SCOPE OF REPORT

This study is about applications of anti-counterfeiting packaging technologies in the global pharmaceutical and food industries. It particularly focuses on authentication and track and trace packaging technologies. This report covers the role of U.S. and foreign manufacturers and regulatory agencies in the market for anti-counterfeiting technologies. Practically all drug and food products go through multiple distribution channels from the original manufacturers until they reach the final consumers. Consequently, the supply chain is integral to the application of anti-counterfeiting packaging technologies. Recognizing that it is impossible to capture the diversity of the global drug and food supply chains in detail, the report uses the U.S. drug and food marketing systems to illustrate the roles of key players (for example, manufacturers, wholesalers, retailers) in the supply chain. Additionally, this report recognizes and highlights the growing role of the Internet in the global supply chain. 

Market projections of global sales of authentication and track and trace packaging technologies to the drug and food industries are developed through 2015. Excluded are the usage and sales of these technologies in other consumer packaged goods sectors. Investment in research and development are important to the ongoing innovations in packaging technologies. This report compiles recent patents awarded for innovations in the categories of technologies included in this report. Profiles of major manufacturers and suppliers of authentication and track and trace packaging technologies are included.

METHODOLOGY AND INFORMATION SOURCES

Both primary and secondary research methodologies were used in preparing this market research report. This report is the result of extensive research covering materials from diverse sources. BCC surveyed numerous scientific and industry publications on anti-counterfeiting technologies to develop a qualitative and quantitative analytical framework for the findings documented in this report. Communications with various government and industry experts provided supplemental information on aspects of the study. Information on manufacturers’ shipments, international trade, regulatory requirements, and global anti-counterfeiting initiatives were obtained from U.S., European, and other inter-governmental sources.

ABOUT THE AUTHOR

Rachel Agheyisi works as a freelance research analyst for BCC Research. Her professional experience includes more than 20 years in academia and business consulting. She holds a Ph.D. in Economics from McMaster University in Canada.

Table Of Contents

Chapter- 1: INTRODUCTION -- Complimentary

STUDY GOALS AND OBJECTIVES 1
REASONS FOR DOING THE STUDY 1
CONTRIBUTIONS OF THE STUDY 1
SCOPE OF REPORT 2
METHODOLOGY AND INFORMATION SOURCES 2
ABOUT THE AUTHOR 3
RELATED BCC REPORTS 3
BCC ONLINE SERVICES 3
DISCLAIMER 3

Chapter-2: SUMMARY

SUMMARY 4
SUMMARY TABLE GLOBAL SALES OF ANTI-COUNTERFEITING PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 5
SUMMARY FIGURE   PROJECTED SHARES OF GLOBAL SALES OF ANTI-COUNTERFEITING PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 ($ MILLIONS) 6

Chapter-3: OVERVIEW

DEFINING A COUNTERFEIT PRODUCT 7
PREVALENCE OF COUNTERFEITING 8
INDUSTRY CONCEPTS 9
SECURE SUPPLY CHAIN 9
PRODUCT PACKAGING 10
Packaging Concepts and Materials 10
Levels of Packaging 11
Smart Packaging 12
PRODUCT IDENTIFICATION 12
Universal Product Code 12
Global Trade Item Number 13
Symbology 13
Covert and Overt Secure Technologies 13
Paper and Electronic Drug Pedigree 13
Automatic Identification and Data Capture 14
Electronic Product Code 14
Mass Serialization 14
Radio Frequency Definitions 15
Read Range 15
IMPORTANCE OF SECURE PACKAGING TECHNOLOGIES 15
FORESEEABLE DEVELOPMENTS 16

Chapter-4: DRUG AND FOOD MARKETING

INTRODUCTION 17
U.S. DRUG MARKETING 17
DRUG MANUFACTURERS 18
Drug Manufacturing Industry Classification 18
TABLE 1 U.S. DRUG MANUFACTURING BY INDUSTRY CLASSIFICATION 18
TABLE 2 BUSINESS PATTERN OF U.S. PHARMACEUTICAL PREPARATION MANUFACTURING INDUSTRY 19
Brand-Name Drug Manufacturers 19
TABLE 3 MAJOR BRAND-NAME DRUG MANUFACTURERS RANKED BY MARKET CAPITALIZATION, SECOND QUARTER 2010 20
Generic Drug Manufacturers 20
TABLE 4 MAJOR GENERIC DRUG MANUFACTURERS RANKED BY MARKET CAPITALIZATION, SECOND QUARTER 2010 21
Prescription Drug Distribution Channel 21
Stimulating Demand for Prescription Drugs 22
Global Sales of Pharmaceutical Preparations 22
TABLE 5 ESTIMATED GLOBAL SALES AND MARKET SHARES OF MAJOR MANUFACTURERS OF PHARMACEUTICAL PREPARATIONS FOR HUMAN USE, 2009 23
U.S. Sales of Pharmaceutical Preparations 23
TABLE 6 U.S. SALES AND MARKET SHARES OF MAJOR MANUFACTURERS OF PHARMACEUTICAL PREPARATIONS FOR HUMAN USE, 2009 24
TABLE 7 U.S. SALES OF PHARMACEUTICAL PREPARATIONS FOR HUMAN USE BY END USE, 2009 24
FIGURE 1 ESTIMATED U.S. SALES OF PHARMACEUTICAL PREPARATIONS FOR HUMAN USE BY TYPE, 2009 (%) 25
International Trade in Pharmaceutical Preparations 26
TABLE 8 U.S. EXPORTS OF PHARMACEUTICAL PREPARATIONS, 2009 26
WHOLESALE DRUG DISTRIBUTORS 26
U.S. Wholesale Drug Industry Classification 26
TABLE 9 U.S. DRUG WHOLESALERS BY INDUSTRY CLASSIFICATION 27
TABLE 10 BUSINESS PATTERN OF U.S. WHOLESALE DRUG DISTRIBUTION INDUSTRY 27
U.S. Wholesale Drug Industry Structure 27
TABLE 11 MERCHANT DRUG DISTRIBUTORS RANKED BY MARKET CAPITALIZATION, SECOND 28
QUARTER 2010
TABLE 12 DRUG SALES BY U.S. MERCHANT WHOLESALE DRUG DISTRIBUTORS, 2009 29
FIGURE 2 DRUG SALES BY THE BIG THREE U.S. MERCHANT WHOLESALE DRUG DISTRIBUTORS 29
BY SALES CHANNEL, 2009 (%)
FIGURE 2 (CONTINUED) 30
Secondary Wholesalers 30
RETAIL DRUG DISTRIBUTORS 31
U.S. Retail Drug Industry Structure 31
TABLE 13 BUSINESS PATTERN OF U.S. RETAIL DRUG DISTRIBUTION INDUSTRY 31
U.S. Retail Prescription Drug Sales 31
TABLE 14 PRESCRIPTION DRUGS FILLED IN THE U.S. BY RETAIL DRUG SEGMENT, 2009 32
TABLE 15 U.S. RETAIL PRESCRIPTION DRUG SALES BY RETAIL DRUG SEGMENT, 2009 32
INTERNET DRUG DISTRIBUTION 32
Benefits of Internet Drug Distribution 33
Challenges Posed by Internet Drug Distribution 33
OpSec Security’s Survey on Bulk Pharmaceuticals and APIs 33
European Alliance for Access to Safe Medicines’ Internet Research 34
Addressing the Illegitimate Internet Drug Distribution 35
U.S. FOOD MARKETING 35
FOOD PROCESSORS OR MANUFACTURERS 36
Food Manufacturing Industry Classification 36
TABLE 16 U.S. FOOD MANUFACTURING INDUSTRY FOR HUMAN CONSUMPTION BY INDUSTRY CLASSIFICATION 36
Food Manufacturing Industry Structure 36
TABLE 17 BUSINESS PATTERN OF U.S. FOOD MANUFACTURING INDUSTRY FOR HUMAN CONSUMPTION 37
Food Distribution from Manufacturer to Wholesale to Retail 37
U.S. Sales of Processed Foods for Human Consumption 38
TABLE 18 ESTIMATED U.S. SALES BY MAJOR PROCESSORS OF FOOD FOR HUMAN CONSUMPTION, 2009 38
U.S. International Trade in Processed Foods for Human Consumption 39
TABLE 19 U.S. EXPORTS OF PROCESSED FOODS FOR HUMAN CONSUMPTION, 2009 39
TABLE 20 U.S. EXPORTS OF PROCESSED FOODS FOR HUMAN CONSUMPTION BY TYPE, 2009 40
WHOLESALE FOOD DISTRIBUTORS 40
U.S. Wholesale Food Industry Classification 40
TABLE 21 U.S. FOOD WHOLESALE INDUSTRY BY INDUSTRY CLASSIFICATION 40
U.S. Wholesale Food Distribution Industry Structure 41
TABLE 22 BUSINESS PATTERN OF U.S. WHOLESALE FOOD DISTRIBUTION INDUSTRY 42
U.S. Wholesale Food Sales 42
TABLE 23 ESTIMATED U.S. SALES BY MAJOR FOOD WHOLESALERS, 2009 42
RETAIL FOOD DISTRIBUTORS 43
U.S. Retail Food Industry Classification 43
TABLE 24 U.S. RETAIL FOOD INDUSTRY BY INDUSTRY CLASSIFICATION 43
U.S. Retail Food Distribution Industry Structure 43
U.S. Retail Food … (Continued) 44
U.S. Retail Food … (Continued) 45
TABLE 25 BUSINESS PATTERN OF U.S. RETAIL FOOD DISTRIBUTION INDUSTRY 46
U.S. Retail Food Sales 46
TABLE 26 ESTIMATED U.S. SALES BY RETAIL FOOD DISTRIBUTORS, 2009 46

Chapter-5: AUTHENTICATION PACKAGING TECHNOLOGIES

INTRODUCTION 47
AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE 47
INKS AND DYES 47
Security Inks 48
TABLE 27 TYPES OF SECURITY INKS AND PRINTING METHOD 48
Color-Shifting Inks 48
Holographic Inks 49
Pearlescent Pigments 49
Thermochromic and Photo-Chromic Inks 49
Taggant Inks 50
Watermark Inks 50
Examples of Proprietary Inks 50
AlpVision SA: Cryptoglyph Solution 50
Evident Technologies: EviDots 51
Inksure Technologies: SmartInk 51
HOLOGRAMS 51
Hologram Types 52
2D and 3D Holograms 52
Dot-Matrix Holograms 52
Electronic Beam Holograms 53
Volume Holograms 53
Light of Holograms 53
Overt and Covert Holograms 53
Recent Trends in Security Holograms 54
3D AG’s Holo-Encrypt System 54
3M’s Holographic Authentication Solutions 54
CFC International’s Dot-Matrix System 55
DNA-Encoded Holograms 55
DuPont’s 3D Hologram 55
JDSU’s HoloFuse 56
Security Hologram’s Integrated Label 56
Tesa-Scribos’ tesa Holospot: Mass Serialization Holograms 56
WATERMARKS 56
Categories of Watermark 57
Physical Paper Watermark 57
Digital Watermark 57
Recent Innovations in Watermarking 58
Incorporation of Encryption Keys 58
Multi-Layered Watermarking 58
TAGGANTS 58
JDSU’s Charms 59
Microtrace’s Taggants 59
Authentix and Forensic Marking 59
REGULATORY PROVISIONS FOR AUTHENTICATION TECHNOLOGIES 59
STRUCTURE OF THE GLOBAL AUTHENTICATION TECHNOLOGY INDUSTRY 60
STRATEGIC ALLIANCES 61
Digimarc and AlpVision 61
Microtrace and PhotoScribe Technologies 62
Microtrace and the Flint Group 62
NAME RECOGNITION AND FULL-SERVICE CAPABILITIES 62
RECENT AND PROJECTED GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES 63
INDUSTRY DATA 63
RECENT GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE 63
Recent Global Sales of Packaging Inks and Dyes 64
FIGURE 3 SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF THE GLOBAL AUTHENTICATION PACKAGING MARKET, 2009 (%) 64
TABLE 28 GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 65
FIGURE 4 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES, BY REGION, 2009 (%) 65
FIGURE 4 (CONTINUED) 66
Recent Global Sales of Packaging Holograms 66
FIGURE 5 SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF THE GLOBAL AUTHENTICATION PACKAGING MARKET, 2009 (%) 66
FIGURE 5 (CONTINUED) 67
TABLE 29 GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 ($ MILLIONS/%) 67
FIGURE 6 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD INDUSTRIES, BY REGION, 2009 (%) 68
Recent Global Sales of Packaging Watermarks 68
FIGURE 7 SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF THE GLOBAL AUTHENTICATION PACKAGING MARKET, 2009 (%) 69
TABLE 30 GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 69
FIGURE 8 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES BY REGION, 2009 (%) 70
Recent Global Sales of Packaging Taggants 71
FIGURE 9 SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF THE GLOBAL AUTHENTICATION PACKAGING MARKET, 2009 (%) 71
TABLE 31 GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 72
FIGURE 10 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES BY REGION, 2009 (%) 72
FIGURE 10 (CONTINUED) 73
Total Recent Global Sales of Authentication Packaging Technologies 73
FIGURE 11 TOTAL GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2009 ($ MILLIONS) 73
FIGURE 11 (CONTINUED) 74
TABLE 32 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 ($ MILLIONS/%) 74
FIGURE 12 ESTIMATED MARKET SHARES OF TOTAL GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY REGION, 2009 (%) 75
MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES 75
TABLE 33 MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2009 76
MARKET DRIVERS AND DRAWBACKS 76
SALES AND MARKET SIZE PROJECTIONS 77
Projected Total Global Sales of Packaging Inks and Dyes 78
TABLE 34 GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 79
FIGURE 13 SHARES OF GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 79
FIGURE 13 (CONTINUED) 80
TABLE 35 GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS) 80
Projected Total Global Sales of Packaging Holograms 80
TABLE 36 GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 81
FIGURE 14 SHARES OF GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 81
FIGURE 14 (CONTINUED) 82
TABLE 37 GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD INDUSTRIES BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS) 82
Projected Total Global Sales of Packaging Watermarks 82
TABLE 38 GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 83
FIGURE 15 SHARES OF GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 83
FIGURE 16 (CONTINUED) 84
TABLE 39 GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS) 84
Projected Total Global Sales of Packaging Taggants 84
TABLE 40 GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES BY 85
END USE, THROUGH 2015 ($ MILLIONS)
FIGURE 16 SHARES OF GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 85
FIGURE 16 (CONTINUED) 86
TABLE 41 GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS) 86
Projected Total Regional Sales of Authentication Packaging Technologies by Type 86
North American Sales of Authentication Packaging Technologies by Type Through 2015 86
TABLE 42 NORTH AMERICAN SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 87
FIGURE 17 ESTIMATED SHARES OF NORTH AMERICAN SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 87
FIGURE 17 (CONTINUED) 88
European Sales of Authentication Packaging Technologies by Type Through 2015 88
TABLE 43 EUROPEAN SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 88
FIGURE 18 ESTIMATED SHARES OF EUROPEAN SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 89
Asia-Pacific Sales of Authentication Packaging Technologies by Type Through 2015 89
TABLE 44 ASIA-PACIFIC SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 90
FIGURE 19 ESTIMATED SHARES OF ASIA-PACIFIC SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 90
FIGURE 19 (CONTINUED) 91
Projected Total Global Sales of Authentication Packaging Technologies by Type 91
TABLE 45 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 91
FIGURE 20 SHARES OF GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 92
FIGURE 21 ESTIMATED MARKET SHARES OF GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2010 AND 2015 (%) 93
Projected Total Global Sales of Authentication Packaging Technologies by End Use 93
TABLE 46 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 94
FIGURE 22 SHARES OF GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 94

Chapter-6: TRACK AND TRACE PACKAGING TECHNOLOGIES

INTRODUCTION 95
TRACK AND TRACE PACKAGING TECHNOLOGIES BY TYPE 96
BAR CODES 96
A Brief History of Bar Codes 96
Commercial Applications of Bar Codes 96
Bar Code Specifications 96
Bar Codes for Different Environment 97
Paper Bar Code Labels 97
Aluminum Bar Code Labels 97
Polyester Bar Code Labels 97
Ceramic Bar Code Labels 97
Bar Code Symbology 97
Continuous or Discrete Symbology 98
Two-Width or Multiple-Width Symbology 98
GS1 Bar Code Standards 98
EAN/UPC Symbology 98
ITF-14 Symbology 98
GS1-128 Symbology 99
GS1 DataBar (RSS) 99
GS1 DataMatrix 99
Composite Component Symbology 100
Bar Code Implementation Steps 100
Bar Code Printing 100
Bar Code Quality 101
RADIO FREQUENCY IDENTIFICATION TECHNOLOGY 101
Commercial Applications of radio frequency identification Technology 101
Overview of the RFID Technology 101
RFID Tags for Different Uses 102
Components of a RFID Tag 102
Classification of RFID Tags 102
Classification of RFID Tags Based on Power Source 103
Active RFID Tags 103
Passive RFID Tags 103
Read-Write Functionality 103
Classification Based on Radio Frequency 103
Low-Frequency RFID Tags 104
High-Frequency RFID Tags 104
Ultra-High-Frequency RFID Tags 104
EPCglobal and RFID Standards 104
Class 1 Generation 2 UHF Air Interface Protocol Standard 105
EPCglobal Adoption Roadmap 106
Advantages of RFID Tags 106
Early Adopters of RFID Tags 107
Wal-Mart and RFID Adoption 108
U.S. Department of Defense and RFID Adoption 108
Early Exploratory Adoptions Through Pilot Studies 109
Pilot Studies: Drug Industry 109
Pfizer’s Pilot Study: Viagra Tagging 109
Purdue Pharma’s Pilot Study: OxyContin Tagging 109
Pilot Studies: U.S. Food Industry 110
Wells’ Dairy Pilot Study: An Integrated Approach 110
Del Monte’s Pilot Study: RFID and Small Metallic Objects with Fluids 110
Pilot Studies: U.S. Wholesale Distributors 111
McKesson Corporation and On Track Pilot 111
AmerisourceBergen’s Pilot 111
Cardinal Health’s UHF RFID Pilot Study 112
Current State of RFID Tagging: Rise of UHF RFID 112
Printed RFID Tags 113
Some Notable UHF RFID Tags 113
Alien Technology’s Brand 113
Impinj RFID Solution 114
Intermec’s Rugged RFID Tag 114
Examples of RFID Adoption-Enablers 115
Data Systems International’s dcLINK RFIDActivator 115
GlobeRanger’s iMotion Edgeware 115
Systech International’s Serialized Product Tracking 115
Addressing Privacy Concerns Regarding RFID Tags 116
RFID Tags for Cold Chain Compliance 117
Recyclable RFID Tags 117
REGULATORY PROVISIONS FOR TRACK AND TRACE TECHNOLOGIES 117
U.S. BAR CODE REGULATIONS RELATING TO DRUG PRODUCTS 118
Key Objectives of the Rule 118
Entities Subject to the Rule 119
Products that Require Bar Codes 119
Information Contained in a Bar Code 119
Specific Bar Code Requirements 119
Bar Code Placement 120
U.S. REGULATION RELATING TO RADIO FREQUENCY DEVICES 120
FCC regulations define radiators as: 120
FCC Restriction on Devices Operating Within the 13.110-14.010 MHz Band (Section 15.225) 121
FCC Restrictions on Devices Operating Within the 890-940 MHz Band (Section 15.243) 121
STRUCTURE OF THE GLOBAL TRACK AND TRACE TECHNOLOGY INDUSTRY 122
RECENT AND PROJECTED GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES 123
INDUSTRY DATA 123
RECENT GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE 124
Recent Global Sales of Packaging Bar Codes 124
FIGURE 23 SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF THE GLOBAL TRACK AND TRACE PACKAGING MARKET, 2009 (%) 124
FIGURE 23 (CONTINUED) 125
TABLE 47 GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 ($ MILLIONS/%) 125
FIGURE 24 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES, 2009 (%) 126
Recent Global Sales of Packaging RFID Tags 126
FIGURE 25 SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF GLOBAL TRACK AND TRACE PACKAGING MARKET, 2009 (%) 127
TABLE 48 GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 ($ MILLIONS/%) 127
FIGURE 26 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING RFID TAGS TO THE FOOD AND DRUG INDUSTRIES, 2009 (%) 128
Total Recent Global Sales of Track and Trace Packaging Technologies 129
TABLE 49 GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2009 ($ MILLIONS/%) 129
TABLE 50 GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2009 ($ MILLIONS/%) 129
FIGURE 27 ESTIMATED MARKET SHARES OF GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2009 (%) 130
MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES 130
TABLE 51 MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES, 2009 131
MARKET DRIVERS AND DRAWBACKS 131
Market Drivers and Drawbacks (Continued) 132
SALES AND MARKET SIZE PROJECTIONS 133
Projected Total Global Sales of Packaging Bar Codes 134
TABLE 52 GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 134
FIGURE 28 SHARES OF GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 135
TABLE 53 GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS) 136
FIGURE 29 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD INDUSTRIES, 2010 AND 2015 (%) 137
Projected Total Global Sales of RFID Tags 137
TABLE 54 GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 138
FIGURE 30 SHARES OF GLOBAL PACKAGING RFID TAGS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 138
FIGURE 30 (CONTINUED) 139
TABLE 55 GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD INDUSTRIES BY GEOGRAPHY, THROUGH 2015 ($ MILLIONS) 139
FIGURE 31 ESTIMATED MARKET SHARES OF GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD INDUSTRIES, 2010 AND 2015 (%) 140
Projected Total Regional Sales of Track and Trace Packaging Technologies by Type 140
North American Sales of Track and Trace Packaging Technologies by Type Through 2015 140
TABLE 56 NORTH AMERICAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 141
FIGURE 32 SHARES OF NORTH AMERICAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 141
European Sales of Track and Trace Packaging Technologies by Type Through 2015 142
TABLE 57 EUROPEAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 142
FIGURE 33 SHARES OF EUROPEAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 142
FIGURE 33 (CONTINUED) 143
Asia-Pacific Sales of Track and Trace Packaging Technologies by Type Through 2015 143
TABLE 58 ASIAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 143
FIGURE 34 SHARES OF ASIA-PACIFIC SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 (%) 144
Projected Total Global Sales of Track and Trace Packaging Technologies by Type 144
TABLE 59 GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2015 ($ MILLIONS) 145
FIGURE 35 SHARES OF GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2010 AND 2015 145
Projected Total Global Sales of Track and Trace Packaging Technologies by End Use 146
TABLE 60 GLOBAL SALES OF PACKAGING TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2015 ($ MILLIONS) 146
FIGURE 36 SHARES OF GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2010 AND 2015 (%) 147

Chapter-7: TECHNOLOGY AND PATENT ANALYSIS

INTRODUCTION 148
RECAP OF AUTHENTICATION PACKAGING TECHNOLOGIES 148
INKS AND DYES 148
HOLOGRAPHY 149
WATERMARKING 150
TAGGANTS 151
RECAP OF TRACK AND TRACE PACKAGING TECHNOLOGIES 152
BAR CODING TECHNOLOGY 152
RFID TECHNOLOGY 153
PATENT ANALYSIS 154
PATENTS RELATING TO AUTHENTICATION PACKAGING TECHNOLOGIES 154
TABLE 61 PATENT AWARDS FOR AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE, 2009 (NUMBER OF PATENTS/%) 155
TABLE 62 PATENT AWARDS FOR AUTHENTICATION PACKAGING TECHNOLOGIES BY REGION, 2009     (NUMBER OF PATENTS/%) 155
Samples of Patents for Inks and Dyes 155
TABLE 63 PATENT AWARDS FOR INKS AND DYES BY REGION, 2009 (NUMBER OF PATENTS/%) 156
Printing Process with Edible Inks 156
Phthalocyanine Dyes Suitable for Use in Offset Inks 157
Waxes for Producing Printing Inks 157
Method for Producing a Proof for a Printing Process Having More Than Four Printing Inks 158
Reproduction of Security Documents and Color Images with Metallic Inks 158
Sample of Patents for Holographic Technology 159
TABLE 64 PATENT AWARDS FOR HOLOGRAPHY BY REGION, 2009 (NUMBER OF PATENTS/%) 159
Three-Dimensional Hologram Image Display Apparatus and Three-Dimensional Hologram Image Display System 159
Computer Hologram and Creation Method Thereof 160
Fabrication Process for Cholesteric Liquid Crystal Media Having a Volume Hologram 161
Volume Hologram Layer and Volume Hologram Transfer Foil 161
Method for Optical Recording, Method for Optical Reproducing, Optical Recording Medium, and Optical Recording and Reproducing Apparatus Utilizing Holography 162
Patents for Watermarking Technology 163
TABLE 65 PATENT AWARDS FOR WATERMARK TECHNOLOGY BY REGION, 2009 (NUMBER OF PATENTS/%) 163
Protecting Images with an Image Watermark 163
Holographic Digital Watermark 164
Reversible Watermarking 164
Visual Watermark 165
Layered Security in Digital Watermarking 165
PATENTS RELATING TO TRACK AND TRACE PACKAGING TECHNOLOGIES 166
TABLE 66 PATENT AWARDS FOR TRACK AND TRACE PACKAGING TECHNOLOGIES BY TYPE, 2009 (NUMBER OF PATENTS/%) 166
TABLE 67 PATENT AWARDS FOR TRACK AND TRACE PACKAGING TECHNOLOGIES BY REGION, 2009 (NUMBER OF PATENTS/%) 166
Sample of Patents for Bar Coding Technology 167
TABLE 68 PATENT AWARDS FOR BAR CODING TECHNOLOGY BY REGION, 2009 (NUMBER OF PATENTS/%) 167
Pallet Content Identification Mechanism that Converts RFID Information to Corresponding Bar Code Information 167
Concentric-Ring Circular Bar Code 167
Method of and Apparatus for Identifying Consumer Products in a Retail Environment When Bar Code Symbols on the Products are Not Readable or Have Been Removed from Packaging 168
Methods and Apparatus for Bar Code Conversion 168
Color Bar Code Producing Method and Apparatus, Color Bar Code Reading Method and Apparatus, and Color Bar Code Reproducing Method and Apparatus 169
Sample of Patents for RFID Technology 169
TABLE 69 PATENT AWARDS FOR RFID TECHNOLOGY BY REGION, 2009 (NUMBER OF PATENTS/%) 169
Active RFID Tag with New Use Automatic Updating 170
RFID Tag Housing 170
RFID Tag Data Retention Verification and Refresh 171
RFID Tag Sensitivity 171
RFID Tags for Enabling Batch Reading of Stacks of Cartons 172

Chapter-8: SAFEGUARDING THE GLOBAL DRUG AND FOOD SUPPLY CHAINS

INTRODUCTION 173
SNAPSHOTS OF GLOBAL DRUG SAFETY 173
FDA AND DRUG SAFETY 173
Revised Requirements for Prescribing Information for Drug Products Since 2006 174
FDA’s Supply Chain Pilot Program 175
E.U. AND DRUG SAFETY 175
Key Elements of the E.U. Pharmavigilance Proposals 176
Clear Roles and Responsibilities for Responsible Parties 176
Creation of the Pharmacovigilance Risk Assessment Advisory Committee 176
Transparency and Communication 176
WHO TASK FORCE: IMPACT 177
RECENT INITIATIVES FOR STANDARDS IN THE GLOBAL DRUG SUPPLY CHAIN 178
MASS SERIALIZATION 178
U.S. FDA Guidance for Numerical Identification 178
Unit of Packaging 179
Package-Level SNI for Most Prescription Drugs 180
SNI Including Expiration Date and/or Lot and Batch Number 180
SNI in Human- and Machine-Readable Forms 180
FDA-Recommended SNI Compatibility with International Standards 181
Coding and Identification of Drug Products in Europe 181
GS1 U.S. 2015 Readiness Program: Visibility/Traceability for Healthcare Applications—Product Recalls, Serialization, and Drug Pedigree 182
GS1 Healthcare Industry Sunrise Dates 183
GS1 Canada’s Pharmacy Sector Engagement 184
Global RFID Interoperability Forum for Standards 184
U.S. DRUG PEDIGREE REQUIREMENTS: THE PRESCRIPTION DRUG MARKETING ACT 185
FDA Risk-Based Enforcement of Pedigree Requirement, 2006 to 2007 186
FDA Guidance for Industry on PDMA Requirements 186
Who Should Maintain a Written Agreement? 186
What Information About the ADR Must a Manufacturer Make Available on the List? 186
How Often Should Manufacturers Update Their ADR Lists? 187
Is Placing the ADR List on the Manufacturer’s Website Adequate to Meet the Provision of Making the List Available on Request to the Public? 187
What Information Does a Manufacturer Have to Provide to a Wholesaler to Enable that Wholesaler to Comply with the PDMA? 187
What Information Does an ADR Have to Provide to a Non-ADR to Enable that Non-ADR to Comply with the PDMA (e.g., to pass a pedigree that lists all prior transactions back to the manufacturer)? 187
Are Contract Manufacturers Considered Manufacturers Under the PDMA? 188
Is a Repackager or Relabeler Exempt from Providing a Pedigree? 188
Is a Pedigree Required if an Exclusive Distribution Agreement Exists? 188
What are the Recordkeeping Requirements for Pedigree Recipients? 188
Is a Pedigree Required for the Distribution of Drug Samples? 188
Can Paper or Electronic Pedigrees be Used? 189
Is RFID the Only Way to Achieve an Electronic Pedigree? 189
State Initiatives Targeting Wholesale Distributor Licensing 189
California State Pedigree Law 190
California Law Requirements 190
Drug Pedigree 191
Florida Drug Pedigree Law 192
Which Prescription Drugs are Subject to the Pedigree Requirements? 192
Who Must Provide a Pedigree? 193
To Whom Must the Pedigree Be Provided? 193
Does a Wholesale Distributor or Repackager Require a Pedigree for the Distribution of an active pharmaceutical ingredient (API)? 193
May a Drug Repackager Provide a Direct Purchase Pedigree? 193
How Are Drop Shipments Handled? 194
Florida Provisions 194
SNAPSHOTS OF GLOBAL FOOD TRACEABILITY 194
CODEX ALIMENTARIUS COMMISSION 194
Codex and Food Traceability 195
Public Sector Motivation for Traceability 196
Private Sector Motivation for Traceability 196
Codex General Principles on Prepackaged Food 196
Codex Mandatory Labeling of Prepackaged Foods 197
Codex Mandatory … (Continued) 198
U.S. FOOD SAFETY REGULATIONS 199
TABLE 70 FEDERAL AGENCIES RESPONSIBLE FOR U.S. FOOD SAFETY SYSTEM 199
TABLE 70 (CONTINUED) 200
U.S. BIOTERRORISM ACT RELATING TO FOOD PRODUCTS 200
Mandatory Recordkeeping 201
Recordkeeping Requirement for Transporters of Food 201
Recordkeeping Requirement for Non-Transporters of Food 201
Effective Date for Compliance 202
Reportable Food Registry 202
FDA Food Protection Plan 203
FOOD TRACEABILITY IN CANADA 204
FOOD TRACEABILITY IN EUROPE 204
TABLE 71 ROLES AND RESPONSIBILITIES WITHIN THE E.U. FOOD SYSTEM 205
RECENT INITIATIVES FOR STANDARDS IN THE GLOBAL FOOD SUPPLY CHAIN 205
GS1 U.S. Standards Initiative for the Food Service Sector 205
GS1 U.S. Standards for Fresh Foods 206
GS1 Canada 207
GS1 Canada Product Recall Initiative 207
Produce Traceability Initiative 2012 207

Chapter-9: COMPANY PROFILES

MAJOR MANUFACTURERS OF AUTHENTICATION PACKAGING TECHNOLOGIES 208
3D AG 208
3M COMPANY 208
APPLIED DNA SCIENCES 209
ALPVISION SA 209
ATLAS TELECOM 209
AUTHENTIX 210
CFC INTERNATIONAL, INC. 210
CONSTANTIA FLEXIBLES 211
CORTEGRA GROUP, INC. 211
DIC (INCLUDING SUN CHEMICAL) 211
DIGIMARC CORPORATION 212
DUPONT AUTHENTICATION 212
EVEREST HOLOVISIONS, LTD. 212
EVIDENT TECHNOLOGIES 213
FLINT GROUP 213
G and W RFID, LLC (INCLUDING PARELEC) 214
HOLOFLEX, LTD. 214
HOLOMEX 214
INKSURE TECHNOLOGIES 215
INTERNATIONAL INK COMPANY, LLC 215
JDSU AUTHENTICATION SOLUTIONS 215
MICROTRACE SOLUTIONS, LLC 216
NOVAVISION, INC 216
OPSEC SECURITY GROUP, PLC 217
OPTAGLIO GROUP 217
PACIFIC HOLOGRAPHICS 217
SECURITY HOLOGRAM, LLC. 218
SICPA HOLDING SA 218
TESA SCRIBOS GMBH 219
ZELLER+GMELIN GMBH 219
MAJOR MANUFACTURERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES 219
ALIEN TECHNOLOGY 219
AVERY DENNISON RFID 220
DATA SYSTEMS INTERNATIONAL 220
DATAMAX-O’NEIL 221
DOMINO INTEGRATED SOLUTIONS GROUP 221
ELEMENT ID 221
FEIG ELECTRONICS, INC. 222
GLOBERANGER CORPORATION 222
IMPINJ 222
INTERMEC TECHNOLOGIES 223
KOVIO, INC. 223
OMRON RFID 224
PRINTRONIX, INC. 224
SATO AMERICA, INC. 224
SAVI TECHNOLOGY, INC. 225
SYSTECH INTERNATIONAL 225
SYMBOL TECHNOLOGIES (MOTOROLA) 226
TAGSYS RFID 226
THINGMAGIC 226
TEXAS INSTRUMENTS RFID SYSTEMS 227
ZEBRA TECHNOLOGIES 227

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