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This BCC Research 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. Includes forecasts through 2020.

REPORT HIGHLIGHTS

The global market for anti-counterfeiting packaging technologies is expected to increase from nearly $74.2 billion in 2015 to $135.6 billion in 2020, with a compound annual growth rate (CAGR) of 12.8% from 2015 to 2020.

This report provides:

- An overview of the global markets for anti-counterfeiting packaging technologies in the pharmaceutical and food industries with particular focuses on authentication and track and trace packaging technologies.
- Analyses of global market trends, with data from 2014, estimates for 2015, and projections of compound annual growth rates (CAGRs) through 2020.
- Discussion in detail covering the impact of government regulatory requirements, growing sophistication of counterfeiters, concern for brand protection, industry mandates, and inter-governmental initiatives.
- Coverage of the role of U.S. and foreign manufacturers and regulatory agencies in the market for anti-counterfeiting technologies.
- Analysis of the market's dynamics, specifically growth drivers, inhibitors, and opportunities.
- Detailed evaluation of the supply chain which is integral to the application of anti-counterfeiting packaging.
- Profiles of major players in the industry.

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 (e.g., 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 2020. 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.

Table Of Contents

Anti-Counterfeiting Packaging Technologies in the Global Pharmaceutical and Food Industries
CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVES 2
REASONS FOR DOING THE STUDY 2
CONTRIBUTIONS OF THE STUDY 2
SCOPE OF REPORT 3
METHODOLOGY AND INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 3
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
SUMMARY 6
SUMMARY TABLE GLOBAL MARKET FOR ANTI-COUNTERFEITING PACKAGING
TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH
2020 ($ MILLIONS) 6
SUMMARY FIGURE GLOBAL MARKET SHARES OF SALES OF ANTI-COUNTERFEITING
PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2020
(%) 7
CHAPTER 3 OVERVIEW 9
DEFINING A COUNTERFEIT PRODUCT 9
PREVALENCE OF COUNTERFEITING 10
INDUSTRY CONCEPTS 11
SECURE SUPPLY CHAIN 11
PRODUCT PACKAGING 11
Packaging Concepts and Materials 12
Levels of Packaging 13
Smart Packaging 13
PRODUCT IDENTIFICATION 13
Universal Product Code 13
Global Trade Item Number 14
Symbology 14
Covert and Overt Secure Technologies 14
Paper and Electronic Drug Pedigree 14
Automatic Identification and Data Capture 15
Electronic Product Code 15
Mass Serialization 15
Radio Frequency Definitions 15
Read Range 16
IMPORTANCE OF SECURE PACKAGING TECHNOLOGIES 16
FORESEEABLE DEVELOPMENTS 16
CHAPTER 4 DRUG AND FOOD MARKETING 18
INTRODUCTION 18
U.S. DRUG MARKETING 18
FOD042C - Anti-Counterfeiting Packaging Technologies in the Global Pharmaceutical and Food
Industries
Copyright © BCC Research, Wellesley MA USA, Website: www.bccresearch.com
TOPIC PAGE NO.
DRUG MANUFACTURERS 19
Drug Manufacturing Industry Classification 19
TABLE 1 U.S. DRUG MANUFACTURING BY INDUSTRY CLASSIFICATION 19
TABLE 2 BUSINESS PATTERNS OF THE U.S. PHARMACEUTICAL PREPARATION
MANUFACTURING INDUSTRY (NO./%) 19
Brand-Name Drug Manufacturers 20
TABLE 3 MAJOR BRAND-NAME DRUG MANUFACTURERS RANKED BY MARKET
CAPITALIZATION, SECOND QUARTER 2015 ($ BILLIONS/%) 20
Generic Drug Manufacturers 21
TABLE 4 MAJOR GENERIC DRUG MANUFACTURERS RANKED BY MARKET
CAPITALIZATION, SECOND QUARTER 2015 ($ MILLIONS/%) 21
Affordable Care Act 22
Stimulating Demand for Prescription Drugs 22
Global Sales of Pharmaceutical Preparations 23
TABLE 5 GLOBAL SALES AND MARKET SHARES OF MAJOR MANUFACTURERS OF
PHARMACEUTICAL PREPARATIONS FOR HUMAN USE, 2014 ($ MILLIONS/%) 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, 2014 ($ MILLIONS/%) 24
TABLE 7 U.S. SALES OF PHARMACEUTICAL PREPARATIONS FOR HUMAN USE BY
END USE, 2014 ($ MILLIONS/%) 24
International Trade in Pharmaceutical Preparations 25
TABLE 8 U.S. EXPORTS OF PHARMACEUTICAL PREPARATIONS, 2014 ($ MILLIONS/%) 25
WHOLESALE DRUG DISTRIBUTORS 25
U.S. Wholesale Drug Industry Classification 25
TABLE 9 U.S. DRUG WHOLESALERS BY INDUSTRY CLASSIFICATION 26
TABLE 10 BUSINESS PATTERNS OF U.S. WHOLESALE DRUG DISTRIBUTION
INDUSTRY, 2015 (NO./%) 26
U.S. Wholesale Drug Industry Structure 26
TABLE 11 MERCHANT DRUG DISTRIBUTORS RANKED BY MARKET CAPITALIZATION,
SECOND QUARTER 2015 ($ MILLIONS/%) 27
TABLE 12 MARKET SALES OF THREE LARGE U.S. MERCHANT WHOLESALE DRUG
DISTRIBUTORS BY SALES CHANNEL, 2014 ($ MILLIONS/%) 27
FIGURE 1 MARKET SHARES OF THREE LARGE U.S. MERCHANT WHOLESALE DRUG
DISTRIBUTORS BY SALES CHANNEL, 2014 (%) 28
Secondary Wholesalers 28
RETAIL DRUG DISTRIBUTORS 29
U.S. Retail Drug Industry Structure 29
TABLE 13 BUSINESS PATTERN OF U.S. RETAIL DRUG DISTRIBUTION INDUSTRY,
2015 (NO./%) 29
U.S. Retail Prescription Drug Sales 29
TABLE 14 PRESCRIPTION DRUGS FILLED IN THE U.S. BY RETAIL DRUG SEGMENT,
2014 (MILLIONS/%) 30
TABLE 15 U.S. RETAIL PRESCRIPTION DRUG SALES BY RETAIL DRUG SEGMENT,
2014 ($ MILLIONS/%) 30
INTERNET DRUG DISTRIBUTION 30
Benefits of Internet Drug Distribution 30
Challenges Posed by Internet Drug Distribution 31
Addressing the Illegitimate Internet Drug Distribution 32
U.S. FOOD MARKETING 32
FOOD PROCESSORS OR MANUFACTURERS 33
Food Manufacturing Industry Classification 33
TABLE 16 U.S. FOOD MANUFACTURING INDUSTRY FOR HUMAN CONSUMPTION BY
INDUSTRY 33
Food Manufacturing Industry Structure 33
TABLE 17 BUSINESS PATTERN OF U.S. FOOD MANUFACTURING INDUSTRY FOR
HUMAN CONSUMPTION, 2015 (NO./%) 34
Food Distribution from Manufacturer to Wholesale to Retail 34
U.S. Sales of Processed Foods for Human Consumption 35
TABLE 18 U.S. SALES BY MAJOR PROCESSORS OF FOOD FOR HUMAN
CONSUMPTION, 2014 ($ MILLIONS/%) 35
U.S. International Trade in Processed Foods for Human Consumption 35
TABLE 19 U.S. EXPORTS OF PROCESSED FOODS FOR HUMAN CONSUMPTION, 2014 36
TABLE 20 U.S. EXPORTS OF PROCESSED FOODS FOR HUMAN CONSUMPTION BY
TYPE, 2014 ($ MILLIONS/%) 36
WHOLESALE FOOD DISTRIBUTORS 37
U.S. Wholesale Food Industry Classification 37
TABLE 21 U.S. FOOD WHOLESALE INDUSTRY BY INDUSTRY CLASSIFICATION 37
U.S. Wholesale Food Distribution Industry Structure 37
TABLE 22 BUSINESS PATTERN OF U.S. WHOLESALE FOOD DISTRIBUTION INDUSTRY,
2015 (NO./%) 38
U.S. Wholesale Food Sales 38
TABLE 23 ESTIMATED U.S. SALES BY MAJOR FOOD WHOLESALERS, 2014 ($
MILLIONS/%) 39
RETAIL FOOD DISTRIBUTORS 39
U.S. Retail Food Industry Classification 39
TABLE 24 U.S. RETAIL FOOD INDUSTRY BY INDUSTRY CLASSIFICATION 40
U.S. Retail Food Distribution Industry Structure 40
TABLE 25 BUSINESS PATTERN OF U.S. RETAIL FOOD DISTRIBUTION INDUSTRY,
2015 (NO./%) 42
U.S. Retail Food Sales 42
TABLE 26 ESTIMATED U.S. SALES BY RETAIL FOOD DISTRIBUTORS, 2014 42
CHAPTER 5 AUTHENTICATION PACKAGING TECHNOLOGIES 44
INTRODUCTION 44
AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE 44
INKS AND DYES 44
Security Inks 45
TABLE 27 TYPES OF SECURITY INKS AND PRINTING METHOD 45
Color-Shifting Inks 45
Holographic Inks 46
Pearlescent Pigments 46
Thermochromic and Photo-Chromic Inks 46
Taggant Inks 46
Watermark Inks 47
Examples of Proprietary Inks 47
AlpVision SA: Cryptoglyph Solution 47
HOLOGRAMS 47
Hologram Types 48
2D and 3D Holograms 48
Dot-Matrix Holograms 48
Electronic Beam Holograms 48
Volume Holograms 49
Light of Holograms 49
Overt and Covert Holograms 49
Recent Trends in Security Holograms 49
OpSec Security 50
3M's Holographic Authentication Solutions 50
Spectra Systems Corporation Smartphone Hologram
Authentication Solution 50
CFC International's Dot-Matrix System 51
DNA-Encoded Holograms 51
DuPont's 3D Hologram 51
Hologram, Industries 51
Tesa-Scribos' tesa Holospot: Mass Serialization Holograms 52
WATERMARKS 52
Categories of Watermark 52
Physical Paper Watermark 52
Digital Watermark 52
Recent Innovations in Watermarking 53
Digital Watermarks 53
Embedded Watermarking 53
TAGGANTS 53
JDSU's Charms 54
Microtrace's Taggants 54
Spectra Systems MultiSur and TagSure 54
REGULATORY PROVISIONS FOR AUTHENTICATION TECHNOLOGIES 54
STRUCTURE OF THE GLOBAL AUTHENTICATION TECHNOLOGY INDUSTRY 55
STRATEGIC ALLIANCES 56
Digimarc and AlpVision 56
Microtrace and the Flint Group 56
NAME RECOGNITION AND FULL-SERVICE CAPABILITIES 56
GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE
DRUG AND FOOD INDUSTRIES 57
INDUSTRY DATA 57
GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE
DRUG AND FOOD INDUSTRIES BY TYPE 57
Recent Global Sales of Packaging Inks and Dyes 57
FIGURE 2 GLOBAL SHARES OF PACKAGING INK SALES VS. SALES OF OTHER
AUTHENTICATION TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2015 (%) 58
TABLE 28 GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 58
FIGURE 3 GLOBAL SHARES OF SALES OF PACKAGING INKS TO THE DRUG AND
FOOD INDUSTRIES BY REGION, 2015 (%) 59
Recent Global Sales of Packaging Holograms 59
FIGURE 4 GLOBAL SHARES OF PACKAGING HOLOGRAM SALES VS. OTHER
AUTHENTICATION TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES,
2015 (%) 59
TABLE 29 GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 60
FIGURE 5 GLOBAL SHARES OF SALES OF PACKAGING HOLOGRAMS TO THE DRUG
AND FOOD INDUSTRIES BY REGION, 2015 (%) 61
Recent Global Sales of Packaging Watermarks 61
FIGURE 6 GLOBAL SHARES OF PACKAGING WATERMARK SALES VS. SALES OF
OTHER AUTHENTICATION TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES,
2015 (%) 61
TABLE 30 GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 62
FIGURE 7 GLOBAL SHARES OF SALES OF PACKAGING WATERMARKS TO THE DRUG
AND FOOD INDUSTRIES BY REGION, 2015 (%) 63
Recent Global Sales of Packaging Taggants 63
FIGURE 8 GLOBAL SHARES OF PACKAGING TAGGANT SALES VS. SALES OTHER
AUTHENTICATION TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2015 (%) 63
TABLE 31 GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 64
FIGURE 9 GLOBAL SHARES OF SALES OF PACKAGING TAGGANTS TO THE DRUG
AND FOOD INDUSTRIES BY REGION, 2015 (%) 65
Recent Global Sales of Authentication Packaging Technologies 65
FIGURE 10 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 ($ MILLIONS) 65
TABLE 32 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 66
FIGURE 11 GLOBAL SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY REGION, 2015 (%) 67
MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES 67
TABLE 33 MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES, 2015 67
MARKET DRIVERS AND DRAWBACKS 69
SALES AND MARKET SIZE PROJECTIONS 69
Projected Total Global Sales of Packaging Inks and Dyes 70
TABLE 34 GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 71
FIGURE 12 GLOBAL SHARES OF SALES OF PACKAGING INKS TO THE DRUG AND
FOOD INDUSTRIES BY END USE, 2015 AND 2020 (%) 71
TABLE 35 GLOBAL SALES OF PACKAGING INKS TO THE DRUG AND FOOD
INDUSTRIES BY REGION, THROUGH 2020 ($ MILLIONS) 72
Projected Global Sales of Packaging Holograms 72
TABLE 36 GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 72
FIGURE 13 GLOBAL SHARES OF SALES OF PACKAGING HOLOGRAMS TO THE DRUG
AND FOOD INDUSTRIES BY END USE, 2015 AND 2020 (%) 73
TABLE 37 GLOBAL SALES OF PACKAGING HOLOGRAMS TO THE DRUG AND FOOD
INDUSTRIES BY REGION, THROUGH 2020 ($ MILLIONS) 74
Projected Global Sales of Packaging Watermarks 74
TABLE 38 GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 74
FIGURE 14 GLOBAL SHARES OF SALES OF PACKAGING WATERMARKS TO THE
DRUG AND FOOD INDUSTRIES BY END USE, 2015 AND 2020 (%) 74
TABLE 39 GLOBAL SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD
INDUSTRIES BY REGION, THROUGH 2020 ($ MILLIONS) 75
Projected Global Sales of Packaging Taggants 76
TABLE 40 GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 76
FIGURE 15 GLOBAL SHARES OF SALES OF PACKAGING TAGGANTS TO THE DRUG
AND FOOD INDUSTRIES BY END USE, 2015 AND 2020 (%) 76
TABLE 41 GLOBAL SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD
INDUSTRIES BY REGION, THROUGH 2020 ($ MILLIONS) 77
Projected Regional Sales of Authentication Packaging Technologies
by Type 78
North American Sales 78
TABLE 42 NORTH AMERICAN SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($
MILLIONS) 78
FIGURE 16 NORTH AMERICAN SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 AND 2020
(%) 78
European Sales 79
TABLE 43 EUROPEAN SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($ MILLIONS) 80
FIGURE 17 EUROPEAN SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 AND 2020
(%) 80
Asia-Pacific Sales 81
TABLE 44 ASIA-PACIFIC SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES
TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($ MILLIONS) 81
FIGURE 18 ASIA-PACIFIC SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 AND 2020
(%) 81
Projected Global Sales of Authentication Packaging Technologies by
Type 82
TABLE 45 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($ MILLIONS) 83
FIGURE 19 GLOBAL SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 AND 2020
(%) 83
FIGURE 20 GLOBAL SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY REGION, 2015 AND
2020 (%) 84
Projected Global Sales of Authentication Packaging Technologies by
End Use 85
TABLE 46 GLOBAL SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 85
FIGURE 21 GLOBAL SHARES OF SALES OF AUTHENTICATION PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2015 AND
2020 (%) 85
CHAPTER 6 TRACK AND TRACE PACKAGING TECHNOLOGIES 88
INTRODUCTION 88
TRACK AND TRACE PACKAGING TECHNOLOGIES BY TYPE 88
BAR CODES 88
A Brief History of Bar Codes 88
Commercial Applications of Bar Codes 89
Bar Code Specifications 89
Bar Codes for Different Environment 89
Paper Bar Code Labels 89
Aluminum Bar Code Labels 89
Polyester Bar Code Labels 90
Ceramic Bar Code Labels 90
Mobile Bar Codes 90
Bar Code Symbology 90
Continuous or Discrete Symbology 90
Two-Width or Multiple-Width Symbology 91
GS1 Bar Code Standards 91
EAN/UPC Symbology 91
ITF-14 Symbology 91
GS1-128 Symbology 91
GS1 DataBar (RSS) 92
Two-Dimensional (2D) Bar Codes 92
Bar Code Implementation Steps 92
Bar Code Printing 93
Bar Code Quality 93
RADIO FREQUENCY IDENTIFICATION TECHNOLOGY 93
Commercial Applications of Radio Frequency Identification
Technology 93
Overview of RFID Technology 94
RFID Tags for Different Uses 94
Components of an RFID Tag 94
Classification of RFID Tags 95
Classification of RFID Tags Based on Power Source 95
Active RFID Tags 95
Passive RFID Tags 95
Read-Write Functionality 95
Classification Based on Radio Frequency 96
Low-Frequency RFID Tags 96
High-Frequency RFID Tags 96
Ultra-High-Frequency RFID Tags 96
EPCglobal and RFID Standards 97
Class 1 Generation 2 UHF Air Interface Protocol Standard 97
Advantages of RFID Tags 98
Early Adopters of RFID Tags 98
Wal-Mart and RFID Adoption 99
U.S. Department of Defense and RFID Adoption 100
Pilot Studies: Drug Industry 100
Current State of RFID Tagging: Rise of UHF RFID 100
Printed RFID Tags 101
Some Notable UHF RFID Tags 102
Alien Technology's Brand 102
Impinj RFID Solution 102
Avery Dennison's RFID Label 102
Examples of RFID Adoption Enablers 103
Data Systems International's Mobile Platform 103
GlobeRanger's iMotion IoT Edgeware Platform 103
Systech International's Citadel 103
Addressing Privacy Concerns Regarding RFID Tags 103
RFID Tags for Cold Chain Compliance 104
Recyclable RFID Tags 105
REGULATORY PROVISIONS FOR TRACK AND TRACE TECHNOLOGIES 105
Drug Quality and Security Act 105
Key Objectives 106
Product Traceability 106
Transaction Definitions 106
Pilot Program 107
U.S. BAR CODE REGULATIONS RELATING TO DRUG PRODUCTS 107
Key Objectives of the Rule 108
Entities Subject to the Rule 108
Products that Require Bar Codes 108
Information Contained in a Bar Code 109
Specific Bar Code Requirements 109
Bar Code Placement 109
U.S. REGULATION RELATING TO RADIO FREQUENCY DEVICES 109
FCC Restrictions on Devices Operating Within the 13.110-14.010 MHz
Band (Section 15.225) 110
FCC Restrictions on Devices Operating Within the 890-940 MHz Band
(Section 15.243) 110
STRUCTURE OF THE GLOBAL TRACK AND TRACE TECHNOLOGY INDUSTRY 111
RECENT AND PROJECTED GLOBAL SALES OF TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES 112
INDUSTRY DATA 112
RECENT GLOBAL SALES OF TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE 112
Recent Global Sales of Packaging Bar Codes 112
FIGURE 22 GLOBAL SHARES OF PACKAGING BAR CODE SALES VS. SALES OF
OTHER TRACE AND TRACK TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES,
2015 (%) 112
TABLE 47 GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD
INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 113
FIGURE 23 GLOBAL SHARES OF SALES OF PACKAGING BAR CODES TO THE DRUG
AND FOOD INDUSTRIES, 2015 (%) 114
Recent Global Sales of Packaging RFID Tags 114
FIGURE 24 GLOBAL SHARES OF PACKAGING RFID TAG SALES VS. SALES OF OTHER
TRACK AND TRACE TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2015
(%) 115
TABLE 48 GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 115
FIGURE 25 GLOBAL SHARES OF SALES OF PACKAGING RFID TAGS TO THE FOOD
AND DRUG INDUSTRIES, 2015 (%) 116
Recent Global Sales of Track and Trace Packaging Technologies 116
TABLE 49 GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 ($ MILLIONS/%) 117
TABLE 50 GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY END USE, 2015 ($ MILLIONS/%) 117
FIGURE 26 GLOBAL SHARES OF SALES OF TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, 2015 (%) 117
MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES 118
TABLE 51 MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES,
2015 118
MARKET DRIVERS AND DRAWBACKS 119
SALES AND MARKET SIZE PROJECTIONS 120
Projected Global Sales of Packaging Bar Codes 122
TABLE 52 GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD
INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 122
FIGURE 27 GLOBAL SHARES OF SALES OF PACKAGING BAR CODES TO THE DRUG
AND FOOD INDUSTRIES BY END USE, 2015 AND 2020 (%) 122
TABLE 53 GLOBAL SALES OF PACKAGING BAR CODES TO THE DRUG AND FOOD
INDUSTRIES BY REGION, THROUGH 2020 ($ MILLIONS) 124
FIGURE 28 GLOBAL SHARES OF SALES OF PACKAGING BAR CODES TO THE DRUG
AND FOOD INDUSTRIES, 2015 AND 2020 (%) 124
Projected Global Sales of RFID Tags 125
TABLE 54 GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD
INDUSTRIES BY END USE, THROUGH 2020 ($ MILLIONS) 125
FIGURE 29 GLOBAL SHARES OF SALES OF PACKAGING RFID TAGS TO THE DRUG
AND FOOD INDUSTRIES BY END USE, 2015 AND 2020 (%) 125
TABLE 55 GLOBAL SALES OF PACKAGING RFID TAGS TO THE DRUG AND FOOD
INDUSTRIES BY REGION, THROUGH 2020 ($ MILLIONS) 126
FIGURE 30 GLOBAL SHARES OF SALES OF PACKAGING RFID TAGS TO THE DRUG
AND FOOD INDUSTRIES, 2015 AND 2020 (%) 127
Projected Regional Sales of Track and Trace Packaging Technologies
by Type 128
North American Sales 128
TABLE 56 NORTH AMERICAN SALES OF TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($
MILLIONS)128
FIGURE 31 NORTH AMERICAN MARKET SHARES OF SALES OF TRACK AND TRACE
PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015
AND 2020 (%)128
European Sales 129
TABLE 57 EUROPEAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($ MILLIONS) 129
FIGURE 32 EUROPEAN MARKET SHARES OF SALES OF TRACK AND TRACE
PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015
AND 2020 (%)129
Asia-Pacific Sales 130
TABLE 58 ASIAN SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE
DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($ MILLIONS) 130
FIGURE 33 ASIA-PACIFIC MARKET SHARES OF SALES OF TRACK AND TRACE
PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015
AND 2020 (%)131
Projected Global Sales of Track and Trace Packaging Technologies by
Type 131
TABLE 59 GLOBAL SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO
THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2020 ($ MILLIONS) 131
FOD042C - Anti-Counterfeiting Packaging Technologies in the Global Pharmaceutical and Food
Industries
Copyright © BCC Research, Wellesley MA USA, Website: www.bccresearch.com
TOPIC PAGE NO.
FIGURE 34 GLOBAL SHARES OF SALES OF TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2015 AND 2020
(%)132
Projected Global Sales of Track and Trace Packaging Technologies by
End Use 133
TABLE 60 GLOBAL SALES OF PACKAGING TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, THROUGH
2020 ($ MILLIONS)133
FIGURE 35 GLOBAL SHARES OF SALES OF TRACK AND TRACE PACKAGING
TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2015 AND
2020 (%)133
CHAPTER 7 TECHNOLOGY AND PATENT ANALYSIS 136
INTRODUCTION 136
RECAP OF AUTHENTICATION PACKAGING TECHNOLOGIES 136
INKS AND DYES 136
HOLOGRAPHY 136
WATERMARKING 137
TAGGANTS 139
Distributed Taggant Systems 139
Particulate Taggant Systems 139
RECAP OF TRACK AND TRACE PACKAGING TECHNOLOGIES 139
BAR CODING TECHNOLOGY 139
RFID TECHNOLOGY 140
PATENT ANALYSIS 140
PATENTS RELATING TO AUTHENTICATION PACKAGING TECHNOLOGIES 141
TABLE 61 U.S. PATENT AWARDS FOR AUTHENTICATION PACKAGING
TECHNOLOGIES BY TYPE, 2014 (NO./%) 141
TABLE 62 U.S. PATENT AWARDS FOR AUTHENTICATION PACKAGING
TECHNOLOGIES BY REGION, 2014 (NO./%) 142
Samples of Patents for Inks and Dyes 142
TABLE 63 PATENT AWARDS FOR INKS AND DYES BY REGION, 2014 (NO./%) 142
Sample of Patents for Holographic Technology 144
TABLE 64 U.S. PATENT AWARDS FOR HOLOGRAPHY BY PATENT HOLDERS' REGION,
2014 (NO./%) 144
Patents for Watermarking Technology 146
TABLE 65 PATENT AWARDS FOR WATERMARK TECHNOLOGY BY REGION, 2014
(NO./%) 146
PATENTS RELATING TO TRACK AND TRACE PACKAGING TECHNOLOGIES 148
TABLE 66 U.S. PATENT AWARDS FOR TRACK AND TRACE PACKAGING
TECHNOLOGIES BY TYPE, 2014 (NO./%) 149
TABLE 67 U.S. PATENT AWARDS FOR TRACK AND TRACE PACKAGING
TECHNOLOGIES BY PATENT HOLDERS' REGION, 2014 (NO./%) 149
Sample of Patents for Bar Coding Technology 149
TABLE 68 U.S. PATENT AWARDS FOR BAR CODING TECHNOLOGY BY PATENT
HOLDER'S REGION, 2014 (NO./%) 149
Samples of U.S. Patents for RFID Technology 151
TABLE 69 U.S. PATENT AWARDS FOR RFID TECHNOLOGY BY PATENT HOLDERS'
REGION, 2014 (NO./%) 151
CHAPTER 8 SAFEGUARDING THE GLOBAL DRUG AND FOOD SUPPLY CHAINS 155
INTRODUCTION 155
SNAPSHOTS OF GLOBAL DRUG SAFETY 155
FDA AND DRUG SAFETY 155
Revised Requirements for Prescribing Information for Drug Products
Since 2006 155
FDA's Supply Chain Pilot Program 156
2013 DRUG SUPPLY CHAIN SECURITY ACT (DSCSA) 156
EU AND DRUG SAFETY 157
WHO TASK FORCE: IMPACT 158
RECENT INITIATIVES FOR STANDARDS IN THE GLOBAL DRUG SUPPLY
CHAIN 159
Mass Serialization 159
U.S. FDA Guidance for Numerical Identification 160
Unit of Packaging 160
Package-Level SNI for Most Prescription Drugs 161
SNI in Human- and Machine-Readable Forms 161
FDA-Recommended SNI Compatibility with International
Standards 161
Coding and Identification of Drug Products in Europe 162
GS1 U.S. Drug Supply Chain Security Act Readiness 163
GS1 Standards Case Studies 163
Abbott Laboratories 163
U.S. Centers for Disease Control and Prevention (CDC) 163
GS1 Healthcare Industry Sunrise Dates 164
GS1 Canada's Pharmacy Sector Engagement 164
U.S. DRUG PEDIGREE REQUIREMENTS: THE PRESCRIPTION DRUG
MARKETING ACT 165
FDA Risk-Based Enforcement of Pedigree Requirement, 2006 to 2007 165
Proposal to Remove Certain Requirements Related to PDMA 166
FDA Guidance for Industry on PDMA Requirements 166
SNAPSHOTS OF GLOBAL FOOD TRACEABILITY 168
CODEX ALIMENTARIUS COMMISSION 168
Codex and Food Traceability 168
Public Sector Motivation for Traceability 169
Private Sector Motivation for Traceability 169
Codex General Principles on Prepackaged Food 170
Codex Mandatory Labeling of Prepackaged Foods 170
U.S. FOOD SAFETY REGULATIONS 172
TABLE 70 FEDERAL AGENCIES RESPONSIBLE FOR U.S. FOOD SAFETY SYSTEM 172
U.S. BIOTERRORISM ACT RELATING TO FOOD PRODUCTS 173
Mandatory Recordkeeping 174
Recordkeeping Requirement for Transporters of Food 174
Recordkeeping Requirement for Non-Transporters of Food 174
Reportable Food Registry 175
Section 415 Amendments Made by Section 102 of the Food Safety
Modernization Act (FSMA) 175
FDA Food Protection Plan 175

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