Anti-counterfeiting Packaging Technologies in the U.S. Pharmaceutical and Food Industries

Published by: BCC Research

Published: Aug. 1, 2007

Table of Contents

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

CONTRIBUTIONS OF THE STUDY AND FOR WHOM

SCOPE AND FORMAT

INFORMATION SOURCES

ABOUT THE AUTHOR

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

Summary Table:

U.S. SALES OF AUTHENTICATION, AND TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, THROUGH 2012 ($ MILLIONS)

Summary Figure 1:

PROJECTED SHARES OF AUTHENTICATION, AND TRACK AND TRACE PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES, 2012 (%)

Summary Figure 2:

PROJECTED SHARES OF ANTI-COUNTERFEITING PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2012 (%)

OVERVIEW

BACKGROUND

WHAT IS A COUNTERFEIT PRODUCT?

WHAT IS A SECURE SUPPLY CHAIN?

WHAT IS PACKAGING?

What is Packaging? (Continued)

INDUSTRY CONCEPTS

LEVELS OF PACKAGING

UNIVERSAL PRODUCT CODE (UPC)

GLOBAL TRADE ITEM NUMBER (GTIN)

SYMBOLOGY

SMART LABEL AND PACKAGING

COVERT AND OVERT SECURE TECHNOLOGIES

PAPER AND ELECTRONIC DRUG PEDIGREE

AUTOMATIC IDENTIFICATION AND DATA CAPTURE

ELECTRONIC PRODUCT CODE (THE EPC)

MASS SERIALIZATION

FREQUENCY DEFINITIONS

READ RANGE

IMPORTANCE OF SECURE PACKAGING TECHNOLOGIES

FORESEEABLE DEVELOPMENTS

U.S. DRUG AND FOOD MARKETING SYSTEMS

BACKGROUND

U.S. DRUG MARKETING SYSTEM

DRUG MANUFACTURERS

Drug Manufacturing Industry Classification

Table 1 U.S. DRUG MANUFACTURING BY INDUSTRY CLASSIFICATION

Table 2 BUSINESS PATTERN OF U.S. PHARMACEUTICAL PREPARATION MANUFACTURING INDUSTRY

Brand Name Drug Manufacturers

Table 3 MAJOR BRAND NAME DRUG MANUFACTURERS RANKED BY MARKET CAPITALIZATION, FIRST QUARTER

Table 4 MAJOR DRUG MANUFACTURERS BY OWNERSHIP AND CORPORATE LOCATION

Generic Drug Manufacturers

Table 5 MAJOR GENERIC DRUG MANUFACTURERS RANKED BY MARKET CAPITALIZATION, FIRST QUARTER

The Prescription Drug Distribution Channel

Stimulating Demand for Prescription Drugs

Safeguarding the Drug Supply Chain

U.S. Sales of Pharmaceutical Preparations

Table 6 MAJOR PHARMACEUTICAL COMPANIES, BY U.S. SALES OF PHARMACEUTICAL PREPARATIONS (HUMAN USE), 2006 ($ MILLIONS)

Table 7 U.S. SALE OF PHARMACEUTICAL PREPARATIONS (HUMAN USE) BY END-USE, 2006 ($ MILLIONS)

Figure 1 U.S. SALES OF PHARMACEUTICAL PREPARATIONS BY TYPE, 2006 (%)

U.S. International Trade in Pharmaceutical Preparations

Table 8 U.S. EXPORTS OF PHARMACEUTICAL PREPARATIONS, 2006 ($ MILLIONS)

WHOLESALE DRUG DISTRIBUTORS

Wholesale Drug Industry Classification

Table 9 U.S. DRUG WHOLESALERS BY INDUSTRY CLASSIFICATION

Table 10 BUSINESS PATTERN OF U.S. WHOLESALE DRUG DISTRIBUTION INDUSTRY

U.S. Wholesale Drug Industry Structure

Table 11 MERCHANT DRUG DISTRIBUTORS RANKED BY MARKET CAPITALIZATION, FIRST QUARTER

Table 12 DRUG SALES BY THE BIG THREE MERCHANT WHOLESALE DRUG DISTRIBUTORS BY DISTRIBUTION CHANNEL, 2006 ($ MILLIONS, %)

Secondary Wholesalers

RETAIL DRUG DISTRIBUTORS

Table 13 BUSINESS PATTERN OF U.S. RETAIL DRUG DISTRIBUTION INDUSTRY

Table 14 RETAIL PRESCRIPTION DRUG SALES BY RETAIL DRUG SEGMENT, 2006 ($ MILLIONS, %)

U.S. FDA AND DRUG SAFETY

U.S. FDA and Drug Safety (Continued)

Examples of Important Drug Safety Issues

Adverse Drug Event

REGULATION OF DRUG LABELING

Revised Requirements for Prescribing Information for Drug Products-2006

U.S. FOOD MARKETING SYSTEM

FOOD PROCESSORS OR MANUFACTURERS

Food Manufacturing Industry Classification

Table 15 U.S. FOOD MANUFACTURING INDUSTRY (FOR HUMAN CONSUMPTION) BY INDUSTRY CLASSIFICATION

Industry Composition and Competition

Table 16 BUSINESS PATTERN OF U.S. FOOD MANUFACTURING INDUSTRY

Food Distribution from Manufacturer to Wholesale to Retail

U.S. Sales of Processed Foods

Table 17 U.S. SALES BY MAJOR FOOD PROCESSORS (FOOD FOR HUMAN CONSUMPTION), 2006 ($ MILLION, %)

U.S. International Trade in Processed Foods

Table 18 U.S. EXPORTS OF PROCESSED FOODS (FOR HUMAN CONSUMPTION), 2006 ($ MILLIONS, %)

Table 19 U.S. EXPORTS OF PROCESSED FOODS (FOR HUMAN CONSUMPTION) BY TYPE 2006 ($ MILLIONS, %)

Table 19 (CONTINUED)

WHOLESALE FOOD DISTRIBUTORS

Wholesale Food Industry Classification

Table 20 U.S. FOOD WHOLESALE INDUSTRY (FOR HUMAN CONSUMPTION) BY INDUSTRY CLASSIFICATION

Table 21 BUSINESS PATTERN OF U.S. WHOLESALE FOOD DISTRIBUTION INDUSTRY

Wholesale Food Industry Composition

U.S. Wholesale Food Sales

Table 22 U.S. SALES BY MAJOR FOOD WHOLESALERS, 2006 ($ MILLIONS, %)

RETAIL FOOD DISTRIBUTORS

Retail Food Industry Classification

Table 23 U.S. RETAIL FOOD INDUSTRY BY INDUSTRY CLASSIFICATION

Table 24 BUSINESS PATTERN OF U.S. RETAIL FOOD INDUSTRY

Retail Food Industry Composition

Retail Food Industry Composition (Continued)

U.S. Retail Food Sales

Table 25 U.S. SALES BY MAJOR FOOD RETAILERS, 2006 ($ MILLIONS, %)

FOOD TRACEABILITY

Private Sector Motivation for Traceability

Public Sector Motivation for Traceability

REGULATORY PROVISIONS FOR U.S. FOOD SAFETY

Table 26 FEDERAL AGENCIES RESPONSIBLE FOR U.S. FOOD SAFETY SYSTEM

U.S. BIOTERRORISM ACT RELATING TO FOOD PRODUCTS

Who Must Establish and Maintain Records?

How Is Food Defined Under the Regulation?

Recordkeeping Requirement for Transporters of Food

Recordkeeping Requirement for Non-transporter

Table 27 U.S. RECORDKEEPING REQUIREMENTS, BY TYPE OF FOOD

Recordkeeping Requirement for Packaging and Food Contact Substances

When Was the Effective Date for Compliance?

What Are the Penalties for Non-compliance?

THE CODEX ALIMENTARIUS COMMISSION (CODEX)

Codex General Principles on Prepackaged Food

Codex Mandatory Labeling of Prepackaged Foods

Codex Mandatory … (Continued)

Codex Mandatory Labeling of … (Continued)

Codex Mandatory … (Continued)

Codex Mandatory Labeling of … (Continued)

AUTHENTICATION PACKAGING TECHNOLOGIES

BACKGROUND

AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE

INKS AND DYES

Security Inks

Table 28 TYPES OF SECURITY INKS AND PRINTING METHOD

Color Shifting Ink

Holographic Inks

Thermochromatic and Photochromic Inks

Taggant Inks

Watermark Inks

Recent Innovations in Ink Technology

Evident Technologies-EviDots

Light Impressions-MagDot

Inksure-SmartInk

Parelec-Parmod VLT Conductive Inks

Pearlescent Pigments

HOLOGRAMS

Types of Holograms

Overt and Covert Holograms

Emerging Hologram Designs-Tighter Security

DNA-Encoded Holograms

3M's Security Solutions

DuPont's 3D Hologram

CFC's Dot Matrix System

Security Hologram's Integrated Label

Tesa-Scribos' Tesa Holospot-Mass Serialization Holograms

WATERMARKS

Categories of Watermark

Physical Paper Watermark

Digital Watermark

Recent Innovations in Watermarking

Incorporation of Encryption Keys

Multi-layered Watermarking

TAGGANTS

Microtrace Brand

Identif GmbH and DNA Coding

Authentix and Forensic Marking

REGULATORY PROVISIONS FOR AUTHENTICATION TECHNOLOGIES

STRUCTURE OF THE U.S. AUTHENTICATION TECHNOLOGY INDUSTRY

STRATEGIC ALLIANCES

DuPont and identif GmbH

Microtrace and Photoscribe Technologies

NAME RECOGNITION AND FULL SERVICE CAPABILITIES

U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE

INDUSTRY DATA

RECENT TRENDS

U.S. Sales of Packaging Inks and Dyes

Figure 2 U.S. SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Table 29 U.S. SALES OF PACKAGING INKS AND DYES BY END USE, 2006 ($ MILLIONS)

U.S. Sales of Holographic Packaging

Figure 3 U.S. SALES OF HOLOGRAPHIC PACKAGING TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Table 30 U.S. SALES OF HOLOGRAPHIC PACKAGING BY END USE, 2006 ($ MILLIONS)

U.S. Sales of Packaging Watermarks

Figure 4 U.S. SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Table 31 U.S. SALES OF PACKAGING WATERMARKS BY END USE, 2006 ($ MILLIONS)

U.S. Sales of Packaging Taggants

Figure 5 U.S. SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 5 (CONTINUED)

Table 32 U.S. SALES OF PACKAGING TAGGANTS BY END USE, 2006 ($ MILLIONS)

Total U.S. Sales of Authentication Packaging Technologies

Figure 6 TOTAL U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2006 (%)

Table 33 ESTIMATED U.S. SALES AND MARKET SHARES OF MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES, 2006 ($ MILLIONS, %)

MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES

Table 34 MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES,

Table 34 (CONTINUED)

MARKET DRIVERS

Role of Nanotechnology

Hybrid Security Products

Niche Markets

SALE PROJECTIONS AND MARKET SIZE

Projected U.S. Sales of Packaging Inks and Dyes

Table 35 U.S. SALES OF PACKAGING INKS AND DYES BY END USE, THROUGH 2012 ($ MILLIONS)

Projected U.S. Sales of Holographic Packaging

Table 36 U.S. SALES OF HOLOGRAPHIC PACKAGING BY END USE, THROUGH 2012 ($ MILLIONS)

Projected U.S. Sales of Packaging Watermarks

Table 37 U.S. SALES OF PACKAGING WATERMARKS BY END USE THROUGH 2012 ($ MILLIONS)

Projected U.S. Sales of Packaging Taggants

Table 38 U.S. SALES OF PACKAGING TAGGANTS BY END USE, THROUGH 2012 ($ MILLIONS)

Projected Total U.S. Sales of Authentication Packaging Technologies

Table 39 U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Figure 7 U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Figure 8 PROJECTED SHARES OF AUTHENTICATION PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2012 (%)

Figure 8 (CONTINUED)

Figure 9 PROJECTED SHARES OF AUTHENTICATION PACKAGING TECHNOLOGY SALES BY END USE, 2012 (%)

TRACK AND TRACE PACKAGING TECHNOLOGIES

BACKGROUND

TRACK AND TRACE PACKAGING TECHNOLOGIES BY TYPE

BAR CODES

Commercial Applications of Bar Codes

Bar Code Specifications

Bar Codes for Different Environments

Paper Bar Code Labels

Aluminum Bar Code Labels

Polyester Bar Code Labels

Ceramic Bar Code Labels

Bar Code Symbology

Continuous or Discrete Symbology

Two-width or Multiple-width Symbology

EAN/UPC Symbol

Symbology for Pallet and Case Labels

GS1-128 Symbol

Composite Component Symbol

Reduced Space Symbology (RSS)-Bar Code of the Future

Bar Code Printing

Bar Code Quality

RADIO FREQUENCY IDENTIFICATION (RFID) TECHNOLOGY

Commercial Applications of RFID

Focus of the Report

Definition of RFID Tags

RFID Tags for Different Uses

Components of a RFID Tag

Classification of RFID Tags

Classification of RFID Tags Based on Internal Power

Active RFID Tags

Passive RFID Tags

Read-Write Functionality

Classification Based on Radio Frequency

Low Frequency RFID Tags (LF RFID tags)

High Frequency RFID Tags (HF RFID tags)

Ultra-high Frequency RFID Tags (UHF RFID Tags)

EPCglobal and RFID Standards

Advantages of RFID Tags

RFID-tagged Pallets and Cases-First Wave RFID Tags Applications

Item-Level RFID Tagging-Next Wave RFID Tag Application

UHF RFID for Item-level Tagging

Some Notable Item-level Tagging Options

TAGSYS' Flexible Tag

Impinj RFID Solution

Integrated Technologies

Systech's TIPS Serialized Product Tracking

Data Systems International (DSI)'s dcLINK RFIDActivator

Cold Chain Compliance and RFID

U.S. REGULATORY PROVISIONS FOR TRACK-AND-TRACE TECHNOLOGIES

U.S. BAR CODE REGULATION RELATING TO DRUG PRODUCTS

What Are the Key Objectives of the Rule?

Who Is Subject to the Rule?

What Products Must Have a Bar Code?

What Information Must a Bar Code Contain?

Does the Rule Require a Specific Type of Bar Code?

Where Does the Bar Code Go?

U.S. REGULATION RELATING TO RADIO FREQUENCY DEVICES

Devices Operating Within the Band 13.110 to14.010 MHz (Section 15.225)

Devices Operating Within the Band 890 to 940 MHz (Section 15.243)

STRUCTURE OF THE U.S. TRACK-AND-TRACE TECHNOLOGY INDUSTRY

STRATEGIC ALLIANCES IN RFID INDUSTRY

3M and Texas Instruments

GlobeRanger and Ross Systems

Zebra's Key Allies

U.S. SALES OF TRACK-AND-TRACE TECHNOLOGIES BY TYPE

INDUSTRY DATA

RECENT TRENDS

U.S. Sales of Bar Codes

Figure 10 U.S. SALES OF BAR CODES TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF TRACK-AND-TRACE PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 10 (CONTINUED)

Table 40 U.S. SALES OF BAR CODES TO DRUG AND FOOD INDUSTRIES BY END USE, 2006 ($ MILLIONS)

U.S. Sales of RFID Tags

Figure 11 PERCENT SHARES OF U.S. SALES OF RFID TAGS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2006 (%)

Total U.S. Sales of Track and Trace Packaging Technologies

Table 41 TOTAL U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2006 ($ MILLIONS)

Table 42 ESTIMATED U.S. SALES AND MARKET SHARES OF MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES, 2006 ($ MILLIONS, %)

MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES

Table 43 MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES,

MARKET DRIVERS FOR BAR CODING TECHNOLOGY

MARKET DRIVERS FOR RFID TECHNOLOGY

U.S. FDA Steering

Table 44 FDA PROPOSED TIMELINE FOR RFID TECHNOLOGY ADOPTION 2004-2007

Table 44 (CONTINUED)

RFID Mandates

Wal-Mart and RFID

U.S. Department of Defense and RFID

Pilot Studies-U.S. Drug Industry

Pfizer's Viagra Study

GlaxoSmithKline's Trizivir Study

Purdue Pharma's OxyContin Study

Pilot Studies-U.S. Food Industry

Wells' Dairy-An Integrated Approach

Del Monte-RFID and Small Metallic Objects with Fluids

Beaver Street Fisheries-Voluntary Quick Start

Pilot Studies-U.S. Wholesale Distributors

McKesson and On Track

AmerisourceBergen and IBM

Cardinal Health and UHF RFID Pilot Study

RESPONDING TO CHALLENGES OF RFID TECHNOLOGY

The Future of RFID Tagging-Item-level

New Packaging Technology

Improvements in RFID Tag Manufacture

Data Management/Data Security

Privacy Concerns

Affordability

SALE PROJECTIONS AND MARKET SIZE

Projected U.S. Sales of Bar Codes

Table 45 U.S. SALES OF BAR CODES BY END USE THROUGH 2012 ($ MILLIONS)

Projected U.S. Sales of RFID Tags

Table 46 U.S. SALES OF RFID TAGS BY END USE, THROUGH 2012 ($ MILLIONS)

Projected Total U.S. Sales of Track and Trace Packaging Technologies

Table 47 TOTAL U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Figure 12 U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Figure 13 PROJECTED SHARES OF TRACK-AND-TRACE PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2012 (%)

Figure 14 U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES BY END USE, 2006-2012 (%)

TECHNOLOGY AND PATENT ANALYSIS

BACKGROUND

AUTHENTICATION PACKAGING TECHNOLOGIES

INKS AND DYES

HOLOGRAPHY

WATERMARKING

Watermarking (Continued)

TAGGANTS

TRACK AND TRACE PACKAGING TECHNOLOGIES

BAR CODING TECHNOLOGY

RFID TECHNOLOGY

PATENT ANALYSIS

PATENTS RELATING TO AUTHENTICATION PACKAGING TECHNOLOGIES

Table 48 U.S. PATENT AWARDS FOR AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE,

Table 49 U.S. PATENT AWARDS FOR AUTHENTICATION PACKAGING TECHNOLOGIES BY REGION,

Sample of Patents for Inks and Dyes

Table 50 U.S. PATENT AWARDS FOR INKS AND DYES BY REGION,

Semiconductor Package Security Features Using Thermo-chromatic Inks and Three-dimensional Identification Coding

Use of Hyper-branched Polyurethanes for Producing Printing Inks

Disazo Dyes and Ink Jet Inks Containing Them

High Conductivity Inks with Low Minimum Curing Temperatures

Yellow Dyes for Ink Jet Inks

Fragile Watermark Printed with Two Component Inks and Process

Liquid Inks Comprising a Stable Organosol

Metallized Dye-based Ink-jet Inks with Improved Ozone Fastness

Phthalocyanine Based Inks with Absorption Maxima in the Near Infrared and Visible Spectrum

Solubilized Dyes for Inks

Phase Change Inks

Optically Variable Water-based Inks

Sample of Patents for Holographic Technology

Table 51 U.S. PATENT AWARDS FOR HOLOGRAPHY BY REGION,

Apparatus and Method for Fabricating Hologram

Color Hologram Display and its Fabrication Process

Method for Generating a Hologram on a Disc Surface

Hologram Transfer Film

Recording Medium for Hologram, Hologram Recording Apparatus, and Hologram Recording Method

Double Hologram

Hologram Preparing Method

Hologram Laminate and Hologram Label

Hologram Plate and its Fabrication Process

Hologram Apparatus Capable of Detecting and Correcting Distortion of Hologram Image

Volume Hologram

Patents for Watermarking Technology

Table 52 U.S. PATENT AWARDS FOR WATERMARK TECHNOLOGY BY REGION,

Watermark Detection

Protecting Images with an Image Watermark

Digital Watermark Embedding Method, Digital Watermark Embedding Apparatus, Digital Watermark Detecting Method, and Digital Watermark Detecting Apparatus

Watermark Systems and Methods

Digital Watermark Embedding and Decoding Using Encryption Keys

Method for Inserting a Watermark into an Image

Proprietary Watermark System for Secure Digital Media and Content Distribution

User Control and Activation of Watermark Enabled Objects

Low Visibility Watermark Using Time Decay Fluorescence

Applying Informed Coding, Informed Embedding and Perceptual Shaping to Design a Robust, High-capacity Watermark

Sample of Patents for Taggant Technology

Magnetic Taggant System

Fragmented Taggant Coding System and Method with Application to Ammunition Tagging

PATENTS RELATING TO TRACK AND TRACE PACKAGING TECHNOLOGIES

Table 53 U.S. PATENT AWARDS FOR TRACK AND TRACE PACKAGING TECHNOLOGIES BY TYPE,

Table 54 U.S. PATENT AWARDS FOR TRACK AND TRACE PACKAGING TECHNOLOGIES BY REGION,

Sample of Patents for Bar Coding Technology

Table 55 U.S. PATENT AWARDS FOR BAR CODING TECHNOLOGY BY REGION,

Automated Bar Code Label Canceller and Method of Cancelling Bar Codes

Method and Apparatus for Capturing and Decoding an Image of a Remotely Located Bar Code

Embedding Bar Code Data in an Auxiliary Field of an Image File

Digitizing Bar Code Symbol Data

Methods and Apparatus for Forming Bar Code Characters

Multi-format Bar Code Reader

Direct Thermal Bar Code Printer

Method and Apparatus for Creating a Bar Code

Method and Apparatus for Bar Code Data Interchange

Add-on Capture Rate in a Bar code Scanning System

Authenticatable Graphic Bar Codes

System and Method for Fast Binarization of Bar Codes in the Presence of Noise

Color Calibration for Bar Codes

Bar Code Detection System

Bar Code Having Enhanced Visual Quality and Systems and Methods Thereof

Bar Code Reader for Automatically Detecting the Presence of a Bar Code Using Laser Flicker

Method and Apparatus for Encoding and Decoding Bar Codes with Primary and Secondary Information and Method of Using Such Bar Codes

Patents for RFID Technology

Table 56 U.S. PATENT AWARDS FOR RFID TECHNOLOGY BY REGION,

RFID Receiver Apparatus and Method

Method of Determining Performance of RFID Devices

Packaging Incorporating Volume-measurement Capability Using RFID Tags

Variable Frequency Radio Frequency Identification (RFID) Tags

RFID Tag and Its Manufacturing Method

Wireless Ad-hoc RFID Tracking System

System for Multi-standard RFID Tags

Method and Apparatus for Configuring the Read-range of an RFID Label or Tag

Article Identification and Tracking Using Electronic Shadows Created by RFID Tags

RFID Material Tracking Method and Apparatus

RFID Manufacturing Concepts

Method to Address Security and Privacy Issue of the Use of RFID Systems to Track Consumer Products

GLOBAL DRUG COUNTERFEITING

BACKGROUND

SOME PERSPECTIVES ON GLOBAL COUNTERFEITING

THE U.S. FDA'S PERSPECTIVE ON COUNTERFEITING

THE U.S. CENTER FOR MEDICINES IN THE PUBLIC INTEREST'S (CMPI) PERSPECTIVE ON DRUG COUNTERFEITING

THE WORLD HEALTH ORGANIZATION'S (WHO) PERSPECTIVE ON GLOBAL DRUG COUNTERFEITING

THE EUROPEAN UNION (EU) ON DRUG COUNTERFEITING

THE ANTI-COUNTERFEITING GROUP (ACG)

FORMS OF COUNTERFEITING

False Labeling or Packaging

Illegal Diversion

Ghost Manufacturer

COMBATING DRUG COUNTERFEITING IN THE U.S.

BACKGROUND

THE PRESCRIPTION DRUG MARKETING ACT (PDMA) AND THE PEDIGREE REQUIREMENT

FDA COUNTERFEIT DRUG TASK FORCE

Initial FDA Task Force Report-2004

FDA Task Force Update-2005

FDA Task Force Update-2006

Moving Forward with the PDMA Pedigree Requirement

FDA Compliance Policy Guide (CPG)-2006

FDA Risk-based Enforcement of Pedigree Requirement, 2006 to

Table 57 FDA RISK-BASED PEDIGREE ENFORCEMENT, 2006-2007 HIGH PRIORITY DRUGS BY RISK FACTOR-HIGH VALUE DRUGS

Table 58 FDA RISK-BASED PEDIGREE ENFORCEMENT, 2006-2007 HIGH PRIORITY DRUGS BY RISK FACTOR-PRIOR INDICATORS

FDA Guidance for Industry-PDMA Requirements

FDA Guidance for Industry-…(Continued)

FDA Guidance for Industry-…(Continued)

FDA Guidance for Industry-…(Continued)

Counterfeit Alert Network (CAN)

U.S. FEDERAL GOVERNMENT LEGISLATION

MODEL RULES FOR WHOLESALE DISTRIBUTOR LICENSING

INITIATIVES AT THE STATE LEVEL

THE FLORIDA DRUG PEDIGREE LAW

The Florida Drug …(Continued)

The Florida Drug …(Continued)

THE CALIFORNIA STATE PEDIGREE LAW

GLOBAL ANTI-COUNTERFEITING MEASURES

US-EU ANTI-COUNTERFEITING COLLABORATION

WHO'S ACTION TO ADDRESS COUNTERFEIT MEDICINES

WHO Support and Guidance

WHO Counterfeit Drug Tracking System-RAS

WHO Task Force-IMPACT

INTERPOL IIPCAG INITIATIVE

COMPANY PROFILES

BACKGROUND

MAJOR MANUFACTURERS OF AUTHENTICATION PACKAGING TECHNOLOGIES

3D AG

3M

APPLIED DNA SCIENCES

ATLAS TELECOM

AUTHENTIX

CFC INTERNATIONAL, INC.

DIGIMARC CORPORATION

DUPONT AUTHENTICATION

EVEREST HOLOVISIONS

EVIDENT TECHNOLOGIES

HOLOMEX

HOLOPOINT, LTD

HOLOSTIK

IDENTIF TECHNOLOGIES

INKSURE TECHNOLOGIES

INTERNATIONAL INK COMPANY

LIGHT IMPRESSIONS GROUP

MICROTRACE SOLUTIONS, LLC

NEW JERSEY PACKAGING

NOVAVISION, INC

PACIFIC HOLOGRAPHICS

PARELEC

SECURITY HOLOGRAM, INC.

SUN CHEMICAL PACKAGING

TESA SCRIBOS GMBH

XSYS PRINT SOLUTIONS (FLINT GROUP)

MAJOR MANUFACTURERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES

ALIEN TECHNOLOGY

AVERY DENNISON RFID

DATA SYSTEM INTERNATIONAL (DSI)

DATAMAX CORPORATION

DOMINO ISG

GLOBERANGER CORPORATION

IMPINJ

INTERMEC TECHNOLOGIES

MONARCH (PAXAR)

OMRON RFID

PRECISIA, LLC (FLINT GROUP)

PRINTRONIX

SATO AMERICA, INC.

SAVI TECHNOLOGY, INC.

SYSTECH INTERNATIONAL

SYMBOL TECHNOLOGIES (MOTOROLA)

TAGSYS RFID

TEXAS INSTRUMENTS RFID SYSTEMS

ZEBRA

LIST OF TABLES

Summary Table:

U.S. SALES OF AUTHENTICATION, AND TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES, THROUGH 2012 ($ MILLIONS)

Table 1 U.S. DRUG MANUFACTURING BY INDUSTRY CLASSIFICATION

Table 2 BUSINESS PATTERN OF U.S. PHARMACEUTICAL PREPARATION MANUFACTURING INDUSTRY

Table 3 MAJOR BRAND NAME DRUG MANUFACTURERS RANKED BY MARKET CAPITALIZATION, FIRST QUARTER 2007

Table 4 MAJOR DRUG MANUFACTURERS BY OWNERSHIP AND CORPORATE LOCATION

Table 5 MAJOR GENERIC DRUG MANUFACTURERS RANKED BY MARKET CAPITALIZATION, FIRST QUARTER 2007

Table 6 MAJOR PHARMACEUTICAL COMPANIES, BY U.S. SALES OF PHARMACEUTICAL PREPARATIONS (HUMAN USE), 2006 ($ MILLIONS)

Table 7 U.S. SALE OF PHARMACEUTICAL PREPARATIONS (HUMAN USE) BY END-USE, 2006 ($ MILLIONS)

Table 8 U.S. EXPORTS OF PHARMACEUTICAL PREPARATIONS, 2006 ($ MILLIONS)

Table 9 U.S. DRUG WHOLESALERS BY INDUSTRY CLASSIFICATION

Table 10 BUSINESS PATTERN OF U.S. WHOLESALE DRUG DISTRIBUTION INDUSTRY

Table 11 MERCHANT DRUG DISTRIBUTORS RANKED BY MARKET CAPITALIZATION, FIRST QUARTER 2007

Table 12 DRUG SALES BY THE BIG THREE MERCHANT WHOLESALE DRUG DISTRIBUTORS BY DISTRIBUTION CHANNEL, 2006 ($ MILLIONS, %)

Table 13 BUSINESS PATTERN OF U.S. RETAIL DRUG DISTRIBUTION INDUSTRY

Table 14 RETAIL PRESCRIPTION DRUG SALES BY RETAIL DRUG SEGMENT, 2006 ($ MILLIONS, %)

Table 15 U.S. FOOD MANUFACTURING INDUSTRY (FOR HUMAN CONSUMPTION) BY INDUSTRY CLASSIFICATION

Table 16 BUSINESS PATTERN OF U.S. FOOD MANUFACTURING INDUSTRY

Table 17 U.S. SALES BY MAJOR FOOD PROCESSORS (FOOD FOR HUMAN CONSUMPTION), 2006 ($ MILLION, %)

Table 18 U.S. EXPORTS OF PROCESSED FOODS (FOR HUMAN CONSUMPTION), 2006 ($ MILLIONS, %)

Table 19 U.S. EXPORTS OF PROCESSED FOODS (FOR HUMAN CONSUMPTION) BY TYPE 2006 ($ MILLIONS, %)

Table 20 U.S. FOOD WHOLESALE INDUSTRY (FOR HUMAN CONSUMPTION) BY INDUSTRY CLASSIFICATION

Table 21 BUSINESS PATTERN OF U.S. WHOLESALE FOOD DISTRIBUTION INDUSTRY

Table 22 U.S. SALES BY MAJOR FOOD WHOLESALERS, 2006 ($ MILLIONS, %)

Table 23 U.S. RETAIL FOOD INDUSTRY BY INDUSTRY CLASSIFICATION

Table 24 BUSINESS PATTERN OF U.S. RETAIL FOOD INDUSTRY

Table 25 U.S. SALES BY MAJOR FOOD RETAILERS, 2006 ($ MILLIONS, %)

Table 26 FEDERAL AGENCIES RESPONSIBLE FOR U.S. FOOD SAFETY SYSTEM

Table 27 U.S. RECORDKEEPING REQUIREMENTS, BY TYPE OF FOOD

Table 28 TYPES OF SECURITY INKS AND PRINTING METHOD

Table 29 U.S. SALES OF PACKAGING INKS AND DYES BY END USE, 2006 ($ MILLIONS)

Table 30 U.S. SALES OF HOLOGRAPHIC PACKAGING BY END USE, 2006 ($ MILLIONS)

Table 31 U.S. SALES OF PACKAGING WATERMARKS BY END USE, 2006 ($ MILLIONS)

Table 32 U.S. SALES OF PACKAGING TAGGANTS BY END USE, 2006 ($ MILLIONS)

Table 33 ESTIMATED U.S. SALES AND MARKET SHARES OF MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES, 2006 ($ MILLIONS, %)

Table 34 MAJOR SUPPLIERS OF AUTHENTICATION PACKAGING TECHNOLOGIES, 2006

Table 35 U.S. SALES OF PACKAGING INKS AND DYES BY END USE, THROUGH 2012 ($ MILLIONS)

Table 36 U.S. SALES OF HOLOGRAPHIC PACKAGING BY END USE, THROUGH 2012 ($ MILLIONS)

Table 37 U.S. SALES OF PACKAGING WATERMARKS BY END USE THROUGH 2012 ($ MILLIONS)

Table 38 U.S. SALES OF PACKAGING TAGGANTS BY END USE, THROUGH 2012 ($ MILLIONS)

Table 39 U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Table 40 U.S. SALES OF BAR CODES TO DRUG AND FOOD INDUSTRIES BY END USE, 2006 ($ MILLIONS)

Table 41 TOTAL U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2006 ($ MILLIONS)

Table 42 ESTIMATED U.S. SALES AND MARKET SHARES OF MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES, 2006 ($ MILLIONS, %)

Table 43 MAJOR SUPPLIERS OF TRACK AND TRACE PACKAGING TECHNOLOGIES, 2006

Table 44 FDA PROPOSED TIMELINE FOR RFID TECHNOLOGY ADOPTION 2004-2007

Table 45 U.S. SALES OF BAR CODES BY END USE THROUGH 2012 ($ MILLIONS)

Table 46 U.S. SALES OF RFID TAGS BY END USE, THROUGH 2012 ($ MILLIONS)

Table 47 TOTAL U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Table 48 U.S. PATENT AWARDS FOR AUTHENTICATION PACKAGING TECHNOLOGIES BY TYPE, 2006

Table 49 U.S. PATENT AWARDS FOR AUTHENTICATION PACKAGING TECHNOLOGIES BY REGION, 2006

Table 50 U.S. PATENT AWARDS FOR INKS AND DYES BY REGION, 2006

Table 51 U.S. PATENT AWARDS FOR HOLOGRAPHY BY REGION, 2006

Table 52 U.S. PATENT AWARDS FOR WATERMARK TECHNOLOGY BY REGION, 2006

Table 53 U.S. PATENT AWARDS FOR TRACK AND TRACE PACKAGING TECHNOLOGIES BY TYPE, 2006

Table 54 U.S. PATENT AWARDS FOR TRACK AND TRACE PACKAGING TECHNOLOGIES BY REGION, 2006

Table 55 U.S. PATENT AWARDS FOR BAR CODING TECHNOLOGY BY REGION, 2006

Table 56 U.S. PATENT AWARDS FOR RFID TECHNOLOGY BY REGION, 2006

Table 57 FDA RISK-BASED PEDIGREE ENFORCEMENT, 2006-2007 HIGH PRIORITY DRUGS BY RISK FACTOR-HIGH VALUE DRUGS

Table 58 FDA RISK-BASED PEDIGREE ENFORCEMENT, 2006-2007 HIGH PRIORITY DRUGS BY RISK FACTOR-PRIOR INDICATORS

LIST OF FIGURES

Summary Figure 1:

PROJECTED SHARES OF AUTHENTICATION, AND TRACK AND TRACE PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES, 2012 (%)

Summary Figure 2:

PROJECTED SHARES OF ANTI-COUNTERFEITING PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2012 (%)

Figure 1 U.S. SALES OF PHARMACEUTICAL PREPARATIONS BY TYPE, 2006 (%)

Figure 2 U.S. SALES OF PACKAGING INKS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 3 U.S. SALES OF HOLOGRAPHIC PACKAGING TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 4 U.S. SALES OF PACKAGING WATERMARKS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 5 U.S. SALES OF PACKAGING TAGGANTS TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF AUTHENTICATION PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 6 TOTAL U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2006 (%)

Figure 7 U.S. SALES OF AUTHENTICATION PACKAGING TECHNOLOGIES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Figure 8 PROJECTED SHARES OF AUTHENTICATION PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2012 (%)

Figure 9 PROJECTED SHARES OF AUTHENTICATION PACKAGING TECHNOLOGY SALES BY END USE, 2012 (%)

Figure 10 U.S. SALES OF BAR CODES TO THE DRUG AND FOOD INDUSTRIES AS A SHARE OF TRACK-AND-TRACE PACKAGING TECHNOLOGY SALES, 2006 (%)

Figure 11 PERCENT SHARES OF U.S. SALES OF RFID TAGS TO THE DRUG AND FOOD INDUSTRIES BY END USE, 2006 (%)

Figure 12 U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES TO DRUG AND FOOD INDUSTRIES BY TYPE, THROUGH 2012 ($ MILLIONS)

Figure 13 PROJECTED SHARES OF TRACK-AND-TRACE PACKAGING TECHNOLOGY SALES TO THE DRUG AND FOOD INDUSTRIES BY TYPE, 2012 (%)

Figure 14 U.S. SALES OF TRACK AND TRACE PACKAGING TECHNOLOGIES BY END USE, 2006-2012 (%)

Abstract

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