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Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits

GBI Research
Published Date » 2012-06-25
No. Of Pages » 60

GBI Research, the leading business intelligence provider, has released its new report Pharmaceutical Supply Chain in the US - Advances in RFID and ePedigree Systems to Limit Drug Counterfeits. It analyzes the overall Supply Chain Management (SCM) scenario and provides profiles of the leading participants in the pharmaceutical supply chain in the US. The report is built using data and information sourced from proprietary databases, as well as primary and secondary research and in-house analysis by GBI Researchs team of industry experts.

The top three wholesalers in the US, AmerisourceBergen Corporation, Cardinal Health and McKesson Corporation, accounted for 86.7% of the overall US pharmaceutical market in 2011 and combined revenue of $295.2 billion. Various supply chain models are followed across the pharmaceutical industry, such as traditional wholesaler models, limited distribution models and direct distribution models. Pharmaceutical companies are now focusing on supply chains as a value-adding process rather than viewing them as a money drain, which was the scenario in the past. Managing a supply chain is a complicated task, as there are a number of issues that can affect performance and disrupt product and information flow.

Counterfeits have emerged as the greatest threat to the smooth functioning of the supply chain in the US. The recent case of fake Avastin entering the legitimate supply chain has raised concerns over administrative abilities, and the Food and Drug Administration (FDA) has taken numerous steps to track and trace counterfeits. The state of California has implemented the E-pedigree model and announced implementation deadlines for wholesalers, manufacturers and pharmacies. In 2009, 1,742 drugs were recalled by FDA, for a range of reasons such as quality of raw materials, defective labeling, packaging issues and contaminated products. Over-the-counter (OTC) and generic products account for the most recalls.

Scope
  • Segmentation of the pharmaceutical supply industry in terms of major components such as manufacturer, wholesaler and pharmacy
  • Key issues facing the pharmaceutical supply chain in the US
  • Analysis of strategies adopted by pharmaceutical manufacturers and wholesalers to remain competitive
  • Key parameters which are considered for rejuvenating the existing supply chain
  • Profiles of key pharmaceutical supply chain management companies
  • Emerging technologies being developed for anti-counterfeit operations.
Reasons to buy
  • Understand the existing market scenario
  • Analyze the requirements for regulatory compliance for pharmaceutical supply chain management
  • Pinpoint key uncertainties facing the pharmaceutical supply chain in the US
  • Develop strategies for implementing lean technology in the pharmaceutical supply chain
  • Develop risk mitigation strategies
Table of Contents

1 Table of Contents
1.1 List of Figures
1.2 List of Tables

2 Executive Summary
2.1 Global Pharmaceutical Companies Changing View of Supply Chain as a Major Driver to Improve Margins and Increase Revenue Growth
2.2 Anti-counterfeiting Technologies such as Radio Frequency Identification to Limit the Introduction of Fake Drugs into the Supply Chain
2.3 Cold-chain Storage to Play Critical Role in the Future Pharmaceutical Supply Chain

3 Pharmaceutical Supply Chain in the US – Introduction
3.1 Report Guidance

4 Pharmaceutical Supply Chain in the US – Introductory Issues
4.1 Evolution of Supply Chain Management
4.2 The Pharmaceutical Supply Chain – Operational Issues
4.2.1 Demand Management with Adequate Forecast Tools to Reduce Inventory Levels
4.2.2 Optimum Inventory Levels Help to Maintain Flow of Working Capital
4.2.3 Supply Chain Performance Visibility in Pharmaceutical Supply Chain Management
4.3 Key Uncertainties in Production Planning and Scheduling
4.3.1 Forecasting Managers have to Deal with the Uncertainty in Demand for Existing Drugs
4.3.2 Uncertainties Experienced by Pipeline Drugs
4.4 Different Supply Chains in Pharmaceutical Industry
4.5 Reverse Logistics Evolving as a Significant Part of the Pharmaceutical Supply Chain
4.6 High Costs Due to Drug Callbacks
4.6.1 Recall Management could Prove Effective if Visibility in the Supply Chain Increases
4.7 Risk Management in Pharmaceutical Supply Chain Management
4.8 Radio Frequency Identification Technology to Play an Important Role in Improving Performance Visibility of the Pharmaceutical Supply Chain

5 Pharmaceutical Supply Chain in the US – Supply Chain Models
5.1 Pharmaceutical Supply Chain Models
5.1.1 Traditional Wholesaler Model
5.1.2 Limited Distribution Model or Specialty Pharmacy Distribution Model
5.1.3 Direct Distribution Model
5.2 Steps to Rationalize Existing Supply Chain
5.3 Cold-chain Storages to Play Critical Role in Supply Chain Management
5.4 Case Study - Implementing Lean Six Sigma to Revamp Pharmaceutical Company Performance

6 Pharmaceutical Supply Chain in the US – Securing a Supply Chain
6.1 Food and Drug Administration’s Role in Addressing Counterfeiting Issues
6.1.1 Case Study: How Counterfeits were Identified at the Border
6.1.2 Case Study: Wholesale Distributor Involved in Diversion Schemes
6.1.3 Case Study: Pharmacies and Pharmacist Involved in Drug Diversion of Samples
6.2 Counterfeiting
6.2.1 Case Study: Fake Cases of Cancer Drug Avastin Raises Issues of Secured Supply Chain Management
6.3 New Technologies Affecting the Performance of the Supply Chain
6.3.1 E-pedigree Track-and-trace Systems
6.3.2 California E-pedigree Implementation Model
6.3.3 Automation of Reports and Consolidated Orders System Reporting
6.3.4 Unique Device Identification for Improving the Traceability of Medical Devices
6.3.5 Radio Frequency Identification, Electronic Product Codes and Physical Mark up Language a Tested Anti-counterfeit Technology
6.4 Anti-counterfeiting Technology Classification
6.5 Overt Technology
6.5.1 Holograms/Diffractive Optical Elements
6.5.2 Optical Variable Device
6.5.3 Sequential Product Numbering
6.5.4 Security Graphics
6.5.5 Product Marking
6.5.6 Color-shifting Security Inks and Films
6.5.7 Film Wrappers
6.5.8 Shrink Seals and Bands
6.5.9 Breakable Caps
6.5.10 Sealed Tubes
6.6 Covet Technologies
6.6.1 Invisible Printing and Watermarks
6.6.2 Hidden Marks and Printing
6.7 Forensic Markers
6.7.1 Chemical Taggants
6.7.2 DNA Fragments
6.7.3 Micro-particle Taggants (Nanotaggants)
6.7.4 Isotope Ratio
6.8 Mass Serialization/Track-and-trace Technologies
6.8.2 Anti-counterfeiting Technologies and their Impact on Pharmaceutical Companies
6.9 Case Study: Sproxil to Benefit from Mobile Technology
6.10 Top Anti-counterfeiting Companies and their Innovative Technologies
6.10.1 Reed-Lane, Inc
6.10.2 Cortegra Group Inc
6.10.3 Nanolnk Inc
6.10.4 TraceLink Inc
6.10.5 Axway
6.10.6 Innovatum Inc
6.10.7 Vetter Pharma International GmbH

7 Pharmaceutical Supply Chain in the US – Legislative Specifications of Pharmaceutical Traceability Enhancement Code Act
7.1 Title l: Immediate Provisions to Enhance Patient Safety
7.2 Title ll: Development of RxTEC System
7.3 Title lll: Enhanced FDA and State Authorities
7.4 Title lV: RxTEC System Assessment
7.5 Title V: Uniform National Policy

8 Pharmaceutical Supply Chain in the US – Wholesale Sector
8.1 Market Leaders in the Wholesale Sector
8.2 Trends Seen Across the US Wholesale Industry
8.3 Prescription Drug Marketing Act of 1987
8.4 Market Share of Wholesalers
8.5 McKesson
8.5.1 Company Profile
8.6 AmerisourceBergen
8.6.1 Company Profile
8.7 Cardinal Health Inc
8.7.1 Company Profile

9 Pharmaceutical Supply Chain in the US – Pharmacy Sector
9.1 The US Pharmacy Sector
9.2 Market Share of Different Channels in the US Pharmaceutical Supply Chain
9.3 Market Share of Top Three Chain Drug Stores in the US

10 Pharmaceutical Supply Chain in the US – Appendix
10.1 Market Definitions
10.2 Abbreviations
10.3 Bibliography
10.4 Research Methodology
10.4.1 Coverage
10.4.2 Secondary Research
10.4.3 Primary Research
10.4.4 Expert Panel Validation
10.5 Contact Us
10.6 Disclaimer

List of Tables


Table 1: Pharmaceutical Supply Chain in the US, Storage and Handling Regimes of Blockbuster Products, 2012 25
Table 2: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Overt Features, 2012 36
Table 3: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Covert Features, 2012 37
Table 4: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Forensic Markers 38
Table 5: Pharmaceutical Supply Chain in the US, Advantages and Disadvantages of Track-and-trace Technologies, 2012 39

List of Figures


Figure 1: Pharmaceutical Supply Chain in the US, Evolution of Supply Chain Management, 2011 11
Figure 2: Pharmaceutical Supply Chain in the US, Implementation of Lean Supply Chain Management, 2011 12
Figure 3: Pharmaceutical Supply Chain in the US, Key Uncertainties Faced by Manufacturers, 2012 14
Figure 4: Pharmaceutical Supply Chain in the US, Number of Drug Callbacks, 2006-2011 16
Figure 5: Pharmaceutical Supply Chain in the US, Impact of Vioxx Withdrawal on Mercks Share Prices, January 2003December 2005 17
Figure 6: Pharmaceutical Supply Chain in the US, Risk Management Benefits, 2012 18
Figure 7: Pharmaceutical Supply Chain in the US, Risk Evaluation Procedure, 2012 19
Figure 8: Pharmaceutical Supply Chain in the US, Working of Radio Frequency Identification Technology, 2012 20
Figure 9: Pharmaceutical Supply Chain in the US, Structure of a Traditional Distribution Channel, 2012 21
Figure 10: Pharmaceutical Supply Chain in the US, Structure of a Limited Distribution Channel, 2012 22
Figure 11: Pharmaceutical Supply Chain in the US, Structure of a Direct-to-pharmacy Distribution Channel, 2011 23
Figure 12: Pharmaceutical Supply Chain in the US, Cold-chain Storage Forecast, $bn, 2011-2016 26
Figure 13: Pharmaceutical Supply Chain in the US, Counterfeit Drugs Identified, 2011 27
Figure 14: Pharmaceutical Supply Chain in the US, Wholesale Distributor Involved in Diversion Schemes, 2011 28
Figure 15: Pharmaceutical Supply Chain in the US, Pharmacies and Pharmacist Involved in Drug Diversion of Samples, 2011 29
Figure 16: Pharmaceutical Supply Chain in the US, Types of Trades Associated with Suspected Counterfeits, (%), 2011 30
Figure 17: Pharmaceutical Supply Chain in the US, Counterfeit Avastin Case Study, 2012 31
Figure 18: Pharmaceutical Supply Chain in the US, E-pedigree in a Pharmaceutical Supply Chain, 2012 32
Figure 19: Pharmaceutical Supply Chain in the US, Paper-based Pedigree in a Pharmaceutical Supply Chain, 2011 33
Figure 20: Pharmaceutical Supply Chain in the US, California E-pedigree Implementation Model, The US, 2012 34
Figure 21: Pharmaceutical Supply Chain in the US, Classification of Anti-counterfeit Technologies, 2012 35
Figure 22: Pharmaceutical Supply Chain in the US, Platform for Protecting Pharmaceutical Value Chain, 2012 40
Figure 23: Pharmaceutical Supply Chain in the US, Company Overview, Reed-Lane Inc, 2012 41
Figure 24: Pharmaceutical Supply Chain in the US, Company Overview, Cortegra Group Inc, 2012 42
Figure 25: Pharmaceutical Supply Chain in the US, Company Overview, NanoInk Inc, 2012 43
Figure 26: Pharmaceutical Supply Chain in the US, Company Overview, TraceLink, 2012 44
Figure 27: Pharmaceutical Supply Chain in the US, Company Overview, Axway, 2012 45
Figure 28: Pharmaceutical Supply Chain in the US, Company Overview, Innovatum Inc, 2012 46
Figure 29: Pharmaceutical Supply Chain in the US, Company Overview, Vetter Pharma International GmbH, 2012 47
Figure 30: Pharmaceutical Supply Chain in the US, Market Share of Wholesalers, (%), 2011 50
Figure 31: Pharmaceutical Supply Chain in the US, Company Profile, McKesson, 2011 51
Figure 32: Pharmaceutical Supply Chain in the US, Company Profile, AmerisourceBergen, 2011 52
Figure 33: Pharmaceutical Supply Chain in the US, Company Profile, Cardinal Health Inc, 2011 53
Figure 34: Pharmaceutical Supply Chain in the US, Market Share of Different Prescription-dispensing Channels, (%), 2011 54
Figure 35: Pharmaceutical Supply Chain in the US, Market Share of Top Three Chain Drug Stores, 2012 55

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