Chapter 1 Executive Summary
1.1 Continual Low Profit Margins is the Major Problem for the W&D Industry
1.2 Parallel Trade Will Not Go Away
1.3 Canada and US Drug Reimportation Will Not Develop Further
1.4 Direct-to-Pharmacy Distribution Will Cut Out the ‘Middle Man’
1.5 Drug Counterfeiting is a Problem for Western Markets but can be Controlled
1.6 Internet drugs (Mail Order and On-line Pharmacies) will Show Increasing Growth
1.7 The Increasing Genericisation of all Drug Markets Remains a Threat to the W&D Industry
1.8 Aims, Scope and Format of the Report
Chapter 2 Introduction
2.1 The Wholesale and Distribution Industry – Overview
2.1.1 Drug Wholesalers - More Than Just a Middleman
2.1.2 Roles and Functions of the W&D Companies
2.1.3 Distinctive Features and Difficulties Facing the Pharmaceutical UK Wholesale Market
2.2 There are Four Different Types of Wholesaler
2.2.1 Full-line wholesalers
2.2.2 Short-line wholesalers
2.2.3 Pre-wholesaling is Predominantly a European Experience
2.2.4 Secondary Wholesaler's and their Effect on the Pharmaceutical Industry
2.3 The Supply Chain: The Importance of an Efficient Supply Chain for Competitive Operations Within the Pharmaceutical Industry
2.3.1 The Internet is Rapidly Becoming an Integral Part of the W&D Supply Chain
2.4 The Big Three Dominates the US W&D Industry
2.5 The Top Ten Countries in the Pharmaceutical Industry – Retail & Hospital Sector Breakdown
Chapter 3 Forces Affecting the Pharmaceutical Wholesale-Distribution Industry
3.1 SWOT analysis
3.1.1 Market Drivers
3.1.2 Market Restraints
3.2 High Demand for Pharmaceutical Products Will Drive the Wholesale-Distribution Industry
3.3 The Efficiency of W&D Operations Helps to Keep Drug Prices Low
3.4 Fee-For-Service is Becoming Predominant in the US But Will Not Affect European W&D
3.5 Globalisation Will Provide an Opportunity to Expand the Wholesale-Distribution Industry – However it Could Increase More Parallel Trading and Drug Counterfeits
3.6 Continual Low Profit Margins is the Major Problem for the W&D Industry
3.6.1 The Increasing Genericisation of all Drug Markets Remains a Threat to the W&D Industry Profit Margin
3.7 The European W&D Industry is Hampered by Strict Drug Price Controls
3.8 Drug Counterfeiting is a Problem for Western Markets but Can be Controlled
3.9 Would Market Harmonisation in the EU Eliminate the Practice of Parallel Trade?
3.9.1 The Exhaustion of IPR Allows for the Importation of Drugs
3.10 Direct-to-consumer distribution channels will diminish the role of wholesalers
3.11 Structural Changes Within the European Pharmaceutical Markets Affecting the Wholesale & Distribution Industry
3.12 W&D and Price Regulation in India
3.13 Antimicrobial Drug Supply and Distribution in the Developing Countries
Chapter 4 Parallel Trade in the W&D Industry
4.1 What is Parallel Trade and Why Does it Exist?
4.2 Pricing in the Pharmaceutical Industry
4.2.1 Factors that Influence Pricing
4.2.2 Price Differentials
4.2.3 Pricing is Not the Only Factor in Determining the Parallel Trade Potential for a Drug
4.2.4 The Repackaging of Pharmaceuticals is an Important Aspect of Parallel Trade
4.3 Exhaustion of Rights
4.3.1 National Exhaustion
4.3.2 Regional Exhaustion
4.3.3 International Exhaustion
4.3.4 Intellectual Property Rights
4.4 Parallel Trade is Predominantly a European Activity
4.5 The UK is the Largest Importer of Parallel Traded Drugs
4.5.1 The Method of Parallel Trade Importing into the UK
4.5.2 The Regulation of UK Parallel Trade
4.6 The Arguments For and Against Parallel Trade
4.6.1 The Drug Company's Arguments Against Parallel Trade are Weak
4.7 EU Drug Price Harmonisation is Unlikely
Chapter 5 Drug Counterfeits – A Major Problem in the W&D Industry
5.1 The Legal Definitions of a Counterfeit Drug
5.1.1 Grouping Counterfeits
5.2 Prevalence of Counterfeiting
5.3 The Economic and Healthcare Cost of Drug Counterfeiting
5.3.1 The Economic Cost of Drug Counterfeiting
5.3.2 The Health Cost of Drug Counterfeiting
5.3.3 The Most Commonly Counterfeited Drugs by Country Region
5.3.4 Counterfeit Drugs Thrive Through Lack of Adequate and Enforceable Legislation
5.4 Counterfeit Drugs is Not Just a Developing World Problem
5.5 Counterfeit Lipitor Dispersed Through the UK Supply Chain
5.6 Global Reports of Counterfeit Medicines
5.7 Moving Counterfeit Drugs into the Supply Chain
5.7.1 The Distribution Network as the Place of Entry for Counterfeit Drugs
5.8 The Detrimental Effects of Counterfeit Drugs on Business Development
5.8.1 The Effect of Counterfeit Drugs on Consumers
5.8.2 The Effect of Counterfeit Drugs on Drug Manufacturers
5.8.3 The Effect of Counterfeit Drugs on Health Care Providers
5.8.4 The Effect of Counterfeit Drugs on Governments
5.9 The Four Types of Counterfeit Drugs
5.10 The Complexity of Wholesale and Distribution Routes Aids the Counterfeiter
5.11 The Regulatory Strategies in Combating Drug Counterfeiting
5.12 The Technical Strategies in Combating Counterfeit Drugs
5.12.1 Holograms as Anti-Counterfeiting Devices
5.12.2 Security Inks as Anti-Counterfeit Devices
5.12.3 Micro Tags as Anti-Counterfeit Devices
5.12.4 Radio Frequency Identification Tags (RFID) as Anti-Counterfeit Devices
Chapter 6 Fee-For-Service Pricing Model in the Pharmaceutical Wholesaling Industry
6.1 What is the Fee-For-Service Pricing Model?
6.1.1 Why Switch to This Pricing Model?
6.2 Advantages and Disadvantages for the Fee-For-Service Pricing Strategy
6.3 Drug Manufacturers Will Want an Incentive to Shift to Fee-For-Service
6.4 Fee-For-Service is a Risk for the W&D Industry
6.5 The US Big Three W&D Companies Have Prepared for Fee-For-Service
6.6 Inventory Management Agreements (IMAs) are the Fee-For-Service Agreements
6.6.1 The Experience of Fee-For-Service/IMAs is Limited
6.7 Fee-For-Service in the US and Europe Compared
6.8 US Based Cardinal Health Signs Fee-For-Service Deal with Eli Lilly
6.9 AmerisourceBergen and McKesson Say Fee-For-Service Negotiations are on Track
6.10 Fee-For-Service is the Future of the W&D Industry
Chapter 7 Canada and US Drug Reimportation
7.1 Pricing Differential Has Led to Drug Reimportation
7.2 Drugs are Not Always Cheaper in Canada Compared With the US
7.3 Generic Drugs Cheaper in the US and not Canada
7.4 It is Legal for the US to Import Drugs from Canada but only if the Drugs are Proven Safe
7.4.1 The US Drug Regulators Cannot Guarantee Imported Drug Safety
7.5 The US States Currently Active in US/Canada Drug Reimportation
7.6 Why are Pharmaceutical Prices Lower in Canada?
7.7 Reimportation is a Form of Price Control That May have Poor Financial Consequences for the Pharmaceutical Industry
7.8 The Response of the Major Drug Companies on Drug Reimportation from Canada
7.9 The Response of the Canadian Pharmacies to Drug Reimportation
7.10 The Overall Savings from Drug Reimportation for the Consumer and the US Government is Small
7.11 Drug Reimportation Will Never Work on a Large Scale
Chapter 8 The Big Three US Wholesalers
8.1 The Big Three - Overview
8.2 McKesson - the Leading Wholesaler in the US
8.2.1 Pharmaceutical Solutions
8.2.2 Medical-Surgical Solutions
8.2.3 Information Solutions
8.2.4 Business Switch to Fee-For-Service Model
8.3 Cardinal Health had Revenues of $81bn for the 2007 Financial Year
8.3.1 Pharmaceutical Distribution and Provider Services
8.3.2 Fee-For-Service Move
8.3.3 Cardinal Health and CMS Sign Primary Distribution Agreement for RFID-enabled Sponge Counting, Detection System
8.4 AmerisourceBergen Will Remain as the Third Largest US Wholesaler
8.4.1 AmerisourceBergen Losses Important VA Contract
8.4.2 ABC Announces $250 Million Accelerated Share Repurchase Transaction
8.4.3 ABC Buys Bellco Health for $190 Million
8.5 Competition Between the Big Three Remains High
Chapter 9 Direct to Pharmacy Distribution in the W&D Industry
9.1 What is Direct to Pharmacy Distribution (DTP)?
9.2 What are the Benefits of This Distribution Model?
9.3 The Concerns of DTP
9.3.1 The Concerns of DTP from the Perspective of Wholesalers
9.3.2 The Concerns of DTP from the Perspective of Pharmacists
9.3.3 The DTP model from the Perspective of the Pharmaceutical Manufacturers
9.3.4 The Implications of DTP
9.3.5 DTP Adoption Will Affect Competition in the W&D Industry
9.4 DTP Model Will Not Stop Counterfeit Drugs Entering the Pharmaceutical Supply Chain, Experts Say
9.5 AstraZeneca UK – The Latest Manufacturer to Introduce DTP Distribution
9.6 DTP is Predominately Adopted in the UK Only – Will This Spread Across the Major Markets?
Chapter 10 Internet Drugs: Mail Order and On-Line Pharmacies
10.1 The Internet - A Relatively New Method of Selling Drugs to the Consumer
10.2 Use of the Internet Usage has Seen High Growth in Both the Developing and Developed Countries/Regions
10.3 The US has the Highest Numbers of Internet Users
10.4 Online Pharmacies Offer a Diverse Number of Services
10.5 US Mail Order/On-line Drugs has High Growth
10.6 Online Pharmacies May Need to Diversify their Business Base
10.7 Most US Online Drug Sales are from Women
10.8 Online Drugs and Services May Pose a Significant Health Risk
10.9 Consumers Satisfied with Mail Order
10.10 On-line Prescriptions Facts
10.11 European Online Drug Sales are Low and Limited to OTC
10.12 Online Pharmacy Sites are A Potential Haven for Counterfeiters
10.13 The Verified Internet Pharmacy Practice Site (VIPPS)
Chapter 11 Conclusions – The Pharmaceutical W&D Sector is Undergoing Significant Change
11.1 High Demand for Pharmaceutical Products Will Drive the W&D Industry
11.1.1 Factors That Will Drive the W&D Industry
11.1.2 Factors That Will Restrain the W&D Industry
11.2 Wholesale Distribution in the European Market Region
11.3 Wholesale Distribution in the US Market Region
11.4 Advantages and Disadvantages for the Fee-For-Service Pricing Strategy
11.5 Despite the Development of Fee-for-Service Both the US and European W&D Industries will see Continually Low Profit Margins
11.6 Direct-to-Consumer Distribution Channels will Diminish the Role of Wholesalers
11.7 The Complexity of Wholesale and Distribution Routes Aids the Counterfeiter
List of Tables
Table 2.1 Types of Wholesalers Described, 2008
Table 2.2 Pharmaceutical retail & hospital breakdown ($bn) in the top ten countries, 2006
Table 2.3 Pharmaceutical retail & hospital breakdown (%) in the top ten countries, 2006
Table 3.1 SWOT Analysis of the W&D Industry
Table 4.1 Comparative Drug Prices in Selected Developed Countries
Table 4.2 All Factors that Influence Drug Prices
Table 4.3 Pricing Differentials for Leading Drugs (30 day supply)
Table 5.1 Top Ranked Countries where Counterfeits were Seized/Discovered
Table 7.1 Comparison of Drug Prices Between the US and Canada, 2008
Table 7.2 Comparison of Generic Drug Prices Between the US and Canada, 2008
Table 8.1 Segment breakdown of McKesson’s Revenue, 2007
Table 8.2 McKesson Revenue Forecast ($bn), 2008-2013
Table 8.3 Cardinal Health’s Revenue ($bn) and Operating Margin (%), 2004-2007
Table 8.4 Cardinal Health Revenue Forecast ($bn), 2008-2013
Table 8.5 AmerisourceBergen Revenue Forecast ($bn), 2008-2013
Table 8.6 ABC’s Operating Income and Revenue ($m), 2005-2007
Table 10.1 World Internet Usage and Population Statistics, 2007
Table 10.2 Top Ten Countries with Highest Number of Internet Users, 2007
Table 10.3 Countries with the Highest Internet Penetration Rate, 2007
Table 10.4 US Prescription Sales ($bn) by Distribution Sector, 2007
Table 10.5 Market Share (%) of US Mail Order Revenue of all Prescription Sales ($bn), 2003-2007
List of Figures
Figure 2.1 Pharmaceutical retail & hospital breakdown ($bn) in the top ten countries, 2006
Figure 5.1 Flow diagram of how drug counterfeits enter the US supply chain
Figure 8.1 Revenues of the big three US wholesalers ($bn), 2007
Figure 8.2 ABC’s Business Segment Breakdown (%), 2007
Figure 8.3 Revenue Forecasts’ of the Big Three US Wholesalers ($m), 2008-2013
Figure 10.1 US Prescription Sales by Distribution Sector, Market Share (%), 2007
Figure 10.2 Market Share (%) of US Mail Order Revenue of all Prescription Sales ($bn), 2003-2007
Companies Listed
AAH Pharmaceuticals
Alliance UniChem
American Bank Note Holographics
(ABNH)
AmerisourceBergen Corp. (ABC)
AstraZeneca
British Association of Pharmaceutical
Wholesalers (BAPW)
Cardinal Health (CAH)
Caremark Rx
Celesio
ClearCount Medical Solutions (CMS)
Department of Health (DH)
DIGEMID
Eli Lilly
EMEA
Express Scripts
FDA
FSHSS
GSK
Health and Human Services (HHS)
Health Maintenance Organisations
(HMOs)
IMS
International Pharmaceutical
Manufacturers Group (IPMG)
IWS
McKesson (MCK)
Medco Health Solutions
Medicines and Healthcare Products
Regulatory Agency (MHRA)
MINSA
National Association of Boards of
Pharmacy (NABP)
National Health Service (NHS)
Nielsen
OFT
Patented Medicine Prices Review
Board (PMPRB)
Pembroke Consulting
Pfizer
Pharmaceutical Care Management
Association (PCMA)
Sanofi-Aventis
UniChem Limited
UnitedHealth Group
World Health Organisation (WHO)
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