PharmaHandbook 2009: Sixth Edition : Market Research Report

PharmaHandbook 2009: Sixth Edition

Published: Jun. 1, 2009

Volume I
About VOI Consulting, Inc
About the Author
Overview
Calculation of GDP and National Healthcare Spending
Market Calculations
Time Considerations
Monetary Figures, Exchange Rates & Growth Calculations.vi
Final Note
2001 to 2009 Global Sales
2008 Sales by Region
2008 Global Sales - Top 15 Therapeutic Categories
2008 Global Sales - Top 15 Products
2008 Global Sales - Top 15 Companies
Australia
Healthcare System
Pharmaceutical Market
Market Profile
Market Structure
The Pharmaceutical Benefits Scheme
Section 100 Programs
2009 Growth Forecasts
Regulatory
Approval Procedures
TGA Reforms
Pricing
Mandatory Price Reductions
PBS Pricing Reforms
Price Disclosure
Payment
Generics
Generic Substitution
The Generic Market
Generic Companies
R&D / Clinical Trials
Manufacturing
Distribution
Pharmacy Guild Agreements
Changes caused by PBS Reforms
Wholesale and Pharmacy Segments
Trade
AUSFTA
Patent & Intellectual Property Issues
Marketing
Marketing Regulations
Marketing Activity
Belgium
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Payment
2009 Reimbursement Cuts
Hospital Drug Purchases
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Patent & Intellectual Property Issues
Marketing
Canada
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance
Market Forecasts
Regulatory
Approval Procedures
Generic Approval Procedures
Pricing
Payment
Generics
Biosimilar Developments in Canada
R&D / Clinical Trials
Manufacturing
Distribution
Trade
Patent & Intellectual Property Issues
Patent Challenges
Data Exclusivity Regime
Exports to Least Developed Countries
Marketing
European Union Overview
Major Events
Introduction
E.U. Overview
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Considerations for Generic Drug Approval
Pediatric Authorizations
Pricing
Payment
Generics
DG Competition Report
Biosimilars in the EU
R&D / Clinical Trials
Manufacturing
Parallel Trade
Court Cases Regarding Parallel Trade
Patent & Intellectual Property Issues
Intellectual Property Implications of the Pediatric Regulation 102
Intellectual Property Implications of EU Expansion
E.U. Aid to Least Developed Countries
Marketing
Potential Changes in Patient Communication Rules
Other Considerations
France
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
ASMR Ratings
Other Pricing Considerations
Hospital Drug Pricing
Generic Drug Pricing
Payment
Pharmacoeconomic Evaluation by HAS
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Patent & Intellectual Property Issues
Marketing
Germany
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Political Reforms
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Trade
Patent & Intellectual Property Issues
Marketing
Greece
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Parallel Trade
Patent & Intellectual Property Issues
Marketing
Ireland
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
The Current (September 2006) Pricing Agreement
Payment
Structure of the Reimbursement System
Community Reimbursement Programs
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Parallel Trade
Patent & Intellectual Property Issues
Marketing
Israel
Pharmaceutical Market
Regulatory
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Parallel Trade
Patent & Intellectual Property Issues
Data Exclusivity
Patent Term Extension
Marketing
Italy
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Innovative Drug Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Parallel Trade
Patent & Intellectual Property Issues
Marketing
Japan
Major Events
Healthcare System
Health Insurance Reform
Healthcare Infrastructure
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
General Procedures
Generic Pricing Procedures
Biennial Price Cuts
Potential “Price Maintenance” for Patented Drugs
Payment
Generics
Generic Market
Generic Target 2012
Generic Companies
Biosimilar Regulations
R&D / Clinical Trials
Manufacturing
Distribution
Patent & Intellectual Property Issues
Marketing
Korea
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Trade
Patent & Intellectual Property Issues
Korea-US Free Trade Agreement
http://www.ustr.gov/Trade_Agreements/Bilateral/Republic_of_Korea_FTA/Final_Text/Section_Index.html
PhRMA’s Position
Marketing
Netherlands
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
2007 Medicines Law
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Distribution
Parallel Trade
Patent & Intellectual Property Issues
Marketing
New Zealand
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
PHARMAC
In late 2007, the Ministry of Health released guidelines for the “Medicines New Zealand strategy.” Its goal is to provide a long-term framework for rational pharmaceutical consumption and spending. From the standpoint of the pharmaceutical industry, it offers little in terms of substantive changes. More information can be found at:
Market Performance and Forecasts
Regulatory
Approval Procedures
ANZTPA
Pricing
Payment
Budgeting Process
Generics
R&D / Clinical Trials
Distribution
Patent & Intellectual Property Issues
Marketing
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Medicines Law of August 2006
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Trade
Patent & Intellectual Property Issues
Marketing
Spain
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Trade
Patent & Intellectual Property Issues
Marketing
Sweden
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Parallel Trade
Patent & Intellectual Property Issues
Marketing
Switzerland
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
2010 Price Control Measures
Payment
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Trade
Patent & Intellectual Property Issues
Marketing
United Kingdom
Major Events
Healthcare System
Pharmaceutical Market
Market Profile and Structure
Market Performance and Forecasts
Regulatory
Approval Procedures
Pricing
2009 PPRS
Payment
Impact of NICE and other U.K. Pharmacoeconomic Boards
Generics
R&D / Clinical Trials
Manufacturing
Distribution
Parallel Trade
Patent & Intellectual Property Issues
Marketing
United States of America
Major Events
Healthcare System
The Health Insurance System
Potential for Health Insurance Reforms
Patent & Intellectual Property Issues
Marketing
List of Figures
Australia
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - Structure of the Australian Pharmaceutical Market 2008 (Aus$ / US$ in Bil)
Figure 5 - FY 2007/08 PBS Activity by Category (Aus$ in 000)
Figure 6 - FY 2007/08 PBS Activity by ATC Level 2 Categories (Figures in 000; A$)
Figure 7 - Highly Specialized Drug Activity FY 2007/08
Figure 8 - Average New Drug Approval Times (H1 2008)
Figure 9 - PBS Reform Schedule
Figure 10 - Top 20 Pharma Companies by PBS Sales FY 2007/08 (A$ and Rx Volume shown in thousands)
Figure 11 - Distribution of Pharmacies
Figure 12 - Top 35 Fastest Growing PBS Drugs FY 2007/08 (A$ and Rx Volume in thousands)
Belgium
Figure 1 - General and Health Statistics
Figure 2 - 2007-08 Belgian Health Budget
Figure 3 - Size of Leading Physician Specialties
Figure 4 - Population Statistics
Figure 5 - Pharmaceutical Market Snapshot
Figure 6 - Cost Containment Measures by Year 2001-09
Figure 7 - Share of Market Volume Single vs. Multi-source Drugs
Figure 8 - Spending by Channel 2005-08 (Euro Mil)
Figure 9 - Spending for Top 20 Products in Public System
Figure 10 - Subsidy Level, Cost and Share by Therapeutic Category in Public System
Figure 11 - Pharmaceutical Expenditure in Public System GPs versus Specialists
Figure 12 - Prescription Volume Share
Figure 13 - Spending for Top 20 Products in Public System
Figure 14 - Tripartite Organization of AFMPS (as of Feb 2009)
Figure 15 - Reimbursement Categories
Figure 16 - Generic Company Sales and Market Share by Company 2008
Figure 17 - Research-based Companies Operating in the Belgian Pharmaceutical Sector (2008)
Figure 18 - Share of End-User Price Received
Canada
Figure 1 - General and Health Statistics
Figure 2 - Canada's Health System
Figure 3 - 2008 Health Spending by Category
Figure 4 - Population Characteristics
Figure 5 - Pharmaceutical Market Snapshot
Figure 6 - 2002-2008 Volume and Value Trends (Ex-mfr; Retail Only)
Figure 7 - Brand and Generic Shares in Retail Channel 2008
Figure 8 - 2008 Retail Sales, Volume and Average Prices of Leading Categories
Figure 9 - 2008 Retail Prescription Activity and Share by Physician Specialty
Figure 10 - Top 10 Office-Based Diagnoses and % Involving Drugs
Figure 11 - 2008 Hospital Sales by Therapeutic Category
Figure 12 - 2008 Growth by Segment
Figure 13 - Drug Classifications
Figure 14 - Sources of Drug Payment 2008
Figure 15 - 2008 Generic Share of Volume by Province
Figure 16 - Pharmaceutical R&D Spending 2002 to 2007
Figure 17 - R&D Investments by Type 2007
Figure 18 - Pharmaceutical Trade Balance 2002-08
European Union Overview
Figure 1 - Current and Future Members of the European Union (July 2009)
Figure 2 - E.U. Population Statistics (July 2009 Estimates)
Figure 3 - 2008 (Actual) to 2009 (Estimated) Pharmaceutical Market Value US$ Billions (Ex-Mfr / Constant Exchange Rates)
Figure 4 - Regulatory Structure of the European Union
Figure 5 - Average Time from Marketing Approval to Market Access (New products approved Jan 2003 to Dec 2006)
Figure 6 - Generic Penetration Rates - 2008
Figure 7 - Biosimilars approved in the E.U. as of April 2009 94
Figure 8 - EU National Policies Regarding Biosimilar Substitutability
France
Figure 1 - General and Health Statistics
Figure 2 - Destination of Health Expenditures 2007 (excluding capital investments)
Figure 3 - Physicians by Specialty
Figure 4 - Population Statistics
Figure 5 - Pharmaceutical Market Snapshot
Figure 6 - Pharmaceutical Reforms 2004 to 2009
Figure 7 - 2002 to 2008 Trends in the French Reimbursed Drug Sector
Figure 8 - Sales and Volume of Top 20 Reimbursed Therapeutic Categories
Figure 9 - Sales and Volume of Top 20 Reimbursed Products
Figure 10 - Summary of Pricing and Reimbursement Process
Figure 11 - Share of Value and Volume by Reimbursement Level
Figure 12 - Products losing patent protection in France 2009-12
Germany
Figure 1 - General and Health Statistics
Figure 2 - SHI Spending by Sector 2007-08
Figure 3 - Population Statistics
Figure 4 - Pharmaceutical Market Snapshot
Figure 5 - 2006-08 Sales by Product Type in Community Pharmacies (Sales at Retail Prices in €Mil)
Figure 6 - SHI 2008 Activity: Patented and Off-patent Products (Sales figures at net pharmacy price)
Figure 7 - Pharmaceutical Cost Containment Measures 2000 to 2009
Figure 8 - Community Pharmacy Sales by Category, 12 Months ending May 2009 (Ex-manufacturer prices)
Figure 9 - Top 20 Therapeutic Categories Ranked by Prescription Volume (SHI-System / 2007)
Figure 10 - Products losing patent protection in Germany 2009-12 (U.S. brand names)
Greece
Figure 1 - General and Health Statistics
Figure 2 - Physicians by Specialty
Figure 3 - Population Statistics
Figure 4 - Pharmaceutical Market Snapshot
Ireland
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - Volume and Value Share of Community Drug Schemes by Product Type 2007
Figure 5 - Top 10 Products in General Medical Scheme 2007 (Ingredient Cost)
Figure 6 - Top 10 Products in General Medical Scheme 2007 (Prescription Volume)
Figure 7 - LTI Conditions
Figure 8 - 2007 CDS Government Spending by Program
Israel
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - Pharmaceutical Exports and Imports 2003 to 2008 (US$ 000)
Italy
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 5 - Pharmaceutical Regulatory Measures 2000 to 2006
Figure 6 - SSN Outpatient Sales and Volume by Product Type 2008
Figure 7 - 2008 Therapeutic Category Share of Value and Volume (Retail Channel)
Figure 9 - 2008 Top 10 Products in Public System (Retail Pharmacy)
Figure 11 - SSN Outpatient Sales and Volume by Product Type 2008
Figure 12 - Clinical Trials initiated in Italy by Phase 2000-07
Figure 13 - Nominal and Post-Rebate Pharmacy Margins 2009
Japan
Figure 1 - General and Health Statistics
Figure 2 - Types of Health Insurance Organizations
Figure 3 - Japanese Physicians by Specialty
Figure 4 - Population Statistics
Figure 5 - Pharmaceutical Market Snapshot
Figure 8 - Sales by Channel 2007-08 (in US$ Mil - Constant 2008 Exchange Rates)
Figure 9 - Sales of Ethical (Prescription) Drugs in Japan 2003-08; Local and US$ Values
Figure 10 - 2008 Sales by Therapeutic Category
Figure 11 - Sales of Top 10 Products 2008
Figure 12 - Pricing Process
Figure 13 - Products Subject to Price Cuts 2000-08
Figure 17 - List of Items included in Clinical Trial Notification
Figure 6 - Sales of Top 10 Companies 2008
Korea
Figure 1 - General and Health Statistics
Figure 2 - NHI Copayment Schedule 2009
Figure 3 - Health Insurance in Korea 2007
Figure 4 - Population Statistics
Figure 5 - Pharmaceutical Market Snapshot
Figure 6 - 2006-08 Outpatient Sales / Share by Therapeutic Category
Figure 7 - Top 15 Companies by 2008 Sales (US$ Mil)
Figure 8 - Drug Copayments (1000 Won = Approx. US$ 1)
Figure 9 - Implementation Schedule for Drug Rationalization
Figure 10 - Generic Penetration Rates
Figure 11 - Share of Total Market by Generic Entry Position
Figure 12 - Locally Developed New Drugs
Netherlands
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - 2007 Activity in Pharmacy Channel
Figure 5 - Share of Retail Sales by Type (2007 w Change from 2006)
Figure 6 - Top 10 Outpatient Products 2008
Figure 7 - Responsibilities of Pharmacotherapeutic Groups 301
Figure 8 - Drug Application Fees 2009 (in Euro)
Figure 9 - Number of Clinical Trials in the Netherlands by Phase 2000-07
New Zealand
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - PHARMAC Spending at Ex-Mfr Level by Category FY 2007/08
Figure 6 - Top 20 Subsidized Products by Prescription Volume FY 2007/08
Figure 1 - General and Health Statistics
Figure 3 - Count of Physicians by Specialty
Figure 4 - Population Statistics
Figure 5 - Pharmaceutical Market Snapshot
Figure 6 - Sales of Subsidized Drugs by Location
Figure 7 - Top 15 Companies MAT Feb 2009
Figure 8 - Sales and Volume Trends 2003 to Apr 2009 (Ex-mfr Levels)
Figure 9 - Generic Penetration Rates 2004- April 2009
Figure 10 - Promotional Spending by Channel 2007-08.345
Figure 11 - Top 10 Companies Share of Promotional Spending 2008
Spain
Figure 1 - General and Health Statistics
Figure 2 - Public Health Spending in Spain 2006-07
Figure 3 - Population Characteristics
Figure 4 - Pharmaceutical Market Snapshot
Figure 5 - Pharmaceutical Regulatory Measures 2000 to 2008
Figure 6 - Retail Pharmacy Market Structure 2008
Figure 7 - Sales by Channel 2004-08 (Ex-Manufacturer Levels)
Figure 9 - 2008 Retail Pharmacy Sales and Volume by Therapeutic Category (Sales at ex-mfr levels)
Figure 10 - Social Security / Total Sales and Volume in Pharmacies: 2004 to 2008 (End-user Prices)
Figure 11 - Retail Pharmacy Market Structure 2008
Sweden
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - 2002 to 2008 Rx and OTC Sales by Channel and Source of Payment (End-User Prices)
Figure 5 - Sales by Therapeutic Category 2008 (Pharmacy Purchase Price)
Figure 6 - Top 10 Categories by 2008 Sales (Total Market / Pharmacy Purchasing Price)
Figure 7 - Top 10 Categories by 2008 Hospital Sales
Figure 8 - Sources of Payment 2008
Figure 9 - Reimbursement Schedule
Figure 10 - Generics Sales and Share Trends 2003-08 (At Pharmacy Purchase Prices)
Figure 11 - Started Clinical Trials and Patients 2001-08
Figure 12 - Leading Companies 2008
Figure 13 - Trends in Parallel Trade 2003-08 (At Pharmacy Purchase Prices)
Switzerland
Figure 1 - General and Health Statistics
Figure 2 - Number of Visits by Diagnosis 2007
Figure 3 - Population Statistics
Figure 4 - Pharmaceutical Market Snapshot
Figure 5 - Share of Sales by Therapeutic Category
Figure 6 - Sales and Distribution of Prescription and OTC Drugs (based on ex-factory prices)
Figure 8 - Value, Volume and Price by Channel 2007-08 (ex-manufacturer levels)
Figure 9 - Patent and Off-Patent Products: 2008 Sales and Share of Market in the Outpatient Market
Figure 12 - Generic Sales and Share Trends in Outpatient Channel 2007-08
United Kingdom
Figure 1 - General and Health Statistics
Figure 2 - Population Statistics
Figure 3 - Pharmaceutical Market Snapshot
Figure 4 - 2008 Community Pharmacy Prescribing and Spending by Country
Figure 5 - Prescribing and Dispensing Patterns 2000 to 2007
Figure 6 - Generic / Brand Share of Market Value 2001-08
Figure 7 - 2008 Retail Sales by ATC 1 Category (England / Net Ingredient Cost)
Figure 8 - 2008 Top 20 Therapeutic Categories by NHS Sales (England / Net Ingredient Cost)
Figure 9 - 2008 Top 20 Products by NHS Sales (England / Net Ingredient Cost)
Figure 10 - Scheduled Brand Drug Price Changes under 2009 PPRS
Figure 11 - Generic Prescribing and Dispensing Penetration by Therapeutic Category 2006-07
Figure 12 - Products losing patent protection in the U.K. 2009-12 (U.S. brand names)
United States of America
Figure 1 - General and Health Statistics
Figure 2 - 2008 Destination of Health Spending
Figure 3 - 2008 Sources of Health Spending
Figure 4 - Source of Health Coverage
Figure 5 - Leading Types of Private Insurance
Figure 6 - Private Plan Enrollment by Type of Plan
Figure 7 - Population Statistics
Figure 8 - Pharmaceutical Market Snapshot
Figure 9 - Volume, Sales and Price Trends 2002-2008
Figure 10 - Generic and Branded Trends Value and Volume Share Trends 1998 to 2008
Figure 11 - 2008 Sales: Top 15 Therapeutic Category (Ex-mfr)
Figure 12 - Top 15 Companies by 2008 US Sales
Figure 13 - Top 50 Branded Products by 2008 Retail Sales
Figure 14 - Top 25 Hospital Drugs 2007
Figure 15 - Forecasts of Brand Sales Facing First Time Generic Competition 2006 to 2020
Figure 16 - Key FDA Terms
Figure 17 - Trends FDA Approvals of New Molecular Entities and New Biologics
Figure 18 - 2003-2009 Sources of Pharmaceutical Payment
Figure 19 - Use of Tiered Copayments in Private Plans
Figure 20 - Average Copayments by Formulary Status
Figure 21 - Medicare Part D Benefits (2009)
Figure 22 - Abbreviated New Drug Application (ANDA) Activity
Figure 23 - Leading Companies by 2007-08 Share of Generic Prescriptions
Figure 24 - Top 50 Generic Products 2008 in Retail Channel
Figure 25 - Patent Expirations of Major Drugs 2008-2012
Figure 26 - PhRMA Member Companies: R&D Spending by Stage 2007
Figure 27 - Sales by Channel 2004 - 2008
Figure 28- Wholesale Company Share of Market
Figure 29 - Major Company Promotional Allocations (2008)

Abstract

The prescription drug industry is among the most globalized and the most heavily regulated — in the world. PharmaHandbook™ is an essential resource for anyone required to navigate the complexities of the global pharmaceutical marketplace.

Our customers have called PharmaHandbook™ “invaluable”, “extremely useful”, “a wonderful resource” and say they “look forward to receiving it every year.”

In previous editions PharmaHandbook has been a single volume publication containing analysis of 40 global markets; however, after careful consideration and discussions with a number of customers, VOI has decided to break PharmaHandbook 2009 (sixth edition) into two separate volumes. The volumes will breakdown along the lines of Developed Markets and Emerging Markets: (Volume I & II - Markets)

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PharmaHandbook 2009: Sixth Edition

Table of Contents

Abstract