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| A Guide to the International Pharmaceutical Industry
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. pharmahandbook™ includes coverage of 37 individual DEVELOPED and EMERGING countries (cumulatively representing more than 99% of worldwide sales), a special section devoted to issues that affect all European Union members and an analysis of the international intellectual property rights system. This edition of PharmaHandbook will be made available to customers in two separate volumes. Volume 1 covers Developed Markets while Volume 2 covers Emerging Markets. |
- 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
- 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
- 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$)
- Figure 7 - Highly Specialized Drug Activity FY 2007/08 .7
- Figure 8 - Average New Drug Approval Times (H1 2008).8
- Figure 9 - PBS Reform Schedule
- Figure 10 - Top 20 Pharma Companies by PBS Sales FY
- 2007/08 (A$ 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 2001-09.31
- 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.55
- 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 2007.63
- 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
- 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
- 189
- 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- 07.226
- 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).
- 273
- 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 (Exmfr
- 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 .383
- 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 .
- 414
- 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 (Exmfr)
- 449
- Figure 12 - Top 15 Companies by 2008 US Sales
- Figure 13 - Top 50 Branded Products by 2008 Retail Sales..
- 451
- 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
- 463
- 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
- 471
- 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)
- 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
- ARGENTINA
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- Payment
- Generics
- Manufacturing
- Distribution
- Patent & Intellectual Property Issues
- Data Exclusivity
- Preliminary Injunctions
- Marketing
- BRAZIL
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- 28
- Payment
- Generics
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Intellectual Property Issues
- Compulsory Licensing
- Marketing
- CHINA
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Impact of 2009-2011 Health Reforms
- Regulatory
- Approval Procedures
- Provisional vs. Final Standards
- Pricing
- Price Controls and the 2009-2011 Health Reforms
- Payment
- Generics
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Parallel Trade
- Patent & Intellectual Property Issues
- The Monitoring Period
- Provisional vs. Final Standards
- Marketing
- Marketing Regulations
- Marketing Practices
- CZECH REPUBLIC
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Approval Procedures
- Pricing
- 2008 Changes to the Pricing System
- Payment
- Generics
- R&D / Clinical Trials
- Distribution
- Trade
- Patent & Intellectual Property Issues
- Marketing
- EU 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
- 135
- Intellectual Property Implications of EU Expansion
- E.U. Aid to Least Developed Countries
- Marketing
- Potential Changes in Patient Communication Rules
- Other Considerations
- HUNGARY
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- Payment
- Structure of the Reimbursement System
- Post-2007 Reimbursement Procedures
- Past and Current Drug Budgets
- Generics
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Patent & Intellectual Property Issues
- Marketing
- Sales Force Structure and Impact of the Licensing Fee
- INDONESIA
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- Payment
- Generics
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Trade
- Patent & Intellectual Property Issues
- Marketing
- INDIA
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Creation of the Department of Pharmaceuticals
- Approval Procedures
- Approval Timeframes
- Central Drugs Authority Plans Abandoned
- New Biopharmaceutical Regulatory Agency
- Pricing
- Innovative Drug Pricing in Practice
- Payment
- Generics
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Patent & Intellectual Property Issues
- Provisions of the Patent Law
- Recent Developments and Future Outlook
- Marketing
- MEXICO
- Major Events
- Healthcare System
- Impact of H1N1 Influenza
- Pharmaceutical Market
- Market Profile and Structure
- Impact of H1N1 Influenza
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Creation of Biologics and Biosimilars Framework
- Elimination of Similars Category
- Elimination of Domestic Manufacturing Requirements
- Pricing
- Generics
- R&D / Clinical Trials
- Distribution
- Patent & Intellectual Property Issues
- POLAND
- 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
- ROMANIA
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Generics
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Parallel Trade
- Patent & Intellectual Property Issues
- RUSSIA
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Segments
- Market Performance and Forecasts
- Regulatory
- Approvals
- Pricing
- Payment
- Public Subsidies
- Private Expenditures
- Generics
- R&D / Clinical Trials
- Manufacturing
- 2020 Strategic Support Program
- Distribution
- Trade
- Intellectual Property
- Marketing
- SOUTH AFRICA
- Major Events
- Healthcare System
- Changes in the 2009-2010 Budget
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- New Drug Regulatory Agency Planned
- Approval Procedures
- Pricing
- Payment
- R&D / Clinical Trials
- Distribution
- Patent & Intellectual Property Issues
- Marketing
- TAIWAN
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- New Drug Regulatory Agency
- Approval Procedures
- Pricing
- Payment
- Health Technology Assessments
- Generics
- R&D / Clinical Trials
- Clinical Trials
- Bridging Study Policies
- Manufacturing
- Distribution
- Trade
- Patent & Intellectual Property Issues
- Marketing
- THAILAND
- Major Events
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- Payment
- R&D / Clinical Trials
- Manufacturing
- Trade
- Patent & Intellectual Property Issues
- Thailand’s use of Compulsory Licensing
- Other IP Concerns
- Marketing
- TURKEY
- Major Events
- Healthcare System
- Status of E.U. Candidacy
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- Payment
- Generics
- Biosimilar Legislation
- R&D / Clinical Trials
- Manufacturing
- Distribution
- Trade
- Patent & Intellectual Property Issues
- Marketing
- VENEZUELA
- Major Events
- Note on Venezuelan Currency
- Healthcare System
- Pharmaceutical Market
- Market Profile and Structure
- Market Performance and Forecasts
- Regulatory
- Approval Procedures
- Pricing
- Generics
- Manufacturing
- Distribution
- Patent & Intellectual Property Issues
- Marketing .
- List of Figures
- ARGENTINA
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- Figure 3 - Pharmaceutical Market Snapshot
- Figure 4 - Retail Sales and Volume Trends 2004-08
- Figure 6 - Top 10 Companies (MAT March 2009)
- BRAZIL
- Figure 1 - General and Health Statistics
- Figure 2 - Total Physicians in Leading Specialties
- Figure 3 - Population Statistics
- Figure 4 - Pharmaceutical Market Snapshot
- Figure 5 - Public Sector Pharmaceutical Programs And
- 2008 Expenditures
- Figure 6 - Generic Share of Value and Volume (Dec 2004
- to Dec 2009)
- Figure 8 - Top Ten Companies 2008
- CHINA
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- Figure 3 - Pharmaceutical Market Snapshot
- Figure 4 - TCMs, Generics and Brands: Share of Sales
- 1999-2008
- Figure 5 - Drug Approval Procedures & Timing
- Figure 6 - 2008 Share of Generic Market by Company
- Figure 7 - Clinical Trial Regulatory Approval Process
- Figure 8 - Top 10 Wholesale Distributors 2008
- CZECH REPUBLIC
- Figure 1 - General and Health Statistics
- Figure 2 - Health Expenditures by Source 2005 - 2008
- Figure 3 - Active Physicians by Specialty 2008
- Figure 4 - Population Characteristics
- Figure 5 - Pharmaceutical Market Snapshot
- Figure 7 - Market Trends (Sales at End User Levels)
- Figure 8 - 2008 Activity by Therapeutic Category (ATC 1 -
- End User Costs)
- Figure 9 - 2008 Sales Top 20 Categories (ATC 2 - End User
- Costs)
- Figure 11 - 2008 Top 11 Products (End User Costs)
- Figure 12 - Clinical Trial Applications by Type 2008
- Figure 13 - Clinical Trials by Therapeutic Area 2008
- EU 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.115
- Figure 6 - Biosimilars approved in the E.U. as of April 2009
- Figure 7 - EU National Policies Regarding Biosimilar
- Substitutability
- HUNGARY
- Figure 1 - General and Health Statistics
- Figure 2 - Allocation of Public Health Spending 2008-09
- Figure 3 - Population Statistics
- Figure 4 - Pharmaceutical Market Snapshot
- Figure 5 - Sales, Volume and Price in Hungarian
- Pharmaceutical Market 2003-08 (Ex-manufacturer level)
- Figure 6 - Reforms Affecting the Pharmaceutical Industry
- 2004 to 2009
- Figure 9 - Previous and Current (post-reform) Subsidy
- Rates
- Figure 10 - Budgeted and Actual Drug Reimbursement
- Spending 2003-09
- Figure 11 - Top 10 Companies 2008
- INDONESIA
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- Figure 3 - Pharmaceutical Market Snapshot
- Figure 4 - Leading Prescription and OTC Companies
- (MAT Jun 2009)
- Figure 5 - Sales and Share by Product Type 2005-09 (Exmanufacturer)
- INDIA
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- .Figure 3 - Pharmaceutical Market Snapshot
- Figure 5 - Indian Regulatory System
- Figure 6 - Responsiblities of Central and State Drug
- Regulators
- Figure 7 - DPCO History
- Figure 11 - Sales Forces and Productivity Levels (based on
- FY 2008/09 retail sales)
- MEXICO
- Figure 1 - General and Health Statistics
- Figure 2 - Coverage by Public Health Insurance Programs..
- Figure 3 - Population Statistics
- Figure 4 - Pharmaceutical Market Snapshot
- POLAND
- Figure 1 - General and Health Statistics
- Figure 2 - Population Characteristics
- Figure 3 - Pharmaceutical Market Snapshot
- Figure 4 - 2003-08 Sales of Prescription and OTC Drugs
- by Channel at End-User Prices (Local Currency)
- Figure 5 - 2003-08 Sales of Prescription and OTC Drugs
- by Channel at End-User Prices (US Dollars)
- Figure 8 - First Half 2009 Outpatient Activity by Product
- and Source of Payment (End-User Levels)
- Figure 9 - Original and Generic Share by Sales and Volume
- 2005 to 2008
- Figure 10 - Leading Companies by 2008 Retail Pharmacy
- Market Share
- ROMANIA
- Figure 1 - General and Health Statistics
- Figure 2 - Romania’s Health Infrastructure 2008
- Figure 3 - Population Statistics
- Figure 4 - Pharmaceutical Market Snapshot
- Figure 5 - Sales by Segment MAT Mar 2009
- Figure 6 - Top 10 Companies 12 Months Ending
- September 2009
- Figure 8 - Margins in the Distribution Chain
- RUSSIA
- Figure 1 - General and Health Statistics
- Figure 2 - Russia's Health Infrastructure
- Figure 3 - Population Statistics
- Figure 4 - Pharmaceutical Market Snapshot
- Figure 5 - 2008 Sales by Market Segment (End-User Prices)
- Figure 6 - Rx versus OTC Activity in Commercial Market
- 2007-08 (Pharmacy Acquisition Prices)
- Figure 7 - Commercial Market Sales by Therapeutic
- Category 2008 (Pharmacy Acquisition Prices)
- Figure 8 - 2008 Top 15 Companies (Pharmacy Acquisition
- Prices)
- Figure 9 - DLO Sales by Therapeutic Category 2008 (End-
- User Prices)
- Figure 10 - 2008 Top 15 Companies by DLO Sales (End-
- User Prices)
- Figure 11 - Sales by Therapeutic Category 2008 (End-User
- Prices)
- Figure 12 - 2008 Top 15 Companies by Hospital Sales
- (End-User Prices)
- Figure 13 - Activity by Segment First Half 2009
- Figure 14 - Clinical Trial Approvals 2004-08
- Figure 15 - Leading Domestic Manufacturers Q1 2009 .302
- SOUTH AFRICA
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- Figure 4 - Sales and Volume by Market Segment and
- Product Type (MAT Mar 2009)
- Figure 5 - Top 20 Companies by Share of Value (Private
- Market; MAT Jun 2009)
- Figure 6 - Top 20 Companies by Share of Volume (Private
- Market; Jan 2007 to Jun 2009)
- Figure 7 - Structure of SA Medicines Control Council
- Figure 8 - Originals and Generics Share of Volume and
- Value 2002-09
- Figure 10 - Maximum Pharmacy Dispensing Fees (June
- 2009 Agreement)
- TAIWAN
- Figure 1 - General and Health Statistics
- Figure 2 - Taiwan's Health Infrastructure 2008
- Figure 3 - Population Characterisitcs
- Figure 4 - Pharmaceutical Market Snapshot
- Figure 5 - Top 10 Products by NHI Sales 2008
- (Reimbursement Prices)
- Figure 6 - Clinical Trial Applications 2004-08
- THAILAND
- Figure 1 - General and Health Statistics
- Figure 2 - Major Sources of Health Coverage
- Figure 3 - Number of Physicians in Leading Specialties.352
- Figure 4 - Patient Help-Seeking Behavior
- Figure 5 - Population Statistics
- Figure 6 - Pharmaceutical Market Snapshot
- TURKEY
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- Figure 3 - Pharmaceutical Market Snapshot
- Figure 4 - 2001-09E Volume and Sales Growth (Ex-mfr
- prices)
- Figure 5 - Share of Value and Volume by Drug Type
- 2002-08
- Figure 6 - Top 10 Pharmaceutical Companies 2008
- Figure 8 - Distributor Compensation and Components of Retail Price
- VENEZUELA
- Figure 1 - General and Health Statistics
- Figure 2 - Population Statistics
- Figure 3 - Pharmaceutical Market Snapshot
- Figure 4 - 2007 to 2008 Market Activity
- Figure 6 - Top 20 Products (MAT May 2009)
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