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Emerging Generic Drug Markets in Europe


Description: A comparative study of high growth markets of opportunity.
Emerging Generic Drug Markets in Europe: France, Italy, Portugal, Spain.
The many generic companies and investors looking to Asian and Latin American markets for generic drug market growth could be missing a trick! The four EU countries analysed in this report are expected to deliver significant double digit growth over the next 5 years and present stable, regulated operating environments with excellent prospects. France
In 2007, the French generic market is valued at US$3.7 billion at retail prices, equal to 8.6% of the total pharmaceutical market. Espicom projects annual real growth in the generic market of 15% which will take the generic market to US$7.4 billion at retail prices by 2012, equal to 15.5% of the total pharmaceutical market. Currently, the generic market remains under-developed, although there has been a marked increase in sales over the past four years. Nevertheless, France remains the third leading generic market in Europe.

The government is keen to control spiralling healthcare costs and therefore reducing pharmaceutical expenditure by using generics is a major aim. France has a number of medium-sized generic companies. These tend to be foreign-owned, by companies such as Merck KGaA (now US company Mylan), Sandoz, Ranbaxy and Teva. In 2006, Merck KGaA expanded its leadership position in France, with market shares of 25.5% in the pharmacy sector and 34% in the hospital sector. The leading domestic company is Biogaran, owned by Servier.

Portugal
Portugal is the only country in the EU where the generic market by value represents a higher percentage than by volume in the pharmacy sector. High generic prices have limited generic market penetration as they are not competitive with original product prices. New government measures have been put in place to reduce generic prices, including a scheme of cumulative price reductions depending on market share, established in 2007.

Growth by value is expected to slow down whilst growth by volume will increase with the market which is expected to reach US$1.7 billion in 2012. The generic market is fragmented, with many companies having low market share. Leading domestic generic producers include Farmoz (part of Tecnimede), Generis (part of Farma-APS), Medinfar, Hovione, Bluepharma and ToLife. Foreign generic producers include Actavis, Alter, Merck (now Mylan), ratiopharm, Stada and Winthrop. Two leading Brazilian generic producers, Medley and EMS, have small subsidiaries in Portugal.


Italy
The current generic market, valued at US$809 million in 2007, is small considering the size of the overall pharmaceutical market, partly due to extended national patent supplementary certificates. In 2007, the Italian generic market value is equivalent to the Portuguese even though the overall Italian pharmaceutical market is over six times bigger. In 2008, the Italian generic market is expected to overtake the Portuguese market and will reach US$1.8 billion in 2012.

Eight blockbuster drugs will be coming off-patent in 2007, increasing market opportunities for the leading generic players. Teva, which acquired Pfizer’s Dorom in 2004, claims to be the leading generic producer in Italy while both Sandoz and Merck Generics have strong positions in the generic market. Being generic pioneers in Italy, German companies still retain a significant presence, including Stada (via Eurogenerici) and ratiopharm Germany (via ratiopharm Italia) as well as Merck Generics, which was acquired by the US company Mylan in 2007.


Spain
The Spanish Association of Generic Medicines believes that the industry has the capacity to double its generic market share by volume by 2012. In 2007, the generic market is valued at US$1.7 billion at retail prices. The generic market is expected to grow by 17.4% per year between 2007 and 2012. As a percentage of the pharmaceutical market, generic sales will rise from 6.7% in 2007 to 11.2% in 2012. Of the generic markets analysed in this report, Spain is second behind France.

Many producers, most of them domestic, decided to enter the generic market in Spain ten years ago, encouraged by the Ministry of Health. Market consolidation, however, has resulted in many acquisitions by foreign generic producers, including Géminis and Bexal by Sandoz, Bayvit by Stada, Edifen, UR and Pliva by Barr, Merck by Mylan, Mabo by Meiji, Davur by Bentley and Mundogen by Ranbaxy. Leading domestic producers remaining include Normon, Cinfa and Alter, all of which have strengthened their local positioning and, slowly, are increasing their export opportunities.


Contents: Foreword
Executive Summary
France
Introduction
Key Data Projections, 2007-2012
Healthcare System
Organisation
Health Insurance System
Health Expenditure
Health Expenditure, 1995-2006 (Billion Euros)
Medical Consumption by Service, 2000-2006 (Billion Euros)
Spending Trends on Pharmaceuticals & Medical Products in the Ambulatory Sector, 1995-2005 (%)
Medical Consumption by Source of Funding, 1995-2006 (%)
Medical Consumption by Sector & Source of Funding, 2005 (%)
Healthcare Infrastructure
Hospital Resources
Hospital Services, 1995-2005
Public Hospitals by Type, 2004
Private Hospitals by Type, 2005
Private Hospitals by Status, 2004
Hospital Beds & Day Places by Specialty & Sector, 2005
Hospital Activity
Hospital Activity, 2001-2005
Hospital Activity by Specialty, 2005
Patient Distribution by Most Frequent Diagnostic Groups in Public & Private Hospitals, 2004
Inpatient Activity in Public Short-Stay Units by Major Diagnostic Groups, 2003
Inpatient Activity in Private Short-Stay Units by Major Diagnostic Groups, 2003
Ambulatory Resources
Independent Practitioners by Type of Practice, 2002 (%)
Medical Personnel
Medical Personnel, 1995-2004
Doctors by Specialty & Sector, 2001-2003
Pharmaceutical Market Overview
Size
Summary of the French Pharmaceutical Market, 2007
Projections
Market Projections, 2007-2012
Local Manufacturers
Mergers & Acquisitions of French Pharmaceutical Companies, 1995-2007
Pharmaceutical Companies Operating in France
Generic Market
Size
Reimbursable Market by Patent Status, 2002-2006 (Million Euros)
Reimbursable Market by Patent Status, 2002-2006 (%)
Change in Reimbursable Market by Patent Status, 2002-2006 (%)
Reimbursable Market by Patent Status, 2002-2006 (Million Units)
Reimbursable Market by Patent Status, 2002-2006 (%)
Change in Reimbursable Market by Patent Status, 2003-2006 (%)
Reimbursable Market by Substitution, 2006
Substitutable Market by Reimbursement Status, 2005-2006 (Million Euros)
Subtitutable Market by Reimbursement Status, 2005-2006 (%)
Projections
Projected Generics Market, 2007-2012 (US$ Billion)
Outlook
Outcomes of the New Reference Pricing System
Increasing Prescribing of Generics
Generic Drugs to Reduce Health Expenditure by 912 Million Euros in 2006
Trends in Generic Drug Consumption, 2003-2006
France Transposes EU Pharmaceutical Directive
Pharmacists Associations Agree New Generics Target for 2007
Generics Penetration Objectives by Volume, 2006
Generics Penetration Objectives by Volume, 2007
SWOT
SWOT Analysis of the French Generics Market, 2007
Trade Association
Members of GEMME, 2007
Domestic Production
Leading French Generic Producers, 2005-2006 (%)
Local Manufacturers
Arrow Génériques
Biogaran
Bouchara-Recordati
EG-Labo
EG-Labo’s Sales, 2002-2006 (Million Euros)
EG-Labo’s Sales as % of Stada’s Sales, 2002-2006
Merck Génériques
Merck Génériques’ Financial Indicators, 2003-2006
Ranbaxy
Ranbaxy Pharmacie Génériques’ Sales, 2004-2006 (US$ Million)
ratiopharm
ratiopharm France’s Sales, 2004-2006 (Million Euros)
Sandoz
Sandoz France’s Sales, 2001-2006 (Million Euros)
Teva
Winthrop
Wockhardt
Zydus France
Zydus France’s Sales, 2003-2005
Regulatory Environment
Registration
Pricing & reimbursement
Pricing
Pricing of Reimbursable Medicines in the Retail Pharmacy Market
Price Revisions
Pricing Activity
Drug Pricing Applications Submitted by Type, 2006
Average Number of Days Taken to Process First-Time Registrations, 2006
Pharmacy Margins
Reference Pricing (TFR)
Pricing of Hospital Medicines
Reimbursement
Distribution of the Pharmaceutical Market According to Reimbursement Rate, 2006
Intellectual Property
Leading Active Ingredients Coming off Patent, 2005-2007
Supplementary Protection Certificates
Generics in the French PPI Market
PPIs on the French market, 2007
Reimbursable Sales of PPPIs (Régime Générale), 2002-2006 (Million Euros)
Reimbursable Sales of PPPIs (Régime Générale), 2002-2006 (%)
Reimbursable Sales of PPPIs (Régime Générale), 2002-2006 (Million Units)
Reimbursable Sales of PPPIs (Régime Générale), 2002-2006 (%)
Reimbursable Sales of PPPIs (Régime Générale), 2002-2006 (Average Unit Price, Euros)
Reimbursable Sales of PPIs by Patent Status (Régime Générale), 2004-2006 (Million Euros)
Reimbursable Sales of PPIs by Patent Status (Régime Générale), 2004-2006 (Million Units)
Omeprazole and esomeprazole
Omeprazole Sales Data (Régime Générale), 2004-2006 (Million Euros)
Omeprazole Sales Data (Régime Générale), 2004-2006 (Million Units) Esomeprazole & Omeprazole Sales Data (Régime Générale), 2002-2006 (Million Euros)
Esomepraole & Omeprazole Sales Data (Régime Générale), 2002-2006 (Million Units)
Generics in the French Statins Market
Statins on the French Market, 2007
Reimbursable Sales of Statins (Régime Générale), 2002-2006 (Million Euros)
Reimbursable Sales of Statins (Régime Générale), 2002-2006 (%)
Reimbursable Sales of Statins (Régime Générale), 2002-2006 (Million Units)
Reimbursable Sales of Statins (Régime Générale), 2002-2006 (%)
Average Unit Price of Statins (Régime Générale), 2002-2006 (Euros)
Reimbursable Sales of Statins & Ezetimibe (Régime Générale), 2002-2006 (Million Euros)
Reimbursable Sales of Statins by Patent Status (Régime Générale), 2005-2006 (Million Euros)
Reimbursable Sales of Statins by Patent Status (Régime Générale), 2005-2006 (Million Units)
Pravastatin
Pravastatin Sales Data (Régime Générale), 2006
Simvastatin
Simvastatin Sales Data (Régime Générale), 2005-2006 (000s Euros)
Simvastatin Sales Data (Régime Générale), 2005-2006 (000s Units)
Simvastatin + Ezetimibe Sales Data (Régime Générale), 2005-2006 (Million Euros)
Simvastatin + Ezetimibe Sales Data (Régime Générale), 2005-2006 (Million Units).
Directory
Government Organisations
Generic Trade Association
Generic Manufacturers
Italy
Introduction
Key Data Projections, 2007-2012
Healthcare System
Organisation
Health Expenditure
Health Expenditure, 2000-2006 (Million Euros)
Public Health Expenditure by Type, 2000-2006 (Million Euros)
Public Health Expenditure by Region & Type, 2006 (Million Euros)
Private Health Expenditure by Region, 1998-2003 (Million Euros)
Healthcare Infrastructure
Hospital Resources
Inpatient Institutions by Type, 2000-2005
Inpatient Institutions by Region, 2000-2005
Hospital Beds by Type, 2005
Hospital Beds, 1997-2005
Hospital Beds by Region, 2005
Hospital Activity
Hospital Activity, 2000-2004
Hospital Activity by Sector, 2004
Public Acute Hospital Activity by Region, 2004
Private Accredited Acute Hospital Activity by Region, 2004
Hospital Activity by Diagnosis Group, 2004
Ambulatory Resources
Guardia Medica Points by Region, 2005
Ambulatory & Other Facilities, 2005
Ambulatory & Other Facilities by Type of Service, 2000-2005
Ambulatory Activity
Clinical, Laboratory & Diagnostic Procedures, 2005
Medical Personnel
Registered Doctors by Region, 2006
SSN Personnel, 2000-2005
Pharmaceutical Market Overview
Size
Summary of the Italian Pharmaceutical Market, 2007
Number of Pharmaceutical Products & Presentations, 2000-2006
Number of SSN Pharmaceutical Products & Presentations, 2000-2007
Projections
Market Projections, 2007-2012
Local Manufacturers
Generic Market
Size
Net SSN Sales by Patent Status, 2002-2006 (Million Euros)
Net SSN Sales by Patent Status, 2002-2006 (%)
Change in Net SSN Sales by Patent Status, 2003-2006 (%)
Generics Sales as % of Net SSN Sales by Region, 2002-2006
Per Capita Net SSN Generics Expenditure by Region, 2002-2006 (Euros)
Net SSN Generics Sales by Region, 2002-2006 (DDD/1,000 Population)
Generics Sales as % of Net SSN Sales by Region, 2002-2006 (DDD/1,000 Population)
Gross SSN Generics Sales by Leading Active Ingredient, 2006 (Million Euros)
Gross SSN Generics Sales by Leading Active Ingredient, 2006 (DDD)
Projections
Projected Unbranded Generic Market, 2007-2012
Outlook
SWOT Analysis of the Italian Generics Market, 2007
Domestic Production
Leading Italian Generic Producers, 2007
Trade Association
ASSOGENERICI
Members of ASSOGENERICI, 2007
Local Manufacturers
Angenerico
Angelini’s Pharmaceutical Companies, 2006
DOC Generici
Eurogenerici
Eurogenerici’s Sales, 2002-2006 (Million Euros)
Eurogenerici’s Sales, 2002-2006 (%)
Eugenerici’s Sales as % of Stada’s Sales, 2002-2006 (%)
Hexan
Merck Generics Italia
Merck Generics Italia’s Sales, 2004-2006 (Million Euros)
Pliva Pharma
Pliva Italia’s Sales, 2003-2005 (US$ Million)
Ranbaxy
ratiopharm Italia
Sandoz
Sandoz’s Italian Sales within the Novartis Group, 2004-2005 (Million Euros)
Teva Pharma Italia
Teva Pharma Italia’s Production Capabilities, 2006
Regulatory Environment
Pricing & Reimbursement
EU Directive on the Transparency of Pricing & Reimbursement
Reimbursement
Intellectual Property
National Supplementary Protection Certificate
Leading Active Ingredients with Patents Close to Expiry, 2007
Directory
Government Organisations
Generic Trade Associations
Generic Manufacturers
Portugal
Introduction
Key Data Projections, 2007-2012
Healthcare System
Organisation
Organic Health Law No. 10/1993
Health Regions, 1993
Decree Law No. 257/2001
Health Expenditure
Projected Health Expenditure, 2006-2012
Health Expenditure, 2000-2005 (Million Euros)
Healthcare Infrastructure
Hospital Resources
Public & Private Hospitals, 1990-2005
Public & Private Hospitals by Region, 2005
General & Specialty Hospitals by Type, 2005
Hospital Beds & Operating Rooms, 1990-2005
Hospital Activity
Hospital Admissions, 1990-2005
Hospital Admissions by Region, 2005
Hospital Admissions by Hospital Type, 2005
Admissions, Discharges & Patient Days by Hospital Specialty, 2005
Hospital Consultations by Specialty, 1990-2005 (000s)
Hospital Consultations by Specialty & Region, 2005 (000s)
Hospitals Diagnostic Procedures, 2001-2005
Public & Private Hospitals Therapeutic Procedures, 2005
Outpatient Resources
Outpatient Health Centres, Sub-Centres & Beds, 1990-2005
Outpatient Activity
Outpatient Admissions & Days, 1990-2005
Outpatient Admissions & Days by Region, 2005
Outpatient Consultations by Specialty, 1990-2005 (000s)
Medical Personnel
Pharmaceutical Market Overview.
Size
Summary of the Portuguese Pharmaceutical Market at Retail Prices, 2007
Projections
Market Projections, 2007-2012
Local manufacturers
INFARMED’s Listed National Manufacturers, 2007
Generic Market
Size
Generics Pharmacy Sales by Value & Volume, 2003-2006
Generics Pharmacy Sales by Month, 2003-2006 (Million Euros)
Generics Pharmacy Sales by Month, 2003-2006 (000 Units)
Generics as a Percentage of the Pharmacy Sector by Volume, 2003-2006
Generics Pharmacy Sales by Therapeutic Area, 2006 (Million Euros)
Generics Pharmacy Sales by Therapeutic Area, 2006 (Million Units)
Generics Pharmacy Sales by Leading Active Ingredient, 2006 (Million Euros)
Generics Pharmacy Sales by Leading Active Ingredient, 2006 (Million Units)
Projections
Projected Generics Market, 2007-2012
Outlook
SWOT
SWOT Analysis of the Portuguese Generics Market, 2007
Trade Association
APOGEN
Members of APOGEN, 2007
Domestic Production
Leading Portuguese Generic Producers, 2007
Leading Generic Producers in the Pharmacy Sector, 2005 (%)
Local Manufacturers
Actavis
Alter
Bluepharma
Ciclum Farma
Ciclum Farma’s Sales, 2005-2006 (Million Euros)
Generis
Germed
Hovione
Labesfal
Medinfar
Merck Genéricos
Ranbaxy
ratiopharm
Sandoz
Tecnimede
Tecnimede’s Financial Indicators, 2003-2007
Tecnimede’s Employees by Company, 2007
ToLife
Winthrop
Regulatory Environment
Registration
Market Authorisations of Generic Medicines in the Pharmacy Sector, 2004-2007
Change in Market Authorisations of Generic Medicines in the Pharmacy Sector, 2005-2007 (%)
Market Authorisations of Generic Presentations, 2004-2007
Change in Market Authorisations of Generic Presentations, 2005-2007 (%)
Pricing & Reimbursement
Generics Presentations by Reimbursement Status & Price Range, 2005
Reimbursement
EU Directive on the Transparency of Pricing & Reimbursement
Reimbursements
Generic Medicines by Reimbursement & Prescription Status, 2005
Generic Presentations by Reimbursement & Prescription Status, 2005
Generic Medicines & Presentations by Reimbursement Level, 2005
Generic Presentations by Reimbursement Level & Therapeutic Group, 2005
Intellectual Property
European Supplementary Protection Certificate
Organon Commences Tibolone Patent Infringement Litigation in Portugal
Directory
Government Organisations
Generic Trade Association
Generic Manufacturers
Spain
Introduction
Key Data, 2007-2012
Healthcare System
Organisation
Health Cohesion & Quality Law
Health Expenditure
Projected Health Expenditure, 2007-2012
Healthcare Infrastructure
Hospital Resources
Hospitals by Provision & Region, 2006
Hospitals by Provision & Specialty, 2006
Hospitals, 1985-2006
Hospital Beds by Provision & Region, 2006
Hospital Beds by Provision & Specialty, 2006
Hospital Beds, 1985-2006
Hospital Activity
Hospital Activity by Provision, 2005
Hospital Activity by Specialty, 2005
Hospital Discharges by Hospital Type & Specialty, 2005
Hospital Discharges, 1994-2005
Ambulatory Resources
Primary Care Consultations, 1994 & 2003
Medical Personnel
Registered Medical Personnel, 2000-2006
Practising Medical Personnel, 2006
Pharmaceutical Market Overview
Size
Summary of the Spanish Pharmaceutical Market, 2007
Projections
Market Projections, 2007-2012
Local Manufacturers
Leading Pharmaceutical Companies in Spain, 2006
Generic Market
Size
Generics Pharmacy Sales by Value & Volume, 2002-2006
Pharmacy Sales Value & Volume by Patent Status, 2006
SNS Pharmaceutical Sales by Patent Status, 2000-2005 (Million Euros)
SNS Pharmaceutical Sales by Patent Status, 2000-2005 (%)
Change in SNS Pharmaceutical Sales by Patent Status, 2000-2005 (%)
SNS Pharmaceutical Sales by Patent Status, 2000-2005 (Million Units)
SNS Pharmaceutical Sales by Patent Status, 2000-2005 (%)
Change in SNS Pharmaceutical Sales by Patent Status, 2000-2005 (%)
SNS Prescription Cost by Patent Status, 2000-2005 (Euros)
Projections
Projected Generics Market, 2007-2012
Outlook
Biosimilars’ Substitution, Not a Viable Option in Spain
Regional INN Prescribing
Regional Generic Penetration
The II Iberian Simposium on Generics
Findings of the Study on Generics Perception, October 2005
SWOT
SWOT Analysis of the Spanish Generics Market, 2007
Trade Association
AESEG
Members of AESEG, 2007
Local Manufacturers
Leading Spanish Generic Producers, 2007
Companies with Generics in the Market, January 2007
Number of Companies with Generics in the SNS Market, 2000-2006
Companies by Number of Generics in the SNS Market, 2000-2006
Companies by Number of Generics in the SNS Market, 2006
Adamed
Alter
Alter’s Financial Indicators, 2005-2006
Barr
Cantabria Pharma
Cinfa
Combino Pharm
DOMAC
Dr Reddy’s
Kern Pharma
Mabo-Farma
Merck
Normon
Normon’s Financial Indicators, 1997-2006
Pharmagenus
Ranbaxy
Ranbaxy Spain’s Sales, 2004-2006 (US$ Million)
ratiopharm
Sandoz
Novartis España’s Sales by Division, 2000-2005 (Million Euros)
Novartis España’s Employees by Division, 2000-2005
Sandoz’s Leading Generics, 2005
Stada
Laboratorio Stada’s Sales, 2003-2006 (Million Euros)
Teva
Regulatory Environment
Registration
Active Ingredients & Presentations of Generic Medicines, 2000-2006
Presentations by Patent Status, 2006
Presentations of Generic Medicines by Administration Type, 2000-2006
Presentations of Generic Medicines by Administration Type, 2000-2006 (%)
Active Ingredients & Presentations of Generic Medicines by Therapeutic Area, 2006
Active Ingredients with the Highest Number of Generic Presentations, 2000-2006
Active Ingredients with the Highest Number of Presentations by Patent Status, 2006
Pricing & Reimbursement
Co-Payments
Co-Payments, 2006
RPS Analysis
SNS Pharmaceutical Sales by the Reference Price System, 2005 (%)
Generic Pricing
Retail Prices of Presentations of Generic Medicines by Type, 2002-2006 (Euros)
Intellectual property
European Supplementary Protection Certificate
Directory
Government Organisations
Generic Trade Association
Generic Manufacturers


Summary: The four EU countries analysed in this report - France, Italy, Portugal, Spain - are expected to deliver significant double digit growth over the next 5 years and present stable, regulated operating environments with excellent prospects. Key Areas Addressed:
5-year market forecasts to 2012 for the pharmaceutical and generic drug markets
Analysis of market trends and outlook of key developments
Domestic production and review of leading companies
Regulatory environment
Health provision and plans

THIS REPORT ANSWERS KEY QUESTIONS
Which therapy sector accounted for the greatest part of the Spanish generics market in 2006?
What measures are in place to reduce generic prices in Portugal?
How might developments in the French reference pricing system affect the generics market?
What developments with supplementary protection certificates will positively affect the Italian generics market after 2010?
What are the 8 leading active ingredients to lose patent protection in Italy in 2007?
How has generic pravastatin fared in the French statin market against simvastatin?


For a complete review of the market, prospects and competitive environment in these important generic drugs markets make sure you read this unique report.




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