Emerging Generic Drug Markets in Europe

Date: December 22, 2007
Pages: 196
Price:
US$ 1,390.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: E5E80D0F342EN
Leaflet:

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Emerging Generic Drug Markets in Europe
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.
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
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