Report: The Latin American Market for Generic Drugs TOC

FOREWORD

About the Author

OVERVIEW: THE LATIN AMERICAN MARKET

KEY DATA
- Key Data in Selected Latin American (LA) Countries, 2005
- Population Projection in Selected LA Countries, 2005-2010 (Million)
- Population Aged 65+ Projection in Selected LA Countries, 2005-2010 (Million)
- GDP Projection in Selected LA Countries, 2005-2010 (US$ Billion)
- Health Expenditure Projection in Selected LA Countries, 2005-2010 (US$ Billion)
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Pan American Pharmaceutical Regulation
- Harmonisation
  - PANDRH's Working Groups
  - IV PACDRH's Conclusions & Recommendations for Bioequivalence and Bioavailability
- Generic Prescription Trends in Latin America
  - Generic Prescription & Substitution in Selected LA Countries, 2005
- Generic Bioequivalence in Latin America
  - Bioequivalence Enforcement in Selected LA Countries, 2005
- Patent Protection & IP Rights Weaknesses in
- Latin America
  - USTR's Special 301 Report in Selected LA Countries, 2005
- Pricing & Reimbursement Encouraging Generics in
- Latin America
  - Pricing Status in Selected LA Countries, 2005
GENERIC MARKET
- Pharmaceutical Market Overview in Latin America
  - Pharmaceutical Market Size in Selected LA Countries, 2005
  - Pharmaceutical Market Expenditure per Capita in Selected LA Countries, 2005
- Generic Market Size in Latin America
  - Generic Market Size in Selected LA Countries, 2005
- Generic Market Projections in Latin America
  - Generic Market Projections in Selected LA Countries, 2005 (US$ Million)
  - SWOT Analysis of the Generic Market in Selected LA Countries, 2005
Generic Production in Latin America
- IVAX' LA Sales, 2000-2004 (US$ Million)
- Generic Producers in Selected LA Countries, 2005
- Generic Market Developments in Latin America
- Increasing generic manufacturing & clinical
- capabilities in Latin America
- Further generic industry consolidation in Latin
- America
- Competition arises from Indian generic producers
- in Latin America
- Generic HIV/AIDS availability in Latin America

MARKET PROFILE: ARGENTINA

KEY DATA
- Key National Data, 2005
- Key National Data Projections, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
  - Population Covered by Generic Prescription by Province, September 2002
- Generic Prescribing
  - Generic Prescribing, 2003 (%)
- Bioequivalence
  - Bioequivalence Regulation, 1992-2003
- Patent Protection & Intellectual Property Rights
- Pricing and Reimbursement
  - Major Measures of the National Policy of Medicines, 2002
  - Potential Savings due to Generic Penetration, 2002-2003 (Million Pesos)
  - Price Reduction by Selected Active Ingredient, 2002-2003 (%)
GENERIC MARKET
- Pharmaceutical Market Overview
  - Summary of the Pharmaceutical Market at Retail Prices, 2005
- Generic Market Size
  - Generic Sales by Sector, 2002-2003 (Million Pesos)
  - Generic Sales by Sector, 2002-2003 (US$ Million)
  - Generic Sales by Sector, 2002-2003 (Million Units)
- Generic Market Projections
  - Generic Market Projections, 2005-2010
  - SWOT Analysis of the Argentinian Generic Market, 2006
- Generic Production
- Generic Trade Association
- CAPGEN
  - Members of CAPGEN, 2005
- Domestic Generic Producers
- Ahimsa Hexa
- Ahimsa
- Hexa-Medinova
- Apolo
- Cevallos
- CONIFARMA
- Denver Farma
- Fabop
- Fabra
- Fada Pharma
- Filaxis
- Instituto Biologico Argentino
- Klonal
- Medipharma
  - Medipharma's Product Portfolio, 2005
- Pablo Cassara
- Richet
- Richmond
- Vannier
- Veinfar
- Vent-3
- Multinational Generic Producers
- Sandoz
- Hexal
- Teva-Tuteur
- IVAX
- Generic Research & Development
  - Plant Developments by Generic Producers, 2003-2005
Generic Market Developments
- Argentina and Brazil working together for cheaper antiretrovirals in
- Latin America
- Local 'generic' producers represented 51% of
- the pharmacy sector in 2004
  - Pharmacy Sales by Manufacturers' Origin, 2004 (%)
  - Pharmacy Sales by Leading Producer, 2004
- The REMEDIAR Programme

MARKET PROFILE: BRAZIL

KEY DATA
- Key National Data, 2005
- Key National Data Projections, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
  - Certified Centres to Perform Bioequivalence Tests, August 2005
- Generic Registration
  - Key Generic Registration Facts, 2003 & 2005
  - Generic Registrations by Origin, July 2005
  - Generic Registrations by Producer, July 2005
  - Producers with Generic Registrations Approved by ANVISA, 2005
  - Marketed Generics by Origin, July 2005
- Generic Labelling & Packaging
- Patent Protection & Intellectual Property Rights
- Pricing Policies
- Generic Pricing
GENERIC MARKET
- Pharmaceutical Market Overview
  - Summary of the Brazilian Pharmaceutical Market, 2005
  - Pharmaceutical Market, 1997-2005
- Generic Market Size
  - Generic Sales by Value & Volume as % of the Pharmacy Sector, Jan-Oct 2005
  - Generic Pharmacy Quarter Sales by Value and Volume, 2005
  - Generic Pharmacy Sales by Value and Volume, 2000-2005
- Generic Market Projections
  - Generic Market Projections, 2005-2010
  - SWOT Analysis of the Brazilian Generic Market, 2005
- Generic Domestic Production
- Generic Trade Association
- Pro-Genericos
  - Pro-Genericos' Associates, 2005
- Domestic Generic Producers
- Biosintetica
  - Biosintetica's Pharmaceutical Sales, 2001-2004
  - Biosintetica's Pharmaceutical Sales by Therapeutic Areas, 2004
- Cimed
- Cristalia
  - Cristalia's Business Units, 2005
- EMS
- Eurofarma
- Farmasa
- Medley
  - Medley's International Agreements, 1992-2005
- Nortec Quimica
- Multinational Generic Producers
- Apotex
- Merck SA
- Novartis Genericos (Sandoz)
- Ranbaxy
- Ratiopharm
- Stada (Avastada Pharma)
- Strides Arcolab
- Generic Research & Development
Generic Market Developments
- New opportunities for mergers & acquisitions in
- the generic sector, December 2005
- EMS, Medley and Eurofarma are investing in the
- generic sector in 2006
- Pharmaceutical producers sentenced in 2005 for
- anticompetitive practices against generics in 1999
- Decree 4,830/2003 used to reduce prices of
- imported AIDS antiretrovirals
- A deal was agreed to reduce the price of Abbott's
- Kaletra in October 2005

MARKET PROFILE: CHILE

Key National Data, 2005
Key National Data Projections, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
- Generic Registration
  - Registrations of Original & Similar Products, 1999-2002
- Patent Protection & Intellectual Property Rights
- Pricing & Reimbursement
  - Cumulative Price Variation, 1998-July 2003 (%)
  - Generic, Branded Generic & Original Drug Prices, 2002 & 2004 (US$)
- Reimbursement
GENERIC MARKET
- Pharmaceutical Market Overview
  - Summary of the Chilean Pharmaceutical Market, 2004-2005
- Generic Market Size
- Pharmacy Sector
  - Sales of Branded Generics, Originals & Generics, 2002 & 2004 Billion Pesos)
  - Sales of Branded Generics, Originals & Generics, 2002 & 2004 (US$ Million)
  - Sales of Branded Generics, Originals & Generics, 2002 & 2004 (Million Units)
  - Sales of Branded Generics, Originals & Generics, 2004
- Hospital Sector
- Public Hospital Sector
  - Public Hospital Branded & Generic Sales, 1999 (Billion Pesos & US$ Million)
- Generic Market Projections
  - Generic Market Projections, 2005-2010 (US$ Million)
  - SWOT Analysis of the Chilean Generic Market, 2005
- Domestic Production
- Domestic Generic Producers
- Andromaco
  - Laboratorios Andromaco's Consolidated Sales,2000-2004 (US$ Million)
- Bestpharma
- Biosano
- LabChile
  - IVAX's Sales, 2000-2004 (US$ Million)
- Maver
- Mintlab
Generic Market Developments
- Draft of the New National Pharmaceutical Policy,April 2004
  - The National Pharmaceutical Policy, April 2004
- Further imports of Indian generics are expected in 2006

MARKET PROFILE: COLOMBIA

KEY DATA
- Key National Data, 2005
- Key National Data Projections, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
  - PFN's Priorities for Ensuring Drug Quality, December 2003
- Generic Registration
- Patent Protection & Intellectual Property Rights
  - Summary of the US-Andean Intellectual Property Concerns, 2005
- Pricing
- ASINFAR, AFIDRO and ANDI suggest a new price
- system in Colombia, June 2005 Reimbursement
GENERIC MARKET
- Pharmaceutical Market Overview
- Summary of the Colombian Pharmaceutical Market, 2002-2005
- Generic Market Size
- Generic Pharmacy Sales
  - Bioequivalent Generic Sales within the Pharmacy Sector, 2003 (US$ Million)
  - Bioequivalent Generic Sales within the Pharmacy Sector, 2003 (%)
  - Pharmacy Generic Sales by Value, 1995 & 2000 (%)
  - Pharmacy Generic Sales by Value, 1995/2000 (%)
  - Pharmacy Sector by Volume, 1999-2002 (Million Units)
  - Pharmacy Generic Sales by Volume, 2002 (%)
- Institutional Generic Sales
- Generic Market Projections
  - Generic Market Projections, 2005-2010 (US$ Million)
  - SWOT Analysis of the Colombian Generic Market, 2005
- Generic Domestic Production
- Trade Associations Relevant to Generic Producers
- ANDI
- ASINFAR
- Generic Producers
- Ecar
- Genfar
- Lafrancol
La Sante
- Generic Market Developments
- Price analysis between MSD's Mevacor (lovastatin) and generic alternatives
  - Price Comparison between Generic Versions of Lovastatin 20 Mg, July 2005
  - Generic Versions of Lovastatin 20 Mg at Manufacturers' Prices, 2000-2004122
- Antiretrovirals to be reduced by up to 66% in Latin America, agreed in August 2005122
- The arrival of foreign pharmacy chains
- New regulation for Colombian prescribers and
- dispensers, issued in June 2005

MARKET PROFILE: MEXICO

KEY DATA
- Key National Data, 2005
- Key National Data Projections, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
- Generic Substitution
- Generic Registration
  - Statistics of Bioequivalent Generics, July 2004
- Patent Protection and Intellectual Property Rights
- Pricing
GENERIC MARKET
- Pharmaceutical Market Overview
  - Summary of the Mexican Pharmaceutical Market, 2005
- Generic Market Size
- Generic Sales, 2003-2004
- Pharmacy Sector by Patent Status, 2003 (%)
- Generic Market Projections
  - Generic Market Projections, 2005-2010
  - SWOT Analysis of the Mexican Generic Market, 2005
- Generic Domestic Production
- Generic Trade Associations
- AMEGI
- ANAFAM
  - Associates to ANAFAM
- Generic Producers
- Apotex
- Kendrick
- Kener
- Probiomed
- QUIFA
- Sandoz
- Silanes
- Strides Arcolab (Solara)
- Teva
- IVAX
- Lemery
  - Products Licensed to Lemery, 2003
- Generic Research & Development
Generic Market Developments
- Farmacias Similares: 'pareciditos' versus generics
- Import regulations against foreign generic producers?
- Dr. Reddy's entered into an agreement to acquireRoche's Mexican API business

MARKET PROFILE: PERU

KEY DATA
- Key National Data, 2005
- Key Data, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
- Proposals to introduce bioequivalence &
- bioavailability tests
- Generic substitution
- Generic Registration
  - Original, Branded Generic & Generic Registrations, August 2004
- Patent Protection & Intellectual Property Rights
  - Pharmaceutical Patents, 1994-2004
  - Granted Pharmaceutical Patents by Company, 1994-2004
- Pricing & Reimbursement
PHARMACEUTICAL MARKET
- Pharmaceutical Market Overview
  - Summary of the Peruvian Pharmaceutical Market, 2004-2005
- Generic Market Size
  - Domestic Producers by Pharmacy Value and Volume, 2003
- Hospital Sector
  - ESSALUD
    - ESSALUD's Pharmaceutical Expenditure, 2003 (US$ Million)
- MINSA
- Generic Market Projections
  - Generic Market Projections, 2005-2010 (US$ Million)
  - Pharmacy Generic Market Projections, 2005-2010 (US$ Million)
  - Generic Market Projections, 2005-2010 (US$ Million)
  - SWOT Analysis of the Peruvian Generic Market, 2005
- Generic Domestic Production
- Parallel importers
- Trade Association Relevant to Generics
- ADIFAN
  - Producers Associated to ADIFAN, 2002
- Generic Producers
- Farmindustria
- Infarmasa Corporation
- Medco Corporation
Market Developments
- MINSA recommendations on drug prices and access, April 2005
- Advances in intellectual property rights as part of the US-Andean Free Trade Agreement
  - Registered Copies of Ten Leading Patented Drugs, 2004
  - Marketed Copies of Ten Leading Patented Drugs, 2004
  - FTA Impact on Drug Prices, 2006-2035 (%)
  - FTA Impact on Drug Prices by Sector, 2006-2036 (US$ Million)
- Antiretrovirals to be reduced by up to 66% in Latin America, agreed in
- August 2005

MARKET PROFILE: VENEZUELA

KEY DATA
- Key National Data, 2005
- Key National Data Projections, 2005-2010
EXECUTIVE SUMMARY
GENERIC REGULATORY ENVIRONMENT
- Generic Regulation
- Generic Registration
  - Pharmaceutical Presentations by Type, 2005
  - Pharmaceutical Products by Type, 2003-2004
- Patent Protection and Intellectual Property Rights
- Pricing
- Generic Pricing
  - Average Price of Generics in the Pharmacy Sector, 2001-2005 (US$)
  - Price Comparison between Selected Generic & Branded Drugs, 2005
GENERIC MARKET
- Pharmaceutical Market Overview
  - Summary of the Venezuelan Pharmaceutical Market, 2005
  - Pharmacy & Hospital Market at Manufacturers' Prices, 2001-2004 (US$ Billion)
- Generic Market Size
- Generic Pharmacy Sales
  - Generic Pharmacy Sales, 2001-2005 (US$ Million)
  - Pharmacy Sales by Sector, 2001-2005 (US$ Million)
  - Pharmacy Sales by Sector as % of Total, 2001-2005
  - Change in Pharmacy Sales by Sector, 2001-2005 (%)
  - Generic Pharmacy Sales, 2001-2005 (Million Units)
  - Pharmacy Sales by Sector, 2001-2005 (Million Units)
  - Pharmacy Sales by Sector as % of Total, 2001-2005
  - Change in Pharmacy Sales by Sector, 2002-2005 (%)
  - Pharmacy Sales of Selected Generic & Branded Drugs, 2001-2005 (Units)
  - Leading Generic Producers by Pharmacy Volume, 2001-2005 (Million Units)
  - Pharmacy Share by Volume by Leading Generic Producers, 2001-2005 (%)
  - Change in Pharmacy Sales by Volume by Leading Generic Producers, 2002-2005 (%)
- Generic Hospital Sales
- Generic Market Projections
  - Generic Market Projections, 2005-2010 (US$ Million)
  - SWOT Analysis of the Venezuelan Generic Market, 2005
- Generic Domestic Production
  - Generic Producers by Origin, 2005 (%)
- Generic Trade Associations
- CANAMEGA
- CIFAR
- Generic Trade Fair
- CEIFAV 2005
- Generic Producers
- Calox Internacional
- Cofasa
- Elmor
- Galeno Quimica (Galeno Quimica & Elter)
- Kimiceg
- Leti (Biocontrolled, Genven Leti, Leti & Megat Leti)
- Meyer (Alian, Meyer & Daliol)
Generic Market Developments
- Essential medicines prices regulated from October 2005
- US$152 million authorised to generic producers between 2003 and 2005
- Supply of antiretrovirals meets 100% of the country's needs
- Antiretroviral prices reduced in Latin America

SOURCES

The Latin American Market for Generic Drugs

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