市場調査報告書：ジェネリック医薬品：ラテンアメリカ

Abstract

The Latin American Market for Generic Drugs

Rapid growth, high unmet clinical needs and increasing regulation are changing the face of Latin American pharmaceuticals. What are the opportunities and challenges for companies and investors wanting to develop or enter this growing market? This major strategic study compares 7 key markets.

Answering important questions about the future of generic drugs in Latin America

What effect is the move to better GMP and bioequivalence having on the market now, and what impact might it have on domestic companies in the future?
Patents and intellectual property have risen to the top of the industry's agenda, but is there political will to enforce compliance?
What role are ambitious Indian generic manufacturers taking in the region and what is their on going impact likely to be?

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

ラテンアメリカのジェネリック医薬品市場動向

The Latin American Market for Generic Drugs

Abstract

The Latin American Market for Generic Drugs

Answering important questions about the future of generic drugs in Latin America

Table of Contents