Printer Friendly Printed from http://www.researchandmarkets.com/reports/455657 Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil Description: THE BRAZILIAN GENERIC MARKET IN CONTEXT A number of products are due to lose their patent protection between 2007 and 2012, bringing market opportunities worth US$307.2 million to the generics sector. Key products affected include Plavix in 2007, Mercilon in 2009 and Viagra and Lipitor, both in 2011. At manufacturers’ prices, their respective sales stood at US$41.1 million, US$58.3 million, US$73.1 million and US$53.4 million in 2005. Furthermore, in March 2007, ANVISA authorised the registration of generic alternatives to oral contraceptives and endogenous hormones. This sector was valued at US$481 million in 2006 and generic producers are expected to account for 60% by 2012. The leading producers, including Medley, EMS-Sigma Pharma and Eurofarma, have indicated that they will enter this market. Meeting the challenge of AIDS Since 1996, antiretrovirals have been provided free of charge to HIV/AIDS patients. The cost per patient fell from R$8,500 (US$4,574) in 1999 to R$3,400 (US$1,162) in 2004, but rose to US$2,500 in 2005. Costs remain high as imported antiretrovirals represent between 80% and 85% of the national AIDS programme’s expenditure. According to the Ministry of Health, public domestic manufacturers produce eight of the 17 antiretrovirals used. Brazil can issue compulsory licences and allow local generic production of imported antiretrovirals. So far, it has negotiated drug price reductions and encouraged local production under licence. However, the rising number of patients, increasing levels of drug resistance, rising costs, the lack of systematic surveillance of HIV prevalence and high-risk behaviour might still be a threat. Domestic producers dominate…for now? There were 66 producers with registrations of generic medicines in 2006, but the four leading producers, which are indigenous, controlled over 80% of the sector. Medley and EMS were the leaders, with a combined 65% market share, followed by Eurofarma and Aché. Mergers & acquisitions will continue to consolidate the Brazilian generics market. Local producers dominate with low prices and increasing production capabilities. They also have the local know-how to deal with bureaucracy and the government favours them. With the global generics markets consolidating into ever bigger groups, markets such as Brazil are increasingly under scrutiny from large generic corporates. All – with the exception of Teva – have some presence or alliance in Brazil, but it is probably only a question of time before the domination of the market by local companies changes. The prescribing challenge. If the generics market is to reach its full potential then it will have to tackle the prescribing habits of a great number of doctors who continue to prescribe branded products. Prescription of generic medicines is still low, representing 15.8% of the total in 2006, compared to 15.2% in 2005 or 11.8% in 2002. For some specific substances, however, generic medicines have achieved high prescription levels, for instance omeprazole (88%), cephalexin (77%) and fluconazole (65%). Using generics, consumers saved about US$2.2 billion in 2006. Domestic producers of generic pharmaceuticals evaluated in the report: - Aché-Biosintética - Americano (FARMASA) - Arrow (Erowlabs) - Brainfarma - Cimed - Cristália - EMS-Sigma Pharma - Eurofarma - Hipolabor - LAFEPE - Medley - Neo Química - Prati, Donaduzzi - Teuto - União Química Foreign producers of generic pharmaceuticals evaluated in the report: - Abbott - Apotex - Mepha-ratiopharm - Merck - Ranbaxy - Sandoz The report answers key questions such as: - What is the estimated value of the bioequivalent generic market now and in 2012? - What is the current regulatory situation for bioequivalent generics and how might it change? - What are the opportunities for international players looking to expand operations in Brazil? - How many products have just a single producer of a bioequivalent generic? What are they and which company is currently producing? - What key educational challenges must the industry overcome if it is to see the wider adoption of generics throughout the country. About the Author: This report has been written by Ricardo Vicente. Ricardo has over 5 years market analysis experience in pharmaceuticals. Among his recent studies are: - The Latin American Market for Generic Drugs - The Outlook for Pharmaceuticals in Latin America to 2011 Contents: FOREWORD EXECUTIVE SUMMARY REGULATORY ENVIRONMENT OF GENERIC MEDICINES IN BRAZIL Regulation of Generic Medicines Regulation of Similar Medicines Future Regulation of Biosimilar Medicines Registration of Generic Medicines How to Register Generic Medicines Centres to Perform Bioquivalence Studies Registrations of Generic Medicines Marketing Authorisations of Generic Medicines Labelling & Packaging of Generic Medicines Proposal to Include the Reference Drug Name Indian Producer Targeting Packaging of Generic Medicines Patent Protection & Intellectual Property Rights Lobbying Against Patent Extensions in the Pipeline System Deal Agreed to Reduce the Price of Abbott’s Kaletra Pricing Policies Implications for the Industry Excessive Taxes on Drugs New Drug Discounts in the Public Sector Pricing of Generic Medicines OVERVIEW OF THE GENERICS MARKET IN LATIN AMERICA OVERVIEW OF THE PHARMACEUTICAL MARKET IN BRAZIL MARKET FOR GENERIC MEDICINES IN BRAZIL Sales of Generic Medicines in the Pharmacy Sector Market Projections for Generic Medicines Market Outlook for Generic Medicines Production of Oral Generic Contraceptives & Hormones More Uniform Market Penetration Across all the Regions Unsustainable Reliance on Original HIV/AIDS Medicines Foreign Generic Producers Squashed by Local Competition Sales Strategies Devised by Producers of Generic Medicines Potential Government Production of Bioequivalent Generic Medicines Original Drugs with Patents Close to Expiry Challenges in the Public Sector Teva’s Acquisition Possibilities in Brazil Generics, High Cost Savings but Low Prescription Levels Domestic Production of Generic Medicines Pólo Farmoquímico de Goiás Investments Undertaken by Producers of Generic Medicines Relevant Trade Associations ALANAC ALFOB Pró-Genéricos DOMESTIC PRODUCERS OF GENERIC MEDICINES IN BRAZIL Aché Product Portfolio Biosintetica’s Product Portfolio Financial Indicators Biosintética’s Financial Indicators R&D Manufacturing Capabilities Biosintética’s Manufacturing Capabilities Contact Details Americano de Farmacoterapia (FARMASA) Product Portfolio Financial Indicators R&D Manufacturing Capabilities Contact Details Arrow (Erowlabs) Product Portfolio Manufacturing Capabilities Contact Details Brainfarma Product Portfolio Financial Indicators Manufacturing Capabilities Contact Details Cimed Product Portfolio Financial Indicators R&D Manufacturing Capabilities Distribution Facilities Contact Details Cristália Product Portfolio Financial Indicators R&D Manufacturing Capabilities Contact Details EMS Sigma Pharma Product Portfolio Financial Indicators R&D Manufacturing Capabilities Contact Details Eurofarma Product Portfolio Financial Indicators R&D Manufacturing Capabilities Contact Details Hipolabor Product Portfolio Manufacturing Capabilities Contact Details LAFEPE Product Portfolio Financial Indicators Manufacturing Capabilities Contact Details Medley Product Portfolio Extended Exclusivity Deal with Abbott International Agreements Financial Indicators Manufacturing Capabilities Contact Details Neo Química Product Portfolio Financial Indicators R&D Manufacturing Capabilities Distribution Facilities Contact Details Prati, Donaduzzi Product Portfolio Manufacturing Capabilities Contact Details Teuto Product Portfolio Financial Indicators Manufacturing Capabilities Contact Details União Química Product Portfolio Financial Indicators Manufacturing Capabilities Contact Details MULTINATIONAL PRODUCERS OF GENERIC MEDICINES IN BRAZIL Abbott Product Portfolio Manufacturing Capabilities Contact Details Apotex Product Portfolio Contact Details Mepha - ratiopharm Product Portfolio Financial Indicators Planned Manufacturing Capabilities Contact Details Merck KGaA Product Portfolio Financial Indicators Production Capabilities Contact Details Ranbaxy Product Portfolio Financial Indicators Manufacturing Capabilities Contact Details Sandoz Product Portfolio Financial Indicators Production Capabilities Contact Details KEY NATIONAL DATA PROJECTIONS APPENDICES DIRECTORY Government Organisations Producers of Generic Medicines Trade Associations List of Tables National Bioequivalence Centres Authorised by ANVISA, 2007 International Bioequivalence Centres Authorised by ANVISA, 2007 Active Ingredients, Registrations & Presentations of Generic Medicines, 2000-2006 Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-2006 Registrations of Generic Medicines by Product Type, 2006 Registrations of Generic Medicines by Product Type, 2006 (%) Registrations of Generic Medicines by Origin, 2006 Registrations of Generic Medicines by Producer, 2006 Original Drugs with the Highest Number of Generic Registrations, January 2007 Producers with Generic Registrations of Leading Original Drugs, January 2007 Marketing Authorisations of Generic Medicines by Producer, July 2006 Registrations & Marketing Authorisations of Generics by Producer, 2006 Drugs with the Highest Number of Generics Marketing Authorisations, July 2006 Producers with Generic Marketing Authorisations to Leading Drugs, July 2006 Marketed Active Ingredients, Registrations & Presentations of Generics, 2005 Marketed Generic Medicines by Origin, July 2005 Drug Price Adjustments, 2003-2006 (%) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (US$ Million) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (Million Units) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%) Summary of the Brazilian Pharmaceutical Market, 2007 Brazilian Pharmaceutical Market by Value & Volume, 1997-2006 Brazilian Pharmacy Sector by Value & Volume, 2003-2006 Brazilian Pharmacy Sector by Value, 1997-2005 Pharmacy Sales of Generic Medicines by Value, 2000-2006 Pharmacy Sales of Generic Medicines by Leading Producer, 2006 Pharmacy Sales of Generic Medicines by Origin, 2006 (%) Pharmacy Sales of Generic Medicines by Volume, 2000-2006 Sales of Generic Medicines by Month as % of the Pharmacy Sector, 2005-2006 Generics Market Projections, 2007-2012 Generics & Total Pharmaceutical Market Projections, 2007-2012 (US$ billion) Original Drugs with Patent Close to Expiry, 2006-2013 SWOT Analysis of the Market of Generic Medicines, 2007 Workforce by Leading Producers of Generic Pharmaceuticals in Goiás Members of ALANAC, 2006 Members of ALFOB, 2006 Pró-Genéricos’ Members, 2007 Aché’s Leading Products by Therapeutic Area, 2005 Aché & Biosintética’s Therapeutic/Product Areas, 2005 Biosintética’s Registrations & Marketing Authorisations of Generic Medicines, 2006 Aché’s & Biosintética’s Gross Revenues by Therapeutic Areas, 2005 Biosintética’s Sales, 2001-2004 Biosintética’s Pharmaceutical Sales by Therapeutic Areas, 2004 Americano’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Erowlabs’ Registrations & Marketing Authorisations of Generic Medicines, 2007 Brainfarma’s Registrations & Marketing Authorisations of Generic Medicines, 2006 Cimed’s Registrations of Generic Medicines, January 2007 Cristália’s Business Units, 2006 Cristália’s Registrations & Marketing Authorisations of Generic Medicines, 2006 EMS’ Generics Registrations & Marketing Authorisations by Division, 2006 EMS’ Registrations & Marketing Authorisations of Generic Medicines, 2007 EMS’ Sales by Division, 2006 Eurofarma’s Generic Medicines, 2005 Eurofarma’s Pharmaceutical & Generic Sales, 2004-2007 Hipolabor’s Registrations & Marketing Authorisations of Generic Medicines, 2006 LAFEPE’s Product Lines, 2007 Medley’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Medley’s International Agreements, 1992-2005 Neo Química’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Prati, Donaduzzi’s Registrations & Marketing Authorisations of Generics, 2007 Teuto’s Registrations & Marketing Authorisations of Generic Medicines, 2007 U. Química’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Abbott’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Apotex’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Mepha’s Registrations & Marketing Authorisations of Generic Medicines, 2006 Merck’s Registrations & Marketing Authorisations of Generic Medicines, 2007 Ranbaxy’s Presentations of Generic Medicines, 2007 .125 Novartis’ (Sandoz) Registrations & Marketing Authorisations of Generics, 2006 Sandoz’s (Hexal) Registrations & Marketing Authorisations of Generics, 2006 Key Data, 2007-2012 Registrations of Generic Medicines by Active Ingredient, January 2007 Marketing Authorisations of Generic Medicines by Active Ingredient, July 2006 List of Figures Bioquivalent Studies, 2002-2005 Cumulative Active Ingredients, Registrations & Presentations of Generics, 2000-2006 Cumulative Registrations of Generic Medicines by Therapeutic Area, 2006 (%) Registrations of Generic Medicines by Product Type, 2006 Registrations of Generic Medicines by Foreign Origin, 2006 Registrations of Generic Medicines by the 20 Leading Producers, 2006 Marketing Authorisations of Generic Medicines by Leading Producers, July 2006 Registrations & Marketing Authorisations of Generics by Leading Producers, 2006 Registrations & Marketing Authorisations of Generics by Leading Producers, 2006 (%) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (US$ Million) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (Million Units) Pharmacy & Generics Sales by Leading Latin American Country, 2006 (%) Brazilian Pharmaceutical Market by Value, 1997-2006 Change in the Brazilian Pharmaceutical Market by Value & Volume, 1997-2006 Brazilian Pharmacy Sector by Value & Volume, 2003-2006 Pharmacy Sales of Generic Medicines by Value, 2000-2006 Pharmacy Sales of Generic Medicines by Volume, 2000-2006 Sales of Generic Medicines by Month as Percentage of the Pharmacy Sector, 2006 Generics & Total Pharmaceutical Market Projections, 2007-2012 (US$ Billion) Pharmacy Sales of Oral Contraceptives & Hormones, 2006 (%) Generics by Region as % of the Pharmacy Sector by Volume, Jan–June 2006 Generics Sales by Volume & Region, Jan–June 2006 (%) Estimated Federal Pharmaceutical Expenditure, 2002-2007 Prescriptions of Generic Medicines, 2002-2006 (%) Cost Savings by Using Generic Medicines, 2001-2006 (US$ Million) Producers of Generic Pharmaceuticals in Goiás PharmaChemical Cluster, 2006 OPPORTUNITIES & CHALLENGES FOR GENERICS IN BRAZIL R&D Investments in the Market of Generic Medicines by Type, 1999-2004 (%) Aché’s Gross Revenues, 2001-2005 (US$ Million) Biosintética’s Sales, 2001-2004 Cimed’s Sales, 2004-2007 Eurofarma’s Generics Sales as Percentage of Total Sales, 2004-2007 Ranbaxy’s Sales, 2003-2006 Sandoz’s Sales, 2003-2006 Summary: An expanding market, a growing population, a regulatory regime supportive of the generics sector, robust domestic production and many untapped opportunities. Is Brazil the place for generic companies to be? The world’s major emerging economies are attracting much investment and interest. Brazil is not least among them, and it is easy to see why with a population of 189 million and a GDP of US$978 billion in 2007. But there are particular attractions for the producers of generic pharmaceuticals. For years the “generic” market was little more than a series of copycat products, similar to the branded product but not necessarily bioequivalent. Under increasing pressure from industry to respect patents, and with one eye on the need to cost effectively meet the growing health needs, the Brazilian authorities have led the way in the region in creating a market for truly bioequivalent generic drugs which now ranks in the top ten worldwide. The generics market, already in a strong growth phase, is well placed to continue its future expansion. The generic production of oral contraceptives and endogenous hormones was approved in March 2007, a number of leading brands are due to lose their patent protection over the next 5 years and the use of generic drugs is expected to grow as price pressures bite. But who are the leading players and what are their strengths? What barriers to market entry exist? What routes to market are favourable? What will be the operating and regulatory environment for companies? The answers to these and many other questions can be found in this new 200-page management report Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil (Published April 2007). Key areas addressed: - 5-Year market forecast to 2012 - The generics market in context - Review of the product registration procedure - Pricing issues and reimbursement - Political, legal and economic assessment - Insightful review of 20 major domestic and foreign players in the market - Detailed product registration data. Who produces what? Includes much information not available in English elsewhere! Companies Mentioned - Aché-Biosintética - Americano (FARMASA) - Arrow (Erowlabs) - Brainfarma - Cimed - Cristália - EMS-Sigma Pharma - Eurofarma - Hipolabor - LAFEPE - Medley - Neo Química - Prati, Donaduzzi - Teuto - União Química - Abbott - Apotex - Mepha-ratiopharm - Merck - Ranbaxy - Sandoz Ordering: Order Online - visit http://www.researchandmarkets.com/reports/455657 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. Page 1 of 2 Printed 20/07/2008 08:52:10 Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to 646-607-1907 (from USA) or +353 1 6849977 (from Rest of World). 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