巴西生物相等性學名藥的機會及課題 是由出版商Espicom Business Intelligence在2007年04月所出版的。
這份英文市場調查報告書包含190 Pages 價格從美金1390起跳。
巴西是全球知名的幾個新興經濟發展大國，在2007年的人口有1億8,900万人，GDP也達到了9億7,800萬美元。
提供製藥、醫療機器市場相關具有權威的資訊的市調公司 Espicom Business Intelligence（總公司：England），針對巴西生物相等性學名藥的機會及課題進行調查分析，並出版報告書"Opportunities and Challenges for Bioequivalent Generic Drugs in Brazil"。
本報告書內容包括：巴西生物相等性學名藥的主要製造商及其優勢、市場進入障礙、規範環境等。包含圖表共計190頁的內容綱要摘記如下：
實施概要
巴西生物相等性學名藥的規範環境
- 對學名藥的規範
- 學名藥的登記
- 學名藥的登記方法
- 生物相等性研究的進行地點
- 學名藥的登記
- 學名藥的行銷權限
- 學名藥的標籤及包裝
- 包含藥劑名稱的提議
- 以印度的製藥企業為競爭對手的學名藥包裝
- 專利保護及智慧財產權
- 在產品線藥系統中增加專利的遊說活動
- Abbott同意Kaletra價格調降的交易
- 價格制定方針
- 對產業的影響
- 對藥物課以過重的税
- 民間領域的新一波藥物折扣
- 學名藥的價格
拉丁美洲學名藥市場概要
巴西學名藥市場概要
巴西學名藥市場
- 製藥領域中學名藥的銷售成績
- 學名藥市場預測
- 學名藥市場發展預測
- 口服學名避妊藥及荷爾蒙的生產
- 在所有地區都更加具整合性的市場滲透
- 缺乏對獨創HIV/AIDS治療藥的信頼
- 疲於與當地企業競爭的外國學名藥生產企業
- 學名藥生產企業的銷售策略
- 獲得政府支援的生物相等性學名藥的生產趨勢
- 專利即將到期失效的藥物
- 民間領域的課題
- 巴西的Teva被收購的可能性
- 學名藥雖大幅降低成本，但處方水準不高
- 學名藥的國内生產
- Polo Farmoquimico de Goias
- 學名藥藥商的投資
- 相關產業團體
- ALANAC
- ALFOB
- Pro-Genericos
巴西的國內學名藥製造企業
- Ache
- Americano de Farmacoterapia
- Arrow
- Brainfarma
- Cimed
- Cristalia
- EMS Sigma Pharma
- Eurofarma
- Hipolabor
- LAFEPE
- Medley
- Neo Quimica
- Prati, Donaduzzi
- Teuto
- Uniao Quimica
巴西的多國籍學名藥企業
- Abbott
- Apotex
- Mepha-ratiopharm
- Merck KGaA
- Ranbaxy
- Sandoz
主要國内資料預測
附錄
索引
圖表
Abstract
This new report puts the generic market in context, providing a review of the
regulatory environment, the major domestic manufacturers, market analysis and
five-year market forecasts to 2012.
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).
Table of 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
- 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
- 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
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