本報告已在2011年09月05日停止出版。
更改為出版
Generic Drugs: The Global Market
出版日期 : 2011年09月
商品編碼: 210210
本報告書內容包括：全球非專利藥品在2014年之前的銷售預測、一直以來都是非專利藥品標的的處方藥主要分類分析、美國、EU、日本非專利藥品的製造及行銷相關法規環境分析、主要供應商介紹等。內容綱要摘記如下：
第1章 介紹
第2章 摘要
第3章 市場概要
- 介紹及簡單的歷史介紹
- 近代藥品市場
- 法規限制狀況
- 非專利藥品的遊說活動
- 非專利藥品的現況
第4章 非專利產品分類
- 「簡單的」非專利藥品
- 適當的市場規模
- 專利到期的治療藥
- 仍在使用中的傳統產品
- 長期使用
- 製造技術
- 應用於基礎照護的藥品
- 超級非專利藥品
- 生物學名藥
- 課題
第5章 產品分類別市場機會
- 非專利分子
- 抗感染藥
- CNS治療藥
- 抗憂鬱劑
- 抗精神病藥
- 抗不安藥
- 睡眠障礙
- 癲癇
- 帕金森氏症
- 偏頭痛
- 心血管疾病
- 抗關節炎
- 類固醇
- 非類固醇抗炎症藥
- 抗類風濕性關節炎藥
- COX-II抑制劑
- 呼吸器官
- 氣喘
- COPD
- 過敏性鼻炎
- 氣喘及COPD使用的藥品
- 抗癌劑
- 細胞毒性藥
- 荷爾蒙治療
- BRM
- 抗血管生長劑
- 單株抗體
第6章 全球及地區別市場
- 全球藥品市場
- 全球非專利藥品市場
- 主要市場
- 非專利藥品產業
- 動向
- 北美
- 歐洲
- 拉丁美洲
- 亞洲
第7章 全球法規限制及專利預測
第8章 非專利藥品產業
Abstract
THIS REPORT:
- Provides an in-depth analysis of the global market for generic
pharmaceuticals, with discussion of the trends most affecting the industry
including an increased demand for generics
- Contains global market forecasts for sales in the generic pharmaceuticals
market through 2014
- Reviews the major categories of prescription drugs that are traditional
targets for generic copies
- Includes profiles of leading suppliers of generics together with a
description of their products and market share
- Describes the regulatory environment for production and marketing of
generics in the three main regulatory regions of the US, EU and Japan.
INTRODUCTION
STUDY GOALS AND OBJECTIVES
The aim of this report is to provide detailed market, technology, and industry
analyses to help readers quantify and qualify the market for prescription
generic drugs. Important trends are identified and sales forecasts by product
categories and major country markets are provided through 2014; these are
based on industry sources and considered assessment of the regulatory
environment, healthcare policies, demographics, and other factors that
directly affect the generic drug market. The wider economic environment is
also taken into account.
The report examines strategies employed by companies specializing in generics
to meet the challenges of this highly competitive market, while also
summarizing strategies employed by "originator" companies to forestall generic
competition.
REASONS FOR DOING THE STUDY
- This is a time of growth and change for the generic pharmaceutical sector.
Major aspects which combine to create an opportunity for an up-to date market
analysis include the following:
- The demand for generics is increasing steadily because of pressure to
control healthcare costs. At the same time fierce price competition in this
area has put some companies in difficulties because of slashed profit margins.
The main result has been a wave of M&A activity, and the rise of
"supergenerics" offering added value as well as low prices. Not all
traditional companies are placed to exploit this trend.
- A major growth driver for the generics sector is the fact that several
blockbuster pharmaceutical brands are coming off-patent and are therefore open
to generic competition. But the "originator" companies are deploying
formidable strategies to protect their franchise, including marketing their
own branded generics.
- With first-generation biopharmaceutical products reaching the end of their
patent lives, a whole new market field - biogenerics, or biosimilars - is
opening up, for those generics companies capable of (or prepared to buy-in)
the technological expertise required.
- The international landscape is changing for generics as for all
pharmaceuticals. China, India, Eastern European countries and Brazil are among
rising centers of generic activity.
SCOPE OF REPORT
This report discusses the implications of all the above-mentioned trends, in
the context of the current size and growth of the generics market, both in
global terms and analyzed by the most important national markets. The nature
and structure of the generics industry is discussed, with profiles of the
leading 10 to 20 generics companies, and an update on M&A activity. Five-year
sales forecasts are provided for the national markets and the major
therapeutic categories of products involved.
Market figures are based on revenues at the manufacturer level and are
projected at 2009-dollar value without attempting to predict the effect of
inflation/deflation.
Therapeutic categories quantified and forecast include antibacterials,
antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs
(e.g., hypolipidaemics and antihypertensives) and drugs for respiratory
conditions including asthma and COPD.
METHODOLOGY
Primary research includes interviews with leading individuals in generics
companies, industry associations and regulatory bodies. Primary sources of
published data include company annual reports, SEC filings, and government and
industry publications. Secondary sources consist of literature searches,
industry journals and other commercial publications. Data for market estimates
and forecasts are pooled from a range of sources, critically assessed by BCC.
INTENDED AUDIENCE
This report is designed to satisfy the information needs of a wide variety of
individuals involved in the generics marketplace, including company senior
management executives seeking to base their strategic decisions on the best
available information on market forces and trends. However it is also aimed at
managers and executives in marketing, research, planning and sales departments
who need readable, comprehensive and up-to-date background on the marketplace
in which they are operating.
INFORMATION SOURCES
Sources of information included marketing strategists, industry executives,
government agencies and regulatory bodies, and surveys of physicians and
pharmacists. Company annual reports and SEC filings, journal articles, and
data from healthcare institutions were also mined, as well as publications of
relevant trade associations such as the Generic Pharmaceutical Association
(GPhA) and the European Generic Medicines Association (EGA).
Table of Contents
Chapter- 1: INTRODUCTION -- Complimentary
- STUDY GOALS AND OBJECTIVES 1
- REASONS FOR DOING THE STUDY 1
- SCOPE OF REPORT 2
- MARKET ANALYSES AND FORECASTS 2
- METHODOLOGY 2
- INTENDED AUDIENCE 2
- INFORMATION SOURCES 3
- ANALYST CREDENTIALS 3
- RELATED REPORTS 3
- BCC ONLINE SERVICES 3
- DISCLAIMER 4
Chapter-2: SUMMARY 4
- SUMMARY 5
- MARKET SIZE AND EVOLUTION 6
- SUMMARY TABLE MAJOR NATIONAL GENERIC MARKETS ($ BILLIONS) 7
- SUMMARY FIGURE LEADING COMPANIES, SHARE OF WORLD GENERIC MARKET (%) 8
Chapter-3: OVERVIEW 7
- INTRODUCTION AND BRIEF HISTORY 9
- MODERN PHARMACEUTICAL ERA 10
- REGULATORY ASPECTS 11
- GENERICS LOBBY 12
- GENERICS LOBBY (CONTINUED) 13
- THE PRESENT GENERIC LANDSCAPE 14
- THE PRESENT GENERIC LANDSCAPE (CONTINUED) 15
Chapter-4: GENERIC PRODUCT CATEGORIES 10
- ' SIMPLE' GENERICS 16
- ADEQUATE MARKET SIZE 16
- PATENT-EXPIRED THERAPIES 16
- OLDER PRODUCTS STILL USED 17
- LONG-TERM USE 17
- STRAIGHTFORWARD PRODUCTION TECHNOLOGY 18
- DRUGS USED IN PRIMARY CARE 18
- SUPERGENERICS 19
- BIOSIMILARS 19
- SPECIAL CHALLENGES 20
- Special Challenges (Continued) 21
- TABLE 1 COMPANIES INVOLVED IN BIOSIMILAR R&D 22
- Biosimilars Market 23
- TABLE 2 MARKET OPPORTUNITIES FOR BIOSIMILARS 24
- Biosimilars Market (Continued) 25
Chapter-5: MARKET OPPORTUNITIES BY PRODUCT CLASS 27
- LEADING GENERIC MOLECULES 26
- TABLE 3 WIDELY PRESCRIBED GENERIC MOLECULES IN U.S. AND EUROPE 26
- ANTI-INFECTIVES 27
- TABLE 4 LEADING ANTI-INFECTIVE PRODUCTS IN 2008 SALES ESTIMATES ($
BILLIONS) 28
- TABLE 5 GENERIC ANTI-INFECTIVES MARKET SALES FORECAST, 2009 - 2014 ($
BILLIONS) 29
- CNS THERAPIES 29
- FIGURE 1 MAJOR DIVISIONS OF CNS MARKET, 2008 % 30
- ANTIDEPRESSANTS 30
- ANTIPSYCHOTICS 31
- TABLE 6 LEADING CNS PRODUCTS SALES ESTIMATES, 2008 ($ BILLION) 32
- ANXIOLYTICS 32
- SLEEP DISORDERS 33
- EPILEPSY 33
- PARKINSON' S DISEASE 34
- MIGRAINE 35
- TABLE 7 GENERIC CNS PRODUCTS MARKET FORECAST, THROUGH 2014 ($ BILLIONS) 35
- CARDIOVASCULAR PRODUCTS 35
- CARDIOVASCULAR PRODUCTS (CONTINUED) 36
- TABLE 8 LEADING CARDIOVASCULAR PRODUCTS, 2008 (SALES ESTIMATES IN $
BILLION) 37
- TABLE 9 GENERIC CARDIOVASCULAR PRODUCTS MARKET FORECAST THROUGH 2014 ($
BILLIONS) 38
- ANTI-ARTHRITIS PRODUCTS 38
- STEROIDS 39
- NSAIDS 39
- COX-II INHIBITORS 39
- DMARDS 40
- TABLE 10 ESTIMATED SALES OF LEADING ANTI-ARTHRITIS PRODUCTS, 2008 ($
BILLIONS) 41
- TABLE 11 GENERIC ANTI-INFLAMMATORY PRODUCTS MARKET FORECAST, THROUGH 2014
($ BILLIONS) 42
- RESPIRATORY PRODUCTS 42
- ASTHMA 42
- COPD 43
- ALLERGIC RHINITIS 43
- Allergic Rhinitis (Continued) 44
- TABLE 12 ESTIMATED SALES OF LEADING RESPIRATORY PRODUCTS, 2008 ($
BILLIONS) 45
- DRUGS USED IN ASTHMA AND COPD 46
- Bronchodilators 46
- Inhaled Bronchodilators 46
- Anticholinergics 46
- Oral Bronchodilators 47
- Leukotriene Antagonists 47
- Steroids 47
- FIGURE 2 ASTHMA MARKET - MAJOR PRODUCT CATEGORIES, 2008 % 48
- TABLE 13 GENERIC RESPIRATORY PRODUCTS MARKET FORECAST 2009 - 2014 ($
BILLIONS) 49
- ANTICANCER PRODUCTS 49
- CYTOTOXIC DRUGS 49
- HORMONAL THERAPY 49
- BIOLOGIC RESPONSE MODIFIERS 50
- ANTIANGIOGENESIS DRUGS 50
- MONOCLONAL ANTIBODIES 50
- TABLE 14 ESTIMATED SALES OF LEADING RESPIRATORY PRODUCTS, 2008 ($
BILLIONS) 51
- TABLE 15 GENERIC ANTICANCER PRODUCTS MARKET FORECAST, THROUGH 2014 ($
BILLIONS) 52
Chapter-6: GLOBAL AND NATIONAL MARKETS 39
- THE GLOBAL PHARMACEUTICAL MARKET 53
- GLOBAL GENERIC MARKET 53
- LEADING NATIONAL MARKETS 54
- THE GENERIC INDUSTRY 54
- TABLE 16 REVENUE DATA AND MARKET SHARES, BY COM PANY, 2008 54
- TRENDS 55
- NORTH AMERICA 55
- U.S. 55
- Market Size and Growth 55
- Recent Trends 56
- Generic Prices 56
- The U.S. Generics Industry 57
- FIGURE 3 LEADING U.S. GENERIC COMPANIES SALES, 2008 ($ BILLIONS) 57
- The Future 58
- TABLE 17 U.S. GENERICS MARKET, THROUGH 2014 ($ BILLIONS) 58
- FIGURE 4 U.S. GENERICS MARKET, 2006-2014 ($ BILLIONS) 59
- CANADA 59
- Canada (continued) 60
- TABLE 18 CANADIAN GENERICS MARKET, THROUGH 2014 $ BILLIONS 61
- FIGURE 5 CANADIAN GENERICS MARKET, 2006-2014 ($ BILLIONS) 61
- EUROPE 62
- FRANCE 62
- France (Continued) 63
- TABLE 19 GENERICS MARKET IN FRANCE, THROUGH 2014 ($ BILLIONS) 64
- FIGURE 6 GENERICS MARKET IN FRANCE, THROUGH 2014 ($ BILLIONS) 64
- GERMANY 64
- TABLE 20 GENERICS MARKET IN GERMANY, THROUGH 2014 ($ BILLIONS) 65
- FIGURE 7 GENERICS MARKET IN GERMANY, 2006-2014 ($ BILLIONS) 66
- ITALY 66
- TABLE 21 GENERICS MARKET IN ITALY, THROUGH 2014 ($ BILLIONS) 67
- FIGURE 8 GENERICS MARKET IN ITALY, 2006-2014 ($ BILLIONS) 68
- SPAIN 68
- Spain (Continued) 69
- TABLE 22 GENERICS MARKET IN SPAIN, THROUGH 2014 ($ BILLIONS) 70
- FIGURE 9 GENERICS MARKET IN SPAIN, 2006-2014 ($ BILLIONS) 70
- UNITED KINGDOM 70
- TABLE 23 GENERICS MARKET IN UNITED KINGDOM, THROUGH 2014 ($ BILLIONS) 71
- FIGURE 10 GENERICS MARKET IN UNITED KINGDOM, 2006-2014 ($ BILLIONS) 72
- LATIN AMERICA 72
- BRAZIL 73
- Brazil (Continued) 74
- TABLE 24 GENERICS MARKET IN BRAZIL, THROUGH 2014 ($ BILLIONS) 75
- FIGURE 11 GENERICS MARKET IN BRAZIL, 2006-2014 ($ BILLIONS) 75
- MEXICO 76
- TABLE 25 GENERICS MARKET IN MEXICO, THROUGH 2014 ($ BILLIONS) 77
- FIGURE 12 GENERICS MARKET IN MEXICO, 2006 2014 ($ BILLIONS) 78
- ASIA 78
- JAPAN 78
- Japan (Continued) 79
- Japan (Continued) 80
- TABLE 26 GENERICS MARKET IN JAPAN, THROUGH 2014 ($ BILLIONS) 81
- FIGURE 13 GENERICS MARKET IN JAPAN, 2006-2014 ($ BILLIONS) 81
- INDIA 82
- Patent Reform 82
- Generic Industry 83
- TABLE 27 SALES IN INDIA OF LOCAL AND FOREIGN COMPANIES, 2008 ($ MILLIONS)
83
- TABLE 28 GENERICS MARKET IN INDIA, THROUGH 2014 ($ BILLIONS) 84
- FIGURE 14 GENERICS MARKET IN INDIA, 2006-2014 ($ BILLIONS) 84
- CHINA 85
- Domestic Industry 86
- Foreign Company Involvement 87
- Market Trends 88
- Generic Exports 89
- TABLE 29 GENERICS MARKET IN CHINA, THROUGH 2014 ($ BILLIONS) 90
- FIGURE 15 GENERICS MARKET IN CHINA, 2006-2014 ($ BILLIONS) 91
Chapter-7: REGULATORY AND PATENT ASPECTS 19
- STRUCTURE OF THE GENERICS INDUSTRY 111
- COMPANY PROFILES 112
- ACTAVIS 112
- ALAPIS 113
- AMNEAL 114
- APOTEX 115
- Apotex (Continued) 116
- ASPEN 117
- Products 117
- Financials 118
- AUROBINDO 118
- Products 119
- Financials 119
- Looking Ahead 120
- BARR 120
- Financials 121
- BERLIN CHEMIE 121
- BIOCON 122
- Products 123
- Financials 124
- BIOGARAN 124
- Financials 125
- Looking Ahead 125
- CIPLA 126
- Financials 127
- COBALT 127
- Products 127
- DR REDDY' S 128
- Products 129
- Acquisitions 129
- Financials 129
- Looking Ahead 130
- EGIS 130
- APIs 131
- Pharmaceutical R&D 131
- Sales of Finished Products and Active Pharmaceutical Ingredients 131
- Products 131
- Products 132
- Financials 133
- TABLE 31 EGIS THIRD-QUARTER SALES, 2007 AND 2008 133
- GEDEON RICHTER 133
- Products 134
- Financials 134
- TABLE 32 GEDEON RICHTER' S TOPLINE RESULTS FOR 2008, FULL YEAR 135
- Looking Ahead 135
- GENEPHARM 135
- Products 136
- HOSPIRA 137
- Biogenerics 138
- Financials 138
- IVAX 139
- KRKA 140
- Products 140
- Financials 141
- Looking Ahead 141
- LUPIN 142
- LUPIN LTD. 142
- Financials 143
- MERCK GENERICS 144
- MYLAN 144
- Mylan (Continued) 145
- Financials 146
- Looking Ahead 146
- NICHI-IKO NICHI-IKO PHARMACEUTICAL CO., LTD. 147
- Products 147
- Financials 148
- Looking Ahead 148
- NIPPON-CHEMIPHAR 148
- Financials 149
- Looking Ahead 149
- NOVARTIS 149
- Financials 150
- Looking Ahead 151
- Products 151
- Products 152
- Financials 152
- Looking Ahead 152
- PAR 152
- Products 153
- Financials 153
- PFIZER 154
- TABLE 33 MAIN PRODUCTS COMING OFF-PATENT, 2010-2021 155
- Products 155
- Financials 155
- Products 156
- Financials 157
- RANBAXY 157
- History 157
- Acquisition by Daiichi Sankyo 158
- Financials 159
- Looking Ahead 159
- ROXANE 160
- SANDOZ 161
- Products 161
- SANOFI-AVENTIS 162
- Financials 163
- Looking Ahead 163
- SAWAI 164
- Products 164
- Financials 165
- Looking Ahead 165
- STADA 165
- Generics 166
- Biosimilars 166
- Financials 166
- Looking Ahead 167
- STRIDES 167
- Products 168
- Financials 169
- Looking Ahead 169
- TANABE SEIYAKU HANBAI 169
- Looking Ahead 170
- TEVA 170
- TEVA (Continued) 171
- Financials 172
- Looking Ahead 172
- WATSON 172
- Products 173
- Financials 173
- Looking Ahead 174
- WOCKHARDT 174
- Financials 175
- Looking Ahead 175
- ZYDUS CADILA 176
- Products 177
- Financials 177
APPENDIX I: FURTHER READING 178
- FURTHER READING (CONTINUED) 179
APPENDIX II: GLOSSARY OF ACRONYMS 180
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