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市場調查報告書
生技學名藥市場展望：市場動態、發展要因、主要企業分析
The Biogenerics Market Outlook: An Analysis of Market Dynamics, Growth Drivers and Leading Players
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本報告已在2011年07月19日停止出版。
品牌生技藥物為生技與醫藥業界創造了320億美元的營收，是醫藥品領域成長最快的部門，但在生技學名藥的引進下，未來的市場狀況更需注意。
專研多領域成長部門策略性調查的英國專業公司 Business Insights（總公司：倫敦），調查分析了美國、歐盟與其他地區的生技學名藥市場後，出版了一本綜合報告書"The Biogenerics Market Outlook: An analysis of market dynamics, growth drivers and leading players"。
報告書內容包括：因生技學名藥而獲利或損失的企業、生技學名藥爭取市佔率的成功策略與需克服的障礙等等，全書含 29 幅圖表，共 87 頁，內容綱要摘記如下：
第1章 生技藥物市場概要
- 生技學名藥的重要性
- 生技學名藥與生物科技業界
- 生技學名藥與醫藥業界
- 生技學名藥與治療費用
- 發展狀況不明的生技學名藥狀況
- 生技藥品市場概要
- 生技藥物年表
- 生技藥品面對的空前風險
- 生技藥品市場動向
- 生物技術的營收流所受到的威脅
- 生物技術：相關風險
第2章 美國生技後進藥品的環境
- 美國生技學名藥環境
- 目前引進生技藥品的進展
- 主要的交涉相左
- 學名藥業界與品牌藥物業界的主要爭論
- 對生技學名藥之可用性的主要障礙
- 生技學名藥物初期引進的潤滑劑
- 美國生技學名藥的引進年表
第3章 歐洲後進藥品環境
- 歐洲生技學名藥環境
- 歐洲引進生技學名藥的進展
- 歐盟對生技學名藥的規範
- 免疫性問題
- 相當主觀的同等性分析
- 密度不足對市場競爭力的影響
- 生產業者臨床研究的負擔
- 制訂規範之政治機關可能延長生技學名藥的時間表
- 歐盟生技學名藥的引進年表
第4章 全球其他地區生技後進藥品的環境
- 其他地區生技學名藥環境
- 各地區市場動向
- 快速成長中國家的生技學名藥
- 生技學名藥在中東
- 生技學名藥在中國
- 生技學名藥在印度
第5章 生技學名藥市場的主要廠商
- 主要企業產品組合
- 生技學名藥業界的合作發展
- 主要企業競爭分析
Abstract
Branded biologic medicines generated an estimated $32bn of sales for the biotechnology and
pharmaceutical industries and represented the fastest growing group of medicines; while continued
high demand, high prices, and applicability in previously untreatable conditions are behind the
success of branded biologics, the absence of generic competition has meant that growth has gone
unchallenged. The Biogenerics Market Outlook: An analysis of market dynamics, growth drivers and
leading players, is a report which examines the key drivers and resistors behind the introduction of
generic biologic medicines in the European Union, United States and the rest of the world. This
report provides analysis on which companies will benefit from the advent of generic biologics and
identifies the companies who have the most to lose by examining the risks associated with the
leading biologic brands. By 2010, biologic medicines that accrue an estimated $11.2bn worth of sales
annually are expected to lose patent protection in developed pharmaceutical markets. This report
identifies strategies for biogenerics success and evaluates the obstacles that need to be overcome
in order to capture a share of this highly profitable, untapped market. Table of Contents
Chapter 1 Biologics market overview 14
- Summary 14
- Introduction 15
- The importance of biogenerics 15
- Biogenerics and the biotechnology industry 15
- Biogenerics and the pharmaceutical Industry 16
- Biogenerics and healthcare costs 16
- The status of biogenerics remains uncertain 17
- Biologics market overview 17
- Biologics timeline 17
- Unprecedented level of patent risk to biologic medicines 19
- Biologic market dynamics 20
- The threat to biotech revenue streams 22
- Biologic technologies -- relative risk 24
Chapter 2 US environment for biogenerics 28
- Summary 28
- Introduction 29
- The environment for biogenerics in the US 29
- Current progress on the introduction of biogenerics 30
- Principal disagreements outlined in talks 31
- Key issues of contention between the generics industry and the branded
- biotechnology industry 32
- The demonstration of bioequivalence 32
- Immunogenicity 33
- Labeling 34
- Key factors impeding the availability of biogenerics 35
- Changes in the manufacturing process determine the equivalence of
- the end-product 36
- Inconsistency in historical precedents set by the FDA 38
- Lack of a regulatory framework for the approval of biogenerics 39
- Organizational change 41
- Factors that promote the early introduction of biogenerics 42
- The economic cost of biologics 42
- Increasing impetus for biogenerics in Congress 44
- A timeline for the introduction of biogenerics in the US 47
Chapter 3 European environment for biogenerics 52
- Summary 52
- Introduction 53
- The environment for biogenerics in Europe 53
- Progress towards the introduction of biogenerics in Europe 54
- EU regulations on biogenerics 56
- The issue of immunogenicity 56
- Analysis of equivalence is highly subjective, with no firm guidelines 59
- Lack of incentives may affect competitiveness of EU biogenerics market 59
- Clinical studies will add to burden on biogenerics manufacturers 60
- Political structures for the regulation of biogenerics may mean extended
- timelines for generics approval 61
- A timeline for the introduction of biogenerics in the EU 61
Chapter 4 Environment for biogenerics in the rest of the world 64
- Summary 64
- Introduction 65
- The environment for biogenerics in ROW 65
- Regional Market Dynamics 67
- Biogenerics in the ex-Tiger economies 68
- Singapore 69
- Background 69
- Major biogeneric programs in Singapore 69
- Taiwan 70
- Background 70
- Major biogeneric programs in Taiwan 71
- South Korea 72
- Background 72
- Major biogenerics programs in South Korea 72
- Biogenerics in Central and Eastern Europe 73
- Biogenerics in China 74
- Biogenerics in India 75
Chapter 5 Key players in the biogenerics market 79
- Summary 79
- Product portfolios of major biogenerics companies 80
- Partnership development in the biogenerics industry 81
- Competitive profiles of major biogenerics companies 83
- Index 85
- Glossary 87
- Glossary 87
List of Figures
- Figure 1.1: Estimated number of biologic treatments approved in the US, 1982-2004 18
- Figure 1.2: Estimated number of biologic treatments approved in the US by major indication, 2003
20
- Figure 1.3: Major players in the biologic medicines market by revenue and sales growth, 2003 22
- Figure 1.4: Estimated exposure to biogenerics by company, 2005-2010 23
- Figure 1.5: Differences in relative risk between various classes of biotechnology drugs 24
- Figure 2.6: The US environment for biogenerics, a PEST analysis 29
- Figure 2.7: Simple biologic medicines are likely to be exempt from rigorous in vivo testing 33
- Figure 2.8: Potential impact of increasing development of biotechnology-derived drugs on
prescription spending 43
- Figure 2.9: Key political issues in both sides of the US biogenerics debate 46
- Figure 2.10: Forecast roadmap for biogenerics legislation in the US 48
- Figure 3.11: The European environment for biogenerics, a PEST analysis 54
- Figure 3.12: Major steps towards the introduction of biogenerics in the EU 55
- Figure 3.13: A timeline for the introduction of biogenerics in the EU 62
- Figure 4.14: The environment for biogenerics in ROW, a PEST analysis 66
- Figure 5.15: Biologic product portfolios of major biogenerics companies 80
- Figure 5.16: Sample agreements between biogenerics manufacturers 82
- Figure 5.17: Outline of key competitive attributes of major biogenerics companies 83
List of Tables
- Table 1.1: Key biologic medicines, sales and estimated risk of generic competition, 2005-201019
- Table 1.2: Key characteristics that determine level of risk from biogeneric competition in high
risk therapeutic areas 21
- Table 2.3: Contrasts in positions on regulation of biogenerics between the generics lobby and
the biotechnology industry lobby, 2004 31
- Table 2.4: Historic precedents in FDA rulings over approving biogenerics 38
- Table 3.5: Issues in cataloguing immunogenicity under EU guidelines 57
- Table 4.6: Overview of regional biogeneric market dynamics 68
- Table 4.7: Major biogenerics projects believed to be active in Singapore 70
- Table 4.8: Major biogenerics projects believed to be active in Taiwan 71
- Table 4.9: Major biogenerics projects believed to be active in South Korea 73
- Table 4.10: Major biogenerics projects believed to be active in the CEE region 74
- Table 4.11: Major biogenerics projects believed to be active in China 75
- Table 4.12: Major biogenerics projects believed to be active in India 76
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