The Biogenerics Market Outlook: An Analysis of Market Dynamics, Growth Drivers and Leading Players

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