The Biogenerics Market Outlook: An analysis of market dynamics, growth drivers and leading players

The Biogenerics Market Outlook: An analysis of market dynamics, growth drivers and leading players

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
 
Executive summary 8
 
Biologics market overview 8
 
US environment for biologics 9
 
European environment for biologics 10
 
Environment for biogenerics in the rest of the world 11
 
Key players in the biogenerics market 12
 
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
 
iv
 
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
 
v
 
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
 
vi
 
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