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.
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Executive summary
Biologics market overview
US environment for biologics
European environment for biologics
Environment for biogenerics in the rest of the world
Key players in the biogenerics market

Chapter 1 Biologics market overview

Summary
Introduction
The importance of biogenerics
Biogenerics and the biotechnology industry
Biogenerics and the pharmaceutical Industry
Biogenerics and healthcare costs
The status of biogenerics remains uncertain
Biologics market overview
Biologics timeline
Unprecedented level of patent risk to biologic medicines
Biologic market dynamics
The threat to biotech revenue streams
Biologic technologies – relative risk

Chapter 2 US environment for biogenerics

Summary
Introduction
The environment for biogenerics in the US
Current progress on the introduction of biogenerics
Principal disagreements outlined in talks
Key issues of contention between the generics industry and the branded
biotechnology industry
The demonstration of bioequivalence
Immunogenicity
Labeling
Key factors impeding the availability of biogenerics
Changes in the manufacturing process determine the equivalence of the end-product
Inconsistency in historical precedents set by the FDA
Lack of a regulatory framework for the approval of biogenerics
Organizational change
Factors that promote the early introduction of biogenerics
The economic cost of biologics
Increasing impetus for biogenerics in Congress
A timeline for the introduction of biogenerics in the US

Chapter 3 European environment for biogenerics

Summary
Introduction
The environment for biogenerics in Europe
Progress towards the introduction of biogenerics in Europe
EU regulations on biogenerics
The issue of immunogenicity
Analysis of equivalence is highly subjective, with no firm guidelines
Lack of incentives may affect competitiveness of EU biogenerics market
Clinical studies will add to burden on biogenerics manufacturers
Political structures for the regulation of biogenerics may mean extended
timelines for generics approval
A timeline for the introduction of biogenerics in the EU

Chapter 4 Environment for biogenerics in the rest of the world

Summary
Introduction
The environment for biogenerics in ROW
Regional Market Dynamics
Biogenerics in the ex-Tiger economies
Singapore
Background
Major biogeneric programs in Singapore
Taiwan
Background
Major biogeneric programs in Taiwan
South Korea
Background
Major biogenerics programs in South Korea
Biogenerics in Central and Eastern Europe
Biogenerics in China
Biogenerics in India

Chapter 5 Key players in the biogenerics market

Summary
Product portfolios of major biogenerics companies
Partnership development in the biogenerics industry
Competitive profiles of major biogenerics companies
Index
Glossary
Glossary
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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

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
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