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The Biogenerics Market Outlook: An Analysis Of Market Dynamics, Growth Drivers And Leading PlayersPublished by: Business Insights Published: Mar. 1, 2005 - 87 Pages Table of ContentsExecutive 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 35 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 List of Figures Figure 1.1: Estimated number of biologic treatments approved in the US, 1982-2004 Figure 1.2: Estimated number of biologic treatments approved in the US by major indication, 2003 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 Figure 1.5: Differences in relative risk between various classes of biotechnology drugs Figure 2.6: The US environment for biogenerics, a PEST analysis Figure 2.7: Simple biologic medicines are likely to be exempt from rigorous in vivo testing Figure 2.8: Potential impact of increasing development of biotechnology-derived drugs on prescription spending Figure 2.9: Key political issues in both sides of the US biogenerics debate Figure 2.10: Forecast roadmap for biogenerics legislation in the US Figure 3.11: The European environment for biogenerics, a PEST analysis Figure 3.12: Major steps towards the introduction of biogenerics in the EU Figure 3.13: A timeline for the introduction of biogenerics in the EU Figure 4.14: The environment for biogenerics in ROW, a PEST analysis Figure 5.15: Biologic product portfolios of major biogenerics companies Figure 5.16: Sample agreements between biogenerics manufacturers Figure 5.17: Outline of key competitive attributes of major biogenerics companies 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 Table 2.3: Contrasts in positions on regulation of biogenerics between the generics lobby and the biotechnology industry lobby, 2004 Table 2.4: Historic precedents in FDA rulings over approving biogenerics Table 3.5: Issues in cataloguing immunogenicity under EU guidelines Table 4.6: Overview of regional biogeneric market dynamics Table 4.7: Major biogenerics projects believed to be active in Singapore Table 4.8: Major biogenerics projects believed to be active in Taiwan Table 4.9: Major biogenerics projects believed to be active in South Korea Table 4.10: Major biogenerics projects believed to be active in the CEE region Table 4.11: Major biogenerics projects believed to be active in China AbstractBranded 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.Get Full Details About This Report >> |
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