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The Biogenerics Market Outlook: An Analysis of Market Dynamics, Growth Drivers and Leading Players
Business Insights, March 2005
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.
'The characteristics of the Chinese and Indian markets have substantially favored domestic companies through less rigorous and abbreviated regulations and low or absent clinical testing standards. In these markets, cost is a major determinant of competitiveness, where prices are commonly government regulated, and the purchasing power of consumers is more limited...'
Top five reasons to order your copy today
1. Compare the strengths and weaknesses of potential major players in the biogenerics market and understand which factors are likely to drive competitive advantage in this emerging sector.
2. Understand the differences between the US biogenerics market and the European biogenerics market, and how regulation is having a dramatic impact on the future of this sector.
3. Gain unique insight into the global biogenerics market and current issues in biogenerics in developing countries and compare and contrast the market opportunities within developed countries.
4. Evaluate which brands, companies and technologies are at the most risk from the threat of biogenerics and how they might be impacted in the future
5. Identify potential future leaders of the biogenerics industry by using the company profiles of the current leading players in the global biogenerics market.
'Pressure from lobbying by the Biotechnology Industry Organization (BIO) and Pharmaceutical Research Manufacturers Association (PhRMA) is likely to be a decisive factor in subduing and delaying steps to pass a bill regulating biogenerics. Political will at the White House and in the House of Representatives is set to remain the most important and uncertain stumbling block to resolving the issue...'
Key findings of the report
- The biologic medicines market was valued at an estimated $32bn in 2003, and by 2010 is forecast to be valued at $53bn.
- The most at-risk groups of biologics are growth hormones, insulins, and blood factors, representing an estimated $13bn of sales in 2003 and blood factors representing an estimated $13bn of sales.
- The key resistors to the introduction of biogenerics are the lack of legal and regulatory processes. These resistors are not forecast to be overcome until at least 2007 in the US, although in the EU it is a more imminent prospect in 2005.
- Companies from outside of the EU and the US are forecast to be among some of the strongest beneficiaries of the introduction of biogenerics, although there is likely to be opportunities for some branded biologic companies and major conventional generic players.
- The companies whose revenue streams face the greatest risk of generic competition are Amgen, Schering-Plough and Novo Nordisk.
'The main focus of biogenerics legislation in the EU has been on determining the extent of human clinical trials and oversight that is required for potential biogeneric drugs in order to address safety issues related to immunogenicity. The issue of immunogenicity, which would exert a significant regulatory burden on potential biogeneric manufacturers, remains contentious and may undermine the ability of the EU to promote the availability of biogeneric drugs in the EU...'
Key questions answered in this report
- What are the most significant factors driving the emergence of the biogenerics market in the US and the EU?
- What are the current obstacles to the emergence of a biogenerics market in the US and the EU?
- Which branded biologics are set to lose market exclusivity over the period 2004-2010?
- Which companies are best positioned to become the key players in the biogenerics industry over the period 2004 - 2010?
- Which biologic technologies represent the most attractive targets for biogeneric companies?
- What strategies will branded biologic companies employ to confront the new threat from biogenerics?
- What is estimated to be the value of the biologic market over the period 2004 - 2010?
'The Indian biogenerics industry is well developed and exports biogenerics products across developing economies in South America as well as Asia. However, despite the depth of the biogenerics industry in India, the lower level of vigilance applied to the approval of domestic biogenerics has negative implications for their marketing in the EU and North America...'
Is your company prepared for the biogenerics revolution?
Decide for yourself with a comprehensive overview of the current and future biogenerics industry detailing strategies for biogenerics success, and survival strategies for biotechnology companies.
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