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Therapeutic Proteins: Strategic Market Analysis and Forecasts to 2010Published by: Datamonitor Published: Aug. 21, 2002 - 252 Pages Table of ContentsOverview Introduction The therapeutic protein market grew by 14% in 2001 and is forecast to achieve sales of over $50bn by 2010. Growth to date has been dominated by sales of erythropoietins and insulins, while future growth will reflect the increasing significance of monoclonal antibodies and therapeutic vaccines. However, there are a number of critical issues that companies must overcome to be successful, notably the threat of biogenerics and the imminent shortfall in biologics manufacturing capacity. Scope Analysis of global and 7 country (US, Japan, France, Germany, Italy, Spain, UK) product and class sales across 13 therapeutic protein classes In-depth evaluation of the commercial potential of the therapeutic protein R&D pipeline Forecast year-on-year sales for all major products and classes to 2010 Recommendations for managing the emerging threat from biogenerics, including a timeline of impact, key companies involved and products most at risk Analysis of the forthcoming shortfall in manufacturing capacity and its implications for future market growth Report Highlights The strategies adopted by Pfizer and Aventis to gain regulatory approval and overcome the safety issues facing the first non-injectable insulin Exubera, will set a precedent for other companies with earlier stage inhalable and oral insulins. The intensive, high volume manufacturing process for monoclonal antibodies has resulted in drugs only being available at premium prices. This has limited their market penetration. However, with over 35 products in phase II development, competition within the monoclonal antibody class will strengthen as more products make it through to market by 2010. Over $13.5bn of the $27bn therapeutic proteins market in 2001 will be exposed to generic competition by the end of 2005.. Reasons to Purchase Optimize penetration with comprehensive knowledge of the sales performance, growth drivers and country-specific factors surrounding competing proteins Identify key pipeline products for in-licensing opportunities and areas of unmet need Maximize your product’s potential by implementing optimal biogeneric defense strategies Target resources more effectively to ensure that your required manufacturing capacity is available Drivers and trends The therapeutic protein industry is undergoing a period of rapid expansion, driven by both mature and emerging classes. The key question is how this can be maintained in the face of increasing challenges to patents and manufacturing capabilities. The report analyzes the future growth potential of the therapeutic proteins market and events shaping each of the major classes. A number of classes are dominated by one product. Which strategies have these products’ marketers employed to achieve this position and how will they be challenged in the future? With no significant biogeneric competition to date, class dynamics have revolved around new products superceding mature ones. How would this model change with the potential entry of many more biogenerics? Which products are most venerable to biogeneric competition? Which class will lead the therapeutic proteins market by 2010? IMPACT OF REFORMULATION ON THE INSULIN MARKET Eli Lilly and Novo Nordisk have dominated the insulin market over the last decade. However, the opportunity to develop new drug delivery formulations has allowed other large pharma to encroach upon this class. By 2010 the class will be more fragmented, with over twice as many major products. GlaxoSmithKline’s M2, an oral insulin, will become the market leader by 2010 with a market share of 22.5% The value of Novo Nordisk’s insulin franchise will decrease from 2005 onwards, due to the launch of the oral insulins Through the launch of Exubera and the continued sales growth of the injectable insulin Lantus, Aventis will be promoted to one of the leading companies in the class THE ENTRY OF BIOGENERICS The first wave of patent expiries is affecting the biologics industry but, unlike in the small molecules industry, generic compounds are not waiting to flood the market. In part, this reflects the lack of established regulatory pathways to approve products as viable biopharmaceutical generics. Analysis of the legal situation concerning entry of biogenerics and landmark legal cases that will influence the development of an approval pathway. Defense strategies for current companies leading the branded therapeutic protein market Leading biogeneric companies: which markets they will target first? ACTION POINTS Five key action points for pharma Action point 1 - The therapeutic protein market increased by 15.6%in 2001 to over $27bn. Growth was led by sales of monoclonal antibodies and from two mature classes, the insulins and erythropoietins Action point 2 - The therapeutic proteins market will nearly double in size by 2010 to over $50bn, presenting growth opportunities in excess of those of the pharmaceutical market as a whole Action point 3 - Monoclonal antibodies will overtake erythropoietins as the largest therapeutic protein class by 2010. However, companies need to address manufacturing capacity problems by forming strategic networks with manufacturing parties Action point 4 - the threat of biogenerics looms over the therapeutic protein market, with the current lack of legal pathway the only true deterrent. Although generic competition is unlikely before 2007, innovator companies must adopt litigation and lifecycle management strategies to defend revenues APPENDIX DATASETS Table 1: Global sales for the leading erythropoietins, 2001 Table 2: Seven country sales breakdown for the leading erythropoietins, 2001 Table 3: Forecast erythropoietin sales by brand to 2010 Table 4: Global sales for the leading insulins, 2001 Table 5: Seven country sales breakdown for the leading insulins, 2001 Table 6: Forecast sales of leading insulin products to 2010 Table 7: Global sales for the leading interferon alphas, 2001 Table 8: Seven country sales breakdown for the leading interferon alphas, 2001 Table 9: Forecast interferon alpha sales by brand to 2010 Table 10: Global sales for the leading interferon betas, 2001 Table 11: Seven country sales breakdown for the leading interferon betas, 2001 Table 12: Forecast interferon beta sales by brand to 2010 Table 13: Global sales for the leading plasminogen activators, 2001 Table 14: Global sales for the leading blood clotting factors, 2001 Table 15: Seven country sales breakdown for the leading plasminogen activators,2001 Table 16: Seven country sales breakdown for the leading blood clotting factors,2001 Table 17: Forecast plasminogen activator sales by brand to 2010 Table 18: Forecast blood clotting factor sales by brand to 2010 Table 19: Growth factor classes and mechanism of action Table 20: Global sales for the leading growth factors, 2001 Table 21: Seven country sales breakdown for leading growth factors, 2001 Table 22: Forecast growth factor sales by brand to 2010 Table 23: Global sales for the leading interleukins, 2001 Table 24: Seven country sales breakdown for the leading interleukins, 2001 Table 25: Forecast interleukin sales by brand to 2010 Table 26: Global sales for the leading colony stimulating factors, 2001 Table 27: Seven country sales breakdown for the leading colony stimulating factors, 2001 Table 28: Forecast colony stimulating factor sales by brand to 2010 Table 29: Global sales for the leading therapeutic vaccines, 2001 Table 30: Forecast therapeutic vaccine sales by brand to 2010 Table 31: Global sales for the leading monoclonal antibodies, 2001 Table 32: Seven country sales breakdown for the leading monoclonal antibodies, 2001 Table 33: Comparative analysis of selected monoclonal antibodies Table 34: Competitive monoclonal antibody indications Table 35: Forecast monoclonal antibody sales by brand to 2010 Table 36: Global sales for the leading growth hormones, 2001 Table 37: Seven country sales breakdown for the leading growth hormones, 2001 Table 38: Forecast growth hormones sales by brand to 2010 Table 39: Leading biogeneric companies, 2002 Table 40: Key biologic products facing patent expiry to 2005 AbstractIntroduction: The therapeutic protein market grew by 14% in 2001 and is forecast to achieve sales of over $57bn by 2010. Growth to date has been dominated by sales of erythropoietins and insulins, while future growth will reflect the increasing significance of monoclonal antibodies and therapeutic vaccines. However, there are a number of critical issues that companies must overcome to be successful, notably the threat of biogenerics and the imminent shortfall in biologics manufacturing capacity. Scope of this Report: * Analysis of global and 7 country (US, Japan, France, Germany, Italy, Spain, UK) product and class sales across 13 therapeutic protein classes * In-depth evaluation of the commercial potential of the therapeutic protein R&D pipeline * Forecast year-on-year sales for all major products and classes to 2010 * Recommendations for managing the emerging threat from biogenerics, including a timeline of impact, key companies involved and products most at risk * Analysis of the forthcoming shortfall in manufacturing capacity and its implications for future market growth . Report Highlights: The strategies adopted by Pfizer and Aventis to gain regulatory approval and overcome the safety issues facing the first non-injectable insulin Exubera, will set a precedent for other companies with earlier stage inhalable and oral insulins. The intensive, high volume manufacturing process for monoclonal antibodies has resulted in drugs having to command premium prices, limiting their market penetration. However, with over 35 products in phase II development, competition within the monoclonal antibody class will strengthen as more products make it through to market by 2010. Over $13.5bn of the $27bn therapeutic proteins market in 2001 will be exposed to generic competition by the end of 2005. Key Reasons to Buy this Report: * Optimize penetration with comprehensive knowledge of the sales performance, growth drivers and country-specific factors surrounding competing proteins * Identify key pipeline products for in-licensing opportunities and areas of unmet need * Maximize your product's potential by implementing optimal biogeneric defense strategies * Target resources more effectively to ensure that your required manufacturing capacity is availableGet Full Details About This Report >> |
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