Printer Friendly Printed from http://www.researchandmarkets.com/reports/607788 Competitor Analysis: Biogenerics & Therapeutic Proteins Description: Overview The consolidation process in the biogenerics industry has commenced after first approvals of biogeneric human growth hormone products in the US and the EU and first filings of biogeneric erythropoietin and insulin in the EU. Smaller biogeneric companies have been taken over by generic players from India and Eastern Europe . Large generic and hospital specialist companies have entered the field by acquisition and licensing deals. Apart from biogenerics, the US$ 42 bln market of the major therapeutic proteins (EPO, insulin, coagulation factors, interferons, G-CSF, hGH, enzyme replacement and FSH) is being challenged by competitor projects arising from various technologies. Oral small molecules or oral delivery of packaged or engineered proteins can bypass conventional next generation solutions such as pegylation, fusion proteins or non-invasive drug delivery technologies. Manufacturing of biopharmaceuticals is getting a commodity in non-regulated countries as local investors paid for technology transfer and infrastructure. Countries such as Egypt , Tunisia and Iran are joining pioneer countries such as Argentina , Cuba , India , South Korea and China which so far service domestic and other non-regulated and less developed countries. Indian companies such as Biocon now are on the move to the European Union with biogeneric proteins and are favored by a less costly local, yet GMP approved infrastructure. Biogeneric proteins not only may directly compete with first generation therapeutic proteins, but also serve for drug delivery solutions requiring larger amounts of protein. Cost-efficient manufacture by an advantageous infrastructure or less expensive expression systems may become crucial in future market competition. The major therapeutic proteins are not only being challenged by biogeneric developments in the Western countries, but also by innovative investigational new drugs. A state of the art approach is pegylation or glycopegylation of the parent protein, but protein engineering technologies may lead to the same effect of a longer half-life and also result in improved pharmacodynamic properties. Oral delivery approaches for hGH, insulin, and interferon are currently being evaluated while oral small molecules stimulating thrombopoiesis or erythropoiesis are already in advanced clinical testing. The use of clinical stage peptide agonist or peptibody molecules are an alternative to proteins such as EPO or TPO. Progress in protein engineering and expression made available recombinant plasmin becoming an attractive alternative to plasminogen activators because it directly degrades fibrin, but yet is readily neutralized. This Competitor Analysis provides a stakeholder evaluation in the US$ 42 bln markets of 10 major proteins: Erythropoietin (EPO); Human growth hormone (hGH); Interferon; Insulin; G-CSF and GM-CSF; Follicle stimulating hormone (FSH); Thrombopoietin (TPO) agonists; Thrombolytics; Coagulation Factors; Enzyme Replacement Therapies. Players in these markets are: first generation product innovator companies; biogeneric companies in regulated markets; biogeneric companies in non-regulated or off-patent countries; drug delivery companies; device companies; next generation innovator companies of proteins, peptides and small molecules. The competitor and pipeline analysis in the field of these major protein products as of April 2007 is structured in a tabular format. The products and projects are listed on 128 pages in ten chapters, one chapter for each protein. Information in the tables is provided on: Drug Codes, Target / Mechanism of Action, Class of Compound, Company, Therapeutic Area, Drug Delivery Technology, Territory or Product Category; Indication, R&D Stage and additional comments with a hyperlink leading to the source of information. Contents: EPO EPO Market: Sales 2006 First Generation Epoetins Second Generation Epoetins EPO Biosimilars First generation EPO in off-patent countries Next generation Erythropoiesis Stimulating Agents Next generation ESAs G-CSF & GM-CSF Branded G-CSF Products Biosimilar G-CSF products Next generation G-CSF products Off-patent G-CSF products Off-patent Pegylated G-CSF products Branded GM-CSF Products Off-patent and follow-up GM-CSF products hGH (Human Growth Hormone) hGH Market Sales 2006 1st generation hGH products in regulated markets 1st generation biosimilar hGH in regulated markets 2nd generation injectable hGH products in regulated markets 2nd generation hGH products in regulated markets Drug Delivery Activities for Hgh Low-cost manufacturing systems for hGH 1st generation hGH in "off-paten" countries 2nd generation hGH in "off-paten" countries Interferon Interferon Market: Sales 2006 Interferon alfa 1st and 2nd generation biosimilar IFN alpha-2a 2nd generation interferon alpha-2a incl. improved manufacturing systems 1st generation IFN alpha-2a in "off-paten" countries 1st generation in "off-patent" countries 2nd generation IFN alpha-2b 1st generation IFN alpha-2b in "off-patent" countries Other rhu interferon alpha Purified interferon alpha Interferon beta Interferon gamma Other Interferons Interferon gene therapy Insulin Insulin Market: Sales 2006 Insulin Market Inhaled Insulin Nasal Insulin Transdermal Insulin Oral Insulin Engineered Insulin Long-acting Insulin Follow-on Insulin FSH (Follicle stimulating hormone) FSH Market: Sales 2006 First generation FSH Second generation FSH FSH in "off-patent" markets Delivery systems for FSH Third generation, glyco-engineered FSH Fourth generation of oral FSH receptor agonists Thrombolytics 1st generation (non-fibrin selective) fibrinolytics 2nd+ 3rd generation (fibrin-selective) fibrinolytics 4th generation fibrinolytics 5th generation fibrinolytics Fibrinolytics in non-regulated markets TPO (Thrombopoiesis-Stimulating Agents) Active projects Stand by or recently discontinued Coagulation Factors Sealants F. VIIa F. VIII F. IX F. XIII von Willebrand Factor ERT (Enzyme Replacement Therapies) Market of ERT Gaucher?s disease Fabry disease Pomp? disease Phenylketonuria CNS delivery Various Metabolic Diseases About La Merie Business Intelligence Summary: The consolidation process in the biogenerics industry has commenced after first approvals of biogeneric human growth hormone products in the US and the EU and first filings of biogeneric erythropoietin and insulin in the EU. Smaller biogeneric companies have been taken over by generic players from India and Eastern Europe . Large generic and hospital specialist companies have entered the field by acquisition and licensing deals Ordering: Order Online - visit http://www.researchandmarkets.com/reports/607788 Order by Fax - using the order form below Order By Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. 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