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Erythropoietin (EPO)

 

Erythropoietin (EPO) Overview

The Competitive Intelligence Report Erythropoiesis Stimulating Agents (ESA) as of July 2008 in its 4th edition provides information on the market size of erythropoietin products in 2007, an overview on existing first and second generation epoetin products on the market, a compilation of first generation erythropoietin products in off-patent countries, and a competitor analysis in the development pipeline of biosimilars (biogenerics, follow-on biologics / FoBs) of erythropoietin (EPO) and of next generation erythropoiesis stimulating agents (ESAs).

After the approval of the first biosimilar versions of epoetin in the European Union and of the first next generation, long-acting EPO product (Mircera), the competitive situation in the pipeline of new erythropoiesis stimulating agents (ESAs) has considerably changed in favour of next generation ESAs with improved features compared to epoetins. A wide spectrum of biologics and of small molecules are under development. Companies are exploting new technologies to improve manufacturing, pharmacokinetics, efficacy and safety of next generation ESAs. At least seven next generation ESAs are in clinical development and 25 in preclinical R&D.

As of 2008, manufacturing of epoetin in off-patent countries has become a commodity all over the globe from countries in Europe (e.g. Ireland, Ukraina, Croatia), South America (e.g. Argentina, Cuba, Brazil, Mexico), Africa (e.g. Egypt, Israel, Iran, South Africa), Asia (India, Vietnam, Korea, China, Taiwan).

Marketed products and development projects are listed in a tabular format providing Information on:

  • Drug Codes,
  • Target / Mechanism of Action,
  • Class of Compound,
  • Company,
  • Product category/Therapeutic Area,
  • Indication,
  • R&D Stage and
  • additional comments with a hyperlink leading to the source of information.

Index

  • EPO Market Size 2007
  • First generation epoetins
  • Second generation epoetins
  • EPO biosimilars
  • Next generation Erythropoiesis Stimulating Agents
  • First generation EPO in off-patent countries

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Competitor Analysis available at Pipelinereview.com

The report describes the market size and sales figures of the branded therapeutic proteins epoetin alfa and beta for 2006 and the challenges represented by biogeneric (syn.: biosimilar , follow-on biologic , follow-on protein ) versions of erythropoietin ( EPO ), further subclasses of epoetin, improved erythropoiesis stimulating proteins and peptides by use of technologies to prolong half-life such as pegylation , engineered fusion and dimeric proteins, oral small molecules, DNA or new molecules with a different mechanism of action but resulting in the same pharmacologic effect.

The biogenerics pipeline of the erythropoietin (EPO) is separately evaluated for developments in the European Union and the United States (US) and in “off-patent” countries and includes Western companies as well as companies from India, South Korea, China, Taiwan, Argentina and Cuba as the major contribuents of biogeneric proteins. Among these companies are Barr Pharmaceuticals, Teva, Sandoz, Bioton, Biocon, Ranbaxy, Reliance Life Sciences and many more.