A Comprehensive Report of Erythropoietins: the Shift from Biosimilars to "More for Less" ESAs.

DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/research/b55dbe/competitor_analysi) has announced the addition of the "Competitor Analysis: Erythropoietin (EPO)" report to their offering.

Despite stagnant erythropoietin (EPO) sales, four new EPO products were introduced in Europe during the last year, but the pipeline shifts from biosimilar based approaches to next generation erythropoiesis stimulating agents (ESA)

The Business Intelligence firm La Merie S.L. reported that for the first time sales of major erythropoietin products declined to US$ 11.8 bln in 2007, down by US$ 100 mln from the previous year. Additionally, four new epoetin based products were launched in European countries, among them two biosimilars, epoetin delta produced in a human cell line and Roche's pegylated version of epoetin beta. Concerns about overusage and safety are expected to further cause a decline of erythropoietin sales in the major markets. Nevertheless, the huge potential of the erythropoietin market still attracts an ever increasing number of competitors. While the pipeline of first generation epoetin biosimilars is stagnant, new technologies stimulate the pipeline of next generation products with at least seven in clinical evaluation and 25 in preclinical R&D. These results and more are to be found in the report

Competitor Analysis: Erythropoietin.

The report provides information on the pipeline of epoetin biosimilars currently in development for highly regulated markets. The marketed biosimilar products currently are priced at 25 to 30 % less than the previous originator price which hardly is convincing prescribing physicians so far. Key success factors for next generation ESAs are technology platforms, the market presence and portfolio as well as the low cost position of the company overall in order to successfully launch an ESA with better clinical features for less money ("more for less"). Teva's recent acquisition of CoGenesys exemplifies this policy. The albumin fusion technology allows to cost-efficiently produce ESAs and other biosimilars with a prolonged half-life to be marketed by the leading generics company. The report compiles in a tabulated format next generation ESAs which include engineered proteins, fusion proteins, conjugated and dimeric peptides, antibodies, small molecules, gene therapy approaches and new expression technologies. The report also provides an overview on the worldwide manufacturers of recombinant epoetin in off-patent countries.

Scope of the report:

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).

Key Topics Covered:

* 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.

For more information visit http://www.researchandmarkets.com/research/b55dbe/competitor_analysi