Human Growth Hormone (hGH)

Product description

The Competitive Intelligence Report Human Growth Hormone (hGH) as of October 2008 provides a competitor analysis in the development pipeline of biosimilar (biogeneric) versions of somatropin and next generation hGH products for treatment of growth hormone deficiency )GHD) in childrens and adults and related diseases. The report includes an evaluation of the hGH market size in 2007 based on published data and provides company pipelines in the field of hGH.

Human growth hormone (hGH; somatropin) was the first therapeutic protein for which a biosimilar version was approved in the US and in Europe in 2006. Novartis generic division Sandoz sells the generic somatropin as Omnitrope at a 25 % discount but only achieved 2007 sales of about US$ 8 mln representing a 0.3 % share of the worldwide hGH market in 2007 of US$ 2.7 bln (published data only). Although 2008 sales of Omnitrope are growing steadily, they can be expected to achieve only about US$ 30 mln (about 1 % of the ww market).

The number of mere copycat hGH biosimilars in regulated markets is rather limited to a total of three approved biosimilar versions in the EU and/or US and two other versions in the pipeline of 1st generation somatropin biogenerics. The majority of next generation products attempts to improve frequency of administration or delivery. To reduce frequency of SC injections, slow-release formulations are the clinically most advanced approaches followed by the PEGylated versions of hGH which is the preferred option of the established hGH marketers. Engineering of hGH to prolong half-life is a next generation approach already in early clinical development, but still requires injection. In contrast, non-injectable delivery approaches promise to avoid injection by oral, transdermal or nasal administration. There are numerous manufacturers of hGH in non-regulated markets, but most of them do not produce in a manner allowing approval in regulated markets although these products are frequently consumed by those interested in gaining muscle mass.

The report includes a compilation of current active projects in research and development of novel hGH products.

Competitor projects are listed in a tabular format providing Information on:

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

Corporate R&D Pipelines for Human Growth Hormone (hGH):

• Altus Biopharmaceuticals
• Ambrx
• Anhui Anke Biotechnology
• Asterion
• Aegis Therapeutics
• Bio-ker
• Bio-Sidus
• Biocon
• BioPartners
• Biovel Life Sciences
• Bolder Biotechnology
• Cangene
• Critical Pharmaceuticals
• Daewoong Pharmaceutical
• Dainippon Sumitomo Pharma
• Dong-A Pharmaceutical Co
• Eli Lilly
• Emisphere Technologies
• Ferring
• Flamel Technologies
• Genentech
• GeneScience Pharmaceutical
• HanAll Pharmaceutical
• Hanmi Pharmaceutical
• Ipsen
• JCR Pharmaceutical
• LG Life Science
• Merck Serono
• Modigene
• Nanogene Biopharmaceutical
• Nautilus Biotech
• Neogenica Biosciences
• Neose Technologies
• Novo Nordisk
• OctoPlus
• Pfizer
• Phage Biotechnology
• PharmaEssentia
• Regeron
• Sandoz (Novartis)
• SciGen
• Shenzhen Kexing Biotech
• Tercica
• Teva Pharmaceutical Industries (CoGenesys; Sicor UAB Biotech)
• TransPharma Medical