The report is an essential source of information on the global GHD therapeutics market, and provides analysis of a number of key areas. The report identifies the key trends shaping and driving the global GHD therapeutics market and provides insights into the current competitive landscape and emerging companies expected to significantly alter the market positioning of current market leaders. Most importantly, the report provides valuable insights into the pipeline products within the global GHD sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by a team of industry experts.
GHD Therapeutics Market Forecast to Display Steady Growth until 2018
They estimates that the global GHD therapeutics market was valued at $1,354.5m in 2010, after increasing at a Compound Annual Growth Rate (CAGR) of 4.0% during 2005–2010. The market is expected to record a CAGR of 3.7% from 2010–2018, to value $1,804.7m by 2018. The growth recorded in GHD therapeutics market during 2005-2010 can be attributed to the increase in the annual cost of therapy of existing treatment options. Aside from these, there are limited numbers of biosimilar formulations such as Omnitrope (somatropin), Valtropin (somatropin) in the GHD therapeutics market. The launches of biosimilars have a modest impact on the market because of the existing availability of these products at a competitive price. Omnitrope was the first biosimilar approved in GHD therapeutics market by the US Food and Drug Administration (US FDA) after long delays and court proceedings in May 2006. Omnitrope was approved by EMEA (European Medicines Agency) in April 2006. The GHD therapeutics market is expected to grow steadily during the forecast period; the expected launch of the sustained release formulation of LB03002 recombinant human growth hormone (hGH), which has a once weekly dosage schedule, will act as a major breakthrough in Growth Hormone (GH) therapy. The anticipated launch of this improved formulation of the existing product will increase patient compliance, and therefore will result in improved efficacy.
Significant Unmet Need in GHD Therapeutics Market, in Terms of Non Adherence to GH Therapy by Patients due to Complicated Dosage schedule
An analysis suggests that the GHD therapeutics market has significant unmet need in terms of patient compliance, current dosage regimen of growth hormone (GH) therapy, inconvenient injection administration and marketed products which show adverse reactions such as joint pain and severe headache. Overall, all these factors suggests poor patient compliance to GH therapy in GHD patients. Although the currently marketed products are able to achieve effective treatment in the majority of patients, a major concern exists over the daily or sometimes twice a day GH injection to GHD patients. There is significant potential for the introduction of improved formulations with convenient dosage regimen in the GHD therapeutics market, however the current pipeline is weak, apart from LB03002 which is currently under review by the US FDA and is in Phase III clinical development in the Europe. Overall, a significant part of the existing unmet need can be addressed by products that have a convenient dosage regimen along with route of administration other than injection (such as the oral route of administration). But to really fulfill the current unmet need, the pipeline molecules need to show better safety and efficacy results as compared to the currently available marketed products for the treatment of GHD.
The Current Competition in the GHD Therapeutics Market is Strong with a Wide Range of Approved Products Available For the Treatment of GHD
An analysis suggests that the current competition in the GHD therapeutics market is strong. The major marketed products in the GHD therapeutics market are Nutropin AQ (somatropin), Humatrope (somatropin), Genotropin (somatropin), Norditropin (somatropin), Saizen and Increlex (mecasermin). The recently launched Omnitrope, a biosimilar version manufactured by Pfizer in the US, EU5 (France, Germany, Italy, Spain and the UK) and Japan has intensified the current competition in the market. Omnitrope has been launched at a lower price, as much as 25% lower than the previously patented products in the GHD therapeutics market. This has resulted in greater levels of acceptance of Omnitrope among patients suffering with GHD. The major marketed products in the GHD therapeutics market have similar efficacy and safety profiles with only marginal differences. This has increased market competition further.. The manufacturers are forced to compete on pricing or on improving the dosage requirements of their currently marketed products. The major players in the GHD therapeutics market are Eli Lilly and Company, Pfizer, Inc., Novo Nordisk, Genentech (A member of Roche group), EMD Serono, Inc. and Ipsen, Inc.
Lack of Novel Therapies under Clinical Development to Render Scope of Entry for New Molecules with Improved Drug Delivery System An analysis shows that the GHD therapeutics pipeline is weak, with 15 molecules in various phases of pre-clinical and clinical development. There is only one molecule in Phase III of clinical development, Arimidex (anastrozole), which is already approved for advanced or metastatic breast cancer in postmenopausal women. The drug lost its patent exclusivity in December, 2009. Another molecule, LB03002, is a sustained release formulation of recombinant hGH, is currently under US FDA review as it is filed by LG Life Sciences. The molecule is also currently in Phase III of clinical development in Europe, and BioPartners plan to file marketing authorization to the EMEA by the end of 2011. The expected launch of LB03002, having a once weekly dosage schedule, would act as a major breakthrough in GH therapy. Phase II has five molecules in the clinical development; of these, four molecules are product extensions and one molecule is first-in-class. Phase I has four molecules in the clinical development; of these, three are classified as product extensions and one molecule is classified as first-in-class.
They predict that the molecule (LB03002), in late stage of clinical development with an improved dosage formulation, is likely to capture a major market share during the forecast period.