Growth hormone deficiency (GHD) therapeutics pipeline is predicted to increase in future mainly due to the increasing prevalence of the disease, globally. The major factors driving the pipeline of growth hormone deficiency include, increasing prevalence of pituitary dysfunction, low market penetration as very limited number of companies are making an analog of growth hormone. The rising affordability of the drugs and increasing geriatric population also serve as major factors leading to growth of the pipeline. According to the Human Growth Foundation, it is estimated that growth hormone deficiency occurs in children between 1 to 4,000 to 1 to 10,000, in the U.S. There are more than 50,000 adults associated with growth hormone deficiency and around 6,000 new cases are being reported per year.
Growth hormone is a major body system metabolic hormone that controls lipid, protein and carbohydrate homeostasis. The principal form of growth hormone is around 22 kD and contains 191 amino acids, known as somatotrope. This hormone is produced by growth hormone cells known as somatotropes located in adenohypophysis of pituitary gland. Growth hormone deficiency is classified into four categories as pituitary or classic GHD, hypothalamic GHD, functional growth hormone deficiency and idiopathic GHD. In case of pituitary GHD, there is an abnormality in brain, due to which there is an incapacity to produce growth hormone. Hypothalamic GHD occurs when there is failure of hypothalamic function of transmitting neurocrine messaging hormone, which directs the pituitary gland to produce growth hormone. Functional GHD occurs when other metabolic hormone fails to secrete or impaired metabolic function due to various unknown etiologies. Idiopathic GHD occurs due to unknown causes. There are various psychological symptoms that occur in growth hormone deficiency such as depression, lack of concentration, emotional distress and poor memory. The disease can also lead to increased fat mass and extra cellular fluid volume, diminished muscle strength and stamina, lethargy and depression.
The recombinant human growth hormone is approved as a safe and efficacious drug by the USFDA. There are various DNA sequencing elements present in rhGH that are identical to natural GH. There are other drugs like somatotropin manufactured by LG life sciences which is in Phase III stage of development and is being expected to be approved by USFDA in 2017. NNC-0195092, a novel drug by Novo Nordisk is also in its Phase III and is expected to be approved till 2018. Some of the other drugs that are upcoming in market for GHD include MOD-4023, ACP-001, TV-1106, VRS-317 etc. that are being developed by various biopharmaceutical companies and are expected to receive approval by 2020. One of the key barrier hindering the growth of the GHD pipeline is the high cost of drugs. Current therapies available that are available for the treatment of GHD include Omnitrope biosimilar, Saizen, Genotropin, Zomacton, Norditropin and humatrope.
American psychological association is working with Pharmacia corporation to assist and promote the growth hormone deficiency in children and to support families dealing with the various psychological disorder.
Some of the companies having a pipeline of growth hormone deficiency therapeutic pipeline analysis include Merck Serono, Pfizer, Inc., Novo Nordisk, F. Hoffman-La Roche AG, Eli lilly and Company, Ferring pharmaceuticals, Inc. LG Life Sciences Pvt. Ltd., Sandoz Internatinal, Teva Pharmaceutical industries, OPKO Health, Inc., AnkeBio Co., Ltd.