Long-Acting Therapies Will Expand Growth Hormone Deficiency Market

22 Nov.,2022


Human Growth Hormone Manufacturer

Growth hormone deficiency (GHD) results from impaired secretion of growth hormone (GH) from the pituitary gland.1 Typically, the disease is classified in one of three categories: congenital, acquired, or idiopathic. Congenital GHD is present at birth and can be caused either by genetic mutations or structural abnormality in the brain. Acquired GHD occurs later in life as a result of an event that affects the brain, such as trauma, infection, or tumor, among many other causes. Finally, idiopathic GHD has an unknown or undiagnosed cause.2

Childhood GHD can often be made up of all three categories and can have developmental consequences as the child matures. Current treatment for GHD consists of patient-specific GH replacement therapy.2 Pediatric GH replacement therapy is given in a calculated weight-based dosing regimen, whereas adult dosing can be either weight-based or non-weight-based.3 Several somatropin, recombinant human GH brands are available.2 Looking to the future, therapies in the pipeline are expected to include long-acting formulations.4 It is anticipated that these formulations will increase the use of and improve adherence to the medications. The entrance of several long-acting GH agents is expected to translate to an increase in global sales from $1.26 billion in 2014 to $1.88 billion in 2024.4

ManufacturerStatusRegimen InformationExpected ApprovalAnticipated Peak Year Sales/PricingSomatropin Biopartners
LG Life SciencesPhase 32 mg per week starting dose via SC injection2017Priced slightly lower than other long-acting GH drugs, at a 15–20% premium above GenotropinNNC0195-0092
Novo NordiskPhase 30.02–0.08 mg/kg per week2018Priced at a premium of 20% above NorditropinVRS-317
Versartis Inc.Phase 31.15 mg/kg per week, or 2.5 mg/kg twice monthly, or 5 mg/kg monthly2018Priced higher than competitors and will command a premium of 25% above GenotropinMOD-4023
OPKO HealthPhase 2/30.02–0.08 mg/kg per week2017Priced at a premium of 20% above GenotropinACP-001
Ascendis PharmaPhase 20.02–0.08 mg/kg per week2020Priced at a premium that has been assumed to be 18% above GenotropinTV-1106
Teva PharmaceuticalsPhase 20.02–0.08 mg/kg per week2019Priced at a premium that has been assumed to be 15% above GenotropinOpen in a separate windowDrug
ManufacturerApproval DateIndicationbRegimen InformationcOmnitrope biosimilar
SandozMay 30, 2006GHD, SGA, PWS, TS, ISS0.16 to 0.24 mg/kg per weekSaizen
Merck SeronoOctober 8, 1996GHD0.18 mg/kg per weekGenotropin
PfizerAugust 24, 1995GHD, SGA, PWS, TS, ISS0.16 to 0.24 mg/kg per weekZomacton
Ferring PharmaceuticalsMay 25, 1995GHD0.3 mg/kg per weekNorditropin
Novo NordiskMay 8, 1995GHD, SGA, TS, NS0.024 to 0.034 mg/kg per dayNutropin AQ
RocheNovember 17, 1993GHD, TS, ISS, GFCKD0.3 mg/kg per weekHumatrope
LillyMarch 8, 1987GHD, SGA, TS, ISS, SHOX-D0.18 to 0.30 mg/kg per weekOpen in a separate window