The rapid uptake of long-acting growth hormones (GH) is set to shake up the growth hormone deficiency (GHD ) market in the three major markets (3MM), namely the US, Germany and Japan. These therapies are projected to capture over 90% of the GHD market share by 2030, according to GlobalData’s recent ‘Growth Hormone Deficiency: Opportunity Assessment and Forecast to 2030’ report. The current leading GH therapeutics such as Novo Nordisk ’s Norditropin (somatropin), Pfizer ’s Genotropin (somatropin) and Eli Lilly’s Humatrope (somatropin) are likely to see their revenues plummet as a result.
GHD is a rare endocrine disorder characterised by inadequate secretion of GH from the anterior pituitary gland. In 2020, there were 135,098 people diagnosed with GHD across the 3MM, according to GlobalData.
GH replacement therapy using recombinant human (rh) GH currently represents the first-line and only treatment option for this condition, which can affect both children and adults. In children, GH replacement therapy is administered in order to promote normal linear growth and development while in adults it is used to normalise metabolism and body composition.
Short-acting GHs that require patients to self-inject on a daily basis have remained the standard of care in GHD for decades. Norditropin, the current market leader, first entered the market in the 1980s. However, based on primary research with key opinion leaders, GlobalData anticipates that the use of short-acting GHs will be decreased over the forecast period, as almost all patients will switch to treatment with long-acting GHs, which only require patients to self-inject on a weekly basis.
Novo Nordisk’s Sogroya (somapacitan-beco) recently became the first long-acting GH to gain marketing authorisation in GHD for the treatment of adult patients in the US in 2020 and in the EU and Japan in 2021. Additionally, there are three more long-acting GHs in late-stage development (Phase II development or later), according to GlobalData’s pipeline products database, namely Ascendis Pharma’s TransCon hGH (lonapegsomatropin), Pfizer and OPKO Biologics ’ somatrogon and Hanmi Pharmaceuticals ’ efpegsomatropin.
GlobalData anticipates strong uptake of long-acting GHs, as these therapies have the potential to address key unmet needs for improved patient convenience and compliance. Due to the chronic nature of GHD, patients may have to self-inject for years or even decades. This heavy treatment burden often leads to poor treatment compliance and consequently suboptimal therapeutic outcomes. By dramatically reducing the injection burden for patients, long-acting GHs may improve compliance considerably.
Across the 3MM, the GHD market was valued at $1.08bn in 2020, approximately 71% of which was attributable to US sales. The market is projected to grow at a compound annual growth rate of 3.84% to reach $1.57bn by 2030. The uptake of long-acting GHs represents the main driver of this growth. These drugs are expected to be priced at a premium to the currently marketed products due to their superior dosing regimens. Furthermore, companies launching long-acting GHs have an opportunity to promote better awareness and understanding of GHD among health care providers, patients and the public, which could lead to improved diagnosis and treatment rates.