The growth hormone deficiency market is expected to see expansion across the 7MM driven by the introduction of innovative therapies, including LUM-201 and SCO-240, among others. Furthermore, the rising prevalence of growth hormone deficiency, driven by improved diagnostics, higher survival rates of premature infants, increased pituitary disorders, and environmental factors like endocrine-disrupting chemicals, is expected to drive market growth for growth hormone replacement therapies.
LAS VEGAS, June 10, 2025 /PRNewswire/ -- Growth hormone deficiency (GHD) is a rare condition resulting from inadequate secretion of growth hormone by the anterior pituitary gland. It can originate from birth, develop later in life, or have no known cause, underscoring the intricate mix of genetic, environmental, and diagnostic influences. Idiopathic cases are particularly difficult to address due to the absence of identifiable causes, revealing gaps in current understanding of the condition's underlying biology.
According to DelveInsight, there were approximately 207,000 prevalent GHD cases across the 7MM in 2024, with around 165,000 diagnosed. This number is projected to increase by 2034. The United States accounted for the largest share of diagnosed prevalent cases in 2024, with roughly 70,000 cases-a figure expected to grow over the 2025-2034 forecast period.
Current treatment options for GHD include approved therapies such as SOGROYA, SKYTROFA, and NGENLA. Standard treatment typically involves daily subcutaneous injections, which can be particularly burdensome for children, especially those with a fear of needles.
Learn more about growth hormone deficiency treatment guidelines @ Growth Hormone Deficiency Treatment Market
SOGROYA (somapacitan-beco) is a long-acting human growth hormone (hGH) analog that replicates the function of natural growth hormone. It's approved for children aged 2.5 years and older with growth failure due to insufficient endogenous GH and is also indicated as replacement therapy for adults with GHD. SOGROYA works by binding to a dimeric GH receptor on target cells, activating downstream signaling pathways, and producing effects largely mediated by liver-derived IGF-1. Key regulatory approvals include: FDA approval for adult GHD in August 2020 and for pediatric GHD in April 2023; EMA approval in March 2021; and PMDA approval in Japan for adult GHD in January 2021 and for pediatric growth issues in June 2023.
SKYTROFA/TRANSCON hGH (lonapegsomatropin-tcgd) is a pegylated, long-acting hGH formulated for once-weekly subcutaneous administration. It's approved in both the US and EU for pediatric patients (aged =1 year, =11.5 kg) with growth failure due to inadequate GH levels. It binds to GH receptors, initiating intracellular signaling and delivering both direct (e.g., tissue and metabolic regulation) and indirect (via IGF-1) effects, including chondrocyte development, increased hepatic glucose production, protein synthesis, and fat breakdown. Regulatory milestones include FDA approval in August 2021 for pediatric GHD, EU approval in January 2022 for patients aged 3-18, and an sBLA accepted by the FDA in December 2024 for adult GHD, with a PDUFA decision expected in July 2025.
NGENLA (somatrogon-ghla) is another long-acting hGH analog developed to address inadequate natural GH production. Approved for children aged 3 and above with growth failure, NGENLA distinguishes itself from daily-injection therapies like GENOTROPIN by offering once-weekly dosing through an adjustable delivery device. It binds GH receptors and activates STAT5b signaling, leading to elevated IGF-1 and promoting linear growth and metabolic effects. NGENLA is approved in the US, EU, and Japan for pediatric GHD and is undergoing global Phase III trials for adult GHD. Regulatory highlights include US FDA approval in June 2023, European Commission approval in February 2022, and PMDA approval in January 2022. In July 2024, OPKO Health entered into a USD 250 million non-dilutive note agreement with HealthCare Royalty, backed by profit-sharing proceeds from its 2014 global partnership with Pfizer.
Find out more on FDA-approved growth hormone deficiency treatment @ Growth Hormone Deficiency Drugs Market
Existing treatments for growth hormone deficiency typically involve subcutaneous injections, available in both daily and newer weekly formats. However, the need for daily administration can be particularly difficult for children, often resulting in low adherence.
To address this issue and enhance patient compliance, researchers are developing long-acting and oral alternatives. Companies like Lumos Pharma and SCOHIA PHARMA are advancing their candidates through clinical trials, contributing to innovation in the growth hormone deficiency space and opening up substantial opportunities for market growth.
Discover which therapies are expected to grab major growth hormone deficiency market share @ Growth Hormone Deficiency Therapy
LUM-201 (ibutamoren), an oral small molecule developed by Lumos Pharma, functions as an agonist of the growth hormone secretagogue receptor to stimulate the natural pulsatile release of growth hormone (GH). This targeted approach supports its use in conditions requiring enhanced GH production. Clinical studies have shown that LUM-201 is both safe and consistently effective in promoting GH secretion. Notably, the Phase II OraGrowtH210 and OraGrowtH212 trials in children with pediatric growth hormone deficiency (PGHD) successfully met all primary and secondary endpoints, reinforcing the drug's therapeutic value.
In 2017, LUM-201 was granted orphan drug designation (ODD) in both the US and EU for treating growth hormone deficiency, which provides development incentives. Data presented at the European Society for Paediatric Endocrinology conference in November 2024 demonstrated sustained growth over 24 months, affirming the effectiveness of its pulsatile secretion mechanism. In December 2024, Double Point Ventures acquired Lumos Pharma through a tender offer, paying USD 4.25 per share along with contingent value rights.
SCO-240, from SCOHIA PHARMA, is an oral small molecule that selectively blocks Somatostatin Receptor 5 (SSTR5), a receptor involved in hormonal regulation. While the exact function of SSTR5 in humans remains under investigation, SCO-240 has shown encouraging results in enhancing GH secretion. In a Phase I clinical study, the drug triggered significant GH release without disrupting other pituitary hormones, underscoring the therapeutic potential of SSTR5 antagonism for GH-related conditions.
The compound exhibited a strong safety profile, was well-tolerated, and is suitable for once-daily oral use. In June 2023, findings from the study were presented at the 96th Annual Congress of the Japan Endocrine Society, highlighting its promise in treating GH deficiency, female infertility, and alopecia. In February 2024, SCO-240 was selected for AMED's Orphan Drug Prior to Designation support program, securing funding for its continued development in PGHD.
Discover more about drugs for growth hormone deficiency in development @ Growth Hormone Deficiency Clinical Trials
The anticipated launch of these emerging therapies for growth hormone deficiency are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the growth hormone deficiency market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for growth hormone deficiency is expected to grow from USD 1.4 billion in the 7MM in 2024 at a significant 5.7% CAGR by 2034. This growth across the 7MM is expected to be fueled by the launch of novel therapies such as LUM-201 and SCO-240, among others. Additionally, the increasing prevalence, attributed to advancements in diagnostic capabilities, improved survival rates of premature infants, a rise in pituitary disorders, and environmental influences like endocrine-disrupting chemicals, is projected to boost the demand for growth hormone replacement therapies.
DelveInsight's latest published market report, titled as Growth Hormone Deficiency Market Insight, Epidemiology, and Market Forecast - 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the growth hormone deficiency country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The growth hormone deficiency market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
- Total Prevalent Cases of Growth Hormone Deficiency
- Total Diagnosed Prevalent Cases of Growth Hormone Deficiency
- Total Diagnosed Prevalent Cases of Pediatric Growth Hormone Deficiency
- Total Diagnosed Prevalent Cases of Adult Growth Hormone Deficiency
- Gender-specific Cases of Growth Hormone Deficiency
- Etiology-specific Cases of Growth Hormone Deficiency
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM growth hormone deficiency market. Highlights include:
- 10-year Forecast
- 7MM Analysis
- Epidemiology-based Market Forecasting
- Historical and Forecasted Market Analysis upto 2034
- Emerging Drug Market Uptake
- Peak Sales Analysis
- Key Cross Competition Analysis
- Industry Expert's Opinion
- Access and Reimbursement
Download this growth hormone deficiency market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the growth hormone deficiency market. Also, stay abreast of the mitigating factors to improve your market position in the growth hormone deficiency therapeutic space.
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