PUBLISHER: DelveInsight | PRODUCT CODE: 1865205
PUBLISHER: DelveInsight | PRODUCT CODE: 1865205
DelveInsight's comprehensive report titled "Adult growth hormone deficiency - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of adult growth hormone deficiency. The report presents historical and projected epidemiological data covering total prevalent cases of adult growth hormone deficiency, total diagnosed prevalent cases of adult growth hormone deficiency, gender-specific cases of adult growth hormone deficiency, age-specific cases of adult growth hormone deficiency, etiology-specific cases of adult growth hormone deficiency and treated cases of adult growth hormone deficiency. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.
The report analyzes the existing treatment practices and unmet medical requirements in adult growth hormone deficiency. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.
Adult Growth Hormone Deficiency Overview
Adult growth hormone deficiency is when the pituitary gland does not make enough growth hormone. Growth hormone is one of eight crucial hormones the pituitary gland produces. It regulates metabolism, muscle and bone strength, blood sugars, and overall energy. Adult growth hormone deficiency is a rare but serious disorder that often goes underrecognized and underdiagnosed. While AGHD may begin in childhood or adulthood, diagnosing adult-onset AGHD is particularly challenging due to the absence of growth-related signs seen in childhood cases, the presence of vague or nonspecific symptoms, and the lack of straightforward, reliable biomarker tests.
Growth hormone deficiency typically results from damage to the pituitary gland or the hypothalamus-the brain region that regulates pituitary function. This damage may arise from tumors, surgical or radiation treatments for those tumors, or impaired blood flow to the pituitary. In some instances, the deficiency is caused by direct injury to the pituitary gland.
Adult Growth Hormone Deficiency Diagnosis and Treatment Algorithm
Diagnosis of adult growth hormone deficiency requires a thorough clinical assessment complemented by biochemical confirmation. Because symptoms are often nonspecific, dynamic stimulation tests are considered the gold standard to evaluate the pituitary gland's ability to secrete growth hormone in response to specific stimuli.
Dynamic Function Testing: Diagnosis of adult growth hormone deficiency is supported by symptom assessment alongside dynamic function testing. This involves an initial blood sample followed by administration of insulin-or glucagon if insulin is contraindicated-to stimulate growth hormone release. Subsequent blood samples are collected over the next 2 to 4 hours to measure the expected increase in growth hormone levels in response to induced changes in blood glucose.
Macimorelin test is a newer, more patient-friendly diagnostic option, the macimorelin test is completed within 90 minutes. The test involves oral administration of a macimorelin suspension, with blood samples drawn at 45, 60, and 90 minutes to assess growth hormone secretion. This method is less invasive and better tolerated compared to traditional stimulation tests.
The primary treatment for adult growth hormone deficiency is daily subcutaneous recombinant human growth hormone (rhGH) replacement, with dosing tailored by age, comorbidities, and clinical response. Recently, long-acting growth hormone therapies allowing once-weekly dosing have been FDA-approved for children and adults, potentially reducing treatment burden. Growth hormone replacement offers well-documented benefits, including improved bone density, muscle mass, metabolic and cardiac function, body composition, and quality of life. It is generally safe when managed appropriately, though contraindications include active malignancy and acute illness. Common side effects such as edema and joint pain are usually manageable with dose adjustments. GH therapy can affect adrenal and thyroid function, necessitating monitoring and possible medication adjustments. Growth hormone treatment during pregnancy is not approved, and diagnosis should be avoided during this period due to hormonal fluctuations. Patients report positive impacts on energy, mood, cognition, and body composition but face challenges with daily injections, medication storage, and insurance approval processes, highlighting the need for better patient support.
The epidemiology section of the Adult growth hormone deficiency market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are included in this section of the report.
This section also presents the data with relevant tables and graphs, offering a clear and concise view of the prevalence of adult growth hormone deficiency. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.
Key Findings
As per study by Hoffman et al. (2022), adult growth hormone deficiency is a rare disorder, affecting about 2 to 3 out of every 10,000 people.
According to National Organization for Rare Diseases (NORD), growth hormone deficiency affects males and females equally except for GHD III which affects only males.
As per study by Martel-Duguech et al. (2020), adult growth hormone deficiency affects between 200 and 300 patients/million population, approximately 100 thousand patients across Europe.
The epidemiology of adult growth hormone deficiency is expected to change during the forecast period (2025-2034).
The adult growth hormone deficiency therapeutics market is further expected to increase by the major drivers, such as the rising prevalence population, technological advancements, and upcoming therapies in the forecast period (2025-2034).
With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the adult growth hormone deficiency market in the 7MM is expected to change significantly during the forecast period 2025-2034.
Marketed Adult Growth Hormone Deficiency Drugs
SOGROYA (somapacitan-beco): Novo Nordisk
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.
In September 2020, The US FDA approved Sogroya (somapacitan) for adults with growth hormone deficiency.
In August 2018, it has been granted Orphan Drug Designation by the European Medicine Agency.
Emerging Adult Growth Hormone Deficiency Drugs
The adult growth hormone deficiency market is expected to evolve gradually, driven by the limited number of emerging therapies currently in development. Key players Ascendis Pharma among others are showing active commitment to addressing this unmet need, with ongoing efforts to advance novel treatment options for this complex condition.
TransCon hGH (lonapegsomatropin): Ascendis Pharma
TransCon hGH, is an once-weekly growth hormone, is designed to deliver unmodified somatropin, thereby preserving the same overall endocrine benefits inherent in endogenous and daily hGH. It is administered once-weekly by subcutaneous injection.
In December 2023, Ascendis Pharma announced that the TransCon hGH (lonapegsomatropin) achieved statistically superior outcomes compared to placebo in Phase III foresight trial of adults with growth hormone deficiency. TransCon hGH significantly reduced trunk fat and increased lean body mass at Week 38 versus placebo, meeting primary and key secondary endpoints. It was generally safe and well tolerated, with no treatment-related discontinuations, and showed comparable target tissue effects to daily hGH in exploratory analysis.
Adult Growth Hormone Deficiency Market Segmentation
DelveInsight's 'adult growth hormone deficiency- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future Adult growth hormone deficiency market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.
Adult Growth Hormone Deficiency Market Size by Countries
The Adult growth hormone deficiency market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) adult growth hormone deficiency market, primarily attributed to the country's higher prevalence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.
This section focuses on the sales uptake of potential adult growth hormone deficiency drugs that have recently been launched or are anticipated to be launched in the adult growth hormone deficiency market between 2020 and 2034. It estimates the market penetration of adult growth hormone deficiency drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the Adult growth hormone deficiency market.
The emerging adult growth hormone deficiency therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the Adult growth hormone deficiency market.
Adult Growth Hormone Deficiency Market Access and Reimbursement
DelveInsight's 'adult growth hormone deficiency- Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of Adult growth hormone deficiency.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
KOL Views
To keep up with current adult growth hormone deficiency market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the adult growth hormone deficiency domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or adult growth hormone deficiency market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the adult growth hormone deficiency unmet needs.
Adult Growth Hormone Deficiency: KOL Insights
DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Stanford University School of Medicine, US, Klinikum der Universitat, Germany, University of Barcelona, Barcelona, Spain, ellvitge-Idibell University Hospital, Barcelona, Spain, Cambridge University, UK, and Nara Medical University, Japan, among others.
"Unlike growth hormone deficiency in children, adult GH deficiency is commonly linked to relative insulin resistance and a higher prevalence of impaired glucose tolerance and type 2 diabetes. These metabolic disturbances are most pronounced in obese individuals, but are also observed in hypopituitary adults with a normal BMI, where an inverse relationship between insulin sensitivity and central fat accumulation-a hallmark of metabolic syndrome-is evident."
"Adult growth hormone deficiency is linked to elevated levels of total cholesterol, LDL cholesterol, and apolipoprotein B, with some studies also reporting a slight reduction in HDL cholesterol. These lipid abnormalities occur in both men and women, though they tend to be more pronounced in women."
"The risk-benefit profile of growth hormone replacement therapy in adults is well established after decades of clinical use. Its benefits include enhanced bone density and muscle mass, along with improvements in metabolic and cardiac functions, which together contribute to better body composition, a lower cardiovascular risk, and improved quality of life. When properly managed, GH therapy is generally safe for most patients, including those with cardiovascular conditions, a distant history of childhood cancer, or an increased risk of diabetes."
Competitive Intelligence Analysis
We conduct a Competitive and Market Intelligence analysis of the Adult growth hormone deficiency Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.
Adult Growth Hormone Deficiency Pipeline Development Activities
The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for Adult growth hormone deficiency. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.
Pipeline Development Activities
The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging adult growth hormone deficiency therapies.
The primary goals in treating adult growth hormone deficiency are to safely restore and maintain optimal growth hormone levels, improve body composition by increasing muscle mass and bone density, enhance metabolic and cardiovascular function, and improve overall quality of life. Treatment aims to alleviate symptoms such as fatigue, poor cognition, and reduced physical capacity, while minimizing adverse effects.
Challenges in managing adult growth hormone deficiency include the subtle and variable symptoms that complicate timely diagnosis, diverse underlying causes requiring individualized assessment, limited availability of convenient long-acting therapies, and the need for specialized monitoring and dose adjustment. Additionally, managing comorbid conditions, ensuring patient adherence, and overcoming insurance or reimbursement barriers pose significant obstacles to effective treatment.
Key factors driving the growth of the adult growth hormone deficiency market include the increasing recognition and diagnosis of AGHD, rising pituitary disorders, growing demand for more convenient and effective long-acting growth hormone therapies, recent regulatory approvals of novel formulations, advancements in drug delivery systems that improve patient adherence, and favorable reimbursement policies. Additionally, rising awareness of the benefits of treatment on quality of life and metabolic health is fueling market expansion.
The report will provide comprehensive insights into the current adult growth hormone deficiency market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.