성인 성장호르몬 결핍증(AGHD) 시장 : 인사이트, 역학, 시장 예측(-2034)

Key Highlights:

• The Adult Growth Hormone Deficiency (AGHD) market is projected to witness steady growth from 2025 to 2034, driven by increased disease awareness, rising prevalence of pituitary disorders, improved diagnostic rates, and advancements in innovative therapies. Continued innovation in drug delivery technologies and expanding clinical research efforts are further supporting the market's positive trajectory.
• SOGROYA (somapacitan-beco), developed by Novo Nordisk, is one of the recently FDA-approved once-weekly growth hormone analog for AGHD, offering a longer-acting alternative to daily somatropin injections. Other FDA-approved daily somatropins therapies include Genotropin, Humatrope, Saizen, Norditropin, and Omnitrope, with biosimilars or generics available for few of them, such as Omnitrope.
• The drug pipeline for adult growth hormone deficiency remains limited, with TransCon hGH (lonapegsomatropin) by Ascendis Pharma standing out as a key emerging therapy. Designed as a long-acting prodrug of somatropin, it offers once-weekly dosing, aiming to reduce treatment burden while maintaining consistent therapeutic effects. This highlights the growing need for therapies that move beyond traditional daily hormone replacement to improve long-term adherence, optimize outcomes, and address the broader clinical challenges of managing adult growth hormone deficiency.
• Market growth in adult growth hormone deficiency (AGHD) is driven by the development of novel long-acting growth hormone therapies that improve dosing convenience and patient adherence. While current treatment mainly involves daily somatropin injections, innovation is spurred by challenges such as treatment burden, inconsistent adherence, and the need for therapies that offer sustained hormone levels and enhanced quality of life.

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.

Adult Growth Hormone Deficiency Epidemiology

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).

Adult Growth Hormone Deficiency Market Outlook

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.

Adult Growth Hormone Deficiency Drug Chapters

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.

Adult Growth Hormone Deficiency Drugs Uptake

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.

Adult Growth Hormone Deficiency Report Insights

• Adult growth hormone deficiency Patient Population
• Therapeutic Approaches
• Adult growth hormone deficiency Pipeline Analysis
• Adult growth hormone deficiency Market Size and Trends
• Adult growth hormone deficiency Market Opportunities
• Impact of Upcoming Therapies

Adult Growth Hormone Deficiency Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Adult growth hormone deficiency Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Adult growth hormone deficiency Market
• Adult growth hormone deficiency Drugs Uptake

Adult Growth Hormone Deficiency Report Assessment

• Adult growth hormone deficiency Current Treatment Practices
• Unmet Needs
• Adult growth hormone deficiency Pipeline Product Profiles
• Adult growth hormone deficiency Market Attractiveness

Key Questions:

• How common is adult growth hormone deficiency?
• What are the key findings of adult growth hormone deficiency epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for adult growth hormone deficiency?
• What are the disease risk, burden, and unmet needs of adult growth hormone deficiency?
• At what CAGR is the adult growth hormone deficiency market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the adult growth hormone deficiency market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of adult growth hormone deficiency in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of adult growth hormone deficiency?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the adult growth hormone deficiency Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for adult growth hormone deficiency?

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.

2. What are the challenges in managing adult growth hormone deficiency?

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.

3. What are the key factors driving the growth of the adult growth hormone deficiency market?

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.

4. How will the adult growth hormone deficiency Market and Epidemiology Forecast Report benefit the clients?

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.

Table of Contents

1. Key Insights

2. Report Introduction

3. Market Overview at a Glance

• 3.1. Market Share (%) Distribution by Therapies in 2024
• 3.2. Market Share (%) Distribution by Therapies in 2034

4. Epidemiology and Market Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types
• 7.3. Causes
• 7.4. Pathophysiology
• 7.5. Symptoms
• 7.6. Risk Factor
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Algorithm
  • 7.7.2. Diagnostic Guidelines
• 7.8. Treatment and Management
  • 7.8.1. Treatment Algorithm
  • 7.8.2. Treatment Guidelines

8. Epidemiology and Patient Population

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: The 7MM
• 8.3. Total Prevalent Cases of Adult Growth Hormone Deficiency in the 7MM
• 8.4. Total Diagnosed Prevalent Cases of Adult Growth Hormone Deficiency in the 7MM
• 8.5. The US
  • 8.5.1. Total Prevalent Cases of Adult Growth Hormone Deficiency
  • 8.5.2. Total Diagnosed Prevalent Cases of Adult Growth Hormone Deficiency
  • 8.5.3. Gender-specific Cases of Adult Growth Hormone Deficiency
  • 8.5.4. Age-specific Cases of Adult Growth Hormone Deficiency
  • 8.5.5. Etiology-specific Cases of Adult Growth Hormone Deficiency
  • 8.5.6. Treated Cases of Adult Growth Hormone Deficiency
• 8.6. EU4 and the UK
  • 8.6.1. Total Prevalent Cases of Adult Growth Hormone Deficiency
  • 8.6.2. Total Diagnosed Prevalent Cases of Adult Growth Hormone Deficiency
  • 8.6.3. Gender-specific Cases of Adult Growth Hormone Deficiency
  • 8.6.4. Age-specific Cases of Adult Growth Hormone Deficiency
  • 8.6.5. Etiology-specific Cases of Adult Growth Hormone Deficiency
  • 8.6.6. Treated Cases of Adult Growth Hormone Deficiency
• 8.7. Japan
  • 8.7.1. Total Prevalent Cases of Adult Growth Hormone Deficiency
  • 8.7.2. Total Diagnosed Prevalent Cases of Adult Growth Hormone Deficiency
  • 8.7.3. Gender-specific Cases of Adult Growth Hormone Deficiency
  • 8.7.4. Age-specific Cases of Adult Growth Hormone Deficiency
  • 8.7.5. Etiology-specific Cases of Adult Growth Hormone Deficiency
  • 8.7.6. Treated Cases of Adult Growth Hormone Deficiency

9. Patient Journey

10. Marketed Therapies

• 10.1. Key Cross Competition
• 10.2. SOGROYA (somapacitan-beco): Novo Nordisk
  • 10.2.1. Drug Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Clinical Trials Information
  • 10.2.5. Safety and Efficacy

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. TransCon hGH (lonapegsomatropin): Ascendis Pharma
  • 11.2.1. Drug Description
  • 11.2.2. Other Development Activities
  • 11.2.3. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analysts' Views

12. Adult Growth Hormone Deficiency: Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
  • 12.2.1. Cost Assumptions and Rebates
  • 12.2.2. Pricing Trends
  • 12.2.3. Analogue Assessment
  • 12.2.4. Launch Year and Therapy Uptake
• 12.3. Market Outlook
• 12.4. Attribute Analysis
• 12.5. Total Market Size of Adult Growth Hormone Deficiency in the 7MM
• 12.6. Market Size of Adult Growth Hormone Deficiency by Therapies in the 7MM
• 12.7. The US Market Size
  • 12.7.1. Total Market Size of Adult Growth Hormone Deficiency
  • 12.7.2. Market Size of Adult Growth Hormone Deficiency by Therapies
• 12.8. EU4 and the UK Market Size
  • 12.8.1. Total Market Size of Adult Growth Hormone Deficiency
  • 12.8.2. Market Size of Adult Growth Hormone Deficiency by Therapies
• 12.9. Japan Market Size
  • 12.9.1. Total Market Size of Adult Growth Hormone Deficiency
  • 12.9.2. Market Size of Adult Growth Hormone Deficiency by Therapies

13. Key Opinion Leaders' Views

14. Unmet Needs

15. SWOT Analysis

16. Adult Growth Hormone Deficiency Market Access and Reimbursement

• 16.1. United States
  • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
• 16.2. EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Abbreviations and Acronyms
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight