Summary

Overview
Global Adrenal Insufficiency Market reached US$ 367.7 million in 2022 and is expected to reach US$ 801.9 million by 2030, growing with a CAGR of 10.5% during the forecast period 2023-2030.
Adrenal insufficiency is of three types namely the primary, secondary, and tertiary. Primary adrenal insufficiency is often anointed as Addison's disease is an uncommon condition that transpires when the body doesn't produce sufficient amounts of specific hormones. In Addison's disorder, the adrenal glands produce very small quantities of cortisol and, frequently, excessively small quantities of another hormone, aldosterone. Distinct kinds of adrenal insufficiency hold diverse reasons. The highly expected reason for adrenal insufficiency overall is abruptly ceasing corticosteroids after taking them for a prolonged period.
Adrenal insufficiency can impact the body’s capability to react to stress and support other fundamental life processes. With treatment, the majority of individuals with adrenal insufficiency can live a normal, active life. Addison’s disease is rare in developed nations, it impacts approximately 100 to 140 per million individuals. However, secondary adrenal insufficiency is highly typical, impacting 150 to 280 individuals per million. Secondary and tertiary adrenal insufficiency are usually grouped jointly, so no statistics for tertiary adrenal insufficiency separately are available.
The increasing research activities and authorizations from distinct regulatory bodies for different treatments are among the primary factors boosting the global adrenal insufficiency market growth during the forecast period. Further, the growing awareness initiatives and support effects from diverse groups are also contributing to the global adrenal insufficiency market growth in the forecast period.
Dynamics
Increasing Research Activities and Product Authorizations
The increasing research activities and product authorizations are expected to boost the global adrenal insufficiency market growth during the forecast period. For instance, in January 2022, the Food and Drug Administration (FDA) awarded Fast Track designation to ATRS-1902 to treat acute adrenal insufficiency in adults and adolescents. The designation is awarded on the basis of favorable outcomes from a Phase I clinical investigation for ATRS-1902 for adrenal crisis.
Moreover, in February 2022, Diurnal reported that the foremost patient has been administered in its phase 2 European clinical investigation of modified-release hydrocortisone. Indicated for the treatment of individuals with adrenal insufficiency (AI), also comprehended as Addison’s disorder, the trial even symbolizes a substantial trade possibility for the corporation across Europe and throughout the UK. The CHAMPAIN phase 2 investigation seeks to assess the effectiveness, safety, and tolerability of modified-release hydrocortisone versus Plenadren in adrenal insufficiency.
Growing Prevalence of Adrenal Insufficiency Cases
The growing prevalence of adrenal insufficiency cases is also expected to contribute to the global market growth in the forecast period. For instance, distinct studies have demonstrated that 2.7%-3.8% of emergency room visits of patients with euvolemic hyponatremia hold an undetected underlying adrenal insufficiency, and it increases up to 15% among those admitted to specialized care units. Moreover, according to NIH, around 144 million people in the developed world suffer from Addison's disease.
Further, according to an article titled "Diagnosis and management of adrenal insufficiency" published in 2023, the preponderance of primary adrenal insufficiency is assessed to be 93–140 per million. In the Western globe, autoimmune adrenalitis makes up over 70% of all patients with primary adrenal insufficiency. Secondary adrenal insufficiency is more typical compared to primary, with a preponderance rate of 150–280 per million. It has indicated that exogenous glucocorticoid usage is the most typical reason for secondary adrenal insufficiency having up to 2.5% of the people dosing them for inflammatory or immune-mediated disorders, making them vulnerable to steroid deficiency if the medicine is ceased abruptly.
Stringent Process and High Cost of Drug Development
The long and stringent procedure for drug development and commercialization with low success probability is expected to hamper the global market growth during the forecast period. For instance, the most evident purpose of clinical investigation is to establish safeness and effectiveness to achieve Food and Drug Administration (FDA) clearance. FDA delivers recommendations to designers regarding what constitutes permitted clinical investments and fair results. Enhancing the drug development approach, particularly by conducting sufficient (meaning delivering more additional data on safeness or effectiveness) and more quick clinical investigations, can encourage innovation in medical product development.
A pharmaceutical corporation pursuing FDA authorization to commercialize a new pharmaceutical drug is required to meet a five-step process: discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring, making it difficult to develop and commercialize the drug product. Further, the large expenditure for new drug development is also expected to hamper the global market growth in the forecast period. For instance, the anticipated cost to develop a new drug including funds expenses and expenses on drugs that fail to achieve market approval has been assessed to vary from less than $1 billion to over $2 billion.
Lack of Awareness
Owing to its low prevalence the lack of awareness about adrenal insufficiency condition is expected to slow the global adrenal insufficiency market growth during the forecast. For instance, according to the NIH, Addison's disease is infrequent. The preponderance is 0.6 per 100,000 of the population annually. The whole number of individuals impacted by this disorder at a given time varies from 4 to 11 per 100,000 of the population.
Further, the difficulty in detection is also pushing the gap in the awareness of adrenal insufficiency disorders as in its earlier phases, adrenal insufficiency is difficult to interpret since symptoms manifest gradually. The health care expert may presume post-examining the medical record and signs. The subsequent measure is blood testing to notice if the cortisol levels are too low and to help find the cause.
Segment Analysis
The global adrenal insufficiency market is segmented based on type, source, treatment, route of administration, distribution channel and region.
Congenital Adrenal Insufficiency Type is Expected to Dominate Market
Congenital Adrenal Hyperplasia (CAH) is a term used to represent a bunch of genetically specified conditions of impaired steroidogenesis that result in varying lack of the end outcomes cortisol and/or aldosterone and their deleterious, including life-threatening, impacts on metabolism and electrolytes with concurrent diversion to the pile of androgens and their virilizing outcomes. The increasing research activities are expected to boost segment growth during the forecast period.
For instance, in February 2023, Biotech corporation HBM Alpha Therapeutics secured a seed round to extend its novel antibody therapies for the treatment of congenital adrenal hyperplasia (CAH) and polycystic ovary syndrome (PCOS), with the top nominee presently in the IND-enabling phase. Further, according to the clinical trials.gov presently five interventional studies with one phase 4, one phase 1, and the remaining three phases 3 are active investigation distinct therapeutic for the treatment of congenital adrenal hyperplasia.
Geographical Penetration
Increasing Number of Ophthalmic Disorders Cases in North America
The growing cases of adrenal insufficiency and increasing market developments in this region are estimated to boost the North America market growth in the forecast period. For instance, according to the rare disease organization, Addison's disorder impacts males and females in equal prevalence. Roughly 1 in 100,000 individuals in the United States suffer from Addison's disorder. The general preponderance is assessed to be between 40 and 60 individuals per million of the general population.
Further, the market developments in this region also contribute to the regional market growth. For instance, in June 2021, Eton Pharmaceuticals, Inc, the U.S. marketer of ALKINDI SPRINKLE, a therapy for adrenocortical insufficiency in pediatric individuals, completed the acquisition of U.S. and Canadian ownership to Crossject’s ZENEO hydrocortisone needleless autoinjector, which is under development as a recovery therapy for adrenal crisis.
COVID-19 Impact Analysis
The pandemic disturbed the global healthcare system with disturbances in diagnosis, treatments, and research activities for rare conditions which negatively impacted the overall rare conditions market growth including adrenal insufficiency. However, as adrenal insufficiency was believed to be among the post-COVID-19 complications leading increase in diagnosis and treatment demands having a positive impact on the market growth.
For instance, according to the NIH, coronavirus disease 2019 (COVID-19) can impact numerous organs and systems, such as the endocrine system. Its manifestations can stay for months, resulting in post-COVID-19 disorders, among others. A small number of cases were reported to have central adrenal insufficiency (CAI) months post-recovery from COVID-19; however, its pathogenesis has not been completely explained.
By Type
• Primary
• Secondary
• Tertiary
By Source
• Congenital
• Acquired
By Treatment
• Glucocorticoid
• Corticotropin
• Others
By Route of Administration
• Oral
• Injectables
• Others
By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Key Developments
• In April 2022, Diurnal Group expanded its distribution arrangement with Er-Kim to possess the distribution and marketing of Alkindi (hydrocortisone granules in capsules for opening) and Efmody (hydrocortisone modified-release hard capsule) in Greece, Cyprus, and Malta.
• In June 2021, Eton Pharmaceuticals completed the acquisition of US and Canadian privileges to Crossject’s Zeneo hydrocortisone needleless autoinjector, which is under development as a recovery therapy for the adrenal crisis.
Competitive Landscape
The major global players in the market include Acrotech Biopharma, Inc., Bausch Health, Canada Inc., AdvaCare Pharma, weefselpharma, Cipla Inc., Pfizer Inc, Wellona Pharma, Eugia US, Sandoz Inc., and Prevego Healthcare & Research Pvt Ltd. among others.
Why Purchase the Report?
• To visualize the global adrenal insufficiency market segmentation based on type, source, treatment, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of adrenal insufficiency market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key product of all the major players.
The global adrenal insufficiency market report would provide approximately 61 tables, 58 figures and 186 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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